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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.