The current COVID-19 pandemic has put a huge spotlight on the life sciences industry’s need to shorten the timeframe it takes to develop effective new treatments. But this was an issue even before COVID-19, as it can take over a decade for a potential therapy to make it out of the clinical trials process and into the hands of the patients who need it. And it has been an issue that Medable has been working to solve since it was founded five years ago by Michelle Longmire, MD and Tim Smith.

Medable’s ultimate goal is to reduce clinical trial timelines by 50%—and the company has already proven to be able to accomplish that in some of the trials it has helped to run. Its solution is a digital trials platform that makes it easier to recruit participants and then run the trials. PM360 spoke with CEO Dr. Longmire about the company’s platform, personalizing trials to each patient and therapeutic area, and how they are now helping to accelerate COVID-19 research.

Michelle Longmire, MD, CEO, Medable

PM360: What made you want to start this company?

Dr. Michelle Longmire: Based on my background, both as a physician and in clinical research, I saw first-hand the need to advance the timelines to getting therapies to patients much faster. The current timeline of 12 years from first in human to broadly available on the market is just not acceptable, especially when you have an incurable or sub-optimally treated disease. So our main focus when we started the company was enabling effective therapies to reach patients faster through digital clinical trials and looking at direct-to-patient, highly patient-centric technologies that allow for research anytime, anywhere. This has also enabled us to broaden access and improve diversity in participation, which results in better research data and ultimately a more effective therapy when it is rolled out to the broader population.

What was it like getting the company off the ground and getting the funding you needed?

That’s never easy. As you probably know, there are not a lot of female-led companies in this industry so I was breaking the mold in that respect, but being a physician also has its own challenges. There is a long-standing bias that physicians don’t know business; however, thankfully we are starting to see strong data indicating that physicians make good CEOs. In addition, we also struggled with the fact that most people are not familiar with clinical drug development, so what we were doing was hard for some people to wrap their head around. The good news is we’ve continued to grow and prove the value of our idea into technology that’s changing lives and bringing value back to our partners.

What makes Medable unique in this area, as there are several startups trying to improve the clinical trial process in some way?

Unlike other organizations in this space, Medable is enabling a new form factor for clinical trials at a global scale. We have launched trials in more than 30 countries and in 26 languages—studies that are using technologies on the phone, which means they are involved in the daily lives of participants, both delivering healthcare as well as capturing essential data to improve the clinical trial process.

How does designing a digital clinical trial differ from the protocols for more traditional trials?

Medable’s digital framework allows optimized individual trials for great efficiency. For example, psoriasis is very different than breast cancer, so trials in those areas may require a different way to connect with patients or a different method of collecting data. That’s why we developed a protocol-specific workflow that’s digitally enabled so we can actually create a therapeutic-specific trial solution that’s also personalized for the patients.

How are you getting the patients more involved in the trials to ensure they are more personalized to their needs?

In February, we formed a new Patient Advisory Council (PAC), which is a group of expert patient advocates, advisors, and caregivers who can provide a patient perspective on Medable’s solution and workflows. So if we’re constructing a study for psoriasis, we want to have the patient with that condition offer their insight into the user experience, the design, etc.

In terms of actual results, what have been some of benefits of these digital clinical trials you are doing?

Ultimately, we reduce the timeline and cost of trials. Because when you connect with participants digitally and enable them to self-select and further evaluate particular studies without a doctor or clinic being involved, then you cast a broad net to a much larger geographic area and reduce the time it takes to find qualified participants. We have reduced clinical trial timelines by 50% and costs by $25 to $30 million.

Medable offers telemedicine and virtual visits to increase patient retention and prevent drop-outs in order to accelerate trial operations.

Just how large of a patient population can you recruit and how quickly?

The largest study we’ve run has one million participants. But all of our studies are different, and sometimes a big Phase III rare disease study may only have a couple hundred patients. In terms of how fast, it really depends on the recruitment strategy. For the study with one million patients, the strategy was to partner with large employers such as Nike, Microsoft, and others in which we could enroll people into the clinical trial at work. This unique approach allowed us to enroll 1,000 patients in a single day for The Healthy Oregon Project.

With the current need for COVID-19 treatments and your company’s desire to help accelerate the overall clinical research process, has your company done anything related to COVID-19 clinical studies?

Yes, in fact, in April we formed an initiative called ACCESS, which is short for American COVID-19 Collaborative Enabling Seamless Science. We are partnering with technology, healthcare, and life sciences companies to provide a mobile app with secure infrastructure that allows researchers and clinical trial teams to connect with millions of home-bound individuals in the U.S. We believe by empowering people in their homes with ACCESS, we can accelerate research by reducing time for enrollment and data collection. This will help advance important monitoring and immunity research, so that we can conquer COVID-19 with effective prevention and intervention strategies.

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