Download Advancing Regulatory Science for Medical Countermeasure by Institute of Medicine, Board on Health Sciences Policy, PDF

By Institute of Medicine, Board on Health Sciences Policy, Forum on Medical and Public Health Preparedness for Catastrophic Events, Development, and Translation Forum on Drug Discovery, Anne B. Claiborne, Bruce M. Altevogt, Theresa Wizemann

Even if the us has secure and potent scientific countermeasures--such as vaccines, medications, and diagnostic tools--available to be used in the course of a catastrophe can suggest the variation among lifestyles and demise for plenty of american citizens. The nutrition and Drug management (FDA) and the medical group at huge may gain advantage from more desirable clinical instruments and analytic innovations to adopt the advanced medical review and determination making had to make crucial scientific countermeasures to be had. on the request of FDA, the Institute of drugs (IOM) held a workshop to check how to increase the improvement, evaluate, approval, and law of scientific countermeasures.

During public healthiness emergencies reminiscent of influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and powerful vaccines, remedies, and different scientific countermeasures are necessary to keeping nationwide safeguard and the health of the general public. Advancing Regulatory technological know-how for clinical Countermeasure Development examines present clinical countermeasures, and investigates the way forward for examine and improvement during this sector. Convened on March 29-30, 2011, this workshop pointed out regulatory technology instruments and techniques which are on hand or below improvement, in addition to significant gaps in presently to be had regulatory technological know-how instruments.

Advancing Regulatory technological know-how for clinical Countermeasure Development is a priceless source for federal companies together with the foodstuff and Drug management (FDA), the dep. of well-being and Human providers (HHS), the dept of safety (DoD), in addition to future health execs, and private and non-private wellbeing and fitness companies.

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NOTE: BLA, biologics license application; IND, investigational new drug application; NDA, new drug application. Figure 2-1 SOURCE: Susan McCune. 2011. Presentation at IOM workshop; Advancing Regulatory Science for Medical Countermeasure Development. Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary MCM ENTERPRISE AND STAKEHOLDER PERSPECTIVES 17 Center for Biologics Evaluation and Research (CBER) Products regulated by CBER include blood, blood components and derivatives, vaccines, allergenic products, cell and gene therapies, xenotransplantation products, human tissues, and various related devices, explained Carolyn Wilson, associate director for research at CBER.

Biomarkers, animal models, correlates of protection). The most significant challenge, Lyons said, is the extrapolation of animal immunological and pathophysiological data to the human setting. What makes a good animal model is highly dependent on the research question, he said. One must consider, for example, whether there is similar pathophysiology as the human disease or similar mediators of immune protection. For product development, are there well-defined generic animal models or platforms that could be used?

While the DoD program has a sound science and technology base, Parker noted that the department lacks the ability to rapidly develop discoveries and manufacture new candidates against unknown threats. The DoD MCM Initiative strategy consists of two major elements, each with multiple initiatives: (1) science and technology (novel platform/expression systems for MCMs, regulatory science technologies, manufacturing technologies for biologics that support good laboratory practices [GLP]/good manufacturing practices [GMP]) and (2) advanced development (further maturation of novel platform/expression systems and integration into a production process; innovative, flexible, and agile manufacturing capabilities).

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