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
Speakers:

• Basics of IND Submission - Jakob Reiser, PhD
• Translational Virotherapy in an Academic Setting - Stephen J. Russell, MD, PhD

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

• 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
Speakers:

• 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
Speakers:

• Analytical Development in Context of Viral Product Development - Wolfgang M. Klump, PhD
• Analytical Methods for use in Characterization and Release of Gene Therapy Products - Phillip Ramsey, MS, MBA, RAC

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

• NHLBI Resources for Gene and Cell Therapy Investigators - Sonia I. Skarlatos, PhD
• PACT 's Role in Supporting Pre-clinical Work and Phase I Clinical Trials - Debbie Wood
• National Gene Vector Biorepository (NGVB) - Kenneth Cornetta, MD

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

• 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
Speakers:

• 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
Speakers:

• 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