Clinical Development
Operations

Need
• Major pharmaceutical company developing biopharmaceutical with over $1 billion market potential in need of viable manufacturing process
• Strategy required to secure competitive market position as second generation compounds advance through development.

Approach
• Evaluated all manufacturing options for producing product to commercial scale
Identified two potential suppliers and negotiated contracts with each to evaluate feasibility of large-scale production
• Analyzed landscape of companies developing second generation products and negotiated in-licensing agreement to access new compounds

Benefits
• Viable process secured for product production
• Strategy implemented for ensuring long-term competitive position for company
• Product development plan forged fully aligned with company’s technical and business objectives