Sai Prathyusha Bhamidipati
Director of Regulatory CMC Moderna
Seminars
Wednesday 22nd July 2026
Fireside Discussion: A Regulatory Perspective on the Complexity of Global Policy & Market Dynamics Towards the First mRNA Therapeutic Approval
9:00 am
The regulatory landscape for mRNA is changing and becoming increasingly complex with new products in clinical development from cancer immunotherapies to cell therapies. Drug developers require further clarity and collaboration with the regulatory authorities to reach their milestones. This panel will feature regulatory and policy experts who will share their understanding of getting new mRNA products into market.
- How are the current global policies and government decisions impacting the mRNA industry?
- How as a community can we work with the regulators to reduce impact on development timelines whilst improving trust with the global community?
- What will it take to see the next therapy successfully achieve market authorization and which indications or innovations will lead to this effort?
Wednesday 22nd July 2026
Reviewing the Regulatory CMC Guideline Landscape for mRNA
11:30 am
- Across FDA, EMA, and Japan (MHLW/PMDA), CMC guidelines require sponsors to submit sufficient information to assure identity, quality, purity, and strength (including potency) of the investigational product, supported by descriptions of manufacture and controls (process and in-process controls, specifications/analytical controls, and stability)
- Where guidelines diverge and what sponsors typically align to: EMA has modality-specific quality guidance explicitly scoped to mRNA vaccines for infectious diseases (manufacturing process, characterisation, specifications/analytical control; definition of starting materials/active substance/finished product, and certain platform/change considerations), while the U.S. and Japan rely more on broader biologics/gene therapy quality frameworks for CMC expectations when modality-specific mRNA guidance is not issued for a given category/indication
- Commonalities for ID and oncology CMC expectations and “make it easier” mechanisms described in guidelines: Regardless of indication, guidelines converge on demonstrating a consistent control strategy for materials, process, specifications/analytical controls (incl. potency), and stability, and provide lifecycle tools to manage global CMC change predictably
