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Natalizumab and Progressive Multifocal Leukoencephalopathy: A Risk Management Case Study
Session Chair(s)
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Natalizumab is a treatment for multiple sclerosis. Cases of progressive multifocal leukoencephalopathy (PML) were reported in treated patients shortly after marketing. This real-life case study explores the issues facing regulators, physicians, and patients with a serious risk where knowledge is evolving.
Learning Objective : Describe the clinical course of multiple sclerosis; Describe the pathogenesis/epidemiology of progressive multifocal leukoencephalopathy in the context of natalizumab; Describe the patient/regulatory/company considerations around risk management of a serious adverse drug reaction.
Speaker(s)
Gary L. Bloomgren, MD
Vice President, Drug Safety and Risk Management, Biogen Idec Inc., United States
Industry Perspective
John Seeger, DrPH, PHARMD
Assistant Professor, Harvard Medical School/Brigham & Women's Hospital, United States
Panelist
Patricia Saddier, MD, PHD
Executive Director, Pharmacoepidemiology, Merck Research Laboratories, United States
Panelist
Melissa Tufeld, PHD
, Clinical and Consulting Psychologist, United States
Patient Perspective
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