CELL & GENE THERAPY WORLD CONGRESS 2023 EUROPE
"Realising the promises of next generation therapies"
Day 2 - Friday 10th March 2023
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
- 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
- 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?
Wenliang Dong, Chief Operating Officer, ORCA Therapeutics