About FDA

Description: Support bioinformatics modernization plan including computational modeling, bioinformatics infrastructure development, participation in budgeting planning, etc. This effort will help to address the findings from the 2007 FDA Science Board Report where it stated that the FDA cannot fulfill its mission because its IT infrastructure is inadequate and it lacks the information science capability and infrastructure to fulfill its regulatory mandate and to regulate products based on new science. This is an agency-wide effort from all the Centers at the FDA.

Definition: Developing a modern bioinformatics infrastructure for efficient electronic regulatory processes and incorporating new technologies, scientific methodologies, and global business activities is a major FDA initiative anticipated to span the next decade. NCTR will be a significant contributor to this plan.

Public Health Outcome: The Bioinformatics Modernization Plan seeks to create new, efficient mathematical and computational techniques for analyzing massive amounts of increasingly complex data. The plan addresses current needs and anticipates future regulatory science needs. Earlier detection of adverse events due to drugs and tailoring medicine to individuals are examples.

Accomplishment: For the Bioinformatics Modernization Plan, NCTR bioinformatics staff actively participated in design of an FDA informatics governance structure that complies with statutes, providing guidance for the CPIC processes including Select (i.e., prioritization and funding), Control (i.e., review) and Evaluate (i.e., lessons learned). The NCTR Information Technology Investment Review Board was realigned with the Agency governance structure and has been functioning accordingly for the past year in evaluating and monitoring the NCTR IT investment portfolio. NCTR bioinformatics staff notably contributed to strategic planning for scientific computing infrastructure and operations, including high performance computing and scientific enclave collaborative environments. NCTR collaborated with other Centers to develop data structures, computational methods and applications appropriate for the regulatory science desktop in analyzing animal data, pharmacogenomics, and pharmacogenetics data; the adequacy of the Janus data schema to handle these data types was assessed.