Advancing the Science of Study Endpoints

戻る Agenda

Session 4: Regulatory Update

Session Chair(s)

Ashley F. Slagle, PhD, MS

Principal, Scientific and Regulatory Consulting

Aspen Consulting, LLC, United States

Hear timely updates from FDA representatives on the 21st Century Cures Act provision to expand the qualification and use of drug development tools (DDTs) to support the drug development process. Attendees will hear an update on FDA’s patient-focused drug development, including their thoughts on leveraging COAs in cancer clinical trials.

Speaker(s)

Paul Kluetz, MD

FDA, United States

Deputy Director, Oncology Center of Excellence, OC

Elektra Papadopoulos, MD, MPH

AbbVie, United States

Director, Patient Experience Data and Strategy