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Cell and Gene Therapy World Congress 2022

"Realising the promises of next generation therapies"

Holiday Inn London - Bloomsbury, an IHG Hotel, LONDON, UK

6th - 7th October 2022

INTRODUCTION

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 2022!

 
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

BENEFITS OF ATTENDING:
 
  • 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 
  • Day 1 - 6th October 2022
  • Day 2 - 7th October 2022

CELL & GENE THERAPY WORLD CONGRESS 2022 EUROPE

"Realising the promises of next generation therapies"

Day 1 - Thursday 6th October 2022

KEYNOTE PANEL DISCUSSION

  • 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

MANUFACTURING AND PROCESS DEVELOPMENT

  • Focus on more challenging purification requirements of gene therapy and oncolytic viruses
  • Factors that can complicate the downstream processing for viral vectors
  • Tailored purification process design for greater process understanding
  • Methodologies, cell manufacturing platforms and technologies that contributes to defining CAR-T cell
  • Core components of autologous CAR-T cell manufacturing that remains constant
  • Quality requirements & quality control assays enabling the release of clinical CAR-T cell products for infusion
  • Challenges in cell manufacturing
  • Recent advances and benefits from different techniques
  • Potential for different applications wide usage of microfluidic devices.
  • Risk assessment analysis
  • Equipment requirements and facility characteristics
  • Beneficial effect of regulatory T cell transfer on the maintenance of self-tolerance and immune homeostasis in different conditions

CASE STUDY

  • 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

CHARACTERISATION AND VALIDATION

  • Upstream and downstream processes for production of rAAV
  • Analytical methods for quantification of rAAV quality attributes
  • Key challenges in transitioning from traditional to newer methods
  • Methods of detect and classify key contaminants in CGT
  • New advances in technology that play a significant role in ensuring the safety of therapeutics
  • Design model where contamination is minimized before manufacturing begins
  • Increase control and implementation of QbD principles and adoption of new assay methodologies

CASE STUDY 

  • Monitoring and control challenges resulting from the extensive range of cell and gene therapy products
  • Understanding the intricacy and processes required to produce these products
    • Challenges in perspective and implementation of regulatory framework
  • Process challenges associated with manufacturing gene therapies and strategies in overcoming them
  • Major components that impact innovation and optimization
  • What can manufacturers do to guarantee a seamless process as the treatment progress form early to commercial stage and through regulatory approval?
  • Future for next generation technologies and process developments

CELL & GENE THERAPY WORLD CONGRESS 2022 EUROPE

"Realising the promises of next generation therapies"

Day 2 - Friday 7th October 2022

KEYNOTE PANEL DISCUSSION

  • EU legal requirement and regulatory framework for classification of advance therapies
  • Comparative analysis between EU and US guidelines
  • Classification Criteria in Europe and US
  • Nuances that may affect development

REGULATORY, ETHICAL AND QUALITY CONSIDERATIONS

  • 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
  • Opportunities for businesses in EU to influence changes in EU law and policy that could make development and commercialization of transformative new treatment less costly.
  • Policy, regulations, and legislative changes to help overcome barriers to more widespread adaptation of CGTs towards its full potential and industries steady progress
  • Ethical issues involved in current gene therapy research and problems inherent to future gene therapies
  • Moral responsibilities of those involve in the development and use of CGTs
  • How to recognize individual’s right to choose to accept or reject testing or treatment?
  • Possible dilemmas involved in the use of genetic science in ways that go beyond prevention and cure of disease
  • Economic impact associated with advance therapies

PANEL DISCUSSION 

  • Conducting early research to better understand patient and indications
  • Smarter clinical trial study designs that support implementation
  • Relieving barriers in manufacturing and supply chain
  • Accelerated pathways for the investigation and approvals of CGTs
  • Strategies and tactical approaches that companies can undertake to aid in achieving consistent and appropriate reimbursement levels
  • How can CGT developers expand capabilities for broader adaptation?

 

  • 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 
  • Can pharma companies demonstrate the cost-effectiveness of this therapies?
  • What are the innovative payment plans between pharma and payers?
  • How to leverage, engage, and coordinate patient care to enable individual patient outcomes
  • Addressing the need for patient assistance programmes
  • Exploring alternative distribution capabilities for reimbursements
  • Changes in value assessment framework to improve adaptation
  • Encouraging payer decision-making while supporting patient access
  • How to ensure sustainability for healthcare system and patients
  • Innovative payment models to ensure timely access and alleviate the financial burden

PANEL DISCUSSION

  • 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?
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