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Building a National Framework for the Establishment of Regulatory Science for Drug Development Workshop Summary (2011) / Chapter Skim
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2 Defining Regulatory Science
Pages 5-12

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From page 5...
... modernize current regulatory pathways, and (3) develop new regulatory pathways where there are currently none." According to the report, this capacity is important because "decisions made in regulation development, pre-market approvals, legal actions and related public health emergencies must be based on understanding of contemporary and emerging science within the context of the risk analysis paradigm" (FDA Science Board, 2007, p.
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From page 6...
... similar regulatory agencies world-wide) comprising public protection oriented medical product regulations, policy and decisions using scien tific methods employing empirical and causal evidence utilized in the evaluation and approval of all the products that FDA regulates.
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From page 7...
... Jeffrey Drazen, Editor-in-Chief of the New England Journal of Medicine and Co-Chair of the Drug Forum, described regulatory science as "a science that has been evolving and is continuing to evolve, but it's not as hard a science as we would like." Thus, enhancement of the regulatory science discipline today represents a concerted attempt to systemize and standardize daily regulatory processes and bolster regulatory decisionmaking capabilities with a sound scientific base. The following chapter explores why such efforts are necessary.
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From page 8...
... When suc cessful, these collaborative efforts will help predict which discoveries will succeed or fail as actual products, thereby reducing product development costs and get ting better products to patients faster." She remarked that FDA should actively participate in research and development by partnering with academia, industry, and other government agencies. The following excerpts represent topical highlights from the Commissioner's presentation at the workshop: • Definition and Application of Regulatory Science "[Regulatory]
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From page 9...
... These biomarkers, originally detected in microarrays, have led to a noninvasive strategy for detecting kidney toxicity in animal models and are more sensitive and specific than the test traditionally used, and … allow us to make assessments early on to prevent the investments of time and money in what may prove to be scientific dead-ends." • Areas of Need for Enhancing Regulatory Science at FDA "Our regulatory scientists must be able to understand therapies that are being developed using the most recent scientific advances, they must have continued
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From page 10...
... a culture where multiple perspectives and opinions are sought and brought to bear on complex regulatory science problems. FDA must support and enhance its workforce, from clinical and scientific reviewers to lab and expert manufacturing, scientists, and inspectors, so that we can ably and effectively engage in the broader biomedical research and development enterprise, and so that we can effectively undertake our vital regulatory oversight and review work." • artnerships to Build and Sustain a Regulatory Science P Infrastructure "[On February 24, 2010,]
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From page 11...
... There are enormous opportunities to collaborate with scientific colleagues around the world on matters of mutual concern, but also to engage with sister regulatory agencies to address the sharing of important information and strategies and to harmonize standards and approaches." In looking forward, the Commissioner said, achieving an enhanced regulatory science at FDA and beyond will require not only a concrete, coordinated plan, but also resources. She reported that, for the first time in history, the President's fiscal year 2011 budget included a targeted initiative to advance regulatory science for public health.
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