7:50 am Registration & Morning Coffee

Paving the Path to Success With Next Generation Innovations

8:50 am Chair’s Opening Remarks

9:00 am Evolution of Anti-Rejection Strategies for Allogeneic Cell Therapy

9:30 am Next Generation Cancer Immunotherapy: CAR-CIK Manufacturing Process

Synopsis

  • Made from allogeneic healthy donor cells
  • No leukapheresis required
  • No cell purification steps
  • Non-viral gene transfer method

10:00 am Showcasing Safety & Clinical Activity of Next Generation Allogeneic Product to Overcome Patient Relapse

10:30 am Presentation by BioSharing Network

10:40 am Morning Refreshment Break & Tech Slam

Synopsis

Quickfire 10-minute presentations on innovative technologies in the space.

Pre-Clinical

Supercharging Solid Tumor Targeting for Broader Success

11:30 am Developing CAR-NK Therapies for Solid Tumors

  • Guanghui Hu Chief Executive Officer, Naki Therapeutics

Synopsis

  • We are developing a “combination” CAR-NK therapy (integrating IL15 with anti-CD147 CAR-NK) that has shown a great promise in treating solid tumors in pre-clinical studies
  • We have also developed a NK / CAR-NK cell expansion technology platform with great expansion efficiency and fidelity

12:30 pm Unlocking the Potential of Gamma Delta TCRs as a Safe and Effective Target Mechanism

Synopsis

  • Using Gamma-Delta TCRs as a mechanism for allogeneic therapies to move into solid tumors
  • Showcasing platform for discovery of true targets for solid tumors whilst developing T cell receptors for robust and specific T cell response against new targets

Translational

Conquering the Tumor Microenvironment to Drive Efficacy of Response

11:30 am Unlocking the Groundbreaking Potential of iNKT Cells for Allogeneic Cancer Therapy

  • Michael Baker Chief Executive Officer & Managing Director, Arovella Therapeutics

Synopsis

  • Arovella is developing its novel iNKT cell therapy platform to develop allogenic cell therapies to treat cancer.
  • Arovella is initially targeting haematological malignancies with its lead product ALA-101. Through a strategic collaboration with Imugene, Arovella will use ALA-101 to target solid tumours.
  • Arovella is also developing its DKK1- CARiNKT cells to target multiple myeloma and solid tumours

12:30 pm Full Landscape Overview of the Allogeneic Cell Therapy Space

Synopsis

  • Assessing how allogeneic cell therapies align with the rest of the cell therapy landscape
  • What does the existing allogeneic landscape consist of and how has it changed over recent years?
  • Insights into potential trends and the potential future of allogeneic therapies for oncology

Manufacturing

Driving Automated Manufacturing Processes for Successful Commercialisation of Allogenic Therapies

11:30 am Developing a New Generation of Manufacturing Tools to Meet the Needs of Allogeneic Products

  • Jim Green Senior Director Platform Engineering and Automation, Bayer

Synopsis

  • Our journey towards developing an automated, modular, single-use, end to end allogeneic manufacturing platform.
  • Combining our internal equipment characterization, PAT, process engineering and process science expertise with external partners to realize our vision.

12:30 pm Roundtable: Leveraging Automation to Minimizing Time & Cost of Batch Release

  • Jim Green Senior Director Platform Engineering and Automation, Bayer

Synopsis

  • Using robotics for process measurement, monitoring efficiency and quality of manufacturing processes
  • Implementing automated filling devices for filling of product containers, inspection, labelling and getting products ready to be frozen.
  • Integrating fast release methods with automatable technologies such as PCR and flow for sustainable execution and data processing
  • Discussing gold standards in batch release for off-the-shelf therapies, and reducing lot-to-lot variability

Supply/Storage

Enhancing Cold-Chain Shipping & Storage to Deliver Truly Off-the-Shelf Products

11:30 am Innovating Sophisticated Digital Tools to Establish a Data Management/ Integration System Equipped to Handle Complex Allogeneic Products

Synopsis

  • As next generation allogeneic products become more complex, how can we develop tools to manage more data and processing volumes?
  • Digitalising the supply chain for greater control and tracking of raw material source, supply and quality

12:30 pm Knowledge Management with Flexible Platform Processes

  • Amol Thote Senior Director - Cell Therapy Capability & Biologics Development, Bayer

Synopsis

  • The complexity and diversity of Cell Therapy processes make them difficult to standardize.
  • Utilizing a standard taxonomy with a phase-appropriate control strategy leverages previous knowledge and allows rapid implementation of new processes

1:00 pm Lunch Refreshment Break & Networking

Pre-Clinical

Pioneering the Next Innovations in Gene Engineering for Enhanced Efficacy of Response

2:00 pm SEAKERs: Targeted Cellular Micropharmacies that Generate Small- Molecule Drugs in situ

  • Derek Tan Member and Chair, Chemical Biology Program, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center

Synopsis

  • SEAKER (Synthetic Enzyme Armed KillER) cells are CAR-T cells engineered to activate small-molecule prodrugs locally at tumor sites
  • SEAKER platform is modular and can incorporate different engineered cells, antigen targets, and enzyme–prodrug combinations in vitro and in vivo proof-of- concept has been established for the SEAKER approach using two different enzyme–prodrug combinations

2:30 pm Roundtable: Developing an Advanced Engineering Strategy to Develop Novel Constructs with Increased Cell Persistence & Expansion

Synopsis

  • Delving into the importance of cell performance and expansion to achieve success in the solid tumor setting
  • Introducing cytokine support to enhance downstream signalling
  • Discussing the balance between long lasting persistence versus the efficacy of the transient allogeneic product

Translational

Unveiling the Tools and Strategies to Maximize Efficiency in IND Filing

2:00 pm Discussing Early Phase Considerations in Preparation for IND Meetings

  • Donna Rill Chief Technology Officer, Triumvira Immunlolgics

Synopsis

  • Exploring what the ideal IND packages looks like in terms of necessary data etc
  • How to prepare for and run a pre-IND meeting for complex allogeneic products
  • Dissecting the ‘moving parts’ of an IND, such as manufacturing, viral vectors, cell sources, to line up timelines for parallel development
  • Gaining and implementing feedback on trial design

2:30 pm Applying a Phase Appropriate Approach to the Development of Cell Therapeutics Processes and Analytical Methods

  • Amnon Eylath VP Head of Global Quality, Minovia Therapeutics

Synopsis

  • Review how Phase Appropriate GMP applies to Cell Therapy Product Development
  • Explore product development
  • Explore Analytical Method Development

Manufacturing

Reviewing the Paradigm of Characterization & Strategical Viability Testing

2:00 pm Standards and Strategies for Establishing Fit-For-Purpose Analytical Methods for Cell Therapy Product Characterization

Synopsis

  • Update on standards available/under development for cell characterization
  • Public-Private partnerships for cell and gene therapy analytical method development
  • Description of an approach to establish fit-for-purpose cell viability methods that are relevant to a cell manufacturing process

2:30 pm Characterizing Raw Starting Materials & Product for Quality, Safety & Efficacy

  • Yu Qian Associate Director, CMC, Cell Therapies, Takeda

Supply/Storage

Revolutionizing Data Management & Process Integration

2:00 pm Cell Therapy Lab / Cell Pharmacy : The Resources Needed for the Onboarding of Cell Therapy Products

  • Albert Ribickas Blood, Marrow Transplant Laboratory, Clinical Trial & Commercial Product Handling Team Manager, Moffitt Cancer Center

Synopsis

  • The field currently
  • Staff, Space, and the Challenge of New Products
  • Standardization – Where do we begin?

2:30 pm Advancing Phase Appropriate Modifications Required for Allogeneic Products

  • Albert Ribickas Blood, Marrow Transplant Laboratory, Clinical Trial & Commercial Product Handling Team Manager, Moffitt Cancer Center
  • Stephen chen CTO, Tevogen Bio

Synopsis

  • Maintaining reproducibility and consistency of cell products through end-to- end development
  • Enabling bulk expansion and storage of allogeneic therapy, considering the conditions needed to keep cells viable
  • Discussing the impact of different SOPs on the cold supply chain

3:00 pm Afternoon Refreshment Break & Networking

Ushering in the Next Wave of Universal Cell Therapy – Future Directions

3:30 pm B Cells as a Novel Off-The-Shelf Cell Therapy

Synopsis

  • CRISPR/Cas gene editing results in high efficiency B cell engineering
  • B cells can be differentiated into long lived plasma cells
  • Plasma cells have naturally allogeneic properties that make them ideal for cell therapy

4:00 pm Development of iPSC-Derived Gamma Delta T Cell Therapies for Treatment of Liquid & Solid Tumors

Synopsis

  • Harnessing the power of induced pluripotent stem cells (iPSCs) to develop novel allogeneic CAR-T cell therapies for cancer
  • Multiplex engineering of iPSCs to develop allogeneic Gamma Delta T cells that can safely and effectively mediate anti-tumor immunity
  • CAR design strategies that address disease-specific challenges

4:30 pm Developing Next-Generation Allogeneic Therapies for Solid Tumors Based on Gamma Delta T cells

Synopsis

  • Discussing characteristics of gamma delta T cells as source for an allogeneic cell therapy approach
  • Redirecting gamma delta T cells with TCRs against peptide-HLA targets to combat solid tumors
  • Exploring next-gen strategies to potentiate anti-tumor activity

5:00 pm Closing Remarks and Close of Conference