Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Mon­cef Slaoui hasn’t start­ed mak­ing plans for his sum­mer va­ca­tion next year. But he of­fers high odds that all Amer­i­cans will be able to do that in the not too dis­tant fu­ture.

In an in­ter­view with a pair of sym­pa­thet­ic pod­cast­ers at the con­ser­v­a­tive Amer­i­can En­ter­prise In­sti­tute, Slaoui pro­vides an ed­u­ca­tion to lis­ten­ers on how any drug or vac­cine can be sped through tri­als. And he leaves the door wide open to the no­tion that the lead­ing vac­cine de­vel­op­ers can demon­strate ef­fi­ca­cy and safe­ty in a com­pelling fash­ion as ear­ly as Oc­to­ber — or as late as the end of this year.

But Slaoui says he is quite con­fi­dent that based on what he knows now, there’s good rea­son to be hope­ful that vac­cines will be avail­able in suf­fi­cient quan­ti­ty to cov­er all the at-risk pop­u­la­tion in the US — up to 40 mil­lion peo­ple — by the end of Feb­ru­ary. And he’s look­ing for sev­er­al vac­cines to cross the fin­ish line, so that the ex­perts can choose which are the most like­ly to work based on de­mo­graph­ics and risk.

Slaoui’s po­si­tion on this will be close­ly fol­lowed. He end­ed a 30-year stint at GSK as chair­man of the vac­cines group, top­ping it off with the high­ly suc­cess­ful Shin­grix pro­gram. With his switch to OWS, Slaoui di­vest­ed his Mod­er­na shares — jump­ing from the board of one of the lead­ing vac­cine de­vel­op­ers to OWS — but kept his GSK stock, which trig­gered some crit­i­cism that he’s still clear­ly deeply re­sent­ful about.

For crit­ics, it’s all fod­der for dis­cus­sion as every­one fo­cus­es in on the high­ly po­tent top­ic of whether Pres­i­dent Trump will force through a vac­cine an­nounce­ment — herald­ing a suc­cess­ful piv­otal tri­al — in time to in­flu­ence the elec­tion. And like every ex­pert in the gov­ern­ment, from FDA com­mis­sion­er Stephen Hahn to NI­AID di­rec­tor An­tho­ny Fau­ci, Slaoui says the sci­ence will be all that mat­ters.

Draw­ing from a tran­script of the call, here’s Slaoui de­scrib­ing in de­tail how vac­cine de­vel­op­ment is done:

We’re run­ning very large tri­als be­cause they al­low us to reach ef­fi­ca­cy faster, not be­cause there’s an elec­tion, be­cause there’s thou­sands of peo­ple dy­ing every day. And the da­ta will be de­fined by the num­ber of cas­es. There is no date. It’s im­pos­si­ble to give you a date. I have been asked about dates, and I didn’t feel any pres­sure what­so­ev­er to say da­ta will de­fine the date. When we have the num­ber of cas­es re­quired and then we have an in­de­pen­dent da­ta safe­ty mon­i­tor­ing board in­de­pen­dent­ly look in­to the da­ta and says we need to con­tin­ue, we need to stop be­cause this is not work­ing, or we need to stop be­cause this is work­ing too well, it’s un­eth­i­cal to con­tin­ue, we now need to start to give the vac­cine to the place­bo arm in the tri­al and to oth­er peo­ple to con­sid­er, then that will be the end. So the end of the tri­als is com­plete­ly in­de­pen­dent of the op­er­a­tion or any­body in­volved in the op­er­a­tion. It’s ac­tu­al­ly great aca­d­e­m­ic ex­perts, whose names are un­known to the pub­lic who are look­ing in­to that da­ta. And this is how all clin­i­cal tri­als are al­ways done. That is how clin­i­cal tri­als are done.

So when will we know?

So the da­ta will dic­tate, the facts will dic­tate. We may have the end point in Oc­to­ber. We may have it in No­vem­ber 4th, who knows? We may have it in De­cem­ber 15th. That’s the an­swer, and to be hon­est, on a per­son­al ba­sis, I would re­sign in­stant­ly if I was forced to do some­thing that I thought would be in­ap­pro­pri­ate.

From the pod­cast­ers: What’s your time­line? Or what’s your thought on that?

I hope we will have enough dos­es of vac­cines in the first two months of 2021 to im­mu­nize the at risk pop­u­la­tions in the US, vac­cines that could have shown ef­fi­ca­cy and ap­proved in­de­pen­dent­ly by the FDA. And I’m talk­ing about maybe the 30 to 40 mil­lion most sus­cep­ti­ble peo­ple in the US across maybe De­cem­ber, Jan­u­ary, Feb­ru­ary.

And then and I think that should de­crease dra­mat­i­cal­ly the bur­den of this dis­ease on so­ci­ety in gen­er­al. Be­cause, as you know, most of the bur­den of the dis­ease is on a high risk pop­u­la­tion. Plus the sec­ondary ef­fect of over­whelm­ing the hos­pi­tal sys­tems, et cetera, which has an im­pact on oth­er pop­u­la­tions for oth­er rea­sons. And I think, from there on, it’s go­ing to be a grad­ual process that will be a bal­ance be­tween the ben­e­fits/risks that the vac­cines will have shown and the risk of par­tic­u­lar sub­pop­u­la­tion.

For in­stance, frankly, im­mu­niz­ing the pe­di­atric pop­u­la­tion, tod­dlers, et cetera, will be some­thing that should be re­al­ly far be­cause they have 70 or 80 years to live. And we need prob­a­bly there to use plat­form tech­nolo­gies that are well un­der­stood in the long range, such as pro­tein based vac­cines, et cetera. We are for­tu­nate that most­ly in that pop­u­la­tion the dis­ease bur­den is very, very low. And so, I think there will be a gra­di­ent of views. But prob­a­bly be­tween the first quar­ter and the sec­ond quar­ter of 2021, the most at risk pop­u­la­tions will have been, I hope, im­mu­nized. And life, I would ex­pect… I hope next sum­mer I can have a va­ca­tion, nor­mal va­ca­tion.

What­ev­er hap­pens to his va­ca­tion plans, one thing seems cer­tain. Mil­lions of peo­ple will be ar­gu­ing over the de­vel­op­ment time­line right un­til the elec­tion is de­cid­ed.

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

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.

Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,500+ biopharma pros reading Endpoints daily — and it's free.