FDA-IXA Symposium
Registration to this symposium is open to all Congress delegates at no additional cost. You may select this symposium during the online registration process. Participants wishing to attend ONLY this symposium must submit an application form at this link. Confirmation emails will be provided on August 15 and September 1.
| 08:00-09:00 | Session 1: Recent Advances in Xenotransplantation |
|---|---|
| Welcome Remarks Muhammad Mohiuddin Chief of Transplantation, Cardiothoracic Surgery Research Program, NHLBI /NIH, Bethesda, MD, United States |
|
| 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 |
|
| Cellular Transplantation Bernhard J. Hering Professor of Surgery and Medicine, Surgery, University of Minnesota, Minneapolis, MN, United States |
|
| 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 |
|
| Discussion |
| 09:00-10:15 | Session 2: The Challenges of Infection and Risk-Benefit in Xenotransplantation |
|---|---|
| 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 |
|
| Donor and Recipient Testing: Known Pathogens (Animal Breeding and Testing) Henk-Jan Shuurman SchuBiomed Consultancy BV, Utrecht, The Netherlands |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Discussion |
| 10:15-11:45 | Session 3: Regulatory Considerations in the Development of Xenotransplantation Products (Session Conducted by FDA) |
|---|---|
| Overview of FDA Guidance on the Development of Xeno Products Judith Arcidiacono FDA |
|
| FDA Expectations for Source Animal Herds and Characterization John Dennis and Evgenij Evdokimov FDA |
|
| Pre-Clinical Trials: Design Considerations Allen Wensky FDA |
|
| Clinical Trials: Design Considerations Bruce Schneider FDA |
|
| Joint IXA-FDA Panel-led Discussion |
