The urgency to develop a vaccine for COVID-19 led to the realization that clinical trials are in dire need of a rethink. Testing new drugs and medical treatments to make sure they’re effective and safe for humans is a long and arduous process that’s beset with inefficiency.
“I’ve always been really interested in transitional medicine and how we can get new treatments into the clinic,” Reify Health Chief Executive Ralph Passarella told Karen Webster in an interview. “But the more work you do there, the more innovation you see happening, the more you notice it sitting in ‘Nature’ and science papers on the shelf for a really long time, sometimes forever.”
Amid that backdrop, Reify has just closed a $220 million Series C funding round that will help advance plans to expand its efforts at shortening clinical trial timelines in order to get new treatments in clinics faster.
“Getting something from pre-clinical work into the clinic is incredibly expensive, really unpredictable, very risky and it’s going to take a ton of time,” Passarella said.
You may also like: COVID-19 Delta Variant Leading To Border Closings, No Fans At Olympics, Travel Worries
Passarella co-founded Reify Health with Michael Lin back in 2012 and spent the first three years of its existence just going around talking to people to learn how and why clinical trials are so difficult to implement and slow to conclude.
“We started to see this bottleneck exist, and it’s largely down to the problem of enrolling patients predictably and reliably into any study,” he said.
The problem exists because clinical trials are still stuck in the 1960s, Passarella said. Pharmaceutical companies, when they hit on a promising new treatment, typically engage with a few hospitals, get them in on the study, and then try to bring in patients living nearby to those hospitals. It’s an outdated practice that leads to the exclusion of the vast majority of patients who might actually be relevant to the study, even though the technology exists to find those perfect matches and bring them into the trial. In short, the problem is largely logistical.
“The problem is finding them [patients] and bringing the resources to them to make it possible for them to enroll in trials,” Passarella said.
More like this: AWS Unveils Amazon HealthLake Data Services For Healthcare Industry
Reify’s StudyTeams product solves the first part of that problem, helping biopharma companies and research sites to recruit and enroll participants more efficiently. The next step involves pairing those people with Reify’s second solution, Care Access, which is a kind of decentralized research platform that brings clinical trial infrastructure to participants remotely.
“So we’ve taken this multi-pronged approach and innovated our way to this future step, and we’ve reached the point where we can now just ask ‘Where are the patients?’ and then bring clinical trials to wherever they may be,” Passarella explained.
Passarella said one of his company’s biggest achievements so far has been to compress clinical trial enrollment times from an average of 18 months to as little as nine or even six months in some cases. Surprisingly, it follows a rather ad hoc approach to enrolling patients for each trial, as opposed to using a basic recruitment model.
“We just start with the question, ‘where are the patients?’ and then from the answer to that we come up with a set of hypotheses,” Passarella told Webster. “So, if we think the best way to engage with patients for this study is to go through long-term care facilities and community clinics, we’ll go and test that. We try lots of things and then we just channel our resources into whichever strategies have been most effective in the first couple of months.”
See more: Moderna Solved The Supply Chain Problem, But Will Consumers Embrace A COVID-19 Vaccine?
Besides enrolling patients faster, Reify Health can also attract clinical trial participants from more diverse backgrounds than biopharma companies have traditionally been able to do. Passarella said this is important because companies need to be sure their new treatments work for different populations, not just one particular demographic.
“A lot of patient populations have been left behind in the research process,” he said. “So we’re always asking ourselves how we can engage with those communities that traditionally haven’t been able to access research.”
Reaching out to those kinds of communities requires an extremely robust infrastructure, and Reify has steadily built this up over a number of years. It did so slowly, piece by piece, working with individual physicians and bringing them in one at a time, taking the time to ensure they know how to conduct very high-quality research.
“Our infrastructure was built to help people who’ve never done research before, and to do it at a very high level,” Passarella said. “And from there we just needed to distribute that.”
Further reading: Delayed Diagnosis: Picture Emerging Of Non-COVID Healthcare Treatments
Reify has done a good job of that too, developing technology to monitor for quality care by remote teams.
“Now we have mobile site vehicles. Those are literally our research on wheels, so we can drive a clinical trial to anywhere in the 48 contiguous states,” Passarella said. “We see ourselves as sitting at the intersection of technology, healthcare and logistics. Our operations are instrumented to know what’s happening everywhere.”
Webster told Passarella that she’s especially grateful for clinical trials. She explained that she is a cancer survivor herself, and that her doctor based her treatment program on the results of clinical trials rather than go with the usual treatment for her type of cancer.
Passarella said this wasn’t surprising, noting how physicians on the whole have been very supportive of Reify’s efforts. He said many of the physicians Reify works with are driven by a strong desire to get the best possible treatment for their patients.
“We see a lot of genuine interest from physicians who look at a study and tell us their patients need access to this option,” Passarella said. “Everyone wants to do this because they want to make clinical trials an option for the patients they’re supporting and serving. And that’s the right reason to do this stuff.”
We’re always on the lookout for opportunities to partner with innovators and disruptors.
Learn More