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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
Paul Kluetz, MD
FDA, United States
Deputy Director, Oncology Center of Excellence, OC
Elektra Papadopoulos, MD, MPH
Elektra Papadopoulos, MD, MPH
AbbVie, United States
Director, Patient Experience Data and Strategy
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