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U.S. Department of Health and Human Services

Advisory Committees

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February 25-26, 2014: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Roster

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
Meeting #59, February 25-26, 2014
Hilton Washington, D.C. North Gaithersburg Hotel
620 Perry Parkway, Gaithersburg, MD 20877


Members
 
Evan Y. Snyder, M.D., Ph.D., Chair
Professor
Program in Stem Cells and Regenerative Biology
Sanford-Burnham Medical Research Institute
10901 North Torrey Pines Road, Rm. 7261
La Jolla, CA 92037
Tabassum Ahsan, Ph.D.
Assistant Professor
Department of Biomedical Engineering
Center for Stem Cell Research and Regenerative Medicine
Tulane University 
500 Lindy Boggs
New Orleans, LA 70118
Scott P. Bruder, M.D., Ph.D. *+
Chief Medical and Scientific Officer
Stryker Corporation
325 Corporate Drive
Mahwah, NJ  07430
William Bugbee, M.D.
Attending Orthopaedic Surgeon
Division of Orthopaedic Surgery
Scripps Clinic
10666 N. Torrey Pines Road
La Jolla, CA  92037
Larry A. Couture, Ph.D.
Senior Vice President
Center for Applied Technology Development
Beckman Research Institute
City of Hope
1500 E. Duarte Road
Duarte, CA  91711
Timothy P. Cripe, M.D., Ph.D.
Professor
Division of Hematology/Oncology/Bone Marrow Transplantation
Nationwide Children’s Hospital
The Ohio State University Wexner College of Medicine
700 Children’s Drive
Columbus, OH  43205
Linda A. Dahlgren, D.V.M., Ph.D., DACVS
Associate Professor
Department of Large Animal Clinical Sciences
Virginia-Maryland Regional College of Veterinary Medicine
Virginia Polytechnic Institute and State University
Phase II, Duck Pond Road
Blacksburg, VA  24061
Leisha A. Emens, M.D., Ph.D.
Associate Professor of Oncology
Johns Hopkins University School of Medicine
Bunting-Blaustein Building
1650 Orleans Street, Room 409
Baltimore, MD  21231
Steven A. Goldman, M.D., Ph.D.
Rykenboer Professor
Department of Neurology
University of Rochester
601 Elmwood Avenue, MRB/Box 645
Rochester, NY  14642
John D. Gearhart, Ph.D.
James Effron University Professor
Institute for Regenerative Medicine
University of Pennsylvania School of Medicine
Biomedical Research Building
421 Curie Boulevard, 1151
Philadelphia, PA  19104
Mei-Ling Ting Lee, Ph.D.
Professor 
Department of Epidemiology and Biostatistics
Biostatistics and Risk Assessment Center
University of Maryland School of Public Health
SPH Building 255, EPIB, Room 2234R
College Park, MD  20742
Patrick Hwu, M.D.+
Professor
Department of Melanoma Medical Oncology
Division of Cancer Medicine
University of Texas M.D. Anderson Cancer Center
1515 Holcombe Boulevard, Unit 430
Houston, TX  77030
Acting Industry Representative
Jane Lebkowski, Ph.D.
President of Research and Development
Asterias Biotherapeutics
230 Constitution Drive
Menlo Park, CA  94028
Stephen M. Rose, Ph.D.**
Chief Research Officer
Foundation Fighting Blindness
7168 Columbia Gateway Drive
Columbia, MD  21046

Temporary Voting Members
 
Maria del Carmen Bustillo
Director of Assisted Reproductive Technology Services
South Florida Institute for Reproductive
Medicine
7300 S.W. 62 Place, 4th Floor
Miami, FL  33143
Marcelle I. Cedars, M.D.
Professor of Obstetrics, Gynecology and Reproductive Sciences
University of California, San Francisco
School of Medicine
Box 0916, 2356 Sutter Street
MZ Building J, 7th Floor
San Francisco, CA  94143
Bruce H. Cohen, M.D., FAAN
Director
Division of Neurology
Akron Children’s Hospital Medical Center
215 W. Bowery Street, Room 4400
Akron, OH  44308
Douglas S. Diekema, M.D., M.P.H.
Professor
Department of Pediatrics
Treuman Katz Center for Pediatric Bioethics
Seattle Children’s Research Institute
University of Washington School of Medicine
C9S-6, 1900 Ninth Avenue
Seattle, WA  98101
David L. Keefe, M.D.
The Stanley H. Kaplan Professor
Department of Obstetrics and Gynecology
New York University School of Medicine
550 First Avenue, NBV 9 North 1-A
New York, NY  10016
Carlos T. Moraes, Ph.D.
Professor
Department of Neurology and Cell Biology
University of Miami Miller School of Medicine
1420 NW 9th Avenue, Room 229
Miami, FL  33136
Sharon Reeder++ 
FDA Patient Representative-
Mitochondrial Disease
United Mitochondrial Disease Foundation
Aliso Viejo, CA  92656
Renee A. Reijo Pera, Ph.D.
Vice President for Research and Economic Development
Montana State University
207 Montana Hall, P.O. Box 174260
Bozeman, MT 59717-2460
Bonnie Steinbock, Ph.D.
Professor
Department of Philosophy
University at Albany
State University of New York
1400 Washington Avenue
Humanities 257
Albany, NY  12222
Katharine D. Wenstrom, M.D.
Professor of Obstetrics and Gynecology
Alpert Medical School of Brown University
Women and Infants Hospital of Rhode Island
101 Dudley Street, 3rd Floor
Providence, RI  02905
Teresa K. Woodruff, Ph.D.
Vice Chair for Research
Department of Obstetrics and Gynecology
Women’s Health Research Institute
Northwestern University
Feinberg School of Medicine
303 E. Superior Street, Lurie 10-121
Chicago, IL  60611
 

Guest Speakers
 
Dieter Egli, Ph.D.
Senior Research Fellow
The New York Stem Cell Foundation
178 Columbus Avenue, #237064
New York, NY  10023
Salvatore DiMauro, M.D.
Lucy G. Moses Professor of Neurology
Columbia University Medical Center
4-424B College of Physicians & Surgeons
630 West 168th Street
New York, NY  10032
Mary Herbert, Ph.D.
Professor of Reproductive Biology
Institute for Aging and Health
Newcastle University
Campus for Aging and Vitality
Newcastle on Tyne, NE4 5PL
United Kingdom
Keith Latham, Ph.D.
Professor of Animal Science
College of Agriculture and Natural Resources
Michigan State University
474 S. Shaw Lane, Room 1230E
East Lansing, MI  48824
Shoukhrat Mitalipov, Ph.D.
Senior Scientist
Division of Reproductive and Developmental Sciences
Oregon National Primate Research Center
Oregon Health & Science University
505 NW 185th Avenue
Beaverton, OR  97006
Gerald S. Shadel, Ph.D.
Director, Pathology Research
Departments of Pathology and Genetics
Yale School of Medicine
310 Cedar Street
New Haven, CT 06520-8023
Marc-André Sirard, D.M.V., Ph.D.
Chaire de Recherche du Canada en
Génomique Animale
Département des Sciences Animales
Pavillon des services
Université Laval
INAF, bureau 2732
Québec
Canada, G1V 0A6
 

FDA Participants
 
Wilson Bryan, M.D.
Director,
Division of Clinical Evaluation
And Pharmacology/Toxicology Review
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD  20852
Deborah Hursh, Ph.D.
Biologist
Cellular and Tissue Therapy Branch
Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD  20852
John Hyde, M.D.
Medical Officer
General Medicine Branch
Division of Clinical Evaluation
And Pharmacology/Toxicology Review
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD  20852
Celia Witten, Ph.D., M.D.
Director
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD  20852

FDA Administrative Staff
Designated Federal Officer
Gail Dapolito
Division of Scientific Advisors and Consultants
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, HFM-71
Rockville, MD  20852
Phone:  (301) 827-1289
E-Mail: gail.dapolito@fda.hhs.gov
Committee Management Specialist
Rosanna Harvey
Division of Scientific Advisors and Consultants
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, HFM-71
Rockville, MD  20852
Phone:  (301) 827-1297
E-Mail: rosanna.harvey@fda.hhs.gov

*Industry Representative
**Consumer Representative
+Not Attending
++Patient Representative