The Bio Report

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.