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 USA 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 existence and demise for lots of americans. The nutrients and Drug management (FDA) and the medical neighborhood at huge may gain advantage from more suitable medical instruments and analytic thoughts to adopt the complicated clinical evaluate and choice making had to make crucial scientific countermeasures on hand. on the request of FDA, the Institute of medication (IOM) held a workshop to envision the right way to enhance the improvement, evaluate, approval, and law of scientific countermeasures.
During public overall healthiness emergencies similar to influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and powerful vaccines, remedies, and different scientific countermeasures are necessary to maintaining 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 learn and improvement during this quarter. Convened on March 29-30, 2011, this workshop pointed out regulatory technology instruments and techniques which are on hand or less than improvement, in addition to significant gaps in at present to be had regulatory technology instruments.
Advancing Regulatory technology for scientific Countermeasure Development is a useful source for federal corporations together with the nutrition and Drug management (FDA), the dept of future health and Human prone (HHS), the dep. of protection (DoD), in addition to healthiness execs, and private and non-private well-being enterprises.
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Additional resources for Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary
Vikram Patel of the Office of Testing and Research at FDA’s CDER reminded participants the ultimate proof of efficacy of an MCM only comes when it is used in humans. In that regard, having a biomarker is very important to help assess whether the MCM, or which of several MCMs, is effective in an emergency situation. He expressed concern that very little attention is being paid to development of biomarkers. Animal Models of MCM Efficacy Throughout the workshop a number of participants discussed limitations of animal models.
Felciano noted that FDA has a Voluntary Exploratory Data Submission (VXDS) program in which industry submits candidate datasets that FDA can use to evaluate the regulatory applicability of these new approaches. Other challenges are that systems biology experiments are complex and interdisciplinary, requiring substantial time, interdisciplinary expertise, and resources for analysis. Thus far, there are few successful applications of in silico techniques to infectious disease. In addition, there are few good predictive models to bridge animal data to humans.
MCM development needs more clearly defined regulatory pathways. Priorities include: ■ Products approved under the Animal Rule, and ■ Diagnostics—prevalidated and pre-positioned in the field • The benefit-risk calculus may be different for MCMs to be used in low-probability/ high-consequence events than for traditional products. • Repurposing of previously licensed products needs to be studied in a systematic and comprehensive manner. Copyright © National Academy of Sciences. All rights reserved.
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