Advancing Regulatory Science for Medical Countermeasure Development Workshop Summary (2011) / Chapter Skim
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5 Crosscutting Themes and Future Directions
5 Crosscutting Themes and Future Directions
Pages 71-78
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, and the available alternative regulatory mechanisms to demonstrate efficacy. In this regard, there was much discussion of the Animal Rule, with a particular focus on the challenges of validation of animal models and establishing true correlates of efficacy.
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. Participants offered a variety of suggestions for metrics, from a goal of adding a defined number of new, approved MCMs to the SNS within a defined time period; to smaller, incremental steps such as developing an assay that solves a key problem, thereby reducing time and/or cost of development; to finalizing MCM-related FDA guidance documents; to approving a product under the Animal Rule.
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that would permit prediction of a reasonably likely favorable clinical benefit-risk ratio in humans. Many of the cuttingedge technologies and methodologies discussed throughout the work shop could be leveraged to help close these gaps so that MCMs could be successfully approved under the Animal Rule (Table 5-1)
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With regard to biomarkers, Richard Hatchett of BARDA noted that in oncology, the co-development of therapeutics and biomarkers is becoming the norm, particularly for trials of targeted therapeutics where the clinical trial population needs to be preselected based on the targeted pathway. 3See Guidance for Industry: Qualification Process for Drug Development Tools (Draft Guidance)
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One example that was cited by a number of workshop participants as successful is C-Path, which, explained Marietta Anthony of C-Path, advances the development of new testing methods or tools for medical product development through establishing precompeti tive collaborative consortia involving over 1,000 scientists from industry, academia, regulatory agencies, government (NIH and CDC) , as well as patient representatives.
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Gail Cassell of Harvard Medical School and the Infectious Disease Research Institute in Seattle recommended that FDA forge closer ties with NIAID-funded Regional Centers of Excellence in Emerging Infections and Biodefense for access to local expertise that might be brought to bear in a public health emergency. 4 See Guidance for Industry, Qualification Process for Drug Development Tools (Draft Guidance)
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SOURCE: Cassell presentation. FDA RESOURCES AND INFRASTRUCTURE ISSUES AFFECTING REGULATORY SCIENCE Cassell noted that many of the challenges for FDA regulatory science have roots in the agency's infrastructure issues.
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■ Operational Level -- Sharing the Data • Cooperation, collaboration, partnerships, and sharing of data among stakeholders. • Internal data sharing and collaboration across FDA centers.
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