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Is the FDA Too Cautious?

Open to Debate

CHAPTER

The Importance of Accelerated Approval in Drug Development

I think what keeps the biotech and pharma industry from investing in a lot of new breakthrough drugs is the regulatory hurdles. It's too expensive, takes too long, and therefore they just don't put the money in. I would say we're technically on the third wave of AI for people who have been in the industry for a long time. At our company, we use it to create digital twins, which are replicas of humans from the genes up that we use to discover new drugs or simulate drug treatment. And so, I think we're going to start to see AI play a bigger role in clinical trial design.

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