IXA-FDA Discussions<\/h2>\n

We would like to share with you the key points of a discussion that took place between your IXA council and two FDA representatives in Boston during the 2016 American Transplant Congress.<\/p>\n

As you all know, xenotransplantation research has made significant progress during the last couple of years in a variety of preclinical models. Consequently, we believe that one or more xeno-based treatment methods may soon make their way to the clinic. The IXA council therefore opened a dialogue with the FDA, offering to make them aware of your scientific progress, and to seek their advice regarding regulatory issues that may arise in the US, and in other jurisdictions, as xenotransplantation moves towards clinical trials.<\/p>\n

This was only an information-sharing meeting. Specifically, the FDA representatives warned us in advance that they would be unable to officially consider any changes to current policy, or commit to specific plans with respect to reconsidering official guidance regarding regulation of xenotransplantation. Members of the IXA council explained the bases for our enthusiasm about the near-term future of xenotransplantation. We then brought up 3 specific concerns regarding existing FDA guidance on xenotransplantation. These issues were: 1) the risk that PERV will emerge as a human pathogen appears to be low, and deserves to be recalibrated in light of improving prospects for therapeutic efficacy of one or more xeno-based treatments; 2) the requirement to assure 50 years of secure archiving of donor and recipient materials represents a formidable and arguably extraordinary burden for a clinical trial sponsor; and 3) some ambiguity exists regarding how genetically engineered source pigs would be classified with respect to the regulatory approvals path.<\/p>\n

FDA shares IXA\u2019s core goal: to facilitate the transition of xenotransplantation to the clinic, as safely as possible, as soon as preclinical evidence supports doing so. The FDA representatives gave their personal, individual opinions about the significant progress toward preclinical benchmarks, and we discussed the current regulatory recommendations. Unofficially, the FDA representatives were interested in exploring further discussions between the xenotransplantation community and the FDA. Specifically, the FDA representatives recommended that IXA provide a summary of the current \u2018state of the art\u2019 in those candidate xeno applications which appear closest to clinical application. That information will be reviewed within the FDA as the basis for making a decision regarding further official discussions with IXA and other interested parties, and regarding a possible recommendation to FDA and HHS leadership regarding revisiting xenotransplantation regulatory guidance. IXA was asked to be prepared to participate in a series of mutual information-sharing workshops with FDA subject matter experts for the purpose of better understanding each other\u2019s viewpoints. IXA Council intends to send pertinent documents soon to the FDA.<\/p>\n

Overall it was a very useful meeting. FDA leadership is now engaged, and aware that xenotransplantation research appears to be progressing rapidly towards clinical trials. Our meeting paved the way for further discussions and workshops. Importantly, we expect that future official interactions with FDA will include public consultative sessions open to all xenotransplantation researchers, potential sponsors, and other interested parties, in accordance with US regulatory policies and procedures.<\/p>\n

On behalf of the IXA council we thank you all for your excellent work that triggered this discussion with the FDA.<\/p>\n<\/div>\n