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Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans
Session Chair(s)
Meghana Chalasani, MHA
Lead, Advisory Committees, Office of New Drugs, CDER
FDA, United States
This session will provide an opportunity for stakeholders to hear about FDA’s effort to advance the development of a publicly available core set(s) of clinical outcomes assessment measures and endpoints.
Learning Objective : Describe FDA efforts, including plans and progress on an anticipated new FDA extramural grants program, to advance the development of a publicly available core set(s) of clinical outcomes assessment (COA) measures and endpoints for specific disease indications; Discuss the opportunities for key stakeholders including, academia, Health Technology Assessors, payers, health care providers, and regulated industry.
Speaker(s)
FDA Update
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
FDA Update
Laura Lee Johnson, PhD
FDA, United States
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
FDA Update
Elektra Papadopoulos, MD, MPH
AbbVie, United States
Director, Patient Experience Data and Strategy
Industry Update
Tara Symonds, PhD
Clinical Outcomes Solutions, United Kingdom
Chief Science Officer
Industry Perspective
Anton Hoos, MD, PhD, MBA
Patient Focused Medicine Development, Belgium
Executive Team
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