The advent of induced pluripotent stem cells, cells that can be coaxed into becoming virtually any type of cell within the body, promised to usher in a new era of regenerative medicine and improved drug discovery. In practice, though, the ability to use these cells to develop desired cell types has proved challenging to do in a predictable way and at scale. Bit.bio, has developed a synthetic biology platform that it says allows it to industrialize this process and produce desired cells in a consistent manner. We spoke to Mark Kotter, founder and CEO of Bit.Bio, about the company’s platform technology, its effort to develop cell therapies, and its growing offering of precision reprogramed human cells for drug development.  

Some 100 trillion gigabytes of data are created and consumed each year, an amount that is expected to double by 2025. The demand for data storage carries the need for significant physical space and power requirements in the form of digital data centers. DNA, though, may represent a solution to what some see as unsustainable growth with environmental consequences. DNA, it turns out, is a dense and durable way to store information. At the end of last year, Paris-based Biomemory launched its DNA Cards, the first DNA data storage ever offered to the general public. The DNA memory cards, about the size of a credit card-sized today may seem more like a curiosity than a viable solution. At $1,000 each, they can store a kilobyte of data, enough to store a single, brief email. We spoke to Erfane Awani, founder and CEO of Biomemory, about the use of DNA for data storage, how it works, and how quickly the technology can scale to where it competes with today’s data storage infrastructure.

People tend to think of each person having their own unique genome. Quotient Therapeutics is taking an approach to drug discovery based on the reality that from cell to cell within a given individual, there can be trillions of divergent genomes. Changes in cells throughout the body can alter how a cell responds to disease and point to new ways to cure, treat, or prevent conditions. We spoke to Jacob Rubens, president of Quotient, about the company’s platform technology, how it uncovers genetic mutations at a cellular level, and its efforts to build a pipeline of therapies around the insights it gains.

Regardless of the cause of a disease, most diseases involve gene dysregulation. Omega Therapeutics is developing a new class of programmable, epigenomic, mRNA medicines designed to make specific epigenetic changes and correct abnormal gene expression to treat or cure diseases. We spoke to Mahesh Karande, president and CEO of Omega Therapeutics, about its pipeline of mRNA therapies, how they work, and its recently announced collaboration with Novo Nordisk to develop an epigenomic controller to treat obesity.

The effects of spinal cord injury extend beyond the loss of mobility. They can include a toll on mental health, a feeling of exclusion, and a general decline in the quality of life as a result of being able to stand and interact eye-to-eye with others. ReWalk Robotics’ Personal Exoskeleton is configured to an individual’s body and enables someone who has suffered a spinal cord injury to stand, walk, and even climb up and down stairs. We spoke to Larry Jasinski, CEO of ReWalk Robotics, about the company’s Personal Exoskeleton, how it works, and the impact it can have on the quality of life for someone with a spinal cord injury.

Mitochondria are often referred to as the “powerhouses” of the cell, but as scientists gain a greater understanding of these essential organelles, they are coming to discover they play a more expansive role in health and disease. The Foundation for the National Institutes of Health named Navdeep Chandel a co-recipient of the 2023 Lurie Prize in Biomedical Sciences for his research that revealed how mitochondria function as signaling organelles that control the body’s normal functions and impact diseases, including cancer and inflammation. We spoke to Chandel, professor of medicine in the Division of Pulmonary and Critical Care and of biochemistry and molecular genetics at the Feinberg School of Medicine, about the state of our understanding of mitochondria, why drug developers are pursuing therapies to target mitochondria across a broad range of diseases, and the need for a concerted effort to conduct fundamental research to better understand the biology of this organelle.

Sandbox AQ, the Alphabet spin-out backed with $500 million in investment, in June 2023 unveiled it AQBioSim division. The division is working to bring SandoxAQ’s AI and quantum-inspired computing to develop new treatments for intractable medical conditions including neurodegenerative diseases and cancer. The company is working with leading drug developers and university medical centers to accelerate drug development, reduce costs, and improve the rate of clinical success. We spoke to Nadia Harhen, general manager of simulation and optimization for SandboxAQ, about the challenges of drug development it is seeking to address, how Sandbox AQ is leveraging quantum technologies, and why it is seeking to tackle an intractable set of diseases. One note: As we were preparing to publish this episode, Sandbox AQ announced it acquired Good Chemistry, a computational chemistry company that leverages AI, quantum, and other advanced technologies to accelerate drug discovery. The deal is expected to enhance SandboxAQ’s existing computational chemistry and simulation capabilities, adding talent, technologies, and industry insights.

It’s long been understood that chromosomal instability (CIN) is a characteristic of cancer cells, but it also represents a key difference between cancer cells and healthy cells that can be exploited. Volastra is developing medicines for a wide range of difficult-to-treat cancers that target the vulnerabilities of these cells. We spoke to Charles Hugh-Jones, CEO of Volastra, about chromosomal instability in cancer cells, how the company is developing a pipeline of therapies to exploit this, and its expanding relationships with Big Pharma companies.

Though the year began with a banking crisis and has been marked with layoffs and restructurings, we have managed to avoid a feared recession. It’s been a big year for new drug approvals, M&A activity has been brisk, and biotech stocks have rallied in recent weeks pushing the widely watched S&P biotech index into positive territory. We continue our annual tradition to look back across the year in biotech and ahead to JPMorgan and beyond with Adam Feuerstein, Polk award-winning journalist and senior biotech writer for STAT. We spoke to Feuerstein about the biotech news that shaped 2023, the year’s best and worst CEOs, and what’s ahead in 2024.

Vik Bajaj has long lived at the intersection of physical sciences, engineering, data science, and the life sciences—first as an academic working to improve diagnostic imaging at Stanford University and later as a chief scientific officer at GRAIL and Verily. Now, as a founder and CEO of Foresite Labs, the technologist turned venture capitalist is using his experience to create new companies that are leveraging AI and other technologies to transform healthcare. We spoke to Bajaj about the changing data landscape around healthcare, the potential for technology to improve health outcomes, and what it takes for an entrepreneur to get his attention today.   

Interleukin-2 therapies have been seen as promising ways to treat solid tumors, but they have proven challenging because of the ability of IL-2 to both activate and suppress the immune system. Their effectiveness has been limited because of potentially toxic side effects, which have included vascular leak syndrome and pulmonary edema. Aulos Biosciences believes the AI-based approach to computational drug design used for its lead experimental therapy allows it to unlock the power of IL-2 without triggering the concerning side effects of existing therapies. We spoke to Aron Knickerbocker, president and CEO of Aulos Biosciences, about the potential for IL-2 therapies to treat solid tumors, the limits of todays IL-2 therapies, and the AI-based design behind its experimental IL-2 therapy in development.

Real-world data promises to provide insights that lead to better therapies, change how we treat diseases, and improve outcomes for patients. One of the limits of realizing benefits from all of the health information we are swimming in is the lack of access to high-quality data in a usable format. Verana Health has built partnerships with medical societies to provide access to exclusive, real-world data from a network of more than 20,000 clinicians. We spoke to Sujay Jadhav, CEO of Verana Health, about the potential for real-world data to improve our understanding of health, how Verana is addressing challenges these data can present, and the areas of medicine on which it is focused.

Artificial intelligence promises to reshape the healthcare landscape and deliver new insights into the molecular drivers of health and wellness, provide rapid diagnoses of patients, and discover and design therapies that extend beyond human imagination. Swaroop ‘Kittu’ Kolluri, founder and managing director of Neotribe Ventures, is using his experience as a Silicon Valley entrepreneur to invest in the emerging TechBio space. We spoke to Kolluri about the state of AI, the potential of technology to transform healthcare, and Neotribe’s approach to investing.

Though many drug developers are harnessing AI to create novel chemical compounds, Iambic Therapeutic’s generative AI is leveraging quantum mechanics to get to better drugs. It says its physics-informed machine learning approach has yielded promising lead candidates with superior profiles in record time. In October, Iambic completed a $100 million series B financing round to support development of its platform and to advance multiple candidates into clinical development. We spoke to Tom Miller, co-founder and CEO of Iambic, about its AI platform,, the insights Iambic gains from using a quantum mechanics-based approach to drug discovery, and its growing pipeline of cancer therapies.

One of the challenges with treating Alzheimer’s disease is diagnosing patients early enough in the course of its progression to have a meaningful impact with treatments. Sunbird Bio said it can accurately detect and differentiate specific proteins that aggregate and signal the presence of Alzheimer's disease, with a simple blood draw. It said its test in development could address the growing need for more sensitive, reliable, non-invasive diagnostic tests to accelerate drug development and enhance patient care. We spoke to John McDonough, executive chair and CEO of Sunbird Bio, about its diagnostic test for Alzheimer’s disease, how it has the potential to impact treatments and outcomes for millions of patients with the condition, and how its merger with Glympse Bio is expected to push it into new markets.

About 40 percent of all drugs in the Western world are derived from plants. But challenges with producing a reliable supply inherent with materials derived from agricultural processes can lead to drug shortages as climate events, pests, and plant diseases can affect yields. Antheia is harnessing synthetic biology to produce active pharmaceutical ingredients as an alternative to reliance on crop production. We spoke to Christina Smolke, co-founder and CEO of Antheia, about the supply-chain challenges underlying drug shortages, how the company is using synthetic biology to create a reliable supply of active pharmaceutical ingredients, and its growing pipeline of products in development.

The COVID 19 pandemic provided a painful reminder of the global need to protect people against the threat of existing and emerging infectious diseases. Emergex Vaccines is developing fully synthetic vaccines that provide advantages over live attenuated and RNA-based vaccines. The company says its vaccines can provide long-lasting T cell immunity, are cost effective, and stable at room temperature. We spoke to Thomas Rademacher, co-founder and CEO of Emergex Vaccines, about the company’s platform technologies, the manufacturing advantages they offer, and the company’s pursuit of universal coronavirus and influenza vaccines that work across variants.

The advent of targeted therapies has contributed to notable progress in the fight against cancer, but the ability of cancers to develop resistance to these precision medicines continues to leave patients in need of new approaches. Concarlo Therapeutics is developing therapies that target a critical driver of cell proliferation that is reactivated once a cancer grows resistant to certain targeted therapies. We spoke to Stacy Blain, co-founder and chief scientific officer of Concarlo, about the development of drug resistance in cancer, the company’s initial focus on breast cancer, and her own journey from academia to biopharma.

There have been significant advances to immunotherapies since their first introduction, but challenges remain to realizing their full potential in solid tumors. That’s because of the ability of tumors to use multiple mechanisms to evade the immune system. Akamis Bio is developing tumor gene therapies that are capable of targeting tumors and driving expression of multiple immunologically active biomolecules and therapeutic proteins to create a robust, antitumor immune responses. We spoke to Howard Davis, CEO of Akamis Bio, about the challenges immunotherapies have faced in addressing solid tumors, the company’s tumor gene therapy platform, and how it turns tumors against themselves to stimulate an immune response.

Mini-proteins have the power and performance of an antibody with the ability to bind tightly to a target. But because of their small size, it can penetrate into places where small molecules can go. Ordaōs Bio is leveraging its generative AI platform to develop a pipeline of mini-protein therapeutics. We spoke to David Longo, co-founder and CEO of Ordaōs, about the company’s focus on mini-proteins, its generative AI platform, and why its building its own pipeline around rare disease indications and partnering with other drug developers on other indications.

The Fas signaling pathway plays a central role in activating cell death. As such, it is implicated in a range of conditions and has been associated with ophthalmic diseases. ONL Therapeutics is developing therapies that target Fas signaling to address a range of retinal conditions. We spoke to Connie Chang, chief operating officer for ONL Therapeutics, about the role Fas-signaling plays in cell death, how this underlies a number of retinal diseases, and the company’s experimental therapy to inhibit Fas signaling.

Antibody discovery is a long, costly, and complex process. LabGenius is reinventing that process by using its platform technology that combines AI with robotic systems capable of designing, conducting, and learning from its own experiments. Its platform not only has the potential to accelerate the drug discovery process but can generate high-performing molecules that likely would not have been found through conventional discovery methods. We spoke to James Field, founder and CEO of LabGenius, about the company’s use of generative AI to discover new therapeutic antibodies, its initial focus on immunotherapies, why he thinks the data the company is generating to train its AI system is a significant point of differentiation.

Opioid overdose, abuse, and addiction affect an estimated 3 million Americans and accounts for $35 billion in U.S. healthcare costs every year. Tris Pharma is developing the opioid Cebranopadol, as an effective pain management therapy without the addictive potential of FDA-approved opioids. We spoke to Ketan Mehta, founder and CEO of Tris Pharma, about Cebranopadol, how it modulates the addictive potential by targeting two receptors at once, and its potential to address the opioid crisis. An editor’s note: since recording this podcast, the National Institute on Drug Abuse, part of the National Institutes of Health, awarded Tris a five-year, $16.6 million grant to advance Cebranopadol.

With the rapid advances in cancer research, it can be difficult for physicians to stay on top of all of the emerging treatments in clinical development. Leal Health has developed an AI-powered platform that provides a personalized list of treatment options to match a patient’s precise diagnosis to advanced therapies in clinical testing. We spoke to Tzvia Bader, co-founder and CEO of Leal Health, about her own experience with cancer, how that led to the creation of Leal Health, and how it is harnessing AI to connect patients to clinical trials based on their exact diagnoses.  

Earlier this year, the venture capital firm SR One closed a $600 million fund, its second since spinning out from the pharmaceutical giant GSK. Despite the difficult investment landscape today for biotechs, it’s a reminder that significant capital is available to be deployed. We spoke to Simeon George, CEO and managing partner for SR One, about the firm’s investment approach, how the current landscape is causing venture capitalists and therapeutics developers to think differently, and what advice he’d offer entrepreneurs seeking to raise money today.  

Cytokines, which play an essential role in immune cell signaling, have long been recognized as having great therapeutic potential, but efforts to harness them have been hampered by their toxicity. Bonum Therapeutics is overcoming this limitation by engineering cytokines with a sensor domain that makes their activity dependent on their environment. While the company is focusing its efforts to develop regulated cytokine to treat cancer, it also has potential as an approach to autoimmune, metabolic, and other conditions. We spoke to Bonum Therapeutics Chief Scientific Officer Diane Hollenbaugh and Bonum Chief Business Officer Neela Patel about the therapeutic potential of cytokines, the challenges of using them as therapeutics, and why Bonum’s context-dependent cytokines may enable wider use of these proteins to treat a range of diseases

The Epstein-Barr virus is among the most common viruses associated diseases including multiple sclerosis and certain cancers. Atara Biotherapeutics is developing off-the-shelf, T-cell immunotherapies designed to target cancers and autoimmune conditions driven by the Epstein-Barr virus. It is also using its EBV T-cell platform to develop next-generation allogenic CAR T therapies to target a range of non-EBV associated diseases. We spoke to Pascal Touchon, president and CEO of Atara, about the role of the Epstein-Barr virus in certain cancers and autoimmune conditions, the company’s platform technology for allogenic CAR T therapies, and why it has implications beyond EBV-driven diseases.

Myeloid cells can stimulate anti-tumor effects in the body and recruit additional immune system cells to turn a cold tumor hot. Bolt Biotherapeutics is developing a new category of immunotherapies that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. By activating and recruiting myeloid cells, the company’s experimental therapies are designed to re-program the tumor microenvironment and invoke an anti-tumor immune response. We spoke to Randy Schatzman, CEO of Bolt Biotherapeutics, about the company’s immune-stimulating antibody conjugates, the case for activating both the innate and adaptive immune systems to fight cancer, and the company’s lead experimental therapy for HER2 positive cancers.

The development of mRNA-based vaccines has represented a major advance in the field of vaccine development. Rather than using weakened or inactivated viruses to stimulate an immune response to generate protective antibodies, mRNA-based vaccines provide a potentially safer and more effective approach. mRNA vaccines work by introducing a small piece of mRNA into the body, which encodes instructions to produce a specific viral protein for the cell to manufacture. This protein then triggers an immune response, leading to the production of antibodies that can protect against specific diseases. Combined Therapeutics has designed a modified mRNA-based vaccine platform that allows for the inhibition of protein expression in specific tissues, enabling targeted vaccine treatment and preventing off-target side effects. It’s designed to be adaptable and efficient, which makes possible rapid production of vaccines for a wide range of diseases and disease variants. We spoke to Thomas VanCott, chief scientific officer of Combined Therapeutics, about the company’s mRNA platform for vaccines, the advantages it provides, and its potential to use the same approach to train the immune system on specific mutations in a tumor.

Infectious diseases and microbial resistance represent major concerns in developing nations. The combination of globalization with the expanded use of antibiotics in resource-constrained environments is worsening the problem. In fact, hospital acquired infection rates in some regions are three times greater than in the United States and as much as 30 percent of all such infections are antimicrobial resistant. HDT Bio is developing immune activators and RNA-based vaccines to address this challenge with cost-effective and accessible medicines. We spoke to Chris Pirie, co-founder and chief operating officer of HDT Bio, about the problem the company is seeking to address, its platform technology for producing safe and stable RNA vaccines, and the potential to use the same platform to produce immunotherapies for cancer.

Bacteriophage are viruses that target bacteria. Though they emerged in the 1920s as treatments for infectious diseases, because of their high level of specificity, they fell out of favor with the advent of broad-spectrum antibiotics. BiomX is developing both natural and engineered phage cocktails designed to target and destroy harmful bacteria in chronic diseases, such as cystic fibrosis, inflammatory bowel disease, and atopic dermatitis. We spoke to Jonathan Solomon, CEO of BiomX, about the case for phage therapies, the company’s approach to creating a phage cocktail that could effectively target a population of patients, and why it's focusing on chronic diseases.

CytoMed, a spin out of A*STAR—Singapore’s Agency for Science, Technology, and Research—is developing novel cell-based immunotherapies that can go beyond the limitations of existing CAR T therapies. The company is focused on the development of off-the-shelf therapies derived from the delta gamma T cells from healthy donors. We spoke to Wee Kiat Tan, chief operating officer of CytoMed, about the company’s platform technology for off-the-shelf CAR T therapies, the advantages they provide over existing autologous CAR T therapies, and why he believes they will be successful at treating solid tumors.

For academic scientists who make groundbreaking discoveries that can lead to new medicines, bridging the so-called valley of death—the gulf between the lab and having a validated candidate that is ready to begin human clinical trials—continues to be daunting. Foundery Innovations, which bills itself as a venture studio, sees a big opportunity in partnering with academic researchers to carry promising new immunotherapies through to the clinic. Its team has deep experience in immunotherapy development and brings a wide range of skills and cutting-edge platform technologies to de-risk development and accelerate the time to the clinic. We spoke to Max Krummel, founder and managing member of Foundery Innovations, about the venture studio’s business model, the resources it brings to bear, and how it works with academic researchers and universities.

Vericel, which acquired Sanofi’s cell therapy and regenerative medicine unit, markets advanced cell therapy products for sports medicine and severe burn care. The company’s MACI is an autologous cellularized scaffold used in the repair of cartilage defects of the knee. Epicel, its cultured epidermal autografts, are a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30 percent of total body surface area. We spoke to Nick Colangelo, president and CEO of Vericel, about the markets the company is targeting, how its products are changing outcomes for patients, and the company’s plans for growth.

Understanding the physical relationship of cells and how they interact can provide new understanding of diseases and help improve drug development and clinical treatment decisions. Nucleai uses its AI-powered spatial biology platform to transform pathology data into insights. The digital assays it develops enhances drug development, supports treatment decisions, and helps stratify patients to improve care. We spoke to Ken Bloom, head of pathology for Nucleai, about the company’s AI spatial biology platform, how it works, and the potential it has to advance precision medicine.

Vaccitech first gained attention as co-inventor of the Covid-19 vaccine licensed to AstraZeneca. The University of Oxford spin-out is developing a pipeline of T cell immunotherapies to treat and cure chronic infectious diseases, autoimmune diseases, and cancers. The company’s lead experimental therapy is a potentially curative monotherapy for chronic hepatitis B viral infection. We spoke to Bill Enright, CEO of Vaccitech, about the company’s platform technologies, how they work, and how they enable the development of more effective immunotherapies.

One reason that CAR T therapies haven’t been more effective at treating solid tumors is their reliance on targeting antigens on the surface of cells, which can often be present on healthy cells as well. Affini-T Therapeutics is addressing this weakness in current cell therapies by using its platform technology to develop T cell receptor engineered T cells. Its so-called TCR-T cells are able to recognize intracellular targets and attack the drivers of mutations that are inaccessible to CAR-T therapies. We spoke to Jak Knowles, CEO of Affini-T Therapeutics, about the company’s TCR-T cell therapies, how they are engineered, and why they have the potential to be effective at treating solid tumors that have evaded the power of CAR T therapies.

More than 138,000 people in the United States and 1.4 million people worldwide are struggling with malignant brain tumors. The average five-year survival rate of people with the most common malignant brain tumor—glioblastoma multiforme—is less than 5 percent and there have been no notable improvements in the last three decades. The Ivy Brain Tumor Center is using phase 0 clinical trials to provide individualized treatment to patients with brain tumors. The U.S. Food and Drug Administration introduced phase 0 trials in 2004 to address concerns about the slow pace and high cost of drug development. The phase 0 trial is used to quickly identify how a drug works in a patient and whether it should be fast-tracked for further development. We spoke to Nader Sanai, director of the Ivy Brain Tumor Center and chief of neurosurgical oncology at the Barrow Neurological Institute, about phase 0 clinical trials, how they work, and how they are allowing the center to take a precision medicine approach to treating patients with brain tumors.

Traumatic injuries and surgical procedures can damage peripheral nerves and cause the loss of muscle or organ function, pain, and the loss of sensation. Axogen has a portfolio of regenerative medicine products to enable surgeons to repair peripheral nerves without the need to harvest nerves from a patient’s own body. We spoke to Karen Zaderej, CEO of Axogen, about peripheral nerve injuries, the company’s portfolio of products, and how it is changing the way surgeons can repair and regenerate damaged nerves.

About 20 years ago, the number of people dying from chronic diseases surpassed the number of people dying from infectious ones. Though vaccines have contributed to this shift, they’ve generally not been harnessed to address chronic conditions. Vaxxinity is seeking to change that by using vaccine technology to address the growing burden of chronic diseases. It’s advancing a new class of synthetic, peptide-based vaccines designed to activate the body’s immune system to produce antibodies to neurodegenerative, cardiovascular and other chronic diseases. The company’s pipeline includes experimental therapies for Alzheimer’s disease, Parkinson’s disease, and hypercholesterolemia. We spoke to Mei Mei Hu, CEO of Vaxxinity, about the case for using vaccines to address chronic diseases, the benefits this approach provides, and how its platform technology activates the immune system to battle non-communicable diseases.      

Developing therapies that work by degrading disease-causing proteins has shown promise, but first-generation approaches have been limited to targeting intracellular proteins and can’t reach membrane and extracellular proteins that represent about 40 percent of the proteome. EpiBiologics is working to expand protein degradation therapies to include membrane and extracellular targets with the goal of eliminating disease-causing proteins that were previously not addressable by traditional therapeutic approaches. We spoke to Rami Hannoush co-founder and interim CEO and president of EpiBiologics, about the company’s platform technology, how its protein degradation approach expands the potential targets for its therapies; and how its built an atlas of tissue-specific degrader antibodies to target proteins involved in cancer, immunologic-, and neurologic-related conditions.

While many people think of biotechnology in terms of its impact on medicine, it’s expected to transform the economy as its power reaches across industries. As biology increasingly becomes an engineering discipline, it is not only reshaping the way we produce food, but a wide range of industrial products as well. Bio-based processes are replacing petroleum-based ones and giving life to new biomaterials, bioplastics, and biofuels. As the SynBioBeta Global Synthetic Biology Conference returns to Oakland, California May 23 to May 25, we spoke to SynBioBeta Founder and CEO John Cumbers, about the state of the emerging bioeconomy, how biotechnology is being embraced across industries, and the unexpected places biotechnology is already showing up.

One reason that cancers can be difficult to treat is that the tumor microenvironment can hamper the ability of drugs to penetrate the tumor and facilitate the development of resistance to medicines. AUM Biosciences is developing targeted therapies that address genetic drivers of a cancer and can disable defenses that hide tumors from the immune system. The company’s lead experimental therapy is being tested in combination with immunotherapies to treat colorectal cancer and other solid tumors. We spoke to Vishal Doshi, chairman and CEO of AUM, about the development of resistance in cancers, the case of combining precision therapies with immunotherapies, and why he believes we can transform cancer from a deadly condition to a chronic disease.

While there has been great interest in harvesting and targeting the microbiome to treat disease, Federation Bio believes for durable benefits its necessary to provide a rich ecosystem of microbes in a single therapy. The company has developed a platform for producing synthetic microbial cell therapies to treat a range of diseases from metabolic disorders to metastatic cancers. Unlike earlier approaches, the company said it is generating potent, reproducible, and complete microbial consortia that stably engraft to provide predictable and durable responses. We spoke to Emily Drabant Conley, CEO of Federation Bio, about its platform technology, how it determines what to include or exclude in a given therapy, and what makes a disease a good candidate for its living therapeutics approach.

One of the challenges of treating traumatic injuries and degenerative conditions is that while there are therapeutic proteins that can promote repair, they can be difficult to deliver to the site of damage and get them to stay there long enough to provide benefit. Therapdaptive has developed platform technology that enables it to produce variants of recombinant proteins that can bind to the surface of implants, devices, and injectable carriers to allow for precision delivery anywhere in the body. We spoke to Luis Alvarez, CEO of Theradaptive, about the company’s platform technology to produce recombinant proteins that bind to materials, the broad applications for the technology, and how the roots of the company go back to a need he saw during his service in the Iraq war.

In 2022, investment in biopharmaceutical companies, pipeline activity, and the launch of novel medicines all dropped from the previous year. A new report from IQVIA’s Institute for Human Data Sciences argues the downturn, after two record-setting years, is a post pandemic return to longer-term trends. We spoke to Murray Aitken, executive director of the IQVIA Institute for Human Data Science, about what happened to the biopharmaceutical sector in 2022, how to make sense of the data, and the shifting landscape in therapeutic and geographic investments.

The aging process is associated with the development of diseases. BioAge Labs is seeking to expand healthy lifespans by developing therapies for aging-related diseases that target key pathways involved in the aging process. The company has built a platform that combines systems biology and AI to leverage extensive data sets to uncover molecular drivers of aging-related diseases. We spoke to Kristen Fortney, CEO of BioAge, about the company's approach to identifying targets for aging-related diseases, its therapeutic pipeline, and whether it's pursuing any novel targets yet.

Cell therapies are revolutionizing the way cancers are treated, but existing cell therapies have their limits. They have been more successful at treating hematologic tumors than solid tumors, and they can sometimes cause serious side effects, such as the destruction of antibodies or what’s known a cytokine storms in which the immune system gets over-revved and attacks healthy cells. Triumvira Immunologics is developing autologous and allogenic T cell therapies that it believes can address the limitations of existing cell therapies and be used to treat both liquid and solid tumors. We spoke to Paul Lammers, CEO of Triumvira, about the company’s platform technology, why it’s robust and versatile, and why its lead indication is for a cancer where effective treatments already exist.

A complex of proteins that play an essential role in regulating the innate immune system known as the NLRP3 inflammasome is becoming a growing target of interest among drug developers to disrupt immune cell signaling. Halia Therapeutics is developing a pipeline of therapies that target the NLRP3 inflammasome to address not only inflammatory disorders like psoriasis and colitis, but neurologic conditions such as Alzheimer’s disease. We spoke to David Bearss, president and CEO of Halia, about the NLRP3 inflammasome, the role it plays in Alzheimer’s and other neurologic conditions, and the case for this therapeutic approach.

Though the transplantation of insulin-producing islet cells has been used to treat people with type 1 diabetes, such procedures require the use of immunosuppressive drugs to prevent the immune system from rejecting the cells. iTolerance is developing platform technology that can be used with tissue, organoid, and cell therapies without the need for life-long immunosuppression. We spoke to Anthony Japour, president and CEO of iTolerance, about the company’s platform technology that eliminates the need for immunosuppressive drugs with tissue and cell transplantation, the company’s lead experimental cell therapy for type 1 diabetes, and the broad range of regenerative therapies that could benefit from the technology.

Dyadic is working to bridge the gap between high-yield, low-cost, and large-scale industrial biotechnology, and low-yield, high-cost, small-scale biopharmaceuticals. It’s C1 technology, which is a fungal expression system, can efficiently produce enzymes and other proteins. Earlier this year, the company achieved a milestone when it began dosing patients in a phase 1 clinical trial in South Africa of its COVID-19 booster vaccine. The company expects the first-in-human trial to accelerate the adoption of the C-1 production platform for vaccine and therapeutic candidates. We spoke to Mark Emalfarb, president and CEO of Dyadic, about the company’s fungal-based manufacturing platform, how it can product large volumes of enzymes and other proteins in a fast and cost-effective manner, and the potential this has to change the way biologics are manufactured.    

Sam Gambhir understood the ravages of cancer. His wife developed breast cancer and survived. His son later developed brain cancer at the age 15 and died. And in 2020, Gambhir himself succumbed to cancer. Before he died, though, Gambhir, who served as division chief of the Canary Center for Early Cancer Detection and Molecular Imaging at Stanford University, hit upon an idea. Rather than hunt for cancers in the hopes of making an early diagnosis, he devised a way for them to produce synthetic biomarkers to cause them to reveal themselves. He co-founded Earli, which seeks to enable the diagnosis cancers when they are most treatable. We spoke to David Suhy, co-founder and chief scientific officer of Earli, about the company’s synthetic biomarker technology that makes cancers visible with a PET scan, how it works, and how this has the potential to alter outcomes for patients by enabling treatments of patients before their disease progresses.

Finding diverse groups of qualified participants for clinical studies can slow the development of needed medicines. The difficulty in attracting racial and ethnic minorities, women, and the elderly also creates concerns that trial results will fail to reflect what would happen in the real world. Some 80 percent of clinical trials fail to meet enrollment deadlines and an average of 30 percent of participants drop out in part because of the location and duration of these studies. CVS Health in 2021 launched CVS Clinical Trial Services, which capitalizes on CVS’ rich database of patients and its large footprint that puts a CVS location within 10 miles of 85 percent of the U.S. population. We spoke to Owen Garrick, chief medical officer of Clinical Trial Services at CVS Health, about the company’s push into clinical trials, the need to expand the diversity of participants in these studies, and how CVS is leveraging its resources to increase access to and participation in clinical trials.

The microbial world has been a rich source of medicines, but our ability to explore the full potential of the microbes both in us and around us has been limited by technology and the difficulty of culturing most microbes in a lab. Biosortia Microbiomics has developed a platform for finding, amplifying, and screening microbes as a potential source of novel, small molecule drugs. We spoke to Ross Youngs, CEO and founder of Biosortia, about the case for exploring various microbiomes to discover new small molecule drugs, how the company’s platform technology enables it to investigate a much broader range of microbes, and its business model for capitalizing on the discoveries it makes.

One of the underlying limitations of most cancer therapies is the fact that only about 1 to 2 percent of the drug that’s administered ever reaches tumors. That limits the dose because of the potential for unwanted side effects, and limits the efficacy by delivering less than ideal amounts of drug to tumors. Shasqi is developing cancer therapies that use click chemistry to activate agents at the site of tumors to reduce systemic toxicity and increase the anti-tumor activity of its medicines. We spoke to José Mejía Oneto, founder and CEO of Shasqi, about the company platform technology, how it works, and why this can lead to safer and more powerful cancer therapies.

The gut is the body’s largest sensory organ with a surface area 100 times that of the skin. It contains more nerve cells than the spinal cord, most of the immune system, and 95 percent of the body’s serotonin. Kallyope has assembled a discovery and translation platform to developed therapies to treat metabolic, gastrointestinal, and neurologic conditions by targeting the gut-brain connection. We spoke to Nancy Thornberry, chair of R&D for Kallyope, about the gut-brain connection, the company’s platform technology, and the case for targeting these interactions to treat a wide range of conditions.

Providers hold vast amounts of health data that can be harnessed to gain better insights into diseases, improve outcomes for patients, and help bring about an era of precision medicine. Despite advances in artificial intelligence to capitalize on these stores of data, much of it has remained siloed and out of the reach of researchers and drug developers who could put it to use. Last year, a group of 14 health providers caring for tens of millions of patients through thousands of care facilities across the country formed Truveta, a company that has built an AI platform to make structured and de-identified patient data available for research. We spoke to Terry Myerson, CEO of Truveta, about its platform technology, the work it is enabling today, and how AI and the availability of real-world data is changing how biomedical research is conducted.

There’s been growing interest in exploring the potential of psychedelics to treat neuropsychiatric conditions. Onsero Therapeutics is part of a growing list of companies that are developing therapies that target the 5-HT2A serotonin receptor, the receptor to which several of psychedelics bind, and one that has been clinically validated in a number of psychiatric conditions. The company believes the therapies it’s developing have the potential to provide the treatment benefits of these substances without their better-known effects. We spoke to Tim Piser, chief scientific officer of Onsero, about the case for these drugs to treat conditions like mood disorder, how it’s developing its experimental therapies so they don’t induce effects, and why he believes benefits of these drugs can exist independently of them packing a psychedelic punch.

When people think of the potential for artificial intelligence to impact the biopharmaceutical industry, the focus is usually on drug discovery or in the clinic to help guide decision making with regards to pairing the right drug to the right patient. Yseop is focused on a more mundane use for the technology—the writing of clinical data reports. The company had been working in the financial services industry when it was approached by Sanofi to see if it could apply its natural language generation to make the creation of these reports faster and less expensive. We spoke to Emmanuel Walckenaer, CEO of Yseop, about artificial intelligence, its potential to change the way biopharmaceutical companies work in non-obvious ways, and why a large number of biopharmaceutical companies are turning AI to do more with less.

ProFound Therapeutics has developed platform technology to catalogue and understand previously undetected human proteins and the role they play in health and disease. By focusing on proteins in the process of translation, the company said it has identified tens of thousands of undiscovered proteins that can provide untapped therapeutic targets. We spoke to Avak Kahvejian, co-founder and CEO of ProFound Therapeutics, about the company’s platform technology, the vastness of the unexplored proteome it seeks to discover, and how this can lead to the development of breakthrough medicines.

It was a difficult year for biotechs with drops in the major biotech indices, fewer new drug approvals, and more than 125 companies announcing layoffs. But there were also triumphs to celebrate. We continue our annual tradition of ending the old year and ushering in the new one with Adam Feuerstein, Polk Award Winning journalist and senior biotech writer for STAT. We discuss the good, the bad, and the ugly of biotech in 2022; Feuerstein’s annual best and worst CEO list; and what’s ahead at JPMorgan and beyond in 2023.

Checkpoint inhibitors are not new, but Immutep is developing therapies that target LAG-3, a checkpoint discovered by its chief scientific officer. The LAG-3 gene codes for a protein that plays a role in the regulation of the immune system and is expressed on T cells. Immutep is seeking to target LAG-3 to both stimulate the immune system to treat cancers and suppress the immune system to treat autoimmune disease. We spoke to Marc Voigt, CEO of Immutep, about the LAG-3 checkpoint, the company’s lead experimental candidate, and its partnerships with GSK and Novartis to develop therapies for cancer and autoimmune diseases.

The ability to engineer biology is not only revolutionizing how we treat illness, but the way grow food, and produce goods as well. With this ability, though, comes an awareness of how the same technology can be used for nefarious purposes. We spoke to Matt McKnight, general manager of Biosecurity of Ginkgo Bioworks, about our increasing ability to engineer biology, the potential risks that come with that, and the steps we are taking to safeguard ourselves against those risks.

Cytokines control nearly all aspects of the immune system. As drugs, though, they have limited potential because of inherent drawbacks. Simcha Therapeutics is engineering versions of cytokines to activate various immune cells in the fight against cancer. Simcha’s most advanced program, ST-067, is the first in a new class of interleukin-18 based immunotherapies designed to overcome a key defense mechanism that the tumor microenvironment produces to prevent Interleukin-18 from doing its work. We spoke to Sanuj Ravindran, CEO of Simcha Therapeutics, about the company’s engineered cytokines, how they work, and why they may represent a powerful addition to the immunotherapy arsenal.

Arcellx is developing controllable cell therapies for the treatment of cancer and autoimmune diseases. It’s platform technology allows it to mark diseased cells within the body for destruction. Its cell therapies then destroy the flagged cells. We spoke to Rami Elghandour, chairman and CEO of Arcellx, about the company’s platform technology, how it works, and how it may lead to safer and more effective cell therapies.

Despite the large human and societal costs of neuropsychiatric disorders, many of these conditions have poor or no treatment options. And there has been a dearth of new mechanisms to treat major neuropsychiatric disorders for decades. PsychoGenics is seeking to change that with its unique approach to drug discovery for these conditions. Rather than rely on a target-based approach, the company has created high-throughput phenotypic screens using validated mouse models and artificial intelligence to detect behavioral changes. We spoke to Mark Varney, chief scientific officer of PsychoGenics, about the company’s use of phenotypic screens to discover new drugs for neuropsychiatric disorders, how it works, and the case for this approach.

Chronic, cancer-related pain affects between 30 and 50 percent of patients undergoing cancer treatment and more than 70 percent of patients with advanced disease. Linda Carlson, Enbridge research chair in psychosocial oncology at the University of Calgary Cumming School of Medicine, is working with digital therapeutics developer Rocket VR Health to study the potential of a virtual reality-guided mindfulness intervention program in adult cancer patients with chronic, cancer-related pain. The thinking is that mindfulness could mitigate chronic cancer-related pain by regulating both physical and emotional resistance to it and that virtual reality could create an immersive environment that could focus patients’ attention on present moment experiences making it easier for them to achieve mindfulness achieve more effective results. We spoke to Carlson about the problem of chronic pain in cancer, the case for mindfulness, and why the use of virtual reality might provide better outcomes for patients.

One reason immunotherapies can fail in cancer is that the tumor microenvironment can suppress activation of the immune system. Surface Oncology is using multiple platform technologies to discover new antibody therapies that activate both the innate and adaptive immune systems to improve how people with cancer respond to these medicines. We spoke to Rob Ross, CEO of Surface Oncology, about the tumor microenvironment, the approach Surface is taking to activate both the adaptive and innate immune system, and its lead therapeutic candidates in development.

The deepening understanding of the biology of aging is giving rise to a growing list of companies that seek not only to address diseases of aging, but find ways to extend the healthy years of life. LongeVC is a venture capital firm focused on seed and early-stage investment in longevity statups. It’s also built a community of like-minded companies to support startups, as well as an acceleration program for them. We spoke to Sergey Jakimov, founding partner of LongeVC, about the firm’s approach to investing, what constitutes a longevity play for it, and the network of companies it has assembled to help advance the startups it backs.

A subset of patients treated with checkpoint inhibitors respond particularly well to these immunotherapies. These so-called “elite responders” produce antibodies that modulate immune cells in the tumor microenvironment. OncoResponse is working to discover the antibodies these elite responders produce to develop a pipeline of cancer therapies. We spoke to Bob Lechleider, chief medical officer of OncoRepsonse, about the tumor microenvironment, how his company is studying elite responders to immunotherapies to discover new antibodies to modulate the immune system, and his company’s lead program in clinical development.

Obesity rates in the United States have doubled in the past 20 years and without changes, nearly half of the adult population will be obese by 2030. Though there are many approaches to weight loss—diet and exercise, drugs, surgery—their safety and efficacy varies widely from patient to patient. Phenomix Sciences is using phenotyping to understand the type of obesity each individual has to tailor treatments that address it specifically. Based on work at the Mayo Clinic, Phenomix breaks obesity into four different subtypes. We spoke to Mark Bagnall, CEO of Phenomix, about the company’s efforts to bring precision medicine to the treatment of obesity, the testing it performs, and the science underlying its approach.

RNA therapies and vaccines have already shown their power. Nutcracker Therapeutics is taking a nod from the high-tech sector to harness semiconductor-like biochips and microfluidic engineering to create a fully automated platform to increase the speed and scale at which RNA therapies can be discovered, developed, and manufactured. It is developing multimodal RNA therapies which serves as an RNA cocktail to attack multiple disease mechanisms at once. We spoke to Geoff Nosrati, chief business officer of Nutcracker, about the company’s platform technology, its lead program targeting HPV-driven tumors, and its focus on multimodal RNA therapies.

Immune checkpoint inhibitors are transforming cancer care, but still have low response rates in most solid tumors. When cancer spreads to the liver, it can render immunotherapies ineffective because of the large number of immune-suppressive macrophages that are present there. Teclison has developed platform technology that chokes off tumors and activates the immune system against the cancer. The company said its technology can significantly enhances the therapeutic benefit of immunotherapies and can be leveraged to treat nearly all solid tumors. We spoke to Ray Lee, founder and chief medical officer of Teclison, about the company’s platform technology, it’s lead therapeutic candidate, and how it can trigger a systemic immune response.

Inspirna is putting RNA biology to work to address difficult to treat cancers that affect large numbers of people, such as colorectal cancer, small cell lung cancer, and non-small cell lung cancer. Its platform technology is being used to discover the underlying drivers of cancer that can be drugged by both small molecules and biologics to address RNA dysregulation. We spoke to Masoud Tavazoie, co-founder and CEO of Inspirna, about the role RNA dysregulation plays in certain cancers, Inspirna’s platform technology, and its clinical pipeline in development.

Kinase inhibitors have become staples in the arsenal to battle cancer. These medicines can disrupt the cell signaling that drives the growth and spread of tumors. There are more than 30 approved kinase inhibitors today, but they often have dose limiting toxicities, in part because they often lack specificity and can have activity against multiple kinases at once. Blueprint Medicines is seeking to develop next-generation kinase inhibitors that are highly selective to treat genomically-defined cancers and rare diseases. We spoke to Fouad Namouni, president of research and development for Blueprint, about the company’s discovery platform, the large unexplored territory of kinases, and what makes Blueprint’s kinase medicines next-generation.

Cell and gene therapies offer great promise for treating, preventing, or curing serious health issues like cancer, genetic disorders, immunodeficiencies, and rare diseases. Nevertheless, the complexity and costs of producing and delivering these personalized medicines creates barriers to patients benefiting from their potential. Orgenesis is seeking to change the business model around cell and gene therapies through its Point-of-Care Platform, which it says can lower the cost, accelerate development, and expand access for patients. We spoke to Vered Caplan, CEO of Orgenesis, about the challenges of cell and gene therapy, how the company’s Point-of-Care Platform technology addresses those, and its network approach to building a pipeline of therapies across a wide range of indications.

Radiopharmaceuticals have long been shown to be effective at killing cancers, but often damage healthy cells because they are so toxic. Convergent Therapeutics has developed platform technology that takes advantage of the power of radiopharmaceuticals, but links them to targeting mechanisms, such as monoclonal antibodies and ligands, to deliver them in a precise and highly targeted ways. Its lead experimental therapy is an actinium-linked monoclonal antibody that targets prostate-specific membrane antigen to treat prostate cancer. The ability to use dual targeting mechanisms offers the potential for powerful combinations of radiopharmaceuticals while limiting their toxicities. We spoke to Philip Kantoff, co-founder and CEO of Convergent, about the company’s platform technology for developing next-generation radiopharmaceuticals, how the company targets tumor surface molecules, and how its approach minimizes the toxicity of these therapies.

Whether it’s capturing the imagination of a venture capitalist, enticing a potential partner, or attracting talent, CEOs need to be able to tell their company’s story effectively. In his new book “Winners Have a Story,” Giuseppe Marzio discusses how CEOs can turn complex science and technology into compelling tales. Marzio, who worked as a scientist in biopharma before launching a communications agency, comes to his interest in storytelling honestly. Growing up with a love for the cinema, he had dreams of becoming a filmmaker and has studied the structure of stories. We spoke to Marzio, founder of the communications agency Chiaro, about his new book “Winners Have a Story,” why a good pitch shares a common structure with novels and movies, and why a company’s strategy and story are inextricably linked.

It’s been understood for more than 60 years that cancer cells overproduce sugars on their surface. More recently it’s been discovered that these sugars can help cancer cells evade the immune system. Palleon Pharmaceuticals is developing immunotherapies that work by targeting these cell surface sugars and make them vulnerable to attack. We spoke to David Feltquate, chief medical officer of Palleon, about the potential to harness glycobiology to treat cancer, how the company is working to modulate cell-surface sugars, and its emerging pipeline of glyco-immuno therapies.

Current treatment of acute myeloid leukemia generally consists of chemotherapy followed by a hematopoietic stem cell transplant to eliminate any remaining cancer cells from the bone marrow. Even though outcomes remain poor with around 40 percent of transplanted patients experiencing cancer relapse, and patients who do relapse having two-year survival rates of less than 20 percent, the approach has changed little in 40 years. One reason is that newly transplanted patients are unable to receive targeted cancer therapies since those therapies would be toxic to the fragile transplanted stem cells. Vor Bio’s solution is to edit the stem cells prior to transplanting them so they lack the receptors targeted therapies attack. We spoke to Robert Ang, president and CEO of Vor Bio, about the company’s platform technology, how it works, and why it has the potential to change outcomes for patients with AML and other hematologic malignancies.

In cancer, the rigorous translational machinery of the human body goes haywire, causing an overproduction of proteins that fuel the growth and spread of tumors, as well as enabling them to evade the immune system. Effector Therapeutics is developing a new class of cancer therapies called selective translation regulator inhibitors, or STRIs, that can inhibit the production of proteins that drive a cancer. We spoke to Steve Worland, president and CEO of Effector, about the company’s new class of therapies, how they target a central node where two major cancer signaling pathways converge, and how they pack the punch of a combination therapy in a single drug.

While cell therapies hold great promise for not only halting the progression of degenerative disease but potentially restoring the body, cost has remained a barrier. Lineage Cell Therapeutics is developing allogenic cell therapies that don’t rely on modifying a patient’s own cells, making them scalable and less costly than autologous ones. At the end of last year, the company entered into a partnership with Genentech to develop and commercialize OpRegen, its experimental cell therapy for dry age-related macular degeneration. We spoke to Brian Culley, CEO of Lineage Cell Therapeutics, about the company’s platform technology for off-the-shelf cell therapies, how its platform works, and what the collaboration with Genentech will do to advance the technology.

A broad range of serious diseases involve chronic inflammation, which causes both pain and progressive damage. Xalud Therapeutics is developing a locally-delivered, non-viral gene therapy that is designed to harness the ability of interleukin-10 to regulate the immune system and restore homeostasis. The company’s lead indication is in osteoarthritis We spoke to Diem Nguyen, CEO of Xalud, about the role inteleukin-10 plays in regulating multiple pathways in the immune system, Xalud’s gene therapy, and the indications the company is pursuing.

Traditional antibody discovery depends, in part, on a bit of good fortune that banks on the hope that either screening antibody libraries or exposing an organism to an antigen will result in the discovery of a compelling therapy. Yanay Ofran, CEO of Biolojic Design, says the problem with this approach is that it ignores many of the performance-related aspects of an antibody beyond its ability to bind to a target. His company’s AI platform for antibody discovery seeks to capitalize on the full capabilities of antibodies to develop smarter therapies that can serve as molecular switches and act conditionally. We spoke to Ofran about Biolojic’s platform technology, how it mimics the way the immune system makes antibodies, and why its approach will lead to smarter therapies.

The rise of antibiotic resistance and the threat of emerging viral pathogens have created global public health threats. Recce Pharmaceuticals is developing a new class of synthetic anti-infectives that it says can overcome the hyper-cellular mutation of bacteria and viruses. What’s more, the company says their potency doesn’t diminish even with repeated use. We spoke to James Graham, CEO of Recce, about its synthetic anti-infectives, how they work, and why they can be used repeatedly against a broad range of bacteria and viruses.

Whether in an operating room or in a trauma situation, the ability to quickly stop bleeding represents a critical need in healthcare. At the end of December, Cresilon filed for U.S. Food and Drug Administration approval to market its hemostatic gel to rapidly stop bleeding. The filing follows the launch of Vitigel, Cresilon’s hemostatic gel for the animal health market. We spoke to Joe Landolina, co-founder and CEO of Cresilon, about how he developed the plant-derived gel, the significant need he is seeking to address, and how the gel is able to halt bleeding in a matter of seconds.

In cancer, synthetic lethality refers to a state in which two genetic mutations that alone may allow a cancer cell to survive will kill it when they exist simultaneously. Cyteir Therapeutics is seeking to exploit that strategy with what it calls next-generation synthetically lethal therapies to treat a wide range of cancers. We spoke to Markus Renschler, president and CEO of Cyteir therapeutics, about synthetic lethality, Cyteir’s pipeline, and life as a small public biotech in 2022.

AI Dynamics is seeking to make AI accessible. Though its NeoPulse platform can be used across industries, the life sciences is one of the key markets the company is targeting with its technology being used to do everything from target identification for drug development to diagnosing and triaging TB patients by the sounds of their cough. We spoke to Rajeev Dutt, CEO and president of AI Dynamics, about the company’s core AI technology, how it seeks to make AI accessible, and why he believes it can transform drug development and healthcare by moving the needle on costs.

Social anxiety disorder can cause debilitating physical and emotional manifestations when a person is doing such things as meeting new people, speaking in public, or interviewing for a job. It can cause sweating, a rapid heartbeat, shortness of breath, and dizziness. The fear of embarrassment and humiliation can lead to depression and even addiction. VistaGen Therapeutics is developing intranasally delivered therapies for CNS disorders that can provide rapid relief at the onset of an episode much like someone with asthma might use a rescue inhaler. We spoke to Shawn Singh, CEO of VistaGen, about social anxiety disorder, the need for innovative approaches to treat that and other CNS conditions, and the potential for rapid onset therapies to treat a range of mental health conditions.

Humacyte’s human acellular vessels are experimental, engineered, off-the-shelf replacement vessels that are being developed for vascular repair, reconstruction, and replacement. The vessels are designed to overcome long-standing limitations in vessel tissue repair and replacement. Though not yet approved, the manufactured vessels are getting a real-world test as the company has been providing them to hospitals in Ukraine to treat wounded civilians and soldiers with vascular injuries. We spoke to Laura Niklason, CEO of Humacyte, about the company’s human acellular vessels, how they are produced, and the potential needs they can address.

The emergence of tyrosine kinase inhibitors represented a major advance in the fight against cancer, but the ability of tumors to mutate and develop resistance to these therapies remains a challenge. Theseus Pharmaceuticals is developing what it calls “pan-variant” kinase inhibitors in the hopes of outsmarting tumors by anticipating the range of kinases that may drive their spread and growth as they change. We spoke to Tim Clackson, president and CEO of Theseus Pharmaceuticals, about its structural-based approach to drug development, how it determines the appropriate targets for its pan-variant kinase inhibitors, and why it believes its next-generation TKIs can overcome the challenge of drug resistance.

The emerging understanding of the role the microbiome plays in wellness and disease is opening up a large number of potential therapeutic targets in the millions of genes that drive the microorganisms that live within the body. Eligo Bioscience is developing a new class of precision medicines that uses gene editing to address the expression of pathogenic genes in the microbiome to treat not only infectious disease, but other conditions such as inflammatory diseases and cancer as well. We spoke to Xavier Duportet, CEO of Eligo Bioscience, about the company’s use of synthetic DNA to target bacterial genes, its platform technology, and the wide range of conditions that can be addressed through this approach.

While cancer immunotherapies have been promising, CAR T cell therapies have been costly, effective on less than half of patients, and focused on hematologic cancers. Cytovia Therapeutics is enlisting natural killer cells, part of the innate immune system, to develop off-the-shelf immunotherapies to treat liquid and solid tumors. The company is leveraging a cluster of technologies to produce CAR NK cell therapies, edited NK cells to enhance their targeting, and NK engagers to redirect NK cells toward tumor targets. We spoke to Daniel Teper, co-founder and CEO of Cytovia, about the case for NK immunotherapies, Cytovia’s platform technologies, and the company’s pipeline of therapies in preclinical development.

Neurodegenerative diseases such as ALS, Alzheimer’s disease, and frontotemporal dementia have been difficult conditions for drug developers to target. Coya Therapeutics is approaching these conditions as diseases of immune system dysfunction to address the neuroinflammation that underlies them We spoke to Adrian Hepner, president and chief medical officer of Coya, about the role a hyper immune response plays in the progress of neurodegenerative diseases, how the company’s experimental regulatory T cell therapy works to halt that, and its pipeline in development.

The introduction of precision medicine has revolutionized the treatment of cancer and other diseases, but mental health conditions have not benefitted from the same type of treatment innovation. Alto Neuroscience is working to move psychiatry away from a trial-and-error approach to develop targeted medicines with the use of biomarkers to match the right drug to the right patient. We spoke to Amit Etkin, founder and CEO of Alto Neuroscience, about its efforts to develop precision medicines for mental health disorders, its AI platform for biomarker discovery, and its therapeutic pipeline in development.

The use of protein degraders is a promising area of emerging small molecule therapies. Rather than inhibit disease-causing proteins, degraders use a natural cellular process to break them down. Origami Therapeutics is using its proprietary drug discovery platform to develop novel protein degraders to target neurodegenerative diseases. The approach allows the company to target proteins that are considered undruggable because they lack an identified binding site. We spoke to Beth Hoffman, founder and CEO of Origami, about its platform for developing degraders, its focus on neurodegenerative diseases, and how its looking to potential partners to exploit the full potential of its platform technology.

Cancer immunotherapies have shown great promise, but many tumors can develop resistance as the changing tumor microenvironment can help cancers evade detection and allow cancer cells to proliferate. Teon Therapeutics is developing immno-oncology therapies for difficult to treat cancers that are designed to have the dual effect of restoring immune activity while suppressing cancer cell proliferation. We spoke to Serge Messerlian, CEO of Teon Therapeutics, about what happens when immunotherapies fail, the unique approach Teon is taking, and how the dual activity of its cancer therapies can restore immune activity while suppressing cancer cell proliferation.

Existing anticoagulants can prevent life-threatening blood clots for people with cardiovascular and metabolic diseases. The problem is that because of their mechanism of action, they also work to suppress the body’s ability to stop bleeding as it should. As a result, these therapies can be under utilized by patients who need them. Anthos Therapeutics is developing an experimental monoclonal antibody that can suppress coagulation without disrupting hemostasis, the biological process of stopping bleeding. We spoke to John Glasspool, CEO of Anthos, about the problems of existing anticoagulants, the novel target its monoclonal antibody acts on, and how it is able to uncouple the pathways for thrombosis and hemostasis.

Though the search for eternal youth has long been the fodder for myths and legends, science has been pushing us closer toward extending healthy years of life and has set some people off on efforts to defy death altogether. Peter Ward, in his new book The Price of Immortality: The Race to Live Forever, explores a subculture of immortality seekers who have turned to cryonics, as well as efforts to merge man with technology as a way to escape death. The growing understanding of the biology of aging and advances in regenerative medicine, though, are creating the potential to alter notions of human lifespans. We spoke to Ward about his book, distinguishing science fact from science fiction, and the growing understanding of the biology of aging that offers the potential for extending healthy years of life.

About 15 years ago, Harvard Business School professor Gary Pisano took at look at how small entrepreneurial biotechs fared against large and mature pharmaceutical companies and found the two sectors were about the same when it came to R&D productivity. Now, a new book From Breakthrough to Blockbuster: The Business of Biotechnology finds that the biotechnology industry is far more effective at bringing innovative therapies to market than Big Pharma and offers a prescription for large drug companies to decentralize decision-making to improve their ability to innovate. We spoke to venture investor and former biotech executive Don Drakeman, co-author of the book, about its findings, how decentralized decision-making can produce greater innovation, and lessons from COVID-19.

Poseida Therapeutics is leveraging its set of platform technologies to develop a range of next-generation cell and gene therapies. By using these technologies, alone or in combination, the company said it’s able to overcome limitations of the current generation of cell and gene therapies. The company’s most advanced candidates in its pipeline include a set of allogenic CAR T therapies. We spoke to Mark Gergen, CEO of Poseida, about the company’s efforts to develop off-the-shelf CAR T therapies, its platform technologies, and why it believes its CAR T cells will provide advantages over competitors’ therapies.

Though structure-based drug discovery has been long been used, technologic advances have given this approach greater power. ShouTi believes its next-generation, computational, structure-based drug discovery platform will allow it to develop small molecule drugs that are superior in safety and efficacy to biologic and peptide therapies its seeking to replace. We spoke to Raymond Stevens, CEO of ShouTi, about the company’s structure-based drug discovery platform, how it works, and why he believes it will be able to produce small molecule drugs that will be superior to biologics.

Virus-like drug conjugates, or VDCs, are a new class of cancer therapies Aura Biosciences is developing to target a broad range of solid tumors. These therapies have a dual mechanism of action. They deliver a toxic payload to cancer cells, but also activate a secondary immune mediated response to kill cancer cells. We spoke to Elisabet de los Pinos, CEO of Aura Biosciences, about the company’s VDCs, how they work, and its pipeline in development.

While the emergence of CAR-T therapies have been promising, these autologous cellular therapies are costly to produce since they require taking T cells from a patient being treated, altering them, and then infusing them back into the patient. Cellectis is among a growing list of companies pursuing off-the-shelf CAR-T therapies. The company’s U-CARTs, or universal chimeric antigen receptor T cells, are allogenic products that can be standardized and carry both time and cost advantages. We spoke to André Choulika, CEO of Cellectis, about the company’s off-the-shelf CAR-T therapies, the platform technology behind them, and its programs in development.

Though it’s been nearly 20 years since the Human Genome Project provided a blueprint for human biology, it still left much work to be done to understand health and disease at a molecular level. The Sweden-based Human Protein Atlas, which is seeking to map human proteins in cells, tissues, and organs, recently published significant updates to the open-access resource. We spoke to Mathias Uhlén, director of the Human Protein Atlas, about how the atlas is changing the diagnosis and treatment of disease, what’s known about the human proteome to date, and how this understanding will be essential to brining about an era of precision medicine.

In 2020, CSL Behring entered into a global license and commercialization agreement with UniQure for the company’s experimental hemophilia B gene therapy. The expected, one-and-done treatment carries the potential to free people with the genetic bleeding disease from reliance on regular infusions of clotting factor IX for which they are deficient. We spoke to Steve Pascoe, senior vice president and head of therapeutic areas and development strategy for R&D at CSL about hemophilia B, how the gene therapy fits into CSL’s broader therapeutic offerings, and the encouraging results from the recent pivotal study.

The promise of data-driven medicine is that it can accelerate the diagnosis of disease, provide patients with the most effective treatments for their particular conditions, and improve drug development. Sophia Genetics is drawing on extensive information from its global, data-sharing network to make data-driven medicine a reality. We spoke to Emily Paul, product director of platform for Sophia Genetics, about Sophia’s vision for data-driven medicine, the challenges of managing vast amounts of data and turning it into actionable information, and how its changing patient care today.

The growing convergence of information technology and biotechnology are creating a compelling new group of companies that live in both these worlds at once. Lux Capital, which has long invested in both sectors, has a growing portfolio of these emerging TechBio companies. We spoke to Adam Goulburn, partner at Lux Capital, about his investment process, how he tempers the promise of technology with management realities and market timelines, and the changing landscape for venture investing.

Cell and gene therapies are among the most promising approaches to treating diseases because they carry the potential to cure chronic and progressive conditions. The problem is that the high cost of producing these therapies, which often need to be tailored to individual patients, limits access to them, particularly in low- and middle-income countries. Caring Cross is seeking to change that through its nonprofit model that focuses on enabling hospitals and health systems to manufacture advanced therapies locally and deliver them in a cost-effective manner. We spoke to Boro Dropulić, co-founder of Caring Cross, about how the nonprofit is seeking to lower the cost of these therapies, how it operates, and why its initially focused on HIV and sickle cell disease.

KeifeRx is developing a pipeline of orally delivered tyrosine kinase inhibitors to treat neurodegenerative diseases. It has a portfolio of these drugs that it has optimized to penetrate the brain, clear damaged cells, and treat these conditions through the bulk disposal of disease-causing toxic proteins. It believes its approach offers the potential to significantly improve on current treatments, which it calls primarily palliative because they fail to adequately eliminate the toxic proteins at the root of these deadly diseases. We spoke to KeifeRx CEO Chris Hoyt and co-founder and head of the company’s scientific advisory board Charbel Moussa, about how it has repurposed and optimized a cancer therapy to treat neurodegenerative diseases, and why it may have broad applications across these conditions.

When AzurRX BioPharma merged with First Wave Bio last year it renamed itself First Wave BioPharma. The company is developing targeted, non-systemic therapies for gastrointestinal diseases with its lead candidate niclosamide, an approved therapy to treat tapeworms that it believes has anti-viral and anti-inflammatory properties. The company is developing niclosamide in six GI-indications including COVID-19 related GI disease, Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients, ulcerative proctitis/ proctosigmoiditis, ulcerative colitis, and Crohn’s disease. We spoke to James Sapirstein, CEO of First Wave BioPharma, about the merger, niclosamide, and its potential to treat a range of gastrointestinal disorders.

HCW Biologics is developing immunotherapies to target chronic inflammation associated with aging. The company’s therapeutics are designed to disrupt the link between chronic, low-grade inflammation and age-related disorders. The company believes this type of inflammation is a significant contributing factor to cancer and several chronic conditions, including cardiovascular disease, diabetes, neurodegenerative disease, and autoimmune disease. We spoke to Hing Wong, CEO of HCW Biologics, about the link between chronic inflammation and diseases of aging, the company’s immunotherapies, and its platform for developing therapies that target this unwanted inflammation to treat cancer and other diseases.

As 2021 fades into the history books, it will be remembered as one with exuberant IPOs, punishing aftermarkets, and a lingering pandemic that once again is turning the annual JPMorgan Healthcare Conference into a virtual event. We continue our annual tradition of sitting down with STAT Senior Writer Adam Feuerstein to discuss the year that was in biotech, the best and worst CEOs of 2021, and what’s ahead in the new year.

The p53 protein is known as the “guardian of the genome.” It plays an essential role in suppressing tumors. Rain Therapeutics is targeting a regulator of p53 that is overexpressed in certain cancer and can inactivate it, allowing certain cancers to grow and progress. We spoke to Avanish Vellanki, chairman and CEO of Rain Therapeutics, about the company’s experimental precision therapy milademetan, how it works, and its potential to treat a range of cancers.

Though HIV has fallen out of the headlines, the virus continues to represent a significant public health threat. American Gene Technologies is developing an experimental cell therapy that it says is potentially curative for HIV. We spoke to Jeff Galvin, CEO and founder of American Gene Technologies, about the state of HIV, the company’s experimental cell therapy for HIV, and why the one-time treatment has the potential to free patients from chronic use of antiviral therapies.

The COVID pandemic has called attention to the United States’ reliance on a supply chain that makes access to critical medicines dependent on the ability to make them overseas and ship them in a timely manner. At the same time, harnessing new ways of making biologics, is making it possible to gain significant savings over traditional manufacturing approaches. rBIO is betting it will be able to cost-effectively produce biologics in the United States and its starting with insulin to prove its point. We spoke to Cameron Owen, co-founder of rBIO, about the how the company is engineering different organism to increase the efficiency of biomanufacturing, why it is starting with insulin, and why reshoring biomanufacturing should be viewed as a critical issue for the United States.

The use of smartphones, low-cost sensors, and ubiquitous connectivity is changing the way researchers think about recruiting, monitoring, and interacting with participants in biomedical research. The use of evolving technology is not just eliminating geographic barriers to participation, but also enabling the collection of new types of data. The Scripps Research Digital Trials Center is pioneering the use of digital health technologies to re-engineer the way studies are conducted. We spoke to Edward Ramos, director of digital clinical trials for Scripps Research Digital Trials Center, about how digital health technology is transforming biomedical research, how it is changing what is possible, and some of the ongoing research projects the center is conducting.

The body has a natural cellular recycling machinery known as the ubiquitin proteasome system that breaks down unwanted proteins. Kymera Therapeutics has developed a drug discovery platform that exploits this natural biologic process to target disease-causing proteins that had been previously considered undruggable using small molecule therapies. We spoke to Nello Mainolfi, co-founder, president, and CEO of Kymera, about the company’s discovery platform, how it exploits a natural housecleaning mechanism within the body, and why this approach could enable the targeting of proteins that previously had been considered beyond the reach of small molecule therapies.

About 70 percent of daily deaths are caused by aging or age-related diseases. The newly formed Alliance for Longevity Initiatives, or A4LI, is an independent nonprofit advocating for greater investment in scientific research, new measures to recognize the value of extending healthy life expectancy, and steps to expedite the development gerotherapies and regenerative medicines. We spoke to Sonia Arrison, chair of the Alliance for Longevity Initiatives, about the need the new organization is seeking to address, its agenda, and how therapeutic advances may be able to alter our notions of longevity.

As concerns about the use of animals to test drugs, scientist have sought new ways to analyze the efficacy and toxicity of their products. Genoskin is seeking to enable better, faster, and safer drug development through the use of its proprietary ex vivo human skin platforms for preclinical drug testing. The company provides natural human skin obtained from patients that it maintains in a living and functional state. We spoke to Pascal Descargues, founder and CEO of Genoskin, about the company’s ex vivo human skin models, how they provide an alternative to animal experiments, and how they can accelerate the generation of reliable human data in drug development.

While cell therapies have been advancing rapidly, therapies that rely on taking a patient’s own cells, altering them, and reinfusing them back into a patient are costly. Part of the reason why is that the process for doing this is labor intensive. Cellino has developed a platform for producing personalized autologous cell therapies in an automated and scalable fashion. We spoke to Marinna Madrid, co-founder and vice president of product, for Cellino, about the company’s platform technology for cell-based therapies, how it works, and why it may help enable a new era of personalized regenerative therapies.

Integrins are a diverse family of proteins that play an essential role in many cellular biological processes. They also have been implicated a number of autoimmune, cardiovascular, and metabolic diseases, as well as fibrosis and cancer. While a number of biologics have come to market that target integrins, drug developers have been stymied in efforts to develop oral therapies that can target these proteins. Morphic Therapeutic is developing a new generation of oral integrin drugs it believes can transform the treatment model for a range of serious medical conditions. We spoke to Praveen Tipirneni, president and CEO of Morphic Therapeutic, about intgerins, the challenges of using small molecule therapies to target them, and why this can have a dramatic effect on how patients with a range of conditions get treated.

As the treatment of cancers has moved toward an increasing emphasis on the role the immune system can play in fighting tumors, a range of new ways to enlist and train the immune system have emerged. Candel Therapeutics is developing oncolytic viral immunotherapies, which it says combines anti-tumor activity while also stimulating the immune system. We spoke to Paul Peter Tak, president and CEO of Candel Therapeutics, oncolytic viral immunotherapies, how they work, and why they may be able to bring benefits to the treatment of a range of solid tumors.

The discovery and cell line development of biotherapeutics has been traditionally a distinct process. Absci is taking what it describes as a more wholistic approach by collapsing the process down and addressing the functionality and manufacturability of therapeutic candidates simultaneously. We spoke to Sean McClain, founder and CEO of AbSci, about how it is using AI and synthetic biology to reinvent the discovery process, how this is expanding the therapeutic potential of proteins, and how it translates into time and cost benefits.

While CAR-T cell therapies have been a promising new area of cancer treatments, they are costly to produce, have had limited success in treating solid tumors, and can carry sometimes serious side effects. Shoreline Biosciences is developing off-the-shelf natural killer and macrophage cellular immunotherapies derived from induced pluripotent stem cells for cancer, inflammatory, and genetic diseases. The company programs these cells to target and kill tumors, as well as repair tissue homeostasis. The company said its approach allows for the creation of a streamlined, affordable, and scalable manufacturing process that can deliver cell therapy treatments to patients in a faster and more cost-effective manner. We spoke to Kleanthis Xanthopoulos, co-founder and CEO of Shoreline Biosciences, about the company’s off-the-shelf cell therapies, its focus on the innate immune system, and how it’s leveraging its technology through recent partnerships with BeiGene and Kite Pharma.

The ability to discover new drugs can be limited by the tools and technologies small companies can access. Alloy Therapeutics says it democratizing access to a set of technologies and capabilities that are foundational for discovering and developing biologics. We spoke to Errik Anderson, CEO of Alloy Therapeutics, discusses the challenges of drug discovery the company is seeking to address, its business model, and the dealmaking it has done to build beyond platform technologies to become involved in the discovery and development of therapeutic candidates.

One of the consequences of the proliferation of genetic sequencing has been a shortage of genetic counselors. It’s left existing counselors to manage a heavy load as its increased the demands on onboarding patients, consenting them, educating them and interpreting results. The digital health company Igentify is helping providers and genetic counselors scale their services with its AI-based platform that extends through the entire genetic testing process. We spoke to Doron Behar, co-founder and CEO of Igentify, about its platform technology, how it works, and why it will allow genetic counselors to handle a much larger volume of patients.

While CAR-T cell therapies have emerged as promising anti-cancer agents, their success have been focused on hematologic cancers. ArsenalBio is working to develop more robust cell therapies capable to treating a broader range of cancers by using synthetic biology to make them programable. We spoke to Ken Drazen, CEO of ArsenalBio, about the company’s next-generation T cell therapies, how it is able to program functions into these cells to overcome solid tumor defenses, and the company’s collaboration with Bristol-Myers Squibb announced at the start of the year.

Liquid biopsies have become associated with the area of oncology as they hold the promise of using fragments of DNA circulating in the blood that have been shed by tumors to provide early indications of recurrence and customize treatment strategies. The same approach, though, can be used for infectious diseases. Karius has developed a liquid biopsy test to provide rapid and non-invasive detections of more than 1000 pathogens from a single blood draw. The Karius test helps clinicians avoid invasive, low-yield, and sequential diagnostic tests that can delay treatment for the most vulnerable hospitalized patients. We spoke to Alec Ford, CEO of Karius, about the company’s liquid biopsy test, how it works, and how it can change the treatment of immunocompromised patients.

The World Health Organization estimates that 270 million people worldwide suffer from chronic hepatitis B virus infections, making it a global epidemic that affects more than twice the number of people with hepatitis C and HIV combined. HBV is a leading cause of chronic liver disease and the need for liver transplantation, with up to 1 million people worldwide dying from HBV-related causes each year. While current treatments reduce the viral load, they don’t eliminate it. Assembly Bio is developing a pipeline of therapies aimed at curing HBV. We spoke to John McHutchison, president and CEO of Assembly Bio, about HBV, the company’s efforts to develop a new class of drugs to treat the condition, and what he’s learned from his work at Gilead successfully developing and commercializing therapies for HCV. A note to listeners: As we were publishing this episode Assembly Bio announced plans to discontinue development of its phase 2 candidate ABI-H2158 because safety concerns. The company said it will focus on advancing ongoing triple combination studies and earlier pipeline candidates.

Psychedelics have become an area of increasing investment and drug development activities as an emerging group of companies is working to develop these compounds as treatments for neurologic and psychiatric conditions. That’s because of the ability of these drugs to target serotonin, which plays a critical role in the regulation of cognitive function, emotions, memory, and the sleep-wake cycle. Bright Minds Biosciences is developing a pipeline of psychedelics as the next generation of serotonin modulators to treat neuropsychiatric, seizure, and pain disorders by restoring serotonin activity to normal levels. We spoke to Gideon Shapiro, vice president of discovery at Bright Minds Biosciences, about the role serotonin plays in the health of the brain, why psychedelics have emerged as compelling therapeutics for a range of conditions, and the company’s pipeline of drugs in development.

Type 2 diabetes affects nearly 500 million people worldwide and more than 34 million people in the United States. The disease carries an elevated risks of heart attack, stroke, and other serious complications. Fractyl Health believes the approach to treating diabetes by controlling blood sugar levels and other symptoms has been faulty. Research has implicated a critical role the first section of intestine, known as the duodenum, plays in the condition and the company has developed a minimally invasive endoscopic procedure that it believes can correct the problem. We spoke to Harith Rajagopalan, CEO of Fractyl Health, about the company’s experimental procedural therapy to target the root cause of diabetes, how it works, and the path forward to commercialization.

The efforts to develop drugs for neurologic and psychiatric conditions has been plagued with failure. Herophilus is combining organoids derived from patient stem cells along with machine learning to gain new insight into the biology underlying these diseases and discover and develop more effective drugs. We spoke to Saul Kato, co-founder and CEO of Herophilus, about the drug development challenges for these diseases, how his company is using organoids and machine learning to better understand how to target them, and its growing pipeline therapeutic candidates.

While the class of immunotherapies known as checkpoint inhibitors has brought a promising new approach to treating cancer, the development of resistance to these therapies limits the number of patients they benefit. Portage Biotech is building a set of platform technologies and a pipeline of immuno-oncology therapeutic candidates to address this problem. We spoke to Ian Walters, CEO of Portage about the problem of resistance, the company’s pipeline of candidates, and its portfolio-based business model.

Earth will not live forever. Whether its destruction comes as the result of cosmic inevitability or human-caused cataclysm, the planet will eventually meet its demise. Though that may be billions of years from now, Chris Mason in his book “The Next 500 Years,” argues humans have a more obligation to do what they can ensure life from Earth can extend beyond the planet. Mason, principal investigator on NASA’s twins study and a professor at Weill Cornell Medicine, discussed the effects of space on the human body, how it may be possible to genetically engineer human and other life forms to thrive in environments less hospitable than Earth through the use of new genetic tools, and the ethical considerations around these issues.

While great strides have been made the fight against cancer with new therapies, dose-limiting toxicities of these agents can have a big impact on the quality of life for patients and lead doctors to alter dosing at the price of optimal outcomes. Rather than treating the symptoms of the side effects of cancer drugs, OnQuality Pharmaceuticals is developing a pipeline of therapies that target the biologic pathways that at their source. It is developing targeted supportive therapies to treat such things as dermatologic conditions and diarrhea caused by cancer medicines. We spoke to Michael McCullar, CEO of OnQuality, about the need his company is addressing, its pipeline, and how he expects others to think about the value of the therapies the company is developing.

While great progress has been made in understanding the human genome, its functional counterpart, the human proteome, remains relatively unexplored. In part, that’s because advances in the tools to identify the far bigger universe of protein variants has been lacking. Seer Bio has developed a platform for large-scale proteomics studies that it says is both unbiased and scalable. We spoke to Omid Farokhzad, chair and CEO of Seer Bio, about the state of proteomics, How Seer’s technology works, and why it can help advance our understanding of health and disease.

The development of mRNA therapies is allowing drug developer to pursue targets once considered undruggable. Anima Biotech has developed a platform that allows it to use small molecule that selectively control mRNA and can decrease or increase the translation of proteins. The approach has broad applicability as evidenced by the company’s pipeline, which includes experimental therapies for oncology, neurology, infectious disease, and fibrosis. We spoke to Yochi Slonim, CEO of Anima, about the company platform technology, how it can modulate the expression of proteins, and how it is leveraging its technology through partnerships with some of the world’s largest pharmaceutical companies.

The biopharmaceutical industry has long struggled with R&D productivity. Long time industry strategic consultant Mike Rea, founder and CEO IDEA Pharma, thinks he’s hit on a possible solution. Taking a cue from the tech industry, Rea in May announced the launch of Protodigm, which he describes as a contract skunkworks company. The approach is intended to allow a multi-disciplinary team work autonomously to take its clients early-stage assets and explore multiple development options at once with the intent of de-risking innovation while saving time and money. We spoke to Rea about the industry’s challenges with R&D productivity, the benefits Protodigm’s skunkworks approach could provide, and how it will work with industry.

While cities across the country have lifted COVID-19 restrictions and public gatherings have returned, the lack of effective treatments for people who develop severe reactions to the virus continues to pose a public health problem. The situation is acute in less developed nations where vaccination levels are low, and hospitals continue to be overrun with patients. Researchers at Mount Sinai earlier this year reported in the journal Cell that a widely available and inexpensive drug targeting inflammatory genes has reduced morbidity and mortality in mice infected with the virus that causes COVID-19. The drug, topotecan, is now in clinical trials in India as a potential treatment for patients who suffer from a hyper-inflammatory response to the virus. We spoke to Ivan Marazzi, senior author of the study and an associate professor of microbiology at the Icahn School of Medicine at Mount Sinai, about topotecan, what makes it compelling as a potential treatment for COVID-19, and why it may be well suited for treating people with the condition across the globe.

Osteoarthritis is a painful, progressive disease of the joints for which there is no cure. The condition affects more than 32.5 million adults in the United State and the incidence is growing as a result of aging, obesity, and sports injuries. Flexion Therapeutics is developing an experimental gene therapy to treat the condition. Rather than correcting an underlying genetic mutation, the experimental therapy delivered into the joint codes for the production of the anti-inflammatory protein interleukin-1 receptor antagonist. It is expected to deliver as-needed anti-inflammatory activity to joint tissues over the long-term. We spoke to Mike Clayman, co-founder and CEO of Flexion Therapeutics, about osteoarthritis, the problem with existing therapeutic approaches, and the company’s efforts to develop a gene therapy to get the body to produce an anti-inflammatory protein as needed.

Sumitomo Dainippon Pharma’s $3 billion strategic transaction with Roivant Sciences that gave rise to Sumitovant, represents an effort by the Japanese drug company to make the drug development process faster and more efficient. A critical piece of this effort is steps the company has taken to harness information technology to capitalize on existing knowledge to inform decision making. We spoke to Bill McMahon, chief algorithmic analytics officer of Sumitovant, about the approach Sumitovant is taking, the way uses information technology to improve the drug development process, and how the subsidiary may be influencing the way its parent company operates.

The ability to identify diseases at their earliest stages through the detection of minute levels of biomarkers offers the potential to make interventions before the outward physical manifestations of illnesses can bloom and long-term damage can occur. Quanterix is developing a platform of ultra-sensitive biomarker tests to give researchers greater insight into the transition from health to disease and the ability to detect diseases at an earlier point in their development. We spoke to Kevin Hrusovsky, chairman, president, and CEO of Quanterix, about the company’s ability to detect minute amounts of biomarkers, the implications this has for drug development and diagnostics, and how this can help drive a future of precision health.

The marriage of synthetic biology to mRNA is creating the potential for a range of programmable therapeutics that can provide new ways of treating deadly and chronic diseases. Strand Therapeutics is creating a platform for developing these long-acting mRNA drugs that it says can be precise, multi-functional, and deliver potentially curative treatments with a single dose. We spoke to Jake Becraft, co-founder and CEO of Strand, about the company’s programmable mRNA therapeutic platform, how it works, and the indications it is pursuing.

Cardiometabolic conditions, such as type 2 diabetes and heart disease, have long been treated with pharmacologic interventions. Better Therapeutics believes cognitive behavioral therapy delivered through its prescription digital therapeutics platform, will provide better outcomes at a lower cost. We spoke to David Perry, co-founder and executive chairman of Better Therapeutics, about the company’s prescription digital therapeutics platform, the case for personalized cognitive behavior therapy delivered this way, and what it will take to get doctor to prescribe it and payers to reimburse for it.

The side effects of opioids and the potential for addiction underlies the need for new approaches to the treatment of pain. SiteOne therapeutics is developing a pipeline of therapies that target sodium ion channels to block the electric signals sent from the site of pain. Unlike other similar drugs, SiteOne is able to target these sodium channels with great specificity to avoid the types of side effect that have limited the value of drugs that target these proteins. We spoke to John Mulcahy, president and CEO of SiteOne, about the company’s approach to pain, its pipeline, and how its therapies are able to hit their targets with precision. Special offer to listeners of The Bio Report: With the Digital Library from DeepDyve, you can search 100 million scientific papers with full access to 20 million articles, annotate them, and share with colleagues. It’s one-stop, affordable research. Try one month of DeepDyve’s enterprise service for free. Go to deepdyve.com/podcast and use the code BIOREPORT.

Earlier this year NovelluxDx rebranded itself as Fore Biotherapeutics signaling a shift from being a diagnostics company to its new life as a precision cancer therapeutics drug developer. Building on its functional genomics platform, the company is in-licensing small molecule drug candidates it sees having potential to treat hyper-targeted patient populations. We spoke to Usama Malik, CEO of Fore Biotherapeutics, about the move from diagnostics to drug development, the approach Fore is taking, and why it thinks it can see value in molecules that others may miss.

When variants of the COVID-19 virus emerged in late 2020, it raised concerns about whether people already infected with the original virus, or vaccinated against it, would be able to generate a protective immune response that would confer protection against these new strains. Researchers at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and Johns Hopkins University recently reported encouraging findings from a study that took a detailed look at the antibodies in the blood from COVID-19 patients. To do this, they used a deep immunomics technology platform developed by ImmunoScape. We spoke to Brian Abel, senior director of business development at ImmunoScape and lead of the company’s COVID-19 Vaccine Task Force, about the COVID-19 study, the company’s technology, and how it is being used to develop the next generation of immunotherapies.

Hypoxia, a potentially fatal shortage of oxygen in tissues, is a complicating factor in a variety of serious illnesses including cancer, cardiovascular disease, and respiratory conditions. Diffusion Pharmaceuticals lead experimental candidate, TSC, enhances the ability of the body to deliver oxygen to where it is needed most. We spoke to Bob Cobuzzi, CEO of Diffusion Pharmaceuticals, about hypoxia, the company’s lead therapeutic candidate to address it in a broad range of conditions, and its clinical development strategy for the drug.

Wet age-related macular degeneration is a progressive disease and a leading cause of vision loss in patients over the age of 60. Vision loss is caused by the leakage of blood and other fluid from abnormal blood vessel growth underneath and into the retina. Though the condition is treated by a class of therapies known as VEGF inhibitors, these biologics need to be repeatedly injected into patients’ eyes and for a variety of reasons patients’ real-world experience with the drugs don’t match clinical trial outcomes. Adverum Biotechnologies is developing a gene therapy to treat the condition. Rather than addressing an underlying genetic cause though, the gene therapy carries a sequence that causes the eye to produce aflibercept, the VEGF inhibitor marketed as Eyelea and Zaltrap. We spoke to Laurent Fischer, CEO of Adverum, about the company’s gene therapy, how it works, and why the one-and-done approach could translate into better results for patients.

TNF inhibitors, such as Humira and Remicade, have been a great biotech success story. These multi-billion franchises treat a range of autoimmune conditions including rheumatoid arthritis, psoriasis, and Crohn’s disease. Jim Woody, who led Centocor’s development team for Remicade, the first of the TNF-inhibitors, is today in pursuit of new uses for these therapies. Now CEO of 180 Life Sciences, Woody and his team are pushing TNF inhibitors into new indications for inflammatory and fibrotic conditions. We spoke to Woody about the role of TNF in the inflammatory process, the indications his company is pursuing, and why these well-established drugs have gone untapped for these purposes. The Bio Report welcomes DeepDyve as a sponsor. Search 100 million scientific papers with full access to 20 million articles. It’s one-stop, affordable research. Try the enterprise version of the service free for one month. Go to deepdyve.com/podcast and use the code BIOREPORT

The plant world has been a ready source of bioactive compounds that can improve human health. There are more than 10 million natural compounds in the plant world, but less than 0.1 percent of these compounds have been explored. Brightseed’s Forager is an artificial intelligence discovery platform that is being used to map millions of bioactive natural compounds to identify ones with potential to address human health needs. We spoke to Jim Flatt, co-founder and CEO of Brightseed, about the company’s discovery platform, its business model, and why it’s pushing beyond nutrition and supplement companies to forge partnerships with drug developers.

TFF Pharmaceuticals thin film freezing technology allows it to take vaccines, small molecule drugs, and biologics and turn them into a fine powder. The process not only can be used to eliminate the need for low temperature storage of certain medicines, but also improve the of water solubility of drugs and allow them to be delivered as inhaled therapies. We spoke to Glenn Mattes, president and CEO of TFF Pharmaceuticals, about its platform technology, the company’s efforts to build a pipeline by reformulating existing therapeutics, and its plans to use partnerships to realize the full potential of the technology.

The gene editing technology CRISPR-Cas9 is being harnessed to alter DNA, but Locanabio is using it to create a new class of genetic medicines that can precisely target and modify dysfunctional RNA. The company says that its approach will allow it to produce in vivo medicines that combine the specificity of RNA-binding proteins with the effect of a one-time gene therapy. We spoke to Jim Burns, CEO of Locanabio, about its platform technology, the benefits of using CRISPR to target disease-causing RNA, and why this approach could be applied to a broad range of genetic diseases.

In January 2020, antisense pioneer and Ionis Pharmaceuticals founder Stanley Crooke launched a nonprofit to design and deliver custom RNA-targeted therapies free of charge for individual patients with ultra-rare diseases. The organization, n-Lorem Foundation, leverages Ionis’ technology platform to speed the discovery and development of custom antisense oligonucleotides. More than a year later, the work of the foundation is well underway with a number of therapies in development to treat individual patients. We spoke to Crooke, CEO of the n-Lorem Foundation, about the need the foundation is addressing, why antisense oligonucleotides are well suited to the task, and what challenges it faces in scaling the operations to address the needs of a greater number of patients.

Octave Bioscience is seeking to transform the way neurodegenerative diseases are managed by providing new insights into the severity of a patient’s condition, its progression, and using evidence-based insights to improve outcomes. The company, which recently raised $32 million, is completing development of its care management platform for neurodegenerative disease. We spoke to Bill Hagstrom, CEO of Octave, about the company’s efforts to harness novel measurements of disease to individualize care, the case it’s making with payers, and why the company is starting with MS.

Phosplatin Therapeutics is developing a class of small molecule cancer therapies designed to avoid the problems of drug resistance and toxicity associated with chemotherapies. The company’s lead experimental therapy is a first-in-class small molecule that promotes immunogenic cell death, a type of cell death that elicits an immune response. We spoke to Matthew Price, co-founder, executive vice president, and chief operating officer of Phosplatin, about the company’s lead therapy, its multiple mechanisms of action, and why it may have benefit in a broad range of cancers.

Earlier this year Paige, a company developing artificial-intelligence driven pathology platforms for the diagnosis of cancer, raised $100 million in a series C venture round. The funding came a month after the company, a spin-out of Memorial Sloan Kettering Cancer Center, scored its first two European approvals for its breast cancer and prostate cancer offerings. We spoke to Leo Grady, CEO of Paige, about how the company’s artificial intelligence platform works, why it may lead to the identification of new biomarkers, and the potential for AI to change the way cancer patients are diagnosed.

While cell and gene therapies represent an area of great therapeutic promise, current manufacturing process are expensive and difficult to scale. As a result, this creates bottlenecks that limit patient access to these therapies and hamper the growth of the sector. Ori Biotech has developed an automated and scalable manufacturing platform for cell and gene therapies that seeks to increase capacity and quality while reducing costs. We spoke to Farlan Veraitch, co-founder and chief scientific officer of Ori, about the challenges of manufacturing cell and gene therapies, how the company’s platform addresses those issues, and why it is initially focusing on CAR-T cell therapies.

There’s been a growing industry effort to explore the use of psychedelics for their medicinal benefits. While much of these efforts have looked to these drugs to treat a range of psychiatric conditions, Eleusis sees a broader potential for them. While the company is pursuing psychedelics as potential treatments for major depressive disorder, it also is developing psychedelic candidate in other indications because of their anti-inflammatory properties. We spoke to Shlomi Raz, CEO of Eleusis, about of the case for psychedelics as treatments for inflammatory conditions, how they work, and what challenges the development of these drugs pose.

Regulatory T cell therapies have been pursued as treatment for cancers, but Sonoma Biotherapeutics believes these cells can be harnessed to delivery lasting and potential curative treatments for autoimmune and degenerative diseases. We spoke to Jeff Bluestone, CEO of Sonoma, about regulatory T cell therapies, why they may have broad application in a range of conditions, and what challenges will need to be overcome to usher in an area of cell therapies beyond cancer.

For more than 15 years, Longhorn Vaccines & Diagnostics has been designing and developing products for potential pandemics in developing economies. The recent COVID-19 pandemic, though, put the scalability of the company’s technology to the test as it landed big contracts in the United States for COVID-19 testing. We spoke to Jeff Fischer, president of Longhorn, about the benefits of the company’s technology for gathering and transporting diagnostic samples, how it’s used partnerships to scales it business with speed, and why the pandemic has forever changed the company.

There are many reasons why the sharing of medical data that could be used to gain new insight into diseases can be hampered. Privacy concern, regulatory burdens, and the need to manage security risks are among the significant impediments. Syntegra believes it can solve these problems through its artificial intelligence technology that creates synthetic datasets designed to mirror the statistical properties of real datasets while removing all links to the original patients behind the data. We spoke to Michael Lesh, co-founder and CEO of Syntegra, about the obstacles to data-sharing, how synthetic datasets are developed, and why they might accelerate the pace and lower the cost of research.

While checkpoint inhibitors represent a class of promising new therapies to treat cancer, the efficacy of these immunotherapies have been limited because of the ability of cancers to develop resistance. In part, that’s because of the multiple mechanisms cancers have to evade the immune system. Compugen is using a computational discovery platform to identify proteins and pathways that drive immune resistance mechanisms to checkpoint inhibitors. We spoke to Anat Cohen-Dayag, CEO of Compugen, about the company’s discovery platform, its efforts to develop new treatments that address patients who don’t respond to current checkpoint inhibitors, and its clinical pipeline in development.

The raging pandemic defined 2020, but it was a big year for biotech as the industry saw soaring stocks, record investment, and an impressive number of new drug approvals despite disruptions from COVID-19. We continue our annual tradition of sitting down with Adam Feuerstein, senior writer for Stat and the publication’s national biotech columnist, to discuss the year that was in biotech, the trends that drove the numbers, and what’s ahead in 2021.

The case for precision medicine to treat cancer has been clear. Understanding the molecular underpinnings of a patient’s cancer can allow doctors to use targeted therapies that can best address their particular tumor type. The people behind One Health believe it should be no different for dogs. The company, which bills itself as the world’s first canine cancer care organization, is seeking to bring precision cancer care to our four-legged friends. We spoke to Christina Lopes, founder and CEO of One Health, about the state of canine cancer care, the company’s FidoCure service and the market for state-of-the art medicine for dogs.

As potential vaccines for COVID-19 approached approval, the focus has been on the safety and efficacy of candidates. Now that vaccines have been approved, attention has been shifting to the complex logistical challenges of manufacturing, distributing, and delivering vaccines to patients. The process has opened up visibility into many aspects of the supply chain that are usual taken for granted. One of those aspects are the vials used to store that vaccines and the threat that a shortage of glass bottles could cripple distribution efforts. SiO2 Material Science, which won a $143 million U.S. government contract for vials and syringes, is applying semiconductor technology to create plastic containers with a nano coating of glass inside. We spoke to Christopher Weikart, head of scientific affairs and chief scientist for SiO2 Material Science, the considerations that go into a vaccine vial, the technology SiO2 is using, and why it offers advantages over traditional glass and plastic.

There are many approved or experimental therapies in development for a range of indications that, because of their mechanisms of action, have been pursued as potential therapies to treat patients with COVID-19. One of the most advanced candidates in this category is lenzilumab, an experimental monoclonal antibody that’s in development for certain cancers and other conditions. The antibody has the potential to neutralize a cytokine known as GM-CSF, which can trigger a severe immune reaction and cause hyperinflammation as a result of a cytokine storm. It is this immune response that underlies the most serious cases of COVID-19 virus. We spoke to Cameron Durrant, chairman and CEO of Humanigen, about lenzilumab, how it was recognized as a potential treatment for COVID-19, and the path forward for the therapy.

One of the challenges of conducting clinical trials is finding enough patient to include in a control arm of a study. This can slow the pace of drug development and increase its costs. Unlearn.AI is seeking to change that by using its artificial intelligence platform to create digital twins of trial participants that can serve as control arms in studies. We spoke to Charles Fisher, founder and CEO of Unlearn, about the concept of digital twins, the potential to accelerate clinical trials with their use, and why the company is focusing on the area of complex neurologic diseases.

Traditional efforts to treat autoimmune conditions have focused on inhibiting proteins involved in the immune response. Abivax is developing therapies that modulate RNA to enhance the body’s natural machinery to disrupt the production of cytokines, the proteins that signal the immune system to mount an attack in the first place. The company’s approach to modulating RNA may not only have utility in autoimmune conditions like inflammatory bowel disease, but in other indications including infectious disease and cancer. We spoke to Hartmut Ehrlich, CEO of Abivax, about the company’s lead therapeutic, how it works, and why the approach can have implications in a broad range of diseases.

Jo Bhakdi wants to build a future where people are protected against most diseases through early detection. His company Quantgene, which marries artificial intelligence with the ability to detect cell-free DNA in the blood with great sensitivity, believes it can help extend the lives of its customers by ten years within ten years. Quantgene is offering both its Serenity subscription service to consumers, as well as other offerings to therapeutic developers to support R&D using its technology. We spoke to Bhakdi, founder and CEO of Quantgene, about his unusual path to becoming a precision medicine CEO, how he expects technology to transform healthcare, and why he believes the company will be able to extend the lives of its customers through early detection of disease.

A gatekeeper of cellular metabolism known as mTORC1 underlies a wide range of age-related diseases. Navitor Pharmaceuticals is developing therapies that can modulate the mTORC1 complex and allow for a new approach to treating a wide range of diseases including autosomal dominant polycystic kidney disease and major depressive disorders. We spoke to Tom Hughes, president and CEO of Navitor, about mTORC1, the company’s platform technology, and why it has implications for a wide range of seemingly unrelated conditions.

Whether it is cells engineered to provide therapeutic benefits or biomanufacturing processes to replace energy-intensive and toxic chemical byproducts of industrial manufacturing, getting the right cell for the job is essential. Berkeley Lights has developed platform technologies that allow researchers to rapidly screen large numbers of cells and analyze them to identify the best cells for their purposes. We spoke to Eric Hobbs, CEO of Berkeley Lights, about the company’s platform technology, how it works, and how it can help accelerate the emergence of the new bioeconomy.

Glen de Vries in his new book "The Patient Equation" says that despite the digital revolution in the way we can capture and analyze data, not much has changed for decades in the how clinical trials are conducted. We spoke to de Vries, co-founder and co-CEO of the clinical trials data platform Medidata, about how clinical trials need to evolve, how technology can be used to improve patient access, and how it can capture new types of data to better answer questions about the safety and efficacy of therapies.

While immunotherapies carry great promise for improving outcomes for people with cancer, the ability of cancers to evade the immune system and develop resistance limits their benefits as monotherapies. BioEclipse Therapeutics is developing therapies that marry activated immune cells with oncolytic viruses. Together, they provide a synergistic effect that attacks cancers while providing protection against relapse and recurrence. We spoke to Pamela Contag, co-founder and CEO of BioEclipse, about the ability of cancers to return after treatment with immunotherapies, BioEclipse’s efforts to develop a multi-mechanistic immunotherapy to overcome that challenge, and why its approach may have broad application across a range of cancers.

While the potential for precision medicine has excited drug developers and clinicians with the promise of delivering more meaningful therapies to patients, the advent of these medicines has largely come in the area of cancer. As the understanding of the biology of other diseases is better understood, efforts to develop precision medicines are advancing into new areas. We spoke to Rachel Laing, managing director of the life sciences consulting firm Bionest, about the state of precision medicine, what can be learned from the experience in cancer, and what it will take to make precision medicine approaches the way we treat diseases broadly.

Zea Biosciences is not a typical contract manufacturing organization. The company uses plants to grow recombinant proteins for biologic therapies. To produce a consistent and predictable product, Zea uses a data-intensive approach and grows plants in clean rooms. The end result is a high-scalable platform that is cost-efficient. We spoke to Jim Wilson, CEO of Zea Biosciences, about the company’s approach to producing biologics in plants, why it is a data-intensive process, and the advantages it provides over traditional biomanufacturing.

United Biomedical has long been in the business of producing animal vaccines, but in recent years it has turned its attention to developing vaccines for chronic human diseases including neurological diseases, diabetes, and other targets. More recently it has used its vaccine platform to develop a multitope peptide COVID-19 vaccine and spun it out into a division dubbed COVAXX. We spoke to COVAXX co-founder and CEO Mei Mei Hu and COVAXX co-founder and Chairman Peter Diamandis, about the company’s efforts to develop a COVID-19 vaccine, how its peptide-based vaccine works, and the case for this approach. Since recording this interview, COVAXX began dosing participants in its phase 1 trial September 28, 2020.

CAR-T therapies are an area of great promise for improving outcomes for cancer patients, but the process of preparing cells taken from a patient and genetically modifying them is time consuming and costly. Exuma Biotech believes it can address the cost and time involved in the preparation of these products with its rapid, point-of-care platform technology. We spoke to Greg Frost, chairman and CEO Exuma Biotech, about CAR-T therapies, how its technology works, and how it is working to cut the cost, and speed the delivery of these immunotherapies to patients.

The administration of biologics can be challenging because of the sheer volume of product needed to deliver a dose to a patient. It is for this reason that many of these therapies must be infused into a patient, a process that is disruptive, costly, and can take several hours. Halozyme’s Enhanze drug delivery technology has been used by a number of biologics producers to take a therapy that would otherwise need to be infused to allow it to be administered with a subcutaneous injection. We spoke to Renee Tannenbaum, vice president of global partnering for Halozyme , about the company’s Enhanze drug delivery technology, how it works, and the company’s reorganization to focus on partnerships around it.

NASH, a form of fatty liver disease, causes progressive damage and can lead to inflammation, fibrosis, and the development of cancer. It has become an increasing health concern as the Western diet has spread throughout the globe. Today it is estimated that as much as 5 percent of the world’s population has NASH with a greater percent of people with the condition in the United States. There is no simple blood test to diagnose NASH, which means it often progresses to a fibrotic stage before it is detected. There is also no approved therapy to treat it. We spoke to Robert Foster, CEO of Hepion, about the company’s experimental therapy for NASH, how it works, and why it may also have utility as a treatment for COVID-19.

The complexity of neurodegenerative diseases has made it a challenging area for drug developers. Gene Kinney, CEO of Prothena, has long been involved in the pursuit of therapies for diseases such as Alzheimer’s and believes there has been great progress in understanding and targeting these conditions. In fact, he says we are entering a golden age of neuroscience. We spoke to Kinney about the state of drug development for neurodegenerative conditions, Prothena’s pipeline, and its effort to target protein dysregulation in these diseases.

The U.S. Food and Drug Administration delivered a blow to Pharnext in 2019 when it told the company it should conduct an additional late-stage study of its experimental therapy for the rare neurological condition Charcot-Marie Tooth disease. A manufacturing problem that affected the dose delivered to some patients invalidated one the arms of its study. The company uses artificial intelligence and network pharmacology to identify molecules that may be involved in modulating a disease and searches for synergistic combinations of both existing and novel therapies to treat conditions. Since it’s clinical setback, the company named David Horn Solomon as its new CEO, sharpened its focus, and moved forward with an additional study. We spoke to Solomon about the company’s approach to therapeutic development, its focus on neurological conditions, and the case for using combination therapies as the best way to tackle the diseases it targets.

MindMotion GO is a first-of-its-kind mobile neurorehabilitation therapy system that helps people regain motor and task functions through a gamified approach. While the game playing aspects of the technology may help engage patients in activities designed to help them recover from brain injury, the technology is validated by clinical studies and has won regulatory clearance. It should not be confused with conventional video games. We spoke to John Krakauer, chief medical advisor for MindMaze, about neurorehabilitation, how MindMotion Go works, and the benefits of being able to move neurorehabilitation out of the medical centers to treat patients in their homes, particularly during a pandemic.

People with the rare and fatal genetic disease spinal muscular atrophy in recent years have seen the approval of an antisense therapy as well as a gene therapy. Genentech has now won U.S. Food and Drug Administration approval for Evrysdi, the first oral, at-home treatment for the condition. We spoke to Levi Garraway, chief medical officer and head of global product development at Genentech, about Evrysdi, how it works, and how it fits into the choices physicians and patients have when it comes to treating spinal muscular atrophy.

While the revolution in genomics has led to rapid improvements in the cost and speed of sequencing and created new insights into the genetic drivers of health and wellness, proteomics has lagged behind. Being able to capture a comprehensive view of the changing level of proteins in an individual could play a significant role in bringing about an era of precision medicine. SomaLogic is providing a push in that direction with its SomaScan Discovery platform, which can read 5,000 protein measurements in the blood through a single assay. We spoke to Roy Smythe, CEO of SomaLogic, about the role proteins play in health and wellness, the way the company’s technology works, and the opportunity for it to help advance the area of precision medicine.

The problem of drug resistance isn’t limited to bacteria. It is also a growing concern with fungal species that is causing an increasing need for new agents to combat these microbes. Scynexis is developing the experimental therapy ibrexafungerp, the first of a new class of therapies for serious fungal infections. We spoke to Marco Taglietti, president and CEO of Scynexis, about the problem of drug resistant fungal infections, the company’s experimental therapy ibrexafungerp, and why it may provide a new way of treating a range of serious fungal infections.

Colorectal cancer is the third most common form of the cancer. While screening is an effective means of preventing it, many people fail to get a colonoscopy because of the invasive nature of the procedure and the preparation and sedation that goes with it. Check-Cap is a clinical-stage company developing C-Scan, the first capsule-based system for preparation-free, colorectal cancer screening. The capsule uses ultra-low dose X-ray and wireless communication technologies to generate information on the contours of the inside of the colon as it passes through it. This creates a 3D map that allows physicians to look for polyps and other abnormalities. We spoke to Alex Ovadia, CEO of Check-Cap, about colorectal cancer, why people avoid being screened as they should, and how the company’s C-scan capsule-based system works.

To see the affects of aging all you have to do is look in a mirror and watch the changes over time. Fountain Therapeutics is training its artificial intelligence platform to look at individual cells to detect changes that occur as cells get older and discover therapeutics that target underlying mechanisms of aging. The company believes this will provide new ways to target therapies to treat a range of diseases associated with aging. We spoke to John Dimos, CEO of Fountain, about the company’s AI platform, it’s approach to understanding aging at a cellular level, and how it provides new ways of discovering and developing therapeutics for diseases of aging.

The emergence of immunotherapies has represented a powerful addition to the cancer arsenal, but frequently they fail to deliver benefits to patients. Understanding what therapies will benefit which patients remains a challenge because of the complexity of the immune system. Immunai is applying artificial intelligence to map the immune system and understand its complexities at a granular level to better understand its role in health and disease. It is applying what it learns to avoid clinical trial failures, improve combinations of immunotherapies, and guiding future therapeutic development in cancer and a broad range of other conditions. We spoke to Danny Wells, scientific founder of Immunai, about the company’s efforts to map the immune system, the challenges in doing so, and how this has the potential to improve drug development.

Artificial intelligence is working its way into all aspects of pharmaceutical companies’ operations. While much attention has been given to the role these systems can play in drug discovery, IQVIA sees a significant opportunity to use them to transform the area of regulatory compliance. We spoke to Ronan Brown, senior vice president and head of IQVIA Integrated Global Compliance, about the role AI system can play in improving flagging returns on investment in R&D by allowing regulatory departments to operate more efficiently, breakdown data silos within pharmaceutical companies that hamper performance, and allow companies to focus less on rote work and more on regulatory strategies.

Delivering biologics orally rather than through injection has been an intriguing goal but has proven difficult. Most efforts have focused on finding ways to turn these large protein molecules into formulations where they would not breakdown in the along the digestive tract before they can be absorbed and provide a therapeutic benefit. Rani Therapeutics has taken an unusual tact. Rather than reconceiving the biologic, Rani has reconceived the pill itself. The company has developed what it calls a “robotic” pill that carries the therapeutic to the gut where it injects the drug into the wall of the intestines. We spoke to Mir Imran, chairman and CEO Rani Therapeutics, about how the Rani Pill delivers biologics orally, the technology underlying it, and how the company thinks about the opportunities it will pursue.

Luis Alvarez, a West Point graduate who earned a Ph.D. in bioengineering from MIT, served 20 years in the military including time as an intelligence officer in Iraq. He saw injured soldiers who doctors were able to save, only to later have their limbs amputated because of the inability for injuries to heal properly. The experience led him to develop a means of turning recombinant proteins into a form that allows them to be used as coatings that act like paint and can be applied to implants to promote growth and other benefits. We spoke to Alvarez, founder of Theradaptive, about his journey from the battlefield to the lab, how his company’s platform technology works, and the range of applications to which it may be applied.

Last month, Canadian regulators provided clearance for Appili Therapeutics to begin a phase 2 study of an approved antiviral therapy as a potential preventative treatment against COVID-19 outbreaks. The study will enroll 760 participants who are in long-term care facilities in Ontario. Though others are looking at the drug as a possible treatment for COVID-19, this is the first study to consider its potential to prevent outbreaks. We spoke to Armand Balboni, CEO of Appili, about drug, how it works, and its potential to prevent outbreaks of COVID-19 in high-risk populations.

The urgency to find treatments for the COVID-19 virus has allowed researchers to set aside institutional bureaucracy and companies to apply their technologies in new ways. One example of this is Scipher Medicine’s collaboration with Northeastern University’s Barabasi Labs, Harvard Medical School, and Network Science Institute. The company is using its artificial intelligence platform to help identify existing therapies that might be repurposed as treatments for COVID-19. We spoke to Alif Saleh, CEO of Scipher, about the collaboration, the approach Scipher is using to identify drug candidates, and how this might expand on the company’s business strategy.

As a researcher, Joe Garcia applied functional genomics to understanding genes that contribute to inflammatory disorders such as acute respiratory distress syndrome, or ARDS. As founder and CEO of the biotech company Aqualung Therapeutics, he’s working to advance therapies to hit these novel targets to treat uncheck inflammation with the company’s lead experimental therapeutic candidate targeting ARDS. We spoke to Garcia about the company’s ARDS therapy, how it works, and why it’s a timely focus given the COVID-19 pandemic.

Bacteriophages have long been used to treat infections. These naturally occurring virus are capable of killing bacteria, but each strain of phage is highly specific. Because of their unique mechanism of action, they provide a potential to address the growing threat posed by multidrug-resistant bacteria, but to treat someone, the right phage must be matched to each patient’s infection. Adaptive Phage Therapeutics believes it’s found a way to create phage therapies suited to treat patients with drug-resistant infections by building a bank of targeted and genomically-screened bacteriophage and testing individual patient’s bacterial colony against that to determine the appropriate phage to treat them. We spoke to Greg Merril, co-founder and CEO of Adaptive Phage Therapeutics, about the origins of the company, how its technology works, and the regulatory hurdles for producing customized therapies to treat individual patients.

As a medical student, David Fajgenbaum nearly died from Castleman disease, a rare autoimmune condition. He would suffer recurring bouts that carried him to the brink of death but was able to push the disease into remission by discovering a drug that could be repurposed to treat the disease. Fajgenbaum co-founded the Castleman Disease Collaborative Network and developed a unique approach to research that is now being adopted by other rare disease organizations. He tells his story in his book “Chasing My Cure.” When the COVID-19 outbreak began, Fajgenbaum recognized that the deadliest aspect of the disease—a hyperactive immune response known as a cytokine storm—shared a common link with Castleman disease. He hoped that a researcher would apply his approach to finding a potential drug to repurpose to treat the virus and soon enlisted his own team to do so. We spoke to Fajgenbaum, assistant professor at the Perelman School of Medicine at the University of Pennsylvania and co-founder and executive director of the Castleman Disease Collaborative Network, about his own experience, how it led him to work on COVID-19, and his effort to help researchers and clinicians track all of the drugs being tried to treat the pandemic virus.

As some jurisdictions move to lift shelter in place orders and seek to restore economic life to normal, there’s growing concerns about the health consequences of moving too fast and the failure to make decisions without adequate testing to guide the process. Fred Brown, president and chief operating officer of the big data health consulting firm Fred Brown Management Consulting, discussed beating the COVID-19 pandemic ahead of a piece he’s writing for the fall issue of the Journal of Commercial Biotechnology. Brown offers a few scenarios but believes it will take time for life to return to what it was like. We spoke to Brown about the path to vaccines and therapies, what it will take to move beyond the pandemic, and what we’re learning from this pandemic that will help prepare us for the next one.

Targeting the epigenome—the regulators that turn on and off the activity of genes—has long been viewed as a promising way to treat cancer. But despite the promise of this approach, early efforts brought few successes in part because of the broad effects of hitting these targets. Constellation Pharmaceuticals is taking a next-generation approach to epigenetics, targeting what it calls the writer, reader, and eraser classes of epigenetic regulators to modulate gene expression in a highly selective manner. It believes its approach can be used to both induce cancer cell killing, as well as enhance anti-tumor immunity. We spoke to Jigar Raythatha, president and CEO of Constellation Pharmaceuticals, about epigenetics, the company’s approach to developing highly selective therapies that target gene regulators, and its programs in myelofibrosis and prostate cancer.

Acepodia has developed platform technology that allows it to chemically modify or conjugate living cell surfaces. The technology can be applied to any immune cell and any antibody or binding protein, without the use of genetic engineering. The company is working to apply the technology to create a family of cost-effective, off-the-shelf immunotherapies. We spoke to Sonny Hsiao, CEO of Acepodia, about the company’s platform technology, how it works, and it why it has the potential to change the cost and efficacy of immunotherapies.

One of the challenges to securing the participation of patients in clinical trials can be simple geography. Sanguine Biosciences is seeking to tear down that barrier to participation by using mobile technology to bring clinical trials to patients. The company recently partnered with Vir Biotechnology to complete a COVID-19 clinical study aimed at better understanding the biology of the disease by sending healthcare personnel to collect blood samples from patients at their homes. We spoke to Brain Neman, co-founder and CEO of Sanguine, about it use of digital health technologies, how the company works, and its recent collaboration with Vir Biotechnology for a COVID-19 study.

One of the challenges cell and gene therapies pose is how to control how much and when a desired protein is delivered. Obsidian Therapeutics has developed a platform that allows a small molecule drug to control with precision the timing and level of protein expression from these therapies. We spoke to Paul Wotton, CEO of Obsidian Therapeutics, about the company’s platform technology, how it works, and how it may improve the safety and efficacy of cell and gene therapies.

Patrick Soon-Shiong likes to talk about the “triangle offense,” the activation of a combination of macrophages, natural killer cells, and memory T-cells to battle cancer. He believes the same approach he has been working to train on cancer can be enlisted in the fight against COVID-19, the virus behind today’s global pandemic. We spoke to Soon-Shiong, chairman and CEO of NantKwest, about his approach to immunotherapy, what results he’s seen to date, and why he believes what he’s learned about harnessing the immune system in the fight against cancer can be applied to treating COVID-19.

The COVID-19 pandemic is threatening to stress healthcare systems throughout the world and it is making the development of a vaccine an important part of a strategy to arrest the virus. Though clinical trials for a vaccine are under way, creating a vaccine alone will not be enough. If those efforts are successful, there will be challenges ahead with manufacturing, distributing, and providing equitable access throughout the world. We spoke to Aurélia Nguyen, managing director for vaccines and sustainability for the The Global Alliance for Vaccines and Immunizations about the COVID-19 outbreak, how it may be playing out in different parts of the world, and what was learned from GAVI involvement in previous efforts to develop an ebola vaccine.

Early detection is a critical means of improving outcomes for cancer patients. When cancer is detected at stage I, patients have a 90 percent chance of survival. By contrast, if cancer is diagnosed at stage IV, patients have just a 5 percent or survival. The use of costly and invasive diagnostic approaches have been a barrier to early detection, but new technology has the potential to change that. Laboratory for Advanced Medicine is developing a simple blood-based test to detect cancer at its earliest stage. We spoke to Ken Chahine, CEO of Laboratory for Advanced Medicine, about the company’s blood-based test, how it works, and how it is prioritizing indications.

As the debate over drug pricing intensifies, biotech investor Peter Kolchinsky is weighing in with a proposed approach to balance access to medicines with the incentive for companies to invest in the development of innovative new therapies. In his new book The Great American Drug Deal, Kolchinsky makes the case for an approach to drug pricing that would ensure that the timely movement of innovative drugs to generic versions while also suggesting mechanisms for cutting the price of therapeutics after patents and exclusivity periods expire when competition fails to arise. We spoke to Kolchinsky about The Great American Drug Deal, his notion of a biotech social contract, and why it’s critical that the industry think differently than it has in the past about approaches to reform drug pricing.

There is growing scientific evidence suggesting that Alzheimer’s disease may be an autoimmune condition. Whether it is or not may be an unsettled issue, but targeting neuroinflammation associated with the disease is viewed by some as a potential therapeutic strategy. INmune Bio is developing an experimental, second-generation, selective TNF inhibitor that targets neuroinflammation. It believes this approach can slow or stop the progression of cognitive and psychiatric symptoms associated with the disease. We spoke to R.J. Tesi, CEO of INmune Bio, about whether Alzheimer’s disease is an autoimmune condition, the role of neuroinflammation in the progress of the disease, and how his company’s experimental therapy differs from existing TNF inhibitors today.

The Gloucester Marine Genomics Institute is seeking to harness biotechnology to discover new therapeutics by studying the DNA of marine life. At the same time, the institute hopes to breathe new life into a 400-year old fishing village that houses it and create new opportunities there. We spoke to Andrea Bodnar, science director at the Gloucester Marine Genomics Institute, about marine biotechnology, the ocean as a source for novel therapeutics, and the institute’s efforts to transform the economy along Cape Ann.

The latest reports on the coronavirus outbreak put the number of infections at nearly 75,000 and deaths at more than 2,100. Against the backdrop of the outbreak, we spoke to Evan Loh, chairman of the Antimicrobials Working Group and CEO of Paratek Pharmaceuticals, about the global changes that are fueling the threat of infectious disease outbreaks, the state of the antimicrobial arsenal, and what needs to be done to spur the development of new agents to combat the rise deadly bugs.

Orchestra BioMed may play at the intersection of drugs and devices, but’s its business strategy is clearly drawn from the biopharmaceutical industry. The company develops its pipeline and then leverages strategic alliances with global partners who can best commercialize its products and maximize their potential. We spoke to David Hochman, CEO of Orchestra BioMed, about the company’s therapeutic devices, the large market opportunities it is targeting, and how it seeks to rewrite the way medtech companies think about partnering.

Psychedelics have long been viewed as having potential to treat a range of mental health disorders including depression, addiction, PTSD, and ADHD. Government policies, though, have long impeded studies of their benefits. Mind Medicine is developing a pipeline of therapies based on psychedelics in the hopes of developing needed medicines for psychiatric conditions. Its lead experimental therapy is an ibogaine-derived molecule for the treatment of opioid addiction. We spoke to Steve Hurst, founder and CEO of MindMed, about the potential for psychedelic-based medicines, what’s known about them to date, and the challenges of working with these substances.

The difficulty in diagnosing Alzheimer’s disease and identifying it at its earliest stages when interventions offer the best opportunity for success, is one of the critical challenges in addressing the neurodegenerative condition. CorTechs Labs has developed quantitative analysis software that allows physicians to analyze brain images to diagnose and monitor patients with the diseases. We spoke to Chris Airriess, CEO of CorTechs, about the difficulty in diagnosing Alzheimer’s disease today, how its technology works, and its efforts to marry its software to genetic data as a way to identify and monitor people who may be at risk of developing the disease.

As people age, the ability of their eyes to focus on objects near to them weakens. The condition, known as presbyopia, affects more than 1.8 billion people worldwide. Though reading glasses provide a solution to the problem, Orasis Pharmaceuticals is developing a corrective eyedrop it says will provide an alternative. We spoke to Elad Kedar, CEO of Orasis, about aging eyes, its experimental eye drop intended to allow people to free themselves from a dependency on reading glasses, and how it works.

Ben Zeskind likens Immuneering’s platform technology to noise-cancelling headphones. Infact, the company’s use of the term “Disease Cancelling Technology” speaks directly to that. The approach, he says, allows the company to build a pipeline of drug candidate that address aspects of disease that have eluded tradition drug development approaches. We spoke Zeskind, CEO of Immuneering, about the company’s evolution from its roots in bioinformatics, its movement into drug development, and how its proprietary platform technology works.

One reason immunotherapies fail is because of the ability to tumors to alter the microenvironment in which they exist and hide themselves from detection by the immune system. In some indications, as few as 20 percent of patients benefit from checkpoint inhibitors. Oncolytics Biotech is developing pelareorep, an immune-oncolytic virus that activates the innate and adaptive immune systems, triggering inflammation in the tumor, and overexpressing checkpoints to increase the number of patients that can benefit from the use of checkpoint inhibitors. We spoke to Matt Coffey, president and CEO of Oncolytics Biotech, about Pelareorep, how it works to treat cancer, and why it can make checkpoint inhibitors more effective.

The brain converts short-term memories into long-term memories through the formation and stabilization of new connections between neurons. Tetra Therapeutics is working to treat cognitive impairment and memory loss from Alzheimer’s disease by developing an experimental therapy intended to stabilize these connections. We spoke to Mark Gurney, CEO of Tetra Therapeutics, about memory loss in Alzheimer’s disease, the company’s experimental therapy to treat the condition, and a recent study he was involved in that suggest TNF inhibitors may provide protection against the condition in patients with autoimmune conditions.

A holiday tradition at The Bio Report is to take a moment to reflect on the year past and look ahead to the new year with Adam Feuerstein, senior writer and national biotech columnist for STAT. We talked to Feuerstein about some of the highs and lows of the year in biotech, a few of the big stories he followed, and the big fourth quarter for biotech stocks. Feuerstein offers us a look at the best and worst CEO of 2019, the upcoming JPMorgan conference, and what to watch in 2020. Last week we released an additional episode of the podcast that featured the Himalayan Cataract Project (https://soundcloud.com/levine-media-group/an-effort-to-eradicate-preventable-blindness), which is working to eradicate preventable blindness throughout the world. There are 18 million people in the developing world who are unable to perform the tasks of daily living because of easily treatable cataracts that can be addressed with a fast and inexpensive procedure. We’re helping raise $100,000 through a GoFundMe Campaign (https://gate.sc/?url=https%3A%2F%2Fcharity.gofundme.com%2Fo%2Fen%2Fcampaign%2Fgiving-the-gift-of-sight-in-ethiopia-and-eritrea&token=26d7bc-1-1577387027965) to bring the organization back to Ethiopia and Eritrea, where on a recent trip to the region they performed 4,300 sight-saving surgeries. If you’d like to learn more, have a listen to the special episode in our feed. We’ll include a link at the bottom of this week’s episode to the campaign. Thanks to all who gave and if you haven’t, we encourage you to consider making a contribution to this cause.

We spend a lot of time on The Bio Report talking about innovation. We are living at a time of great scientific advances that are translating into remarkable therapies that are changing people’s lives. Sometimes, though, the type of innovation needed to address a global health problem has more to do with access and delivery than technology. This was brought home to me when my friend Menghis Bairu, an Eritrean-born physician, life sciences executive, and philanthropist, returned from a recent trip. Menghis had gone to Ethiopia and Eritrea, where he worked with the Himalayan Cataract Project. HCP is working to eradicate curable blindness. There are some 18 million people in the developing world who are unable to perform the tasks of daily living because of easily treatable cataracts that can be addressed with a fast and inexpensive procedure. During a one-week period in these countries, the organization performed nearly 4,500 sight-saving surgeries and provided training to doctors in there. We spoke to Matt Oliva, associate clinical professor in the division of international ophthalmology at the Casey Eye Institute and Oregon Health Sciences University, and a member of the Himalayan Cataract Project board who is involved in the clinical and programmatic direction of HCPs outreach in Ethiopia, about the burden of blindness in the developing world, the global health need HCP is addressing, and its model for delivering care and training to cure preventable blindness. We’re doing this special edition of The Bio Report podcast to help Menghis’ fundraising efforts to bring HCP back to Ethiopia and Eritrea in 2020. The campaign is seeking to raise $100,000. We’ve provided a link to the GoFundMe campaign (https://charity.gofundme.com/o/en/campaign/giving-the-gift-of-sight-in-ethiopia-and-eritrea). We encourage all of our listeners to consider making a contribution to support the effort.

Inhaled insulin has been one of those biotech ideas that have seemed better on paper than in practice. Huge investments have been made to carry these products through challenging development only to end in market flops. Aerami Therapeutics, a company founded by one of the pioneers in the field, is advancing its version of inhaled insulin and building a pipeline of other inhaled biologics behind it We spoke to Anne Whitaker, CEO of Aerami, about its pursuit of inhaled insulin, why she believes the company will be able to avoid the pitfalls others have faced, and the case for delivering insulin and other biologics through the lung with its technology.

In August, Nabriva Therapeutics won U.S. Food and Drug Administration approval for Xenleta for the treatment of community-acquired bacterial pneumonia in adults. It was the first new antibiotic with a novel mechanism of action approved by the FDA in nearly two decades for the condition. We spoke to Ted Schroeder, CEO of Nabriva about Xenleta’s unique mechanism of action, why it may be less prone to the development of resistance, and why policymakers still need to take additional steps to spur development of novel antibiotics.

Healthcare decisions are often flawed because of the limited information on which they are based. But with the growing ability to capture massive amounts of data digitally and apply artificial intelligence to its analysis, there is a growing potential to gain better insights into healthcare and improve patient outcomes. Komodo Health has an ambitious plan to do that with its AI-drive platform that captures 15 million patient encounters with the healthcare system daily to provide a real-time picture of patients and their various encounters. We spoke to Aswin Chandrakantan, chief medical officer and senior vice president of corporate development at Komodo Health, about the changing data landscape, how Big Data has the potential to reshape healthcare decision-making, and what it is enabling everyone from patient groups to payers to do differently.

In the United States, more than 100,000 people are on a transplant waiting list and many other simply do not qualify. In 2009, 25 people per day died while on the waiting list. Transplant procedures are costly and require lifelong use of immunotherapies. BioLife4D is seeking to disrupt organ transplantation with the development of bioprinted hearts produced using a patient’s own cells. The technology also has the potential to have an impact in other areas, such as drug discovery and development. We spoke to Steve Morris, founder and CEO of BioLife4D, about its effort to bioprint a transplantable human heart, a recent milestone it achieved to produce a mini-heart, and the range of challenges it must overcome to make its vision a commercial success.

Sermo describes itself as a “virtual doctors’ lounge” where physicians can express their opinions and interact with other doctors. One of the newer features on the physician-only social network is the ability to crowdsource solutions for difficult cases. We spoke to Erin Fitzgerald, senior vice president of marketing at Sermo, about the social networking platform, how it’s used to solve hard-to-crack cases, and the business model underlying the free service for physicians.

Essential tremors, uncontrollable shaking of the hands, arms, and other parts of the body, have been traditionally treated through drugs or surgery. Cala Health is providing a new option to patients with its wristwatch-like neuromodulation device that uses electrical pulses to stimulate peripheral nerves to treat the condition. We spoke to Renee Ryan, CEO of Cala Health, about the company’s Cala Trio device, the potential for bioelectric medicine to treat a broader range of neurologic, psychiatric, and cardiologic indications; and what it will take to get payers and providers to embrace the technology.

The ability to engineer biological systems to replace chemical processes is making the promise of the emerging bioeconomy a reality. Some of the leading industry players, though, see a growing need to have a voice in the policy arena and have formed the Bioeconomy Alliance to ensure the sector can flourish and realize its potential. We spoke to Jason Gammack, chief commercial officer of Inscripta and a founding member of the Bioeconomy Alliance, about how synthetic biology is reshaping the economy, why there is a need for this new organization, and the issues it will address.

Efforts to develop effective therapies to treat Alzheimer’s disease have been stymied by a long history of clinical failures. Those disappointments have included two, late-stage failures of AC Immune’ Crenezumab, which the company is developing with it partner Roche. The two companies are continuing to pursue the drug under the belief that treating patients earlier in the progress of the disease will be critical. We spoke to Andrea Pfeifer, CEO of AC Immune, about the company’s efforts to identify and treat Alzheimer’s at its earliest stages, its efforts to develop a vaccine against the condition, and why she believes the future of Alzheimer care will involve combination therapies similar to what has emerged in the area of cancer.

The study of microbes and their interactions is changing our understanding of biology, but only a small fraction of microbial species have been cultured. One of the challenges researchers have faced is the limits of existing tools used to study microbes. We spoke to Peter Christey, co-founder and CEO of GALT, about our emerging understanding of the microbiome, the need for a technological transformation of microbiome-based science, and how his company is hoping to fuel the emergence of new insights with its high-throughput technology to isolate and cultivate microbes.

Cofactor Genomics believes RNA provides a better means than DNA and other biomarkers to diagnose disease, monitor health, and enhance treatment decisions. The company’s Predictive Immune Modeling provides insight into a cancer patient’s immune response at the tumor to determine whether an individual is likely to response to an immunotherapy. We spoke to Jarret Glasscock, founder and CEO of Cofactor Genomics, about its RNA diagnostics, the case for the use of multidimensional biomarkers, and the challenges it faces with physician adoption and reimbursement.

Scientists can understand individual tumors at a molecular basis, but clinician don’t yet routinely profile and treat cancers based on this knowledge. Strata Oncology, with drug developers as its customer, is providing tumor profiling to cancer patients in the hopes of directing them into appropriate clinical trials. We spoke to Dan Rhodes, co-founder and CEO of Strata, about the state of precision medicine, Strata’s business model which works around the often-difficult issue of reimbursement for in vitro diagnostics, and the company’s long-term plan for building a commercial diagnostics business.

Bellicum Pharmaceuticals is developing cellular immunotherapies that modulate T cell function through controllable molecular switches. The company is developing these immunotherapies to treat a range of cancers, as well as rare inherited blood disorders. The company believes the ability to modulate these cells once they are in the body will provide safer and more effective immunotherapies. We spoke to Rick Fair, CEO of Bellicum, about the company’s approach, how its molecular switches work, and its current therapeutic pipeline.

Senti Bio is using synthetic biology to build intelligence into cell and gene therapies, altering the way they act depending on the changing biological circumstances they may encounter in the body. Doing so may lead to safer and more effective therapies and address such things as the tumor microenvironment and mechanisms cancer have to grow, spread, and become resistant to treatments. Ahead of his appearance at the SynBioBeta conference that runs October 1-3 in San Francisco, we spoke to Tim Lu, co-founder and CEO of Senti Bio, about the company’s efforts to engineer a new class of intelligent medicines, its ability to design therapies that hit multiple targets, and its strategy to leverage its technology to reach beyond oncology through partnerships.

Nurix Therapeutics is harnessing the body’s natural process for controlling protein levels to target and degrade proteins that drive cancer and other diseases. Its small molecule therapies control key enzymes responsible for protein breakdown and can be used to modulate the levels of proteins within cells. The company believes it can leverage the approach to treat a range of diseases. We spoke to Arthur Sands, CEO of Nurix, about the company’s discovery platform, its pipeline of cancer therapies, and its recent collaboration with Gilead Sciences to discover and develop drug candidates against up to five targets.

The biopharmaceutical industry has been embracing artificial intelligence as a way to address complex issues of drug design and development, but Aktana is betting that such big data analysis can improve decision-making around sales and marketing too. Aktana’s AI technology integrates with a company’s customer relationship management system to synthesize data from a wide variety of sources and guide marketing teams and sales reps about such things as which physicians to contact, when to do so, and how to best approach them. We spoke to David Ehrlich, president and CEO of Aktana, about the company’s decision support products, how they work, and the case for using AI to improve sales and marketing decision-making.

When David Fajgenbaum was in medical school, he became stricken with a rare autoimmune disease that nearly killed him. Though he recovered, he would suffer recurring, life-threatening flares only to discover the poor state of research into condition. Fajgenbaum chronicles his rare disease journey and his efforts to drive research and find treatments in his new book “Chasing My Cure: A Doctor’s Race to Turn Hope into Action.” Fajgenbaum, who is executive director of the Castleman Disease Collaborative Network, will be featured at this year’s Global Genes Rare Patient Advocacy Summit, which begins in San Diego September 18. Ahead of the summit, we spoke to him about his experience as a rare disease patient, his efforts to find treatments for his conditions, and how his innovative approach to developing a patient-driven research agenda has provided a roadmap for other rare disease organization to follow suit.

Among the many challenges to developing stem cell therapies is the need to match donors to recipients and the risk of graft vs. host disease that requires the use of immunosuppressants. Athersys has developed a stem cell therapy platform known as MultiStem that makes use of a type of stem cell that doesn’t carry the risk of causing an immune response. What’s more, cells from a single donor can be expanded to provide potentially millions of doses to treat a wide range of conditions making it a scalable, off-the-shelf therapy. The company’s is in late-stage clinical testing of its cell therapy for the treatment of ischemic stroke, a leading cause of serious disability. We spoke to Gil Van Bokkelen, CEO of Athersys, about the company’s MultiStem platform, how it works, and the range of indications it is pursuing.

Immunotherapies have mostly sought to harness the adaptive immune system, but Silverback Therapeutics believes its technology platform will allow it to enlist the innate immune system in the fight against cancer, fibrosis, and infectious diseases. The company is developing antibody conjugates that activate myeloid cells to target tumors. It’s lead indication is in HER-2 positive tumors. We spoke to Peter Thompson, co-founder and CEO of Silverback, about the company’s platform technology, its potential applications, and the challenges of activating the innate immune system in a targeted fashion.

Artificial intelligence is all the rage in drug discovery today, but there are efforts to apply to technology to other aspects of the drug development continuum to improve decision making and increase efficiency. One such example is Phesi, which has developed an artificial intelligence platform to improve clinical site selection, evaluate protocol designs and patient inclusion criteria, and manage the implementation of trials. We spoke to Gen Li, founder and president of Phesi, about his company’s AI platform, how it works, and the case for the use of artificial intelligence as a tool to improve drug development.

Antibody-drug conjugates marry the precise targeting of an antibody to a cytotoxic payload. That has the potential to provide a powerful treatment approach to a variety of cancers with less toxicity than systemically delivered chemotherapy. The problem has been producing large quantities of antibody-drug conjugates in a consistent manner where all the pieces are where they belong. Sutro Biopharma has developed a technology platform that allows it to precisely design and consistently manufacture these molecules. We spoke to Bill Newell, CEO of Sutro, about the promise of antibody-drug conjugates, the company’s platform technology, and its lead therapeutic candidates.

While much of the focus of drug developers looking to act on the genetic mechanisms underlying diseases has focused on the genes that code for proteins, Syros Pharmaceuticals is looking to the regulatory regions of the genome. This is the noncoding part of the genome that controls the expression of genes, turning them on or off, or modulating their level of activity. We spoke to Eric Olson, chief scientific officer of Syros Pharmaceuticals, about the company’s discovery platform, its pursuit of cancer and monogenic diseases, and the lead programs in its pipeline.

Anixa Biosciences is harnessing the immune system to both diagnose and treat cancer. It recently announced a licensing agreement with the Cleveland clinic for a novel breast cancer vaccine that is being developed for both therapeutic and prophylactic use. It’s lead candidate is a CAR-T cell therapy in development for ovarian and other solid tumors. We spoke to Amit Kumar, president and CEO of Anixa, about the company’s strategy to pursue both therapeutic and diagnostic products, its partnerships with leading research institutes, and its development strategy going forward.

There’s growing interest in cannabinoids for their therapeutic potential in a range of conditions, but one challenge therapeutic developers face is a reliable and consistent supply. Teewinot Life Sciences is using synthetic biology to produce a range of cannabinoids. We spoke to Michael Luther, president and CEO of Teewinot Life Sciences, about the companies process for producing cannabinoids, its business model, and the therapeutic and consumer areas it plans to pursue.

Much has been made about a cancer moonshot, but in the world of oncology, rocket fuel is rarely a topic of conversation except maybe as a metaphor. EpicentRx, though, is looking to rocket fuel as a source for its lead experimental therapy RRx-001. It believes this high-energy molecule, derived from rocket fuel, has the potential to improve immunotherapies and radiotherapies, as well as having anticancer activity on its own. We spoke to Corey Carter, president and CEO of EpicentRx about how RRx-001 came about, how it works, and the company’s oncolytic viral pipeline also in development.

The complexity of individual tumors creates a challenge for physicians to determine the optimal treatment for any given patient. This complexity may also require a combination of therapies to target the multiple pathways a given cancer may exploit to grow and spread. My Personalized Therapeutics is taking a model systems approach to pair patients to customized drug regimens by using fruit fly models of a patient’s cancer to screen hundreds of FDA approved therapies and combinations. We spoke to Laura Towart, co-founder and CEO of My Personalized Therapeutics, about the company’s Personalized Discovery Process, how it works, and why it may lead to better outcomes for cancer patients.

As biomedical data proliferates and the life sciences becomes more closely integrated with data science, the ability for researchers to access, use, and learn from the growing universe of information requires new tools. InveniAI is seeking to address this need with its artificial intelligence platform for biopharmaceutical companies to both monitor innovation and to enhance their own drug development capabilities. We spoke to Krishnan Nandabalan, president and CEO of InveniAI, about the company, how its artificial intelligence platform is being used, and what he expects the ultimate payoff from this technology will be.

The convergence of information technology with the life sciences is opening up new ways of approaching the challenges of drug discovery and development. While much has been made about approaches that seek to leverage artificial intelligence, Nanome is bringing virtural reality into the process. With the company’s technology, scientists can take a fantastic journey to view and manipulate proteins, compounds, and other molecules at a nanoscale. We spoke to Steve McCloskey, founder and CEO of Nanome, about the company’s virtual reality platform, how scientists can use it to collaborate in real time, and its potential to change the way researchers discover and develop drugs.

The high cost of developing therapies impedes the pharmaceutical industry’s ability to bring innovative products to market, but also leaves potentially valuable discoveries languishing on university shelves. The Swiss non-profit foundation Molecule is trying to alter the landscape by establishing an online marketplace to create shared ownership of intellectual property and provide a new funding mechanism for early-stage experimental therapies that could also lead to distributed research and development of promising drugs. We spoke to Paul Kohlhaas, founder of Molecule, about the market it is developing, how it would work, and the challenges it will need to overcome to make it a reality.

Mesenchymal stem cells may be a powerful way to treat a range of medical conditions but realizing the therapeutic potential of these cells has been hampered in part by the challenges of manufacturing a consistent product at scale. Cynata Therapeutics believes its platform technology addresses these challenges. The company lead cell therapy candidate is being developed to treat graft vs. host disease, a potentially deadly response to the transplantation of cells from a donor. We spoke to Ross MacDonald, CEO of Cynata, about the company’s platform technology, the potential for these therapies, and the indications the company is pursuing.

The placebo response in clinical trials can derail a promising experimental therapy that might benefit patients. In cases where trials rely on subjective endpoints or patient-reported outcomes, the placebo response can be more pronounced. Tools4patient has developed a means of identifying patients who are likely to be placebo responders and allow trial sponsors to take steps to account for that in clinical studies. We spoke to Erica Smith, vice president of business development at Tools4Patient, about the placebo response, the consequence this phenomenon has on drug development, and how the company is seeking to address this problem.

Artificial intelligence is being embraced the pharmaceutical industry as a way to reduce the time and cost of drug development. BioXcel Therapeutics is using AI to leverage as a means to identify new targets for approved drugs and clinically-validated drug candidates with a focus on oncology and neurology. We spoke to Vimal Mehta, CEO and founder of BioXcel Therapeutics, about the company’s AI platform, what makes it unique, and its pipeline of repurposed therapies.

The ability to capture and parse data in real-time and at a vast scale is transforming our approach to biomedical research and has the potential to change the way we think about the causes of disease, public health, and medical interventions. Paul Glimcher, president and CEO of Datacubed Health and professor of Neural Science, Economics and Psychology, at New York University, where he directs the Institute for the Study of Decision Making, is conducting an ambitious study known as The Human Project. The study will gather data on the everyday habits and health of 10,000 New Yorkers over 20 years to find critical connections between biology, behavior, and the environment to drive evidence-based public policies to improve lives. Through his company Datacubed Health, he’s using the same technologies to drive patient-centered research. We spoke to Glimcher about his work, how technology is changing the nature of health research, and how he sees digital technology transforming the healthcare continuum from discovery to care.

Cidara Therapeutics is developing new anti-infectives using its Cloudbreak platform to develop antiviral conjugates that both directly kill pathogens and also enlist a patient’s immune cells to attack and eliminate them. The company is advancing its first therapy developed through the platform to the clinic, CB-012, an experimental therapy that is being developed to both treat and prevent flu infections. We spoke to Jeff Stein, CEO of Cidara, about the therapy, how it works, and the need the company is trying to address.

Roivant Sciences doesn’t fit easily into conceptions of drug companies, venture capital firms, or accelerators. It is building highly-focused drug development companies around promising undervalued assets it licenses. In five years’ time, it’s raised more than $3 billion, amassed a broad pipeline of more than 35 therapies, and has more than 800 employees. We spoke to Eric Venker, chief operating officer of Roivant, about the company’s business model, how it leverages its resources, and how it may be changing the industry’s approach to drug development.

Advances in precision medicine have helped to reshape the cancer landscape with the development of diagnostics to determine whether a patient may benefit from a specific drug. Little progress, though, has been made outside of the area of oncology to avoid the waste of time and money on therapies that won’t work for an individual patient. Scipher Medicine is working to change that for the treatment of autoimmune diseases by identifying which patients would benefit from which drugs. We spoke to Alif Saleh, CEO of Scipher, about the company’s approach, the opportunity it is addressing, and how he sees the area of precision medicine evolving.

Concerns about the threat posed by the growth of drug-resistant pathogens has often focused on the need to reinvigorate our arsenal of antibiotics, but health authorities are paying new attention to the rise of invasive fungal infections. Globally, about 1.5 million people each year die from these infections. There’s been a lack of investment and innovation in new types of antifungals and the worry is growing about the emergence of fungal strains that are resistant to existing treatments. We spoke to Ciara Kennedy, president and CEO of Amplyx, about the need for new antifungals, why this problem is emerging, and her company’s first-in-class experimental therapy to fight fungal infections.

The effort to cost-effectively accelerate the development of new therapies has led to the rise of new business models that seek to provide expertise, capital, and access to professional networks that can help early-stage companies navigate pitfalls and overcome challenges. Xontogeny is a bit of a hybrid in its approach, preferring the term aggregator to accelerator or incubator. We spoke to Chris Garabedian, chairman and CEO of Xontogeny, about the company’s approach, what it looks for in the biotechs it backs, and what he’s learned from his own experience as a biotech executive that he thinks will benefit others.

Agenus is an immuno-oncology company with a long history and a broad portfolio. To help fund its pipeline, it entered into a significant alliance with Gilead Sciences in December 2018 and has used an unusual funding mechanism by raising money through what it described as the first asset-backed digital-security offering. We spoke to John Castle, head of translational medicine and bioinformatics at Agenus, about the company’s approach to managing and prioritizing its pipeline, its use of artificial intelligence, and the recent deals it’’s done to fund development.

The recent late-stage failure of another high-profile Alzheimer’s disease drug candidate is a reminder of the challenges of developing drugs for neurological diseases. These challenges are driven by the fact that there are hundreds of different brain cell types and complex circuits and pathways in the brain that make it difficult to identify the right protein to target to treat a given disease. Cerevance says its proprietary platform overcomes the limitations of must approaches used today to study human brain cells. We spoke to Brad Margus, CEO of Cerevance, about the company’s platform technology, how it addresses the challenges drug developer face, and the programs it has advanced to date.

Intensity Therapeutics argues that cancer is both a micro and macro disease. Therapies need to act at the site of tumors, but they also need to treat the systemic effects of the disease that results from micro-metastases. Intensity is developing cancer therapies that are delivered directly into tumors, but also stimulate the innate immune system to address the more systemic effects of cancer. We spoke to Lewis Bender, CEO of Intensity, about the company’s platform technology, how it enlists the innate immune system in the battle against cancer, and the thinking behind the company’s approach.

SQZ Biotech believes its platform technology can enable the engineering of virtually any function into any cell type allow for a new world of cell therapies to revolutionize the treatment of diseases. As its name implies, it does this by squeezing a cell to momentarily disrupt its membrane to allow it to insert a range of substances. We spoke to Armon Sharei, CEO of SQZ Biotech, about the company’s platform technology, its initial focus on oncology and auto-immune diseases, and the broad potential for this approach.

As concerns grow about the rise of antibiotic resistant bugs, the ability to combat them is being undermined by the economics of antibiotic drug development. Many large pharmaceutical companies stepped away from the space and despite the passage of the GAIN Act in 2012 and government investment in antibiotic research and development, drug companies argue more action is needed. We spoke to Michael Dunne, chief scientific officer at Iterum Therapeutics, about the state of the antibiotic arsenal today, the challenges drug developers face, and whether Congress will be willing to provide the industry incentives to address societal needs at a time when there is growing animosity towards the industry over issues such as pricing.

Neurotrope is developing its experimental therapy bryostatin as a potential treatment for Alzheimer’s disease and other neurodegenerative conditions. The company believes the drug has multiple mechanisms of action and can stimulate synaptic growth factors to repair damaged synapses, form new ones, and prevent neuronal death. The company, though, found itself in a controversy over the way it characterized results from a phase 2 study of the drug in 2017. It is now conducting a second phase 2 study of the drug in the hopes of demonstrating meaningful benefits for patients. We spoke to Daniel Alkon, chief scientific officer of Neurotrope, about bryostatin, the controversy over the way it reported its previous results, and the path forward for the drug.

As people age, their bodies lose the ability to regenerate as well as they were able to when they were younger. Alkahest believes this is tied to changes in the mix of proteins that are present in the blood as we age. It is developing therapies for diseases of aging that seek to target specific proteins that are upregulated in diseases of aging, as well as providing a wide set of proteins drawn from purified human plasma as a therapeutic approach to counter the depletion of regenerative proteins. We spoke to Elizabeth Jeffords, chief commercial and strategy officer for Alkahest, about the science underlying the company’s approach, the controversy around others who have offered so-called “young-blood” transfusions, and the pipeline the company is pursuing.

There was a time when scientists could spend their careers talking only to other scientists about their work, but that’s changed. Whether it’s the current funding climate, the need to understand complex scientific issues underlying public policy debates, or opportunities to fund translational work and commercialize important discoveries, scientists are increasingly being tasked with addressing lay audiences. In “Championing Science: Communicating your Ideas to Decision Makers” the husband and wife team of Roger and Amy Aines offer a detailed guide for scientists on how to communicate effectively with non-scientists. Roger Aines is chief scientist of the energy program at Lawrence Livermore National Laboratory and Amy Aines is CEO of Damianakes Communications. Each bring their professional experience to the book. We spoke to the duo about their book, why it's needed, and why they believe scientists not only need to learn how to communicate their ideas, but to compel action and change the world for the better.

Kleo Pharmaceuticals is a developing next-generation immuno-oncology drugs that are small-molecule compounds designed to act like biologics. Kleo’s compounds activate patients’ immune systems to target and destroy cancer cells but are faster and less costly to design and produce than biologics. We spoke to Doug Manion, CEO of Kleo, about the company’s platform technology, why he thinks it will produce safer and more effective immunotherapies, and the potential to use these compounds in conjunction with existing biologics to enhance their activity.

Josiah Zayner calls himself a biohacker. He’s got a Ph.D. in molecular biophysics from the University of Chicago and worked as a fellow in NASAs synthetic biology program. But it is Zayner’s evangelism for democratizing the tools of biotechnology, his flair for attention-grabbing self-experimentation, and efforts to share the knowledge and equipment necessary to perform procedures like gene editing that have given him some notoriety. As founder and CEO of The ODIN, Zayner is helping move biotechnology from the labs of universities and biopharmaceutical companies to high schools and garages. We spoke to Zayner about his efforts, how biotechnology is becoming accessible to laypeople, and how he sees this fueling innovation.

One-third of adults suffer from high blood pressure and 9.4 million people a year will die from complications relating to the condition. In fact, cardiovascular disease remains the leading cause of death worldwide. Quantum Genomics is developing a new class of drugs that target an enzyme in the brain for the treatment of high blood pressure and the prevention of related cardio-vascular risks. We spoke to J.P. Milon, CEO of Quantum Genomics, about its platform technology, how it works, and why it may have promise as an approach to treating both hypertension and heart failure.

Atrial fibrillation, a condition characterized by an irregular and rapid heartbeat, affects up to 6.1 million Americans and can cause strokes. It is not well addressed by current medical approaches. Chris Larson, an adjunct associate professor at Sanford Burnham Prebys Medical Discovery Institute is part of a team working to find new drugs to treat the condition by identifying every gene in the human genome that can affect the rhythm of the heart. We spoke to Larson about the condition, SBP’s drug discovery efforts, and why he left industry to work on drug discovery at a non-profit institute.

Current therapies for autoimmune diseases represent a $100 billion market, but available drugs often provide limited benefits to patients or cause problematic side effects. Landos Biopharma is targeting the area of autoimmune diseases with an initial focus on inflammatory bowel disease by pursuing therapies that target a novel pathway. We spoke to Landos founder and CEO Josep Bassaganya-Riera, about IBD, why new therapies are needed, and the approach Landos is taking.

The ability to print human tissue is changing the way drug research is conducted today and opens the possibility of one-day printing replacement organs with the technology. CellInk saw an opportunity in making bioinks and started to produce a line of lower-priced printers as well in the hopes of expanding the marketing by lowering the cost of the technology. We spoke to Erik Gatenholm, CEO and co-founder of CellInk, about the technology, how its being used today, and how he expects applications for it to evolve.

Bing Wang trained as an electrical engineer, but his experience as a cancer survivor led him into the world of healthcare investment banking and then to his current role as CEO of the cancer therapeutics company Refuge Biotechnologies. Refuge is leveraging CRISPR technology, but rather than editing genes, the company is using it as a way to activate or inhibit specific genes by harnessing it for its targeting mechanism. We spoke to Wang about his own journey from patient to CEO, the company’s technology, and why he believes this will lead to safer and more effective cancer therapies.

As the year draws to a close, we continue what’s become an annual tradition and look back on the year in biotech and ahead to the J.P. Morgan Healthcare Conference and beyond with Adam Feuerstein, senior biotech writer for STAT News. Adam tries to make sense of a puzzling year for biotech that seemed full of contradictions, offers some thoughts on the highs and lows of the past 12 months, and discusses what he’ll be watching for during the J.P. Morgan Healthcare Conference.

The ability to manipulate and understand biology at the molecular level coupled with powerful computing capabilities is opening up new possibilities to harness technology to improve human health. The OS Fund is focused on investing in entrepreneurs developing platform technologies that have the ability to address global problems. We spoke to Bryan Johnson, co-founder of the OS Fund, about his investment vision, what it takes to attract his eye, and how he sees these platform technologies reshaping the world healthcare and beyond.

Paul Keckley is a long-time healthcare policy analyst whose both worked within hospital systems and advised major healthcare organizations, but when he recently collapsed on a golf course due to severe dehydration, he was given an up-close and personal view of the murky world of hospital billing. We spoke to Keckley about his experience, the challenges of deciphering hospital bills, and why he thinks it will be market forces, rather than price transparency, that rein in healthcare costs.

Matt State is known for his work trying to understand the biology underlying psychiatric illnesses, but as the chairman of the University of California, San Francisco’s Department of Psychiatry, part of his job has been to help address the city’s homelessness crisis. Homelessness is a complex issue, but the role mental health plays in the problem is often overlooked. With about 10,000 people who are homeless in San Francisco, more than a third of these people have a psychiatric or substance abuse problem. We spoke to State about the connection between homelessness and mental health issues, UCSF’s efforts in this area, and how it fits with the mission of a leading public institution.

Gecko Biomedical’s first product Setalum is a sealant that prevents bleeding after the use of sutures to repair blood vessels, but the polymers underlying the product represent a platform technology that can be used to develop a broad array of tissue reconstruction offerings addressing bone, nerve, ophthalmic, and urological applications. We spoke to Christophe Bancel, CEO of Gecko, about the company’s platform technology, its versatility, and how the company is looking to partnering to expand its reach.

In 1988, researchers showed that they could extend the lifespan of worms by manipulating the genetics of these model organisms. The implications that the normal aging process could be altered ignited scientific research into the emerging area of geroscience. As the Buck Institute for Research on Aging readies to mark the anniversary of this landmark research with a day-long celebration, we spoke to Gordon Lithgow, chief academic officer of the Buck. Lithgow discussed how the field has advanced from that key discovery, our understanding of aging today, and what progress has been made to identify compounds that could extend healthy years of life.

People with attention-deficit/hyperactivity disorder who use stimulants to treat the condition often face afternoon crashes and require the use of booster doses. Cingulate Therapeutics is using its proprietary drug delivery technology to target this $14 billion market with timed released formulations of commonly used ADHD drugs it is developing. We spoke to Shane Schaffer, CEO of Cingulate, about ADHD, the company drug delivery technology, and its clinical path forward.

Problems of women’s reproductive health represent a growing worldwide concern, but it remains an area of unmet medical needs. ObsEva is advancing a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. We spoke to Ernest Loumaye, CEO of ObsEva, about the issue of women’s reproductive health, the company’s lead therapies in development, and the plan for commercializing its products.

CytoDyn’s lead candidate for HIV is part of a new class of therapies that work by protecting healthy cells by blocking viral infection. But the receptor that the drug targets also plays a role in cancer metastasis and may provide a new approach to treating a wide range of cancers. We spoke to Richard Pestell, chief medical officer of CytoDyn, about the drug, how it works, and why it may have value in a range of serious medical conditions.

The rise of the Internet, social media, and communications technology has transformed consumer behavior. Consumers today are better informed, expect a high-level of engagement, and a modern service experience. Shay Brill, vice president of corporate development for Atlantic Research Group, in a white paper released at the recent Global Genes Rare Patient Advocacy Summit, argues that similar changes are underway in the behavior of patient-consumers. We spoke to Brill about these trends, how they’re is changing drug developers’ relationships with patients, and what these changes mean for sponsors of clinical trials.

DxTerity is a genomics company that’s providing real-world monitoring of patients with autoimmune disease with from-home RNA testing to improving the management of these conditions. The company’s technology not only has the potential to change the way diseases such as multiple sclerosis, lupus, and rheumatoid arthritis are managed, but change the way clinical trials in these conditions are conducted. We spoke to Bob Terbrueggen, CEO of DxTerity, about the company’s from-home RNA tests, how they work, and the potential application of the technology.

The availability of a growing body of real-world evidence has regulators considering how clinical trials using disparate sources of data might work. Many see harnessing such information as a way to provide better insight into the safety and efficacy of drugs while reducing the cost of clinical trials. A number of issues, though, will need to be addresses as the U.S. Food and Drug Administration takes a first pass at a framework for using real-world evidence. We spoke Nancy Dreyer, chief scientific officer & senior vice president of real-world & analytic solutions for IQVIA, about real-world data, its potential to change the way clinical trials are conducted, and the challenges to applying it.

Immunotherapies are changing the way physicians treat various cancers, enabling and enlisting a patient’s immune system in the fight against a deadly disease. But this approach has largely been limited to the field of oncology. Cidara Therapeutics, which is developing new anti-infectives, is using its Cloudbreak platform to develop antibody-drug conjugates that directly kill pathogens and also direct a patient’s immune cells to attack and eliminate bacterial, fungal, or viral pathogens. We spoke to Jeff Stein, CEO of Cidara Therapeutics, about the company’s platform technology, the pipeline its advancing, and why innovative approaches are needed to address infectious disease.

Nucleoside analogs are a widely used class of chemotherapeutic agents, but the ability of cancer cells to evade them and develop resistance limits their benefits and increases their side effects. NuCana, which is developing a new class of cancer agents dubbed ProTides believes it can address this problem with nucleoside analogs by delivering them efficiently into cancer cell and preventing their degradation before they can act. We spoke to Hugh Griffith, founder and CEO of Nucana, about the pr oblems of resistance, how the company’s ProTide technology works, and the pipeline the company is advancing in the clinic.

Synlogic is using synthetic biology to engineer probiotic bacteria to deliver therapeutic benefit. By targeting the microbiome of the gut, the company believes it can produce systemic effects to treat metabolic and other diseases with its new class of therapies it dubs Synthetic Biotics. We spoke to Aoife Brennan, interim CEO and chief medical officer of Synlogic, about the company’s platform technology, how its seeking to exploit the microbiome, and how its engineered bacteria may offer a safer and more effective way to treat certain conditions.

One way to improve drug discovery and development is to work with more accurate models of human biology and human disease. Organ-on-a-chip technology that provides three-dimensional cell models in conventional microfluidic plates is helping to do that. Mimetas is one company that’s delivering this technology to the hands of researchers today. We spoke to Jos Joore, co-founder and CEO of Mimetas about the technology, how its changing drug development, and whether organ-on-a-chip technology may one day find its way into the clinic.

Insilico Medicine is working to harness artificial intelligence to address diseases of aging and in the process reinvent the way new drugs are discovered and developed. Its AI platform is integrated into the continuum of the discovery and development process and seeks to improve target identification, the selection of drug candidates, and predict clinical trial outcomes. In addition to working in collaboration with the large pharmaceutical companies, Insilico is pursuing internal drug discovery programs in range of diseases of aging. We spoke to Alex Zhavoronkov, CEO of Inisilco Medicine, about the company’s platform technology, the potential for AI to transform the discovery and development of drugs, and why Insilico focuses its efforts on diseases of aging.

Digital health technologies are providing new ways of monitoring patients and delivering care. In the realm of clinical trials, they provide a way to remove geographic barriers to patient participation, improve compliance, and reduce costs while also creating a way to capture real-world data. We spoke Bryan Silverman, CEO of ObvioHealth, about the company’s ClamiIt platform, the workings of siteless clinical trials, and the potential for digital technologies to address a variety of challenges trial sponsors face.

The convergence of artificial intelligence and the life sciences is promising to revolutionize the entire healthcare continuum including the way drugs are discovered, how clinical trials are conducted, the methods physicians use to diagnose patients, and how patients are monitored and treated. The life sciences investment firm Foresite Capital, armed with a new $668 million fund, is helping to bring about this change by backing innovative companies working at this nexus information technology and biotechnology. We spoke to Brett Zbar and Vik Bajaj, managing directors of Foresite, about their new fund, what constitutes a Foresite investment, and why they believe this is not just the latest fad, but a meaningful change in the way life sciences companies seek to address the challenges in all aspects of healthcare.

In this encore edition of The Bio Report, we revisit an interview that original ran in December 2017. Climate change and the increasing frequency and intensity of extreme weather events carry a toll on human health. Not only do floods, hurricanes, and other similar phenomenon cause death and injury, they also create long-term health effects. Jesse Bell, a research scientist at the North Carolina Institute for Climate Studies at North Carolina State University recently examined the issues in an article in the Journal of the Air & Waste Management Association. We spoke to Bell about the health consequences of these weather events, the challenges they create for public health systems to plan and prepare, and why new research is needed to better understand the relationship between these events and human health.

One of the reasons for the high cost of drug development is that most drugs fail in clinical development. Even though preclinical testing can provide a good insight into whether a drug hits an intended target, once in the body, drugs can interact with a large number of proteins and have unintended consequences. A-Alpha Bio, a spinout from the University of Washington's Institute for Protein Design and Center for Synthetic Biology, is developing a platform that can measure thousands of protein interactions simultaneously and how drugs affect them. We spoke to David Younger, co-founder and CEO of A-Alpha, about the company’s platform, the bottleneck in drug development it is addressing, and the business model it is pursuing.

Stem cell therapies represent an area of great promise for treating intractable eye diseases, but there’s growing concern about clinics that promote costly stem cell treatments that have not been approved by the U.S. Food and Drug Administration and have not been proven to be safe or effective. This is already a multi-billion business and researchers have found some disturbing practices that have resulted into harm to patients. We spoke to Ajay Kuriyan, assistant professor at the Flaum Eye Institute and University of Rochester Medical Center, about his research into these clinics, how they sometimes disguise their work as legitimate clinical trials, and why this represents a threat not only patients, but this emerging therapeutic area.

Say “Oklahoma” and someone might think of wheat fields, natural gas, or the wind sweepin' down the plain. Cutting edge biomedical research, though, is probably not the first thing that comes to mind. Nevertheless, the Oklahoma Medical Research Foundation has for more than 70 years been conducting innovative scientific work that has forged new understandings of disease and made discoveries that have led to new drugs and diagnostics. We spoke to Manu Nair, vice president of Technology Ventures for the Oklahoma Medical Research Foundation, about the work it does, its efforts to commercialize its discoveries, and the challenges of getting on industry’s radar when you are outsides of a major biotech center.

Recursion Pharmaceuticals is reinventing the drug discovery process by turning biology into a data science problem. The company has set an audacious goal for itself of developing 100 drugs in 10 years. Though Recursion initially focused on repurposing existing drugs to treat rare diseases, it has expanded its work into new disease areas and is looking at new chemical entities as well. We spoke to Chris Gibson, founder and CEO of Recursion, about the approach the company is taking, the challenges of mixing biologists and data scientists together, and why he’s holding fast to his goal of attaining an unparalleled level of drug development efficiency through the use of artificial intelligence.

The blood-brain barrier provides essential protection against pathogens while allowing needed oxygen and nutrients to pass. However, one challenge it presents is getting therapeutics delivered to the brain and central nervous system. Bioasis Technologies has developed a way to attach fusion proteins to drugs to allow them to pass the blood-brain barrier. We spoke to Mark Day, CEO of Bioasis, about its platform technology, what is known about it from testing to date, and the potential therapeutic implications of being able to deliver drugs systemically that can reach the central nervous system and brain.

There’s been much made of the potential of the microbiome to address disease and promote wellness. While much of the therapeutic efforts in this area have focused on the microbiome of the gut, Azitra has developed a platform for selecting bacteria native to the skin and engineering it to produce therapeutic proteins. We spoke to Travis Whitfill, chief science officer of Azitra, about the company’s platform, why it may be preferable to apply bacteria to the skin that can produce therapeutic proteins where they are needed, and why some of the biggest opportunities for the technology may be in the health and beauty markets.

Incubators and accelerators come in many flavors. Mass Innovation Labs is seeking to distinguish itself with its approach to providing research scientists with infrastructure comparable to what a discovery and development team might have at a mature pharmaceutical company. We spoke to Amrit Chaudhuri, CEO of Mass Innovation Labs, about what it does to accelerate the movement of its client companies down the path to commercialization, what its track record has been, and how it differs from the competition.

Intrexon has been at the forefront of efforts to harness biotechnology to address significant issues in health, energy, food, and environmental sustainability. The company is applying synthetic biology to a wide range of applications from halting the spread of mosquito-borne disease to preventing apples from browning. We spoke to Tom Schrader, vice president of communications and strategy for Intrexon, about the company’s use of acquisitions and collaborations, the challenge the industry has faced in scaling production to commercial scale, and why synthetic biology will have implications for industries not traditionally thought of using biotechnology.

The field of behavioral economics is premised on the fact that people are irrational. By harnessing tools, such as incentives, healthcare providers and drugmakers are trying to change patient behavior as a way to improve outcomes and keep people heathy. Susan Garfield, principal in the life sciences practice of EY, discussed the opportunities for the application of behavioral economics in the healthcare realm, the role digital technologies can play in enabling this approach, and what companies are doing today to move this from academic to industry practice.

Dmitry Kaminskiy does not have a lot of kind words for aging. In fact, the general partner at Deep Knowledge Ventures and managing trustee of the Biogerontology Research Foundation has called it the “ultimate evil.” As part of his ongoing war against aging the venture capitalist is offering a $1 million prize to the first person to reach the age of 123. We spoke to Kaminskiy about the longevity industry today, how a shift in medicine from treatment to prevention will alter lifespans, and what he’s trying to accomplish with his longevity prize.

Children undergoing chemotherapy often face permanent hearing loss as a result of the toxicity of these treatments. The Children’s Cause for Cancer Advocacy is organizing a Patient Focused Drug Development meeting with the FDA in September in the hopes of getting the agency to put greater consideration into the harmful effects these drugs can have and what it means for patients to lose their hearing. We spoke to Nawal Ouzren, CEO of Sensorion, which will participate in the FDA meeting and is developing a treatment for sudden hearing loss that may be able to help these patients. We spoke to Ouzren about the problem of hearing loss for children receiving chemotherapy, why regulators and others may dismiss it as an unfortunate price to pay for a life-saving treatment, and how Sensorion’s experimental drug may help prevent these children from going deaf.

Alzheimer’s disease has been a costly and elusive area for drug developers. Despite many promising results in early-stage trials, drug companies have seen millions of dollars of R&D investment end in spectacular late-stage failures. While treatments for the disease are desperately needed, one of the barriers to success has been the availability of diagnostics that can detect the disease at early stages when therapeutic interventions may have their best chance for success. We spoke to Rachel Laing, managing partner of Bionest Partners about the problem, whether there are fundamental misunderstandings about the disease that have sent drug companies in pursuit of the wrong targets, and why diagnostics can play a critical role in reshaping the pursuit of an effective treatment for the neurodegenerative condition.

The lack of diversity in genomic data has been an issue of growing concern. It threatens to limit the benefits from the massive investment that has been made to date to transform biomedical research, drug development, and the clinical care of patients. We spoke to Jonas Korlach, chief scientific officer of Pacific Biosciences, about the problem, how it’s being addressed, and the role advancing technology can play in gleaning greater insights from the genomes that are analyzed.

Developers of cancer immunotherapies are in a race to find combinations that can distinguish their products for specific indications. Biomarkers, which have played an essential role in the development of targeted therapies, have proven a much more complex challenge in the realm of immuno-oncology. Nevertheless, biomarkers may be the key to winning the competitive battles in immuno-oncology. We spoke to Rachel Laing, managing partner of Bionest Partners, about the role for biomarkers in immuno-oncology, why immuno-oncology companies have much at stake in the hunt for biomarkers that can better select patients for their therapies, and the role biomarkers will play in the move toward real-time oncology.

As the value of the patient perspective gains greater recognition throughout the healthcare continuum, Wego Health is seeking to both tap and provide that perspective to guide a range of clients within the world of healthcare. The company has amassed a network of more than 100,000 people that includes patients, caregivers, thought leaders, and influencers. We spoke to Jack Barrette, founder and CEO of Wego, about the company, the changing role of patients, and how the patient voice is being harnessed to transform healthcare today.

It seems to be strange times when people feel the need to take to the streets to voice their support for science, but that’s what happened earlier this month as the second annual March for Science was held in Washington, D.C. and 250 other cities around the world. To mark the occasion, we spoke to Mary Woolley, CEO of Research!Amercia, about the public perception of science, the state of funding for science in the United States, and why scientist increasingly feel the need to step off the sidelines to advocate for what they do.

The global demand for meat is rising as is concerns about the health dangers, environmental toll, and animal welfare issues related to the way we produce meat today. The Good Food Institute is a nonprofit working with scientists, investors, and entrepreneurs to advance efforts to make clean meat and plant-based alternatives a commercial reality. We spoke to Liz Specht, senior scientist for The Good Food Institute, about the problems with meat production today, efforts to develop alternatives, and the role biotechnology can play in creating healthier, safer, and more humane sources of meat.

Familial hypercholesterolemia, or FH, is an inherited disorder that leads to premature cardiovascular disease. It can lead to heart attacks, strokes, and the narrowing of heart valves. In people with the condition, genetic mutations impair the ability of the liver to metabolize excess fats. While an estimated 1.3 million people in the United States have FH, only about 10 percent are diagnosed. We spoke to Katherine Wilemon, founder and CEO of the FH Foundation, about the condition, why so many people are undiagnosed, and why patients face significant barriers getting access to a new class of promising drugs to treat the condition.

While most drug developers have sought to target aberrant genes or the proteins driving diseases, Syros Pharmaceuticals has developed a proprietary platform that targets the regulatory region of DNA to not only turn genes on or off but modulate their activity as well. The company is initially focusing on cancer and monogenic diseases. We spoke to Nancy Simonian, CEO of Syros, about the company’s platform technology, the opportunities in targeting regulators of genes, and why this could represent a broad new approach to treating diseases.

A sharp spike in generic drug prices that triggered an investigation in Connecticut continues to deepen. The antitrust case that alleges price-fixing and widespread collusion between generic drug companies to divvy up markets and avoid competition has now grown to include attorneys general in 49 states seeking action against 18 companies and two executives for activity involving an expanding list of widely-used drugs. We spoke to Joseph Nielsen, assistant attorney general in the Antitrust Department of the Connecticut Office of the Attorney General, about the case, how it has evolved, and its implications for generic drugmakers, consumers, and the healthcare system.

Rural counties in the United States have seen a steady loss of hospital-based obstetric services. A new study published in JAMA that looked at nearly 5 million births in almost 1,100 rural U.S. counties found a connection between the loss of these services and eroding outcomes for newborns and their mothers. We spoke to Carrie Henning-Smith, deputy director of the University of Minnesota’s Rural Health Research Center and co-author of the JAMA study, about the findings, their implications, and what can be done to address eroding healthcare for women giving birth in rural America.

The convergence of technology and life sciences, changing consumer behavior, and increasing pricing pressures on drug and device makers are forcing these companies to rethink business models and how they derive value from their products, according to a new EY Progressions 2018 report. The report argues that life sciences companies will no longer be able to rely exclusively on product-centric innovations, which face diminishing returns as health systems wrestle with cost constraints. We spoke to Pamela Spence, EY global life sciences industry leader, about the report, what a growing trend in collaborations between technology and healthcare companies may say about where the industry is heading, and why the future of life sciences companies may be as health technology companies.

Matthew Levy worked in the biopharmaceutical industry in human resources when he was confronted with a life-changing event. A doctor told him he had advanced cancer and just 90 days to live. An aggressive treatment regimen saved him, but it also led Levy to rethink his life. Now a motivational speaker and executive coach, Levy is trying to help others who may have settled into safe and comfortable jobs but find them unfulfilling. We spoke to Levy about his experiences, how it changed him, and what others could do to make turning points in their lives without having to face death.

Despite the often remarkable advances in cancer therapies, radiation is still widely used to treat a variety of cancers. Nanobiotix believes it can make radiation therapy more effective by injecting its nanomedicines into tumors to amplify the effects of radiation without damaging healthy tissue. We spoke to Laurent Levy, CEO of Nanobiotix, about the company’s technology, how it works, and why it may be broadly applicable to a wide range of cancers.

As medical advances have helped extend lifespans, older people still experience a decline in quality of life in their later years as a result of diseases associated with aging. This can cause a loss of independence, isolation, and suffering. The Biogerontology Research Foundation, a United Kingdom-based nonprofit, is funding work to understand the molecular and cellular processes of aging and develop biotechnological interventions to halt or reverse damage from it. We spoke to Franco Cortese, deputy director of The Biogerontology Research Foundation, about a new report it’s issued that characterizes the longevity and geroscience landscape today, areas of research that hold promise, and why aging might best be thought of as a disease.

Caelum Biosciences, a Fortress Biotech company, is a clinical-stage biotech developing treatments for rare and life-threatening diseases. It’s lead therapeutic in development is a novel antibody to treat patients with amyloid light chain amyloidosis, a rare disorder of the bone marrow that causes misfolded proteins to accumulate in tissue and organs throughout the body and cause damage. We spoke to Michael Spector, president and CEO of Caelum, about the company’s business model, its lead therapeutic, and how the competitive landscape for a rare disease therapy may shape development strategies.

Incubators create success stories, but usually aren’t thought of as success stories themselves. The newly renamed MBC Biolabs, which started with humble beginnings in a utility closet as the first technology incubator in the University of California system, has been a big success by meeting the needs of entrepreneurial scientists. We spoke to Doug Crawford, managing director of Mission Bay Capital and General Manager MBC Biolabs, about its recent rebranding, how it operates, and its plans for expansion.

Across the continuum of drug discovery, development, and delivery there’s a growing effort to incorporate the patient perspective into the process. Last year FasterCures, the nonprofit focused on accelerating and improving medical research, held a multi-stakeholder workshop to discuss the challenges and opportunities of patient reported outcomes and how to make them a more powerful tool for incorporating patients’ perspectives into R&D and care decision-making. A new report from the organization captures the results of that workshop. We spoke to Cynthia Grossman, director of science of patient input at FasterCures, about the report, why patient reported outcome measures and patient-centric outcomes are not one and the same, and what can be done to better reflect what matters to patients.

CellMax Life believes it can transform cancer diagnostics with its affordable non-invasive tests for early cancer detection. The company says with its platform it has been able to overcome the challenge of detecting rare circulating tumor cells in pre-cancer and early-stage cancer patients when the disease can be successfully treated. We spoke to Atul Sharan, co-founder and CEO of CellMax, about the challenges of liquid biopsies, how the company’s technology works, and why he thinks it has the potential to change the way cancer is diagnosed today.

The development of a biomarker to identify people with prostate cancer increased the diagnosis of the disease, but did little to suggest the appropriate course of treatment for individual patients. Kenneth Pienta, professor of urology and co-director of the Johns Hopkins University InHealth Signature Initiative, is trying to change that by using surveillance and extensive data gathering to continuously stratify patients and refine treatment approaches. Pienta, who will be speaking at the Precision Medicine World Conference in Mountain View, California January 22 to 24, discussed InHealth, how its transforming the treatment of prostate cancer patients, and why it may be a model for applying precision medicine approaches to a broad range of diseases.

A surge in merger and acquisition activity in the life sciences is expected this year, according to a new report from EY. The company annual M&A Firepower Report says increased competition, new sources of capital, and the change in U.S. corporate tax laws will drive greater dealmaking in the sector. We spoke to Jeff Greene, EY global life sciences transaction advisory services leader, about the report, the drivers of the activity, and why nontraditional players in the sector may be in a better position to make a splash in 2018.

We conclude our biotech review-preview series with our final installment this week as we take a look at the year ahead as the industry readies for the JPMorgan Healthcare Conference. We spoke to Jon Gardner, U.S. News Editor for EP Vantage, about the EP Vantage 2018 Preview(http://bit.ly/2CT2RDP), the outlook for big-value drug launches, and whether dealmaking or clinical success will drive stock prices in 2018. As a note, this podcast was recorded prior to Spark Therapeutics announcement of its pricing for its gene therapy Luxturna.

In the second installment of our three-part review-preview series of podcasts, we continue an annual tradition by sitting down with Adam Feuerstein, senior biotech writer for STAT, to discuss the year that was in biotech and what to look for in 2018. We talked to Feuerstein about the themes that emerged in 2017, his annual best and worst biotech CEOs, and what he’ll be watching at JPMorgan and beyond.

It’s that time of year when we begin to look back and think ahead. Starting with this week’s interview, we begin a three-part review-preview series to discuss the year in biotech and what to look for in 2018. In 2017, there were exciting developments in the area of immune-oncology with the approval of the first Car-T therapies and Gilead’s acquisition of Kite Pharma. As the year approached the finish line, investors got to view data from a range of studies at the American Society of Hematology meeting in Atlanta, setting the stage for 2018 when data from studies looking at combinations of immunotherapies will be closely watched. We spoke to Brad Loncar, CEO of Loncar investments, about the state of immunotherapies, what caught his attention at the ASH meeting, and what he’ll be watching in 2018.

Last month Otsuka Pharmaceutical and Proteus Digital Health won U.S. Food and Drug Administration approval for what’s being hailed as the first digital pill. Abilify Mycite, a drug-device combination that marries Otsuka’s Abilify, used to treat schizophrenia, with Proteus’ ingestible sensor, wearable sensor, and smartphone app intended to monitor and improve compliance. We spoke to George Savage, chief medical officer of Proteus, about the technology, other potential uses, and how it may help address the quality and cost of healthcare.

Climate change and the increasing frequency and intensity of extreme weather events carry a toll on human health. Not only do floods, hurricanes, and other similar phenomenon cause death and injury, they also create long-term health effects. Jesse Bell, a research scientist at the North Carolina Institute for Climate Studies at North Carolina State University recently examined the issues in an article in the Journal of the Air & Waste Management Association. We spoke to Bell about the health consequences of these weather events, the challenges they create for public health systems to plan and prepare, and why new research is needed to better understand the relationship between these events and human health.

Tom Frieden, after eights years of running the U.S. Centers for Disease Control and Prevention, is turning his sights to global health. Frieden has set a goal of saving 100 million lives from cardiovascular disease in low- and middle-income countries by applying proven strategies used in developed countries. His program Resolve to Save Lives, an initiative of Vital Strategies, will also work to prevent infectious disease epidemics and pandemics by strengthening public health systems in these nations. We spoke to Frieden about the initiative, whether strategies that worked in the developed world can be translated to low- and middle-income countries, and what it will take to be successful.

A public-private consortium is seeking to cut the time it takes to discover and advance new cancer therapies to the clinic to one year from the six years it takes on average today. Accelerating Therapeutics for Opportunities in Medicine, or ATOM, brings together scientists from government, academia, and industry with the ambitious goal of harnessing supercomputers to transform cancer drug discovery into a rapid process that can determine molecules that will be safe and effective before advancing them to human clinical trials. We spoke to Michelle Arkin, a member of ATOM and associate professor of pharmaceutical chemistry at the University of California, San Francisco’s school of Pharmacy, about the consortium, the approach its taking, and why it may alter the way therapies for a much broader range of diseases than cancer are developed.

Merger and acquisitions may be a path to creating value for life science companies, but talks can breakdown because of flaws in management thinking that skew their sense of the value of their company. Oded Ben-Joseph, managing director of Outcome Capital, applied behavioral economics to the M&A front to discuss how cognitive biases can derail M&A transactions in an article in the September issue of In Vivo. We spoke to Ben-Joseph about cognitive biases, why the life sciences sector is particularly prone to the problem, and what executives can do to minimize their effects.

The growing problem of bacterial resistance to antibiotics represents a significant public health threat. That’s been made worse by the dearth of new therapies that have come to market. AmpliPhi Biosciences is developing bacteriophages, viruses that infect and kill bacteria, to provide a way to target drug-resistant bugs. We spoke to Paul Grint, CEO of AmpliPhi about the health need, AmpliPhi’s approach, and why harnessing these natural killers of bacteria may provide a promising source of new therapeutics.

Bioelectronic therapies are being developed to treat a number of conditions that currently can only be addressed using pharmaceutical interventions. Thync, a bioelectronics company, believes its technology that targets the cervical and thoracic spinal nerves to modulate the autonomic nervous system, can be used to treat variety of ailments including mental health, inflammatory disorders, and skin conditions. It points to a growing body of scientific literature that demonstrates the important role the nervous system plays in regulating the body’s immune response. We spoke to Thync CEO Isy Goldwasser about the technology, how it works, and why the company’s first clinical trial of it will be as a potential treatment for psoriasis.

Despite the growing volume of electronic health records, they have so far left the recruitment of clinical trial patients, clinical trial designs, and site selection largely unchanged. The result is that drug companies are often designing clinical trials with gaps in information about the patient population they are serving, the medical issues these patients face, and where they can find them. This adds to the high cost and long timelines required to move an experimental therapy through clinical development. TriNetX is trying to address this problem through its health research platform that allows drug developers to analyze large amounts of patient data from healthcare organizations within its network. We spoke to Gadi Lachman, CEO of TriNetX, about its platform, how it works, and why he believes this could lead to more efficient drug development.

Synthetic biology is promising to harness living organisms to replace industrial processes that rely on toxic chemicals, consume large amounts of energy and water, and leave environmental degradation in their wake. One such example of a company seeking to transform an industry in this way is Colorifix, which is developing a revolutionary dyeing process to help the textile industry dramatically reduce its environmental impact in a cost-effective way using a synthetic biology based approach. We spoke to Orr Yarkoni, founder and CEO of Colorifix, about the company, how it is using synthetic biology to change the process of dyeing materials, and why he expects it to change the environmental toll of the textile industry.

Kindred Biosciences is looking to leverage the billions of dollars that others have invested in approved drugs by modifying, improving, and repurposing them for the animal market. The company believes it can formulate, develop, and win approval for these medicines for between $3 million and $5 million each in a matter of three to five years, and capture markets that range between $10 million and $100 million annually. We spoke to Richard Chin, founder and CEO of Kindred, about the business strategy, the company’s pipeline, and the opportunity created by our willingness to spend big money on our pets.

When the BIO Investor Forum convenes in San Francisco October 17 and 18, a key point of discussion will be the availability of funding for emerging life sciences companies. One of the panelist addressing that issue this year will be Asish Xavier, vice president of venture investments for Johnson & Johnson Innovation’s venture arm JJDC. We spoke to Xavier about JJDC’s approach to investing as a strategic investor, the changing landscape for venture capital, and how competitive the environment is for access to compelling technologies today.

In April 2016, the consulting firm LifeSci Advisors adopted a comprehensive action plan to advance gender diversity in the life sciences industry. It has partnered with Women in Bio and Girls Inc. of New York City to provide mentorship and advancement programs for women and girls in the STEM fields, started its own board diversity initiative, and created the LifeSci Advisory Board on Gender Diversity. We spoke to Michael Rice, LifeSci Advisors founding partner, about the state of gender diversity in biotech boardrooms, what the firm has been doing, and why it decided to focus its efforts there.

Regenerative medicine is rapidly moving from the lab to the clinic, but as life-saving therapies advance to the marketplace, there are questions about whether the U.S. Food and Drug Administration needs to modernize its regulatory approach to gene and cell therapies. We spoke to Michael Werner, executive director of the Alliance for Regenerative Medicine, about the state of the industry, the regulatory environment today, and whether it will ultimately be payers who are more demanding of data to convince them of the worth of a therapy.

Glioblastoma is a devastating and fatal brain cancer that progresses rapidly. Median time from diagnosis to death is 12 to 15 months. In recurrent cases, treatment consists of both symptomatic and palliative therapies, but the disease remains fatal. VBL Therapeutics is developing a targeted anti-cancer gene-based therapy that is in late-stage testing for recurrent glioblastoma. We spoke to Dror Harats, CEO of VBL, about the therapy, how it works, and why it might be useful in treating a variety of cancers.

The promise of precision health is to transform a healthcare system that is today based on treating sickness to harnessing a range of technologies to predict and prevent illness. Health 2.0’s Technology for Precision Health Summit in San Francisco October 24 will explore the state of precision health and what’s needed to make it a reality. We spoke to Linda Molnar, chair of the summit, about precision health, what gaps in the healthcare continuum need to be addressed to create a healthcare system geared toward prediction and prevention, and how companies will make a business out of this.

Winning regulatory approval for a drug to treat obesity would seem like a great accomplishment, but for Orexigen Therapeutics, that’s when the hard work began. After its marketing partner Takeda ended their agreement because of disappointing sales, the company found itself in the position of having to market a drug to doctors who often don’t consider obesity an illness and believe willpower and discipline, not a pill, is what’s needed. Orexigen’s solution centered on a novel approach. The company decided to make a pitch directly to patients and connect them to telehealth-based doctors, who could ensure use of the drug is appropriate and help them avoid the embarrassment they may feel when speaking to their own doctors. We spoke to Thomas Cannell, Chief Operating Officer and President of Global Commercial Products for Orexigen, about its obesity drug Contrave, its marketing strategy, and whether it represents a marketing model that others may follow.

Though breakthroughs in the ability to read, write, and edit DNA have broad implications for healthcare, they are also fueling a far-reaching transformation of industries and laying the foundation for a new bioeconomy. The SynBioBeta conference, which has developed into a critical annual event for innovators and investors within the synthetic biology sector, will be held in San Francisco October 3 through October 5. We spoke to John Cumbers, founder of SynBioBeta, about trends within synthetic biology, key drivers and challenges for the sector, and why companies in all industries today need to begin crafting their own bio strategies.

The pharmaceutical industry has long argued that high drug prices are necessary to incentivize investment in and fund high-risk research and development of innovative new therapies. In a working paper published by the Institute for New Economic Thinking, William Lazonick, professor of Economics at the University of Massachusetts Lowell, and his colleagues challenge the industry’s premise. They argue that top pharmaceutical companies, spend more of their profits on buying back their shares to boost their stock prices than they do on R&D, a move that enriches senior executives. We spoke to Lazonick about the paper, why he believes this so-called financialized business model is counterproductive to innovation, and what steps he thinks are necessary to change the landscape.

Gonorrhea is a common sexually-transmitted infection, but the growth of an antibiotic-resistant strain of the disease is creating what the U.S. Centers for Disease Control and Prevention has called an urgent public health threat that requires aggressive action. Entasis Therapeutics is launching a pivotal study of Zoliflodacin, a new class of oral antibiotic that has demonstrated potent activity against resistant gonorrhea. The company last month entered into a novel partnership with the non-profit Global Antibiotic Research & Development Partnership to fund the pivotal trial and assure access to the drug in low- and middle-income countries if successful. We spoke to Manos Perros, CEO of Entasis, about Zoliflodacin, the partnership with GARDP, and whether it serves as a model for the development of a broader arsenal of new antibiotics.

A number of clinical successes and the U.S. Food and Drug Administration’s granting of designations that provide accelerated pathways to experimental therapies speaks to the progress of research funded by the California Institute for Regenerative Medicine. We spoke to Kevin McCormack, ‎senior director of public communications and patient advocate outreach for CIRM, about the growing pipeline of therapies, the changing regulatory environment, and whether the institute will have a future beyond its existing funding.

The problem of counterfeit and falsified medicines is not just an economic problem for the pharmaceutical industry, but also a threat to public health. TruTag Technologies is seeking to address the problem with its nano-scale technology that allows drugmakers to encode information on individual doses of medication to authenticate a drug and provide details on its origin and intended market. We spoke to Barry McDonough, senior vice president of business development for TruTag, about the technology, how it works, and how it can address a global health concern.

Mosquitoes are more than just pesky. Certain types of insect serve as efficient vectors for infectious diseases that pose great harm to humans. Oxitec, a subsidiary of Intrexon, has developed a genetically altered male of the Aedes aegypti mosquito designed to mate with wild females to produce offspring that die before becoming adults. The effort is meant to provide a highly targeted alternative to insecticides that are broad acting, can cause harm to humans and other animals, and may be unable to effectively reach their intended targets in urban environments. We spoke to Hadyn Parry, CEO of Oxitec, about how the company breeds billions of mosquitos that can’t reproduce, how it delivers them to where they are needed, and how the company is addressing the regulatory barriers to demonstrate its technology is safe and effective.

Scrutiny of drug prices around the globe is expected to exert growing pressure on the biopharmaceutical sector. EvaluatePharma, in its recently issued World Preview 2017, Outlook to 2022 says that despite consensus forecasts for worldwide drug sales hitting more than $1 trillion in 2022, it does reflect a drop from the same period last year. We spoke to Antonio Iervolino, head of forecasting for evaluate pharma, about the new report, the outlook for the sector and the potential for a new patent cliff with the advent of biosimilars.

Celiac disease, an autoimmune disorder that has helped to drive the gluten-free food craze, can carry serious complications. There’s no treatment for the disease, which afflicts an estimated 2.4 million people in the United States. PvP Biologics is taking a unique approach to treating celiac disease with its Kumamax, a synthetic enzyme that degrades the parts of gluten that trigger an immune response. We spoke to Adam Simpson, president and CEO of PvP Therapeutics, about the interesting history behind Kumamax, how it works, and why it will be the only drug PvP ever develops.

The lack of clarity over healthcare reform, changes to tax policy, and concerns about new pricing pressures are creating uncertainty over the future health of the biotech industry. EY, in its just released annual report on the industry, looks at the effect the growing uncertainty has had on the performance of the biotech companies and strategies for contending with what’s ahead. We spoke to Glen Giovannetti, Global Biotechnology Leader for EY, about the new Beyond Borders report, what the numbers tell us, and ongoing efforts for the industry to adapt to a healthcare world moving from volume to value.

The high cost of drug development, the challenge of translational research, and continuing concerns with R&D efficiency has had entrepreneurs, investors, and drugmakers open to experimenting with new models of innovation. COI Pharmaceuticals, born out of a collaboration between the pharmaceutical giant GlaxoSmithKline and Avalon Ventures, is one such model that is showing traction. With management expertise, R&D infrastructure, and a collaborative environment, COI is providing promising startups with a way to accelerate their development in a capital efficient way. We spoke to Jay Lichter, president and CEO of COI Pharmaceuticals, about the COI model, the challenges of cost-effective innovation, and what can be learned from COI’s experience.

The production of biologics is costly and takes time. Dyadic International has developed a proprietary manufacturing process that replaces the use of Chinese hamster ovary cells, long used to produce protein therapeutics, with a fungus that has a long history in industrial biotechnology applications. The company believes its process can produce drugs faster, in greater volumes, and at significantly lower costs than biotech processes in use today. We spoke to Mark Emalfarb, CEO of Dyadic, about its manufacturing process, the benefits it could bring, and why it may have big implications for drugmakers.

Alzheimer’s disease is the sixth leading cause of death and it continues to rise. Today it is costing the U.S. healthcare system $200 billion a year and there are no therapies that prevent, halt, or reverse the disease’s progression. United Neuroscience is taking a new approach to the disease with its endobody vaccines, a class of synthetic biologics it is developing to treat Alzheimer’s and other CNS conditions. We spoke to Ajay Verma, chief medical officer of United Neurosciences, about Alzheimer’s, the company’s platform technology, and the promise of enlisting the immune system in the fight against CNS diseases.

Gene therapy represents an expanding area of potential to correct and modulate the activities of genes driving diseases. One of the major challenges these groundbreaking technologies face, though, is delivering them to where they need to go within the body to be effective. Nanogenic Solutions believes its solved the problem with its LipTide technology that marries a payload carrying-lipid with synthetic peptides that target cell suface receptors and allow DNA or RNA into the cell. We spoke to Simon Newman, director of preclinical development for Nanogenic Solutions, about the challenges of gene therapy, the LipTide technology, and what it could mean for advancing a range of RNA and DNA therapies.

Brexit, the United Kingdom’s plan to withdraw from the European Union, carries a long list of unintended consequences, one of which is the relocation of the European Medicines Agency. As many as 20 cities are competing to become the new home of the drug regulator. We spoke to Rory Mullen, International Investment Executive for IDA Ireland, about Dublin’s efforts to woo the EMA, the process going forward, and why its viewed as an economic prize.

Nearly one in three drugs has a postmarket safety event, according to a study published earlier this month in JAMA. The study looked at 222 novel therapies approved between 2001 and 2010. We spoke to Nicholas Downing, clinical fellow in the Department of Medicine at Brigham and Women's Hospital and lead author of the study, about the findings, the limits of clinical trials, and whether the U.S. Food and Drug Administration needs to do more to improve surveillance of drugs once they are approved.

Climate change is not often viewed as a public health threat, but it can have unexpected consequences on the spread of infectious diseases. As changing temperatures make new areas more hospitable to mosquitos, its can raise the risk of mosquito-borne diseases, such as dengue, chikungunya, and zika in areas not usual thought as prone to outbreaks of tropical disease. We spoke to Erin Mordecai, assistant professor of Biology at Stanford University and lead author of a recent study in PLoS Neglected Tropical Diseases that looks at how climate change may affect the spread of mosquito-borne disease. We spoke to Mordecai about the study, what it means for potential infectious disease outbreaks, and how public health officials and drugmakers in the developed world may need to think differently about neglected tropical diseases.

Ten years ago, a group of San Francisco State University alumni working at Genentech got together with the Michael Goldman, the university’s chairman of the biology department, to establish the school’s annual Personalized Medicine Conference. This year, the conference will revisit topics from its past ten years as well as exploring the future of personalized medicine ask speakers to reflect on how personalized medicine has changed their lives. We spoke to SF State’s Goldman and Dan Maher, one of the alumni who drove the creation of the conference, about the state of personalized medicine, the pace of advances, and what’s surprised them most about where we are today.

The promise of precision medicine to provide more effective and safer cancer therapies that target the genetics driving each patient’s disease has been hindered by the lack of understanding of the specific genetic alterations underlying many cancers. Elana Fertig thinks math can solve that problem. Fertig, with a nod to the algorithm Netflix uses to help recommend movies users might like, is working to identify the genes that drive an individual’s cancer. Fertig, assistant professor of Oncology Biostatistics and Bioinformatics at Johns Hopkins Kimmel Cancer Center, discussed the proliferation of genetic data relating to cancer, how researchers may be able to capitalize on that, and how such an approach may also bring a new understanding of why patients suffer relapses and develop resistance to cancer therapies.

For anyone who has ever sought to find the price of healthcare services before obtaining them it will come as little surprise that information is not readily available. A recent study from Public Agenda, with support from the Robert Wood Johnson Foundation and the New York State Health Foundation, set out to find how Americans seek and use healthcare price information. We spoke to David Schleifer Director of Research for Public Agenda about what extent healthcare consumers seek price information, the implications of having a system with little price transparency, and what can be done to fix the problem.

As the Trump Administration calls for significant increases in military spending, it is also seeking steep cuts to the National Institutes of Health, the Centers for Disease Control and Prevention and programs used to address issues of global health. Michael Osterholm director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in a recent op-ed in The New York Times argues that issues such as vaccine development, the need to combat antibiotic resistance, and respond to new infectious disease outbreaks are fundamental issues of national security. We spoke to Osterholm about global trends fueling the threat of infectious disease, the dangers of proposed budget cuts, and why the administration needs to invest in new ways to respond to the threats we face.

Recent mumps outbreaks are raising questions about strategies to combat the spread of the virus. One issue of concern is that the current vaccine is designed to protect against a different strain of the virus than the one that is sparking the outbreaks. Though the vaccine can help prevent some people from getting the disease or minimize its effects, the outbreaks have raised questions about whether a new vaccine is needed. We spoke to Stanley Plotkin, an expert on vaccines and a member of the editorial board of the journal Clinical and Vaccine Immunology, about what’s driving the outbreak, whether boosters can adequately address the problem, and why developing a new vaccine is not an easy solution to the problem.

The landmark legislation known as the Genetic Information Nondiscrimination Act of 2008, or GINA, anticipated growing concerns about genetic privacy, although it left much work undone. Now, though, as genetic information proliferates, proposed legislation would weaken protections by allowing employers to compel employees to share their genetic information in workplace wellness programs. Though voluntary, those who choose not to share this information could face thousands of dollars more for health insurance, according to reports. We spoke to Jeremy Gruber, past president of the Council for Responsible Genetics and someone credited with helping enact GINA, about the proposed legislation, what more needs to be done to protect genetic information, and how to best balance privacy concerns with the opportunities to leverage genetic data to better understand health and wellness.

By the time signs of Alzheimer’s disease manifests in the form of memory problems, behaviorial changes, or loss of executive function, years of irreversible damage to the brain has already occurred. In the latest annual report from the Alzheimer’s Association, the organization looks at the potential for biomarkers to diagnose the disease at its earliest appearance and allow for treatments to hold the disease in check. We spoke to Heather Snyder, senior director of medical and scientific operations for the Alzheimer’s Association about the report, where efforts to validate biomarkers of early-stage Alzhimer’s disease stand, and why this holds the potential to change the way Alzheimer’s disease is viewed and treated much in the way diagnostic tools have turned heart disease into a chronic condition.

The Personalized Medicine Coalition’s recently issued its 2017 report on the opportunities and challenges for the industry. Chris Wells, communications director for the organization, will be kicking off The 4th Annual Business of Personalized Medicine Summit in South San Francisco March 28, drawing from the new report to discuss trends and the pace of advances. We spoke to Wells about the state of personalized medicine, the obstacles to greater clinical adoption, and what the growing legislative battles in Washington will mean for the industry.

Orphan drugs, therapeutics that target small patient populations, have become an enticing area for Big Pharma as companies are attracted to the premium prices, lower development costs, and faster path to market. A new EvaluatePharma report on the Orphan Drug market forecasts a compounded annual sales growth rate of more than 11 percent through 2022 with orphan drug accounting more than 20 percent of total worldwide prescription sales by then. We spoke to Jon Gardner, U.S. editor for EP Vantage, about the growth of orphan drugs, what’s driving the sector, and whether the way the industry is taking advantage of the Orphan Drug Act will cause policymakers to push back.

The Broad Institute has emerged victorious in a battle with researchers at the University of California, Berkeley over patents covering breakthrough gene-editing technology that allows scientists to easily and inexpensively alter genetic material with precision. Last month, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled that patents held by the Broad Institute relating to certain aspects of CRISPR-Cas9 gene editing did not interfere with those being sought by UC Berkeley researchers. We spoke to Kevin Noonan, Partner and Chair of the Biotechnology & Pharmaceuticals Practice Group of McDonnell Boehnen Hulbert & Berghoff and founding author of the Patent Docs blog, about the decision, what it means, and to what extent it resolves patent issues regarding the gene-editing technology.

Earlier this month the National Academy of Sciences and the National Academy of Medicine issued a report that considered the scientific, ethical, and governance issues surrounding human genome editing. The report comes as new gene editing technologies have reduced the cost and increased the ease of manipulating the human genome. We spoke to Alta Charo, co-chair of the study committee that wrote the report and professor of Law and Bioethics at University of Wisconsin-Madison, about the study, the potential for this science, and where the committee thought limits should be imposed.

The emergence of cancer immunotherapies, drugs that activate and enlist the immune system to fight cancer, has emerged as a promising approach to combat the disease in its many forms. Lawrence Fong, co-leader for the Cancer Immunotherapy Program at the University of California, San Francisco, stands at the intersection of several initiatives involving UCSF to better understand the immune system’s response to cancer and develop more effective drugs in the battle against it. We spoke to Fong about the potential of immunotherapies, the various efforts underway at UCSF, and what we known and don’t know about the immune system.

The start of Trump administration, a new cabinet, and a new Congress are raising concerns within the scientific community about how the changes in Washington will affect the health of science and innovation in the United States. At issue is not only funding for research, but a range of policy decisions relating to everything from public health to climate change that some fear will not be informed by science. We spoke to Mary Woolley, president of Research!America, about the new administration, why it is critical for scientists to become advocates, and the planned March for Science in Washington, D.C. this April.

For a number of diseases that require chronic administration of a substance naturally produced by the body, patients may have to rely on regular injections or infusions. Sernova is working to free patients from these types of regimes with it combination device and cell therapy that implants a pouch that contains living cells that produce the missing hormone, factor or other substance. We spoke to Phil Toleikis, CEO of Sernvoa, about its technology, the challenges involved in such an approach, and the company’s initial focus on diabetes and hemophilia.

Telehealth, which encompasses an array of technologies to deliver healthcare, is a rapidly growing area. Stratus Video, a language services company, is making a push into telehealth where it sees a big opportunity to leverage its expertise and apply it to healthcare. We spoke to Lee Horner, president of the Stratus Telemedicine division, about telehealth trends, how its altering the practice of medicine, and whether it can deliver on the promise of improving care while reducing costs.

Drug discovery and development is a slow and costly process, but the Regeneron Genetics Center represents a drugmakers’ bet that harnessing large amounts of genetic data can point the way to better targets, greater success rates, and ultimately better drugs. We spoke to Aris Baras, vice president and head of the Regeneron Genetics Center ahead of the Precision Medicine World Conference 2017 in Silicon Valley about how large genetic studies are brining fundamental change to the drug development process, the approach Regeneron is taking, and why its becoming a necessary element of drug development today.

Last year, KemPharm was on its way to winning an FDA approval for its opioid Apadaz designed to deter users from snorting, injecting, or otherwise abusing it. But the regulatory agency stymied the company’s efforts when it declined to label it as an abuse-deterrent opioid. Apadaz is a prodrug that is converted to its active form through an enzyme present in the intestinal tract that releases the hydrocodone in it. The decision sent shares in KemPharm tumbling. Now, as the company works to resolve regulatory issues around Apadaz, it’s moving forward with the rest of its prodrug pipeline. We spoke to KemPharm CEO Travis Mickle about abuse-deterrence, the ongoing discussion with the FDA, the company’s prodrug pipeline.

In the realm of mental health, a lack of biologic measures for diagnosing and treating patients has at times made this an area where doctor’s subjective decisions can play a disproportionate role. Ehave is seeking to improve diagnosis and treatment of patients with its data-rich management, assessment, and remediation tools that sit on its cloud-based software platform. The company’s initial product focuses on ADHD, although it plans to roll-out other applications in the future. We spoke to Prateek Dwivedi, CEO of Ehave, about its platform, the problems the company is trying to address, and how digital technologies are changing the way doctors diagnose, treat, and interact with patients.

With 2016 drawing to a close and the biotech industry gearing up for the annual JPMorgan Healthcare Conference in San Francisco, we continued our holiday tradition of checking in with Adam Feuerstein, senior columnist for TheStreet. We spoke to Feuerstein about the year in biotech that was, the winners and losers of 2016, and what to look for at the JPMorgan Healthcare Conference and beyond.

While there has been much buzz in the industry over the potential for harnessing the microbiome and using it as a way to treat disease, it remains early days for the therapeutic pipeline. Rebiotix, which is delivering human-derived microbes to treat recurrent Clostridium difficile infections, is ready to move its lead experimental therapeutic into late-stage clinical testing. The company says it is the most advanced human clinical program evaluating a microbiota-based drug conducted in coordination with a regulatory authority. We spoke to Lee Jones, founder and CEO of Rebiotix, about the microbiome, the opportunity for drugs targeting the colonies of bacteria in the gut, and the indications beyond c. diff Rebiotix is pursuing.

Investors bid up biopharmaceutical stocks following the election of Donald Trump as President of the United States. It reflected a belief that a Trump administration will remove the threat of price controls on drugs and bring about a friendlier regulatory environment at the FDA. We spoke to Amy Brown, senior reporter and author of the EP Vantage 2017 Preview, about what’s in store for the biopharmaceutical sector in the year ahead, what to look for, and why it may turn out to be a big year for M&A activity.

The advent of digital health devices and mobile health apps has the potential to improve care, change patient behavior, and permit doctors to intervene early when the health of a patient changes. But the American Medical Association wants to ensure that as these devices proliferate, doctors have a role in guiding their design and determining their worth. We spoke to James Madara, CEO of the AMA, about new principles its adopted to promote safe and effective mHealth applications, the concerns physicians have about the use of these apps, and how he sees them reshaping healthcare.

A clinical trial of an experimental vaccine against HIV that just began in South Africa is raising new hopes of making new strides against the disease. The trial follows recent news of tests in animals that suggest the vaccine, in combination with an innate immune stimulant may be able to put infected patients into remission. We spoke to Colonel Nelson Michael, director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research, about the new trial, how this vaccine builds on what was learned from a clinical trial in Thailand from an earlier version of the vaccine, and why there’s hope of related work moving researchers towards a functional cure for the disease that could free patients from the need for antiretroviral therapy for extended periods.

Pain takes both a personal toll on individuals who suffer from it and an economic toll on society more broadly. Though there is a wide range of drugs available to treat pain, it’s a problem that is still not well addressed. The need for new pain therapies has become even more acute as the problem of opioid addiction has grown. We spoke to Kerrie Brady, founder and chief business officer of Centrexion Therapeutics, which is developing a pipeline of non-opioid pain drugs. Brady discussed the problem of today’s existing pain therapies, how the company is using Big Data in its pursuit of new drugs, and its strategy of building out its pipeline.

A number of studies have recently called attention to the lack of gender diversity in leadership positions in the life sciences industry. Women in BIO and LifeSci Advisors have taken steps to increase the presence of women in the boardroom of biotech companies through a new training program to get women boardroom ready, as well as the creation of an initiative to help place qualified women onto the boards of companies. We spoke to Dawn Hocevar, president elect of Women in Bio and Michael Rice, founding partner of LifeSci Advisors about their efforts, why there aren’t more women on the boards of biotech companies today, and what has to be done to remedy the problem.

Perlara is a drug discovery company focused on using model organisms to find treatments for diseases previously believed to be too rare to cure. Recently Perlara entered into a drug discovery and development collaboration with Novartis, a deal that included an equity investment and is seen as validating Perlara’s platform. We spoke to Ethan Perlstein, CEO of Perlara, about the company’s unique approach to drug discovery, why it focuses on the diseases it does, and the significance of its agreement with Novartis.

There’s been much buzz about the microbiome, but what that constitutes can mean different things to different people. Biosortia Pharmaceuticals is focusing on the aquatic microbiome as a rich source of potential first-in-class small molecules to address unmet medical needs. We spoke to Ross Youngs, founder and CEO of Biosortia, about what makes the aquatic microbiome compelling as a source of new drugs, how the company goes about mining it for potential compounds, and what the company’s growing pipeline looks like.

It can take up to six years to accumulate enough evidence to support advancing an experimental drug into clinical development. twoXAR is working to rapidly accelerate that process through the use of Big Data and its proprietary algorithms to find screen large public and proprietary data sets to indentify new drug candidates and determine their efficacy. We spoke to Andrew Radin, co-founder and CEO of twoXAR, about the company’s technology, how it’s being applied today, and the evolution of the company’s strategy.

Robert Goldman had been a successful Internet age inventor having developed some of the critical technology underlying the way digital music is stored, searched, and purchased online. But when his sister developed cancer, he found himself turning his skills as an inventor into an unchartered area for him. Eventually he developed a new type of catherter to deliver cancer medicines directly to where they are needed in the body. But despite his company’s success at winning marketing clearance from the U.S. Food and Drug Administration, his company Vascular Designs has had difficulty raising money. On October 17 Vascular Designs launched a campaign to raise $500,000 through the crowdfunding site Indigogo. We spoke to Goldman about his IsoFlow catheter, the funding environment for innovative medical device companies, and his decision to turn to crowdfunding.

One of the issues researchers face is getting access to needed biospecimens with detailed clinical data that can expand the understanding of a specific disease or treatment. The difficulty in obtaining biospecimens can hamper R&D productivity, extend the time of project, and increase costs. Novaseek has developed a platform that provides access to real world data and supports the ability to define patient cohorts based on detailed clinical criteria, such as demographics, diagnoses, medications, and lab test results, and supports the collection of biospecimens at various time points. The platform also offers healthcare organizations an opportunity to develop a new source of revenue. We spoke to Kate Torchilin, CEO of Novaseek, about the challenges researchers face in getting biospecimens, how Novaseek seeks to address that, and how the company’s platform can help to accelerate biomedical research.

Evaluate Pharma, in its latest World Preview report, is projecting solid growth for prescription drug sales through 2022. Driving that growth is both the new products expected to come to market during that time and the industry’s embrace of orphan drugs, the source of half of that growth. We spoke to Antonio Iervolino, head of forecasting for Evaluate, about the new report, the growing number of drug approvals, and the challenges drugmakers face that could alter the outlook for the industry.

The growing promise to harness biology to address environmental, agricultural, health, and energy needs is fueling a new bioeconomy. The state of engineering biology will be on display at the SynBioBeta SF 2016 conference in South San Francisco October 4 through October 6. We spoke to John Cumbers, founder of SynBioBeta, about the state of the industry, the challenges it faces, and the long-term potential it holds for transforming our manufacturing sector.

About 380,000 infants in the United States—about one in 10— are born prematurely each year. Preterm births, defined as any birth before 37 weeks of pregnancy, is the leading cause of death for infants and puts these babies at greater risk for cerebral palsy, respiratory and cardiovascular complications, and delays in development. Sera Prognostics has developed a predictive diagnostic that can identify pregnant woman at risk of delivering prematurely, allowing for interventions. We spoke to Greg Critchfield, CEO of Sera Prognostics, about the test, how it works, and what it take to get doctors to adopt the test and payers to reimburse for it.

The Johns Hopkins University School of Medicine and the Salk Institute for Biological Studies are leading a $15.4 million effort to develop new systems for quickly screening libraries of drugs for potential effectiveness against schizophrenia and bipolar disorder. The National Institute of Mental Health is funding the work. We spoke to Hongjun Song, professor of neurology and neurosciences at the Johns Hopkins University School of Medicine, about the effort, the challenges of understanding the underlying biological mechanism of these disorders, and how the consortium expects to change the development of drugs to treat mental illnesses.

The recent controversy over Mylan Pharmaceuticals sharp increase to the price of its EpiPen, an emergency injection of epinephrine to treat someone suffering a severe and potentially fatal allergic reaction, has once again ignited public debates over drug pricing. While drugmakers have been in the sights of the public, other players in the supply chain have escaped scrutiny. David Balto, a Washington, D.C.-based antitrust attorney, in a recent piece in The Hill, calls attention to the role pharmacy benefits managers play in the price equation. We spoke to Balto about PBMs, their growing power, and the perverse incentives they have to work against the best interest of consumers.

Werner’s and Hutchinson-Gilford Progeria Syndromes are rare, genetic diseases that causes children to appear to suffer from advanced aging at young ages. The syndromes are of particular interest to researchers because of the potential they may have to help understand the biology of normal again and lead to ways to counter aging-related diseases. We spoke to Brian Kennedy, president and CEO of the Buck Institute for Research on Aging, about his progeria research, the potential to repurpose existing drugs to combat these syndromes, and what insights into normal aging are being gained from the study of progeria.

Concern about the spread of the Zika virus has sparked efforts to develop therapies and vaccines to counter it. But the outbreak reflects a growing threat from zoonetic diseases, once thought of as being contained to tropical regions, that are making incursions into the developed world. We spoke to Jim Pannucci, director for infectious disease research at Southern Research, about Zika, the work his organization is doing around the virus, and whether we need to rethink investment in prevention and treatment of such diseases.

Lee Hood was a visionary who helped enable the genomics age. Journalist Luke Timmerman, in his newly published biography of Hood, chronicles the scientist career and achievements, as well as the controversies that surrounded him. We spoke to Timmerman about Hood, the conflicts that shaped his career, and the significance of his contributions to the field of biology.

Despite continued scientific and medical progress, the American Society of Clinical Oncology offered a mixed picture in its annual report on The State of Cancer Care in America earlier this year. While advances have been made in combating some cancers, mortality rates for others remain unchanged or have increased. There’s disparity in care, concerns about the rising cost of therapy, and uncertainty about how new payment models will affect care. We spoke to Julie Vose, immediate past president of ASCO, about the report, where additional work is needed, and how to balance the need to make cancer care affordable while encouraging innovation.

People with multiple chronic conditions represent about 5 percent of the patient population in the United States, but account for half of the nation’s healthcare spending. In order to improve care and reduce costs overal there’s an urgent need to do a better job of treating these patients, according to a recent perspective in the New England Journal of Medicine from the heads of five leading healthcare foundations. We spoke to David Blumenthal, president of the Commonwealth Fund and one of the authors of the piece, about why improving care for this population is critical, why there’s not a single solution to treating what is actually a diverse population of patients, and what these foundations are doing to address the problem.

Neglected diseases and drugs to counter addiction represent unmet medical needs, but they have been areas that pharmaceutical companies have been reluctant to pursue. Savant HWP is in clinical development on an experimental drug that targets both of these indications. We spoke to Stephen Hurst, CEO of Savant HWP about the company’s strategy, the unique compound that can address two seemingly unrealated indications, and the role priority review vouchers can play in providing drug developers with incentives to pursue indications that might otherwise be ignored.

The use of biomarkers has long held the promise accelerating drug development and producing safer and more targeted drugs to meet the needs of patients. The explosion of genetic, proteomic, and metabolomic data, as well as the emergence of the human microbiome, is rapidly growing the world of biomarkers, but with that comes challenges for researchers and drug developers about knowing what’s available and how well validated these biomarkers may be. We spoke to John Audette, president and co-founder of Amplion, about the company’s database, which seeks to make biomarker information accessible to researchers, the role biomarkers can play in improving the drug development process, and how their increased use can bring about a long anticipated era of precision medicine.

Incubators and accelerators have been proliferating in California, but little has been done to track their activities and analyze their performance. The California Business Incubation Alliance recently released a study of the performance of incubators and accelerators in California, the contribution they make to the state’s economy, and whether they deliver value to the entrepreneurs that use them. We spoke to Matt Gardner, CEO of the California Technology Council and lead author of the report, about its findings, why gathering data about incubators and accelerators is so challenging, and why the findings include a word of caution to entrepreneurs. As a matter of full disclosure, Matt is a friend, client, and partner and I served as an editor on this report.

The growing problem of antibiotic-resistant bacteria and the evolution of next-generation sequencing technology is giving rise to new approaches to combat what’s become a serious global health threat. Epibiome, which describes itself as a precision microbiome engineering company, is working to develop cocktails of bacteriophages to use in animal and human health. We spoke to Nick Conley, CEO of Epibiome, about the urgent need for new therapeutics, the renewed interest in phages, and Epibiome’s unique approach to address the problem.

The ability to find and tumor cells and DNA fragments shed by tumors circulating in the blood has given rise to liquid biopsies. This emerging area of diagnostics promises to improve cancer care, better monitor patient response to a therapy, personalize care, and provide earlier evidence of recurrence. We spoke to Andre de Fusco, CEO of Cynvenio, about the company’s liquid biopsy rare cell isolation platform, and its implications for changing how cancer patients

KaloBios, a biotech best known for a series of disastrous events including failed clinical trials, a bankruptcy filing, lawsuits, and the arrest of its CEO, is being reborn. In the process, it may provide a valuable contribution to the ongoing discussion over drug pricing. In April, the development-stage company unveiled a pricing plan based on transparency, affordability, and reasonable profit. We spoke to Cameron Durrant, CEO of KaloBios, about his efforts to clean up the mess he inherited, turnaround the fortunes of the company, and introduce an innovate pricing model that could reshape the way industry thinks about pricing its products.

Despite a rapid advance of technology there’s been little change in the preclinical drug development process. Vium is hoping to change that by using sensors, automation, and bioinformatics to change the way data is gathered in the preclinical process to fuel better and faster decisions about the potential value of an experimental drug. We spoke to Tim Robertson, co-founder and CEO of Vium and Joe Betts-Lacroix, co-founder and CTO of Vium, about the company, how its hoping to change the preclinical drug development process, and why that’s essential.

The biotechnology industry continued to post record numbers, attract significant investment, and won approval for a solid number of new drugs in 2015. Nevertheless, EY in its new Beyond Borders report warns that there’s a deceleration within the industry that points to threats that could undermine the robust growth it has enjoyed. We spoke to Glen Giovannetti, EY Global Biotechnology Leader, about the new report, the need for the industry to innovate pricing models for new drugs, and why as companies seeks to demonstrate the value of a product they will need to consider the unique perspective of each payer.

Wall Street’s attention will turn to Chicago as the annual meeting of the American Society of Clinical Oncology gets underway June 3 to June 7. Though this is a scientific conference, it is one closely watched by investors, who have been pouring through the abstracts that have been available and keeping an eye open for late-breakers that could move stocks. We spoke to Jon Gardner, deputy news editor for EP Vantage, about the ASCO meeting, what the early abstracts say, and who will likely be making headlines at this year’s meeting.

Lupus is an often misunderstood and misdiagnosed autoimmune disease. While some 1.5 million people—mostly women—have lupus, it can take years for someone with the disease to get a correct diagnosis. We spoke to Susan Manzi, medical director of the Lupus Foundation of America and Co-founder and director of the Lupus Center of Excellence at Allegheny Health Network, about the disease, why there are so few treatments available today, and why she holds out hope for the pipeline of new therapies moving through the clinic.

Global innovation activity experienced broad gains across industry sectors last year, according to Thompson Reuters newly released 2016 State of Innovation report. We spoke to Anthony Trippe, senior patent analyst for Thomson Reuters about the report, its upbeat outlook, and what it says about the direction of innovation in the biotechnology, pharmaceutical, and medical device sectors.

The Campaign for Sustainable Rx Pricing, a coalition of healthcare stakeholders, thinks that the rising cost of prescription drugs can be addressed through a series of market-based solutions that will strike a balance between preserving innovation and ensuring affordability. Its recently released plan outlines steps to increase transparency, competition, and value. We spoke to John Rother, executive director of the Campaign for Sustainable Rx Pricing, about the organization, its focus on market-based solutions, and what it will take to make them a reality.

The emergence of smartphones at the center of a growing universe of digital health devices is giving rise to new ways to monitor and measure our bodies in real time. MyDx, one of the latest entrants into this area, is working to enable consumers to test the food they eat, the water they drink, and the air they breathe to ensure they’re safe. Its first offering allows cannabis users to analyze samples for THC content, the presence of pesticides, and their potential effects on users. We spoke to Daniel Yazbeck, chairman and CEO of MyDx, about his handheld analyzer, how it works, and how he expects it to both enable and be fueled by changing consumer behavior in the emerging world of the quantified self.

The Obama Adminstration’s Cancer Moonshot initiative is a boost to cancer researchers, but Bruce Zetter says in order for it be as effective as possible, it must not repeat the same funding priorities of the past and instead should support innovative projects and research against the deadliest cancers. In a recent commentary in Politico, Zetter, a professor of cancer biology at Harvard Medical School and Boston Children’s Hospital, notes that researchers follow the money and that the cancers with which we have made the least progress still seem to get the least amount of funding. We spoke to Zetter about his commentary, the opportunities being created by the Cancer Moonshot, and how he thinks cancer funding needs to change.

For people with type I diabetes, the day-to-day management of the disease can be a full-time job involving the monitoring blood glucose levels and injection of insulin. The medical device giant Medtronic has been working toward the development of what it’s called an artificial pancreas, a steady improvement of pump and sensor technology to free type I diabetes patients and allow them to think less about the management of their disease. We spoke to Fran Kaufman, chief medical officer of Medtronic Diabetes, about the progress the company has made, its newest technology that is moving towards the market, and how close it is to realizing its vision of an artificial pancreas.

By using data from routine testing about the genetic evolution of the HIV /AIDS virus in the Canadian province of British Columbia, researchers have shown they are able to identify emerging outbreaks of the disease in near real-time and intervene to control its spread. The first-of-its-kind system is the focus of a study in an April edition of The Lancet HIV. We spoke to Art Poon, Associate Research Scientist for the British Columbia Centre for Excellence in HIV/AIDS and lead author of the study, about the monitoring system, the impact it has had, and whether such an approach is transferable to other regions and other disease outbreaks.

As pricing pressure grow on the pharmaceutical industry, a recent article in Invivo argues that drugmakers must look to a variety of new pricing models built around collaborations with payers and providers. Such an approach, the authors argue, would minimize conflicts between stakeholders, close the information gap about the real-world value of new drugs, and allow for a more evidence-based approach to pricing. We spoke to Susan Garfield, a principal in EY's Life Sciences Advisory Services practice and co-author of the Invivo article, about the need for new approaches to pricing, why the existing unit price approach is too one-dimensional, and what’s at stake for the industry if it fails to innovate new models.

The France-based biotech Gensight Biologics is developing gene therapy treatments for rare, mitochondrial, and neurodegenerative diseases of the eye. Its lead therapeutic candidate is in late-stage trials for Leber’s Hereditary optic neurophathy, a sudden condition that afflicts young adults and leaves almost all of them blind. We spoke to Gensight’s CEO Bernard Gilly about the company, the challenges and promises of gene therapy, and why eye disease is a particularly attractive target for this emerging area of treatment.

Nearly $3 billion a year is wasted on cancer drugs because of the way they are packaged, according to a study in BMJ. These expensive drugs that are injected or infused come in fixed size vials and patients often require less drug than what is sold as a single dose. Because of restrictions on the ability to use leftover drug, the result is that it is usually thrown out. Nevertheless, drugmakers have little incentive to do things differently because the waste enhances their profitability. We spoke to Leonard Saltz, an oncologist with Sloan Kettering Memorial Cancer Center and coauthor of the study, about the findings, why Europe doesn’t have the same problem, and what can be done to stop the waste.

The walking dead live, but it's value, not brains, they are eating. So-called zombie funds, life sciences venture capital funds that are fully invested and unable to raise new money, still maintain their board seats. But Outcome Capital’s Managing Directors Oded Ben-Joseph and Arnie Freeman say their divergent interest from their fellow board members often lead to disputes that can end the life of promising technologies and lead to acquisitions that leave much value on the table. We spoke to Ben-Joseph and Freeman about the boardroom dynamics were zombies lurk, the consequence of this board misalignment, and how acquirers may seek to leverage the situation

Last month, the Senate confirmed Robert Califf, a cardiologist and clinical researcher from Duke University, as commissioner of the U.S. Food and Drug Administration. Though he was overwhelming confirmed, some expressed concerns about his ties to the pharmaceutical industry. Others used the confirmation process to protest the FDA’s handling of opioid painkillers as the problem of addiction to these drugs have become a growing concern. We spoke to Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, about Califf, why he’s well suited for the job, and the challenges he will face in his new role.

Bird Rock Bio, a small, San Diego-based biotech, is planning to take aim at some of the biggest biologics on the market with an antibody in development to treat rheumatoid arthritis that it says it expects to market at an annual cost of just $2,000 a year. That compares to around $30,000 a year for drugs such as Humira, Remicade, and Enbrel that are TNF inhibitors. The experimental therapeutic known as Gerilimzumab targets IL-6. We spoke to Paul Grayson, president and CEO of Bird Rock Bio about the company, the benefits of targeting IL-6, and how the company expects to be able to offer the drug at such a disruptive price point.

The embattled pharma executive Martin Shkreli, whether intentional or not, has ignited a long smoldering public policy discussion about the pricing of pharmaceuticals. As there are growing calls for steps to restrain drug prices, there are also industry concerns about the effect such actions would have on the ability to attract investment and pursue the development of high-risk, innovative therapies. We spoke to Denis Corin, CEO of Q BioMed, an acceleration and development company, for a perspective on the fallout from Shkreli, how to balance innovation with affordability, and whether he expects any lasting impacts on small drug developers.

The California Institute for Regenerative Medicine, California’s voter-established stem cell agency, is thinking about its future. The institute recently issued a strategic plan for the next five years that it says represents a “radical overhaul of the way the institute conducts business” and emphasizes “coordination, speed, partnerships, and patients.” We spoke to Randy Mills, president of the California Institute for Regenerative Medicine, about the strategic plan, the ambitious goal it has set for the next five years, and whether CIRM will have a life beyond the $3 billion voters approved for its funding.

About 1.3 million people in the United States have type 1 diabetes, which requires constant monitoring and regular injections of insulin. The autoimmune disease attacks the insulin producing beta cells in the pancreas and replacement of those cells has long been viewed as an ideal approach to treating the disease. The problem, though, has been finding a reliable supply or replacement cells and protecting them from the body’s immune system while allowing them to recieve needed nutrients, as well as deliver insulin to the body. San Diego-based ViaCyte is now in human clinical trials with a promising approach to treating the disease. We spoke to Paul Laikind, president and CEO of ViaCyte, about the company’s cell therapy, its critical financial support from the California Institute for Regenerative Medicine and JDRF, and why its investigational product may represent a functional cure.

Non-steroidal anti-inflammatory drugs are the most widely used medications in the world. They are used to treat pain resulting from diseases such as arthritis, but these drugs can raise blood pressure and cause serious problems including heart attacks, strokes, and death. We spoke to Paul Waymack, founder, chairman, and chief medical officer of Kitov Pharmaceuticals about its efforts to bring to market a combination therapy that addresses these safety concerns. Waymack discussed the issues surrounding pain medications, his company’s approach, and how the company’s smart FDA strategy is significantly cutting its cost and time to market.

The American Association for Cancer Research, with seven leading cancer research centers, has launched Project GENIE to determine how to better tailor treatments to patients’ individual cancers. The effort will take tumor genomic profiling data from the various institutions and aggregate it into a single database for researchers to harness. We spoke to Barrett Rollins, chief scientific officer at the Dana-Farber Cancer Institute, about the project, how far down the path of precision medicine we have travelled, and how he expects it to reshape cancer care in the years to come.

As medical device makers are building network connectivity and intelligence into their products, they are adding new vulnerabilities and risks as well. The U.S. Food and Drug Administration has just issued draft guidance for postmarket management of cybersecurity of medical devices. It follows previous guidance on premarket submissions for management of cybersecurity in medical devices. We spoke to Russell Jones, partner with Deloitte & Touche, cyber risk leader for the firm’s State of California Practice and co-leader of the firm’s medical device safety and security practice, about the FDA actions, how these connected devices can be exploited by hackers, and what medical device makers can learn from industries that have already faced these issues.

The pharmaceutical industry appears to have lost ground in 2015 on the ongoing debate around drug pricing, a problem that Christopher Bowe sees in part as a failure of leadership within the industry. In a recent guest column in Forbes, Bowe, who advises industry CEOs on communicating their strategies and ideas, argued that the industry needs CEOs capable of reframing the discussion with fresh ideas, forging new alliances, and disrupting existing business models. We spoke to Bowe about this leadership vacuum, why it is critical for the industry to move beyond its tired arguments, and what it needs to do to rebuild trust and credibility with the public.

As 2015 came to a close, Congress passed a package of tax extenders that among other things expanded the Research and Development Tax Credit and made it permanent. The move represents a big win for innovation-based industries, but the life sciences in particular, which will benefit from a new provision that allows companies to capitalize on the credit ahead of producing revenue. We spoke to Dan Mennel, California Market Leader of Strategic Federal Tax Services for Grant Thorton and Matt Gardner, CEO of the California Technology Council, about the R&D tax credit, what it does, and what it means for the life sciences.

The year 2015 was another big one for biotech with record dealmaking, big drug approvals, and solid performance, but it somehow didn’t feel as good as it looks on paper. Pricing concerns that garnered big attention are expected to grow in intensity in the new year with the presidential election and negotiations for the renewal of the Prescription Drug User Fee Act. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about the year in biotech, the highs and lows, and what’s ahead in the new year.

Growing costs pressures, the integration of technology, and the transformation of the patient into a healthcare consumer is giving rise to a new health economy. In its report on the top health industry issue for 2016, PwC highlights the forces expected to have the most impact on the industry in the coming year. We spoke to Karla Anderson, principal of U.S. pharmaceuticals and life sciences for PwC, about the report, how an increasing emphasis on value is reshaping the sector, and what’s in store for 2016.

Despite a record number of new drug approvals this year, the return on R&D investment for the largest pharmaceutical companies continues to fall, according to a new report from the Deloitte Centre for Health Solutions and Deloitte’s R&D services group. In fact, the report finds R&D returns for this group of companies have fallen to their lowest point since Deloitte began tracking them in 2010. We spoke to Neil Lesser, principal with Deloitte Consulting in the Life Sciences strategy practice and a leader in the Research & Development strategy practice, about the report, the pressures on the industry that are hurting returns, and what R&D strategies companies can pursue that might reverse the trend.

Retail prices for more than 100 widely used specialty drugs rose nearly 11 percent in 2013, according to a new report from AARP Public Policy Institute. The report found that the average annual cost of a specialty drugs used to treat chronic diseases rose to more than $53,000 — greater than the U.S. median income and more than twice the $23,500 median income of people on Medicare. We spoke to Leigh Purvis, director of health services research in AARP’s Public Policy Institute about the report, trends that are fueling demand for these drugs, and whether there are public policy solutions to rein in rising drug prices that can be implemented without harm to innovation.

A team of biohackers is developing the first open source protocol to produce insulin simply and economically. The hope is that their work will serve as the basis for generic production of insulin and provide a foundation for continued research into improved versions of the life saving biologic. We spoke to Anthony Di Franco, co-founder of the Open Insulin project and a board member of Counter Culture Labs, about the work, the challenges they are encountering, and whether the DIY movement can teach the corporate world anything about cost-effective innovation.

A large number of clinical trials underlying the approval of drugs never come into public view. This not only has legal and ethical ramifications, but implications for the healthcare system as a whole. We spoke to Jennifer Miller, founding president of Bioethics International and assistant professor at the NYU School of Medicine about her recent study in BMJ Open, part of an effort to improve transparency through the creation of a Good Pharma Scorecard. Miller discussed the study, the scorecard, and the state of transparency in the pharmaceutical industry.

The power of genetic engineering will soon be available for the home thanks to the Amino One, a piece of hardware about the size of a laptop computer that would allow users to manipulate the DNA of microorganisms for productive purposes or just plain fun. We spoke to Julie Legault, founder and CEO of Amino One’s creator Amino Labs, about the device, its target market, and the implications of putting the tools of synthetic biology into the hands of kids.

New gene editing technologies are expanding the ease and power with which scientists can manipulate biological systems with the promising of addressing not only human health issues, but problems the plant faces with regards to food, fuel, and the environment. But while much of the concerns raised about the potential consequences of this technology have focused on its use in humans, Elizabeth Alter, assistant professor of biology at City University of New York’s York College, argues its potential environmental implications will likely be far more significant. We spoke to Alter about her recent op-ed in The New York Times, the need for public discussion about the technology, what should be done today as we work through broader questions of policy.

The U.S. Securities and Exchange Commission last week finalized rules on crowdfunding that opens the door for the participation of non-accredited investors. The rules complete a long process for the commission set into motion by the passage of the JOBS Act. We spoke to Richard Swart, director of research for the Program for Innovation in Entrepreneurial and Social Finance at the University of California at Berkeley and chief strategy officer for the crowdfunding investment site NextGen Crowdfunding, about the new rules, how this will change the investment landscape, and what it all means for the biotech industry.

Growing challenges in the areas of health, food, energy, and the environment have increased efforts to harness biology to create sustainable solutions to global problems. With advances in the ability to engineer microbes to perform desired tasks, the rapidly evolving area of synthetic biology is expected to fundamentally reshape industrial processes and give rise to a new bioeconomy. Leading scientists, entrepreneurs, and investors will gather in San Francisco November 4 through 6 for SynBioBeta SF 2015 to explore the state of synthetic biology. We spoke to Richard Kitney, professor of biomedical systems engineering at Imperial College London and one of the leading scientists behind the United Kingdom’s efforts in synthetic biology, about the upcoming conference, where the state of the science is today, and why scaling up to industrial sized processes remains a big challenge.

A new class of immunotherapies is promising to radically alter the treatment of cancers and has generated excitement among investors for their groundbreaking potential. Now the Loncar Cancer Immunotherapy ETF provides a way for investors to bet on the sector through an exchange traded fund that consists of both Big Pharma and emerging growth biotechs leading the sector. We spoke to Brad Loncar, CEO of Loncar Investments and creator of the ETF, about the fund, why the focus on this narrow slice of the biotech world, and why he thinks immunotherapies will dramatically reshape cancer care in the years ahead.

Wall Street doesn’t like uncertainty and there are a number of policy issues now brewing that threaten to create some uncertainty for the biotechnology industry. As the BIO Investor Forum kicks off in San Francisco October 20 and 21, bringing together investors and CEOs for two days of panels and presentations, the conference will turn its attention to policy issues and the effects they have on valuations within this industry. We spoke to Sara Radcliffe, president and CEO of the California Life Sciences Association and a policy panelist and the BIO Investor Forum, about policy issues the industry faces, the growing controversy over pricing, and what policy matters investors should be watching.

The medtech industry has enjoyed robust M&A activity, strong financings, and a rise in R&D investments, but other numbers point to troubling developments that threaten the future health and growth of the industry, according to a new report from EY. We spoke to Ellen Licking, EY Life Sciences lead analyst, about the report, concerns about the venture capital industry’s move away from the sector, and questions about who will fund early-stage innovation that will be necessary for the future growth of the industry.

Vtesse, a rare disease drug development company, this week announced that it was initiating a late-stage pivotal trial for its lead experimental therapeutic to treat Niemann-Pick Type C1 disease. The start of the trial for the nine month old company represents a major milestone and suggest its history with the National Institutes of Health and the rare disease drug accelerator Cydan Development may point to new ways of cutting the time and cost of advancing a drug to market. We spoke to Ben Machielse, CEO of Vtesse, about the rapid pace at which the company has been able to move, the role NIH has played, and whether this points to new ways to accelerate the drug development process.

The U.S. Department of Health and Human Services has been working to move Medicare from fee-for-service to value-based payments. It’s seeking to get 90 percent of payments to being value-based by 2018. The problem, according to a recent Viewpoint in JAMA, is that when addressing life-ending chronic conditions faced by older patients, traditional professional standards that drive today’s metrics don’t effectively address patient desires. We spoke to Joanne Lynn, director of the Altarum Institute’s Center for Elder Care and Advanced Illness and lead author of the JAMA Viewpoint, about what value-based care means for patients near the end of their lives, the need to recognize the great variance in patient desires, and how healthcare systems will need to change to account for this.

The California legislature earlier this month passed a bill that would allow physicians to aid terminally ill patients who wanted to end their lives. California would become the fifth state to enact such legislation. We spoke to David Grube, national medical director of Compassion & Choices, a nonprofit working to expand end of life options, about the legislation, how attitudes among the public and physicians have changed, and what we’ve learned since Oregon passed the first such law 17 years ago.

The U.S. Food and Drug Administration recently released long-awaited draft guidance regarding the naming of biologics, biosimilars, and interchangeable biologics. At the same time the agency released a proposed rule to apply the naming scheme to six current biological products with, or expected to soon have, biosimilar competitors. We spoke to Gillian Woollett, senior vice president with the healthcare business strategy and public policy advisory firm Avalere Health, about the FDA’s actions, their implications, and some potential unintended consequences.

The National Comprehensive Cancer Network in October will release a new tool designed to help doctors understand the value of different cancer therapies by taking into account the costs of treatments. The effort from the influential group follows similar initiatives by Sloan Kettering Cancer Center and the American Society of Clinical Oncology. We spoke to Bob Carlson, CEO of the National Comprehensive Cancer Network, about the rising costs of cancer care, the new tool, and what impact it will likely have on drug pricing in the future.

President Jimmy Carter, at a recent press conference discussing his cancer diagnosis and treatment, expressed his wish to outlive the last Guinea worm. The Carter Center, since 1986, has led a global effort to eradicate Guinea worm disease with great success and its goal is within reach. We spoke to Ernesto Ruiz-Tiben, director of The Carter Center’s Guinea Worm Eradication Program, about its efforts, the history behind it, and what lessons can be drawn in combating other public health threats throughout the world.

Sprout Pharmaceuticals earlier this week won a controversial U.S. Food and Drug Administration approval of Addyi, the first drug approved in the United States to treat female sexual dysfunction. Following the news, Valeant Pharmaceuticals said it would acquire Sprout for $1 billion. We spoke filmmaker Liz Canner, director of the documentary Orgasm, Inc., about Addyi, the drug industry’s long standing pursuit of a female Viagra, and why its approval is troubling to many people.

Earlier this month in a preemptive challenge from Amarin Pharma against the U.S. Food and Drug Administration a federal judge ruled that the FDA cannot prohibit a drugmaker from promoting the off-label use of a drug if it does so through the dissemination of truthful and non-misleading information. The decision about the First Amendment Rights of a pharmaceutical company is seen as a significant ruling in a long-standing battle between the agency and the industry that has played out over the past 20 years. We spoke to John Kamp, executive director of the Coalition for Healthcare Communication, about the case, the issues behind it, and its implications for how the industry and agency will act going forward.

Drugmakers about 10 percent of the time fail to report serious adverse events to the U.S. Food and Drug Administration within the time required, according to a recent study in the Journal of the American Medical Association. We spoke to Pinar Karaca-Mandic, study co-author and associate professor of Health Policy and Management at the School of Public Health at the University of Minnesota, about the study, the concerns it raises, and whether regulators need to rethink the way adverse events are reported.

A growing problem with drug resistant infections acquired in hospitals is catching the eye of Consumer Reports, which has added the incidence of two common and deadly infections to their hospital ratings. The ratings come in the second part of a three-part investigation in the antibiotic crisis. We spoke to Doris Peter, director of Consumer Reports’ Health Ratings Center, about the study, what the highest rated hospitals are doing that the lower rated ones are not, and things patients can do to safeguard themselves when they face a hospital stay.

The controversy over the high price of new drugs and the question of the value they provide will come under increased scrutiny thanks to a grant to a Boston-based nonprofit that works to get at these questions. The Laura and John Arnold Foundation this week announced it is providing $5.2 million to the Institute for Clinical and Economic Review aimed at transforming the way new drugs are evaluated and priced. We spoke to Sarah Emond, COO of the institute, about the work it does, what this new grant will do to expand that work, and how to get a the question of the value of new drugs.

Researchers at the University of California, Berkeley and the Gladstone Institutes have grown beating cardiac tissue from stem cells in work that may lead to new ways to quickly screen for drugs likely to cause birth defects in the heart and identify drugs that may be dangerous during pregnancy. We spoke to Bruce Conklin, a senior investigator at the Gladstone Institute of Cardiovascular Disease, about the work, which was published in the journal Nature Communications, the promise it has for providing more accurate insights than animal models, and whether the approach could be expanded to other cell types to screen for drug toxicity to other organs.

For many patients with rare and difficult to diagnose conditions, it can take many years and many doctors to find a correct answer. CrowdMed is trying to offering an alternative to patients by allowing them to tap the wisdom of crowds and letting medical detectives who sign on to the site try to find the right answer. We spoke to Jared Heyman, founder and CEO of CrowdMed, about the problem with the traditional way doctors diagnose patients, the wisdom of crowds, and the case for making medicine a team sport.

Last year, the biotechnology industry set records across the board for financial metrics, a reflection of product success, new drug approvals, and free-flowing investment capital. Despite the record performance, concerns continue about growing pricing pressure and maturing pipelines that represent challenges with which the industry must contend. We spoke to Glen Giovannetti, EY’s Global Life Sciences Leader about his firms recently released Beyond Borders report, what the numbers tell us, and what the industry will need to do to keep the good times rolling.

A detailed view of funding of emerging therapeutic companies over the past ten years shows despite a rebound in venture financing, companies continue to struggle to find early-stage money. Nevertheless, the report shows the overall health of investment in the sector is thriving. We spoke to Dave Thomas, senior director of industry research and analysis for the Biotechnology Industry Organization and co-author of the report, about BIO’s findings, what therapeutic areas attracted the most financing, and what impact the capital markets have had on partnering and licensing activity.

To improve the long-term value of biopharmaceutical companies, management should learn to think more like activist investors, according to a new report from EY. The report argues that capital allocation and strategic decision-making could benefit from company leaders setting aside their assumptions and challenging themselves by thinking more like outsiders. We spoke to Jeff Greene, Global Life Sciences Transaction Advisory Services Leader for EY, about the report, what industry executives could learn from activists, and whether shareholder activists indeed have a track record worth emulating.

Bernard Muller was a successful businessman in the maritime and oil industry, but when he was diagnosed with the neurodegenerative disease ALS in 2010, he turned his entrepreneurial skills toward developing new therapies to treat the disease. Muller co-founded the world’s largest genetic research project for ALS, project MinE, and launched Treeway, a biotech company developing new therapies for ALS. As the Biotechnology Industry Organization kicks off its BIO 2015 International Convention in Philadelphia June 15, Muller is a finalist as one of the organization’s Everyday Superheroes in the pharma/biotech category. We spoke to Muller about his decision to launch Treeway, the active role he sees for patients, and why he thinks traditional approaches to drug development and clinical trial design have not served ALS patients well.

Sleep researchers and clinicians will be gathering in Seattle June 6 - 10 for SLEEP 2015, a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society. It is the largest gathering of sleep medicine physicians, sleep and circadian researchers, and health professionals in the sleep field. We spoke to Chris Winter, a fellow of the American Academy of Sleep Medicine and a board-certified sleep specialist with a background in neurology, about our understanding of sleep today, how genetics and digital health technologies may be altering our understanding of sleep, and what we should do to get a decent night’s rest.

Wall Street’s attention will turn to Chicago as the annual meeting of the American Society of Clinical Oncology runs from May 29 to June 2. Some 5,000 abstracts became available mid-month and investors have been sifting through them to gain insights into which drugmakers will rise and fall on news from the meeting. We spoke to Adam Feuerstein, senior columnist for TheStreet, about the ASCO meeting, what the early abstracts say, and who will likely be making headlines at the meeting this year.

A recent article in Nature Chemical Biology that shows it is possible to convert sugar into morphine with genetically engineered yeast has sparked public attention over the potential illicit use of the technology and the need for regulation. The work, though, also opens up significant possibilities for producing a wide range of drugs and the discovery of new ones to treat everything from cancer to infectious diseases. We spoke John Dueber, assistant professor of bioengineering at the University of California, Berkeley and one of the authors of the study, about the work, its implications, and what role biologists need to play in regulating themselves.

Universities are moving away from a passive approach to technology transfer to engage with industry in new partnerships, put a greater emphasis on translational research, and nurturing technologies so they can give rise to new products and companies. We spoke to Eric Tomlinson, chief innovation officer of Wake Forest Baptist Medical Center, about these changes, the approach Wake Forest is taking, and how it is forging new relationships with industry and the regional economy.

With the mapping of the human microbiome, a new understanding is emerging of the complex relationship between the microorganisms that live in the human gut, skin, and elsewhere on the body, and the role they play both in disease and in maintaining health. Along with growing concerns about drug resistant bacteria, this is giving rise to opportunities for narrow spectrum antibiotics. We spoke to David Martin, founder and CEO of AvidBiotics, about the problems of antibiotic resistance, the benefits narrow spectrum therapies offer, and how the sequencing of the microbiome is leading to new approaches to not only treat infectious diseases, but other diseases not traditional thought of as being driven by microorganisms.

AgeneBio is developing drugs to treat the pre-dementia stage of Alzheimer’s disease, and other neurological and psychiatric conditions. The company announced encouraging mid-stage results for its lead therapeutic, which works by quieting hyperactivity in the hippocampus portion of the brain, which plays a critical role in the formation of memory. We spoke to Jerry McLaughlin, CEO of AgeneBio about the company’s efforts, why this approach holds promise in delaying the onset of dementia in Alzheimer’s patients, and whether this approach may have implications for other neurological and psychiatric diseases.

In April, the IMS Institute released a new report that U.S. drug spending in 2014 rose 13.1 percent to $373.9 billion, the largest single year increase in spending since 2001. A number of factors drove the increase including the launch of innovative new therapies such as Gilead’s hepatitis C drug Sovaldi. We spoke to Murray Aitken, executive director of IMS Institute for Healthcare Informatics, about the new report, the confluence of factors that drove spending higher, and what the outlook is for 2015 and beyond.

AARP, the advocacy group serving people over the age of 50, is taking steps to ensure that digital health technologies best serve its membership. The organization has embarked on an initiative to test the design and functionality of digital health devices for older people and provide feedback to the marketplace. It’s enlisted partners United Healthcare and Pfizer as part of its effort. We spoke to Jeff Makowka, director of thought leadership for AARP, about its efforts, how it’s going about testing devices, and what it hopes to accomplish. We had some technical difficulties on this podcast that were not apparent during the interview. We’ve done our best to clean it up, but you will hear some static early in the recording. We apologize to our listeners and our guest, who we think you’ll find nonetheless interesting.

A newly discovered archive of documents reveal the sugar industry’s efforts to shape the national research agenda away from the effects of sugar on tooth decay and push for programs to focus on alternatives to reducing consumption. We spoke to Cristin Kearns, a University of California, San Francisco postdoctoral scholar who discovered the papers, about her research, how the agenda of the National Institute of Dental Health became aligned with the sugar industry’s, and how industry can subvert research agendas to protect their economic interests at the expense of public health.

Drug resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States, according to the U.S. Centers for Disease Control and Prevention. The problem of resistance also limits the ability to treat patients using certain medical procedures, such as chemotherapy, surgery, and organ transplants. Last week, the Obama Administration released its National Action Plan for Combating Antibiotic Resistant Bacteria, a multipronged approach to cut inappropriate use of antibiotics, improve surveillance, and develop new drugs. We spoke to Amanda Jezek, vice president of public policy and government relations at the Infectious Diseases Society of America, about the administration’s plan, whether it offers any new ideas, and what needs to be done to ensure its success.

Adverse events from drugs cost the U.S. healthcare system an estimated $25 billion in 2013, but data from adverse events reporting is generally not factored into payer and provider decisions about what drugs are most cost-effective. The healthcare analytics firm AdverseEvents is trying to change that by turning adverse events data gathered by the U.S. Food and Drug Administration into actionable information. We spoke to Brian Overstreet, CEO of AdverseEvents, about its RxCost offering, why payers and providers rely on mostly pre-approval clinical data in their drug decision making, and why it’s important to consider the broader costs associate with a drug.

Tomasz Sablinski believes the drug development process is broken and has sought to reinvent it. His company, Transparency Life Sciences, relies on crowdsourcing to design its clinical trials, makes all of its data public, and employs digital technologies to remotely monitor participants and dramatically reduce the costs of studies. Now, several years into his efforts, we checked in with Sablinski, CEO of Transparency, about the progress he’s made, what barriers his encountered, and whether his success is having any impact on the way other companies are conducting drug development today.

The biopharmaceutical industry has long been considered immune to the threat of patent trolls, patent holders who seek to monetize the value of a patent through enforcement rather than productive use. But a paper by UC Hastings Robin Feldman and Harvard Fellow Nicholson Price argues that the biopharmaceutical industry should be worried and that steps should be taken now to counter the threat before it blossoms into an industrywide problem. We spoke to Feldman, professor of Law and Director of the Institute for Innovation Law at the UC Hastings College of Law about the study, why the biopharmaceutical industry should be concerned, and what steps can be taken to deter abusive behavior while protecting innovation.

A first of its kind study of venture investment in therapeutics by disease area and innovation finds that venture investment following the Great Recession has not yet recovered to the levels seen in the years leading up to the financial crisis. In addition, the study shows great disparities in the level of funding of disease categories and finds that chronic diseases with large patient populations have seen some of the biggest drops in investment. We spoke to Dave Thomas, one of the authors of the study from the Biotechnology Industry Organization, about its findings, where dollars are going and where they are not going, and what effect recent policies may have had in attracting investment to certain areas.

At the end of January, after nearly a year of hearings, roundtables, and white papers, the House Energy and Commerce Committee’s Subcommittee on Health released a draft of the much anticipated 21st Century Cures Act. The draft, nearly 400 pages long, addresses a broad range of issues in the drug and device development and review process. We spoke to Nick Manetto, principal with the national advisory and advocacy firm FaegreBD, about the legislation, where the points of controversy lay, and whether despite its bipartisan birth political brawling is ahead.

There’s no shortage of data created in the world of healthcare, but harnessing it to improve care and reduce costs remains a challenge. Apervita, backed with $18 million recent venture investment from GE Ventures, Baird Capital, and others is a marketplace for people to buy and sell their healthcare analytics. We spoke to Paul Magelli, CEO of Apervita, about the pressures on healthcare providers today, the challenges to integrating analytics into practice, and how Apervita hopes to change that.

President Obama unveiled the details of his $215 million precision medicine initiative, the centerpiece of which is a 1 million person study that seeks to correlate genetic data, with health records, lifestyle information, and more to better understanding wellness and disease and fuel the development of new therapies. We spoke to Amy Miller, executive vice president of The Personalized Medicine Coalition, about the initiative, if the funding for it will match its ambition, and whether concerns about privacy will stand as a barrier to its success.

CAR-T cell immunotherapies seek to harness the body’s immune system to fight tumor cells. The promise of this new class of therapies has ignited investor’s imaginations, but a new report from EP Vantage argues that the enthusiasm that has driven valuations of CAR-T companies should be tempered by an eye towards the risks. We spoke to Jacob Plieth, report author and senior reporter for EP Vantage, about the promise of these therapies, what we know about their safety and efficacy, and why the muddy intellectual property landscape is a concern.

Investment in biomedical research in the United States is declining at a time when other countries have been increasing their spending. While this is raising concerns about the threats this poses to the nation’s economic competitiveness, a new study in the Journal of the American Medical Association suggests new strategies will be necessary to fund research and development if the clinical value of past investments and opportunities to improve care are to be fully realized. We spoke to study co-author Ray Dorsey, Professor of Neurology and Co-Director of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center, about the findings, what strategies can be employed to reverse the trends, and why new investment alone is not the answer.

It was an unprecedented year for M&A activity in the life sciences, but even though Big Pharma returned to dealmaking after largely spending 2013 on the sidelines, it’s been unable to close its growth gap through acquisitions. Specialty Pharmaceutical and Big Biotech have been building muscle and key acquisitions that could address growth for Big Pharma continue to be snapped up by competitors. We spoke to Jeff Greene, EY’s Global Life Sciences Transaction Advisory Services Leader, about his firm’s new M&A report, at what point the growing price of assets becomes too rich, and what the outlook is for 2015.

Ron Cape, co-founder, chairman and CEO of Cetus, the first biotechnology company, died earlier this month at 82. Cetus, which developed PCR technology, as well as Betaseron and Interleukin-2,has faded from the minds of industry watchers, but its impact has been lasting. The company not only provided scientific, but financial and cultural innovations that helped shaped the industry. Chiron acquired the company in 1991. We spoke to Mark Jones, director of research for the Life Sciences Foundation about Cape, the innovations he made, and his lasting contributions.

The rapidly growing area of regenerative medicine is promising to replace chronic therapies with cures. As the biotechnology industry gathers in San Francisco for a big week of meetings, the Alliance for Regenerative Medicine is readying to deliver its annual State of the Industry Briefing. We spoke to Edward Lanphier, president and CEO of Sangamo Biosciences and the newly elected chairman of the alliance, about the transformation of medicine that’s underway, the particular excitement among investors and industry over gene therapy, and why he’s confident payers are ready to embrace the new technology.

As the biotech industry ramps up for the JPMorgan Healthcare conference, we continue our conversation with TheStreet.com’s Adam Feuerstein. In part two of our conversation, we look ahead to what’s in store for the biotech industry in 2015. We get Feuerstein’s thoughts on who and what to watch in the new year, what Big Pharma company may be the target of a takeover, and whether fights over drug pricing will put an end to biotech’s bull market.

The year 2014 was one for the record books for the biotech industry. In part one of a two-part podcast, we take a look back at the year that was with Adam Feuerstein, senior columnist for TheStreet.com. Feuerstein discusses the growing controversy over drug pricing, the newsmakers of 2014, and lessons from the Dendreon bankruptcy.

Two-thirds of Americans say they are willing to anonymously share their health information with researchers, but only about 1 in 5 is willing to provide their purchase history or social media activity, according to a recent Truven Health Analytics-NPR Health Poll. The findings suggests that while there is growing comfort with electronic health records, privacy concerns may hinder the ability of Big Data to deliver on its full promise to improve the health of individuals. We spoke to Michael Taylor, chief medical officer of Truven Health Analytics, about the survey, the level of theft and misuse of health data, and who people trust the most with their information.

The cost of drug development, a metric that underlies discussions ranging from investment in startups to drug pricing, is a matter of great interest and controversy within the pharmaceutical industry. The Tufts Center for the Study of Drug Development recently completed a new estimate of the cost of developing a new prescription drug and raised it to $2.6 billion, up from $802 million in 2003. We spoke to Joe DiMasi, director of economic analysis at the Tufts center for the Study of Drug Development and principal investigator for the study, about the findings, why there’s been dramatic growth in cost despite efforts to reinvent drug development, and whether there’s reason to think the trend will reverse itself anytime soon.

News last month of the Cystic Fibrosis Foundation’s $3.3 billion sale of royalty rights to Kalydeco and other Vertex Pharmaceuticals drugs it helped fund served as a bold statement to the growing prominence and power of venture philanthropy. We spoke to Margaret Anderson, executive director of FasterCures, about the transaction, the role new funding and collaboration models are playing in accelerating drug development, and what traditional investors and disease groups are learning from each other.

While many may think of telemedicine as an example of digital health technologies that will reshape the future landscape of medicine, a new survey from the law firm Foley & Lardner shows it is very much part of healthcare’s here and now. We spoke to Monica Chmielewski, special counsel to Foley & Lardner, about the survey’s findings, how the Affordable Care Act is fueling growing use of telemedicine, and why reimbursement concerns remain the biggest barrier to wider adoption.

IBM’s Watson Group recently announced an investment in Pathway Genomics, part of a $100 million initiative by the computing giant to spur innovation in entrepreneurial companies that seek to leverage its cognitive computing platform Watson. Pathway Genomics will develop an app that will use Watson to provide health and wellness guidance customized to a user’s genetics. We spoke to Lauri Saft, director of IBM Watson Partner Programs, about the agreement, the things Watson can do better than doctors, and how this cognitive wonder promises to transform healthcare.

Brittany Maynard, a 29-year-old woman with terminal brain cancer who chose to end her own life with a lethal dose of medication, sparked a renewed discussion of so-called death with dignity laws. Maynard had become visible on social and traditional media in her final weeks as she campaigned for legislation now pending in several states. We spoke to Alan Meisel, professor of law and bioethics at the University of Pittsburgh and founder and director of the university's Center for Bioethics and Health Law, about the Maynard case, the state of existing and pending legislation, and whether Americans are becoming more willing to discuss the need to balance technological interventions with quality of life issues when considering their own deaths.

The market for Orphan drugs is growing at more than twice the rate of other prescription medicines In 2013, a record 260 therapeutics won orphan designations in the United States alone as science, policy, and pricing are fueling the trend for drugmakers to develop expensive drugs for small patient populations. We spoke to Jon Gardner, author of a new report from EvaluatePharma, about the growth of the orphan drug market, how successful drugmakers have been at expanding the use of these drugs for non-orphan indications, and whether growing pricing pressure will lead to disruptions in the market for these products.

A new government report finds that healthcare providers in the United States are increasing their adoption of health information technology, but their willingness to do so is tied to the incentives available. What’s more, the government is implementing a new plan to improve interoperability, a suggestion that results from past efforts have fallen short of expectations. We spoke to Joe Smith, chief medical officer and chief science officer for West Health, about the current state of health information technology, the barriers to interoperability, and what it will take to deliver on the promise of technology to improve healthcare.

The National Science Foundation and the National Institutes of Health, concerned about seeing the science they fund commercialized, have embraced the Lean Startup method as a way to improve the odds of success for new companies. Steve Blank, whose work launched the Lean Startup movement, has long worked with entrepreneurs, but last year began working with life sciences startups to apply the approach to an area he once thought it would not work. We spoke to Blank, entrepreneur, author, and Lean Startup guru about what startups do wrong, what he’s learned from applying the method to the life sciences, and whether there are lessons to be learned from lean startups for older, established companies.

There’s growing global concern about threat from antibiotic resistant pathogens. That’s leading to new interest in looking beyond traditional antibiotics to monoclonal antibodies to address the problem. We spoke to Ken Stover, senior director of infectious disease for MedImmune, about the problem, the role monoclonal antibodies could play, and why new efforts hold more promise than previous ones to enlist these powerful therapeutics, which are more often associated with cancer and autoimmune diseases.

Scientific breakthroughs, innovations in technology, and the changing use of data are among the forces that are driving disruptive changes to healthcare. A new report from the IMS Institute for Healthcare Informatics highlights a number of these developments and what they mean for the way healthcare is accessed and delivered. We spoke to Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, about the report, how these developments are reshaping the healthcare landscape, and how they are altering the role drugs will play in advancing healthcare.

As pressure on government and corporate research budgets grow, organizations like the Multiple Myeloma Research Foundation are playing an increasingly critical role in advancing and accelerating drug development. The foundation’s efforts, including its landmark genetic study of multiple myeloma patients, are helping advance innovative therapies in an area that had long been characterized by its lack of new treatment options. We spoke to Walter Capone, president and CEO of the Multiple Myeloma Research Foundation, about his organization’s efforts, how it’s breaking down barriers to cooperation between its partners, and what it’s doing to get the biggest bang for its research bucks.

There has been dramatic progress in the understanding and treatment of relapsing remitting multiple sclerosis, a debilitating neurodegenerative disorder. But progressive MS, a more advanced form of the disease, has remained elusive. Now, a novel collaboration has brought an international group of MS societies together to fund research. We spoke to Bruce Bebo, executive vice president of research for the National MS Society and a member of the Progressive MS Alliance, about the intractability of progressive MS, how the unusual cooperation between MS groups came about, and whether the alliance will stand as a model for groups working in other disease areas looking to get the most out of their research investments.

The U.S. Food and Drug Administration is moving to expand its regulatory domain by adding oversight of certain diagnostics it does not regulate today. The agency says thousands of these test are used daily to guide treatment decisions and diagnose disease, and it wants to ensure their validity and advance personalized medicine. We spoke to Nathan Beaver, a partner with Foley & Lardner, about the FDA’s efforts, the implications for diagnostics companies, and why the agency’s plans are being met with some resistance from industry and Congress.

One problem with drug discovery and development is that answers about the way substances act in the human body are often not apparent early in the process. Though human cell assays have been used, they have their limitations. BioSeek’s BioMap technology seeks to improve the success rate of research and development by bringing the complexity of human biology to cell assays and incorporating that into the earliest stages of drug discovery process. We spoke to Ellen Berg, director and general manager at BioSeek, about the company’s technology, how it seeks to improve discovery and development, and other ways the technology is being used by the industry.

Drugmakers have employed new technologies to reduce the cost and time and it takes develop drugs and produce therapies that more precisely target the underlying biology driving diseases. Boston-based Berg Pharma is using artificial intelligence with a variety of other technologies to reengineer the discovery and development process. We spoke to Niven Narain, co-founder, president, and chief technology officer of Berg, about the problems with drug development today, what makes his company's approach unique, and what its pipeline can tell us about whether the approach is working.

The biotech sector surged in the first half of the year despite volatile markets. M&A and financing continued to be robust as EvaluatePharma weighed in with its Pharma & Biotech Half-Year Report. We spoke to Jonathan Gardner, deputy news editor of EP Vantage, about the trends in the first half of the year, whether 2014 will set new records for M&A activity, and the threats out there that may put an end to the good times.

The regulatory pathway for biosimilars is still a work in progress at the U.S. Food and Drug Administration, but around the world the industry is growing as regulators have resolved issues that remain obstacles in the United States. We spoke to Amit Munshi, CEO of Epirus Biopharmaceuticals, about the opportunities in emerging and developed markets, his company’s strategic approach, and when we’ll see a vibrant biosimilars industry in the United States.