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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)
Representative Invited
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States
Overview of Recent US FDA CMC Programs/Policies & Next Steps
Representative Invited
Director, CMC Policy and Advocacy, GSK, United States
Industry Insights on Recent US CMC Policy Changes: Navigating Opportunities and Challenges for Oligonucleotide Therapeutics
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