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DIA 2021 Global Annual Meeting


Towards a Patient-Focused Drug Development Ecosystem: Adoption of Core Outcome Sets

Session Chair(s)

Samantha  Roberts, PhD

Samantha Roberts, PhD

  • Group Director, US Regulatory Policy
  • 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)

Allison  Martin, MS

Measuring What Matters Most: AD PACE

Allison Martin, MS

  • Director
  • Faegre Drinker Consulting, United States
Robyn  Bent, MS, RN

FDA CDER Standard Core Sets Pilot Program

Robyn Bent, MS, RN

  • Director, Patient Focused Drug Development Program, OCD, CDER
  • FDA, United States
Eleanor M. Perfetto, PhD, MS

Patient-Centered Core Impact Sets

Eleanor M. Perfetto, PhD, MS

  • Executive Vice President of Strategic Initiatives
  • National Health Council (NHC), United States