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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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4 Barriers to Enhanced Regulatory Science
Pages 23-30

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From page 23...
... FINDINgS OF THE FDA SCIENCE BOARD Cassell summarized the findings of the FDA Science Board report regarding barriers to enhanced regulatory science at FDA. While noting the tremendous advances that FDA has made toward standardizing regulatory science prior to and since the publication of the report, Cassell provided the following overview to describe the need for continual sup port for the agency.
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From page 24...
... Since the FDA Science Board report was published, FDA has received limited increases in funding, yet its budget still pales in comparison with the funds allocated to similarly sized agencies. For example, FDA shared a similar budget and workforce as the Centers for Disease Control and Pre vention (CDC)
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From page 25...
... The FDA Science Board recommended that the agency establish a Chief Scientific Officer to establish strong scientific leadership, and the agency has implemented this recommendation. Given the scope and magnitude of the need for an adequate and robust science base at FDA, Cassell suggested, however, that the need must be addressed more systemically and comprehensively than is within the capacity of a single office.
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From page 26...
... Kim cited three distinct but interdependent components of IT that are necessary to support regulatory science, all of which suffer due to IT deficiencies: • T infrastructure -- Similar to other infrastructures, such as roads I and bridges, IT infrastructure comprises the basic physical and organizational elements needed for the operation of a system. Examples include data centers, networks, computer servers, stor age systems, and the organization of an operations panel.
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From page 27...
... Kim referred to an intramural collaboration concept introduced in the FDA Science Board Report, called the Incubator for Innovation and Regulatory Information Science (IIRIS) 3 model, which would function as a data sharing mechanism.
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From page 28...
... , and work closely with the Director of External Collaborations and Training to create strategic partnerships with academia, industry and governmental laboratories to deliver the competency necessary in science, technology, commerce and policy to support industry innova tion and the delivery of safe and efficacious products to the marketplace." SOURCE: FDA Science Board, 2007, p.
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From page 29...
... They include attrition of scientific talent due to a lack of financial incentives, driving (and restriction) of research based solely on funding sources and not on science, and reluctance to collaborate because of burdensome legal requirements.
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  • fda centers

  • regulatory work
  • six fda
  • robust science
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  • fda fellowship

  • enhancing regulatory
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  • compounding daily

  • miss opportunities
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