Problem

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.

Solution

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.

Outcome

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

Deborah Minor