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21st Century Cures Act could use a second look; It’s time for the FDA to open up

Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.

thumb  The 21st Century Cures Act would benefit from a closer look before it’s passed

A slightly modified 21st Century Cures Act has been gaining momentum in the lame duck Congress, with Democrats and Republicans coming together in a rare kumbaya moment to back a bill industry lobbyists have been pushing hard for the past two years. It’s not hard to see why. There’s something in here for everyone, with plenty to rile the left in the form of an even warmer welcome for drug developers. One of the biggest plums is an offer to consider “real world evidence” in approving drugs. It should not automatically be assumed that the FDA will willy-nilly ignore long established guidelines on clinical data in approving drugs, but the agency has already gone a long, long way to accommodating developers and speeding approval timelines. To a fault. Perhaps rather than just rolling this out, the Senate should make some thoughtful adjustments. But it is clear that the mood in Congress is calibrated to supporting the industry, rather than punishing it. That kind of fair wind has been blowing in biotech’s favor for 5 years now. We’re happy to see the sails that have been filled. We just hope it doesn’t end up with many of these ships, and the patients that board them, on the rocks.

thumb down  A suggested Cures Act amendment: More sunshine inside the FDA

I’ve already had my say on the fiasco at Juno following two more patient deaths. But I would like to make one quick addition. As long as Congress is so interested in improving things at the FDA, it would make a lot of sense to require — or perhaps I should say allow — the agency to open up about the communications between regulators and biopharma companies. That means publishing CRLs, outlining regulatory actions like clinical holds and informing patients about safety issues that arise in clinical studies — as we saw at Juno. Leaving all of this in the hands of the companies leaves too much to the whim of individuals willing to pull every punch in order to save its share price. By all means, advantage biopharma at the FDA. But let’s shine a spotlight where we can.

thumb down  Eli Lilly execs aren’t the only individuals complicit in the latest Alzheimer’s snafu

One of the biggest stories of the last few days centered on Eli Lilly’s latest Phase III flop for solanezumab. Word has begun circulating that layoffs may now be in the works, which would be completely understandable. But let’s also not overlook the benefits to be had from a careful post-mortem on the data. Much has been said about this drug and the theory that amyloid beta is behind Alzheimer’s disease. To me, one of the biggest lessons provided by sola is that journalists covering this field don’t need to be in the business of supporting companies when they claim benefits that can’t be proven by the data. When Lilly’s executive team highlighted shreds of evidence of efficacy in 2012, by and large everyone in the big-name media world bought off on it, encouraging this latest display of clinical overreach. When a study fails, we should all call it out for what it is. As it stands, some of the biggest names in media only helped encourage another massive waste of money, once again fanning the flames of hope for patients only to serve it up as another dead end years later. We can all do better.

thumb  Vanderbilt’s neuroscience team takes a giant step into the clinic

Over the past year I’ve seen a few instances where academic investigators have been going much further than normal in setting up a drug development program. In some cases (Forty Seven) they’ve been given extraordinary access to new funds. In others (Harvard), there’s been an underlying sense that a solid preclinical program would allow a new company to start up in the clinic, without spending a lot of time and money getting through its IND phase. So hats off to Vanderbilt’s neuroscience operation. They’ve seen too many cases where the biopharma partner they had turned around and exited the field. So they raised extra money to get through early human safety studies to make sure that their next partnership won’t just be abandoned. This speaks to a commitment to advancing new drugs intended to get all the way to patients. It’s a necessary, real-world step forward that we hope more academic groups will follow.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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