FDA's Scott Got­tlieb is field­ing a new team of re­cruiters to start scout­ing top tal­ent

Biotech ex­ecs have been bull­ish sup­port­ers of the FDA in re­cent years, of­fer­ing their ap­pre­ci­a­tion of faster re­view times with new pro­grams like the break­through ther­a­py des­ig­na­tion. But if there’s one re­cur­rent gripe you hear fre­quent­ly, it’s that the reg­u­la­tors bio­phar­ma com­pa­nies and pa­tient ad­vo­cates deal with don’t have the right kind of sci­en­tif­ic ex­pe­ri­ence for the drugs un­der re­view — es­pe­cial­ly as you stray out­side of on­col­o­gy.

Scott Got­tlieb, FDA Com­mis­sion­er

Now, new broom and broad man­date in hand, FDA Com­mis­sion­er Scott Got­tlieb is rolling out a pi­lot pro­gram to start a tal­ent hunt, look­ing to bet­ter match new hires with the many jobs they have open. And the agency plans to start by re­cruit­ing new staffers for the PDU­FA-re­lat­ed po­si­tions in the drugs and bi­o­log­ics pro­grams.

“To take on this new ef­fort, we’re es­tab­lish­ing a ded­i­cat­ed group of full-time staff with the re­spon­si­bil­i­ty to en­sure that we re­li­ably and pre­dictably iden­ti­fy, re­cruit, and ef­fi­cient­ly hire the sci­en­tif­ic per­son­nel the Agency needs,” notes Got­tlieb in a new blog post out this morn­ing. “Pro­fes­sion­al staff from our cen­ters with ex­pe­ri­ence re­cruit­ing spe­cial­ized sci­en­tif­ic and med­ical staffing will be key mem­bers of this new pi­lot ef­fort. Staff from the Of­fice of Op­er­a­tions will as­sist with the iden­ti­fi­ca­tion of po­ten­tial can­di­dates from key sci­en­tif­ic dis­ci­plines.”

Melanie Keller

Got­tlieb has asked CDER’s Melanie Keller to take charge. She’ll be run­ning the pi­lot from a new­ly-cre­at­ed po­si­tion in­side the Of­fice of Med­ical Prod­ucts and To­bac­co.

The FDA has been plagued by hun­dreds of po­si­tions long left open at the agency, mak­ing re­cruit­ment a key is­sue for Got­tlieb as he nav­i­gat­ed his re­cent con­fir­ma­tion hear­ing at the Sen­ate. With­out a le­gion of reg­u­la­tors to help clear the back­log of gener­ic ap­pli­ca­tions, Got­tlieb’s plan to ac­cel­er­ate a wave of cheap new drugs to the mar­ket will be ham­pered by a lack of hands on deck. And he’s al­so re­ly­ing on bet­ter ex­per­tise at the agency to help with the adop­tion of new tech­nolo­gies that will be cen­tral to faster, more ef­fi­cient drug de­vel­op­ment.

That’s where the rub­ber hits the road for the glob­al biotech in­dus­try. No one wants to have to ex­plain the sci­ence they’re us­ing when look­ing to set up a de­vel­op­ment plan or an­gle for an ap­proval. A com­mit­ment to sharp­en the FDA’s ex­per­tise and keep the fo­cus on ac­cel­er­at­ed OKs won’t meet with any ob­jec­tions in the in­dus­try — or any­where else for that mat­ter.

De­liv­er­ing on this promise will be key to Got­tlieb’s con­tin­u­ing pop­u­lar­i­ty in biotech.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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