Badrul Chowd­hury jumps ship at the FDA and moves to As­traZeneca, join­ing an ex­o­dus of agency of­fi­cials

Twen­ty-year FDA vet­er­an Badrul Chowd­hury, most re­cent­ly di­rec­tor of the Cen­ter for Drug Eval­u­a­tion and Re­search’s (CDER) Di­vi­sion of Pul­monary, Al­ler­gy and Rheuma­tol­ogy Prod­ucts, has tak­en a job this month as se­nior vice pres­i­dent at As­traZeneca.

As­traZeneca tells End­points News that Chowd­hury will be mov­ing in­to a top re­search job, tak­ing on the role of se­nior vice pres­i­dent of re­search de­vel­op­ment at As­traZeneca and Med­Im­mune, where he will be head­ing up the Res­pi­ra­to­ry, In­flam­ma­tion, and Au­toim­mu­ni­ty, In­no­v­a­tive Med­i­cine and Ear­ly De­vel­op­ment Bio­med Unit.

Chow­dury joined the agency in 1997 and left on 16 April. And Chow­dury isn’t the on­ly one to leave in re­cent months for an in­dus­try job, FDA said.

Sarah Pope Miksin­s­ki, for­mer di­rec­tor of the Of­fice of New Drug Prod­ucts in FDA’s Of­fice of Phar­ma­ceu­ti­cal Qual­i­ty, left the agency in Feb­ru­ary, al­so for As­traZeneca. And last Ju­ly, Ge­of­frey Kim, for­mer di­rec­tor of FDA’s Di­vi­sion of On­col­o­gy Prod­ucts moved to As­traZeneca to be­come its VP of on­col­o­gy and head of on­col­o­gy strate­gic com­bi­na­tions.

Mean­while, Jean-Marc Guet­ti­er, for­mer di­rec­tor of FDA’s Di­vi­sion of Me­tab­o­lism and En­docrinol­o­gy Prod­ucts, left FDA in De­cem­ber 2017 for Sanofi, Ni­raj Mehta, for­mer as­so­ciate di­rec­tor for glob­al reg­u­la­to­ry pol­i­cy at FDA moved over to Mer­ck as a di­rec­tor in March 2018, and Thomas Cos­grove, for­mer di­rec­tor of FDA’s Of­fice of Man­u­fac­tur­ing Qual­i­ty in the Of­fice of Com­pli­ance, left in No­vem­ber 2017 to join the law firm Cov­ing­ton & Burl­ing.

Reg­u­la­to­ry con­sult­ing firms like Green­leaf Health al­so fre­quent­ly poach for­mer FDAers with decades of ex­pe­ri­ence, in­clud­ing for­mer Of­fice of New Drugs Di­rec­tor John Jenk­ins.

Ques­tions have been raised in re­cent years on the re­volv­ing door be­tween in­dus­try and FDA, par­tic­u­lar­ly as ex­pe­ri­ence at the agency can lead to lu­cra­tive salaries and cre­ate con­flicts where re­la­tion­ships be­tween in­dus­try and FDA are al­ready cozy.

Back in 2015, the Eu­ro­pean Med­i­cines Agency tight­ened its pol­i­cy on the re­volv­ing door, not­ing that if nec­es­sary, it would be­gin ver­i­fy­ing if pre­vi­ous sci­en­tif­ic re­views in which a per­son jump­ing ship to in­dus­try had been com­pro­mised.

On the flip side, FDA re­lies on in­dus­try funds to do its work, of­ten hires in­dus­try ex­perts and us­es out­side ex­per­tise from phar­ma­ceu­ti­cal com­pa­nies to in­form guid­ance doc­u­ments and rule­mak­ings.

FDA Com­mis­sion­er Scott Got­tlieb and his pre­de­ces­sor, Robert Califf, were both crit­i­cized ahead of their con­fir­ma­tion hear­ings for be­ing too close­ly linked to in­dus­try, but both com­mis­sion­ers have al­so shown how their ex­pe­ri­ence can be uti­lized in the top job.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.
Im­age: Badrul Chowd­bury.
FDA

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US, UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal a Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as “Cozy Bear,” that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Mer­ck KGaA takes its I/O op­tion on F-star Ther­a­peu­tics; Nephron spends $215M, eye­ing spot in Covid-19 vac­cine chain

→Merck KGaA has taken an early option on an immuno-oncology program developed at F-star Therapeutics. This is their second option in the collaboration. And they added a pair of preclinical discovery programs to the alliance as well.

Any biotech going public these days wouldn’t feel right if they didn’t upsize the offering. And that’s just what Phase I biotech Pandion Therapeutics did. The autoimmune company is now selling 7 million shares, a 1.5 million share bump, for $16 to $18 a share.