Orphan Drug Development May Be Well-Suited To Digital/Wearables

Pfizer feels that orphan products may present a particularly good area for testing wearable monitors and other digital devices as research tools. The small patient populations and fine distinctions in functional improvement or delay of disease progression may be ideally suited for the digital collection of data.

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Pfizer Inc. is investigating wearables to improve, expand and accelerate the capture of data in the small population of rare diseases. The company demonstrated its interest in digital monitoring in a recent presentation at a patient advocacy meeting in Friedreich’s Ataxia in Hyattsville, MD.

The meeting, hosted by the Friedreich’s Ataxia Research Alliance (FARA), was one of the new wave of “patient-focused drug development” meetings held outside FDA, with participation by the agency. FDA is encouraging the meetings as a way to expand the effort and format created by the agency under the PDUFA V-chartered meetings organized by the agency

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