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Tuesday, June 26 • 2:00pm - 3:15pm
#252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore select endpoints FDA has already accepted in traditional clinical trials but which are now collectable using mobile technology in lieu of traditional means to obtain marketing approval, and the timing/options to engage FDA.

Learning Objectives

Describe select endpoints FDA has already accepted in traditional clinical trials which may lend themselves to data collection using digital/mobile technology in clinical trials for marketing approval; Evaluate the challenges faced in adapting these endpoints to use of mobile technology; Apply this information to engage with the FDA early in your product development; Discuss the challenges.

Chair

Wayne Amchin

Speaker

Clinical Trials Using Mobile Technology
Mintu Turakhia, MD, MS

FDA Perspective
Bakul Patel, MBA, MS

Industry Perspective
Stephen Amato, PhD



Speakers
avatar for Stephen Amato

Stephen Amato

Director, Clinical Innovation, Pfizer Inc
Dr. Stephen Amato is a Director of Clinical Innovation within Global Product Development at Pfizer, where he is working to drive clinical innovation by leveraging digital tools and mobile technologies to make clinical trial participation more engaging, informative and less burdensome... Read More →
avatar for Wayne Amchin

Wayne Amchin

Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER, FDA
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... Read More →
avatar for Bakul Patel

Bakul Patel

Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical... Read More →
avatar for Mintu Turakhia

Mintu Turakhia

Executive Director, Center for Digital Health; Chief of EP, Palo Alto VA, Stanford University
Mintu Turakhia M.D. M.A.S. is an Associate Professor of Medicine at Stanford University. He is Director of Cardiac Electrophysiology at the VA Palo Alto Health Care System and Executive Director of the Stanford Center for Digital Health, where he oversees a large research portfolio... Read More →


Tuesday June 26, 2018 2:00pm - 3:15pm
Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA