Nonclinical Data Interconnectivity for Endpoint Predictivity (NICE)
Overall Goals of the project
Explore means by which nonclinical and clinical data can be interconnected in ways that facilitate their use for identifying hazards and risks of pharmaceuticals. Key parameters for inteconnecting clinical with nonclinical data include drug class, pharmacologic class, pharmacologic target and/or mechanism of action. An outcome of this project could be guidance for the US FDA and the pharmaceutical industry regarding design/analysis of SEND datasets to allow for nonclinical data to be associated with metadata that accurately describes the drug’s mechanism of action, target and/or pharmacologic class. In addition, strategies for interconnecting nonclinical with clinical data, based on pharmacologic class, could be developed.
Specific topics to consider include:
- What are accepted terminologies/nomenclatures for pharmacologic class and/or mechanism of action ? How are these developed ?
- What in silico tools/databases are available for interconnecting clinical adverse events/toxicities with nonclinical toxicity data using pharmacologic class ?
- Can guidance be developed regarding the use of in silico/computational tools for interconnecting pharmacologic class with clinical and nonclinical data ?
- What resources are available regarding this topic ?
Current Project Objectives and Timelines
- Identify 1-2 case examples of a pharmacologic class/target in which clinical and nonclinical safety data are likely available in the public domain (via various data bases , literature, sources; examples include: FDA SBA’s, DailyMed, Pharmapendium, drug labels, PubMed). Complete by 3Q 2014
- Document the process of data searching and analyses. What types of data are available and unavailable ? Can relationships be developed between clinical and nonclinical safety data ? What limitations exist regarding these analyses ? Complete by 4Q 2014
- Identify a process/strategy for analyzing data in the future, assuming there are no limitations. Can a search strategy be developed which is SEND-centric ? 1Q 2015
If interested, please consider joining our group. Individuals interested in bioinformatics, statistics, pharmacology, toxicology, drug safety and epidemiology should inquire with the Nonclinical Working Group of FDA PhUSE.
- Alan P. Brown (co-lead; Novartis)
- Paul Brown (co-lead; US FDA)
- Carol Rivera-Lopez (US FDA)
- Philip Judson (Lhasa Ltd.)
- Lee Geiger (GlaxoSmithKline)
- Mike Kelly (GlaxoSmithKline)
- Randall Smith (GlaxoSmithKline)
- The following article was recently published by members of the Nonclinical Working Group:
Kasturi J, Brown AP, Brown P, Madhavan S, Prabakar L, Wally JL. Interconnectivity of disparate nonclinical data silos for drug discovery and development. Therapeutic Innovation & Regulatory Science, OnlineFirst version 22 April 2014
Conference Calls and Minutes
17 September 2014 Meeting Minutes
29 July 2014 Meeting Minutes
9 July 2014 Meeting Minutes
16 June 2014 Meeting Minutes
29 April 2014 Meeting Minutes - 2nd TC
29 April 2014 Meeting Minutes
11 December 2013 Meeting Minutes
16 October 2013 Meeting Minutes
30 September 2013 Meeting Minutes
FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.
Last revision by APBrown,09/17/2014