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

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

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On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

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Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

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Abeliovich and Prevail, though, aren’t taking this one lying down.

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CEO Pascal Soriot via Getty Images

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

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