Who we are:

The Transplant Therapeutics Consortium (TTC) was launched in April 2017 and co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). The TTC is a collaboration between the transplant community, including industry, academia, professional societies, and regulatory agencies, and is managed and supported by the Critical Path Institute (C-Path).

What we do:

• Convene stakeholders across the global field of transplantation to advance regulatory science needs in transplantation
• Provide a pre-competitive and neutral space to articulate and identify shared unmet needs of the transplant medical product development community
• Maintain established scientific relationships with the global regulatory authorities (i.e., FDA and EMA) to ensure solutions developed by the TTC align with regulatory agency priorities
• Hold regular meetings with an FDA CDER liaison, who plays an integral role in promoting good science through rigorous, detailed discourse with the consortium

Our mission:

The long-term goal of the TTC is to accelerate the medical product development process for transplantation, identifying 1) areas that have hindered product development, 2) potential biomarkers, endpoints, quantitative tools, or process improvements as solutions to address those areas, and 3) appropriate pathways to achieve regulatory endorsement for developed solutions. The consortium is first focusing on kidney transplant and long-term graft survival but may expand to other solid organ transplants in the future.

Long-term graft survival is an important area of unmet need for kidney transplantation recipients. Graft failure is associated with a significant negative impact, including a return to dialysis, increased mortality, and a need for retransplantation. Patients need new immunosuppressive therapies that improve long-term kidney transplant outcomes. Extending the longevity of transplant kidneys will increase the quality of life for transplant recipients, ensure fewer patients require multiple transplants, and increase the number of organs available to patients on the transplant waiting list. The TTC is committed to improving long-term graft survival in kidney transplantation through the regulatory endorsement of the iBox Scoring System (Composite Biomarker Panel) with FDA and EMA as well as developing novel methodologies focused on the practical application of this surrogate endpoint. These solutions have the potential to accelerate the pace of drug development in the field of kidney transplantation and help bring new therapies to patients faster.

The TTC is actively pursuing data to support these regulatory efforts. Data sets of interest include those with the following variables of interest. If your organization is interested in collaborating, please contact Nicole Spear at nspear@c-path.org.

Public health need(s) in transplantation

In the United States, there are currently 600,000 patients receiving dialysis every year, with more than 105,000 patients on the kidney transplant waiting list. In 2016, there were 19,000 kidney transplants in the US, and the failure rates for living donor kidney transplants at 1, 5, and 10 years were approximately 3%, 15%, and 40%, respectively. Deceased donor kidney transplant failure rates are even higher, with 8%, 27%, and 53% failing at 1, 5, and 10 years, respectively. Developing new immunosuppressive therapies that can reduce long-term kidney transplant failure will ensure that fewer patients receive multiple transplants, and that more patients on the waiting list can receive a kidney.

In order to address the unmet need of kidney transplant recipients, it is necessary for experts in the field, and other interested parties, to work collaboratively on prioritizing the needs and providing viable solutions to those needs. The TTC is bringing together key stakeholders in the transplant community with the primary goal of identifying these unmet needs and delivering novel drug development tools that may enable the development and approval of new therapies in transplantation.