The Bio Report

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.