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.”

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Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

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Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

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David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

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Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.