FDA-IXA Symposium
Registration to the FDA-IXA Symposium is now closed. Onsite registration will be available on September 20, 2017 as of 07:30am at the venue: SMC Campus Center, 621 West Lombard Street, 2nd Floor.
| 08:00-09:00 | Session 1: Recent Advances in Xenotransplantation |
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| Welcome Remarks Muhammad Mohiuddin Chief of Transplantation, Cardiothoracic Surgery Research Program, NHLBI /NIH, Bethesda, MD, United States |
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| Solid Organ Transplantation David Cooper Professor of Surgery; Co-Director, Xenotransplantation Program, Department of Surgery, Division of Transplantation, University of Alabama at Birmingham, School of Medicine, Birmingham, AL, United States |
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| Cellular Transplantation Bernhard J. Hering Professor of Surgery and Medicine, Surgery, University of Minnesota, Minneapolis, MN, United States |
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| Advances in Genetic Engineering: Implications for Xenotransplantation Joe (Alfred) Tector Professor of Surgery, Director of Xenotransplantation, Department name, University of Alabama at Birmingham, Birmingham, AL, United States |
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| Discussion |
| 09:00-10:15 | Session 2: The Challenges of Infection and Risk-Benefit in Xenotransplantation |
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| Overview: Determinants of Risk and Acceptable Risk: The Allotransplantation Experience Jay Fishman Associate Director, MGH Transplantation Center, Director, Transplant Infectious Disease & Compromised Host Program, Massachusetts General Hospital, Professor of Medicine, Harvard Medical School |
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| Donor and Recipient Testing: Known Pathogens (Animal Breeding and Testing) Henk-Jan Shuurman SchuBiomed Consultancy BV, Utrecht, The Netherlands |
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| Donor and Recipient Testing: Unknown Pathogens (Technology and Need) and PERV (Including Genetic Engineering Jay Fishman Associate Director, MGH Transplantation Center, Director, Transplant Infectious Disease & Compromised Host Program, Massachusetts General Hospital, Professor of Medicine, Harvard Medical School |
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| Assays: Methods for Detection of PERV Ralf Tonjes Head of Section, Division of Medical Biotechnology, Paul-Ehrlich-Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany |
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| Calibrating the Risk/Benefit Ratio for Clinical Xeno Trial Design David Sachs Professor of Surgery, Columbia Centre for Translational Immunology (CCTI), Columbia University of Medical Center, Harvard Medical School, Boston, MA, USA |
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| Discussion |
| 10:15-11:45 | Session 3: Regulatory Considerations in the Development of Xenotransplantation Products (Session Conducted by FDA) |
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| Overview of FDA Guidance on the Development of Xeno Products Judith Arcidiacono FDA |
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| FDA Expectations for Source Animal Herds and Characterization John Dennis and Evgenij Evdokimov FDA |
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| Pre-Clinical Trials: Design Considerations Allen Wensky FDA |
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| Clinical Trials: Design Considerations Bruce Schneider FDA |
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| Joint IXA-FDA Panel-led Discussion |
