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Advancing the Science of Study Endpoints


Session 4: Regulatory Update

Session Chair(s)

Ashley F. Slagle, PhD, MS

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

Paul Kluetz, MD

  • Deputy Director, Oncology Center of Excellence, OC
  • FDA, United States
Elektra  Papadopoulos, MD, MPH

Elektra Papadopoulos, MD, MPH

  • Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER
  • FDA, United States

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