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 powerful clinical countermeasures--such as vaccines, medications, and diagnostic tools--available to be used in the course of a catastrophe can suggest the variation among existence and loss of life for plenty of american citizens. The meals and Drug management (FDA) and the clinical neighborhood at huge may benefit from enhanced clinical instruments and analytic recommendations to adopt the advanced clinical evaluate and determination making had to make crucial clinical countermeasures on hand. on the request of FDA, the Institute of medication (IOM) held a workshop to ascertain tips on how to enhance the improvement, overview, approval, and rules of clinical countermeasures.
During public healthiness emergencies resembling influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and potent vaccines, remedies, and different scientific countermeasures are necessary to preserving nationwide defense and the health of the general public. Advancing Regulatory technological know-how for scientific Countermeasure Development examines present scientific countermeasures, and investigates the way forward for study and improvement during this quarter. Convened on March 29-30, 2011, this workshop pointed out regulatory technological know-how instruments and techniques which are to be had or lower than improvement, in addition to significant gaps in at present on hand regulatory technological know-how instruments.
Advancing Regulatory technological know-how for scientific Countermeasure Development is a precious source for federal businesses together with the nutrients and Drug management (FDA), the dep. of wellbeing and fitness and Human companies (HHS), the dep. of protection (DoD), in addition to wellbeing and fitness pros, and private and non-private well-being agencies.
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Additional info for Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary
George Korch of HHS noted that a challenge is conducting a benefit-risk calculus that captures rare and yet highly consequential events. Hatchett added that it is very hard to define, in advance of a real event, criteria for a benefit-risk analysis that are able to take into account the operating environment that exists once the event has occurred. Cal- Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 28 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT culating the risk and benefit of an anthrax antitoxin today, for example, is very different from calculating the risk and benefit of the anthrax antitoxin once there has been a widespread anthrax release.
Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 18 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT TABLE 2-1 Examples of Potential Areas for Pillar 2 Research in CDER Phase of Development Potential CDER Research Areas Identification of Potential Molecules for Study Repurposing drugs Molecular modeling Screen approved drugs for other pathogens Effects of combinations of antimicrobials Animal Toxicology Studies and Animal Models for MCM Animal models: For pregnancy Modeling of disease states in general To study toxin effects on organ systems Qualified through the drug development tools qualification process For combination added benefit studies For placebo studies For postexposure prophylaxis To evaluate potential safety signals For studies of natural history and pathophysiology of disease Conversion of data from animal model studies to standard format Animal model database Human Safety Studies for MCMs or Clinical Safety and Efficacy Studies for Influenza Evaluation of the effects of genetic variations Studies of dosage forms for special populations Extrapolation models from animal to human, including dose scaling for special populations Pediatric safety studies, including ethical issues Understanding human disease through the world literature Development of clinical endpoints for seriously ill influenza patients Development of threat-based data standards Development of standardized case report forms for data collection Modeling drug interaction studies Modeling of PK/PD to labeled drugs for special populations Manufacturing and Product Quality Therapeutic protein PK/PD comparability studies Shelf-life extension studies Develop stable product formulations Rapid detection of problems with marketed products Copyright © National Academy of Sciences.
Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 24 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT • W hat criteria define an animal model correlate? • Can mechanistic efficacy substitute for disease efficacy? ) In discussion, Kurilla pointed out that much of what was discussed by the panels, and many of the major elements needed, are productindependent regulatory science and product-independent tools.