Marriane Hamilton Lopez

Company: Duke-Margolis Institute for Health Policy, Duke University

Job title: Senior Research Director, Biomedical Innovation

Seminars:

Next Steps for Advancing Gene Therapy Commercialization: Takeaways & Action Items 4:00 pm

Key recommendations for companies looking to move forward with gene therapy development and commercialization Practical guidelines for navigating regulatory, financial, and market challenges Strategies for developing commercially viable therapies that provide long-term value to patients and stakeholdersRead more

day: Conference Day Two pt 2

Panel Discussion: Navigating Global Regulatory Challenges in Cell & Gene Therapy 4:30 pm

• Diverging Regulatory Pathways: Understanding key differences in regulatory requirements between the FDA, EMA, and other global regulators in cell and gene therapy • Exploring ongoing initiatives for global regulatory convergence and the impact on innovation and patient access • Perspectives from regulators in the U.S., EU, Asia, and other countries on navigating local challenges…Read more

day: Conference Day One- pt 2

Panel Discussion: Foundations for Commercializing Gene Therapies: Key Activities for Successful Transition to Common Disease Markets 1:00 pm

• Identify core activities to adapt manufacturing, supply chains, and distribution models for larger patient populations • Develop effective market access strategies, including pricing, reimbursement, and partnerships, to ensure a smooth entry into common disease markets • Understand regulatory requirements and navigate challenges for scaling up gene therapy from rare to widespread applications while maintaining…Read more

day: Focus Day

Panel Discussion: Breaking Boundaries: Navigating the Shift from Rare to Common Diseases in Gene Therapy 1:30 pm

• Exploring the unique challenges and benefits of expanding gene therapy into more prevalent conditions, including patient access, cost, and treatment scalability • Evaluating the feasibility of widespread gene therapy applications in common diseases by 2025, along with realistic goals and potential hurdles • Essential factors for successful translation, including regulatory preparedness, CMC adaptation, and…Read more

day: Focus Day