Conference Day One
Wednesday, December 4, 2024
7:30 am Check In & Morning Coffee
8:00 am Chair’s Opening Remarks
Navigating Analytical & Regulatory Frontiers to Propel Cell Therapy Development Forward
8:40 am Industry Leaders’ Fireside Chat: Pioneering Analytical Frontiers to Overcome the Complexities of Cell Therapy Products – Insights from Cell Therapy’s Foremost Analytical Minds
Synopsis
- Delve into the key obstacles and complexities currently facing analytical development in cell therapy, exploring issues such as assay standardization, data interpretation, and regulatory compliance.
- Discuss the latest advancements and innovations in analytical techniques and methodologies, including single-cell analysis, high-content imaging, and omics technologies, and their applications in cell therapy development.
- Share insights and strategies for overcoming current challenges and maximizing the potential of analytical development in advancing cell therapy research and clinical applications. This includes discussions on collaboration, data management, and regulatory strategies to navigate the evolving landscape of cell therapy analytics.
9:30 am Navigating the Path to Successful CGT Assay Development
Synopsis
- Identify and address common pitfalls: Avoid the frequent challenges faced in CGT assay development by employing these strategies to mitigate these issues early in the process.
- Optimize reproducibility and data integrity: Best practices for implementing robust flow-based methods that ensure consistency and reliability across different assays.
- Implement efficient workflow strategies: Reduce time to market and improve overall project outcomes.
9:45 am Leveraging the MACSQuant® Analyzer to Optimize Assays for Analytical Development
Synopsis
- Automate for efficiency: Explore how one-way automated compensation on the MACSQuant Analyzer can streamline workflows and reduce manual errors commonly associated with traditional flow cytometry methods.
- Seamlessly transfer technology: Learn about effective R&D tech transfer strategies to MACSQuant Analyzer, including the practical implications of converting assay panels and ensuring instrument compatibility.
10:00 am Enhancing Regulatory Strategies & Navigating Eyebrow Raising Regulatory Guidelines for Streamlined Compliance
Synopsis
- Learn effective strategies for engaging with regulators early and continuously throughout the cell therapy development process. Understand how to navigate evolving regulatory landscapes, including recent guidelines such as Q14 on analytical development and Q2 R2 on method validation. Gain insights into implementing these guidelines effectively and addressing any controversial aspects or recommended modifications raised by regulatory bodies.
- Explore the latest methodologies used to characterize cell therapies, considering regulatory expectations outlined in recent potency draft guidance. Delve into the nuances of assay validation for potency assessment and understand how to align analytical methods with regulatory requirements to meet expectations and ensure compliance.
- Discover the benefits of industry collaboration in establishing standardized approaches to analytical development, including interpretation and implementation of regulatory guidelines. Explore how collaborative initiatives streamline compliance efforts and facilitate the adoption of best practices, particularly in addressing the complexities of new regulatory guidance and ensuring alignment with evolving expectations.
10:30 am Tools to Standardize Cell Analysis for Cell Therapy Development and Transfer to Manufacturing QC
Synopsis
At BD Biosciences, we partner globally, across all stages of the drug development process, to support leading biopharmaceutical companies and CDMOs from discovery to market approval and commercialization. BD’s automation solutions can accelerate multisite collaboration and drive standardization.
This talk will demonstrate:
- The efficiency improvements in flow cytometry workflows when sample preparation and staining is automated,
- The reproducibility of flow cytometry data with easy assay transfer across BD FACSLyric™ instruments,
- The advantages of automating flow cytometry data analysis, with the BD ElastiGate™ auto-gating feature onboard the BD FACSLyric™ Flow Cytometer with few training files
11am Morning Break & Speed Networking
Synopsis
As this community reunites, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections.
Track A – Cell Based Assay
Track B - Immunophenotype Assay
Track C - Molecular Assay
Unravelling Potency by Overcoming Complexities in Assessing Therapeutic Efficacy
12:00 pm Expanding Perspectives on Potency Assays in Cell Therapy: Beyond Primary Mechanisms
Synopsis
- Explore the evolving definition of potency assays beyond traditional metrics like cell-based killing, delving into engineered attributes crucial for therapeutic efficacy.
- Discuss the need for functional assays to evaluate engineered functions such as evading the host immune system, aligning with evolving FDA guidance and label claim requirements.
- Delve into the role of protein expression as a surrogate marker for potency.
12:30 pm Quantitative Cell Characterization Using Laser Force Cytology™ (LFC): Predictive Insights into CAR T Donor Variability
Synopsis
- Label-free analysis of intrinsic biochemical and biophysical properties of cells provides real-time insights into cellular changes occurring throughout a manufacturing process. Additionally, ensuring robust cellular fitness of starting material is a crucial component to manufacturing and treatment success
- Learn how Laser Force Cytology™, a label-free, quantitative precision PAT enables real-time monitoring of CQAs and CPPs delivers insights into complex manufacturing processes through its optical force univariate and multivariate machine learning predictive capabilities
- Exciting new data on the correlation of CAR T potency with donor cellular starting material as well as T-cell activation road mapping using LumaCyte’s Laser Force Cytology™ will be shared
1:00 pm Timing & Challenges of Potency Assessment in Cell Therapy Development
Synopsis
- Learn how to effectively balance the need for robust and validated potency assays with the practicalities of clinical trial timelines and resource allocation, optimizing both development speed and product quality.
- Explore strategies for meeting regulatory expectations on potency assays early in development while maintaining flexibility for product optimization, ensuring compliance without stifling innovation.
- Discuss the impact of the evolving understanding of mechanisms of action on potency assays, and how to adapt these assays to capture critical therapeutic attributes throughout the product lifecycle.
Navigating Complexities in Assay Qualification for Immunophenotyping for Enhanced Consistency & Repeatability
12:00 pm Bridging the Gap: Overcoming the Challenges Linking Immunophenotyping to Treatment Efficacy in Cell Therapy
Synopsis
- Delve into the inherent complexity and dynamic nature of the immune system, exploring how individual variability and temporal dynamics impact the correlation between immunophenotyping and treatment outcomes.
- Discuss the need for standardized guidelines and protocols in immunophenotyping to ensure consistent, reliable data collection and analysis across different cell therapy modalities and patient populations.
- Explore innovative methodologies and computational tools required to integrate immunophenotyping data with other clinical and molecular data, enhancing the predictive value of immune profiles in determining treatment efficacy.
12:30 pm Program Partner Presentation by Accellix
Synopsis
Speaker TBC
1:00 pm Strategies for Validating Reference Standards in Immunophenotyping Assays to Ensure Consistency
Synopsis
- Explore the complexities of creating robust and universally accepted reference standards for immunophenotyping assays, crucial for maintaining consistency and accuracy.
- Discuss the challenges in achieving consistent results across different laboratories and studies, emphasizing the need for standardized protocols and reference materials.
- Highlight innovative approaches and best practices for validating reference standards, ensuring reliable and reproducible data in immunophenotyping research and clinical applications.
Enabling Expedited Release of Cell Therapy Products with Accelerated Testing Timelines
12:00 pm Develop a Quality Control-Friendly Cytokine Independent Growth Assay
Synopsis
- Introduction of cytokine independent growth release method
- Selection of proper assay controls
- Method validation and training
12:30 pm Program Partner Presentation by BioMerieux
Synopsis
Speaker TBC
1:00 pm Precision in TCR-T Therapy: Mastering ddPCR Assay Development and Qualification for Seamless Product Release
Synopsis
- Crafting High-Fidelity ddPCR Assay: Innovative approaches to designing ddPCR assays that deliver precise and reliable results for TCR-T cell therapies.
- Ensuring Regulatory Excellence: Comprehensive strategies for the qualification and validation of ddPCR assays to meet stringent regulatory requirements.
- Navigating Development Hurdles: Solutions to common obstacles in ddPCR assay development, focusing on enhancing sensitivity, specificity, and reproducibility for efficient product release.
1:30 pm Lunch Break & Networking
Leveraging Automation & Technology to Streamline Processes & Speed Up Assay Development
2:30 pm Automation in Cell-Based Assays for Enhanced Efficiency & Reproducibility
Synopsis
- Explore how automation reduces human error and increases throughput, accelerating assay development processes.
- Discover the impact of liquid handling robots, scheduling software, and organs-on-a-chip on improving assay workflows.
- Learn how automation ensures reproducibility and scalability, enhancing the reliability of potency testing in cell therapy development.
3:00 pm Panel Discussion: Future Prospects of Automation & Technologies in Cell-Based Assays for Cell Therapy
Synopsis
- Discuss how next-generation automation systems and AI technologies will enhance assay efficiency, precision, and reproducibility, driving faster and more reliable cell therapy development.
- Explore the integration of cutting-edge technologies like organ-on-a-chip and microfluidics into automated workflows, providing deeper insights and more physiologically relevant data.
- Learn how automation will support scalable, flexible, and standardized production processes, ensuring regulatory compliance and consistent quality control in the manufacturing of cell therapy products.
Overcoming the Challenges of Immunophenotype Assays with Robust Data Strategy
2:30 pm Navigating Data Challenges in Cell Therapy Analytical Development & Improving Overall Product Quality
Synopsis
- Exploring strategies for optimizing data collection, storage, and analysis to enhance product understanding and process optimization in cell therapy development.
- Highlighting the importance of robust data management and curation practices to derive meaningful insights and inform decision-making in cell therapy analytical development.
- Addressing the need to stay updated and flexible in data interpretation amidst rapidly evolving research and technological advancements, emphasizing the role of data platforms in facilitating informed decisions.
3:00 pm Enhancing Predictive Value in Immunophenotyping for Cell Therapy Efficacy
Synopsis
- What are the main obstacles in establishing a direct correlation between immunophenotyping data and therapeutic outcomes in cell therapy?
- How can we develop and implement standardized guidelines for immunophenotyping to ensure consistent and reliable results across different contexts?
- What innovative methodologies or technologies could enhance the assessment of inflammation and immune activity, thereby improving the predictive value of immunophenotyping in therapeutic settings?
Transitioning from Conventional Approaches to Enhance Cost Effectiveness & Efficiency
2:30 pm Characterization of Genomic Integrity of GE products for a Cell Therapy
Synopsis
- Discussing the technologies to assess the genomic integrity: WGS, etc.
- Improving WGS analysis with both short-read and long-read NGS.
- Discussing the challenges and considerations in the characterization of genomic integrity.
3:00 pm Panel Discussion: Innovative Molecular Assays through Revolutionizing Genomic Analysis in Cell Therapy Development
Synopsis
- Harnessing the power of next-generation sequencing for comprehensive genomic profiling, enabling precise characterization of genetic variations, gene expression profiles, and molecular pathways relevant to cell therapy efficacy and safety.
- Exploring the applications of digital PCR in quantitative nucleic acid analysis, offering enhanced sensitivity, accuracy, and reproducibility for detecting rare mutaons, monitoring gene expression levels, and assessing viral vector integration sites.
- Leveraging CRISPR technology for targeted genomic manipulation and nucleic acid detection, facilitating the development of high throughput screening assays, precise gene editing tools, and sensitive diagnostics for cell therapy quality control and safety assessment.
4 pm Afternoon Break & Poster Session
Synopsis
This is your opportunity to contribute to the conversation and share your cutting-edge research with this community, while discovering exciting work carried out by your peers. To submit a poster, please contact info@hansonwade.com.
Navigating the Analytical Lifecycle for Strategic Management & Streamlined Product Development
5:00 pm Innovation Partner Presentation: Immudex
5:10 pm Adapting Analytical Development Strategies Across Clinical Trial Phases
Synopsis
- Delve into the shifting landscape of analytical development strategies from early clinical trials to post-approval phases, highlighting the evolving needs and challenges at each stage.
- Explore the unique challenges encountered during transitions between clinical trial phases and discuss strategies for adapting analytical methodologies to address changing requirements effectively.
- Focus on post-approval analytical strategies aimed at maintaining product efficacy and safety over the long term, emphasizing the importance of continuous monitoring and refinement in response to real-world data and feedback.
5:40 pm Effective Analytical Solutions for Ensuring Quality and Efficiency in Cell Therapy
Synopsis
- Explore innovative analytical techniques for cell therapy manufacturing and learn how they can be applied to various stages of the production process
- Develop a comprehensive understanding of the advantages of analytical kits in cell therapy production
- Discover ways to overcome bottlenecks and reduce time constraints in sterility testing and mycoplasma detection
6:10pm Chair’s Closing Remarks
6:40 pm Drinks Reception
7:15pm End of Conference Day One
