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

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

Covid-19 roundup: Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta; FDA ap­proves Pfiz­er/BioN­Tech vac­cine stor­age at stan­dard freez­er temps

Merck is pushing back plans to supply the US government with a Covid-19 drug after the FDA asked for more data to support an emergency use authorization.

The antibody, MK-7110, had looked promising in a Phase III study conducted by OncoImmune before Merck came along and bought the biotech for $425 million. At the interim analysis, investigators looked at data from 203 patients and concluded that a single dose of the drug cut the risk of death or respiratory failure by more than 50% among severe patients. And those taking the drug had a 60% higher chance of improvement in clinical status compared to placebo.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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