Big Phar­ma part­ners join ini­tia­tive to dri­ve eq­ui­ty and in­clu­sion in dig­i­tal tri­als

As dig­i­tal tri­als picked up steam amid the pan­dem­ic, some said the tech­nol­o­gy could al­so be used to ad­dress bio­phar­ma’s his­toric lack of di­ver­si­ty in the clin­ic. But if im­ple­ment­ed the wrong way, it could al­so ex­ac­er­bate the prob­lem, the Dig­i­tal Med­i­cine So­ci­ety (DiMe) warns.

That’s why DiMe is look­ing to cre­ate a frame­work and re­sources for suc­cess­ful­ly run­ning dig­i­tal tri­als. And a suite of in­dus­try play­ers — in­clud­ing Am­gen and Glax­o­SmithK­line — are join­ing the new ini­tia­tive.

“We’re at a re­al­ly im­por­tant junc­ture as we think about the dig­i­ti­za­tion of health­care,” DiMe CEO Jen­nifer Gold­sack told End­points News. “What we’re com­mit­ted to, along with our part­ners, is mak­ing sure that we cap­ture this op­por­tu­ni­ty and we pro­vide re­sources not just for par­tic­i­pat­ing part­ners, but for the en­tire field that are ac­tion-ori­ent­ed and en­sure that as we go dig­i­tal, we bring more pa­tients with us.”

The ini­tia­tive is what DiMe calls a “Tour of Du­ty,” in which the or­ga­ni­za­tion spends four to six weeks ad­dress­ing a press­ing chal­lenge in the field. The goal? To emerge with re­sources for the in­dus­try, rang­ing from check­lists to new guid­ance.

Over the past cou­ple years, the pan­dem­ic has cast a harsh spot­light on bio­phar­ma’s di­ver­si­ty prob­lem. Of the 53 drugs ap­proved in 2020, Black par­tic­i­pants rep­re­sent­ed just 8% of par­tic­i­pants in the tri­als reg­u­la­tors based their de­ci­sions on. Lat­inx pa­tients rep­re­sent­ed just above 12% of par­tic­i­pants, and Asian pa­tients just above 6%.

Some have said that vir­tu­al tri­als could help bridge the gap in rep­re­sen­ta­tion — but while that may be a good op­tion for some pa­tients, it ex­cludes every­one who doesn’t have ac­cess to the tech­nol­o­gy or to broad­band.

“Now is the time to en­sure tri­al plan­ning is mind­ful of the po­ten­tial of tech­nol­o­gy as a bar­ri­er to par­tic­i­pa­tion by po­si­tion­ing dig­i­tal health tech­nolo­gies for greater trust, use, and im­pact,” said Pamela Tenaerts, CSO at dig­i­tal tri­al-fo­cused Med­able (which is al­so join­ing the ini­tia­tive), in a news re­lease.

Up­on snag­ging a $91 mil­lion Se­ries C round back in 2020, Med­able told End­points that cus­tomers us­ing its vir­tu­al tri­al plat­form re­port­ed faster pa­tient en­roll­ment and in­creased re­ten­tion rates.

“Clin­i­cal tri­als are a sig­nif­i­cant part of the process for de­vel­op­ing med­i­cines. Yet, for too long, tri­als have lacked di­ver­si­ty with un­der­rep­re­sen­ta­tion of cer­tain groups of peo­ple across many dis­eases,”  said Pon­da Mot­sepe-Dit­shego, VP, glob­al med­ical ther­a­peu­tic area head, and leader of Am­gen’s Rep­re­sen­ta­tion in Clin­i­cal Re­search (RISE) team, in the news re­lease. “Hav­ing the means to en­gage these pop­u­la­tions via new tech­nolo­gies helps us move to­wards a fu­ture where they are no longer un­der­rep­re­sent­ed, un­der­stud­ied, and un­der­treat­ed.”

In ad­di­tion to Am­gen, GSK and Med­able, a slate of oth­er in­dus­try play­ers have joined the ini­tia­tive, in­clud­ing Ac­cli­nate, Light­ship, Ru­bix LS, Sage Bionet­works, Savvy Co­op­er­a­tive, and THREAD Re­search.

“In or­der to say we’re go­ing to do this bet­ter than we have be­fore, we have a re­spon­si­bil­i­ty … to bring every­one to the ta­ble and to deeply un­der­stand how these new prod­ucts work in every­body,” Gold­sack said.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.