Unclogging the Pipeline of Innovation in Transplantation
As I look back over the previous 12 months, I am filled with both gratitude and pride in our leadership; how so many of our volunteers have stepped up and successfully navigated challenges and opportunities for the Society in 2012-2013. We all share the common goal of strengthening, preserving and advancing the field of organ transplantation – understanding that success and failure are never permanent and we must remain constantly vigilant and proactive to protect our field of medicine.
Although I am stepping down this week as President, I am not stepping away from the work of the Society. I am thankful to have the opportunity to continue the advancement of our field as the new Chair of the AST Public Policy Committee. As you know, much of this work involves the early identification and influencing of oversight policies flowing from Federal and State Capitols that have a direct impact on how we practice medicine and conduct research.
One initiative that I will continue to move forward is a specific dialogue with the U.S. Food and Drug Administration (FDA) as well as the transplant community at large (pharma, medical device, etc). 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 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.
A special thanks to the AST executive editorial team of Drs. Rita Alloway, Timothy Schroeder, and Flavio Vincenti for assisting in the development of the proposal. I cannot thank them enough for their efforts in bringing a variety of important ideas together.
As we move forward with this initiative, the Society will be calling upon many of you to assist us with this important Call to Action for the future of transplantation. This will require a concerted effort and commitment from our entire community.
To access and review the Call to Action paper and the Transplant Therapeutics Initiative (TTI), please click here.
Thank you all for your commitment, passion and efforts over the past year. It’s been an honor serving as your President!