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 And the FDA released new draft guidance last week to tell drugmakers and medical device manufacturers that they should set goals for enrollment and specify their retention strategies.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more diversity in trials and said it will be a “key focus throughout the FDA” in last week’s announcement of the new draft guidance.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.