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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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