BOX 5-2
MCM Data Issues as Tactical, Operational, and Strategic Concerns

Tactical LevelGetting the Data

  • Developing animal models for specific applications.
  • Defining appropriate models or methods to collect data (including for at-risk populations such as children, pregnant women, and others for whom absorption, distribution, metabolism, or excretion may be altered):
    • platform approaches,
    • qualification of tools (e.g., biomarkers), and
    • diagnostics.

Operational LevelSharing the Data

  • Cooperation, collaboration, partnerships, and sharing of data among stakeholders.
  • Internal data sharing and collaboration across FDA centers.

Strategic LevelManaging the Data

  • Maintaining competencies as new areas of science unfold (e.g., systems biology, computational biology, biostatistics).
  • Benefit-risk calculus, communicating risk data.

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