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Patient Voice and its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures
Session Chair(s)
Alexander Varond, JD
Partner
Goodwin Procter LLP, United States
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 Objective : Develop endpoints that capture individuals' most burdensome aspect of the disease; Identify the role of the patient voice in endpoint selection and assessment.
Speaker(s)
FDA Perspective
Patroula Smpokou, MD
FDA, United States
Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER
Industry Perspective
Alison Skrinar, PhD, MPH
Ultragenyx Pharmaceutical, United States
Vice President, Clinical Outcomes Research and Evaluation
Patient Perspective
James Valentine, JD, MHS
Hyman, Phelps & McNamara, PC, United States
Director
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