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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”