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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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