FDA nom­i­na­tion in hand, Got­tlieb pre­pares to dis­en­tan­gle him­self from a long list of bio­phar­ma jobs and in­vest­ments

Steve Burd (R), pres­i­dent and CEO, Safe­way, Inc. and Scott Got­tlieb (L), res­i­dent fel­low at Amer­i­can En­ter­prise In­sti­tute par­tic­i­pate in a Sen­ate Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee hear­ing on Capi­tol Hill, June 11, 2009 in Wash­ing­ton, DC. (Cred­it: Mark Wil­son/Get­ty Im­ages)


Scott Got­tlieb wasn’t idle dur­ing the eight years of the Oba­ma ad­min­is­tra­tion. With De­moc­rats in the White House and Re­pub­li­cans out, the for­mer agency of­fi­cial turned to a busy ca­reer work­ing with quite a range of bio­phar­ma in­vestors and com­pa­nies.

Now that Got­tlieb has se­cured Trump’s nom­i­na­tion as the next FDA com­mis­sion­er and lined up an April 5th hear­ing at the Sen­ate, he’s be­gun the process of un­wind­ing those in­vest­ments and busi­ness re­la­tion­ships in bio­phar­ma. Got­tlieb filed a dis­clo­sure form yes­ter­day with the Of­fice of Gov­ern­ment Ethics that will sure­ly pro­vide fod­der for a De­mo­c­ra­t­ic at­tack dur­ing his con­fir­ma­tion hear­ings.

And there’s a lot to see.

Got­tlieb’s con­sult­ing work with Glax­o­SmithK­line is well known, and he’s put the phar­ma gi­ant on a long list of com­pa­nies he will steer clear of dur­ing his first year as com­mis­sion­er, re­cus­ing him­self from any FDA ac­tion re­gard­ing GSK. He’s al­so been a board mem­ber of Me­dA­vante, a med­ical de­vice com­pa­ny. Me­dA­vante owes him some com­pen­sa­tion, he says in the ethics form, but he’ll for­feit that if it doesn’t ar­rive ahead of his con­fir­ma­tion. And if it does, he’ll re­cuse him­self for two years.

There were board po­si­tions with Tolero and the clin­i­cal di­ag­nos­tic lab Com­bi­Ma­trix, which he re­signed from last De­cem­ber. And he set up a com­pa­ny to com­plete a sin­gle con­sult­ing con­tract with Bris­tol-My­ers Squibb. More con­sult­ing was done for Ver­tex and he wrote a se­ries of ar­ti­cles for Forbes.

He al­so has a po­si­tion with Amer­i­can Pathol­o­gy Part­ners and Col­lec­tive Health, but he plans to re­sign from those po­si­tions once he is con­firmed, then re­cuse him­self from ac­tions re­lat­ed to those com­pa­nies.

There are stock op­tions in Gradalis, Glytec and Strike Bio. He’s re­signed re­cent­ly from po­si­tions at Gradalis and Strike, and plans to re­cuse him­self from all three, di­vest­ing his in­vest­ments in 90 days af­ter he is con­firmed as com­mis­sion­er.

Got­tlieb was a part­ner at T.R. Win­ston, a bou­tique in­vest­ment bank, where he picked up in­vest­ments in Cell Bio­ther­a­py, An­gion Phar­ma­ceu­ti­cals, Chan­ti­cleer Hold­ings and:

  • Em­maus Life Sci­ences
  • In­spyr Ther­a­peu­tics
  • Kure
  • Lil­lis En­er­gy
  • Neu­ral­stem
  • Phar­ma-Bio Serv
  • Pros­et­ta Bio­sciences
  • So­cial Re­al­i­ty
  • Syn­the­sis En­er­gy Sys­tems
  • Tivor­san Phar­ma­ceu­ti­cals

All of that will go when he gets the nod from law­mak­ers.

He will still need to re­sign from po­si­tions at Amer­i­can En­ter­prise In­sti­tute, the New York Uni­ver­si­ty School of Med­i­cine, the So­ci­ety of Hos­pi­tal Med­i­cine, the BDO Cen­ter for Health­care Ex­cel­lence and In­no­va­tion, and Daichii Sankyo US.

(Whew.)

And he’ll re­cuse him­self from any ac­tions in­volv­ing all of them.

Chances are that the De­moc­rats will do what it can to paint these ties as an ex­am­ple of Got­tlieb’s too cozy re­la­tion­ship with an in­dus­try he plans to reg­u­late. But with the Re­pub­li­cans in charge of Con­gress and the White House, and bio­phar­ma of­fer­ing sol­id sup­port for the nom­i­na­tion, it’s un­like­ly he’ll be blocked.

The in­dus­try learned to yearn for Got­tlieb at the helm of the FDA pre­cise­ly be­cause his ex­pe­ri­ence had to make him aware of the re­al­i­ties in­volved in de­vel­op­ing ther­a­pies — a per­spec­tive that of­ten seems lack­ing in the White House. There’s no ques­tion his port­fo­lio took him on a glob­al jour­ney in bio­phar­ma that makes him a safe bet to run the agency.

But ex­pect to hear a lot more about this in the weeks to come.

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In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

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Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

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The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

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The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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