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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.


Wayne Amchin


Clinical Trials Using Mobile Technology
Mintu Turakhia, MD, MS

FDA Perspective
Bakul Patel, MBA, MS

Industry Perspective
Stephen Amato, PhD

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

Chief Data Officer, OCD, CDRH, FDA, United States
BAKUL PATEL is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate... 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 EDT
Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Session