February, 2020 London, UK

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

PRE-CONFERENCE WORKSHOP DAY

MONDAY 25TH FEBRUARY

Workshop E

8.00-10.00 Understanding Clinically-Relevant Antigen-expression Thresholds for TCR & CAR-T Cells to Drive Next Generation Cell Therapies in Solid Cancer

  • Explore novel targets for new therapeutic windows by discussing patient population mapping, considerations on dose selection and predictive engineering
  • Explore clinical responses in patients with high and low expression of NY-ESO to understand the effect antigen expression and expansion on the durability of a response
  • Identify the antigen-thresholds in NSCLC that drive functional responses in TCR-T cells in vitro
  • Outline additional engineering necessary to enhance efficacy of TCR-T cells in solid tumours with preclinical data outlining co-expression of dominant negative receptor for TGF Beta

Cedrik Britten, Head Oncology Cell Therapy Research Unit, GSK

 

 

 

Workshop B

8.00-10.00 Manufacturing Challenge and Opportunity for Global Clinical Trial of CAR-T Cell Therapy

  • Discuss challenges and considerations in the manufacturing of CAR-T cell product for solid tumour treatment
  • Explore the CMC regulatory challenge and solution in support of the global clinical trial of CAR-T cell therapy
  • Opportunities in the development of standardized manufacturing process to reduce cost and improve process consistency

Jie Jia, Vice President, Strategic Alliances CARsgen Therapeutics

 

10.00 Morning Refreshments

Workshop C

11.00-13.00 Can we CRISPly Treat any Patient to Create a Potent, Safe CAR-T Therapy?

  • Explore current strategies to gain IND approval of allogeneic CAR-T to initiate clinical trials
  • Gain a clear understanding of the benefits of allogeneic therapy compared to autologous
  • Optimise the building of CAR products through precise CRISPR editing  to reduce off-target effects creating a safer therapeutic
  • Learn strategies to enhance CAR potency in solid tumours and the challenges this environment provides
  • Understand methods to overcome the suppressive nature of the tumour microenvironment with synthetic biology to prevent T cell exhaustion and initiate endogenous immune response

Tony Ho, Executive Vice President, Head of Research & Development CRISPR Therapeutics

Workshop D

11.00-13.00 Optimize the Planning of Regulatory Applications to Initiate Clinical Trials in Desired Timeframes

  • Discuss experience initiating both US and EU clinical trials and various hot topics including: scientific advice, non-clinical prerequisites, CMC considerations & first-in-human clinical trials considerations
  • Outline of Clinical Trial Authorisation (CTA) applications required including the different tiers of approval required for such products such as, genetically modified organism notifications in the EU versus institutional biosafety committee (IBC) approval in the US and focusing on their different requirements
  • Review logistical considerations around the traceability of patient starting material to be equipped for advanced planning of clinical and or commercial strategy
  • Leave this workshop with key highlights to optimize the planning for your regulatory applications and be prepared to meet the expectations of the different authorisations to speed up your approvals

Vicki Coutinho, Senior Director, Regulatory Affairs, Autolus

 

13.00 Lunchtime Refreshments

Workshop A

14.00-16.00 Discovery of Novel Targets and T-cell Receptors for Cancer Immunotherapies

  • Outline XPRESIDENT; a unique platform for identification, selection and validation of novel cancer targets
  • Understand how XPRESIDENT can guide the discovery and toxicity screening for novel T-cell receptors
  • Explore the clinical application of novel targets and TCRs

Harpreet Singh Chief Executive Officer Immatics

Workshop F

14.00-16.00 Payment and Reimbursement for CAR-T: Elements for Selective Contracts

  • Gain an overview of the perspectives and positioning of payers in Europe
  • Advance your understanding of differences between health insurers and their views on market access, payment and reimbursement
  • Understand how CAR-T as a “hospital only drug” is reimbursed in Germany according to hospital reimbursement regulations
  • Review how CAR-T is assessed by Germany's health technology assessment body G-BA, within AMNOG assessment framework, to have a clear understanding of what data is required for approval
  • Determine how to include elements like risk-share and pay for performance in selective contracts in the triangle of manufacturers, hospitals and health insurance companies to secure accessible reimbursement arrangements

Detlev Parow, Head of Pharmaceutical Tools, DAK-Gasundheit

Menno Aarnout, Executive Director
International Association of Mutual Benefit Societies

16.00 Evening Refreshments