8:30 am Virtual Coffee Networking

8:50 am Chair’s Opening Remarks

  • Evren Alici Head of Cell & Gene Therapy, Karolinska Institutet

Allogeneic Cell Therapies: Current Findings & Looking to the Future

9:00 am Keynote Panel: Achieving an Off-the-Shelf Future for Europe

Synopsis

  • An executive panel discussion from the C-level leaders in the allogeneic cell therapy field
  • Understand their thoughts about the future of off-the-shelf therapies
  • Ask your questions to understand expert’s thoughts on key topics including cell type, viral vs non-viral vectors, persistence, gene engineering, and more

10:00 am Kiadis Off-the-Shelf NK Therapeutics: Universally Applicable to a Wide Variety of Patients and Continents

  • Robert Igarashi Head of Kiadis Research, Kiadis Pharma - A Sanofi Company

Synopsis

  • Describe Kiadis cell-free base expansion technology
  • Applicable for a wide variety of patients – truly “off-the-shelf”
  • Share clinical supporting information

10:30 am Speed Networking

Synopsis

Like speed dating, but for business! Turn on your camera and randomly connect
with speakers, delegates and partners of the conference so you can meet as many
people as possible. Your random connection could lead to your next collaboration!

11:00 am Refreshment Break

Synopsis

Take this time to go for a walk, make a coffee, or reach out to your colleagues on
the online chat feature and schedule a video call!

Tackle the Challenge of Manufacture Scale-Up to Achieve Off-the-Shelf Products

11:45 am Allogeneic Manufacturing on the Crossroads between Bioprocess and Cell Therapy: Critical Raw Materials and Scale Up

Synopsis

  • Discussing the impact of serum and other undefined reagents in the scalability of
    allogeneic therapies
  • Closed process liquids essential for aseptic manufacturing at scale
  • Understanding the importance of security of supply

12:00 pm Becoming Cell Therapy “Makers”: Opportunities and Challenges Regarding In-House Manufacturing of Allogeneic Cell

Synopsis

  • Outline the pros and cons of manufacturing in house
  • Review the regulatory aspects that must be considered
  • Describe how to best troubleshoot when problems arise

12:30 pm Understanding the Key Considerations to Achieve Large Scale & Commercial Manufacture

Synopsis

  • Cellectis’ integrative approach with an industrial manufacturing platform and established end-to-end supply chain
    – US based large-scale production plant with state-of-the-art technology to manufacture products for clinical development and future commercial use
    – European based production plant of starting materials (plasmids, RNAs, and vectors)
  • Strategic and technical considerations when manufacturing allogeneic CAR-T therapies: process and analytical development strategies, scaling-up and technology transfers

1:00 pm Refreshment Break

Optimise Cryopreservation & Cold Chain Logistics to Store Therapies Whilst Maintaining Potency & Functionality

2:00 pm Cryopreservation of Allogeneic Cells: An Academic’s Perspective

  • Roland Fleck Professor of Ultrastructural Imaging, King’s College London

Synopsis

  • Principals of slow and rapid cryopreservation with their respective pros and cons
  • DMSO – is efficacy balanced by toxicity?
  • Opportunities for clinical cryopreservation and key considerations for scale-up

2:30 pm Exploring Early Consideration & Planning for Logistical Success

  • Shree Patel SVP Global Clinical Operations & Supply Chain, Achilles Therapeutics

Synopsis

  • Patient supply chain operations, translating learnings from an autologous to an allogeneic setting
  • The importance of considering logistics early in process development
  • Considering how cell type and shelf-life impacts product transportation

3:00 pm Refreshment Break

Address Clinical Trial Set-Up in Europe to Effectively Run Multi-Centric Trials

3:30 pm Off-the-Shelf NK Cells in European AML Clinical Trial

Synopsis

  • Phase I/II a clinical trial in AML ongoing in the EU
  • First outcomes at low doses
  • Upcoming geographical and indication expansion

4:00 pm Academic to Commercial Development of an Off-the-Shelf Allogeneic ATMP: Three Clinical Trial Case Studies

  • Mark Lowdell Professor of Cell & Tissue Therapy, University College London

Synopsis

  • Demonstrate the need for a target-product profile even at the time of preclinical development – lessons learned
  • The importance of planning for success even at phase I in development of the product CMC
  • The importance of choosing the correct disease setting for first-in-human trial
  • How to repurpose an ATMP which struggles in first-in-human trial

4:30 pm Chair’s Closing Remarks & Close of Day 1