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Towards a Patient-Focused Drug Development Ecosystem: Adoption of Core Outcome Sets
Session Chair(s)
Samantha Roberts, PhD
Group Director, US Regulatory Science
Genentech, A Member of the Roche Group, United States
This forum will explore efforts by regulators and the patient community to develop core outcome sets within specific diseases. Panelists will discuss how these can be leveraged to support drug development programs and facilitate shared learnings.
Learning Objective : Describe the rationale for and existing efforts to develop core outcome sets; Describe how adoption of core outcome sets facilitates patient-focused drug development; Propose a mechanism to facilitate shared learnings across stakeholders to advance adoption of core sets.
Speaker(s)
Measuring What Matters Most: AD PACE
Allison Martin, MS
Faegre Drinker Consulting, United States
Director
FDA CDER Standard Core Sets Pilot Program
Robyn Bent, MS, RN
FDA, United States
Director, Patient Focused Drug Development, OCD, CDER
Patient-Centered Core Impact Sets
Eleanor M. Perfetto, PhD, MS
University of Maryland School of Pharmacy , United States
Professor of Practice, Sciences, and HEOR
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