FDA Engages Collaborators to Address Nonclinical Data Challenges

Therapeutic Innovation & Regulatory Science - Tập 47 - Trang 41-45 - 2013
Timothy J. Kropp1, Lilliam A. Rosario1, Susan DeHaven2, William Houser3, Lou Ann Kramer4, Shree Nath5, Troy Smyrnios6, Jeremy L. Wally7
1Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, USA
2Sanofi-Aventis, Bridgewater, USA
3Bristol-Myers Squibb, Evansville, USA
4Eli Lilly & Company, Indianapolis, USA
5PointCross Life Sciences Inc, Foster City, USA
6MPI Research, Mattawan, USA
7Center for Biologics Evaluation and Research, US Food & Drug Administration, Rockville, USA

Tóm tắt

FDA and PhUSE cohosted a Computational Science Symposium (CSS) in 2012 that brought stakeholders from the pharmaceutical industry and government to work collaboratively to solve common needs and challenges. A nonclinical informatics workgroup was formed, dedicated to improving nonclinical assessments and regulatory science by identifying, collecting, and prioritizing key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner. This paper discusses the process and outcomes of the nonclinical informatics workgroup during the CSS and describes an approach which crossed organizational barriers to optimize computational science for nonclinical assessment.

Tài liệu tham khảo

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Therapeutic Innovation & Regulatory Science

Tập 47

41-45

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