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Bethesda North Marriott Hotel and Conference Center

18 mar 2014 8:30 a.m. - 20 mar 2014 4:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

Session Chair(s)

Paivi  Miskala, PHD

Paivi Miskala, PHD

Endpoints Reviewer, Study Endpoints and Labeling Development, CDER

FDA, United States

Speaker(s)

Patrick  Marquis, MD, PHD, MBA, FACP

Practical Consideration when Planning the Evaluation of Measurement Properties

Patrick Marquis, MD, PHD, MBA, FACP

Two Legs Consulting LLC, United States

President

Laura Lee  Johnson, PHD

Longitudinal Psychometric Evaluation

Laura Lee Johnson, PHD

FDA, United States

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER

Lisa A Kammerman, PHD, MS

Interpretation of Scores

Lisa A Kammerman, PHD, MS

Kammerman Consulting, LLC, United States

Regulatory Statistics and PRO Consultant

Paivi  Miskala, PHD

Panel Discussion Moderator

Paivi Miskala, PHD

FDA, United States

Endpoints Reviewer, Study Endpoints and Labeling Development, CDER

Cynthia A Bens

Panel Discussion

Cynthia A Bens

Personalized Medicine Coalition, United States

Senior Vice President, Public Policy

Jeremy  Hobart, PHD, FRCP

Jeremy Hobart, PHD, FRCP

Peninsula College of Medicine and Dentistry, United Kingdom

Professor, Clinical Neurology and Health Measurement

Laura Lee  Johnson, PHD

Laura Lee Johnson, PHD

FDA, United States

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER

Lisa A Kammerman, PHD, MS

Lisa A Kammerman, PHD, MS

Kammerman Consulting, LLC, United States

Regulatory Statistics and PRO Consultant

Patrick  Marquis, MD, PHD, MBA, FACP

Patrick Marquis, MD, PHD, MBA, FACP

Two Legs Consulting LLC, United States

President

Elektra  Papadopoulos, MD, MPH

Elektra Papadopoulos, MD, MPH

AbbVie, United States

Director, Patient Experience Data and Strategy

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