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May 17-18, 2010
Marriott Wardman Park Hotel
Washington, DC

Note: Following are links to the presentation slides from faculty members who gave ASGCT authorization to post them on this web page.

May 17, 2010

Co-Chairs: Katherine High, MD & Helen Heslop, MD

Session I: Planning for a Clinical Trial
Moderator: Andra Miller, PhD

Session II: Preclinical Development
Moderator: Stephanie Simek, PhD

  • Preclinical Considerations for Cell and Gene Therapy Products: CBER Perspective - Mercedes Serabian, MS
  • Preclinical Biodistribution of Cell and Gene Transfer Vectors - Edwin Horwitz, MD, PhD
  • Preclinical Toxicology: Combining Novel Designs with Traditional Principles
    • Case Study: How Do You Know When Your Preclinical Work in Cell Therapy is Ready for the Clinic? – Jeffrey Miller, MD
    • A Phase I Pilot Study of Safety and Feasibility of Stem Cell Therapy for AIDS Lymphoma Using Stem Cells Treated with a Lentivirus Vector Encoding Multiple Anti-HIV RNAs – John J. Rossi, PhD
    • Preclinical Studies in Gene Delivery Biodistribution & Host Response Examples from AAV – Barrie J. Carter, PhD & Katherine A. High, MD

May 18, 2010

Session III: Clinical Trial Design, Approval Process and Trial Conduct
Moderator: Jacqueline Corrigan-Curay, MD, JD

  • General Considerations for Clinical Trial Design - Steven Winitsky MD
  • Special Considerations in Gene Transfer: Small Populations – Orphan Diseases - Zi-Fan Yu, ScD
  • Special Considerations in Gene Transfer: Surrogate Endpoints - Michael Kalos, PhD
  • Updates to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guideleines) - Jacqueline Corrigan-Curay, MD, JD
  • Federal and Institutional Approval Process (IRB, IBC, NIH/RAC, FDA) - John Zaia, MD
  • Good Clinical Practices (GCP) Overview - Martha Reitman, MD (Materials Unavailable)

Session IV: Clinical Trial Compliance, Monitoring and Oversight
Moderator: John Rossi, PhD

Session V: Bioethics, Research Integrity and Conflicts of Interest
Moderator: Traci Mondoro, PhD

Session VI: Special Considerations for Follow Up in Gene and Cell Therapy Clinical Trials
Moderator: Barrie Carter, PhD