In a ma­jor blow to vac­cine ef­forts, se­nior FDA lead­ers step­ping down

Mar­i­on Gru­ber

Two of the FDA’s most se­nior vac­cine lead­ers are ex­it­ing from their po­si­tions, rais­ing fresh ques­tions about the Biden ad­min­is­tra­tion and the way that it’s side­lined the FDA.

Mar­i­on Gru­ber, di­rec­tor of the FDA’s Of­fice of Vac­cines Re­search & Re­view and 32-year vet­er­an of the agency, will leave at the end of Oc­to­ber, and OVRR deputy di­rec­tor Phil Krause, who’s been at FDA for more than a decade, will leave in No­vem­ber. The news, first re­port­ed by Bio­Cen­tu­ry, is a mas­sive blow to con­fi­dence in the agency’s abil­i­ty to reg­u­late vac­cines.

The bomb­shell an­nounce­ment comes at a par­tic­u­lar­ly cru­cial mo­ment, as boost­ers and chil­dren’s shots are be­ing weighed by the reg­u­la­tor. The de­par­tures al­so come as the ad­min­is­tra­tion has re­cent­ly jumped ahead of the FDA’s re­views of boost­er shots, an­nounc­ing that they might be avail­able by the week of Sept. 20.

A for­mer se­nior FDA leader told End­points that they’re de­part­ing be­cause they’re frus­trat­ed that CDC and their ACIP com­mit­tee are in­volved in de­ci­sions that they think should be up to the FDA. The for­mer FDAer al­so said he’s heard they’re up­set with CBER di­rec­tor Pe­ter Marks for not in­sist­ing that those de­ci­sions should be kept in­side FDA. What fi­nal­ly did it for them was the White House get­ting ahead of FDA on boost­er shots.

FDA’s for­mer act­ing chief sci­en­tist Lu­ciana Bo­rio added on Twit­ter, “FDA is los­ing two gi­ants who helped bring us many safe and ef­fec­tive vac­cines over decades of pub­lic ser­vice.”

“These two are the lead­ers for Bi­o­log­ic (vac­cine) re­view in the US. They have a great team, but these two are the true lead­ers of CBER. A huge glob­al loss if they both leave,” For­mer BAR­DA di­rec­tor Rick Bright wrote, weigh­ing in on the news. “Dr. Gru­ber is much more than the Di­rec­tor. She is a glob­al leader. Vi­sion­ary mas­ter­mind be­hind glob­al clin­i­cal reg­u­la­to­ry sci­ence for flu, Ebo­la, Mers, Zi­ka, Sars-cov-2, many oth­ers.”

Phil Krause

In a let­ter from Marks to staff, he ex­plained:

Janet Wood­cock told End­points that she wish­es Gru­ber and Krause well and thanks them for their sig­nif­i­cant ser­vice.

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.

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 faceplants 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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FDA's can­cer drug ad­vi­sors will re­view 2 more dan­gling ac­cel­er­at­ed ap­provals for mul­ti­ple myelo­ma, leukemia

In an attempt to get its house of accelerated approvals in order, the FDA is holding its second adcomm of 2021 to review cancer drugs that won accelerated approvals but failed to confirm clinical benefit in subsequent trials or have taken a long time to read those data out.

On Dec. 2, the FDA’s Oncologic Drugs Advisory Committee will review two accelerated approvals from Secura Bio’s Farydak (panobinostat), a third-line multiple myeloma drug, and Acrotech Biopharma’s Marqibo, as a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Both drugs have been marketed for more than five years under their accelerated approvals but have recorded negligible sales in their respective indications in recent years.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Fol­low­ing con­tro­ver­sial Aduhelm ap­proval, DC-based neu­rol­o­gy cen­ter bans Bio­gen rep­re­sen­ta­tives from its of­fices — re­port

CEO Michael Vounatsos confessed earlier this month that Biogen was struggling to get its controversial new Alzheimer’s drug Aduhelm off the ground, with some major health systems refusing to administer it.

Now, a DC-based medical center is taking its small rebellion against the drug’s approval one step further.

The Neurology Center has reportedly banned all Biogen representatives from its seven DC-area offices, according to a photo circulating on Twitter.

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Martin Babler, Esker CEO

Fore­site re­cruits Prin­cip­ia vet Mar­tin Babler — and his old team — to oc­cu­py the C-suite of a start­up

Almost a year to the day after Sanofi closed on its $3.7 billion Principia buyout, handing CEO Martin Babler $81 million for his chunk of equity, the biotech exec is ending his sabbatical and getting back to the helm of a startup. And he’s bringing the old Principia team along with him for the R&D scrimmage ahead.

Babler is taking over the top post at Esker Therapeutics from June Lee, who helped found the upstart, which Foresite hatched out of its labs and endowed with a $70 million launch round. The immunology specialist broke out of stealth mode back in May with a tiny staff and a Phase I plan for a TYK2 drug — initially for psoriasis — part of its plan to address genetically defined patient groups in a field dominated by blockbusters and blockbuster wannabes.

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Sen. Mitch McConnell (R-KY) at the Capitol (J. Scott Applewhite/AP Images)

Mitch Mc­Connell, top Re­pub­li­cans ques­tion Biden on get­ting ahead of FDA on Covid-19 boost­ers

Senate Minority Leader Mitch McConnell, Senate Health Committee ranking member Richard Burr and other top Republicans are questioning the Biden administration’s decision to get out in front of the FDA and announce that Covid-19 vaccine boosters would be ready for administration by this week.

While Burr praised the FDA’s EUA for the boosters Wednesday evening, the Republicans earlier in the day called on White House coronavirus response coordinator Jeffrey Zients to release an updated strategy on leveraging vaccines to end the pandemic and to clarify what exactly happened with the premature announcement on the boosters.

Kunwoo Lee, GenEdit CEO

Eli Lil­ly gets be­hind the lat­est ap­proach to solv­ing gene ther­a­py's de­liv­ery prob­lem

Kunwoo Lee was a graduate student at UC-Berkeley when gene editing pioneer Jennifer Doudna — who happened to work in the same building where he studied — published a paper on CRISPR/Cas9. So he did what any aspiring bioengineer would do: He ran to her lab, and grabbed a postdoc there.

“We started really thinking about the future coming (for) gene therapy and gene editing,” he said.

Lee’s research with Doudna led him to co-found a small San Francisco-based biotech called GenEdit in 2016, the same year he graduated. After five quiet years, the team is now unveiling a $26 million Series A round with support from some big names like Eli Lilly to fund their work on one of the most pressing challenges in gene therapy: what Lee calls the “delivery problem.”

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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In step for­ward for re­ju­ve­na­tion field, re­searchers turn back the clock on mice hearts

When Thomas Braun was starting out as a young professor at Germany’s University of Würzburg in 1997, he decided to try his hand at a new field: heart regeneration, a sci-fi-esque premise that could offer a way to treat patients recovering from a heart attack. He thought it would take a few years before they got results.

“We were,” he acknowledges now, “rather naïve.”

But on Thursday, after two and a half decades of fitful starts and abandoned leads, Braun and a team of researchers at the Max Planck Institute showed that they could reprogram heart cells in mice and get the animals to regenerate cardiac tissue after a heart attack. The breakthrough, published in Scienceadds new evidence that it will eventually be possible to help patients recover muscle lost in heart attacks and gives another boon to anti-aging researchers who want to one day apply these rejuvenation techniques across much of the body.