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Session 6 Track 3: Navigating Change: Unlocking Opportunities and Overcoming Challenges in Recent US CMC Policy Developments
Session Chair(s)
Rumi Raquel Young, MS
Director, Regulatory Policy, Novo Nordisk A/S, United States
This session will provide an in-depth overview of the latest US FDA programs and policies including Pre-check, Platform designation, and CMC Development and Readiness Pilot Program (CDRP) which were designed to accelerate drug product manufacturing and may support emerging frameworks such as the Plausible Mechanism Pathway . Leading industry and FDA experts will also explore practical strategies for leveraging these regulatory flexibilities, address common hurdles, and clarify outstanding questions faced by oligonucleotide manufacturers. Real-world examples and actionable insights will equip participants to implement best practices in navigating this evolving regulatory landscape.
Learning Objective : At the conclusion of this session, participants should be able to: - Describe the latest US FDA programs – Pre-check, Platform Designation, CDRP, CMC aspects of the Plausible Mechanism Pathway
- Understand industry challenges/opportunities with implementing these programs with specific considerations for oligos
- Determine next steps in formalizing these programs and best practices
- Focus on US (e.g., Platform Designation, CDRP, PreCheck)
Speaker(s)
Overview of Recent US FDA CMC Programs/Policies & Next Steps
Mahesh Ramanadham, PharmD, MBA
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States
Industry Insights on Recent US CMC Policy Changes: Navigating Opportunities and Challenges for Oligonucleotide Therapeutics
Katie Duncan
Director, CMC Policy and Advocacy, GSK, United States
Speaker
Mark Stewart, PhD
Vice President, Science Policy, Friends of Cancer Research, United States