CONFERENCE DAY TWO
Thursday October 3, 2024

8:00 am Check-In, Coffee & Light Breakfast

8:55 am Chair’s Opening Remarks

Targeting Novel Indications & Applications for iPSC Therapeutics to Meet Patient Need

9:00 am Unlocking the Potential of iPSC Therapies for Parkinson’s Disease

Synopsis

  • Investigating the expanding application of iPSC technology to create cell-based therapies for Parkinson’s disease
  • Highlighting the importance of developing reliable preclinical models to assess the safety and effectiveness of iPSC therapies in Parkinson’s disease

9:30 am Tailoring iPSC Therapies for Autoimmune Diseases to Address Unmet Patient Needs

  • Chong Luo Director, Cell Therapy, Tome Biosciences

Synopsis

  • Delving into the potential of using patient-derived iPSCs to create targeted cell therapies for specific autoimmune diseases
  • Regulating the immune system and achieving disease remission in autoimmune conditions
  • Developing rigorous preclinical models that accurately reflect the human immune response to assess the safety and effectiveness of iPSC therapies for autoimmune diseases

10:00 am Panel Discussion: Unlocking the Potential of iPSC Therapies for Non-Cancer Indications

Synopsis

  • Promising new applications for iPSC therapies, highlighting specific examples beyond heart failure, and focusing on areas of significant unmet medical need
  • Examining the unique challenges and opportunities associated with developing iPSC therapies for non-cancer diseases, exploring the path from basic research to patient care

11:00 am Morning Refreshment Break & Poster Session

Synopsis

As the iPSC community is reunited, this poster session will allow attendees to share research that will not be presented in speaking sessions. Don’t forget to enjoy some refreshments before we split off into 2 tracks: Research & Development and Manufacturing & Analytical Development

Research & Development

Novel Approaches to Advanced Gene Editing of iPSCs to Enable Improved Control & Safety

12:00 pm Streamlining Gene Editing for iPSC Therapies to Reduce Off-Target Edits & Reduce Delays

Synopsis

  • Exploring the latest gene editing technologies like mRNA reprogramming for precise modification of iPSCs in preclinical research
  • Streamlining gene editing workflows, minimizing unintended edits, for faster development of iPSC therapies

12:30 pm Ensuring Safety in Gene-Edited iPSC Therapies to Accelerate Development of Next-Generation Treatments

  • Matt Angel Chief Executive Officer, Factor Biosciences

Synopsis

  • Focusing on methods for maintaining genomic stability and minimizing mosaicism after gene editing in iPSCs, promoting safety
  • Developing new genomic stability testing methods to ensure the safety of iPSC-derived cell therapies

Manufacturing & Analytical Development

Enhancing Quality & Potency Assay Development for iPSC Processes

12:00 pm Enhancing Assay Development & Cell Bank Characterization for iPSC Manufacturing

  • Dhruv Sareen Associate Professor & Executive Director - Biomanufacturing Center & Induced Pluripotent Stem Cell, Cedars-Sinai Medical Center

Synopsis

  • Streamlining iPSC manufacturing with robust quality control to ensure consistent, high-quality iPSCs for efficient and reliable production
  • Unlocking therapeutic potential of iPSCs by linking cellular traits to efficacy for targeted therapies and improved patient outcomes

12:30 pm Developing Standardized & Scalable Potency Assays to Ensure Effective Quality Control of iPSC Therapeutics

  • Bruna Paulsen Director - Manufacturing and Quality Control, Gameto

Synopsis

  • Elevating the importance of comprehensive quality control procedures throughout the iPSC manufacturing process to ensure consistent product quality and safety
  • Exploring ongoing research into identifying cellular and functional characteristics within iPSC-derived cells that correlate with therapeutic efficacy, aiding in dose selection and improving overall product quality

12:30 pm Presentation from Cellino

Synopsis

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1:00 pm Lunch Refreshment

Safety Considerations for Developing iPSC-Derived Cell Therapies for Treating Solid Tumor

2:00 pm Revolutionizing the Treatment of Solid Tumors Utilizing iPSCs to Unlock Treatments for a New Frontier of Oncology

Synopsis

  • Engineering iPSCs designed to target and treat solid tumors as a promising new approach to cancer treatment
  • Utilizing iPSCs to address the three major hurdles associated with cancer treatment: metastasis, treatment resistance, and relapse
  • Combating the tumor microenvironment using iPSCs to stimulate a stronger immune response

2:30 pm Roundtable Discussion: Implementing GMP Compatible Practices into Preclinical iPSC Research

Synopsis

  • Integrating GMP principles and processes into preclinical iPSC research workflows to enhance the development of treatments for solid tumors and ensure a smooth transition to clinical development
  • Addressing the challenges of sourcing GMP-grade reagents and adapting research protocols to meet the specific needs of solid tumor treatments and aligning with large-scale manufacturing requirements for future clinical trials

Tailoring Logistics & Storage for Successful iPSC Therapies

2:00 pm Optimizing Logistics & Cryopreservation of iPSCs to Streamline Product Delivery

  • Sherry Hikita Director - Project, Cell Therapy Research & Development, Novo Nordisk

Synopsis

  • Examining best practices for selecting starting materials, such as donor tissue or reprogramming methods, to ensure the safety and efficacy of iPSC therapies in preclinical research
  • Evolving GMP requirements for starting materials used in iPSC therapy development, including considerations for media components and reagents

2:30 pm Panel Discussion: Optimizing the iPSC Therapy Pipeline: Balancing Quality, Potency, & Cost

  • Zhu Pirot Director & Technical Leader - Platform CGT Analytical Development, Bayer

Synopsis

  • Convening researchers, industry, and regulators for a comprehensive discussion on quality and potency in iPSC therapies
  • Facilitating discussion on assays, quality control, and manufacturing for consistent, high-quality iPSC therapies

3:00 pm Afternoon Refreshment Break & Networking

Rethinking Translational & Strategical Priorities to Drive Next Steps Across the iPSC Industry

3:30 pm Exploring Partnership Models to Optimize Investment in iPSC-Derived Cell Therapies

Synopsis

  • Structuring deals to balance risks and rewards between industry and investors
  • Understanding different partnership models to find the best fit for you
  • Case studies of innovative partnership models to fund iPSC development

4:00 pm Panel Discussion: Accelerating iPSC Therapy Development by Streamlining Processes & Mitigating Delays

Synopsis

  • Minimizing the need for retesting when transitioning between research-grade and GMP-compliant materials and processes, reducing development timelines and associated costs
  • Streamlining iPSC production workflows through automation, integration of advanced technologies, and process optimization to expedite development timelines and reduce overall costs

4:30 pm Chair’s Closing Remarks & End of Conference