Diana Brainard, incoming AlloVir CEO

One of the mas­ter­minds be­hind remde­sivir, Gilead­'s Di­ana Brainard jumps ship to an­tivi­ral T cell play­er AlloVir

As one of the star­tups tapped to join David Hal­lal’s dis­rup­tive man­u­fac­tur­ing out­fit El­e­vate­Bio in the Boston area, AlloVir has built an ag­gres­sive clin­i­cal pro­gram for its virus-spe­cif­ic T cells. Now, the biotech is tap­ping as chief a Gilead vet­er­an with her own ex­pe­ri­ence rac­ing a high­ly tout­ed an­tivi­ral to mar­ket.

Di­ana Brainard, one of the key dri­vers be­hind Gilead’s push to se­cure an emer­gency use au­tho­riza­tion for an­tivi­ral remde­sivir in Covid-19, will take over as CEO of the up­start vi­ral play­er on May 17.

A long­time Gilead vet­er­an head­ing the drug­mak­er’s vi­ral ther­a­peu­tics area, Brainard has served on AlloVir’s board since and as an in­de­pen­dent di­rec­tor since April 2019. Her el­e­va­tion to AlloVir’s top spot comes as Hal­lal moves over to the ex­ec­u­tive chair­man role.

Gilead was one of AlloVir’s ear­li­est in­vestors af­ter Hal­lal tapped the biotech for its next-man­u­fac­tur­ing “base­camp” at El­e­vate­Bio in ear­ly 2019. The com­pa­ny, pre­vi­ous­ly known as Vira­Cyte and based in Hous­ton, scored a $120 mil­lion fundrais­ing round at the time to chase its al­lo­gene­ic virus-spe­cif­ic T cells.

Brainard will take the helm as AlloVir nav­i­gates eight sep­a­rate clin­i­cal tri­als, part of an R&D pro­gram Brainard said has “blown up” over the course of the past year. The most ad­vanced of those can­di­dates, a mul­ti-spe­cif­ic T cell ther­a­py dubbed Vi­ra­lym-M, tar­gets five vi­ral pathogens and is cur­rent­ly in a Phase III piv­otal study against virus-as­so­ci­at­ed he­m­or­rhag­ic-cys­ti­tis. The can­di­date is be­ing test­ed in cy­tomegalovirus, BK virus, ade­n­ovirus, Ep­stein-Barr and hu­man her­pesvirus-6.

Jump­ing in­to the CEO role is a big leap for Brainard on two fronts: She’s nev­er held the top post, and, as a vet­er­an of Gilead and Mer­ck, she’s nev­er been hand­ed the keys to a nim­ble biotech.

“To be hon­est, I’m ter­ri­fied. It’s a brand new thing for me — but those but­ter­flies are part of the ap­peal of the job,” she told me. “I think that’s part of the dri­ver for me is miss­ing that, miss­ing that sense of ‘wow, I’m re­al­ly stretch­ing my­self.'”

With a cou­ple months be­fore she starts, Brainard has leaned on her A-list cir­cle of peers for guid­ance, in­clud­ing Nor­bert Bischof­berg­er, the for­mer Gilead R&D head who jumped ship to steer Kro­nos Bio, and Robin Wash­ing­ton, for­mer­ly Gilead CFO, now a board mem­ber at Google’s Al­pha­bet. Mean­while, she hopes to mod­el her lead­er­ship style off Gilead head Daniel O’Day and in­cum­bent leader Hal­lal and his ex­pe­ri­ence at Alex­ion.

“There will be con­ti­nu­ity, and we have a great part­ner­ship,” Brainard said of Hal­lal. “We have com­ple­men­tary back­ground and skills, and that will be ter­rif­ic.”

Hal­lal will be watch­ing from his ex­ec­u­tive chair seat as well as steer­ing the biotech that made this all hap­pen: El­e­vate­Bio, which has been on a rapid growth clip in its own right. Ear­li­er this month, the start­up closed a mas­sive $525 mil­lion Se­ries C it will use to keep build­ing its next-gen start­up en­gine and one-stop-shop cell and gene ther­a­py man­u­fac­tur­ing “ecosys­tem.” AlloVir is one of three star­tups on board at El­e­vate’s Cam­bridge, MA site, and Hal­lal re­cent­ly said the plan is to add a new com­pa­ny each year mov­ing for­ward.

The move up the cor­po­rate lad­der al­so struck a per­son­al tone for Brainard, who is leav­ing the Bay Area to re­turn to Boston, where she spent near­ly 10 years at Mass Gen­er­al and met her hus­band, the ven­ture cap­i­tal­ist David Shay­witz. Mak­ing the move with three teenage daugh­ters will be no easy task, she said, but the new land­ing spot feels like a “home­com­ing.”

AlloVir will im­me­di­ate­ly lean on Brainard’s lengthy ex­pe­ri­ence at Gilead build­ing and run­ning the he­pati­tis C port­fo­lio in Fos­ter City as well as her clos­ing act in bring­ing remde­sivir to mar­ket. In a con­ver­sa­tion with Fier­cePhar­ma in Oc­to­ber, Brainard dis­cussed her team’s role in re­pur­pos­ing remde­sivir, an an­tivi­ral once de­vel­oped for Ebo­la, in record time to treat hos­pi­tal­ized Covid-19 pa­tients. De­spite some mixed re­sults in ben­e­fit­ting Covid-19 pa­tients across the treat­ment spec­trum, remde­sivir has emerged as an ear­ly stan­dard-of-care in hos­pi­tal­ized pa­tients. That rapid scale-up didn’t hap­pen with­out some sweat eq­ui­ty.

“There was a chance for us to make a dif­fer­ence, and if we were go­ing to do that, we were go­ing to have to work re­al­ly hard,” she said at the time.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

Endpoints Premium

Premium subscription required

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

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Chris Sheldon, AstraZeneca's former VP and head of investor relations

As­traZeneca files law­suit against for­mer ex­ec as he jumps to GSK

AstraZeneca and GSK are once again wrangling over talent.

The British pharma giant has filed suit against former VP and head of investor relations Chris Sheldon as he prepares to start a new job at its rival next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg reported.