Table 1.

Drivers and enablers of adaptive licensing (adaptive pathways)

Drivers
Patient expectations: demand for timely access and emphasis on unmet medical need
Emerging science: fragmentation of treatment populations and early disease interception
Healthcare systems under pressure: rise of payer influence
Pharma/investors under pressure: sustainability of drug development
Enablers
Improved understanding of disease processes, better knowledge management
Innovative clinical trial designs
Rapid learning systems in the healthcare environment
Bringing patients to the table: understanding acceptable uncertainty
From prediction to monitoring
Targeted prescribing