PhD / Genzyme Corporation / Risk Management Office / Sanofi Company / NeuroRx Research Inc. / Biostatistics Genzyme Gary Cutter / RAC / /
Facility
Clinic Foundation Pharmacology / Sheraton Silver Spring Hotel / Mellen Center / Cypress Ballroom / University of Texas Clarifying Questions BREAK FDA PRESENTATIONS Clinical Review / Public Health University of Alabama / /
MedicalCondition
SAD / multiple sclerosis / MS / disease / Head Multiple Sclerosis / /
NaturalFeature
Genzyme Stephen Lake / /
Organization
Risk Management office of Surveillance and Epidemiology / office of New Drugs / Food and Drug Administration / Biostatistics office of Translational Sciences / Case Western Reserve University / National Multiple Sclerosis Society / Food and Drug Administration Center for Drug Evaluation / McGill University / Multiple Sclerosis Association of America / Division of Neurology Products / Peripheral and Central Nervous System Drugs Advisory Committee / Risk Management office of Medication Error / Medication Error and Risk Management office of Surveillance and Epidemiology / Information Office / Center for Drug Evaluation and Research / University of Alabama at Birmingham / University of Texas / /
Person
Carrie Scott / Ying Lu / Mitchell T. Wallin / Robert R. Clancy / Timothy Coetzee / Maureen Katheryn Russell / Karen Munley / Safety Evelyn Mentari / Biostatistics Genzyme Gary / Sharon Yan / T. Mark Woods / Ellis Unger / David E. Blumenthal / Nyedra W. Booker / Ellen J. Marder / Jeffrey A. Cohen / Roy E. Smith / Joao Ascensao / Melissa Burdick / Lynn Kramer / Amy Love / Justin A. Zivin / Eric Bastings / Cynthia Sitcov / Paul B. Rosenberg / G. Caleb Alexander / Multiple Sclerosis / David Goldblatt / Edward Fox / David K. Klassen / Billy Dunn / Douglas G. Franklin / Michael Panzara / Richard J. Kryscio / Introductory Remarks Eric Bastings / Richard P. Hoffmann / Michelle M. Mielke / Jason W. Todd / Nathan B. Fountain (Chairperson) / Nathan B. Fountain / Evelyn Mentari / Harold C. Johnson / PCNS FDA / Glendolynn S. Johnson / Emilia Bagiella / E. Ann Yeh / David Margolin / Jennifer Panagoulias / /
Position
Professor of Neurology / Montreal Neurological Institute / President / Professor of Biostatistics / Federal Officer / Professor of Neurology / VP / Therapeutic Area / Acting Director / CEO / Director / Director / Regulatory Affairs / Director / Clinical Research Genzyme Stephen Lake / ScD Senior Director / Chairperson / Representative / PharmD Designated Federal Officer / R.N. / Director / Mellen Center / Senior Director / Regulatory Affairs / Senior Medical Director / Clinical Research / H Risk Management Analyst Division / Head / M.P.H Risk Management Analyst Division / /
Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting November 13, 2013 Location: The Sheraton Silver Spring Ho