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CELL & GENE THERAPY WORLD CONGRESS 2023 EUROPE

"Realising the promises of next generation therapies"

Day 1 - Monday 3rd July 2023

  • 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

Panelist: 

Zhimei Du, MD/PhD,  VP of Process Sciences, Atara Biotherapeutics

Wenliang  Dong, Chief Operating Officer, ORCA Therapeutics

OVERVIEW, CURRENT LANDSCAPE & FUTURE TRENDS

  • 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

PANELIST:
Wenliang Dong, Chief Operating Officer, ORCA Therapeutics B.V.

  • 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

Marianthi Psaha, Global Head Cell & Gene Therapy, Santen Pharmaceutical

  • 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

Amir Hefni, Global Head, Cell & Gene Therapy, Novartis

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
    therapy

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

  • Leveraging success of gene therapy pioneers to enable accelerated development
  • Front-loading manufacturing investment to reduce clinical trial timelines
  • Bloomsbury Genetic Therapies case study: building a de-risked portfolio for maximal clinical
    translation and approvability

Adrien Lemoine, Co-Founder & CEO, Bloomsbury Genetic Therapies

  • 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
    operations.
  • 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

  • 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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