Office of Cellular Tissue and Gene Therapies

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Office of Cellular Tissue and Gene Therapies

• Celia M.Witten, Ph.D., M.D.
• Director, Office of Cellular, Tissue, and Gene
  Therapies
• Cellular, Tissue, and Gene Therapies Advisory
  Committee Meeting
• February 10, 2006

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OCTGT Mission

• Facilitate development, approval, and access to
  safe and effective medical products

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Outline

• Science in Research and Review
• Products Regulated
• Office Overview

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Science in Research and Review Critical Path
Initiative

• Bring scientific advances to medical product
  development process (simulation models, validated
  biomarkers, new clinical trial designs)
• Stimulate development of applicable research
  programs in critical path scientific areas, aim
  to develop techniques that address challenges
  encountered during product development
• Regulatory guidance/practice and standards to
  reflect best available science, integrate FDA
  involvement

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OCTGT Regulation

• Cellular therapies
• Tumor vaccines
• Gene therapies
• Tissue and tissue based products
• Xenotransplantation products
• Combination products
• Devices used for cells/tissues
• Anti-idiotype antibodies

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Office of Cellular, Tissue, and Gene
Therapies Celia M.Witten, Ph.D, M.D. Office
Director Eda Bloom, Ph.D. Acting Deputy
Director Suzanne Epstein, Ph.D., Associate
Director for Research Richard McFarland, M.D.,
Ph.D. Acting Associate Director for Policy
Division of Cellular and Gene Therapies Raj Puri,
Ph.D., M.D., Director Stephanie Simek, Ph.D.,
Deputy Director
Division of Human Tissue Products Ruth Solomon,
M.D., Director
Division of Clinical Evaluation and
Pharmacology/Toxicology Ashok Batra, M.D.
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DCGT Reorganization

• Consolidate research-reviewer PIs with similar
  background
• Branch names reflect regulatory responsibilities
• Critical mass and efficient operations

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New Structure
Division of Cellular and Gene Therapies Raj Puri,
Ph.D., M.D., Division Director Stephanie Simek,
Ph.D., Deputy Director
Gene Therapies Branch Maritza McIntyre, Ph.D.,
Chief
Gene Transfer and Immunogenicity Branch Eda
Bloom, Ph.D., Chief
Cell Therapies Branch Kimberly Benton, Ph.D.,
Chief
Tumor Vaccines and Biotechnology Branch Raj
Puri, Ph.D., M.D., Acting Chief
Cellular and Tissue Therapy Branch Steve Bauer,
Ph.D., Acting Chief