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.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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In­vestors give ail­ing Unum a lease on life and a whole new suite of ex­per­i­men­tal can­cer drugs

Investors, it seems, are willing to give Unum Therapeutics one last shot — or at least one last shot to a company of that name.

The ailing cancer biotech, beset by a series of clinical holds and multiple failed lead programs, announced today that they’ve acquired Kiq LLC and that investors are putting in $104 million to advance Kiq’s pipeline of kinase inhibitors. Unum shareholders will now own only 16.2% of the company and CEO Chuck Wilson indicated that the cell therapies the biotech has worked on since its founding may be on their way out, saying Unum will “explore strategic options” for those products.

RA Cap­i­tal dou­bles down on Sid­dhartha Mukher­jee's vi­sion for a new cell en­gi­neer­ing ap­proach, lead­ing Vor's $110M Se­ries B

Vor Biopharma is muscling up.

CEO Robert Ang, who was reluctant to divulge the headcount when discussing his move from Neon Therapeutics to Vor last August, readily offered that the team has grown from 6 to 50 in less than a year. The biotech is moving to a larger office on Cambridge Parkway Drive in weeks, giving it more space to complete the IND-enabling work and manufacturing scale-up — conducted by a CDMO partner — in preparation for clinical trials planned for the first half of 2021.

Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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UP­DAT­ED: Im­munomedics spells out PFS ben­e­fit of Trodelvy in mTNBC, hunt­ing a full OK just weeks af­ter ac­cel­er­at­ed ap­proval

By the time the FDA finally granted an accelerated OK for Immunomedics’ Trodelvy, we already got a very strong hint that their confirmatory Phase III study in metastatic triple-negative breast cancer was a success.

That’s because the independent data safety monitoring committee recommended that the trial be stopped early. But just what pointed them to the conclusion was still unclear.

“We do not know the totality of their decision other than it’s pretty evident that the primary endpoint was met; otherwise they could not request to halt the study,” Behzad Aghazadeh, the executive chairman, told Endpoints News at the time.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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