With Trump’s new FDA com­mish nom­i­nee loom­ing, in­dus­try ex­ecs are keep­ing their fin­gers crossed for Scott Got­tlieb

Scott Got­tlieb

Last week Pres­i­dent Trump said he was just days away from an­nounc­ing an ab­solute­ly “fan­tas­tic” new FDA com­mis­sion­er. One who would cut up to 80% of the reg­u­la­tions around drug de­vel­op­ment, blaz­ing a short­er path to an ap­proval. One who would get ex­per­i­men­tal meds to dy­ing pa­tients, over­haul­ing time­lines and slash­ing de­vel­op­ment bud­gets.

By and large, the mes­sage has spurred more than a lit­tle trep­i­da­tion in the in­dus­try that the pres­i­dent, who has earned a rep­u­ta­tion for shoot­ing first and ask­ing ques­tions lat­er, was go­ing to rad­i­cal­ly change the ap­proval process at the FDA. And that might in­di­cate that lib­er­tar­i­an “seast­ead­er” Jim O’Neill — who has fa­mous­ly said that drugs should be ap­proved on safe­ty alone — has the in­side track with the new pres­i­dent.

But he’s not the in­dus­try’s first choice. That dis­tinc­tion ap­pears to be re­served al­most en­tire­ly for Scott Got­tlieb, the for­mer deputy com­mis­sion­er at the FDA un­der George W. Bush with a rep­u­ta­tion as a staunch con­ser­v­a­tive with no known ap­petite for toss­ing grenades in­to the reg­u­la­to­ry un­der­brush.

Mizuho Se­cu­ri­ties USA ran a quick sur­vey of 53 drug com­pa­nies ask­ing them which of the four can­di­dates men­tioned so far in the me­dia — Got­tlieb, O’Neill, Bal­a­ji Srini­vasan and Joseph Gul­fo — would get their vote.

Sev­en­ty-two per­cent picked Got­tlieb. The rest were al­so rans. O’Neill got a hand­ful of votes at 8%, with Gul­fo at 9% and Srini­vasan at a mere 2%. (Gul­fo has pro­mot­ed his own can­di­da­cy with­out any in­de­pen­dent con­fir­ma­tion from the Trump ad­min­is­tra­tion that he’s ever been a se­ri­ous can­di­date or been with­in 100 feet of the new pres­i­dent.)

In his week­ly roundup on Fri­day, Baird’s Bri­an Sko­r­ney came to the same con­clu­sion with­out any polling. He wrote: “We be­lieve in­dus­try and in­vestor sup­port is over­whelm­ing­ly in fa­vor of Scott Got­tlieb.”

“He leans right, he’s got ex­pe­ri­ence in the agency, he’s got the M.D. cre­den­tial, and he’s out­spo­ken,” Michael Ga­ba, fed­er­al pol­i­cy leader of law firm Hol­land & Knight’s na­tion­al Health­care & Life Sci­ences Team, told Reuters re­cent­ly.

I asked Ga­ba to elab­o­rate on that. And he sent me this:

When it comes to the FDA, bio­phar­ma, and reg­u­lat­ed in­dus­try as a whole, puts a pre­mi­um on pre­dictabil­i­ty, speed to mar­ket, and the abil­i­ty to make dif­fer­en­ti­at­ing claims in the mar­ket­place about their prod­ucts’ ef­fec­tive­ness to treat and mit­i­gate dis­ease.  Safe­ty is the giv­en once a prod­uct makes it through the FDA, and by it­self doesn’t dis­tin­guish prod­ucts in the mar­ket­place.  Among the FDA com­mis­sion­er can­di­dates we’ve read about, Dr. Got­tlieb is well known to in­dus­try and has the req­ui­site ex­pe­ri­ence and tal­ent to re­form and stream­line the FDA ap­proval process.

The theme among the oth­er can­di­dates ap­pears to be to speed prod­ucts to mar­ket by lim­it­ing the agency’s role to eval­u­at­ing safe­ty on­ly.  Not on­ly would this dy­nam­ic be chal­leng­ing to in­dus­try, providers and pa­tients, it would re­quire a statu­to­ry change to the FD­CA – and we all know that the leg­isla­tive process it­self can be very messy and un­pre­dictable.

Got­tlieb’s nom­i­na­tion would con­tin­ue a long­stand­ing tra­di­tion of nam­ing a trained physi­cian for the top job at the FDA. As a res­i­dent fel­low at the Amer­i­can En­ter­prise In­sti­tute, he’s kept the heat on Oba­macare through a se­ries of op-eds in high pro­file pub­li­ca­tions like the Wall Street Jour­nal. As a ven­ture part­ner at New En­ter­prise As­so­ci­ates he’s a board mem­ber at Me­dA­vante, which mar­kets soft­ware for an­a­lyz­ing clin­i­cal tri­al da­ta. And he’s an ad­vi­sor to Glax­o­SmithK­line, which has shown no ap­petite for rad­i­cal change in the way de­vel­op­ers prove a drug works.

It’s the kind of re­sume that would in­di­cate a sym­pa­thy for con­tin­u­ing to evolve reg­u­la­tions to speed de­vel­op­ment, but with­out any ap­petite for play­ing rev­o­lu­tion­ary.

Of course, that’s one rea­son why he may not get the job. Trump has glee­ful­ly named new cab­i­net mem­bers based on their hos­til­i­ty to the agen­cies they’ll be run­ning and the reg­u­la­tions they’ve been in­volved in cre­at­ing. And his ex­ec­u­tive or­der de­mand­ing the elim­i­na­tion of two rules for every new one un­der­scores his com­mit­ment to elim­i­nat­ing hun­dreds of pages of regs for every one that sur­vives.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”