The Bio Report

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://ga

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 Mat

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.