Explore the Agenda
8:45 am Registration & Coffee
9:20 am Chair’s Opening Remarks
Developing Regulatory Confidence Through Stronger Quality Standards & Material Risk Assessment
9:30 am Creating Confidence Through Raw Materials Quality Standards for Cell & Gene Therapies
- Discussing USP Chapter <1043> on ancillary material quality, risk assessment and material qualification
- Noting recent developments in compendial methods for raw materials
10:00 am Interactive Discussion: Ask the USP
- Opening up discussion on proposed revisions to USP Chapter 1043, with a focus on the 4-tier risk assessment system
- Bringing together differing views on the tiered approach, encouraging participants to share perspectives and challenge assumptions
- Exploring what these potential changes mean in practice for raw material risk assessment and decision-making
10:45 am Morning Break & Networking
Ensuring Manufacturing Consistency & Supply Continuity to Improve Safety & Reduce Disruption
11:45 am Reducing Safety Risk & Improving Consistency in Next Generation Allogeneic Treg Manufacturing
- Enabling mid process purification to achieve best-in-class drug product purity
- Reducing graft versus host disease risk through tighter process control
- Designing raw material and supply strategies with late-stage trials and commercial scale in mind
12:15 pm Panel Session: Navigating Supplier Diversification to Reduce Risk & Maintain Product Continuity
- Addressing challenges in qualifying secondary suppliers for critical materials
- Understanding comparability and change control requirements when switching vendors
- Balancing supply chain flexibility with IP constraints
1:15 pm Lunch Break & Networking
Building Stronger Buyer–Supplier Alignment to Enable Reliable, Scalable Raw Material Strategies
2:15 pm Roundtable Discussion: Defining What Biopharma Needs from Raw Material Suppliers to Enable Scalable, Reliable CGT Manufacturing
- Aligning expectations on material quality, data transparency, and change control to reduce downstream risk
- Understanding where current supplier offerings fall short across development through commercial scale
- Defining what strong partnerships look like in practice, from early engagement to long-term collaboration
2:45 pm Strengthening Shelf-Life Strategies for Raw Materials
- Aligning shelf-life approaches across sites and CDMOs while leveraging supplier data and scientific justifications
- Assessing chemical sensitivities and microbial risk in order to support the shelf-life decisions
- Developing strategies to mitigate gaps in supplier stability data