Badrul Chowdhury. FDA via Flickr
November 19, 2019 11:00 AM EST
People
Pharma

As­traZeneca los­es an­oth­er ex­ec­u­tive to biotech, as Badrul Chowd­hury moves to Savara

Natalie Grover

Reporter

An­oth­er ex­ec­u­tive is mi­grat­ing from the ech­e­lons of Big Phar­ma to the cor­ri­dors of small biotech.

In April 2018, Badrul Chowd­hury took his more than two decades of ex­pe­ri­ence at the FDA to As­traZeneca, where he took on the role of se­nior vice pres­i­dent and chief physi­cian-sci­en­tist for res­pi­ra­to­ry, in­flam­ma­tion and au­toim­mu­ni­ty late-stage de­vel­op­ment in bio­phar­ma­ceu­ti­cals R&D.

Af­ter about a year and a half in this role, Chowd­hury is mov­ing to a small Texas biotech called Savara, where he will serve as chief med­ical of­fi­cer.

Its lead drug, Mol­gradex, is be­ing test­ed for a pletho­ra of or­phan lung dis­eases. Months ago the com­pa­ny’s shares $SVRA took a hit af­ter the drug failed to help pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis (aPAP) in a piv­otal study.

Rob Neville

“His ap­point­ment comes at a crit­i­cal time as we con­tin­ue dis­cus­sions with the FDA and EMA on the best path for­ward for the Mol­gradex aPAP pro­gram,” said Savara chief Rob Neville in a state­ment.

“With two decades of reg­u­la­to­ry lead­er­ship ex­pe­ri­ence at the FDA’s Pul­monary Di­vi­sion, where he presided over nu­mer­ous ap­provals of med­i­cines for pul­monary and or­phan dis­eases, Dr. Chowd­hury brings a unique per­spec­tive to the Com­pa­ny and we be­lieve he will be in­stru­men­tal in help­ing us achieve our goals.”

Chowd­hury’s move from As­traZeneca may have some­thing to do with some big changes im­ple­ment­ed un­der chief Pas­cal So­ri­ot ear­ly in 2019. A sweep­ing re­struc­tur­ing of its R&D en­gine de­lin­eat­ed the com­pa­ny’s on­col­o­gy ef­fort from every­thing else and erad­i­cat­ed the sub­sidiary struc­ture. The process stripped se­nior ex­ec­u­tives from the top ranks of As­traZeneca’s big bi­o­log­ics sub­sidiary Med­Im­mune, which is where Chowd­hury start­ed out.

Chowd­hury is the lat­est name in the ex­ec­u­tive ex­o­dus from As­traZeneca. David Berman, who was head of I/O re­search at As­traZeneca, has tak­en the top R&D job at Im­muno­core, a biotech that al­so lured Med­Im­mune chief Bahi­ja Jal­lal to take on the CEO role. Berman left As­traZeneca ahead of the re­struc­tur­ing that al­so in­clud­ed the de­par­ture of CMO Sean Bo­hen.

AUTHOR

Natalie Grover

Reporter

natalie@endpointsnews.com @NatalieGrover
Natalie Grover on LinkedIn
SPONSORED
October 19, 2020 06:00 AM EDT

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Alison Holland

Head of Decentralized and Remote trials

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

October 19, 2020 09:09 AM EDT
R&D
Pharma

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

John Carroll

Editor & Founder

Jason Mast

Associate Editor

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

October 19, 2020 07:28 AM EDTUpdated 08:21 AM
R&D

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

John Carroll

Editor & Founder

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

October 20, 2020 04:21 AM EDT
R&D
Coronavirus

Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

Jason Mast

Associate Editor

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

Derek Chalmers, Cara Ther
October 20, 2020 01:00 AM EDT
Deals
Regulatory

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

Nicole DeFeudis

Associate Editor

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

Joe Biden (Carolyn Kaster, AP Images)
October 19, 2020 10:47 AM EDT
Pharma

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

Amber Tong

Editor

From an ill-fated proposal to ban rebates for pharmacy benefit managers to an executive order demanding a “most-favored-nation price” for Medicare, if nothing else President Donald Trump has introduced Americans to a flurry of ideas to rein in pharma, an industry he once accused of “getting away with murder.” And now we’re getting the first glimpse of what a Joe Biden presidency might mean for prescription drug pricing.

October 19, 2020 07:30 AM EDTUpdated 10:01 AM
Coronavirus

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

Max Gelman

Associate Editor

Nicole DeFeudis

Associate Editor

John Carroll

Editor & Founder

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

New Dewpoint Therapeutics CEO Ameet Nathwani (Sanofi)
October 14, 2020 08:53 AM EDT
People
Startups

A long-haul biotech with some im­pres­sive back­ers and big goals re­cruits a ma­jor league R&D ex­ec to the helm. What’s next?

John Carroll

Editor & Founder

A few weeks ago Kite and Allogene founder Arie Belldegrun jumped into the expanded syndicate for a Boston-based biotech called Dewpoint Therapeutics — a Polaris-birthed venture that’s styled itself as a drug development pioneer out to craft a major pipeline.

That round — which also added deep-pocket player ARCH to the list of backers — came up with $77 million for the next step in the long journey toward the clinic, a nice add to the A round that launched the company. Now we hear that Dewpoint has recruited Ameet Nathwani to the executive suite as the new CEO, who’s taking the helm from Polaris managing partner Amir Nashat, who brought the company into existence.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)
October 15, 2020 04:56 PM EDT
R&D

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

John Carroll

Editor & Founder

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca los­es an­oth­er ex­ec­u­tive to biotech, as Badrul Chowd­hury moves to Savara

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

A long-haul biotech with some im­pres­sive back­ers and big goals re­cruits a ma­jor league R&D ex­ec to the helm. What’s next?

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs