Day 1
2nd CELL & GENE THERAPY WORLD CONGRESS 2024 EUROPE
"Driving Innovation, Addressing Significant Unmet Medical Needs, and Ultimately Improving Patient Outcomes"
Day 1 - Monday 8th July 2024
COMMERCIALISATION & REGULATORY LANDSCAPE
- Latest trends and valuable insights to drive innovation and remain competitive
- Cutting-edge technologies revolutionizing treatment paradigms
- Aligning with international regulatory standards in order to support the broadest possible patient access.
- Ensuring affordability and accessibility of these therapies
- Key drivers for attracting investment
- Pricing models and reimbursement strategies
- Introduction
- Demonstrating the UKās continuous strength in the cell and gene therapy sector.
Challenges facing companies in this space
Collaborative work and initiatives to guarantee continued growth of the sector
Lessons learned and strategies to unlock the full potential of this developing field
- Brief overview and important breakthoughs of the EU HTA regulation
- Implications to drug developer of ATMPs
- Potential effect on clinical development plans, commercialization strategies, and patient access
- What are the opportunities the EU market presents
- Proactive preparations needed for upcoming changes
- Understanding the key logistics requirements in operationalizing Cell and gene therapy trials
- Comprehensive strategies to logistics management
- Addressing a whole range of intricacies across all types of CAGT assets
- Significance of stakeholder partnerships to optimize supply chain and enhance patient experience
- Ways to navigate and succeed in this promising yet competitive sector
Strategic portfolio assessments and management critical to success
Importance of robust clinical pipeline to attract interest from investors
Considering the complexity of the manufacturing process, supply chain requirements of each, along
with the required regulatory pathway to market.
- Improving clinical trials, strengthening regulatory authorities
- Foster use of health data for innovation
- Promoting innovative research projects
- Reimbursement for gene therapies and ATMPs
DEVELOPMENT & MANUFACTURING
- An overview of diverse synthetic receptor systems being used to reprogram therapeutic cells and their wide applications in biomedical research
- Cutting edge synthetic receptor systems at the forefront
- Strategies to design, construct and improve synthetic receptors
- Expanding landscape of therapeutic applications of the synthetic receptor systems
- Current challenges in their clinical translation
- Scientific and regulatory considerations when planning for the development of genetically altered cell therapy products
- Framework for approaching these projects from a pre-clinical perspective
- Recent trends across projects in the pre-clinical aspects of cell therapy development
- Current landscape of CAR-T cells manufacturing
- Challenges limiting production capacity
- Latest technical developments in GMP production platform design
- Challenges associated with translation of new scientific developments into clinical products for patients
- Challenges in integrating robotics to automate parts of the development process
- Key standards to develop automation technology that would allow large scale development efficiently
- Advances in robotics
- Acknowledging the scaling-up challenge is a critical point in the development of cell and gene therapies
- When does aspects of scale up and manufacturing ought to be considered
- Importance of integrating data driven approaches to address current hurdles
- Current development in scalable technologies and automation
- Advancements that pave the way for more therapies to successfully move from development, to clinical trials, and on to commercialisation.
- State of continuous process implementation and some ongoing challenges.
- Technological advancements that helps drive batch productivity and reduce the costs for patients
- Improving the design and efficiency of facilities to focus on quality, getting into manufacturing quicker
- Lowering the overall cost of goods and the amount of raw materials used
- Lessons learned and best practices