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 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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

Endpoints Premium

Premium subscription required

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

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from 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 key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.