CONFERENCE DAY TWO | Thursday, October 9
8:00 am Check-In & Light Breakfast
9:00 am Chair’s Opening Remarks
Developing Regulatory Compliance for GMP Manufacturing for Raw Materials in Cell & Gene Therapy
9:10 am Panel Discussion: Shaping the Future of Ancillary Materials in Cell & Gene Therapy Insights from ISO Standard Development
Synopsis
- Firsthand experience contributing to a new ISO standard, focused on ancillary materials used in advanced therapies
- Overview of the U.S. TAG validation process and transition to a New Work Item Proposal within the ISO framework
- What this upcoming standard means for developers, manufacturers, and regulators over the next 3 to 4 years
9:45 am Audience Discussion & Q&A for the ISO Panel
Synopsis
Your chance to ask the group developing the new ISO standards how this will affect your product moving forward.
10:15 am Morning Break & Networking
Understanding & Controlling Raw Materials through Critical Quality Attribute Characterization
11:15 am Material for ATMP Manufacturing: Characterization Analytical Strategy
Synopsis
- Establishing reliable material characterization methods is key to ensuring the consistency, safety, and efficacy of raw materials used in ATMP manufacturing
- Defining phase-appropriate release testing strategies that align with clinical stage and material risk
- Leveraging panels of complementary tests and risk-based approaches for performance assessment of critical raw materials
- Development of platform methods and exploring new technologies for complex materials
11:45 am Roundtable Discussion: Defining the Right Material Attributes for Consistency & Control in Cell & Gene Therapy Manufacturing
Synopsis
- Identifying all properties that need to be assessed when testing a raw material for use in cell and gene therapy
- Developing the knowledge of distinguishing between critical and non-critical attributes based on risk and functional relevance
- How to create a robust plan of attribute to be tested in a new raw material
12:15 pm Lunch & Networking
Collaborating with Suppliers to Ensure Material Quality & Regulatory Readiness
1:15 pm Building Trust from the Start: Strategies for Qualifying New Suppliers in Cell & Gene Therapy
Synopsis
- Using a risk-based approach to define qualification criteria based on material criticality
- Assessing supplier GMP compliance quality systems and technical capabilities
- Setting clear quality agreements to manage change control and ensure transparency
1:45 pm Building Custom Raw Materials with Vendors for Cell & Gene Therapy
Synopsis
- Working with vendors to understand the unique process-driven requirements in cell and gene therapies that demand tailored raw materials
- Exploring strategies for partnering with suppliers to co-develop custom materials including plasmid DNA and lentiviral vectors
- How to define critical quality attributes, set specifications, and agree on change control mechanisms
2:15 pm Quality & Supply Risk Assessment of Raw Materials
Synopsis
- Evaluation of how changes in raw material attributes can introduce risk to critical quality attributes (CQAs) and overall product consistency
- Strategies for ensuring the consistency, purity, and regulatory compliance of raw materials used in cell and gene therapies
2:45 pm Afternoon Break & Networking
3:15 pm Think Tank: Streamlining Supplier & Material Selection & Qualification – Opportunities for Collaboration & Harmonization
Synopsis
- Review of RFI/RFP documents and information requests from suppliers for initial selection of material/supplier
- Supplier qualification practices and opportunities to streamline – paper audits, remote audits, on-site audits, 3rd party audits, certifications
- Material qualification practices and opportunities to streamline – fit-for-purpose questionnaires and risk assessments
Creating Common Ground for GMP Raw Materials in an Evolving Global Trade Environment
4:15 pm Fireside Chat: Adapting Raw Material Supply Chains to the Changing Economic Climate Navigating Tariffs & Market Challenges
Synopsis
An interactive panel discussion from the industry leaders of the field to set the scene on the raw material space. Ask your questions live to understand the expert’s thoughts on key topics including:
- Exploring how companies are strategically adjusting their raw material supply chains in response to evolving economic pressures, including tariffs, trade policies, and global market uncertainties
- How to mitigate the effects of traffics and trade policies on supply chain
- How are companies adapting supplier networks to mitigate risks related to tariffs and geopolitical shifts?
- What role does supplier diversification and local sourcing play in these adjustments?
4:45 pm Roundtable Discussion: Creating Industry-Wide Definitions for GMP Raw Materials
Synopsis
- In the rapidly evolving field of cell and gene therapy, the lack of standardized, industrywide definitions for GMP raw materials has become a critical bottleneck
- This roundtable will bring together key stakeholders’ manufacturers, quality leaders, regulatory experts, and suppliers to explore the pressing need for a harmonized framework that defines what constitutes a “GMP-grade” raw material in CGT manufacturing