The public health emergency medical countermeasures enterprise innovative strategies to enhance products from discovery through approval : workshop summary (National Academies Press, 2010)
Includes bibliographical references
Background. The public health perspective on medical countermeasure development, acquisition, and use -- The FDA perspective on the countermeasures enterprise: moving forward -- Government procurement of science -- Partners in a single mission, diverse concerns and challenges. The growing threat of bioweapons -- Gaps and barriers to international collaboration -- Issues for federal agencies engaged in countermeasures development -- Challenges facing the innovative biopharmaceutical industry -- Research infrastructure and resources -- Liability -- End users: challenges for public health and providers -- Examples of successful countermeasures development and deployment. Features of successful government countermeasures efforts -- countermeasures development in industry -- Partnerships and alternative business models. Venture philanthropy and orphan product development models -- Pharmaceutical shared-risk approaches -- Planning for failure -- Open innovation business strategies -- Public-private partnerships -- Independent third-party facilitation of collaboration -- Strategic investor model -- Engaging industry. Incentives: Push vs. Pull -- Incentives not needed?: making a strong business case -- New paradigms, strategies, a nd tactics for enhancing the countermeasures development enterprise. Outsourcing program management -- Government as a strategic partner --Platform technologies -- Revised PHEMCE implementation plan -- Existing regulatory tools and approaches that can be applied to advance countermeasures development. Opportunities for accelerating approval of medical countermeasures: evolving the regulatory framework -- The way forward: themes from the workshop
"During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE--a partnership among federal, state, and local governments; industry; and academia) is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health."