FDA, R&D, Regulatory

We’ve scheduled your Type T meeting with FDA commish Scott Gottlieb, where you can learn the art of rapid fire R&D

Here we’re introducing the Type T(witter) meeting with the head of the FDA on streamlined drug development.

Anybody who’s been paying attention to our surveys of the Endpoints 100 would not be surprised to learn that a large majority of biotech execs have a big crush on FDA commissioner Scott Gottlieb. One big reason for the love affair between the industry and the commish is that from the execs’ perspective Gottlieb’s pushing to make the agency far more responsive to criticism and the need to batter down some longstanding hurdles in the way of drug developers. And they want it done without tossing the gold standard of R&D out the window and making it a free-for-all.

On Sunday, Gottlieb took to one of his favorite bully pulpits, Twitter, to outline some recent moves at the FDA designed to help you. And he provides a good overview of where the FDA is looking to improve, and how developers can make some needed upgrades as well.

So here we go:

JC: A lot of this boils down to the cost of drug development, which is steep by any standard.

JC: Perhaps some companies could do a much better job with R&D discipline?

JC: Whatever is driving it, R&D costs are unsustainable. And that hurts consumers.

JC: Here’s one trend that Gottlieb doesn’t like at all.

JC: And here’s why it’s happening.

JC: Here’s what we need to do to stop it.

JC: What we’re talking about here is change for the better. No one is killing the FDA’s gold standard. Do you need me to repeat that?

JC: We have to be much more efficient about R&D, whether you like it or not.

JC: So why don’t you give up your go-it-alone approach? (There’s no sign this is happening in any significant numbers.)

JC: Here’s a popular notion that everyone supports.

JC: Faster, better, cheaper trials — what’s not to like?

JC: We told you about those surrogate endpoints here. They are plenty popular in biopharma.

JC: As usual, oncology is leading the way. Everyone must follow. But how do you do that in cardio? Or diabetes? Who would pay for it?

 

JC: Here’s something on devices, which I don’t cover.

 

JC: New standards at FDA are aimed at making the agency more responsive in ways that can be clearly tracked.

JC: One final commercial break before the exit.


Image: Scott Gottlieb. SHUTTERSTOCK


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