The interagency strategic plan for research and development of blood products and related technologies for trauma care and emergency preparedness 2015-2020

Abstract

Intensive blood use is expected to occur at levels, which will overwhelm blood supplies as they exist with current capabilities and technologies, both in civilian mass casualty events and military battlefield trauma. New technologies are needed for trauma care, and specifically to provide safer, more effective, and more logistically supportable blood products to treat patients with, or at risk of developing, acquired bleeding disorders resulting from trauma, acute radiation exposure, or other causes. Three of the primary agencies with major research and development programs related to blood products, the Biomedical Advanced Research and Development Authority (BARDA), the Department of Defense (DoD), and the National Heart, Lung, and Blood Institute are uniquely positioned to partner in addressing these issues, which have significant implications for each respective agency, as well as for the US population. Providing leadership, coordination, and oversight for the Food and Drug Administration’s national and global health security, counterterrorism, and emerging threats portfolios, the US Food and Drug Administration Office of Counterterrorism and Emerging Threats serves in a critical advisory and facilitative role regarding development and availability of blood products. This plan is informed by the 2012 PHEMCE Strategy (US Department of Health and Human Services, 2012), the 2007 “Shaping the Future of Research” Strategic Plan for the National Heart, Lung, and Blood Institute, the 2011 BARDA Strategic Plan, the DoD Combat Casualty Care Research Program: Policy Review, the 2015 DoD Hemorrhage and Resuscitation Research and Development Strategic Plan, and more than 30 participants from other agencies who participated in planning.