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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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