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Nonclinical Data Interconnectivity for Endpoint Predictivity (NICE)

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. A topic for exploration and discussion for 2014 involves the use of pharmacologic class for interconnecting nonclinical and clinical toxicities.

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 ?

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.

Note: this project is derived from the combination of 2 former projects in the Nonclinical WG: Endpoint Predictivity and Data Interconnectivity

NICE Members

  • Alan P. Brown (co-lead; Novartis)
  • Paul Brown (co-lead; US FDA)
  • Jyotsna Kasturi (Janssen R & D, Johnson & Johnson)
  • 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

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,06/23/2014