The aim of this symposium is to provide a forum to discuss whether Progressive multifocal leukoencephalopathy (PML) that has been seen in multiple drug trials is a direct consequence of the mechanism of therapeutic action or whether it’s an off-target adverse effect of the therapeutic agent. Progressive multifocal leukoencephalopathy (PML) is a rare, but fatal disease that leads to severe brain inflammation and neural demyelination for presenting patients. This disease is caused by the JC Virus, a polyomavirus generally widespread but latent in human populations. While rare in the general population, the prevalence of PML is increased in HIV patients and notably, has recently been associated with several immunomodulating drug therapies. In order to gain broader perspective on PML and JC virus biology, the impact on clinical practice, and associated regulatory issues, this one day symposium will bring together experts from academia and medicine as well as representatives from drug discovery and the FDA for an interactive series of discussions.

7:30 AM
Registration & Breakfast
8:00 AM
Welcome Address
William Loging, PhD, Boehringer Ingelheim Pharmaceuticals, Inc
Session I: Keynote Address: Overview and Clinical Perspective of PML and Biology of the JC Virus
8:15 AM
Joseph Berger, MD, University of Kentucky Medical Center
Session II: Biology of the JC Virus
9:15 AM

Eugene Major, Ph.D., National Institutes of Health
Session III: Hypotheses of PML Pathogenesis
10:15 AM
Richard Ransohoff, M.D., Cleveland Clinic Foundation
11:00 AM

Leonid Gorelik, M.S., Biogen IDEC
11:45 AM
Lunch
1:00 PM
Introduction to Afternoon Sessions
Patricia Giblin, PhD, Boehringer Ingelheim Pharmaceuticals, Inc
Session IV: PML Association With Tysabri, Raptiva and Rituxan Theraputics
1:30 PM
Mariska Kooijmans, Biogen IDEC
2:15 PM
TBD
3:00 PM
TBD
3:45 PM
Panel Discussion
Christian K. Schneider, EMEA, Paul-Ehrlich-Institut Federal Agency for Sera and Vaccines
Alice Hughes, M.D, Food and Drug Administration
All speakers

5:30 PM
Networking Reception