8:00 am Coffee & Networking

8:55 am Chair’s Opening Remarks

Delving into iPSC-derived Cell Therapies for Regenerative Medicine to Emphasize the Breadth of Applications

9:00 am What Does the Perfect Value Chain Look Like to Develop iPSC Therapies?

  • Jacob Sten Petersen Head of Cell Therapy Research & Development, Novo Nordisk

Synopsis

  • What is the perfect cell line?
  • Developing robust differentiation protocols
  • What does it take?

9:30 am Cymerus™ iPSC-Derived MSCs: Global Clinical Development Update

Synopsis

  • Overview of unique iPSC-derived MSC manufacturing process
  • Summary of clinical data to date
  • Ongoing/planned trials in multiple indication

10:00 am A Look at Healios K.K.’s iPSC-Derived Cell Therapy Programs

  • Hardy Kagimoto Founder, Chairman & Chief Executive Officer, Healios K.K.

Synopsis

  • Showcasing preclinical programs and the science behind them
  • Healios’ plans for regenerative medicine in the future

10:30 am Morning Refreshment Break & Networking

DISCOVERY & TRANSLATION TRACK

Harnessing Effective Differentiation to Increase Product Efficiencies & Yield

11:30 am Improving Differentiation Efficiency to Increase Yield of Desired Product

Synopsis

  • Determining the optimal growth factor combination to create the differentiated cell of choice
  • Reducing the use of intermediates to accelerate differentiation of iPSCs
  • Evaluating the optimal time to differentiate cells to maximize efficiency

12:00 pm Eliminating Residual Undifferentiated Cells to Remove Product Impurities

  • Joseph Wu Co-Founder
    Khloris Biosciences
    Director, Stanford Cardiovascular Institute

Synopsis

  • Identifying markers of undifferentiated cells to distinguish cells for removal
  • Utilizing differences in metabolism or osmotic pressure to detect undifferentiated cells
  • Applying cell sorting methods to purify intermediate cell lineages and decrease the need for final product sorting

CMC & REGULATORY TRACK

Advancing Analytical Development for iPSCs to Drive Product Quality, Potency & Purity

11:30 am Early Assay Development for Characterization & Qualification of Cardiac Cell Therapies

Synopsis

  • The potential of cardiac cell therapy to treat heart failure
  • Features of developmental biology and physiology of cardiomyocytes which facilitate early analytical assay development
  • Pipeline of assays to characterize and qualify cardiomyocyte cell therapies

12:00 pm Characterizing iPSC-Derived T Cell Products to Develop Safe & High Quality Products

  • Yu Qian Associate Director, Oncology Cell Therapies, Takeda

Synopsis

  • Identifying markers to efficiently characterize safe T cell products
  • Distinguishing release criteria to develop safe T cell products
  • Leveraging T cell product characterization to guarantee safety

12:30 pm Lunch Break & Networking

Reviewing Approaches to Enhance Therapy Safety

1:30 pm Roundtable: Exploring Methods to Prevent Immunogenicity & Tumorgenicity of iPSC Therapies

Synopsis

  • Reviewing methods to control iPSC therapies post administration to increase therapy safety
  • Looking at utilizing gene-editing to incorporate a controllable suicide safety switch
  • Exploring the possibility of switches to control individual cells instead of cell populations to prevent whole cell suicide

2:30 pm Overcoming the Allogeneic Immune Barrier for Off-the-Shelf iPSC-Derived Therapies

  • Sonja Schrepfer Scientific Founder, Senior Vice President & Head of Hypoimmune Platform, Sana Biotechnology

Synopsis

  • Determining effective methods to avoid therapy removal by the immune system
  • Encapsulating iPSC-derived cells to deter immune recognition
  • Developing a universal iPSC to tackle allogeneic immune rejection

Reflecting on the Regulatory Requirements of iPSC Therapies to Accelerate Preclinical & Clinical Development

1:30 pm Round Table: Tackling the Regulations of Genetically Engineered Products

Synopsis

  • Analyzing the CMC requirements for genetically engineered products to incorporate them into editing protocol
  • Discussing whether each unique engineered product requires its own regulatory application
  • Reviewing the regulatory requirements of genetic characterization to integrate into safety and regulatory affairs

2:30 pm Panel: Approaching Regulatory Affairs for iPSC-Derived Cell Therapies

  • Byeongtaek Oh Associate Director, Regulatory Affairs, BlueRock Therapeutics
  • Luis Borlado Head, Cell Therapy Product Development Research, Takeda

Synopsis

  • Discussing whether regulations should vary for each iPSC product and how often regulations should be updated to influence the future of iPSC guidelines
  • Sharing experience on addressing regulations to outline preparations required
  • Addressing differences in regulations for autologous and allogeneic products to distinguish varying regulatory demands

3:00 pm Afternoon Refreshments & Networking

Reimagining iPSC Product Quality to Guarantee Clinical Grade iPSC Products

3:30 pm Development & Quality Control of the World’s Largest Biobank of iPSC-Derived Cardiomyocytes

Synopsis

  • Defining critical quality attributes to safeguard product quality and safety for intended use
  • Determining the quality control assays to utilize in measuring cell quality
  • Harnessing methods to increase cell quality and prevent loss of quality during cell production to safeguard product efficacy

4:00 pm Chair’s Closing Remarks

4:05 pm Close of Conference Day Two