February 2019
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Day One
Wednesday 21st February, 2018

Day Two
Thursday 22nd February, 2018

08.00
Breakfast & Networking

09.00
Chairman’s Opening Remarks

Innovations for Global CAR-TCR Commercialisation

09.30
Developing a Supply Chain that is Tailored for Personalized Cell Therapy

Synopsis

  • Integrated Supply Chain Planning to Facilitate Cell Journey
  • Integrated Tracking and Delivery Solution from Apheresis Collection to Final Product
  • Active Supplier Engagement to Deliver Product Quality

10.00
Creating a Highly Innovative Cell Production Platform for a CDI9 CAR in Lymphoma

Synopsis

  • Latest clinical trial data in lymphoma
  • Proprietary Streptamer™ reversible reagents for cell therapy manufacturing
  • A fully automated process enabling a high recovery of T cells
  • Selective expansion and activation while decreasing processing time and costs

10.30
Creating a Universal Donor based Cell Therapy

  • Thierry Wurch Director. Immuno-Oncology External Research & Innovation, Servier

Synopsis

  • How to make off-the-shelf, industrialized CAR-TCR therapies?
  • Safety of Allogeneic therapies
  • Durability of allogeneic CAR-Ts
  • Requirements of Allogeneic products
  • Developing allogeneic or universal donor cell therapies
  • Current progress in allogenic space

11.00
Morning Refreshments & Networking

Improving Cell and Process Quality for Flawless Transactions

11.30
BD Solutions in Cell Therapy Development and Production

  • Gert Boschman Scientific Affairs Director Europe , BD Biosciences

Synopsis

  • In depth-characterization of cell preparation is central to the optimization of cell production and the development of successful cell therapies. Fluorescent Activated cell sorting (FACS) delivers a unique solution, providing high-content information at the
    single cell level.
  • The BD FACSLyric™ cell analyzer enables standardization and consistency across instruments, time, operators and sites making it an ideal platform for the evaluation of cell preparations and release test development.
  • BD FACS™ cytometer systems can be matched with custom, dried reagent panels and automated analysis for further improvements in consistency and standardization.
  • Achieving a high yield of one specific cell population is a key step toward successfully developing cell therapies. A currently in development BD sorter aims to provide an approach to achieving high purity and protected sterility for your cell populations.

12.00
Development of TCR-engineered T Cell Therapies for solid tumors: From Target to T Cell Product

Synopsis

  • Immatics has a proprietary tumor antigen targets discovery platform, XPRESIDENT® The platform not only identifies novel tumor-specific targets, but also screens TCR candidates against off-target toxicities in absence of reliable in vivo models
  • Selected TCRs against these specific peptide targets are used in Immatics’ TCR-based ACTengine® programs (Adoptive Cellular Therapy with autologous engineered T cells)
  • Extensive process development was carried out using primary T cells derived from multiple healthy donors to optimize each step in the manufacturing of IMA201 and IMA202 products and confirmed using T cells from cancer patients
  • Process Qualification runs were successfully completed in GMP environment for both engineered TCR T-cell products in anticipation for patient enrolment in 2 clinical trials IMA201-101 and IMA202-101

12.30
Lunch & Networking

Ensuring Cost Effective Scalability: Up & Out

13.30
Automated Manufacturing of Clinical-Scale Gene-Engineered T Cells Using the CliniMACS Prodigy

Synopsis

  • Manufacturing gene-engineered T cells like chimeric antigen receptor (CAR) T cells is both time consuming and labor intensive. The CliniMACS Prodigy is a device for the automated production of CAR T cells
  • Manufacturing occurs in a single-use closed tubing set that protects the user and sample from contamination
  • Our CliniMACS Reagents have been developed ready to be easily used with the CliniMACS Prodigy
  • Using the CliniMACS Prodigy, we can expand CAR T cells ready for adoptive cell therapy. The future is here

14.00
Improving CAR Gene Delivery by T-Cell Targeted Lentiviral Vectors

  • Jessica Hartmann Research Unit for Molecular Biotechnology and Gene Therapy, Paul Ehrlich Institute

Synopsis

  • Viral vectors can be engineered to enable cell type selective gene delivery
  • Binding domains for receptor re-targeting can be derived from antibodies or selected from DARPin libraries
  • These novel vectors facilitate the process of CAR gene delivery into defined T cells subsets
  • High transduction efficiencies even at low MOIs can be reached with receptor targeted LVs
  • CAR gene delivery to T cells in vivo may become possible in the future

14.30
Development of First Manufacturing Process to Produce CAR-Treg Cells for Clinical Use

Synopsis

  • TxCell has completed the development of its first-generation production process for its
    proprietary CAR-Treg technology
  • TxCell has isolated a subset of Treg cells that have shown to be stable and to display a
    strong anti-inflammatory activity
  • Despite the rarity of the selected Treg subset, TxCell has successfully produced its CARTreg
    cellular product within two weeks (before post-production quality control)
  • IND and/or CTA filing is planned in Q4 2018 in order to launch first-ever CAR-Treg
    clinical trial in solid organ transplantation
  • TxCell will transfer its process to a CMO before the start of this first-in-man trial

Streamlining Logistics for Global CAR-TCR Therapy Delivery

15.00
Panel: Logistics, Scheduling and Supply Chain Management

Synopsis

  • Supply chain for autologous therapies vs allogeneic
  • Commercialization of CAR-T product
  • CAR-T global delivery strategies
  • Logistics and case management for improved distribution of therapy
  • Ensuring global supply chain and distribution of CAR-T’s
  • Digital integration of supply chain for streamlined delivery
  • Next generation analytics and data science to inform CAR-T commercialization
  • CAR-T cell cold chain shipping and storage

16.00
Chairman’s Closing Remarks & Close of Summit