Client needed to secure a Phase-3 API supplier supporting a Phase-3 clinical trial for a cardiovascular therapeutic.
The current supplier provided a $2 million dollar proposal for registration batch.
Cost was more than double the competitive bids.
Drug Discovery Alliances evaluated the clients needs and determined a CMC consultant was needed.
The Consultant evaluated a number of supplier’s capacity, regulatory history, and cost of manufacturing in order to find the best solution.
50% savings on initial Phase 3 batch
$10,000,0000 dollars of total savings for subsequent batches supporting commercial
$800,000,000 dollars realized by client when asset was licensed to Novartis