Ralph Passarella, Reify Health CEO

Reify Health thinks clin­i­cal tri­als can be rep­re­sen­ta­tive by 2030 — and it’s se­cured the cap­i­tal to help part­ners put in the work 

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.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Andrew Phillips, Nexo Therapeutics CEO

Scoop: Ver­sant, NEA launch new biotech helmed by ex-CEO of pro­tein de­grad­er C4 Ther­a­peu­tics

Long-time biotech venture firms Versant and New Enterprise Associates are backing a new startup run by former C4 Therapeutics chief executive Andrew Phillips.

The fledgling biotech has raised at least $30 million so far, according to paperwork filed with the SEC this week. The round could balloon to $60 million.

Phillips, who left protein degradation startup C4 in 2020 to be a managing director at Cormorant Asset Management, is running the show of the new venture as president, the SEC filing outlines. He also served as interim CEO of Cormorant-backed and Hansoh Pharmaceutical-partnered Blossom Bioscience last year.

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Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.