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.

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.