Therapeutic Workshop
Targeting Seizure Disorders - A Pipeline at the Threshold of Broader CNS Opportunity
Thursday, October 30, 2008
9:30am - 10:45am
Twin Peaks North
Epilepsy is a well-defined clinical category with compelling CNS targeting opportunities and significant unmet need. A panel of experts will discuss the fascinating track record in epilepsy drug development and innovation across CNS applications. What's in the pipeline today and what can we learn about drug development that will inform clinical strategy and life cycle planning?
Moderator
- Samuel P. Wertheimer, PhD, Private Equity Partner, OrbiMed Advisors LLC
Panelists
Industry:
- Elizabeth Garofalo, MD, Consultant Neurologist, Acting Medical Officer, Marinus Pharmaceuticals Inc.
- Seth V. Hetherington, M.D., Senior Vice President, Clinical and Regulatory Affairs, Icagen
Clinician:
- David Treiman, MD; Newsome Chair in Epileptology and Director, Epilepsy Center, Barrow Neurological Institute; Research Professor of Bioengineering and Clinical Professor of Neuroscience, Arizona State University
- Roger Porter, MD, Adjunct Professor of Neurology, University of Pennsylvania; Adjunct Professor of Pharmacology, Uniformed Serv. Univ. (USUHS), Bethesda
Who's Who
Samuel P. Wertheimer, PhD, Dr. Wertheimer joined OrbiMed in 2000 and is a Principal in the private equity funds management group. Dr. Wertheimer's prior experience includes work in biotechnology finance, technology transfer, intellectual property and research in immunology and molecular biology. Dr. Wertheimer was a Fellow at the Memorial Sloan-Kettering Cancer Center. Dr. Wertheimer received a Ph.D. in Molecular Biology from New York University, an M.P.H. from Yale University and a B.A. from The Johns Hopkins University. He has served as a Director of Salmedix and Corus Pharma and currently serves on the boards of several private biotechnology companies including Biodel and ChemoCentryx.
Elizabeth Garofalo, MD Dr. Garofalo is one of four founders and current President of the Technical Center, Michigan Technology and Research Institute. At MITRI, she provides consulting services to the pharmaceutical industry. She is the Acting Medical Director for Marinus Pharmaceuticals.
Dr. Garofalo is a pediatric neurologist/epileptologist with fifteen years of clinical drug development experience, including two years in regulatory affairs while at Pfizer. She received her medical training and completed a Pediatric Residency at the Indiana University School of Medicine followed by a fellowship in Neurology/Pediatric Neurology and a fellowship in Epilepsy at The University of Michigan.
In the early 1990s, Dr. Garofalo joined Parke-Davis/Warner-Lambert where she worked in clinical research. In 1995, Dr. Garofalo became Senior Director and Therapy Head, Clinical Research. In 2002, following the Pfizer merger, she became Executive Director and site therapeutic area leader, Central Nervous System. In 2003, Dr. Garofalo became Site Head, Worldwide Regulatory Affairs for Pfizer. During her years at PD/Pfizer, Betsy designed and conducted many trials in adults and children with epilepsy and in adults with neuropathic pain for both Neurontin and Lyrica. In addition to her consulting work, she is an Adjunct Associate Professor of Pediatrics at The University of Michigan where she attends clinic and teaches the Pediatric Neurology Fellows.
Seth V. Hetherington, MD, Dr. Hetherington joined Icagen in June 2006 as Senior Vice President, Clinical and Regulatory Affairs. Dr. Hetherington's career in clinical drug development and academic medicine spans a period of over twenty-five years. From 2002 to May 2006, Dr. Hetherington served as Vice President, Clinical Development and Chief Medical Officer at Inhibitex, a biotechnology company. From 1995 to 2002, Dr. Hetherington served in positions of increasing responsibility in clinical drug development at GlaxoSmithKline and Glaxo Wellcome. During this period, Dr. Hetherington made significant contributions to several clinical development programs, including work on the currently marketed pharmaceuticals Ziagen, Trizivir and Agenerase. During this period Dr. Hetherington also served as a faculty member at the University of North Carolina School of Medicine. Prior to joining Glaxo Wellcome, Dr. Hetherington held appointments at several leading academic medical centers, including the University of Tennessee, St. Jude Children's Research Hospital in Memphis and Albany Medical College. Dr Hetherington earned his B.S. at Yale University and his M.D. at the University of North Carolina, Chapel Hill. He completed his postgraduate training in pediatrics and pediatric infectious diseases at the University of North Carolina and the University of Minnesota, respectively. Dr. Hetherington currently serves as the industry representative to the Vaccines and Related Blood Products Advisory Committee of the FDA. Dr. Hetherington has published extensively in the medical and scientific literature, and is board certified in both pediatrics and pediatric infectious diseases.
David M. Treiman, MD, Dr. Treiman is the Newsome Chair in Epileptology, Director of the Epilepsy Center, and Vice-chair of Neurology at the Barrow Neurological Institute in Phoenix, Arizona and Professor of Neuroscience and Bioengineering at Arizona State University in Tempe, Arizona. He has authored nearly 200 scientific articles, chapters, and invited papers in the area of epilepsy. Dr. Treiman's research has been focused on treatment issues in epilepsy, and include mechanisms and treatment of status epilepticus, development of new drugs and novel non-pharmacological interventions for the treatment of epilepsy, and the prevention of epileptogenesis.
Roger Porter, MD, Dr. Porter is an Independent Consultant to the pharmaceutical industry, primarily in the area of development of antiepileptic drugs. He is also an Adjunct Professor of Neurology at University of Pennsylvania and an Adjunct Professor of Pharmacology at Uniformed Services University of the Health Sciences. Dr. Porter has spent over 20 years at the National Institutes of Health (NIH) in leadership positions including Chief of the Epilepsy Branch, Chief of Medical Neurology Branch, and Deputy Director of the National Institute of Neurological Disorders and Stroke (NINDS). He is a past president of the American Epilepsy Society. In 1992, he was appointed the Vice President of Clinical Pharmacology at Wyeth, and later promoted to Vice President and Deputy Head of Clinical Research in January 1998, where he worked until his retirement in 2002. Dr. Porter has published over 180 articles and chapters, and over 13 books.