Integrated CMC-Based Pharmaceutical Development - Accelerating The Molecule To FIH And Beyond

Date: Tuesday, November 18th, 2025
Time: 11am ET | 4pm GMT | 8am PT

CMC activities should be initiated by defining the right strategy at the beginning of development.

A thorough assessment of drug substance volumes, quality attributes, and the impact on toxicology and drug product, needs to be done early on. Similarly, the design of pre-formulation studies, analytical methods, dosage form selection, and development for toxicology and FIH studies should be considered in parallel with drug substance development. IND/IMPD filing can be achieved faster if all the CMC functions understand the phase-appropriate quality and regulatory guidelines.

Join us In this webinar, attendees will learn about:

• The importance of a rational, well-coordinated approach and a robust CMC strategy for achieving a timely start
• Incorporating phase-specific formulation and process design adjustments to mitigate risk at each stage
• How to leverage data of DCS, biopharmaceutical and DS properties to derisk and strategise FIH
• Evaluating the scalability of manufacturing processes and the potential regulatory impact of any changes in further clinical phases
• Tightening performance standards and minimizing variability in the final formulation in Phase III based on confidence achieved during earlier phases.