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.

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.

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 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.

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.