President Joe Biden (AP Images)

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

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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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.