Rick Bright (HHS)

BAR­DA chief leaves po­si­tion as agency en­ters un­prece­dent­ed vac­cine cam­paign, rais­ing ques­tions about fed­er­al Covid-19 re­sponse

Rick Bright, the head of the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty and a lead­ing re­searcher on vac­cines and an­tivi­rals, is no longer run­ning the agency.

Bright’s sud­den de­par­ture, first re­port­ed by STAT, comes just as the agency, com­mon­ly called BAR­DA, has been thrust in­to the na­tion­al spot­light as it leads a na­tion­wide ef­fort to de­vel­op vac­cines and treat­ments for SARS-COV-2, the virus that caus­es Covid-19. Last week, the agency an­nounced an up-to $483 mil­lion agree­ment with Mod­er­na to help ush­er its vac­cine to ap­proval and scale up man­u­fac­tur­ing. That came af­ter an agree­ment with J&J to put $1 bil­lion — split be­tween the gov­ern­ment and the phar­ma com­pa­ny — be­hind their vac­cine ef­fort.

Bright will still have a role in the Covid-19 re­sponse, but it won’t be in de­vel­op­ing drugs or vac­cines. He will move in­to an un­spec­i­fied po­si­tion at the NIH to join an ef­fort to scale up di­ag­nos­tic test­ing for the virus, a spokesper­son for the De­part­ment of Health and Hu­man Ser­vices, which over­sees BAR­DA, said in an emailed state­ment. Gary Dis­brow, Bright’s for­mer deputy, will serve as act­ing chief.

“Bright will trans­fer the skills he has ap­plied as Di­rec­tor of the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA) to the Na­tion­al In­sti­tutes of Health, as part of a bold plan to ac­cel­er­ate the de­vel­op­ment and de­ploy­ment of nov­el point-of-care test­ing plat­forms,” the spokesper­son said. “Dr. Bright brings ex­ten­sive ex­pe­ri­ence and ex­per­tise in fa­cil­i­tat­ing pow­er­ful pub­lic-pri­vate part­ner­ships that ad­vance the health and well-be­ing of the Amer­i­can peo­ple.”

The abrupt shake­up shocked those who have long watched and worked with the agency and who won­dered what pre­cip­i­tat­ed a ma­jor lead­er­ship shift in the midst of one of the worst bi­o­log­i­cal threats the US has faced in BAR­DA’s 14-year-his­to­ry. Al­though his­tor­i­cal­ly a small agency, the most re­cent stim­u­lus pack­age al­lo­cat­ed an ad­di­tion­al $1 bil­lion for Covid-19 work. Bright has led it since 2016.

“I would like to know why,” Amesh Adal­ja, a se­nior schol­ar of in­fec­tious dis­ease at Johns Hop­kins Uni­ver­si­ty’s Cen­ter for Health Se­cu­ri­ty, told End­points News. “It’s hard to know what the im­pli­ca­tions are. Lead­er­ship changes in the mid­dle of the cri­sis of are of­ten more dif­fi­cult. I hope it doesn’t di­min­ish BAR­DA’s role.”

The move al­so re­newed ques­tions about the role pol­i­tics may be play­ing in the gov­ern­ment’s re­sponse to the pan­dem­ic. Al­ready, the FDA has faced crit­i­cism over its de­ci­sion to au­tho­rize use of a malar­ia drug long ad­vo­cat­ed by Pres­i­dent Trump over the ob­jec­tion of his top sci­en­tif­ic ad­vi­sors and ap­prove a clin­i­cal tri­al for a cell ther­a­py pushed by Trump’s per­son­al at­tor­ney Rudy Giu­liani.

The di­rec­tor of BAR­DA is not a Sen­ate-con­firmed po­si­tion. It an­swers di­rect­ly to the HHS as­sis­tant sec­re­tary for pre­pared­ness and re­sponse.

“I can­not imag­ine any­thing good com­ing from this loss of lead­er­ship at a cru­cial time in a plague,” Art Ca­plan, founder of NYU’s Di­vi­sion of Med­ical Ethics, said in an email to End­points. “But I do not know why he left. Pre­sum­ing pol­i­tics then it is moral­ly rep­re­hen­si­ble and ir­re­spon­si­ble in the ex­treme.”

Bright, who pre­vi­ous­ly worked in biotech and has ad­vised the WHO, joined the agency in 2010. Formed in 2006, in the wake of 9/11 and the sub­se­quent an­thrax scare, BAR­DA was de­signed to pro­tect the US against bio-threats, in­clud­ing bioter­ror­ism and po­ten­tial nat­ur­al out­breaks. Al­though lit­tle known be­fore the Covid-19 pan­dem­ic, over the en­su­ing 14 years they hand­ed out gov­ern­ment con­tracts worth hun­dreds of mil­lions of dol­lars to build vac­cines and treat­ment for pan­dem­ic flu, Ebo­la and the Zi­ka virus, among oth­ers.

Last year, two of those ef­forts came to fruition with the ap­proval of a small­pox an­tivi­ral and an Ebo­la vac­cine. For­mer FDA chief Scott Got­tlieb, who en­tered his role short­ly af­ter Bright, praised his lead­er­ship dur­ing those ef­forts.

The agency emerged as a key play­er ear­ly in the Covid-19 out­break, hand­ing out small­er con­tracts to long­time part­ners Re­gen­eron and Sanofi in Feb­ru­ary be­fore call­ing for new ap­pli­ca­tions and even­tu­al­ly promis­ing around $1 bil­lion.

Dis­brow, the new act­ing di­rec­tor, joined the agency months af­ter its in­cep­tion in De­cem­ber 2006 and be­gan work­ing on the small­pox vac­cine pro­gram. A for­mer as­sis­tant pro­fes­sor of on­col­o­gy and pathol­o­gy at George­town Med­ical Cen­ter, he worked on an HPV vac­cine and re­ceived grants for de­vel­op­ing new vac­cine tech­nol­o­gy from the Bill & Melin­da Gates Foun­da­tion. He has over­seen the bud­get for Pro­ject BioShield, a long-run­ning gov­ern­ment ef­fort to pur­chase vac­cines for use in a po­ten­tial bio-ter­ror at­tack.

Matthew Wat­son, a se­nior an­a­lyst for the Hop­kins Cen­ter for Health Se­cu­ri­ty, said that while the sud­den change could in­ter­rupt the agency’s work, Dis­brow was well-suit­ed for the role.

“Lead­er­ship tran­si­tions can be dis­rup­tive, and for this to be hap­pen­ing in the midst of a pan­dem­ic cer­tain­ly isn’t ide­al,” Wat­son said in an email to End­points. “That said, it’s re­as­sur­ing that Dr. Gary Dis­brow will be tak­ing on the role of BAR­DA di­rec­tor on an act­ing ba­sis. He’s well-known in the com­mu­ni­ty and is a vet­er­an of MCM R&D.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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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!

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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.

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#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.

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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.

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Albert Bourla (Photo by JOHN THYS/POOL/AFP via Getty Images)

As boost­er sea­son awaits, US re-ups sup­ply of Pfiz­er Covid-19 vac­cine with new $3.2B deal

The US government said late Wednesday that it will pay Pfizer and its partner BioNTech $3.2 billion upon receipt of the first 105 million Covid-19 vaccine doses, potentially the new Omicron-adapted boosters pending EUA.

Under this agreement, the US government also has the option to purchase up to 195 million additional doses, bringing the total number of potential new doses to 300 million. The US has now spent almost $15 billion on Pfizer’s Covid-19 vaccine.

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.

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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.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.