FDA taps PatientsLikeMe to harness patient info for drug-safety monitoring

PatientsLikeMe President Ben Heywood

PatientsLikeMe has been on a roll, inking deals with biopharma giants such as AstraZeneca ($AZN), Genentech and Biogen ($BIIB) to provide its patient-reported data for the companies' R&D initiatives. Now the company is shifting gears, planning to work with the FDA to see how its patient reports could improve drug safety.

PatientsLikeMe draws its data from a network of 350,000 patients, collecting information in real time about issues ranging from drug tolerance and adherence to quality of life. The company's data could help regulators pinpoint a new med's risks and benefits sooner than the FDA's current surveillance program, which compiles information over time from patients, physicians and manufacturers. Regulators and PatientsLikeMe will initially focus on issues such as access to data and pharmacovigilance analysis, but the team also will explore other areas where patient input could affect drug regulation, PatientsLikeMe co-founder and president Ben Heywood told FiercePharma.

"We want to find not only new signals or new signals faster. We are endeavoring to take the patient voice and capture it and quantify it in a scalable way," Heywood said. "It's a huge opportunity to bring the patient voice into regulatory risk and benefit."

This is not the first time PatientsLikeMe has teamed up with regulators to improve drug safety. In 2008, the company launched a pilot program to help MS patients report side effects to the FDA. And PatientsLikeMe counts a number of regulatory partnerships to its name, teaming up with government groups such as the Institute of Medicine and the National Institutes of Health (NIH) to explore drug safety issues.

The company is also busy on the R&D front, working with key industry players to use its patient-reported data to improve drug development and treatment. Last year, PatientsLikeMe inked a 5-year deal with Genentech to provide its data for the company's research purposes and clinical trials. In April, the patient network said it would partner with AstraZeneca to let the pharma heavyweight to cull data from its patient network to "shape future medicine development and help improve outcomes across its main therapeutic areas," AstraZeneca said at the time.

- read the release

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