25-27 February, 2019London, UK

250+Attendees ♦ 40 World Class Speakers   33+ Case Studies ♦ 2 Tracks  6 Deep Dive Discussion Sessions 

Day One
Tuesday 26th February, 2019

Day Two
Wednesday 27th February, 2019

07.15
Coffee & Registration

08.15
Chairman’s Opening Remarks

Synopsis

Andrew Sewell, Research Director of the Institute of Infection and Immunity, Cardiff University

08.45
Cell Therapy Manufacturing and Commercialization: Challenges and Opportunities

Synopsis

Adrian Bot, Vice President of Translational Medicine, Kite, a Gilead Company

09.15
Industry Leaders’ Fireside Chat

Synopsis

With the first CAR-T product approved in Europe, what are the next steps and where do we go now?

Take this opportunity to ask the leaders what their future plans are and what we can expect from the CAR-TCR space over the next few years.

Topics to be discussed:

  • Is the future of CAR-T off-the-shelf?
  • Perspectives on the clinical potential of novel and innovative next generation CAR-T products
  • Experience with the setting up and running of clinical trials in Europe
  • Strategies to reduce the overall cost of CAR-T therapeutics acknowledging manufacturing processes and hospitalisation costs
  • Regulatory challenges when applying to different fragments of the EMA

10.15
The Need for Decentralisation in Closed Loop Supply Chain Management

Synopsis

  • Take a closer look at closed loop supply chain processes of personalized medicine
  • Learn how distributed ledger technology can secure and optimize the chain of identity and custody of personalized medicine

Andreas Göbel, Managing Director, Hypertrust Patient Data Care

10.45
Speed Networking & Morning Refreshments

11.45 Circumventing Tolerance – the Mouse as a TCR Factory

  • Humanized mice as a TCR factory
  • Outline optimal TCR affinity
  • Report on preclinical screening of toxicity

Elisa Kieback, Chief Executive Officer, T-knife

12.15 Next Generation TCR-T Cell Therapies Can Offer Improved Safety and Enhanced Efficacy

  • Review the need for cutting-edge in vitro technologies to fill a critical gap in pre-clinical safety and efficacy studies of TCR-T therapies in the absence of adequate animal models
  • Evaluate how genetic modifications of recipient T cells can give them additional capacity to display enhanced functions in hostile tumour microenvironments
  • Turning negative signals into positive signals through expression of chimeric co-stimulatory proteins to enhance effector cell functions and overcome negative effects of tumour cells

Dolores Schendel, Chief Executive Officer & Chief Scientific Officer, Medigene

12.45 Screening CAR-T Cells for Target Specificity using Human Cell Microarray Technology

  • Discuss how to outline the optimisation of the human cell microarray technology for off-target screening of whole engineered CAR-T cells, in addition to antibodies and ScFvs
  • Explore an efficient approach for specificity screening of novel cell therapies to support safety assessment and provide key data prior to IND submissions

Jim Freeth, Co-managing Director, Retrogenix

11.45 Process Development and Manufacturing Strategies for ATMPs

  • Advance process development of primary T-cell using an automated high throughput microbioreactor system
  • Increase the control of raw materials to significantly reduce variation and improve process consistency, resulting in fewer batch failures and reduction in overall process cost
  • Establishing the development of an automated manufacturing facility for the scalable production of ATMPs

Qasim Rafiq, Senior Lecturer in Bioprocessing of Regenerative, Cellular & Gene Therapy, UCL

12.15 Current Strategies to Reduce Cost of Manufacture

  • Explore the optimal T cell phenotype which does not require extensive culture times
  • Discuss how off-the-shelf therapy reduces cost of manufacture as autologous therapy requires a new supply chain for every patient and less manipulation results in less contamination and simplicity in process

Juan Vera, Chief Development Officer, Marker Therapeutics

12.45 The Future of CAR-T Cell Manufacturing

  • Adopting the CliniMACS Prodigy T Cell Transduction process for fast clinical development
  • Assess the characterization of of CAR T cell manufacturing process and final cell product
  • Upscaling the CAR T cell production process

Michael Papadimitrious, Product Manager for Clinical Engineered T Cells, Miltenyi Biotec

13.15
Lunch & Networking

14.15 Allogeneic CAR-T Reality and Future Directions

  • Overview of current allogeneic approaches
  • Update on Serviers’ 1st allogeneic CAR-T cell product
  • Explore future directions for allogeneic CAR-T

Véronique Blanc, Immuno-oncology Program Director, Servier

14.45 Development of “Off-the-Shelf” Allogeneic CAR-T Cells

  • Hear gene editing approaches to produce allogeneic CAR-T cells devoid of Graft-Versus-Host potential
  • See preclinical data as well as first clinical results
  • Discuss the main challenges associated with allogeneic therapy and present the different ways of improvement

Ioana Kloos, Deputy Chief Medical Officer, Cellectis SA

15.15 In Situ Monitoring of CAR-TCR Cell Therapy: Tumor Infiltration, Efficacy, and Adverse Events

  • Hear gene editing approaches to produce allogeneic CAR-T cells devoid of Graft-Versus-Host potential
  • See preclinical data as well as first clinical results
  • Discuss the main challenges associated with allogeneic therapy and present the different ways of improvement

Kai Wilkens, Senior Director Europe ACD, Bio-Techne

Yescarta Case Study

14.15 Two Year Follow up in the Registrational Study for Yescarta®, a First-in-Class CAR-T Cell Product for Large B Cell Lymphomas: Key Learnings to Date

  • A description of product design, manufacturing and major phenotypic and functional attributes
  • The concept of “T cell fitness” as key product attribute influencing clinical product performance of CAR T cells
  • Mechanisms of CAR treatment activity and toxicities, leading to product, treatment and platform optimization strategies

Adrian Bot, Vice President of Translational Medicine, Kite, a Gilead Company

14.45 Novel Supply Chain Routes to Enhance Accessibility and Cost Efficiency

  • Reflect on industry experience in site selection of geographical distribution centres to increase patient accessibility
  • Explore methods to reduce cost of supply chain logistics for patient specific therapies
  • Optimise current tracking processes to monitor logistics

Marc Kamp, Director CAR-T Product Distribution & Supplier Quality Management, Kite Pharma

15.15 Regulatory Considerations on the Path to MAA

  • Regulatory considerations on the path to MAA
  • Insights from the first CAR-T marketing approval
  • Regulatory guidelines vs. reality

Maureen Graham, Managing Director, Diamond Pharma Services

15.45
Afternoon Refreshments & Poster Session

16.15 Panel Discussion: The Future of CAR-T Therapy with Next Generation Technology

  • Explore the benefits of next generation CAR-T products to overcome the tumour microenvironment and antigen escape
  • What are the common challenges that need to be addressed?

Stefanos Theoharis, Senior Vice President, Corporate Development & Partnering, Cell Medica
Tony Ho, Executive Vice President, Head of Research & Development, CRISPR Therapeutics
David Gilham, Vice President, Research & Development, Celyad

16.45 Hairpins and Peptides: Development of a Non-Gene Edited Approach for Allogeneic CAR-T Cell Therapy

  • Discuss our first non-gene edited approach which involves the co-expression of a peptide inhibitor of T cell receptor signaling with a NKG2D-based CAR which achieved FDA approval in 2018
  • Evaluate our next generation approach involving RNA interference to disrupt the TCR thereby providing a platform approach for allogeneic CAR T cell therapy

David Gilham, Vice President, Research & Development, Celyad

17.15 Non-viral Gene Transfer to Commercialize T-cell Therapies

  • Understand the role of DNA plasmids from Sleeping Beauty (SB) system to reduce the cost and complexity of manufacturing T cells which express chimeric antigen receptor (CAR) and T-cell receptor (TCR)
  • Exploit personalized T-cell therapy using DNA plasmids from SB system to target neoantigens from solid tumours
  • Identify the expression of cytokines to improve the therapeutic potential and improve safety of genetically
    modified T cells

Laurence Cooper, Chief Executive Officer, Ziopharm Oncology

16.15 Panel Discussion: Explore the Need to Reduce the Cost of Manufacturing in Order to Ensure Feasible Reimbursements

  • Discuss the future of CAR-T manufacture to ensure accessibility of therapy
  • Explore the current strategies to reduce expensive processes and streamline methods
  • Review time of manufacture vs. time to patient

Laurence Cooper, Chief Executive Officer, Ziopharm Oncology
Qasim Rafiq, Senior Lecturer in Bioprocessing of Regenerative, Cellular & Gene Therapy, UCL
Therese Solstad Saunders
, Senior Advisor, Head of Quality Assessment of Biological Medicinal Products, Member of CHMP’s Biologics Working Party, EMA

Enhance Final Products through Analytics and Process Development

16.45 Process Development of CAR-T Cell Manufacturing

  • Optimisation of the CAR-T cell manufacturing process and analytics to supply clinical trials
  • CMC challenges of product consistency and scale to enable widespread distribution and commercialization of CAR-T cell technology

Emma Chan, Senior Scientist, Process Development, Autolus

17.15 Cellular Characterisation by Flow Cytometry of CTL019 Final Product

  • Review the final characteristics and phenotype of the final product for Pediatric ALL
  • Contrast this to the final product for DLBCL
  • Discuss the characterisation of cell products and how they relate to the overall safety and efficacy of the CAR-T therapy

Therese Choquette, Analytical Project Leader, Cell & Gene Therapy Development and Manufacturing, Novartis

17.45
Chairman’s Closing Remarks

18.00
End of Day 1