Drug de­vel­op­ers have lacked on the di­ver­si­ty front for years, es­pe­cial­ly when it comes to test­ing in­ves­ti­ga­tion­al treat­ments, vac­cines and oth­er tools to fight dis­eases.

The in­dus­try has beefed up re­sources and ini­tia­tives in re­cent years, but the prob­lem is like­ly to take years and years of work to en­sure clin­i­cal tri­als are rep­re­sen­ta­tive of the pop­u­la­tion and the peo­ple that are dis­pro­por­tion­ate­ly af­fect­ed by cer­tain dis­eases. And the FDA re­leased new draft guid­ance last week to tell drug­mak­ers and med­ical de­vice man­u­fac­tur­ers that they should set goals for en­roll­ment and spec­i­fy their re­ten­tion strate­gies.

But more work needs to be done. And it will re­quire a hefty amount of cap­i­tal to bring to­geth­er biotechs, phar­mas, schools, com­mu­ni­ty health cen­ters, lo­cal on­col­o­gy clin­ics, pri­ma­ry care physi­cians, in­di­vid­ual com­mu­ni­ty lead­ers, church­es and oth­er groups.

In steps 10-year-old Reify Health, which helps drug de­vel­op­ers re­cruit and en­roll pa­tients for in-per­son tri­als and car­ry out de­cen­tral­ized stud­ies. The com­pa­ny wants to am­pli­fy work to right the ship and boost tri­al di­ver­si­ty to in­clude more peo­ple who have been tra­di­tion­al­ly un­der­rep­re­sent­ed in drug de­vel­op­ment and are dis­pro­por­tion­ate­ly af­fect­ed by Alzheimer’s, car­dio­vas­cu­lar dis­ease, cer­tain types of can­cers and oth­er dis­eases.

Af­ter se­cur­ing a $220 mil­lion Se­ries C last Au­gust, the com­pa­ny didn’t need any more funds, but it cal­cu­lat­ed the tri­al di­ver­si­ty prob­lem is so vast and cap­i­tal-in­ten­sive that it went back to the in­vestor com­mu­ni­ty to reel in an­oth­er $220 mil­lion to fund its new ini­tia­tive geared at this is­sue. The mul­ti-year pro­gram, of which part­ners will be un­veiled in the com­ing weeks and months, is dubbed BRIDGE (for Bring­ing Rep­re­sen­ta­tion, In­clu­sion and Di­ver­si­ty to Glob­al En­roll­ment).

“We be­lieve very deeply that the amount of work and ef­fort re­quired to make a re­al dif­fer­ence here, to get to the point where tri­als are ap­pro­pri­ate­ly rep­re­sen­ta­tive, is go­ing to re­quire a lot of time and in­vest­ment. This isn’t a ‘Jan. 1, 2023, OK, tri­als are rep­re­sen­ta­tive.’ This is more like, hope­ful­ly by Jan. 1, 2030, we’re there,” CEO Ralph Pas­sarel­la told End­points News.

FDA com­mis­sion­er Robert Califf ac­knowl­edged more work needs to be done to in­clude more di­ver­si­ty in tri­als and said it will be a “key fo­cus through­out the FDA” in last week’s an­nounce­ment of the new draft guid­ance. Pas­sarel­la said the na­tion’s top drug reg­u­la­tor has “right­ly tak­en a very clear stance on their view on the im­por­tance of this.”

“[F]or every Black po­ten­tial can­di­date iden­ti­fied, they are two times less like­ly to make it to screen­ing than a white po­ten­tial can­di­date in the clin­i­cal tri­al process, which is to­tal­ly as­ton­ish­ing, com­plete­ly un­ac­cept­able. And now we’re dig­ging in­to why,” Pas­sarel­la said. Through one of its two core units, StudyTeam, Reify helps clients see through­out the en­roll­ment process whether they’re fail­ing to en­gage peo­ple from var­i­ous groups.

Reify will hire lead­er­ship for the BRIDGE ini­tia­tive this year and will al­so de­ploy the cap­i­tal on build­ing out its over­all work­force, which stands at more than 900, the com­pa­ny said.

As it works in a field of oth­er clin­i­cal re­search or­ga­ni­za­tions and de­cen­tral­ized tri­al providers — all of which have raised heaps of cap­i­tal in the past few quar­ters, in­clud­ing 4G Clin­i­cal, Med­able, Sci­ence 37, Cas­tor and oth­ers — Reify will look to spread its work in­to oth­er re­gions. It is “ac­tive­ly mak­ing head­way” in South Amer­i­ca, Latin Amer­i­ca and ar­eas of Eu­rope, Pas­sarel­la said.

With near­ly $450 mil­lion raised in the past few quar­ters, at a val­u­a­tion above $4.8 bil­lion, from the likes of Al­time­ter Cap­i­tal, Coat­ue, Drag­oneer, ICONIQ Growth, Adams Street and Bat­tery Ven­tures, Reify has the mon­ey to spend on ac­qui­si­tions. The CEO said there are “cer­tain op­por­tu­ni­ties that we are look­ing at in that space. We’ll let you know when there’s stuff to share there.”

“We know that the spon­sors that we talk to want to do work here, they want to make progress. The re­search sites that we talk to care about en­gag­ing peo­ple more ef­fec­tive­ly, and so I think there is a re­al­ly in­cred­i­ble op­por­tu­ni­ty now, not just for us, but for our in­dus­try to re­al­ly make head­way and cre­ate mo­men­tum that does not dis­si­pate in 2023 and 2024,” Pas­sarel­la said.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.