Scientific Publications by FDA Staff

Ther Innov Regul Sci 2013 Jan;47(1):41-5

FDA Engages Collaborators to Address Nonclinical Data Challenges

Kropp TJ, Rosario LA, DeHaven S, Houser W, Kramer LA, Nath S, Smyrnios T, Wally JL

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.