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Table 3 Costs for full development used for modelling (numbers in millions of USD)

From: A novel valuation model for medical intervention development based on progressive dynamic changes that integrates Health Technology Assessment outcomes with early-stage innovation and indication-specific clinical success rates

 DiMasi OOP-CE (high)Sertkaya CP-CE (low)DiMasi OOP-Bio (high)Sertkaya CP-Bio (low)
a. Abbreviated cost estimate
Registration1.31.31.31.3
Phase III255.425255.425
Phase II58.6758.67
Phase I25.3225.32
Preclinical110715910
Discovery11961196
Total cost569.648.3618.651.3
b. FEC cost estimate
Manufacturing costs400400400400
Facility costs6565350350
Launch/post-market R&D350350350350
Registration1.31.31.31.3
Add. HTA CTs510.850510.850
Phase III255.425255.425
Phase II58.6758.67
Phase I25.3225.32
Preclinical110715910
Discovery11961196
Total1895.4913.32229.41201.3
  1. a. Low cost estimates corresponding to values obtained from 3 independent sources in which costs end at the registration phase for both chemical entity and biologic-based medical interventions
  2. b. High cost estimates corresponding to values obtained from 3 independent sources in which costs end at the registration phase for both chemical entity and biologic-based medical interventions