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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.