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Wednesday, June 30 • 10:00am - 11:00am
#315 SL: Towards a Patient-Focused Drug Development Ecosystem: Adoption of Core Outcome Sets

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-605-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Samantha Roberts, PhD

Speaker

Measuring What Matters Most: AD PACE
Allison Martin, MS

FDA CDER Standard Core Sets Pilot Program
Robyn Bent, MS, RN

Patient-Centered Core Impact Sets
Eleanor M. Perfetto, PhD, MS



Speakers
SR

Samantha Roberts

Director, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Samantha Roberts is currently a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize and improve the efficiency of drug development and review. Before joining Roche/GNE in 2016, she worked... Read More →
avatar for Eleanor Perfetto

Eleanor Perfetto

Executive Vice President of Strategic Initiatives, National Health Council (NHC), United States
She is also a professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and the assistant editor of the Journal of Managed Care and Specialty Pharmacy (JMCP). Perfetto has previously served in various public policy and research positions... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development Program, OCD, CDER, FDA, United States
Robyn Bent joined the US FDA in 2019 as the director of CDER’s Patient-Focused Drug Development (PFDD) Initiative, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making... Read More →
AM

Allison Martin

Director, Faegre Drinker Consulting, United States
Allison Martin, MS draws on over a decade of experience at the crossroads of health and government. As a Director at Faegre Drinker Consulting, she partners with organizations in the patient advocacy and biomedical science space to advance their missions through advocacy and federal... Read More →


Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Session