Exploring Novel Clinical Trial Designs for Gene-Based Therapies Proceedings of a Workshop (2020) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 83-88
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Charge to Workshop Speakers and Participants Krishanu Saha, Workshop Co-Chair Associate Professor Retina Research Foundation Kathryn and Latimer Murfee Chair 83
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Clarifying Questions from Workshop Participants SESSION I: DEVELOPING FIRST-IN-HUMAN GENE THERAPY CLINICAL TRIALS Session Objective: • Explore the issues arising in the design of early-stage clinical gene therapy trials, including choice of endpoints, relevance, and requirements for preclinical data and identifying and using appropriate controls or natural history datasets. Session Moderator: Cindy Dunbar, National Heart, Lung, and Blood Institute, National Institutes of Health 9:15 a.m.
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From page 85... ...
Session Moderator: Mildred Cho, Stanford University 10:45 a.m. Courtney Fitzhugh Lasker Clinical Research Scholar Laboratory of Early Sickle Mortality Prevention National Heart, Lung, and Blood Institute National Institutes of Health 11:00 a.m.
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From page 86... ...
Panel Discussion with Speakers and Workshop Participants 12:30 p.m. Working Lunch SESSION III: CONSIDERING THE CHALLENGES WITH DEVELOPING ENDPOINTS FOR GENE THERAPY CLINICAL TRIALS Session Objective: • Learn about successes and challenges in accurately measuring clinical endpoints and outcomes for gene-based therapies and moving products through the translational pathway.
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From page 87... ...
Session Moderator: Michael DeBaun, Vanderbilt University 3:15 p.m. Tejashri Purohit-Sheth Director Division of Clinical Evaluation, Pharmacology, and Toxicology Office of Tissues and Advanced Therapies Center for Biologics Evaluation and Research Food and Drug Administration 3:30 p.m.
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From page 88... ...
Final Panel Discussion Ron Bartek Mildred Cho Richard Finkel Pat Furlong Katherine High Julie Kanter 5:20 p.m. Final Remarks from Workshop Co-Chairs Celia Witten, Workshop Co-Chair Deputy Director Center for Biologics Evaluation and Research Food and Drug Administration 5:30 p.m.
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