FDA Engages Collaborators to Address Nonclinical Data Challenges

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 assessment...

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Bibliographic Details
Published in:Therapeutic Innovation & Regulatory Science 2013-01, Vol.47 (1), p.41-45
Main Authors: Kropp, Timothy J., Rosario, Lilliam A., DeHaven, Susan, Houser, William, Kramer, Lou Ann, Nath, Shree, Smyrnios, Troy, Wally, Jeremy L.
Format: Article
Language:English
Subjects:
Data mining
Drug Safety and Pharmacovigilance
Innovations
Pharmaceutical industry
Pharmacotherapy
Pharmacy
Product development
Regulatory Science
Science
Standardization
Studies
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Summary: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.
ISSN:2168-4790
2168-4804
DOI:10.1177/0092861512466398