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1DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONFDA SCIENCE BOARD ADVISORY COMMITTEEThursday, April 22, 20048:00 a.m.Advisors and Consultants Staff Conference Room5630 Fishers LaneRockville, Maryland
 
2PARTICIPANTSKenneth I. Shine, M.D., ChairJan. N. Johannessen, Ph.D., Executive SecretaryBOARD MEMBERS:Gail H. Cassell, Ph.D.Josephine Grima, Ph.D., Consumer RepresentativeSusan Harlander, Ph.D.Cato T. Laurencin, M.D., Ph.D.Cecil B. Pickett, Ph.D.F. Xavier Pi-Sunyer, M.D., M.P.H.Jose C. Principe, Ph.D.Jim E. Riviere, D.V.M., Ph.D.Allen D. Roses, M.D.Katherine M.J. Swanson, Ph.D.John L. Thomas, Ph.D.OFFICE OF THE COMMISSIONER:Lester M. Crawford, D.V.M., Ph.D.,Norris E. Alderson, Ph.D.FDA:Daniel A. Casciano, Ph.D.David W. Feigel, Jr., M.D., M.P.H.Kathy Carbone, M.D.John MarzilliRobert E. Brackett, Ph.D.Steven Galson, M.D., M.P.H.
 
3C O N T E N T SCall to Order, Kenneth I. Shine, M.D., Chair, 5Welcome and Opening Remarks,Lester M. Crawford, D.V.M., Ph.D., ActingCommissioner of Food and Drugs 9Overview of the FDA Initiative on Obesity,Robert E. Brackett, Ph.D., CFSAN, FDA 19Obesity - Therapeutics, David G. Orloff, M.D.,CDER, FDA 27Obesity - Research, David W.K. Acheson, M.D.,CFSAN, FDA 47Highlights of the Obesity Working Group Report,Alan Rulis, Ph.D., CFSAN, FDA 76Questions and Discussion with theBoard/Presenters 96Update on ORA Peer Review Process,John R. Marzilli, Deputy AssociateCommissioner for Regulatory Affairs, FDA 129John J. Specchio, Ph.D., ORA Science Advisor 135Open Public Hearing:Arthur Frank, M.D., George Washington University 150Elizabeth Jacobson, Ph.D., AdvaMed 158Richard Atkinson, M.D., AmericanObesity Association 170Introduction to Critical Path, Janet Woodcock,M.D., Acting Deputy Commissioner forOperations, FDA 175Perspective on Anti-Infectives and Vaccines,Gail H. Cassell, Ph.D., Eli Lilly and Company 220Perspective on Chronic Disease Therapies,Robert M. Califf, M.D., Duke University 241
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