John Damonti, Bristol Myers Squibb Foundation president (BMS)

Bris­tol My­ers Squibb Foun­da­tion launch­es pro­gram to tack­le di­ver­si­ty prob­lem in clin­i­cal tri­als

Over the last sev­er­al months, the pan­dem­ic has am­pli­fied calls for more di­verse clin­i­cal tri­als.

While mi­nor­i­ty pop­u­la­tions are con­tract­ing Covid-19 at high­er rates than white Amer­i­cans, they are no­tably un­der­rep­re­sent­ed in clin­i­cal tri­als. Black Amer­i­cans make up 13% of the US pop­u­la­tion, but on­ly 7% of par­tic­i­pants in clin­i­cal tri­als, ac­cord­ing to the FDA. And they’re be­ing in­fect­ed with Covid-19 at a 2.6 times high­er rate than white Amer­i­cans.

“The im­por­tance of di­ver­si­ty in the clin­i­cal tri­als for the vac­cines is just an­oth­er spot­light on an is­sue that’s been go­ing on for decades,” John Da­mon­ti, pres­i­dent of the Bris­tol My­ers Squibb Foun­da­tion, told End­points News. 

On Tues­day, the foun­da­tion launched a new pro­gram with the non­prof­it or­ga­ni­za­tion Na­tion­al Med­ical Fel­low­ships and backed it with $100 mil­lion to help clin­i­cal tri­als reach un­der­served pop­u­la­tions. The pro­gram con­sists of three parts: a train­ing com­po­nent for 250 new clin­i­cal in­ves­ti­ga­tors, fel­low­ships for 250 mi­nor­i­ty med­ical stu­dents, and an in­fra­struc­ture fund to help in­ves­ti­ga­tors build new clin­i­cal tri­al sites.

The new sites, he said, would ide­al­ly go “in clin­i­cal tri­al deserts where … the dis­ease bur­den is high but clin­i­cal tri­als don’t ex­ist in those sites, or even look to build­ing out in ur­ban cen­ters through safe­ty net hos­pi­tals and oth­ers.”

Prin­ci­pal in­ves­ti­ga­tors will men­tor the new clin­i­cal in­ves­ti­ga­tors who will men­tor the med­ical stu­dents, who will work in fed­er­al­ly qual­i­fied health cen­ters, safe­ty net hos­pi­tals and oth­er med­ical cen­ters in their com­mu­ni­ties.

“At the end of the day, even if you have 250 di­verse clin­i­cal in­ves­ti­ga­tors, if they’re not ac­tive­ly work­ing in the com­mu­ni­ties to build those re­la­tion­ships and build that trust, the pro­gram will not be as suc­cess­ful as it po­ten­tial­ly could be,” Da­mon­ti said.

The mon­ey comes from a $300 mil­lion com­mit­ment that Bris­tol My­ers Squibb and its foun­da­tion made back in Au­gust for health eq­ui­ty, di­ver­si­ty and in­clu­sion ef­forts. Na­tion­al Med­ical Fel­low­ships will help with im­ple­men­ta­tion, such as man­ag­ing com­po­nents of the ap­pli­ca­tion process and an in­de­pen­dent ad­vi­so­ry board.

Ap­pli­ca­tions will open in Jan­u­ary for clin­i­cal in­ves­ti­ga­tors, and Da­mon­ti ex­pects the first class to be­gin some­time in Sep­tem­ber.

“While the pa­tient re­sponse to med­ical ther­a­pies may dif­fer across racial and eth­nic sub­groups, clin­i­cal tri­als of­ten fail to rep­re­sent the de­mo­graph­ic di­ver­si­ty of the pop­u­la­tions that these prod­ucts aim to serve,” said Robert Winn, di­rec­tor of the Vir­ginia Com­mon­wealth Uni­ver­si­ty Massey Can­cer Cen­ter and chair of the na­tion­al ad­vi­so­ry com­mit­tee of the Bris­tol My­ers Squibb Foun­da­tion’s new pro­gram.

Black Amer­i­cans made up 20% of par­tic­i­pants in the NI­AID-fund­ed ACTT-1 tri­al of remde­sivir, ac­cord­ing to a New Eng­land Jour­nal of Med­i­cine piece. And Lat­inx and Na­tive Amer­i­cans, who are at a 2.8 times high­er risk of in­fec­tion than white Amer­i­cans, made up 23% and 0.7% of the ACTT-1 par­tic­i­pants, re­spec­tive­ly.

The is­sue isn’t unique to the pan­dem­ic. Out of 230 tri­als lead­ing to FDA on­col­o­gy OKs in the last decade or so, Black and Lat­inx par­tic­i­pants were “un­der­rep­re­sent­ed… rel­a­tive to their pro­por­tion among the US can­cer pop­u­la­tion,” ac­cord­ing to a piece pub­lished in JA­MA last year.

“The re­al out­come, and the im­pact of this pro­gram is go­ing to be mea­sured by the role that these in­di­vid­u­als can play in terms of at­tract­ing di­verse pa­tient pop­u­la­tions in­to clin­i­cal tri­als. That’s what this pro­gram has been cre­at­ed to do,” Da­mon­ti said. “We just want to make sure that the end of the day it’s the pa­tient that gets in­to the tri­al.”

A pre­vi­ous ver­sion of this ar­ti­cle stat­ed that the Bris­tol My­ers Squibb Foun­da­tion made a $300 mil­lion com­mit­ment in Au­gust for health eq­ui­ty ef­forts. The piece has been up­dat­ed to clar­i­fy that the biotech al­so par­tic­i­pat­ed in the com­mit­ment.

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.

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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.

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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.

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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.

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‘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.

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.

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UP­DAT­ED: CMS to re­strict cov­er­age of Bio­gen's con­tro­ver­sial Alzheimer's drug to on­ly clin­i­cal tri­als

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

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.