Analytical Framework for Examining the Value of Antibacterial Products. 4.2.2 Pre-Clinical, Clinical Phase, and BLA Submission Costs


We estimated per-phase costs for vaccine development using out-of-pocket pre-clinical and clinical period costs per investigational biopharmaceutical compound from DiMasi & Grabowski (2006).  These estimates were given in 2005 dollars; therefore, we inflated them using a consumer price index for medical care from BLS.  This resulted in cost totals of $73.9 million, $39.8 million, $46.5 million, and $118.6 million for the pre-clinical phase, Phase 1 trials, Phase 2 trials, and Phase 3 trials, respectively.

The reported new drug application fee for those drug or biologic product applications requiring clinical data is $1,958,800 for fiscal year 2013.  Thus, we use this figure as the BLA submission cost in the model as we did for antibacterial drug products.

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