Co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS), the Transplant Therapeutics Consortium (TTC) is a collaboration between the transplant community, industry, and regulatory agencies, and is managed and supported by Critical Path Institute (C-Path). 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, or process improvements to address those areas, and 3) appropriate regulatory pathways to achieve endorsement for the proposed solutions. The consortium is first focusing on kidney transplant but may expand to other solid organ transplants in the future

Key regulatory science areas have been identified as critical to accomplish the mission of TTC and have resulted in the following workgroups:

• Workgroup I. Endpoints and Biomarkers
• Workgroup II. Drug Safety Profile Characterization and Labeling