R&D, Special

Top 10 pipeline blowups, setbacks and snafus in H2 2017

No company I’ve ever featured on my semi-annual list of top setbacks in biopharma has ever managed to beat Juno Therapeutics at the disaster game. At least not yet. Its string of deaths, before and after an FDA hold, remains in the top spot for the mother of all clinical trial disasters in recent times.

But it didn’t kill the biotech. In fact, the intense focus shifted to their comeback program for JCAR017, which just inspired a $9 billion takeover by Celgene.

Juno offers the important lesson that failure doesn’t have to be a permanent condition. Next-gen drugs are put into the clinic to help increase the odds of success. And in a game like this, where the Phase I through Phase III failure rate runs somewhere around 90% to 95%, who doesn’t think about trying to improve the odds of success.

Nevertheless, my latest top 10 disaster rundown has all sorts of cautionary tales included, with plenty to learn from each. This round includes some regulars, such as:

— Researchers and biopharmas remain wed to drugs long after the data would indicate they should abandon them as losers.

— Even the top fields like I/O are seeing some stunning failures, underscoring that there’s still plenty to learn in a field that has attracted billions in research cash with a slate of approved drugs already on the market.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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