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"Realising the promises of next generation therapies"

Day 1 - Monday 23rd October 2023


  • Setting the scene: comparison of rare disease/CGT and traditional pharma
  • The importance of stakeholder engagement: perspectives across different functions
  • Creating a CGT platform: stakeholder engagement as a tool to support not only the
    development/commercialization of specific assets, but to build a sustainable platform
  • Complex challenges and key considerations for cell & gene therapy development
  • Pre-clinical solutions to address scientific, regulatory, and commercial risks to accelerate development
  • How to maximize the potential and simplify the transition from basic cell therapy research to clinical manufacturing and beyond
  • Current trends and innovations to advance cell & gene therapies

Wenliang Dong, Chief Operating Officer, ORCA Therapeutics B.V.
Alejandro Fernandez-Martell, Former Principal Bioprocess Engineer, Achilles Therapeutics

  • Challenges and obstacles in bringing this highly complex therapies to market
  • Stakeholder collaboration on the road towards a solution
  • Lessons learned and applications for new entrants
  • Strategies that can be taken to improve timely market access and access for patients

Doug Danison, Head of Commercial, Cell and Gene Therapy Unit, Bayer

  • Standardized approaches being developed to address complexity of trial design and lack of
    experience with CGT trials
  • Considerations to overcome constraints in manufacturing capacity
  • Strategies and best practices in facilitating patient recruitment and retention in CGT clinical trials


  • T-Cell Receptors modified T-cell therapies (TCR-T) unlock immense tumour-selective target space
  • Identifying the best targets and TCRs requires a systematic Precision Biology approach.
  • Precision Biology platform that uses programmable human cells to systematically map the target space and engineer TCRs.

Reagan Jarvis, CEO and Co-founder, Anocca

Zhimei Du, VP, Process Sciences, Atara Biotherapeutics

  • PDC*line is a new potent and scalable therapeutic cancer vaccines based on a proprietary allogeneic
    cell line of Plasmacytoid Dendritic Cells
  • PDC*line is much more potent to prime and boost antitumor antigen, including neoantigens, specific
    cytotoxic T-cells than conventional vaccines and improves the response to checkpoint inhibitors
  • The technology can be applied for any cancer

  Eric Halioua, President & Chief Executive Officer, PDC*line Pharma

  • Introduce the development of novel gene therapies
  • Introduce pivotal non-clinical studies
  • Discuss the relevant non-clinical considerations within the context of a case study of a novel gene

Mark Singh, Non-Clinical Manager, Cell and Gene Therapy Catapult

  • Muscular dystrophies as paradigm for orphan drug development
  • Most promising gene therapy strategies for the treatment of muscular dystrophy
  • Future perspectives; orphan drugs in the pipeline

Alberto Malerba, Lecturer in Gene Therapy, Royal Holloway University of London

  • Present innovative approaches for flexible Cell Therapy facility design solutions.
  • Provide an overview of the latest Cell Therapy manufacturing technologies.
  • Outline the benefits of implementing robust methods of process closure in the manufacturing
  • Discuss sustainability factors associated with the design of modern manufacturing facilities.
  • Outline how all these factors can increase speed to market while reducing the environmental footprint
    of a facility.

Stephen Judd, Process SME – Biologics / Cell & Gene Therapy, DPS Group

  • Why we need to consider the long-term when developing processes, even at phase I
  • When is it appropriate to consider automation?
  • Why automation early in the product development lifecycle matters.

Stuart M Curbishley, Chief Manufacturing and Development Officer, adthera

  • Current GMP and general process validation concepts and practices that applies to CGT manufacturing
    processes and analytical methods
  • Key challenges in analytical method validation and proposed solutions.
  • Extensive regulatory requirements for a controlled validation
  • Robust CMC package that creates a path toward commercialization
  • Vigorous process validation strategy through the life cycle of these novel therapies


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