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2011 Translational Science Training Course:
Bench to Bedside Facilitating First in Human Trials
May 17, 2011

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

May 17, 2011

Session I: Introduction
Speakers: Richard O. Snyder, PhD

Session II: Regulatory Considerations
Moderator: Douglas J. Jolly, PhD

Session III: Design of Preclinical Efficacy and Safety Studies
Moderator: Joy Cavagnaro, PhD, DABT, RAC, FATS, FRAPS

  • Consideration in Design of Preclinical Safety Evaluation Programs for Novel Therapies: Highlighting Gene, Cell and Oligonucleotide-Based Therapies - Joy Cavagnaro, PhD, DABT, RAC, FATS, FRAPS
  • Tumorigenicity and Pluripotent Stem Cells - Melissa Carpenter, PhD (Materials Unavailable)

Session IV: Manufacturing and Quality Systems/Quality Management (to clinical studies)
Moderator: Derek J. Hei, PhD

  • The Evolution of Chemistry, Manufacturing & Control (CMC) Systems during Product Development - Peter Lutwyche, PhD
  • Development and Validation of a Cellular Therapy Product to Support Regulatory Applications and Commercial Supply - Michael G. Covington

Session V: Analytical Development
Moderator: Kenneth Cornetta, MD

Session VI: Resources
Moderator: Larry A. Couture, PhD

Session VII: Case Studies on Cell Therapies, Genetic Therapies, and Oligonucleotide Therapies
Cell Therapy
Moderator: Michael Jensen, MD

  • Stem Cell-Mediated Therapies for CNS Disorders: Bench to Bedside - Karen S. Aboody, MD (Materials Unavailable)
  • A Case Study: Embryonic Stem Cell Derived Cellular Therapy, Interacting with the FDA - Edmund V. Mickunas (Materials Unavailable)

Gene Therapy

Moderator: Douglas J. Jolly, PhD
  • Clinical Development of an Adenoviral Vector as a Cancer Therapeutic: Case Study of AdV-tk for Malignant Glioma - Laura K. Aguilar, MD, PhD (Materials Unavailable)
  • Autologous CD4 T cell Disruption in HIV Subjects Using Zinc Finger Nucleases - Dale Ando, MD (Materials Unavailable)

Oligonucleotide Therapy

Moderator: Scott Henry, PhD
  • Progress in the Development of Therapeutic Antisense Oligonucleotides - Scott Henry, PhD
  • Nanoparticle Targeted siRNA Cocktail Therapeutic Translation: The Next “Antibody” Cancer Therapy? - Martin C. Woodle, PhD