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Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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3 Strengthening the Scientific Base of the Agency
Pages 19-25

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From page 19...
... While the majority of the report's recommendations focus on postmarket safety, panelists emphasized that there are opportunities to improve safety throughout the drug development pathway. Gaining a better understanding of the safety profile of a drug and being able to discriminate more precisely among drugs within the same class before clinical testing begins would strengthen the drug safety system before a drug ever reaches the market.
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From page 20...
... . Considering that funding for CDER totals approximately $500 million for fiscal year 2007 -- of which about $240 million is from user fees, $225 million is base appropriations, and $16 million is dedicated for orphan drug research grants -- less than a few million dollars remains to fund research (after infrastructure costs, salaries, document and adverse event processing costs, etc.
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From page 21...
... Without good biomarkers, even skilled data mining of medical records will not provide adequate answers. The C-Path Institute's Predictive Safety Consortium, a group of 16 pharmaceutical firms based in Phoenix, Arizona, that shares and cross-validates new safety assays, could serve as a model for what the IOM report recommended.
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From page 22...
... . Barbara Alving, Acting Director, National Center for Research Resources, NIH, described the Clinical and Translational Science Award program funded by NIH, and gave several examples of current collaborative safety research efforts (see Chapter 5)
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From page 23...
... • The scientific results from both animals and humans poorly informed the epidemiological studies in terms of both design and analysis.
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From page 24...
... Many of the symposium panelists expressed similar views on this issue. Gail Cassell, Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, encouraged the audience to consider additional ways of increasing the availability of and interest in epidemiology training programs, perhaps in 4Currently NIH has only one training grant for pharmacoepidemiology; this grant has slots for only two researchers per year.
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From page 25...
... Finally, Dr. Tilson emphasized that before embarking on these programs, it will be important first to understand what competencies the scientists being trained need to have and then develop the appropriate training accordingly.
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Key Terms

  • drug development
  • drug discovery
  • adverse events
  • safety research
  • clinical trials

  • critical path
  • epidemiological studies
  • path initiative
  • improve drug
  • postmarket safety

  • development pathway
  • translational science
  • limited ability
  • molecules directed
  • communicated effectively

  • drug action
  • views drug
  • drug target
  • proposed drug
  • drug advertisements

  • molecular drug
  • selective drug
  • orphan drug
  • supporting drug
  • drug research

  • epidemiological drug
  • current drug
  • selected drug
  • improved drug
  • drug evaluation


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