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Activity Number:
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223
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Type:
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Invited
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Date/Time:
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Tuesday, July 31, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310436 |
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Title:
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Preparing the Critical Path to Acceptance of Toxicogenomic Data in Drug Safety Evaluation
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Author(s):
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Alex Nie*+
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Companies:
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Johnson & Johnson PRD
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Address:
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1000 Rt. 202 S, Raritan, NJ, 08869,
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Keywords:
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Abstract:
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Toxicogenomics is the application of genomics and bioinformatics in drug safety evaluation. On the one hand, the industry wants to find out safety problems for their drug candidates early to avoid higher developmental cost in later stages. On the other hand, the regulators want to encourage the use of toxicogenomics to prevent unsafe drugs from coming into clinical trials. What has been done so far in achieving a mutual understanding between the industry and the regulators for the use of toxicogenomics in drug safety evaluation? The application and acceptance of toxicogenomics have benefited greatly from a number of non-profit collaborative research programs such as the ILSI/HESI, HL7/CDISC/I3C, and the Critical Path Institute. This presentation will explain how these collaborative efforts helped to pave the way for acceptance of toxicogenomics data, and it will also show some examples from Johnson & Johnson's participation.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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