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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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