Use of library resources to compile publicly available information from all available sources regarding the competitors of the drug, including all possible effects and covariates, into custom designed searchable databases
• A surprisingly vast knowledgebase exists on competitors for most TA’s
• Certainly the base for placebo is very large as it is independent of the actual treatment!
 

Incentives
• Functional efficacy/ safety / biomarker models can be developed for an NCE even before phase I is finished!
• Communication between modelers/consultants and all members of the development team starts earlier is more intensive
• Key questions can be identified faster by different team members
• Most of the competition is already using metadata to accelerate MBDD
• The FDA almost always uses metadata to compare application with competitors