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2015 年 10 月 06 日 1:00 下午 - 2015 年 10 月 06 日 4:30 下午

Tutorial-Study-Endpoint-Development-in-Rare-Diseases

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Marianne  Clancy, MPA

Marianne Clancy, MPA

Executive Director, Cure HHT, United States

Linda S. Deal, MS

Linda S. Deal, MS

Head of Patient-Centered Outcomes Measurement, Pfizer Inc., United States

Linda currently serves as PCOA Lead working across Pfizer’s therapeutic categories addressing efforts to develop, validate and use COAs as endpoints for providing evidence of medical treatment benefit differentiation, labeling and value. Linda has served patients and the pharmaceutical industry for the past 20 years in similar roles at Wyeth, Janssen, Shire and Pfizer. Linda has developed and/or validated COAs across multiple therapeutic categories. Linda is trained as a statistician.

Susan  Martin

Susan Martin

Head, Patient Reported Outcomes, RTI Health Solutions, United States

Annabel  Barbier, MD, PhD

Annabel Barbier, MD, PhD

Vice President, Clinical Development Rare Genetic Diseases, Agios Pharmaceuticals Inc, United States

Elektra  Papadopoulos, MD, MPH

Elektra Papadopoulos, MD, MPH

Director, Patient Experience Data and Strategy, AbbVie, United States

Dr. Papadopoulos serves as the Deputy Director (acting) of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The Division provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome assessments (COAs) regarding their development, validation, interpretation and overall suitability to support labeling claims and also manages the COA drug development qualification program.

Lori  McLeod, PhD

Lori McLeod, PhD

Head, Psychometrics , RTI Health Solutions, United States

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