FDA: Evidence-Based Treatment Decisions In Transplantation

Sep 27 8:00 AM - Sep 28, 6:00 PM 2018
Sep 27, 2018 8:00 AM - 6:00 PM

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.

To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to by September 14, 2018. Registrants will receive email confirmation when they have been accepted. Persons without access to the Internet can call 301-796-1300 to register. Onsite registration on the day of the meeting will start at 7:00 am and will be provided based on space availability.