Pfizer CEO Albert Bourla (AP Images)

Alone in the spot­light, Pfiz­er CEO Bourla swears pure in­ten­tions in the rush to de­vel­op a Covid-19 vac­cine. But will the pub­lic be­lieve it?

Bioreg­num Opin­ion Col­umn by John Car­roll

Now that Mod­er­na has shift­ed ex­pec­ta­tions on piv­otal da­ta for its Covid-19 vac­cine to some time just af­ter the elec­tion and As­traZeneca has been stalled by a safe­ty is­sue, the sole play­er that can de­liv­er a shot through an emer­gency use au­tho­riza­tion this month is Pfiz­er.

And Pfiz­er CEO Al­bert Bourla wants no part of the po­lit­i­cal furor that has swelled around that top­ic.

In an open let­ter, Bourla lament­ed the spot­light that Pres­i­dent Trump di­rect­ed at Pfiz­er dur­ing the first chaot­ic pres­i­den­tial de­bate. Trump — who has just test­ed pos­i­tive for the coro­n­avirus, push­ing the pan­dem­ic back in­to the head­lines — is shov­ing Pfiz­er in­to gale force po­lit­i­cal winds by in­sist­ing that a vac­cine could be OK’d in the next few weeks. And the CEO in­sists that pol­i­tics has noth­ing to do with the crash R&D project Pfiz­er has mount­ed with BioN­Tech to get an mR­NA jab on­to the mar­ket as soon as pos­si­ble.

Now, we are ap­proach­ing our goal and de­spite not hav­ing any po­lit­i­cal con­sid­er­a­tions with our pre-an­nounced date, we find our­selves in the cru­cible of the U.S. Pres­i­den­tial elec­tion. In this hy­per-par­ti­san year, there are some who would like us to move more quick­ly and oth­ers who ar­gue for de­lay. Nei­ther of those op­tions are ac­cept­able to me.

Right now, Bourla rep­re­sents the en­tire bio­phar­ma in­dus­try, and the stakes for every­one are enor­mous. If Trump does push through a vac­cine with­out the da­ta nec­es­sary to sat­is­fy most peo­ple about its safe­ty and ef­fi­ca­cy, the fall­out will go a long way to de­stroy­ing pub­lic con­fi­dence in the FDA and the abil­i­ty of the drug gi­ants to act re­spon­si­bly. It will al­so in­cite a sharp pub­lic back­lash against the first vac­cine, threat­en­ing herd im­mu­ni­ty.

FDA com­mis­sion­er Stephen Hahn opened that door by scram­bling to OK con­va­les­cent plas­ma with the sketchi­est of da­ta, read­i­ly tout­ing the ther­a­py by Trump’s side. His protests about in­tegri­ty and an abil­i­ty to re­sist pres­sure from Trump are mean­ing­less.

So it’s all on Bourla, who runs one of the largest phar­ma com­pa­nies on the globe. And he has to con­vince a deeply skep­ti­cal pub­lic — which has reg­u­lar­ly as­signed phar­ma to the low­est rungs of pub­lic re­gard — that Pfiz­er can be trust­ed to act in their best in­ter­est.

That’s a tough act, par­tic­u­lar­ly as Bourla now rep­re­sents a deep-seat­ed hope in bio­phar­ma that the in­dus­try has a shot at re­demp­tion in the pub­lic’s eyes by com­ing up with good drugs and vac­cines to end the pan­dem­ic.

What is im­por­tant, says Bourla in his let­ter, is that the glob­al death toll from the pan­dem­ic is ap­proach­ing a mil­lion peo­ple. And Pfiz­er will con­tin­ue to meet the cru­cial chal­lenge of reign­ing it in by trav­el­ing “at the speed of sci­ence.”

Sec­ond, we would nev­er suc­cumb to po­lit­i­cal pres­sure. The on­ly pres­sure we feel—and it weighs heavy—are the bil­lions of peo­ple, mil­lions of busi­ness­es and hun­dreds of gov­ern­ment of­fi­cials that are de­pend­ing on us. We’ve en­gaged with many elect­ed lead­ers around the globe through this health cri­sis, but Pfiz­er took no in­vest­ment mon­ey from any gov­ern­ment. Our in­de­pen­dence is a pre­cious as­set.

Third, our pri­or­i­ty is the de­vel­op­ment of a safe and ef­fec­tive vac­cine to end this pan­dem­ic. I have a du­ty to Pfiz­er’s 171-year his­to­ry to hon­or our lega­cy of dis­cov­er­ing and man­u­fac­tur­ing high-qual­i­ty med­i­cines. We will nev­er cut a cor­ner. Pfiz­er’s pur­pose is sim­ple: “Break­throughs that Change Pa­tients’ Lives.” It’s our North Star.

Bourla’s ap­peal like­ly won’t change the po­lit­i­cal de­bate that is now boil­ing around this is­sue. That can on­ly die down once the votes are count­ed and the bat­tle against the virus con­tin­ues. And if Pfiz­er does seek and get an EUA be­fore the elec­tion, don’t ex­pect any res­ur­rec­tion of pub­lic opin­ion re­gard­ing phar­ma — even if it’s a good vac­cine. In this frac­tious en­vi­ron­ment, no one gets the ben­e­fit of doubt. Least of all phar­ma.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,400+ biopharma pros reading Endpoints daily — and it's free.

Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

Af­ter sting­ing FDA set­back, Glax­o­SmithK­line's Vi­iV fi­nal­ly notch­es US ap­proval for long-act­ing HIV in­jec­tion

GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game.

The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen.