Joe Biden (AP Photo/Susan Walsh)

Opin­ion: Plen­ty of qual­i­fied peo­ple are ready to run the FDA. Time for Biden to choose one

As the Delta vari­ant ramps up and the FDA pre­pares to ful­ly ap­prove Covid-19 vac­cines and quick­ly re­view boost­er shots this fall, the agency des­per­ate­ly needs a per­ma­nent com­mis­sion­er.

Al­though FDA of­fi­cials have re­as­sured the pub­lic that their jobs con­tin­ue as ex­pect­ed, even with­out a per­ma­nent leader for more than 200 days now, there’s no ques­tion that hav­ing a Sen­ate-con­firmed head for FDA is ex­treme­ly im­por­tant dur­ing a once-in-a-cen­tu­ry pan­dem­ic, and even more so to de­vel­op longer-term, agency-wide strate­gies to help pre­pare for the next pan­dem­ic.

The White House doesn’t seem to have the votes (or doesn’t want a Re­pub­li­can-led con­fir­ma­tion) to tran­si­tion Janet Wood­cock and her four decades of FDA ex­pe­ri­ence from act­ing to per­ma­nent sta­tus. The opi­oid cri­sis and oth­er de­ci­sions she made while lead­ing CDER (e.g., Sarep­ta’s eteplirsen and Bio­gen’s ad­u­canum­ab ap­provals) weigh on her nom­i­na­tion, with at least one De­mo­c­ra­t­ic sen­a­tor, Joe Manchin of West Vir­ginia, pub­licly call­ing on Biden not to nom­i­nate Wood­cock.

But Wood­cock can re­main in her cur­rent, act­ing role un­til about mid-No­vem­ber, and it seems like the Biden ad­min­is­tra­tion has every in­ten­tion to run out the clock on her tenure, even if she isn’t nom­i­nat­ed for the per­ma­nent spot in the end.

Strange­ly, the ad­min­is­tra­tion has con­sis­tent­ly be­moaned the lack of promis­ing FDA com­mis­sion­er can­di­dates, even as the White House has had plen­ty of time to se­lect and vet qual­i­fied can­di­dates.

With this dif­fi­cul­ty in iden­ti­fy­ing FDA com­mis­sion­er can­di­dates in mind, here are 10 qual­i­fied peo­ple who could serve the agency well in the top slot, and ad­vance FDA’s role in cre­at­ing the gold stan­dard in med­ical prod­uct ap­provals (pre­sent­ed in no par­tic­u­lar or­der):

The aca­d­e­mics

  • Er­ic Topol — He’s a well-re­spect­ed car­di­ol­o­gist who un­der­stands the way FDA works, isn’t afraid to stand up to po­lit­i­cal med­dling in sci­en­tif­ic de­ci­sions, es­pe­cial­ly with re­gard to the pan­dem­ic, and is a well-round­ed pub­lic health com­mu­ni­ca­tor.
  • Joshua Sharf­stein — His name was float­ed as an ear­ly con­tender for the FDA’s top job, but then Biden seemed to think he might not be a good se­lec­tion. Per­haps his name resur­faces again? His aca­d­e­m­ic col­leagues all think high­ly of him, and he knows the agency well giv­en his pri­or ex­pe­ri­ence.
  • Aaron Kessel­heim — Al­though Kessel­heim, a Har­vard pro­fes­sor of med­i­cine, re­cent­ly re­signed from the FDA ad­comm that vot­ed unan­i­mous­ly to re­ject Bio­gen’s new Alzheimer’s drug when it was ap­proved, per­haps the Biden ad­min­is­tra­tion can bring him back in­to the fold at FDA. Again, he’s a well-re­spect­ed physi­cian, pro­fes­sor and fre­quent au­thor of pa­pers on var­i­ous FDA poli­cies. Cer­tain­ly, the learn­ing curve would be sig­nif­i­cant­ly less steep for some­one like Dr. Kessel­heim when com­pared with oth­ers.
  • Caleb Alexan­der — An­oth­er aca­d­e­m­ic leader with a strong un­der­stand­ing of the FDA, and who has served on mul­ti­ple FDA ad­comms, in­clud­ing the re­cent Bio­gen one. Alexan­der, a pro­fes­sor at Johns Hop­kins, might pro­vide a unique per­spec­tive to an agency that hasn’t seen an aca­d­e­m­ic leader in the top spot since Duke’s Rob Califf led it.
  • Car­los Del Rio — The Emory pro­fes­sor has been track­ing and ad­vis­ing state and lo­cal gov­ern­ments on the ins and outs of the pan­dem­ic since it be­gan. His clear com­mu­ni­ca­tions have made him a well-re­spect­ed source of in­for­ma­tion.

For­mer FDAers and in­dus­try lead­ers

  • Ken Fra­zier — The for­mer Mer­ck CEO, who stepped down at the be­gin­ning of Ju­ly, is a high-pro­file trail­blaz­er who could of­fer a fa­mil­iar face to the FDA, es­pe­cial­ly with his knowl­edge of the bio­phar­ma in­dus­try, its in­ner work­ings and his ex­cep­tion­al lead­er­ship skills.
  • Michelle Mc­Mur­ry-Heath — As the head of in­dus­try group BIO, Mc­Mur­ry-Heath’s name has sur­faced and re-sur­faced again as a pos­si­ble top con­tender for the FDA com­mis­sion­er job. While she hasn’t com­ment­ed on the prospect, her pub­lic op­po­si­tion to cer­tain Biden-backed ini­tia­tives, like the TRIPS waiv­er be­fore the WTO and Medicare ne­go­ti­a­tions on drug prices, may not win over too many more De­moc­rats than Wood­cock.
  • John Jenk­ins — A long-time FDA di­rec­tor in the Of­fice of New Drugs, Jenk­ins knows the agency (more than 2 decades of ex­pe­ri­ence) and un­der­stands how it works. He al­so served in a high-pro­file po­si­tion for more than a decade, as well as on the oth­er side, with his re­cent in­dus­try con­sult­ing work at Green­leaf Health.
  • Scott Got­tlieb — Clear­ly a fa­vorite among FDA staff from his pre­vi­ous run as com­mis­sion­er dur­ing the Trump ad­min­is­tra­tion. Got­tlieb’s name comes up again, de­spite his role on Pfiz­er’s board and oth­er lu­cra­tive po­si­tions, per­haps be­cause of how con­sis­tent­ly ac­cu­rate he’s been in dis­cussing the pan­dem­ic week in and week out on tele­vi­sion and Twit­ter.
  • Lu­ciana Bo­rio — A for­mer act­ing chief sci­en­tist at FDA, she was vet­ted by Biden’s team for the top job ear­ly on, but has since tak­en on new roles at ARCH Ven­ture Part­ners, so she may be out of the run­ning.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

More man­u­fac­tur­ing is­sues: Fen­nec preps for sec­ond CRL for po­ten­tial hear­ing loss drug

Shares of Fennec Pharmaceuticals stock were cut almost in half early Monday as the company said manufacturing issues caused another FDA rejection of its reformulated version of sodium thiosulfate, which is intended to help kids who lose hearing due to chemo treatment.

The biotech had resubmitted an NDA for the drug to treat platinum-based, chemo-related ototoxicity in young children earlier this year. The first NDA was denied by the FDA last year, with the agency citing manufacturing issues with the biotech’s supplier.

Giovanni Caforio, Bristol Myers Squibb CEO (Pablo Martinez Monsivais/AP Images)

Amid JAK de­ba­cle, Bris­tol My­ers set­tles in for FDA's long re­view of po­ten­tial first TYK2 drug

Bristol Myers Squibb has $4 billion hopes for its late-stage TYK2 inhibitor deucravacitinib, but the FDA’s recent negative review for the JAK inhibitor class has dampened hopes somewhat. Now, the agency will get its first good look at TYK2, and Bristol Myers will have to wait and hold its breath.

The FDA has set a target review date of Sept. 10, 2022, for deucravacitinib, a potential first-in-class oral inhibitor for the TYK2 signaling pathway in psoriasis that would be a challenger to the controversial JAK inhibitors, the drugmaker said Monday.

Shankar Musunuri, Ocugen CEO

Ocu­gen hits an­oth­er snag in bring­ing its Bharat Biotech-part­nered Covid-19 vac­cine to the US

Back in July, Ocugen and Bharat Biotech unveiled some Phase III data suggesting their Covid-19 vaccine, Covaxin, was 77.8% effective at preventing overall disease in India. They’re now looking to launch an immuno-bridging study to see if those numbers hold up in the US — but on Friday, the FDA said not so fast.

Regulators have placed a clinical hold on the partners’ IND, Ocugen shared on Friday. Ocugen’s stock $OCGN sank 9% on the news Friday, but was up almost 7% in pre-market trading on Monday.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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