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

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

ISBN-10: 0309214904

ISBN-13: 9780309214902

Even if the us has secure and potent clinical countermeasures--such as vaccines, medications, and diagnostic tools--available to be used in the course of a catastrophe can suggest the adaptation among existence and demise for plenty of americans. The nutrition and Drug management (FDA) and the medical group at huge may gain advantage from greater clinical instruments and analytic ideas to adopt the complicated clinical assessment and determination making had to make crucial scientific countermeasures on hand. on the request of FDA, the Institute of medication (IOM) held a workshop to envision how you can enhance the advance, review, approval, and law of scientific countermeasures.

During public future health emergencies reminiscent of influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and powerful vaccines, remedies, and different clinical countermeasures are necessary to preserving nationwide safety and the health of the general public. Advancing Regulatory technology for scientific Countermeasure Development examines present scientific countermeasures, and investigates the way forward for learn and improvement during this region. Convened on March 29-30, 2011, this workshop pointed out regulatory technological know-how instruments and strategies which are to be had or less than improvement, in addition to significant gaps in at the moment to be had regulatory technology instruments.

Advancing Regulatory technological know-how for clinical Countermeasure Development is a necessary source for federal firms together with the nutrition and Drug management (FDA), the dept of well-being and Human companies (HHS), the dep. of protection (DoD), in addition to well-being pros, and private and non-private wellbeing and fitness businesses.

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One example of current CBER research on animal model biomarkers involves luciferase-expressing Bacillus anthracis, which allows for more precise staging of the bacterial infection in mice, and improved design for studies of such things as postexposure prophylaxis and combination therapies. This approach is generalizable, Wilson said, and could be applied to other pathogens and to the development of improved animal models. Other examples of ongoing CBER research mentioned by Wilson include using phage display libraries to evaluate the human immune response, developing faster methods to generate reference reagents for influenza vaccines, and improving detection of adventitious infectious agents in complex samples.

There are 109 proteins for which tests have been approved or cleared by FDA, and 96 additional proteins that can be tested for using laboratorydeveloped tests (that have not been reviewed by FDA). 5 new protein biomarkers per year over the last 15 years. This rate, he said, is insufficient to meet broad clinical needs, without even considering MCM development. Part of this dearth of new biomarkers is caused by the lack of a real pipeline for systematic discovery, development, and marketing of biomarkers.

Copyright © National Academy of Sciences. All rights reserved. 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.

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Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 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

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