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Natalizumab and Progressive Multifocal Leukoencephalopathy: A Risk Management Case Study

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
370

Room Number:
8

Level:
Intermediate

Type:
Session

Title:
Natalizumab and Progressive Multifocal Leukoencephalopathy: A Risk Management Case Study

Chair(s):
Peter Richard Arlett, MRCP
Head of Pharmacovigilance Department
European Medicines Agency, European Union, United Kingdom

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Industry Perspective
Gary L. Bloomgren, MD
Vice President, Drug Safety and Risk Management
Biogen Idec Inc., United States

Panelist
John Seeger, DrPH, PharmD
Assistant Professor
Harvard Medical School/Brigham & Women's Hospital, United States

Panelist
Patricia Saddier, MD, PhD
Executive Director, Epidemiology
Merck Research Laboratories, United States

Patient Perspective
Melissa Tufeld, PhD
Clinical and Consulting Psychologist, United States