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A legacy of our generation -- Ch. 1. We need to invest more in vaccines -- Ch. 2. Promoting private investment in vaccine development -- Ch. 3. A market not a prize -- Ch. 4. Design choices -- Ch. 5. $3 billion per disease -- Ch. 6. Meeting industry requirements -- Ch. 7. How sponsors can do it.
New medicines are usually financed by a mixture of public funding by governments, philanthropic giving, and investment by private firms. Private investment is especially important in paying for and managing the later stages of clinical trials, regulatory approval, and investment in manufacturing capacity. But for diseases that mainly affect people in developing countries, the prospective sales market is tinyâ€"and not sufficient to justify commercially the large scale investment that is needed to develop new products. An advance market commitment to accelerate the development of vaccines for diseases concentrated in developing countries, donors could make a binding commitment to pay for a desired vaccine if and when it is developed. This advance market commitment would mean firms could invest in finding a vaccine with the confidence that if they succeed there would be a market for the product.
Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The current political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding, and administering safe and effective vaccines for all people. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. The book makes recommendations about priority actions in the update to the National Vaccine Plan that are intended to achieve the objectives of disease prevention and enhancement of vaccine safety. It is centered on the plan's five goals in the areas of vaccine development, safety, communication, supply and use, and global health.
Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies Authors from different major pharmaceutical and biotechnology companies Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market
In the wake of September 11th and recent anthrax events, our nation's bioterrorism response capability has become an imminent priority for policymakers, researchers, public health officials, academia, and the private sector. In a three-day workshop, convened by the Institute of Medicine's Forum on Emerging Infections, experts from each of these communities came together to identify, clarify, and prioritize the next steps that need to be taken in order to prepare and strengthen bioterrorism response capabilities. From the discussions, it became clear that of utmost urgency is the need to cast the issue of a response in an appropriate framework in order to attract the attention of Congress and the public in order to garner sufficient and sustainable support for such initiatives. No matter how the issue is cast, numerous workshop participants agreed that there are many gaps in the public health infrastructure and countermeasure capabilities that must be prioritized and addressed in order to assure a rapid and effective response to another bioterrorist attack.
Examines the development and allocation of vaccines against emerging diseases from the viewpoint of technology and innovation policy.