Explore the full event guide to gain insights into the 3 days of content, speakers & partners at this year's summit!
7:45 am Check-in & Coffee
Streamlining Regulatory Strategies & Advancing Cell Delivery for Successful iPSC Therapy Development
8:30 am Panel Discussion: Understanding Evolving Frameworks & Addressing Regulatory Expectations Towards iPSC Based Therapies
Synopsis
- Exploring the challenges posed by regulatory inconsistencies between agencies and strategies to navigate evolving requirements for iPSC therapies
- Discussing best practices to propose new data, technologies and assays to regulators
9:30 am Case Study: Discussing the Regulatory Pathway to Clinic
Synopsis
- Highlighting the journey of advancing gene-edited iPSC therapies from preclinical to clinical trials, sharing lessons learned and insights on meeting regulatory and CMC expectations
10:00 am Refining the Path to Delivering Cells to Patients
Synopsis
- Ensuring iPSC-derived cell delivery methods are accessible, viable, and adaptable to a range of clinical settings
- Applying lessons from iPSC based organ development to optimize trial design and prepare for future applications
10:30 am Morning Break & Networking
Preclinical Track
Demonstrating Safety for iPSC-Derived Therapies to Ensure a Smooth Path to Clinic
11:30 am Roundtable Discussion: Analyzing Different Approaches to Toxicology Assays
Synopsis
- Diving into different methods to conduct residual IPS assays and how to best present results to regulators
- Comparing and contrasting toxicology assays between different cell types
Selecting the Right Conditions to Nurture Desired iPSC Differentiation
12:00 pm Accurately Recapitulating T-Cell Development for Autoimmune & Oncology Applications
Synopsis
- Strategies to mimic thymic selection and T-cell maturation in vitro to ensure functional and self-tolerant T-cell populations
- Tailoring iPSC-derived T-cell for tumor-specific or autoimmune-resistant profiles through precise developmental control
- Overcoming current challenges in achieving lineage specificity and scalability for clinical-grade T-cell products
Process Development & CMC Track
Enabling Scalable & Reliable Manufacturing of iPSCDerived Cells for Broad Therapeutic Impact
11:30 am Session Reserved for ThermoFisher
12:00 pm Standardizing iPSC Differentiation to Improve Reproducibility in Manufacturing
Synopsis
- Overcoming heterogeneity and variability in large-scale differentiation processes
- Implementing robust quality control strategies to ensure batch-to-batch consistency
- Aligning differentiation protocols with GMP requirements for clinical translation
12:30 pm Lunch
1:30 pm Evaluating the Impact of Cell Culture Environments on iPSC Differentiation
Synopsis
- Highlighting the process of differentiating iPSCs to iMSCs
- Discussing how factors such as temperature, timing, culture media, nutrients, and more impact the behaviour of iPSC-derived cells
2:00 pm Advanced Technologies for Engineering iPSC-Derived Tissues & Organs
Synopsis
- Cutting-edge biotechnologies for functional tissue and organ engineering
- Personalized biomaterials for engineering autologous iPSCderived tissues
- 3D and 4D printing of personalized tissues and organs
- Integration of micro/nanoelectronics into engineered tissues to create cyborg and bionic organs
Advancing Cell Characterization Techniques & Parameters for Validation of Processes
1:30 pm Defining Parameters to Assess the Quality of Desired End Cell Type
Synopsis
- Implementing strategies to validate the accuracy of cell differentiation
- Exploring morphological, molecular, and functional assays to confirm cell identity
- How can we evaluate the genomic stability of the final cell product?
2:00 pm Finding the Right Balance when Monitoring iPSCs
Synopsis
- How often should differentiating cells be analyzed
- Are there any differentiation milestones that need to be observed?
- What needs to be observed at every point (morphology, marker expression, purity)?
2:30 pm Afternoon Break
Leveraging iPSCs Beyond Cellular Therapies
3:00 pm Advancing Cancer Modeling with iPSCs: Current Approaches & Opportunities
Synopsis
- Modeling hereditary cancers using iPSC-derived cancer organoids
- Understanding novel signaling pathways in cancer progression
- Uncovering novel targets for drug and future cell therapies
3:30 pm Harnessing iPSCs for Drug Development, Applications in Drug Screening & Hit Identification
Synopsis
- Using iPSC-CM reporter lines for small molecule screening
- Effects of identified hits on gene expression and cardiomyocyte morphology