Looking ahead to a new year and a new decade

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(Pixabay/Larisa Koshkina)

As we come to the end of 2019 and the twenty-teen era, we look ahead to what we see as the biggest and most pressing issues facing biotech in 2020.

The most looming issue for the U.S. life science space is the election: Last time around, stocks were hit by talk of drug pricing and control, public arguments over the costs of R&D and marketing and whether Americans are getting the best deal from biopharma.

In what promises to be another volatile political environment, expect to see more saber-rattling over the same issues. (Though always with the caveat: Talk does not always turn into action.)

Virtual Event

Virtual Clinical Trials Online

This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

A bigger unknown is the new FDA chief, Stephen Hahn, who is a political novice but is taking up a job that is certainly far from being apolitical. There are some big decisions coming to Hahn’s desk, including Biogen’s controversial attempt to file a failed and very nearly dumped Alzheimer’s disease drug. A positive decision here could spell a new path for the FDA.

The opportunity to drug nonalcoholic steatohepatitis (NASH), or fatty liver disease, continues to be hyped up given the potential market size, but so many companies keep being hit by setbacks as they vie to be first: Intercept and Genfit, both following a bumpy road, are hoping to be the first to bring a NASH drug onto the market, but it’s no slam dunk for either.

And finally, the fall of neuroscience research, in-house at least: Over the past few years, we’ve seen company after company ditch work in CNS disorders given just how tough they are to crack and the bottomless hole of money the research has consumed with little-to-no ROI. The new thinking is spinning out assets with capital partners and hoping for better. We’ll start to see a little more clearly if that works out in 2020.

— Ben Adams, senior editor at FierceBiotech

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