Moderator
Jacqueline Corrigan-Curay, MD, JD
Speakers
Jacqueline Corrigan-Curay, MD, JD
Introduction
Steven Winitsky, MD
Clinical Trial Design - General Principles of Study Design
Zi-Fan Yu, ScD
Special Considerations in Gene Transfer: Small Populations - Orphan Disease
Michael Kalos, PhD
Special Considerations in Gene Transfer: Surrogate Endpoints
Jacqueline Corrigan-Curay, MD, JD
New NIH Guidelines
John A. Zaia, MD
Federal and Institutional Approval Process (IRB, IBC, NIH/RAC, FDA)
Martha Reitman, MD
Good Clinical Practice (GCP) Overview - (Including sponsor and investigator responsibilities under GCP)
Jacqueline Corrigan-Curay, MD, JD, Steven Winitsky, MD, Michael Kalos, PhD, John A. Zaia, MD, Martha Reitman, MD
Panel Discussion and Audience Questions
Moderator
John J. Rossi, PhD
Speakers
John J. Rossi, PhD
Introduction
Helen Heslop, MD
Reporting on Adverse Events
Bambi Grilley, RPh
Data and Safety Monitoring
Colleen Allen
Site Monitoring Visits: What to Expect and How to Prepare
Moderator
John J. Rossi, PhD
Speakers
Patricia A. Holobaugh
Preparing for an FDA Inspection
John J. Rossi, PhD, Bambi Grilley, RPh, Colleen Allen, Patricia A. Holobaugh, Helen E. Heslop, MD
Panel Discussion and Audience Questions
Moderator
Traci Mondoro, PhD
Speakers
Traci Mondoro, PhD
Introduction
Robyn S. Shapiro, JD
Bioethics in Clinical Research
Moderator
Traci Mondoro, PhD
Speaker
Steven Joffe, MD, MPH
Conflicts of Interest in Clinical Studies
Traci Mondoro, PhD, Robyn S. Shapiro, JD, Steven Joffe, MD, MPH
Panel Discussion and Audience Questions
Moderator
Barrie Carter, PhD
Speakers
Barrie Carter, PhD
Introduction
Cynthia Dunbar, MD
Genotoxicity - Considerations in Integrating Vectors
Adrian Gee, PhD
Reporting on unused products and facility issues in response to Dear Cell and Gene Therapy IND holder issues
Jane Lebkowski, PhD
Stem Cells - Safety
Wilson W. Bryan, MD
Phase III Labeling Issues
Barrie Carter, PhD, Cynthia Dunbar, MD, Adrian Gee, PhD, Jane Lebkowski, PhD, Wilson W. Bryan, MD
Panel Discussion and Audience Questions
