avatar for Wayne Amchin

Wayne Amchin

Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER
Wayne manages the pulmonary arterial hypertension (PAH) portfolio, which includes many drug-device combination products, along with other therapeutic areas. He is the winner of the FDA’s Innovation Lab 1st Prototype Challenge for Mobile Apps, and he is developing the first mobile app for PAH and FDA’s first disease specific mobile app, with the intent to develop the mobile app as a PRO instrument in the context of FDA’s commitment to Patient-focused Drug Development.