President Joe Biden (AP Images)

How will the Biden ad­min­is­tra­tion af­fect fund­ing for life sci­ence re­search?

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

The ad­vent of a new ad­min­is­tra­tion in Wash­ing­ton of­ten por­tends ma­jor changes in bud­get­ing and spend­ing, and thus it will be in the ad­min­is­tra­tion of Joe Biden, if he ad­heres to the 2020 De­mo­c­ra­t­ic Par­ty plat­form.

But one thing that is not like­ly to change is the on­go­ing uptick in fund­ing for re­search in the life sci­ences — par­tic­u­lar­ly the fund­ing for the Na­tion­al In­sti­tutes of Health, the Cen­ters for Dis­ease Con­trol, and oth­er fed­er­al agen­cies fo­cused on life sci­ence re­search.

The rea­son for that is sim­ple: Covid-19 is still with us, and based on re­cent num­bers, it shows no sign of leav­ing any­time soon — de­spite the de­vel­op­ment of vac­cines by Pfiz­er, Mod­er­na, and oth­er phar­ma­ceu­ti­cal com­pa­nies. In a speech on the week­end pri­or to his in­au­gu­ra­tion, Biden said that it was his goal “to help re­store faith in Amer­i­ca’s place in the fron­tier of sci­ence and dis­cov­ery.” Sci­ence, he added, “is dis­cov­ery … it’s about hope.”

And while politi­cians — whether they be city coun­cil mem­bers or pres­i­dents — are known for their hy­per­bol­ic de­c­la­ra­tions that don’t al­ways lead some­where, Biden is not an un­known quan­ti­ty. As a mem­ber of the Sen­ate for decades, he has an eas­i­ly-ex­am­ined record on mat­ters of all kinds, in­clud­ing life sci­ence fund­ing and re­search.

Ac­cord­ing to med­ical jour­nal The Lancet, Biden “has had a long-stand­ing in­ter­est in med­ical re­search.” As Vice Pres­i­dent un­der Barack Oba­ma, he was in charge of the ad­min­is­tra­tion’s Can­cer Moon­shot Task Force, which “brought a new ur­gency to the Fed­er­al gov­ern­ment ef­forts to fight can­cer, and forged new part­ner­ships and cre­at­ed new pro­grams and poli­cies.” A re­port is­sued at the end of the ad­min­is­tra­tion’s term shows that sig­nif­i­cant progress was made in mar­shal­ing re­sources, both pub­lic and pri­vate, to “achieve a decade’s worth of progress in five years” in the fight against can­cer.

With a pan­dem­ic still rag­ing, Biden has pledged to bring the same com­mit­ment to fight­ing Covid-19 — in which he promis­es “a de­ci­sive pub­lic health re­sponse” that in­cludes de­vel­op­ment of vac­cines, fund­ing for its dis­tri­b­u­tion, and “the full de­ploy­ment and op­er­a­tion of nec­es­sary sup­plies, per­son­nel, and fa­cil­i­ties.”

If Biden does in­deed in­crease bud­gets for life sci­ence re­search, he will be fol­low­ing in a decades-strong tra­di­tion. The bud­get for the NIH, for ex­am­ple, has near­ly quadru­pled since 1995, grow­ing every year, in­clud­ing in 2021; in its bud­get for this year, Con­gress ap­proved a 3% in­crease in the agency’s fund­ing, with the to­tal al­lo­ca­tion for the year at $42.9 bil­lion, $1.25 bil­lion more than the 2020 lev­el.

Last year, the NIH award­ed 10 grants for the es­tab­lish­ment of the first-ever Cen­ters for Re­search in Emerg­ing In­fec­tious Dis­eases (CREID), a “glob­al net­work will in­volve mul­ti­dis­ci­pli­nary in­ves­ti­ga­tions in­to how and where virus­es and oth­er pathogens emerge from wildlife and spillover to cause dis­ease in peo­ple.”

That ini­tia­tive is a sign of things to come; the Covid-19 pan­dem­ic has raised con­cerns among sci­en­tists that hu­man­i­ty could see a rise in zoonot­ic dis­eases, re­sult­ing in even greater pub­lic health threats in the years to come.

One of the lessons of the pan­dem­ic is that we can­not rest on our lau­rels when it comes to health­care re­search. Along with pre­vent­ing pan­demics, the NIH will con­tin­ue fund­ing the many oth­er ar­eas in which it is ac­tive, in­clud­ing can­cer re­search, ar­ti­fi­cial in­tel­li­gence, Alzheimer’s treat­ment, etc. That fund­ing will go to uni­ver­si­ties, star­tups, phar­ma­ceu­ti­cal firms, and oth­er or­ga­ni­za­tions that are do­ing deep-dive re­search in all these ar­eas.

While much of that fund­ing goes to aca­d­e­m­ic re­search, the NIH pro­vides bil­lions of dol­lars an­nu­al­ly for small life sci­ence re­search firms, who are at the fore­front of de­vel­op­ing sci­en­tif­ic ini­tia­tives in­to prod­ucts and ser­vices that will help solve some of our most press­ing health prob­lems.

In fact, it was such non-di­lu­tive gov­ern­ment fund­ing that en­abled the phar­ma­ceu­ti­cal firms to quick­ly de­vel­op the Covid-19 vac­cines, based on the use of mR­NA tech­nol­o­gy to en­able the de­vel­op­ment of an­ti­bod­ies to the virus. That tech­nol­o­gy has been around for years, based on re­search con­duct­ed by small and start­up biotech firms and labs stretch­ing back decades.

An­oth­er les­son learned from Covid-19: Lis­ten to the sci­ence. The vac­cines are the re­sult of years of re­search and ex­ten­sive col­lab­o­ra­tion be­tween sci­en­tists all over the world, and that col­lab­o­ra­tion suc­ceed­ed. If that ap­proach was able to bring a so­lu­tion to one of the biggest prob­lems we’ve faced in mod­ern times, it can help solve many oth­er prob­lems, too — and there is no doubt that the new ad­min­is­tra­tion will ap­ply that Covid-in­duced les­son to oth­er prob­lems, too.

Ram May-Ron is a man­ag­ing part­ner at Free­Mind.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,800+ biopharma pros reading Endpoints daily — and it's free.

A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,800+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,800+ biopharma pros reading Endpoints daily — and it's free.

Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,800+ biopharma pros reading Endpoints daily — and it's free.

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,800+ biopharma pros reading Endpoints daily — and it's free.

‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

Endpoints Premium

Premium subscription required

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