Immunomodulating Therapies and Progressive Multifocal Leukoencephalopathy (PML)

Speakers

Organizers

David W. Brewster

Hoffmann-La Roche Inc.

Matthew S. Bogdanffy

Boehringer Ingelheim Pharmaceuticals, Inc.

Patricia Giblin

Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Patricia Giblin is a Senior Research Fellow in the Department of Immunology and Inflammation Research at Boehringer Ingelheim Pharmaceuticals. Her major field of expertise is immune cell trafficking and activation. Over the past 12 years Dr. Giblin's research has focused on integrin and chemokine receptor biology with the goal of advancing therapies for the treatment of multiple sclerosis and psoriasis. Prior to joining Boehringer Ingelheim, Dr. Giblin completed postdoctoral training in the laboratory of Dr. Steven Rosen at UCSF after receiving her Ph.D. at Yale University.

William Loging, PhD

Boehringer Ingelheim Pharmaceuticals, Inc.

William Loging is a Director in the Biologics and Integrative Biology Group within Research at Boehringer-Ingelheim Pharmaceutics Inc. The team under his supervision conducts high through-put analysis of biological/chemical content data for disease and mechanisms of toxicity understandings. His previous work lead to advancements in the use of CCR5 (Chemokine (C-C motif) receptor 5) inhibitors for the treatment of Human Immunodeficiency Virus (HIV); as well as making contributions to the successful launch of Maraviroc.

Donna L. Mendrick

National Center for Toxicological Research

Speakers

Joseph R. Berger

University of Kentucky College of Medicine

Works Professor and Chairman of the Department of Neurology at the University of Kentucky College of Medicine where he is director of the Multiple Sclerosis Clinic and the Neuro-AIDS Program. Dr. Berger’s research interests include the neurological complications of HIV/AIDS, progressive multifocal leukoencephalopathy, multiple sclerosis, and other inflammatory disorders of the brain. He has published more than 140 refereed papers, more than 80 chapters, and has edited three textbooks. Dr. Berger is an Associate of the Journal of Neurovirology and has served or is serving on several other editorial boards. He is a fellow of the American Academy of Neurology and a member of the American Neurological Association, currently serving as Treasurer of the latter.

Leonid Gorelik

Biogen Idec Inc.

Leonid Gorelik is Principal Scientist in Neurobiology Department at Biogen Idec. Dr. Gorelik leads discovery research efforts at Biogen Idec to identify ways of mitigating risk of PML via discovery of PML risk factors as well as identification of new potential treatments for PML. He received a M.S. degree in physics from the Moscow Institute of Physics and Technology, and a Ph.D. in tumor immunology from the University of Illinois at Chicago. He conducted his postdoctroral studies with Richard Flavell at Yale University, where he elucidated role of transforming growth factor-beta (TGF-beta) in T-cell regulation in autoimmunity and anti- tumor immune responses. Subsequently he moved to Biogen Idec where he worked on and led a number of drug discovery projects for treatment of autoimmune diseases.

Alice Hughes

Food and Drug Administration

Alice Hughes is the Deputy Director for Safety of the Division of Neurology at the Food and Drug Administration’s Center for Drug Evaluation and Research. She oversees the identification, assessment, and management of post-marketing safety issues for drugs for neurological indications. She joined the FDA six years ago as a medical officer safety reviewer and subsequently was the leader of the division’s safety group prior to assuming her current position. She has been extensively involved in the review of, and regulatory actions pertaining to, safety data for natalizumab (Tysabri), notably Tysabri-associated Progressive Multifocal Leukoencephalopathy. Dr. Hughes received a B.A. from Princeton University and an M.D. from the Mount Sinai School of Medicine prior to completing a residency in Internal Medicine at the Duke University Medical Center. She was a Morris Fishbein Fellow in Medical Editing at the Journal of the American Medical Association prior to joining the FDA.

Mariska Kooijmans-Coutinho 

Biogen Idec Inc.

Mariska Kooijmans-Coutinho is Senior Director of Clinical Trial Safety and Risk Management at Biogen Idec Inc., Cambridge (MA), USA. After receiving her M.D. in 1985 from Erasmus University Rotterdam, The Netherlands, Dr. Kooijmans-Coutinho trained and worked in internal medicine (1986-1991) and nephrology (1991-1995) at the Leiden University Medical Center, The Netherlands. She was awarded a Ph.D. in nephrology (renal transplantation immunology) in 1997. Dr. Kooijmans-Coutinho became Manager Medical Department at Excerpta Medica Medical Communications, The Netherlands, in 1995. She moved to Biogen in 1998 where she worked as Medical Manager Northern Europe at Biogen International B.V., The Netherlands, until 1999, when she transferred to Biogen’s clinical research department in Cambridge, MA. She was Director of Clinical Research until January 2003, when she was promoted to her current position, in which she initially was responsible for Global Clinical Trial Safety and Risk Management, and currently leads the group that is responsible for drug safety and risk management of marketed drugs. She also leads the cross-functional PML Mitigation Research Team. Dr. Kooijmans-Coutinho is a member of the American Academy of Neurology, the Dutch Association of Internal Medicine, the Dutch Society of Nephrology, the Dutch and the British Association of Pharmaceutical Physicians, and of DIA and ISoP.

Eugene O. Major

National Institute of Neurological Disorders and Stroke

Dr. Major is Senior Investigator at the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH). Dr. Major has developed a basic research laboratory, the Laboratory of Molecular Medicine and Neuroscience, focusing on mechanisms of viral pathogenesis in the human nervous system, which includes JC Virus-induced demyelination, Progressive Multifocal Leukoencephalopathy, and HIV-1 associated encephalopathy. As Chief of the Laboratory of Molecular Medicine and Neuroscience, Dr. Major’s investigations focus on the biology of virus infections in nervous system cells derived from human brain and the molecular regulation which controls cellular and viral gene expression.

Richard M. Ransohoff

Lerner Research Institute

He is the Director of the Neuroinflammation Research Center in the Department of Neurosciences of Lerner Research Institute and Professor of Molecular Medicine at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. He is also Staff Neurologist in the Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Ohio. For the past decade, Dr. Ransohoff’s research has focused on the functions of chemokines and chemokine receptors in development and pathology of the nervous system. He also has a longstanding and continuing interest in the mechanisms of action of interferon-beta. Dr. Ransohoff has published more than 150 scientific reports, more than 50 reviews and book chapters, and edited three books. Among multiple honors and awards, Dr. Ransohoff was elected to the American Association of Physicians in 2006, he received the Cleveland Clinic Lerner Research Institute’s Award for Excellence in Science in 2006, and was elected a Fellow of the American Association for the Advancement of Science in 2007.

Christian K Schneider

Paul-Ehrlich-Institut Federal Agency for Sera and Vaccines

Christian K Schneider, MD, is Director and Professor and Head of Division “EU Co-operation/Microbiology” at the Paul-Ehrlich-Institut, the German Federal Institute for Vaccines and Biomedicines. He is the chairman of the EMEA’s Committee for Advanced Therapies (CAT), which started its work in January 2009. Further, he is co-opted member of the CHMP, the Committee for Medicinal Products for Human Use at the European Medicines Agency EMEA, for the area of “Quality and safety (biological), with expertise in Advanced Therapies – Gene, Cell and Tissue Therapies”. Further, he is chairman of the CHMP Working Party on Similar Biological Medicinal Products (BMWP). Christian Schneider is Rapporteur or Co-Rapporteur for the CHMP for more than 50 biological medicinal products, e.g. Tysabri (natalizumab), Herceptin (trastuzumab), or Remicade (infliximab). He has been actively involved in the drafting of several multidisciplinary guidelines, including the CHMP Guideline on Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (the former “high-risk products guideline”), the CHMP Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process - Non-Clinical and Clinical Issues, and CHMP Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins for which he acts as Rapporteur. Before he joined the Paul-Ehrlich-Institut, Christian K Schneider was working for more than two years as a postdoctoral researcher at the Max-Planck-Institute for Neurobiology, Department of Neuroimmunology (Martinsried, Germany), where he worked in experimental immunology in the field of T cell immunology of inflammatory myopathies and multiple sclerosis. During his clinical career, Christian K Schneider worked in clinical immunology and hemato-oncology (Department of Internal Medicine III, University Erlangen-Nuremberg, Germany).

David Yocum

Genentech

Dr. David Yocum is the US Head of Drug Safety and the Global Safety Cluster Head for Inflammation and Ophthalmology at Genentech. He is also Adjunct Clinical Professor of Medicine at Stanford School of Medicine in the Section of Rheumatology. Prior to coming to Genentech in 2005, he was Professor of Medicine and Director of the Arizona Arthritis Center at the University of Arizona where his primary research interests centered around the development of immunomodulatory and biologic therapies for the rheumatic diseases, new treatments for osteoarthritis and the development of new imaging techniques for musculoskeletal diseases. Dr. Yocum is a Fellow of the American College of Rheumatology. He has published widely in peer-reviewed journals in his area of research, written several book chapters and edited books in the field of Rheumatology.