8:00 am Check-In & Coffee
8:55 am Chair’s Opening Remarks
Transforming Tomorrow: Innovative Approaches & Cutting-Edge Automation for Consistent and Cost Effective Cell Therapies
9:00 am Maximising Efficiency & Conservation with Digital PCR: Development & Validation of ddPCR Methods for Gene Expression & Vector Copy Number Applied from DP Characterisation to Clinical Trial Samples
Synopsis
- Discuss the unparalleled accuracy and sensitivity of ddPCR in absolute quantification of nucleic acids, enabling precise measurements with minimal sample input and reagent usage
- Understand the cost-saving benefits of ddPCR technology, which not only conserves materials but also streamlines experimental workflows, making it an economically viable option for cell therapy analytical development and beyond
- How a long-term vision can optimise the process to reduce cost and save time
9:30 am The Transformative Power of Automation in Analytical Development Through Empowering Streamlined Regulatory Compliance
Synopsis
- Explore how automation streamlines sample handling, assay execution, and data analysis in cell therapy analytical development, reducing manual labour and improving efficiency
- Discuss the role of automation in improving the accuracy and reproducibility of analytical results by minimising human error and variability, leading to more reliable data generation
- Highlight how automated systems ensure adherence to regulatory requirements by performing standardised quality control and release testing procedures, facilitating timely product approvals and commercialisation
10:00 am Morning Break & Networking
11:00 am Standardising Cytometry & Data Analysis in Cell Therapy
Synopsis
- Implement standardised cytometry protocols for uniformity and reproducibility in cell therapy experiments
- Adopt uniform data analysis methods to ensure reproducibility and high-quality data
- Understand how standardised practices support regulatory requirements, expediting approval for cell therapy products
11:30 am Revolutionising Apoptosis Assessment: A Novel Direct Assay Approach
Synopsis
- Explore how bypassing traditional washing and spinning down methods leads to more accurate assessments of apoptosis in cells
- Discover how this direct assay approach eliminates potential artefacts introduced by conventional techniques, ensuring more reliable results
- Learn how adopting this novel method simplifies the workflow, saving time and resources while maintaining the integrity of cell samples
12:00 pm Lunch Break & Networking
Propelling Analytical Development to Regulatory Success & Commercial Triumph
1:00 pm Advancing Analytical Development Strategy for Successful IND/IMPD Applications Through All Stages of Product Development
Synopsis
- Discuss the importance of strategic assay development tailored to the specific characteristics of cell therapy products, emphasising the need for comprehensive characterisation assays and how to use these assays during product development
- Explore strategies for aligning with regulatory expectations and interpreting guidance documents effectively.
- Discuss why and when to proactively engage with regulatory agencies during product development
- Highlight the value of collaborative risk assessment and mitigation efforts involving cross-functional teams and how those activities guide the control strategy for the product and analytical development.
- Analytical development approaches in ICH Q14 will be discussed
1:30 pm Advancing Analytical Methods in Clinical & Commercial Stages
Synopsis
- Emphasise the iterative optimisation of analytical methods throughout clinical and commercial phases to address emerging challenges and improve assay performance and being challenged by resource limitation and complexity of the product
- Discuss the integration of cutting-edge technologies into analytical workflows to enhance efficiency and scalability, leveraging automation and high-throughput screening
- Highlight the importance of regulatory compliance and adapting methods to meet evolving requirements, emphasising proactive engagement and adherence to GMP standards for product release and post-market surveillance
2:00 pm Afternoon Break & Networking
2:30 pm Navigating Regulatory Waters: Insights into Cell Therapy Analytical Development Across the Regulatory Landscapes
Synopsis
- Explore the efforts to harmonise regulatory standards for cell therapy analytical development across the US, EU, and UK.
- Discuss the importance of aligning regulations to ensure consistency in product quality and safety assessments
- Delve into the unique regulatory challenges and considerations faced by cell therapy developers.
- The differences in regulatory pathways, requirements, and expectations, and how they impact analytical development strategies
- Examine strategies for adapting to evolving regulatory landscapes.
- Discuss the importance of staying abreast of regulatory updates, engaging with regulatory agencies, and proactively addressing emerging requirements to ensure compliance and expedite product development
3:00 pm Panel Discussion: Unlocking Tomorrow’s Potential – Advancing Cell Therapy Analytical Development into the Future
Synopsis
- Expectations for the future of cell therapy analytical development include the integration of advanced technologies like high-throughput screening, single-cell analysis, and AI/ML to enhance assay sensitivity, specificity, and biomarker discovery
- Standardisation and quality control measures to ensure reproducibility and comparability across different laboratories and manufacturing sites, facilitating regulatory approval and commercialisation
- The development of real-time monitoring techniques and point-of-care testing platforms, alongside ongoing regulatory innovation and collaboration between industry, academia, and regulatory bodies to address emerging challenges and expedite the translation of promising cell therapy products into clinical applications