Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee meets next month to dis­cuss the de­vel­op­ment and au­tho­riza­tion of Covid-19 vac­cines, the chair­woman won’t be there.

Hana El Sahly

Hana El Sahly has re­cused her­self from the ex­pert pan­el’s re­view of the top­ic, cit­ing her role as a lead in­ves­ti­ga­tor in Mod­er­na’s Phase III tri­al, Reuters re­port­ed. An as­so­ciate pro­fes­sor of vi­rol­o­gy and mi­cro­bi­ol­o­gy at Bay­lor Col­lege of Med­i­cine in Hous­ton, El Sahly was ap­point­ed the chair­woman last year.

The FDA has yet to re­lease the ros­ter for the Oct. 22 meet­ing. The vac­cine ad­vi­so­ry com­mit­tee cur­rent­ly con­sists of 15 vot­ing mem­bers; they are set to de­lib­er­ate on Covid-19 vac­cines gen­er­al­ly in­stead of de­bat­ing any spe­cif­ic ap­pli­ca­tion.

While this marks the first in­stance an FDA ad­vi­sor has stepped aside due to po­ten­tial or per­ceived con­flict of in­ter­est, it fol­lows two high-pro­file res­ig­na­tions from Mod­er­na’s board for the same rea­son.

Mon­cef Slaoui, the for­mer head of Glax­o­SmithK­line’s vac­cines de­part­ment, stepped off once the White House tapped him as the chief sci­en­tif­ic ad­vi­sor of Op­er­a­tion Warp Speed. Two months lat­er, Brigham and Women’s pres­i­dent Eliz­a­beth Nabel fol­lowed in his foot­steps as her hos­pi­tal was set to be a site for Mod­er­na’s Phase III tri­al.

Work­ing on the broad­er, na­tion­al lev­el, El Sahly re­cent­ly de­scribed her role to the lo­cal af­fil­i­ate ABC13: “Re­view­ing the re­lat­ed doc­u­ments, the com­mu­ni­ca­tions that sort of laid the ground for the process of get­ting the study start­ed.”

Al­though reg­u­la­tors are not bound to fol­low the ad­comm’s rec­om­men­da­tions, this par­tic­u­lar meet­ing is spe­cial. FDA com­mis­sion­er Stephen Hahn has spot­light­ed the event — which will be open to the pub­lic — as an il­lus­tra­tion of the kind of trans­paren­cy and sci­ence-dri­ven ap­proach that his agency is striv­ing for.

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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of face plants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.