Reading Room Production — page 449

PROTECTING AGAINST WMD AND OTHER PUBLIC HEALTH THREATS The accelerated development of effective drugs, vaccines, and diagnostics is a national security imperative. Our approach to the development and procurement of these medical "countermeasures" against biological weapons and other WMD threats, as well as emerging infectious diseases and pandemics has not produced the results we demand. Our results reflect in part the state of the pharmaceutical industry as a whole. As a nation, we are spending more time and money in research and development of pharmaceuticals, but fewer licensed products are emerging from the pipeline. As the array of public health threats expands, we can and must do better. Recognizing this need, the Obama Administration is launching an initiative aimed at responding faster and more effectively to public health threats. Health and Human Services Secretary Kathleen Sebelius took an important first step on December 1, 2009 when she announced a review of medical countermeasure development efforts. Pursuant to this review, President Obama is calling to action key U.S. Government leaders to re-design our medical countermeasure enterprise to protect Americans and advance global health efforts. The goal is a national capability for the rapid, reliable, and affordable production of an array of medical countermeasures against public health threats. Prior government efforts have been mostly unable to counter market forces driving private industry toward more profitable products outside of key public health needs. Our new approach will turn this around. We will pursue a business model that leverages market forces and reduces risk to attract pharmaceutical and biotechnology industry collaboration with the U.S. Government. Four principles will guide this initiative: (1) a concerted, enterprise approach to medical countermeasure development that is goal-oriented and mission-driven; (2) a focus on multi-use products and flexible, platformbased capabilities; (3) an emphasis on innovation and disruptive technologies; and (4) the establishment of new and more effective public-private partnerships based on common interests to mitigate risks and reduce costs. The initiative will apply these guiding principles in four focus areas: Research and Discovery - Re-aligning programs to support systems-biology approaches, mission-driven research for multi-use products and platform-based solutions, translation of basic discovery into clinical application, and improved data sharing to enhance discovery. Regulatory Science and Innovation - Modernizing our regulatory process to create licensure pathways that are more predictable, transparent, and faster; in particular, advancing the emerging field of regulatory science to improve efficiency of product development and evaluation while enhancing confidence in safety and effectiveness. Industrial Process Improvement - Partnering with industry to improve development and manufacturing processes, share best practices, and identify solutions. Markets and Financing - Designing programs in which public and private financing collaborate to foster innovation and harness market forces to develop multi-use biodefense products with durable markets appealing to private investment. This initiative will include: (1) A concerted effort to advance regulatory science and practice by engaging our vast national scientific resources to evolve, evaluate, and validate new tools and approaches for biomedical product development; (2) government-facilitated collaborations to leverage opportunities for innovation in applied biotechnology, advanced development, and manufacturing; and (3) the provision of approaches to meet core services needs and lower barriers to entry, reduce opportunity costs, enhance innovation, and clarify regulatory requirements for safety and effectiveness. A successful model created for this purpose can be applied more broadly to the urgent need for novel medical countermeasures in global health, provide a pathway toward more affordable and effective pharmaceuticals here at home, and ensure that the United States remains at the forefront of the global biotechnology revolution. We must commit ourselves fully to this effort now - there is no higher priority than our public health and security.