A Call to Action
Tuesday, May 21, 2013
The field of organ transplantation is currently experiencing a severe decline in therapeutic and device innovation. Although previous investments in transplant research have saved and improved countless lives, the medical science behind the gift-of-life has entered a period where it may lose its edge if pharmaceutical and device development strategies are not encouraged.
AST has been meeting with officials within the U.S. Food and Drug Administration (FDA) Office of Medical Policy, Division of Transplantation and the Center for Drug Evaluation and Research to identify and discuss some of the unmet needs in our field. We have shared our belief that this is a make-or-break opportunity for transplantation and expressed our desire to enter into a partnership with the agency to establish a “Transplant Therapeutics Initiative (TTI).” In addition to meetings and conference calls with FDA, we also recently drafted a paper, “A Call to Action, Reviving the Pipeline of Therapeutic Agent and Device Innovation in Transplantation,” which includes AST's specific recommendations for the establishment of a Memo of Understanding (MOU) with FDA to improve transplant therapies. The paper addresses:
• Historic background and current status of solid organ transplantation and the unmet needs of the field;
• Blueprint for action;
• Harnessing health information through technology; and
• New approaches to therapeutic drug and device development.
The AST executive editorial team were Drs. Rita Alloway, Timothy Schroeder, Flavio Vincenti, and Roslyn Mannon who assisted in the development of the proposal. As the initiative is moved forward, AST will be calling upon many members to help assist with this important Call to Action for the future of transplantation. It will require a concerted effort and commitment from the entire community.
Please access and review the Call to Action paper and the Transplant Therapeutics Initiative (TTI) here.