Founders: Michelle Longmire (CEO), Tim Smith, James Sas, Perry Robinson
Headquarters: San Francisco
Funding: $521 million
Valuation: $2.1 billion
Key technologies: Cloud computing, Internet of Things
Industry: Health care
Previous appearances on Disruptor 50 List: 0
Inequality in the world of clinical trials isn't new, but the Covid-19 vaccine effort highlighted the issue in a way it had not previously received widespread public scrutiny.
When it was discovered that Black participation in the Moderna vaccine trial was only about half of the Black population by percentage in the U.S., the company pulled back on the trial to find a more representative sample of the American public.
Many studies have confirmed that clinical trials remain more white than they should be relative to population statistics, and in many cases under-represent not just racial and ethnic groups but women and the elderly. This remains the case even as the government has in recent decades attempted to close the gap through National Institutes of Health, and more recently, U.S. Food and Drug Administration, efforts.
The private sector is targeting the issue through start-ups like Medable. Founded by CEO Michelle Longmire, Medable uses a cloud-based approach to making participation more consumer-friendly and more equitable.
Longmire, who told CNBC last November that she was a hypochondriac as a child and "thought I had every disease under the sun," learned through her post-doctoral research at Stanford University medical school to release that anxiety, and her own clinical work on auto-immune skin diseases led her to the conclusion that the core research activity needed a redesign.
The issues in clinical trial design are not limited to lack of diversity. Less than 4% of Americans participate in clinical studies; 30% drop out before study completion; and 80% of studies do not meet enrollment deadlines. But it wasn't until Covid hit that the rest of the world caught up to Longmire's view on the value of technology in improving these numbers.
"There was a lot of interest but not a lot of uptake, so when Covid hit, suddenly, the entire medical infrastructure on the research side needed a technology like Medable to be able to execute clinical trials … within a week I was getting calls from all over the world," Longmire told CNBC.
Now, technology like Medable's has solved its own under-representation problems: increasing from use as part of roughly 5% of trials to 60-70% of trials. "Everything shifted," Longmire said.
Medable's technology allows trials to be conducted remotely, so participants do not need to visit a clinic in-person every time they need to take tests. The Medable app can be accessed on a smartphone and as a result cut down on the problem of clinical trial access – whether a person lives far from a clinic or has mobility and transportation issues.
Over the course of the pandemic, Medable decentralized more than 150 clinical trials to over one million participants across 41 countries and in over 60 languages, including Covid-19 vaccine and therapeutic treatment. By the end of 2022, Medable expects to boost its access to patients by 100 times, with a consumer strategy that it says "removes the barrier between research and everyday life."
In February, it announced a partnership with CVS Health's new clinical trials arm to expand access to trials through CVS MinuteClinic select sites using Medable software.
Enrollment in trials can take years, and represent 40% to 50% of the cost of a trial, which range from a total cost of tens of millions to even a billion dollars-plus. The stakes are high for participants and disease sufferers, researchers who need data to make the right medical decisions, and regulators who approve drug and device breakthroughs. In 2021, Medable's workforce grew 180% to more than 500 people and it expanded to multiple European locations.
Medable is not the only private company seeking to upend the world of medical trials, but it is a leader. In October, Medable raised $304 million led by Blackstone Growth and Tiger Global, its fourth round since 2020, at a valuation over $2 billion.
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