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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Paul Burton, incoming Moderna CMO (J&J/file photo)

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

The FDA is offering a fuller account of what went wrong at Emergent BioSolutions’ Covid-19 manufacturing facility in Baltimore, where the cross contamination of J&J and AstraZeneca vaccines led to the discarding of about 75 million vaccine doses.

CBER director Peter Marks released a memo on Saturday with new specifics, making clear up front that no vaccine manufactured at this plant has been distributed for use in the US yet.

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