Focus on a good strategy for early drug product CMC development is critical for commercial success. A well-structured, forward-looking, and phase-appropriate CMC development strategy, including risk assessments and mitigation plans at various stages, is crucial for avoiding late-stage roadblocks, dead-ends, and rework. Good decisions in early CMC development can provide flexibility for the clinic, faster and lower cost development, and a more streamlined commercial manufacturing process that provides better results and lower unit conversion costs.  

Learning Objectives: 

• Formulation mindset for clinical flexibility and process scalability 
• Analytical approaches to reduce re-validation and workload 
• The importance of early-stage CMC risk assessment