January 15, 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Draft Roster

Meeting #57, January 15, 2013
NATIONAL INSTITUTES OF HEALTH
BUILDING 29B, CONFERENCE ROOM C

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

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

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

Francis J. Hornicek, Jr., Ph.D., M.D.
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

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.
Senior Investigator
Laboratory of Immunology
Associate Director for Research
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

Arulvathani Arudchandran, Ph.D.
Microbiologist
Laboratory of Immunology
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD 20993

Raymond Donnelly, M.S., Ph.D.
Senior Investigator
Laboratory of Immunology
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD 20993

Michael Norcross, M.D.
Senior Investigator
Laboratory of Immunology
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD 20993

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

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. *
Industry Consultant
Franklin Lakes, NJ 07417

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

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

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

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

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

Daniela Verthelyi, M.D., Ph.D.
Chief
Laboratory of Immunology
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

Harold Dickensheets, Ph.D.
Staff Scientist
Laboratory of Immunology
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD 20993

Hugh McFarland, Ph.D.
Staff Scientist
Laboratory of Immunology
Division of Therapeutic Proteins
Office of Biotechnology Products
Office of Pharmaceuticals Sciences
10903 New Hampshire Avenue, HFD-122
Silver Spring, MD 20993

Jack Ragheb, M.D.
Senior Investigator
Laboratory of Immunology
Division of Therapeutic Proteins
Office of Pharmaceuticals Sciences
Office of Biotechnology Products
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