7:30 am Registration & Coffee

8:20 am Chair’s Opening Remarks

Reflecting on iPSC Successes & Learnings to Understand the Prospects of iPSC-Derived Cell Therapies

8:30 am A Case Study to Benchmark the Road to Success For a Precision Engineered iPSC-Derived Effector Cell


  • Experiences, learnings and challenges when moving to a PH1 clinical trial
  • Laying the regulatory foundations
  • Future directions with next-generation programs

9:00 am New Era of Heart Failure Treatment: Regenerative Cell Therapy Using Ventricular Specific Purified Cardiomyocytes


  • Scalable method to eliminate undifferentiated iPSCs by difference of metabolism between iPSCs and cardiomyocytes
  • Clinical data from FIH study of purified cardiomyocyte spheroids
  • Platform technology to develop high quality iPSC-derived product

9:30 am An Automated Platform to Scale Autologous iPSC Therapy Production


  • Developing automated reprogramming processes using a multidisciplinary automated workcell
  • Designing & building automated closed clinical-grade systems for scalable autologous iPSC manufacturing
  • Using image-based analysis and laser removal of cells to automate cell processes & reduce operator variability for massive scale

10:00 am Morning Refreshment Break & Networking

Diving Into Differentiation to Optimize iPSC-Derived Cell Functions & Fulfill Clinical Potential

11:00 am Precise and Mb-scale iPSC genome engineering for cell therapy & regenerative medicine by Logomix Geno-WritingTM Platform


  • Geno-Writing™, an innovative genome-writing platform, facilitates precise and Mb-scale manipulation of genomic sequences within human ES/iPS cells.
  • Universal donor iPSC lines were constructed through large scale deletion encompassing all of the HLA class I and the HLA class II gene loci, complemented with targeted integration of HLA genes of strategic choice.
  • Through site-specific integration of ~40 kb gene cluster constructs, Geno-Writing™ enables creation of a library of iPSCs containing distinct combinations of multiple transgenes and functional screening of their derivatives.

11:30 am Directing Differentiation to High-Purity Cell Populations Appropriate for Cellular Therapy


  • Examining current and novel technologies to successfully characterize undifferentiated cells to reduce product contamination
  • Diving beyond karyotypic screening to drive reliable assessment of genomic integrity
  • Evaluating the role maturity plays in differentiation to understand why iPSCs do not always fully differentiate into their potential

Improving Data Strategies to Streamline Clinical Success

12:00 pm GMP Process for High-Quality iPSC Manufacturing & Development of Improved Differentiation Methodologies

  • Junxia Wang Senior Director, Product Development - Cell Therapy, Catalent Pharma Solutions


• Principle of reprogramming and key considerations of iPSC derivation and banking 

• GMP-compliant iPSC manufacturing and improved iPSC differentiation protocols for cell therapy

12:30 pm Roundtable Discussion: Considerations of Quality Control Strategies to Increase Confidence in Preclinical Processes & Advance Candidates to the Clinic


• What reference and control materials should we be using for our QC and potency assays?

• Best practices for defining your endpoints for QC/potency assessments to highlight the effect on end products

• Identifying ways QC and the manufacturing process can be commonly optimized to increase regulatory acceptance

1:00 pm Lunch Break & Networking

The Future is iPSCs: Re-Evaluating Translational & Strategical Priorities to Drive Next Steps Across the iPSC Industry

2:00 pm Genetic Engineering of Allogeneic Donor Cells for Acceptance by the Host’s Immune System

  • Sonja Schrepfer Senior Vice President, Hypoimmune Platform, Sana Biotechnology


  • Overcoming the immune barrier in allogeneic cell transplantation – discussion of the concept of immune evasion
  • Understanding the immune response to different iPSC-derived cell types in different transplantation sites
  • From mice to patients – various preclinical and translational models to bridge the gap from bench to bedside

2:30 pm Diabetes cell therapy with Evotec iPSC-derived islet-like clusters in the Sernova Cell PouchTM


  • Update on Evotec’s end-to-end integrated platform for iPSC-based cell therapeutics
  • Results from pre-clinical testing of iPSC-derived islet-like clusters combined with the implantable Cell Pouch

2:40 pm Discovering How to Make iPSC Cell-Derived Therapies a Reality: A Pharma Perspective

  • Stefan Frank Director, Cell & Gene Therapy Platform Strategy, Bayer


  • Benchmarking pharma priorities when translating a smaller scale process to a larger scale
  • Streamlining the process to clinical success
  • Highlighting common challenges and solutions of iPSC platform strategies to turbocharge iPSC therapies to the clinic

3:10 pm Afternoon Break & Networking

3:40 pm Exploring the Potential of Human Trophoblast Stem Cells (TSCs)

  • Yuta Lee Founder and Chief Executive Officer, Accelerated Biosciences


  • Human trophoblast stem cells as a starting stem cell source with product-market fit
  • GMP hTSC and hTSC-derived iPSC source with complete regulatory support package
  • Out-licensing to save cell and gene therapy developers 3 to 5 years in time and $10M in costs

4:10 pm Evidence-Based Quantitative Decision Making in Cell Therapy Clinical Development


  • Developing an evidence-based quantitative decision framework
  • Benchmarking endpoints and data package development for decision making
  • Discussing criteria for a go/no-go decision based on pre-specified target and/or reference values

4:40 pm Close of Conference Day Two