Evidence-Based Treatment Decisions In Transplantation: The Right Dose & Regimen for the Right Patient/Individualized Treatment
September 27 – 28, 2018
Summary:
The Food and Drug Administration is announcing the following public workshop titled “Evidence-Based Treatment Decisions In Transplantation: The Right Dose & Regimen for the Right Patient/Individualized Treatment. This public workshop is planned and presented in collaboration with the Transplant Therapeutics Consortium (TTC), a public-private partnership between the FDA, transplantation societies and members of the pharmaceutical and biotechnology industries, founded by the American Society of Transplantation (AST), the American Society of Transplant Surgeons (ASTS), and Critical Path Institute (C-Path) in March 2017. The workshop is intended to discuss potential candidate biomarkers to determine organ transplant patients’ immunologic risk for organ rejection or tolerance. The meeting will include discussion of the biomarker qualification process and how it could be used to develop biomarkers for use in clinical trials in transplantation, to develop new drugs to address unmet needs, and in clinical practice to guide patient treatment selection. Patient speakers will provide perspective on challenges of living with a transplant, managing immunosuppression and perspectives on tolerability, adherence and risk that may inform PRO and patient focused drug development.
Presentations and discussions will cover identifying potential candidate biomarkers that could:
- be considered for the biomarker qualification process
- be used in identifying patients at high immunologic risk or low immunologic risk
- be used in clinical trials to develop drugs to address unmet individual needs in transplantation
- be used to make appropriate immunosuppressive regimen treatment decisions
In addition, patient speakers will provide perspectives on
- challenges of living with a transplant,
- managing immunosuppression, and
- tolerability, adherence and risk of therapy
The goal of these presentations is to inform PRO and patient focused drug development.
This workshop will be held at the FDA White Oak Campus, Silver Spring, MD. Registration for this workshop is free, but all attendees must register.
