FDA Presentations

• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Statistical Analyses of Efficacy in Studies IT-R-005 and IT-R-006 (PPT - 145KB)
  Shiowjen Lee, Ph.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: Isolagen Therapy (IT) BLA 125348 (PPT - 2MB)
  Agnes Lim, MD and Yao-Yao Zhu, MD, PhD
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Presentation: azfibrocel-T (previously Isolagen Therapy (IT)) BLA 125348 (PPT - 93KB)
  Terrig Thomas, PhD, Agnes Lim, MD and Shiowjen Lee, PhD

Sponsor

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• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Sponsor Package (PDF - 1MB)
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Briefing Document (PDF - 933KB)
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Fibrocell Introduction (PDF - 13.6MB)
  Jeanne M. Novak, Ph.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Fibrocell Manufacturing (PDF - 6.2MB)
  Jeanne M. Novak, Ph.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Biological Effect (PDF - 12.3MB)
  Lillian B. Nanney, Ph.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Early Clinical Development of Azfibrocel-T (PDF - 12.4MB)
  Robert A. Weiss, M.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Efficacy Results from Pivotal Clinical Trials (IT-R-005 and IT-R-006) (PDF - 27.8MB)
  Girish Munavalli, M.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Safety of Azfibrocel-T and Safety Results from Pivotal Clinical Trials (IT-R-005 and IT-R-006) (PDF - 6.5MB)
  Stacy R. Smith, M.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Clinical Experience and Market Context of Azfibrocel-T (PDF - 11.2MB)
  Robert A. Weiss, M.D.
• October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Post Approval Safety Assurance and Closing Remarks (PDF - 4.6MB)
  Jeanne M. Novak, Ph.D.