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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.

08:00-09:00Session 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
09:00-10:15Session 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
10:15-11:45Session 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

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