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CELL & GENE THERAPY WORLD CONGRESS 2023 EUROPE

"Realising the promises of next generation therapies"

Day 1 - Monday 23rd October 2023

Eugean Jiwanmall, Senior Research Analyst, Independence Blue Cross

OVERVIEW, CURRENT LANDSCAPE & FUTURE TRENDS

  • 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
  • Current trends and innovations to advance cell & gene therapies

Stuart M Curbishley, Chief Manufacturing and Chief Development Officer, adthera bio
Eugean Jiwanmall, Senior Research Analyst, Independence Blue Cross
Yue (Dina) Du, Senior Scientist, Gene Therapy R&D, AstraZeneca
Daniel Gibson, Director of Cell and Gene, Anthony Nolan

  • Swissmedic Innovation Office:

-Mission, Role and Responsibilities
– Presence and visibility near the innovation, promote Innovation
– Early dialogue and reduce barrier between Regulator and Stakeholders

Swissmedic’s Competence Center Advanced Therapy Medicinal Products (ATMP) :

Advanced Therapy Medicinal Products as Pilot Project to develop the Innovation Office
– ATMP Risk Based —  — Approach – accelerate and facilitate the access of innovative therapies to the patients

Dr. Thomas Schochat, Clinical Assessor, Division Advanced Therapy Products, Swissmedic

  • Improving clinical trials, strengthening regulatory authorities
  • Foster use of health data for innovation
  • Promoting innovative research projects
  • Reimbursement for gene therapies and ATMPs

Thomas Muller, Head Of Directorate General, Federal Ministry of Health Germany

  • 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

  • Utilising NHSBT’s supply chain and infrastructure to deliver ATMPs into NHS
  • Manufacturing of red blood cells in vitro for RESTORE clinical trial
  • Manufacture of gene therapy products at NHSBT’s Clinical Biotechnology Centre

Dr Lilian Hook, Director Cell, Apheresis & Gene Therapies, NHS Blood and Transplant

  • 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

  • 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
    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

  • 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

Eugean Jiwanmall, Senior Research Analyst, Independence Blue Cross

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