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

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.