OSTP nominee Arati Prabhakar (Mike Windle/Getty Images for Vanity Fair)

Biden nom­i­nates first woman to be top, Sen­ate-con­firmed sci­ence ad­vi­sor, re­plac­ing Er­ic Lan­der

More than four months af­ter Er­ic Lan­der, the fa­mous found­ing di­rec­tor of the Broad In­sti­tute of MIT and Har­vard, re­signed from his top White House spot af­ter bul­ly­ing staff, Pres­i­dent Joe Biden has nom­i­nat­ed Arati Prab­hakar to serve as the next di­rec­tor of the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy (OSTP), which is a Sen­ate-con­firmed po­si­tion.

Prab­hakar is the first woman, im­mi­grant, or per­son of col­or nom­i­nat­ed to serve as the di­rec­tor of OSTP, and if con­firmed, she would al­so take the role of As­sis­tant to the Pres­i­dent for Sci­ence and Tech­nol­o­gy.

Prab­hakar can im­me­di­ate­ly take up the sci­ence ad­vi­sor post, ac­cord­ing to Sci­ence, which first re­port­ed Prab­hakar’s new ap­point­ment last week. In be­tween Lan­der’s de­par­ture and yes­ter­day’s nom­i­na­tion, Biden had to scram­ble to find sci­en­tif­ic lead­er­ship, bring­ing for­mer NIH di­rec­tor Fran­cis Collins back from re­tire­ment to help. Biden still has yet to nom­i­nate Collins’ Sen­ate-con­firmed re­place­ment.

“Dr. Prab­hakar is a bril­liant and high­ly-re­spect­ed en­gi­neer and ap­plied physi­cist and will lead the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy to lever­age sci­ence, tech­nol­o­gy, and in­no­va­tion to ex­pand our pos­si­bil­i­ties, solve our tough­est chal­lenges, and make the im­pos­si­ble pos­si­ble,” Pres­i­dent Biden said in a state­ment. “I share Dr. Prab­hakar’s be­lief that Amer­i­ca has the most pow­er­ful in­no­va­tion ma­chine the world has ever seen. As the Sen­ate con­sid­ers her nom­i­na­tion, I am grate­ful that Dr. Alon­dra Nel­son will con­tin­ue to lead OSTP and Dr. Fran­cis Collins will con­tin­ue to serve as my act­ing Sci­ence Ad­vi­sor.”

Prab­hakar is a safe se­lec­tion for Biden as she was unan­i­mous­ly con­firmed by the Sen­ate to lead the Na­tion­al In­sti­tute of Stan­dards and Tech­nol­o­gy, which she led from 1993 to 1997. She al­so led DARPA more re­cent­ly, from 2012 to 2017.

At DARPA, ac­cord­ing to the White House, she es­tab­lished a new of­fice to spur nov­el biotech­nolo­gies and jump-start­ed the de­vel­op­ment of a rapid-re­sponse mR­NA vac­cine plat­form, mak­ing pos­si­ble the in­cred­i­bly fast roll­out of Covid-19 vac­cines. And that work may trans­late in­to help­ing out with the cre­ation of ARPA-H, which is just be­gin­ning to stand up un­der the NIH.

Born in In­dia and raised in Texas, Prab­hakar earned her PhD in ap­plied physics from the Cal­i­for­nia In­sti­tute of Tech­nol­o­gy in 1984 (where she was the first woman to earn a PhD in ap­plied physics).

“She is the right per­son at the right time to sup­port the U.S. in­no­va­tion ecosys­tem, im­prove trans­la­tion­al sci­ence, at­tract and re­tain di­verse tal­ent pools, and en­sure that in­vest­ments in re­search and de­vel­op­ment solve the re­al chal­lenges fac­ing the Amer­i­can peo­ple,” Sen. Maria Cantwell (D-WA), chair of the com­mit­tee that over­sees sci­ence pol­i­cy, said in a state­ment on the nom­i­na­tion.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

Endpoints Premium

Premium subscription required

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

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Bo Cumbo, AavantiBio CEO

Scoop: A small gene ther­a­py biotech, flush with ex-Sarep­ta and blue­bird lead­ers, guts CMC

En route to entering the clinic with its first AAV-based gene therapy for a rare neuromuscular disease, AavantiBio has let go of 30 employees, Endpoints News has learned.

The move comes after a year stacking its executive bench with ex-Sarepta and bluebird bio leaders and inking multiple partnerships with the likes of Aldevron, Catalent and Resilience. The biotech also formed a scientific advisory board in February.

Endpoints Premium

Premium subscription required

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

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

Anand Parikh, Faeth Therapeutics CEO

Sid Mukher­jee, Lew Cant­ley be­hind new can­cer biotech with food+drug com­bo treat­ment am­bi­tions 

Famed oncologist Sid Mukherjee and repeat biotech co-founder Lew Cantley have teamed up to form Faeth Therapeutics, a startup aiming to treat cancer the way other conditions are addressed: pairing nutrition with therapeutics.

The goal is to transform cancer treatment with nutrition and make it the fourth “pillar” in the oncology regimen, which to date has centered on radiotherapy, surgery and drugs, Faeth CEO Anand Parikh told Endpoints News. Other conditions have already been addressed with a side of nutrients or diet, he said, pointing to diabetes, irritable bowel syndrome and other diseases.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.