A schedule of events for the Workshop on Improved Characterization of Mesenchymal Stem Cells for Clinical Trials is provided below for your convenience.
This one-day workshop will be held in the Southern Management Campus Center at the University of Maryland, Baltimore from 8:00 a.m. to 1:00 p.m. It is open to the public. For a printable agenda, please download the conference brochure.
| Time | Activity |
|---|---|
| 8:00 a.m. | Welcome from the UM Center for Stem Cell Biology & Regenerative Medicine Curt Civin, MD Director, Center for Stem Cell Biology & Regenerative Medicine Associate Dean for Research Professor of Pediatrics and Physiology University of Maryland School of Medicine Welcome from the Food and Drug Administration Frank Weichold,PhD Director of Regulatory Science and Innovation Food and Drug Administration |
| 8:10 a.m. | Meeting Introduction: "What Should You Measure to Characterize Your MSCs for Clinical Use and What Can We Learn from Animal Models" Curt Civin, MD Director, Center for Stem Cell Biology & Regenerative Medicine Associate Dean for Research Professor of Pediatrics and Physiology University of Maryland School of Medicine Steven R. Bauer, PhD Chief, Cell and Tissue Therapy Branch Division of Cellular and Gene Therapies Office of Cellular, Tissue, and Gene Therapies FDA/Center for Biologics Evaluation and Research Workshop Moderator: Joseph Stains, PhD Assistant Professor of Orthopaedics and Physiology Department of Orthopaedics University of Maryland School of Medicine |
| 8:15 a.m. | "History and Clinical Development of MSCs" Arnold I. Caplan, PhD Director, Skeletal Research Center Professor of Biology Professor of General Medical Sciences (Oncology) Case Western Reserve University |
| 8:45 a.m. | "Imaging and Applications of MSCs in Pre-Clinical Animal Models" Dara L. Kraitchman, VMD, PhD, FACC Associate Professor, Department of Radiology Section Head, Cardiovascular Intervention Johns Hopkins University |
| 9:15 a.m. | "International Society for Cell Therapy's Perspective on Characterization of MSCs for Clinical Trials" Donald G. Phinney, PhD Professor, Department of Molecular Therapeutics The Scripps Research Institute |
| 9:45 a.m. | "Characterization of MSCs for Clinical Application" Jacques Galipeau, MD, FRCP(C) Co-Director, Winship Cancer Institute Tumor Immunology-Immunotherapy Director, Emory Personalized Immunotherapy Center [EPIC] Professor of Hematology and Medical Oncology Professor of Pediatrics & Medicine Emory University |
| 10:15 a.m. | "Clinical Application of MSCs" Stanton Gerson, MD Asa and Patricia Shiverick -- Jane Shiverick (Tripp) Professor of Hematological Oncology Director, Case Comprehensive Cancer Center Director, National Center for Regenerative Medicine Case Western Reserve University |
| 10:45 a.m. | Break |
| 11:00 a.m. | "Industry Perspective/Experience with MSC Characterization" Robert Deans, PhD Executive Vice President, Regenerative Medicine Athersys, Inc. |
| 11:30 a.m. | "Systems Biology/Bioinformatics and Characterization of Stem Cell-Based Cell Therapy Products" Amitabh Varsheny, PhD Director, University of Maryland Institute for Advanced Computer Studies Professor of Computer Science University of Maryland, College Park Carl G. Simon, Jr., PhD Biologist, Biosystems & Biomaterials Division Biomaterials Group Material Measurement Laboratory National Institute of Standards and Technology |
| 12:00 p.m. | "FDA Perspectives on MSC Characterization and the MSC Consortium" Steven R. Bauer, PhD Chief, Cell and Tissue Therapy Branch Division of Cellular and Gene Therapies Office of Cellular, Tissue, and Gene Therapies FDA/Center for Biologics Evaluation and Research |
| 12:30 p.m. | Panel Discussion Chair: Mark Pittenger, PhD Chief Science Officer Pearl Lifesciences Partners |
| 1:00 p.m. | Adjourn |