FDA Engages Collaborators to Address Nonclinical Data Challenges

Area of Science:

• Computational science
• Regulatory science
• Nonclinical informatics

Background:

• Stakeholders from the pharmaceutical industry and government convened at the 2012 FDA and PhUSE Computational Science Symposium (CSS).
• The symposium aimed to foster collaboration for addressing common needs and challenges in computational science.
• A dedicated nonclinical informatics workgroup was established to improve nonclinical assessments.

Purpose of the Study:

• To discuss the process and outcomes of the nonclinical informatics workgroup during the CSS.
• To describe an innovative framework for addressing key needs and challenges in nonclinical informatics.
• To optimize computational science for nonclinical assessment by crossing organizational barriers.

Main Methods:

• Formation of a nonclinical informatics workgroup.
• Identification, collection, and prioritization of key needs and challenges in nonclinical informatics.
• Development of a collaborative framework to address identified issues.

Main Results:

• Successful collaboration between pharmaceutical industry and government stakeholders.
• Establishment of a prioritized list of needs and challenges in nonclinical informatics.
• An innovative framework was created to guide collaborative efforts.

Conclusions:

• The nonclinical informatics workgroup effectively addressed challenges through collaboration.
• The developed framework offers an approach to optimize computational science for nonclinical assessment.
• Crossing organizational barriers is crucial for advancing regulatory science through computational methods.