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U.S. Department of Health and Human Services

Advisory Committees

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April 17, 2013 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 #58, April 17, 2013
Rockwall Building II, 5515 Security Lane, Rockville, MD 20852
Conference Room 1033


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 32037 

Michael R. Bishop, M.D.
Director
Hematology Stem Cell Transplantation Program
University of Chicago
Section of Hematology/Oncology
5841 South Maryland Avenue, MC2115
Chicago, IL  60637

William Bugbee, M.D.+
Attending Orthopaedic Surgeon
Division of Orthopaedic Surgery
Scripps Clinic
10666 N. Torrey Pines Road
La Jolla, CA  92037

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

Leisha A. Emens, M.D., Ph.D.
Associate Director of Oncology
Johns Hopkins University School of Medicine
Bunting-Blaustein Building
1650 Orleans Street, Room 409
Baltimore, MD  21231

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

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 450
Houston, TX  77030

Stephen M. Rose, Ph.D.**
Chief Research Officer
Foundation Fighting Blindness
7168 Columbia Gateway Drive
Columbia, MD  21046

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

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

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

Steven A. Goldman, M.D., Ph.D.
Rykenboer Professor
Department of Neurology
University of Rochester
601 Elmwood Avenue, MRB/Box 645
Rochester, NY  14642

Francis J.  Hornicek, Jr., Ph.D., M.D.
Temporary Voting Member
Chief
Orthopedic Oncology Services
Massachusetts General Hospital
Yawkey Building, Suite 3700
55 Fruit Street
Boston, MA  02114

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  

*    Industry Representative
**  Consumer Representative
+      Not Attending


FDA Participants

Steven Kozlowski, M.D.
Director
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
Center for Drug Evaluation and Research
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD  20993

Edward Max, M.D., Ph.D.
Associate Director for Research
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
Center for Drug Evaluation and Research
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD  20993

Serge Beaucage, Ph.D.
Chief (Acting)
Laboratory of Chemistry
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD  20993

Jacek Cieslak, Ph.D.
Senior Staff Fellow
Laboratory of Chemistry
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD  20993

Amy Rosenberg, M.D.
Director
Division of Therapeutic Proteins
Office of  Biotechnology Products
Office of Pharmaceuticals Sciences
Center for Drug Evaluation and Research
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD  20993

Gibbes Johnson, Ph.D.
Deputy Director (Acting)
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
Center for Drug Evaluation and Research
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD  20993

Kula Jha, Ph.D.
Senior Staff Fellow
Laboratory of Chemistry
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD  20993


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