Advancing Regulatory Sci. for Med. Countermeasure Devel. -

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As a result, the rule is often inconsistently applied to sponsors. Elizabeth Leffel, director of nonclinical sciences at PharmAthene, said that a strategic plan for utilizing the Animal Rule is needed, starting with finalizing the current draft guidance. Rose noted in his remarks that the Animal Rule is the primary obstacle to demonstrating substantial effectiveness of a product. He pointed out that many threat agents are not testable in clinical scenarios (one could not conduct a randomized trial of an Ebola treatment, for example), yet the Animal Rule has never been the basis for approval of a new chemical entity.

These new data enhance and align with existing knowledge of disease pathways and mechanisms from the literature. A typical systems biology approach is philosophically data driven 29 Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 30 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT Discovery Use understanding of disease mechanisms to identify and validate targets Toxicology Biomarkers Pharmacogenomics Understand Identify novel Elucidate biological mechanisms behind biomarkers by mechanisms of understanding role differential response drug action and to R(x) in disease pathways toxicity Patient Docetaxel Disease mechanisms Cellular mechanisms Molecular mechanisms Prostate cancer Apoptosis Angiogenesis Fas Vegf Cancer Experimental Data Computational Modeling Literature and Prior Knowledge FIGURE 3-1 In silico modeling of disease mechanisms for drug development.

One of the primary challenges is prioritization of studies as they relate to the MCM initiative. In closing, McCune said, CDER has a robust regulatory science program with significant expertise to support the research agenda of the MCM initiative, and CDER researchers and reviewers are eager to collaborate on efforts to advance the regulatory science needs of the initiative. Pre-IND • Identification of potential compounds • Animal toxicology studies IND • • • • Phase I studies Phase II studies Phase III studies Manufacturing NDA/BLA Postmarketing Review Surveillance • Adverse event reporting • Data mining FIGURE 2-1 FDA regulatory review cycle.

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