| Day 1 | |||
| 8:30 a.m. | Opening Remarks | ||
| [Harold Vanderpool, SACX Chair] | |||
| 8:35 a.m. | Conflict of Interest Statement | ||
| [Mary Groesch, SACX Executive Director] | |||
| Introduction to Cross-species Transmission of Infectious Agents | |||
| 8:40 a.m. | Biological Aspects of Zoonotic Transmission 0 | ||
| [Jon Allan, SACX] | |||
| 9:00 a.m. | Global Experience with Cross-species Infections: Lessons for Xenotransplantation | ||
| [Brian Mahy, CDC] | |||
| 9:30 a.m. | Discussion | ||
| Infectious Agent Transmission in the Allotransplantation Setting | |||
| 10:00 a.m. | Infectious Disease Issues in Allotransplantation | ||
| [Marian Michaels, SACX] | |||
| 10:30 a.m. | Break | ||
| 10:45 a.m. | Discussion | ||
| Porcine Infectious Agents: Implications for Xenotransplantation | |||
| 11:15 a.m. | Porcine Endogenous Retrovirus (PERV): Background and Recent Advances | ||
| [Clive Patience, Immerge BioTherapeutics] | |||
| 11:45 a.m. | Q & A (clarification) | ||
| 11:50 a.m. | In Vivo Studies of PERV Transmission/infectivity and Recent Advances That May Have Implications for Reducing this Risk | ||
| [David Onions, Q-One Biotech] | |||
| 12:10 p.m. | Q & A (clarification) | ||
| 12:15 p.m. | Retrospective Studies in Patients to Detect PERV Transmission and Pathogenicity | ||
| [Dan Salomon, SACX] | |||
| 12:30 p.m. | Q & A (clarification) | ||
| 12:35 p.m. | Lunch | ||
| 1:45 p.m. | Porcine Infectious Agents Other than PERV | ||
| [Barbara Potts, Genentech] | |||
| 2:10 p.m. | Discussion | ||
| 2:50 p.m. | Public Comment | ||
| Minimizing the Risk of Transmission of Infectious Agents at the Level of the Source Animal | |||
| 3:05 p.m. | FDA Requirements and Recommendations for Xenotransplantation Animal Sources and Products | ||
| [Eda Bloom, FDA] | |||
| 3:25 p.m. | Q & A (clarification) | ||
| 3:40 p.m. | Current Approaches in Animal Husbandry for Minimizing the Risk of Transmission of Infectious Agents | ||
| [Michael Swindle, SACX] | |||
| 3:55 p.m. | Q & A (clarification) | ||
| 4:00 p.m. | Break | ||
| 4:15 p.m. | General Features of and Considerations in Screening Programs | ||
| [Anthony Lubiniecki, SACX] | |||
| 4:35 p.m. | Discussion | ||
| 5:10 p.m. | Public Comment | ||
| 5:25 p.m. | Adjourn for the Day | ||
| Day 2 | |||
| Minimizing the Risk of Transmission of Infectious Agents at the Recipient/contact Level: Clinical Monitoring for Known and Unknown Agents | |||
| 8:00 a.m. | FDA Requirements and Recommendations for Monitoring Xenotransplantation Recipients and Close Contacts | ||
| [Lou Marzella, FDA] | |||
| 8:20 a.m. | Considerations in Designing and Implementing Monitoring Programs | ||
| [Louisa Chapman, CDC] | |||
| 8:40 a.m. | Discussion | ||
| 9:15 a.m. | Committee Discussion: Infectious Disease Risks in Xenotransplantation—Ethical, Social, Legal Considerations | ||
| [Moderator: Harold Vanderpool, SACX Chair] | |||
| 10:15 a.m. | Public Comment | ||
| 10:35 a.m. | Setting the Stage for Future SACX Deliberations | ||
| [Federal Representatives] | |||
| 10:55 a.m. | Closing Remarks | ||
| [SACX Chair] | |||
| 11:00 a.m. | Meeting Adjourns | ||