Cell & Gene Therapy

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Key Industry Expert Speakers

Zhimei Du, MD/PhD

VP of Process Sciences

Atara Biotherapeutics

Doug Danison

Head of Commercial, Cell and Gene Therapy Unit

Bayer

Reagan Jarvis

CEO and Co-founder

Anocca

Manal Morsy

Executive Vice President, Head of Global Regulatory Affairs

Athersys, Inc.

Mohamed Oubihi Ph.D.

Founder and CEO

YAKUMED LIMITED

Chris Williams

SVP Corporate Development

Autolus Ltd.

Stuart M Curbishley

Chief Manufacturing and Chief Development Officer

adthera bio

Thomas Mueller

Head of Directorate General “Drugs, Medical Devices, Biotechnology”

Federal Ministry of Health, Germany

Matthias Bozza

Director

Vector BioPharma

ERIC HALIOUA

President & Chief Executive Officer

PDC*line Pharma

STEPHEN JUDD

Process SME – Biologics / Cell & Gene Therapy

DPS Group

AMIR HEFNI

Global Head for Cell & Gene Therapy

Novartis

ALEJANDRO FERNANDEZ-MARTELL

former Principal Bioprocess Engineer

Achilles Therapeutics

Wenliang Dong

Chief Operating Officer

ORCA Therapeutics

STEFANOS THEOHARIS

Senior Executive

Independent Expert

DR. ANAND SRIVASTAVA

Chairman and Co-founder

Global Institute of Stem Cell Therapy and Research

NICK FORSYTH

Faculty Dean of Research

Keele University

Mark Fowler

Global Head of Procurement

Autolus

MARK SINGH PHD

Non-Clinical Manager

Cell and Gene Therapy Catapult

Ben Doak

Head of Innovative Treatments

NHS England

Cecilia Götherström

Research Group leader, Associate Professor in Stem Cell Science

Karolinska Institutet

Alberto Malerba

Lecturer in Gene Therapy

Royal Holloway, University of London

Chris Williams

SVP Corporate Development

Autolus Ltd.

Julia Djonova

Head, Advanced Therapy Medicinal Products

Swissmedic

Francois Hallac

Research Associate

King's College London

VANESSA WELLINGTON

Research Scientist

University of Nottingham

Dr Lilian Hook

Director Cell, Apheresis & Gene Therapies

NHS Blood and Transplant

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Cell & Gene Therapy World Congress 2023 Europe

Cell and Gene therapies are life-changing new categories of medicines whose full potential is only just beginning to emerge. They are cutting-edge and rapidly progressing fields of Biological Therapies. Both therapies aim to
treat, prevent or potentially cure diseases and both approaches offer the potential to diminish the fundamental cause of genetic and acquired diseases by substituting the missing protein or cells causing the disease’s symptoms. Cell and gene therapies may offer longer lasting effects than traditional medicines. They are overlapping fields of biomedical research and treatments. However, cell and gene therapies work differently. Cell therapy aims to treat diseases by restoring or altering certain sets of cells or by using cells to carry a therapy through the body while gene therapy treats diseases by replacing, inactivating or introducing genes into cells— either inside the body (in vivo) or outside of the body (ex vivo). Some therapies are considered both cell and gene therapies. These therapies work by modifying genes in specific types of cells and inserting them into the body.

With the promising significance of Cell and Gene therapy, it is poised to transform the healthcare and biopharma industry soon. The market is estimated to increase expeditiously, encompassing sales forecasts of
EUR 27.9 billion by 2026. The development of biological therapies is rapidly expanding, however, it poses different challenges to research and development, authorisation, manufacturing, accessibility, and ensuring safety throughout the lifecycle of the product.

The two-day Congress will provide an interactive, cutting edge, and comprehensive discussions in collaborative format led by key experts with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies, and concepts to help you gain access to the booming CGT market.

We are putting together an agenda that focuses on “Realising the promises of next generation therapies”.

We are gathering high calibre expert speakers to participate and share their knowledge and expertise through Keynote Presentations and Panel discussions, addressing all aspects of the industry.

We look forward to welcoming you to the CGT World Congress 2023!

GAIN LATEST INSIGHTS ON:

  • Gain the latest insights to successfully navigate the complex access landscape of CGT
  • Explore ways on how to strategically navigate the state of the art technologies in cell and gene therapies
  • Understand approaches in advancing research and drug development 
  • Learn the production process which is crucial for new players entering the field
  • Know how to engage early with regulators and payers to enable swift roll-out of new therapies for the benefit of the patients
  • Have a meaningful conversation on how to improve access efficiently to innovative treatment in order to reach patients in a shorter period of time
  • Network and collaborate with key stakeholders, regulators, academia, HTAs, and payers 
WHO SHOULD ATTEND?                                 
This congress is specially created for valued stakeholders in the Cell & Gene therapy community: Presidents, Heads/Chiefs, VPs, Directors, and Managers in the area of:
 

• Clinical Research Organizations
• Research and Development
• Personalised Medicine
• Regenerative Medicine
• External R&D Innovation
• Innovative Medicine
• Rare and Ultra-Rare Diseases
• Cell and Gene Therapy
• Translational Science
• Molecular Geneticist
• Program Management
• Patient and Patient Groups
• Public Affairs
• Medical Affairs
• Regulatory Affairs
• Market Access
• Pricing and Reimbursement
• Health Economics Outcomes Research
• Commercial Development
• Investments and Funding
• Product Specialist
• Global Strategic Services
• Business Planning and Operations
• Pharmacies
• Academia

The program

CELL & GENE THERAPY WORLD CONGRESS 2023 EUROPE

"Realising the promises of next generation therapies"

Day 1 - Monday 23rd October 2023

OVERVIEW, CURRENT LANDSCAPE & FUTURE TRENDS

  • 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

PANELIST:
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

RESERVED

  • 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
    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

  • 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

 

CELL & GENE THERAPY WORLD CONGRESS 2023 EUROPE

"Realising the promises of next generation therapies"

Day 2 - Tuesday 24th October 2023

ADVANCE THERAPEUTICS

  • Challenges in quality and regulatory perspective
  • Main sources of quality issues, and solutions that have been developed?
  • Best practices for robust regulatory strategies
  • Harmonisation among the various regulatory agencies

PANELLIST:
Manal Morsy, Executive Vice President, Head of Global Regulatory Affairs, Athersys, Inc
Thomas Muller, Head Of Directorate General, Federal Ministry of Health Germany

Julia Djonova, Head, Advanced Therapy Medicinal Products, Swissmedic

  • An introduction to the way ATMPs are commissioned in England, including what has been achieved to date

Ben Doak, Head of Innovative Treatments, NHS England

  • targetable VLPs for selective tissue tropism.
  • Enhanced safety for gene therapy approaches through selective tissue targeting.
  • Large cargo capacity (36.5 Kb) for building more regulated gene circuits.

Dr Matthias Bozza, Director, Vector Biopharma AG

Francois Hallac, Research Associate, King’s College London

  • Tendon structure is hierarchically organised with defined subunits and membranous envelopes
  • Biologically distinct tendon cell sub-populations exist within these distinct compartments
  • Tendon-derived cell population promote distinct localised and far reaching immunological behaviours

Nick Forsyth, Faculty Dean of Research, Keele University

MARKET ACCESS, AND REIMBURSEMENT

  • The experimental evidences strongly suggest that embryonic stem (ES) cell lines can be created from human blastocyst-stage embryos and stimulated to develop into practically all types of cells found in the body.
  • Cellular treatments produced from Stem cells have attracted fresh interest. The potential utility of
    Stem cells for gene therapy, tissue engineering, and the treatment of a wide spectrum of currently untreatable diseases is simply too vital to ignore; however, further improvements in our understanding of the basic
  • biology of ES cells are required to deliver these forms of therapy in a safe and efficient manner.
  • In this meeting, I'll share my research using ES cells and how they can be used to treat hematopoietic and neurodegenerative disorders.

Dr. Anand Srivastava, Chairman and Co-founder, Global Institute of Stem Cell Therapy and
Research

  • Overcoming the manufacturing obstacles to meet specifications and regulatory approval
  • Ongoing innovation in CGT process development, manufacturing, and clinical testing based on quality by design (QbD)
  • Early implementation of broad and robust analytics to accelerate optimization
  • Planning for comparability studies for ongoing innovations from discovery to commercialisation
  • Introduction of GCT Market Potential and Trends in Japan (commercial, regulatory and reimbursement)
  • Opportunities in Japanese GCT market (political considerations and incentives)
  • Challenges and Recommendations

Mohamed Oubihi, Founder and CEO, YAKUMED

  • Past (learnings…)
  • Benefit Structures / Cost / Contracting (e.g., Outcomes Based)
  • Evidence & its Evaluation
  • Special Considerations (e.g.,

– Dealing with surrogate endpoints
– Modifications & Flexibilities for Evaluation of Rare Diseases)

  • Examples:

– Gene Therpaies
– Cellular Therapies
– Aduhelm & Leqembi (not gene therapies… but relevant for general understanding)

Eugean Jiwanmall, Senior Research Analyst, Independence Blue Cross

  • Breakthroughs and innovations in research and development
  • Implementing next-generation technologies
  • Novel pricing and market access strategies pharma will employ to increase patient access
  • Various CGTs in the pipeline
  • What will the next decade hold for these life-changing therapies? 

PANELLIST:
Chris Williams, SVP Corporate Development, Autolus Ltd.
Stefanos Theoharis, Independent Expert

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Testimonials

Thank you for a good experience with the PARADIGM Global Events… very high level, very good Organization, we overpassed our expectatives, we will be pending for another congress related to pharmaceutical and biotech… we learned a lot, and i think that the content of agenda was state of the art, thank you again.
SALVADOR BERRIOS
ERP/ CRM / Product Configurator Manager
The consistently high quality of international faculty was most impressive. It was also obvious that they were carefully chosen not only for their particular expertise but also for their ability to communicate the subject matter to clinical and non-clinical participants alike. As market access consultant for pharma clients of various sizes, I now feel much better prepared to explain the nuances & dynamics involved in bringing their products to market. In addition, I am in a much better position to intelligently advice my clients & help them set realistic expectations
THOMAS MARTIN
Associate Vice President, VCGA - Quintiles
I was impressed with the organization of this event. I attend many conferences per year and find the organizers on site to be detached and not focus on good service to the delegates. This team was even providing weather forecast warning to ensure everyone was aware and made appropriate plans. Well Done.
ADRIANA E. MANZI
PhD, Managing Director, Atheln, Inc

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