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
  • David Main President & Chief Executive Officer, Notch Therapeutics

Synopsis

  • 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

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

Synopsis

  • 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

Synopsis

  • 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

DISCOVERY & TRANSLATION TRACK

1:00 pm Boosting Genetic Engineering of iPSCs to Prevent Genetic Instability

Synopsis

  • Maximizing on-target editing to ensure higher yields of stable cells
  • Improving efficiencies of multiplex targeting to reduce genetic variation
  • Distinguishing the optimal time to edit iPSC cells to enhance editing efficiency

Turbocharging Gene Editing to Boost iPSC Therapies While Redefining Safety

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
  • Ryan Crisman Co-Founder & Chief Technical Officer, Umoja Biopharma
  • Gregory Fiore Chief Executive Officer, Exacis Biotherapeutics

Synopsis

  • 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

Synopsis

  • 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

CMC & REGULATORY TRACK

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

  • John Lu President & Chief Executive Officer, HebeCell

Synopsis

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

Synopsis

  • 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

2:30 pm Considerations for Allogeneic Cell Therapy Development

Synopsis

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

3:00 pm Afternoon Refreshments & Poster Session

4:00 pm Engineering an Autologous iPSC Therapy for Limb-Girdle Muscular Dystrophy

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

Synopsis

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

Exploiting iPSC Product Potency to Maximize Therapeutic Efficacy

4:30 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

Synopsis

  • 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

5:00 pm Modifying Administration to Boost iPSC Product’s Ability to Work

Synopsis

  • 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

Synopsis

  • 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

Synopsis

  • 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

Tackling Materials & GMP Challenges to Turbocharge Preclinical & Clinical Development

5:00 pm Transferring from Research to GMP Protocol & Materials to Mediate Smooth Transition to the Clinic

  • Emily Titus Senior Vice President, Technical Operations, Notch Therapeutics

Synopsis

  • Ensuring your differentiation protocol is GMP grade to guarantee therapeutic potential
  • Securing a stable supply of GMP materials to mitigate risk and safeguard availability
  • Certifying donor cells are GMP compliant to assure patient safety and conformity to regulations

5:30 pm Chair’s Closing Remarks

5:35 pm Close of Conference Day One