Cost

This session will focus on improvements that reduce the cost and effort required to develop and manufacture biopharmaceuticals, thereby helping to increase availability of investigational medicines and the financial viability of and access to important therapies throughout the world. Potential efforts in bioprocess, analytical, formulation and delivery (as well as bringing various technical disciplines together in new ways) that create efficiencies, reduce development costs and/or allow more products to be developed without traditional resource expansion would be highly relevant for this session. Additional topics of interest include: technologies and approaches aimed at reducing FTE requirements for process and product development; reducing cost to clinic; streamlining the overall effort required for CMC development; improving product manufacturing costs (e.g., commercial costs of goods for drug substance, drug product, device); reducing enterprise manufacturing costs, including capital/facility costs, infrastructure, staffing requirements to support clinical and commercial supply; flexible manufacturing and single-use; strategies and opportunities in strategic outsourcing.