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Appendix A: Workshop Agenda
Pages 89-94

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From page 89...
... 8:35 a.m. Charge to Workshop Speakers and Participants Martha Lundberg, Workshop Co-Chair Program Director, Division of Cardiovascular Sciences Advanced Technologies and Surgery Branch National Heart, Lung, and Blood Institute National Institutes of Health 89
From page 90...
... Case Study 2: Sources of Variability in Preclinical and Clinical Research on Stem Cell Therapies for Amyotrophic Lateral Sclerosis Clive Svendsen Kerry and Simone Vickar Family Foundation Distinguished Chair in Regenerative Medicine Cedars–Sinai Medical Center
From page 91...
... Fox Foundation for Parkinson's Research 10:35 a.m. Jennifer Elisseeff Morton Goldberg Professor Wilmer Eye Institute and Biomedical Engineering, Translational Tissue Engineering Center Johns Hopkins University 10:50 a.m.
From page 92...
... Session Moderator: Martha Lundberg, Program Director, Division of C ­ ardiovascular Sciences, Advanced Technologies and Surgery Branch, National Heart, Lung, and Blood Institute 1:00 p.m. Andrew Fesnak Assistant Professor of Clinical Pathology and Laboratory Medicine University of Pennsylvania Perelman School of Medicine 1:15 p.m.
From page 93...
... Panel Discussion with Speakers and Workshop Participants SESSION V: EXPLORING OBJECTIVE METRICS AND OUTCOMES FOR CLINICAL TRIALS AND THE REGULATORY APPROVAL PATHWAY Session Objectives: • Discuss ideas for objective metrics and reliable approaches to inter preting the outcomes of clinical trials of regenerative engineering therapies. • Explore how variability in regenerative engineering products can affect the regulatory approval pathway.
From page 94...
... Final Remarks from Workshop Co-Chairs Martha Lundberg, Workshop Co-Chair Program Director, Division of Cardiovascular Sciences Advanced Technologies and Surgery Branch National Heart, Lung, and Blood Institute National Institutes of Health Kathy Tsokas, Workshop Co-Chair Regulatory Head of Regenerative Medicine and Advanced Therapy Johnson & Johnson 5:10 p.m. Adjourn


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