7:30 am Registration & Coffee

8:25 am Chair’s Opening Remarks

Trailblazing iPSC-Derived Therapies for Immuno-Oncology to Reaffirm Their Advantages

8:30 am Industry Leaders’ Fireside Chat: Taking a Look at the Current Learnings from iPSC-Derived Cell Therapies & Determining Future Outlook & Developments

  • Wei Li Chief Scientific Officer, Cytovia Therapeutics
  • Adrienne Farid Chief Operating Officer, Century Therapeutics
  • Xiaokui Zhang Chief Scientific Officer, Aspen Neuroscience
  • Gregory Fiore Chief Executive Officer, Exacis Biotherapeutics
  • Emily Titus Senior Vice President, Technical Operations, Notch Therapeutics


  • Reflecting on current learnings from therapy development to drive focus and motivation while highlighting demands of the future
  • Validating iPSCs as a starting material for immuno-oncology and regenerative medicine therapies to drive further investment and efforts in the space

9:30 am QbD in iPSC Manufacturing & Realization of its Automated Process

  • Shin Kawamata Director, Research & Development Center for Cell Therapy, Foundation for Biomedical Research & Innovation Ajinomoto


  • Discuss current challenges in cell manufacturing that examine all characteristic features of the final cell product, skipping in process monitoring or traceability of materials used, and repeat full set of QC tests at very shipment
  • Manual operation or robotic system that mimics the performance of operators without in process monitoring will leave the cell manufacturing backward, isolation from other industry and hinder the industrialization of cell manufacturing business
  • Introduce the quality by design (QbD)-based pluripotent stem cell manufacturing system to solve these issues and promote the dissemination of PSC-based cell therapy

10:00 am Morning Refreshment Break & Speed Networking

11:00 am Gamma Delta iPSC as a Strategy to Increase Depth of Response in the Allogeneic Setting

  • Lawrence Lamb Chief Scientific Officer & Executive Vice President, IN8Bio


  • Persistence of allogeneic cell products is limited by depth and duration of lymphodepletion
  • Engineered allo-evasion is a potential strategy requiring deep editing and upgraded safety measures
  • Multiple dosing at high effector numbers customized for the malignancy is an alternative strategy for tumor eradication and prolonger CR

11:30 am iPSC-Derived Blood Lineages for IO applications

  • George Daley Dean of Faculty of Medicine, Harvard Medical School


  • Describe strategies for overcoming barriers to producing functional, developmentally mature blood lineages from embryonic cell sources
  • Describe genetic and chemical screens that identify mechanisms for directing lymphoid cell fates
  • Characterization of lymphocyte and NK cell subsets and applications in immune-oncology

12:00 pm Lunch Break & Networking


Turbocharging Gene Editing to Boost iPSC Therapies While Redefining Safety

1:00 pm Engineering an Autologous iPSC Therapy for Limb-Girdle Muscular Dystrophy

  • Peter Andersen Co-Founder & Chief Scientific Officer, Vita Therapeutics


  • Successful gene replacement
  • Safe and efficient genome editing
  • Tackling GMP Manufacturing

1:30 pm Panel:Reviewing Methods to Editing iPSCs to Increase Therapy Persistence & Cell Retention in vivo

  • Xi Shi Associate Director, Platform Design & Genetic Engineering, Oncology Cell Therapies, Takeda
  • Gregory Fiore Chief Executive Officer, Exacis Biotherapeutics


  • Discussing how to increase cell survival to produce effective regenerative cell replacement therapies
  • Assessing methods to ensure iPSC therapies for immunology persist long enough for effective tumor killing
  • Does administration of the cell therapy affect retention in the body?

2:30 pm From 2D Cell Line Development to 3D Organoids, Automate and Simplify Complex iPSC Workflows


  • The workflows associated with growing iPSCs, CRISPR gene editing, and differentiating iPSCs in 2D and 3D culture are inefficient and low-throughput, costly, time-consuming, and manually labor intensive
  • We demonstrate that thousands of single human iPSCs can be screened on a single integrated system without the use of feeder cells
  • The development of 2D and 3D stem cell workflows on an automated platform has the potential to increase the utility, ease, and throughput of these workflows to get to the desired clone in the shortest time possible

2:45 pm Track Closed


Leveraging Scalable Expansion of iPSCs to Advance Manufacturing Processes

1:00 pm Scalable Manufacture of CAR-NK Cells from Engineered Pluripotent Stem Cells with 3-D Bioreactor


  • A proprietary scalable 3D iPS-NK manufacture platform with defined, serum-free and feeder-free conditions: pure and strong functional iPS-NK with CD8+ effector cell identity for immunotherapy
  • Establishment of permanent, stable, genetically-engineered and clonal iPS-CAR lines for the manufacture of unlimited homogenous CAR-NK cells from multiple master iPS-CAR cell banks
  • Development of next-generation 3D bioreactor platform and logistics: the ultimate goal of making CAR-NK products affordable and available for ordinary patients

1:30 pm Considerations for Allogeneic Cell Therapy Development


  • The advantages of iPSCs as starting material
  • Requirements for successful allogeneic cell therapy manufacturing
  • Working with a partner

2:00 pm Panel: Points to Consider When Preparing for Scale-Up to Drive Efficient Transfer to the Clinic & Commercialization


  • Reflecting on the manufacturability of products to aid in scale-up of therapy
  • Examining future demands of commercialization to adjust current processes before it’s too late
  • Collaborating to identify the future needs of technology to master scalable iPSC products

2:45 pm Addressing Process Development Challenges in Clinical & Commercial Stages


  • Critical raw materials and space: Required to support program portfolio
  • Talent: companies require resources with cGMP & scientific experience
  • Timeline: 3-6 months to transition from open system to cGMP compliant closed system
  • Cost: federally-backed incentives provide up to 50% for expenditure from R&D to commercialization

3:00 pm Afternoon Refreshments & Poster Session

4:00 pm Enhancing the Cytotoxic Anti-Tumor Activity of iNK Cell Therapy Using a Flex-NK™ Cell Engager

  • Daniel Teper Co-Founder & Chief Executive Officer, Cytovia Therapeutics
  • Armin Rath Head of New Product Development & R&D Alliances, Cytovia Therapeutics


  • Flex NK Cell Engager antibodies redirect NK cells to kill target tumor cells
  • Flex NK cell Engager antibodies enhance the cytotoxicity of PBNK cells as well as iPSC derived NK cells (iNKs)
  • Pre-clinical data supports initiation of clinical trials in both hematological malignancies and solid tumors

Exploiting iPSC Product Potency to Maximize Therapeutic Efficacy

4:30 pm Modifying Administration to Boost iPSC Product’s Ability to Work


  • Use of iPSCs in tissue therapeutics
  • Therapeutics efficacy with local administration
  • Advantages of tissue approaches, dosing, regulatory, etc.

4:00 pm Developing a Best Practice Directed Differentiation Protocol to Efficiently Produce a Patient Friendly iPSC Product

  • Rita Perlingeiro Professor of Medicine, Cardiovascular Division, University of Minnesota


  • Establishing robust and scalable differentiation processes to ensure optimal development
  • Ensuring differentiation protocol generates a safe cell product
  • Establishing a differentiation protocol that is reproducible to facilitate and accelerate cell production as well as testing

Leveraging Potency Assays to Benchmark Product Efficacy

4:30 pm Establishing Effective Potency Assays to Test Therapy Efficacy


  • Identifying markers and characteristics that predict clinical effectiveness to measure in assays
  • Establishing potency assays to assess the actions and functions of iPSC products to safeguard cell activity
  • Certifying that iPSC products have potency levels of original cells through assays

5:00 pm Close of Conference Day One & Drinks Reception