The Bio Report

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.