Session: Challenges Facing CMC Organizations in the Changing Business and Regulatory Environment

In recent years, the Pharmaceutical industry has been facing significant challenges due to patent expirations for blockbuster drugs, rising R&D costs, increased regulatory expectations and fewer new product approvals. These pressures have resulted in major changes to the development strategies of CMC organizations across the industry. New strategies call for enhanced scientific understanding (QbD) to drive development efficiency and globalization of R&D to manage costs. This session will invite speakers from industry to discuss these challenges and various approaches to address them.