Q&A With Shawn Tedman, Vice President of Innovation At ixlayer

Shawn Tedman
ixlayer

New technologies are helping the pharma industry improve the way it conducts clinical trials. Medical Device & Technology spoke with Shawn Tedman, vice president of innovation at ixlayer, about how his company’s new platform is helping to make clinical trials more diverse.

(MDT:) How important are digital therapeutics and decentralized trials in the modern pharma landscape?

Shawn Tedman: They’re as important as anything else going on. It’s about meeting patients where they are. People are used to doing their banking online, making appointments, engaging as much as possible online. The old, traditional model of going to a clinical trial site in person and doing everything at that site is just outdated. Everybody in the clinical trial ecosystem has known that for a while, but we’ve gotten to the point where the quality of vendors and technology are high enough where we can do a lot of this virtually.

It's important because that’s the expectation that patients have. If we want to continue engaging patients and successfully enroll trials, we must do it in a way that they expect. Asking patients to conform to outdated models is just a recipe for disappointment for all stakeholders.

(MDT:) How does ixlayer choose which companies to collaborate with?

Tedman: We’re looking at the different verticals, not just within bio pharma. We’re trying to work with best-in-breed in each of these subspaces. Some companies are leading the way for digital therapeutics, others for decentralized trials, and others are innovating with virtual models. We want to make sure our partners are really strong, top-notch, and collaborative. That’s what we’ve seen in our partners.

We’ve got other verticals within our own company and we’re working with retail pharmacies and health systems. You would see the same framework across each of these verticals, however.

(MDT:) How important is it to have diverse populations in clinical trials?

Tedman: It’s huge. Not just for doing things the right way and providing additional access to patients, but it’s also smart. Regulators are starting to require that the populations in these trials look like the actual disease population. If you submit to the FDA and your population is all white, middle-aged men and the actual disease population is totally different, they’re actually pushing back. They’ve issued draft guidance saying that it needs to look like the actual population. This has been a long time coming. Honestly, it’s always been a challenge, but it’s increasingly getting better with digital ways to access patients. We’re absolutely able to help companies access patients who might have mobility challenges, or populations where the disease limits whether they can go out in public. What we can do is help them with the testing portion, further qualify these patients, bring the testing to the patients so they don’t necessarily need a caregiver to take them to the clinical trial site where they can be exposed to various things. That’s a big lift for them to have to arrange that sort of visit. We can bring the test to them, see if they qualify based on lab values, and then, if so, start arranging further visits or trips to trial sites from there. At least they know they passed the initial bar to qualify for a trial.

There are lots of populations with these issues. For example, stay-at-home mothers with childcare responsibilities, people who work from home but can’t take half-a-day to a full day off to travel to a clinical trial site. Those are all of the areas where companies see the benefit of using a digital platform to expand health testing up front for qualification to engage a broader population.

Two areas of focus are that up-front qualification and long-term follow-up. Regulators are increasingly putting on requirements for things like a 15-year safety follow up, which can be unrealistic to expect that patients are going to go into a clinical trial site quarterly for 15 years and be compliant with that. We can reduce that burden of testing. Those are often very routine tests that can be done remotely. If you make it more patient-friendly, you’re going to get more compliant and complete data, so pharma companies and patients benefit.

(MDT:)What are the struggles that come with organizing decentralized trials?

Tedman: Even just five years ago, the technology wasn’t quite there. Cloud-computing has made it much less expensive and technically less complicated to deliver some of these solutions. People are more ready for this now. For better or worse, the pandemic prompted people to be more comfortable with virtual meetings. We can do a lot more things remotely and people are ok with that. Also, the ecosystem of vendors has improved. It’s a rapidly evolving space and there are really strong vendors in each of the areas that need solutions. That’s been one of the evolving challenges that’s been getting better over time. There’s still a lot of complexity. If a pharma company wants to do this on their own, they have to maintain contracts, source vendors, and also react to any changes with the trial or vendors. You really need a full-time team to manage that and if you don’t have that team, it’s pretty hard to manage a program like this.

That’s where pharma companies have tended to stick with the traditional model because it’s too daunting for them to take this on. Even for an organization that’s very tech-forward, these sorts of responsibilities aren’t their core competence.