A Call to Action: Reviving the Pipeline of Innovation in Transplantation

As I look back over the previous 12 months, I am filled with both gratitude and pride at how so many of our volunteer leaders have stepped up and successfully navigated a variety of challenges and opportunities for the Society in 2012-2013. Among our ranks, we all share the common goal of strengthening, preserving and advancing the field of solid organ transplantation. That said, success and failure are never permanent...and it is required of us to constantly remain vigilant and proactive as the guardians of 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 soon be in a position to continue to advance 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 of my current Presidential initiatives that I will continue to advance moving 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). As you know, 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 "cutting edge" if pharmaceutical and device development strategies are not encouraged. Upon identifying this challenge, the AST has been meeting with officials within the FDA Office of Medical Policy, Division of Transplantation and the Center for Drug Evaluation and Research. These efforts have included officially presenting to an FDA panel to identify and discuss some of the unmet needs in our field. We have expressed to FDA officials that we believe this is a make or break time for transplantation and that we would like 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 recently drafted a paper, "A Call to Action, Reviving the Pipeline of Therapeutic Agent and Device Innovation in Transplantation". The paper 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. The effort will require a concerted effort and commitment from the entire community.

I look forward to seeing everyone at ATC in Seattle!!

Sincerely,

Roslyn B. Mannon
President