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Tuesday, June 16 • 2:00pm - 3:00pm
#237 L: Patient Voice and Its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-702-L04-P; CME 1.00; IACET 1.00; RN 1.00

Patients are playing an increasing role in drug development. This session discusses on one area where this true -- in understanding clinical meaningfulness and selection and development of clinical outcome measures.

Learning Objectives

Develop endpoints that capture individuals' most burdensome aspect of the disease; Identify the role of the patient voice in endpoint selection and assessment.

Chair

Alexander Varond, JD

Speaker

FDA Perspective
Patroula Smpokou, MD

Industry Perspective
Alison Skrinar, PhD, MPH

Patient Perspective
James E. Valentine, JD, MHS



Speakers
avatar for James Valentine

James Valentine

Attorney, Hyman, Phelps & McNamara, PC
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →
AS

Alison Skrinar

Vice President, Clinical Outcomes Research and Evaluation, Ultragenyx Pharmaceutical
avatar for Patroula Smpokou

Patroula Smpokou

Deputy Director, Office of New Drugs, CDER, FDA
Patroula Smpokou, MD, currently serves as an acting deputy director in the Division of Rare Diseases and Medical Genetics at FDA’s Center for Drug Evaluation and Research where she is involved in the scientific review and regulation of products intended for rare genetic diseases... Read More →


Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session