MCM Data Issues as Tactical, Operational, and Strategic Concerns
Tactical Level—Getting 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
Operational Level—Sharing the Data
- Cooperation, collaboration, partnerships, and sharing of data among stakeholders.
- Internal data sharing and collaboration across FDA centers.
Strategic Level—Managing the Data
- Maintaining competencies as new areas of science unfold (e.g., systems biology, computational biology, biostatistics).
- Benefit-risk calculus, communicating risk data.