The AST has convened a new conference to address unmet needs in transplantation. This new initiative continues a long and successful collaboration among the various stakeholders involved in care and research surrounding solid organ transplantation. The partnership between caregivers, academic research, pharmaceutical/biotechnology companies, and regulatory authorities has advanced the science dramatically over the past several decades. We are now at the precipice of rapid transformation of these advances into clinical utilization. By bringing together thought leaders from multiple disciplines, we aim to discuss, explore, and advance our thinking around the future of transplantation.

The past decade has seen an explosion in the number of biomarkers approved for use in transplantation or in various stages of investigation. However, the majority of the studies used to support the use of a specific candidate biomarker are limited and serve primarily to validate the biomarker’s analytic accuracy or its ability to predict a surrogate endpoint. Randomized prospective studies designed to demonstrate improved outcomes are missing. This session aims to review the current biomarker landscape in renal transplantation, identify the most likely context of use for various candidate biomarkers, and identify a path forward for the intentional development of biomarkers.

Recent changes in delivery of healthcare and research have provided the opportunity to consider and implement changes in the design, conduct, and analysis of clinical research trials. Potential advances include flexible design, the use of surrogate endpoints and biomarkers, and new analytical approaches involving big data and novel datasets. These developments offer the promise of more relevant research outcomes and more timely information, with lower cost and higher relevancy, that will both support approval of new drugs and devices as well as provide meaningful clinical data for caregivers.

Cellular therapies have made become commonplace in disease settings such as cancer therapies but have been used more sparingly in the transplant setting. This session will introduce current and envisioned cell therapies as treatments in the setting of transplantation. We will cover gene modification approaches, cells that can be used to suppress anti-graft responses as well as for immunosuppression-related infectious complications.

Current approach to maintenance immunosuppression has been ‘one size fits all’ approach with greater than 80% of patients being maintained on tacrolimus and mycophenolate mofetil based immunosuppression. Approximately 40% of kidney allograft failure is attributable to immune mediated injury in the form of rejection or recurrent disease. Novel targeted therapeutics addressing co-stimulatory pathways, complement pathways, signal transduction and B-cell activation offers opportunities to personalize immunosuppression at the onset of immune mediated injury. Utilizing novel therapeutics informed by clinical phenotypes and biomarkers to manage immune mediated injury should improve long-term survival of allografts and minimize the adverse consequence of immunosuppression.

Delayed graft function, a clinical consequence of ischemic and non-ischemic injury sustained during the transplant process has always been an attractive target for intervention given its potential negative correlation with kidney transplant outcomes. Furthermore, it remains an attractive surrogate target for non-transplant ischemic injury, as it occurs at a known time and hence has been thought of as a target for testing of modifiers of the consequences of ischemia. This session will outline the current thinking on approaches to minimizing delayed graft function and place these in the larger context of the potential value of such approaches.

Scientific and technical breakthroughs present us with a unique opportunity in transplant research. While the use of xenotransplantation and artificial organs has been heavily researched over the past three decades, better understanding of xenobiology, along with advancements in artificial intelligence and genetics, may finally facilitate movement of these paradigm-changing efforts from the lab to the clinic. Though ethical and logistic considerations may require additional efforts, the current environment appears ripe for these novel interventions to move to the clinic within the next decade.