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The current drug development paradigm
Proof of mechanism
Proof of concept
Early
Late
Safety, tolerability, on target
and off target effects
Predictive
biomarkers
explored
Predictive biomarkers confirmed
Preliminary antitumor
activity
Antitumor
activity seen
using
surrogate
endpoints
Proof of concept using a validated
clinical endpoint
Evidence of target
engagement in valid
pharmacodynamic
biomarkers
ORR
TTP
PFS
OS