It’s the time of year for editors to look ahead and attempt to predict, based on the patterns of the past 12 months, what the next trip around the sun will bring.
But, as you well know, pundits and journalists have done a poor job on that front this year. We were all sure that Republican Donald Trump couldn’t possibly be elected president; as about as sure that Brexit couldn’t happen, or that Leicester City would be toppled as the Premier League leaders before the season ended.
But we were all wrong, and I tread very carefully in making any assumptions, and hold on to that axiom that human behavior cannot be predicted, no matter how much data you may hold.
With that warning, let’s start with President-elect Donald Trump, and the known unknowns that have already marked his nascent presidency. We know that he has a deregulating bent and wants to surround himself with wealthy business leaders, such as Carl Icahn and the regulation advisory role he’s just been given, that feel the same way.
How far this will stretch into the FDA remains to be seen, but he may well choose next year a new, and possibly radical, leader of the agency if some reports are to believed, and has already made a vague promise to “reform the FDA.” In more concrete plans, we know the Cures Act will change up R&D for biopharmas and the FDA, so 2017 will be the test for how that starts to work.
And then there’s Brexit. In the end, it did little to move the needle for U.S. stocks as many shrugged and asked, how big is British biotech anyway? In the same week that the vote for the U.K. to leave the EU happened, that jewel in the British biotech crown Circassia lost its shine when one of its leading programs blew up in phase 3, which was a bigger hit for the country than leaving the EU.
But one of the more immediate issues will be the "will it stay or will it go" saga over the European Medicines Agency (EMA), which is housed in London for now, but has seen suitors from other countries coming to its doors for months.
Can a European body really stay in a country not part of the EU, when it will likely not be governing medicines in that country anymore (although that still remains, as so much else, unclear)? The EMA is not willing to talk publicly about that, but losing the agency could be an early casualty over Brexit as the government wrings its hands over when to push the 2-year exit button, which is currently set to happen next year.
In the science arena, next year could also see the first CAR-T blood cancer med approved, with both Kite Pharma and Novartis hoping it will get the FDA nod first, with CRISPR also starting human trials in China this year, with plans for this to start in the U.S. in 2017.
And finally, we come to money and deals. It’s been a great year for VC funding, although this doesn’t mean every biotech has got every cent it wanted, and on the flip side, biotech M&A has been relatively weak given the volatility of presidential elections and tweets over drug pricing, with biotech IPOs also seeing a dismal year, with many being delayed or cancelled as biotechs sought private placements instead.
A Trump presidency has given the promise of more deals overall in 2017, but analysts warn that volatility, and even that specter of drug pricing, is never far away.
And remember, FierceBiotech is for life, not just for Christmas, so be there in 2017 for our daily and weekly news reports, events and special projects in what promises to be another unpredictable year.