Marriane Lopez

Company: Duke University

Job title: Senior Research Director

Seminars:

Next Steps for Advancing Gene Therapy Commercialization: Takeaways & Action Items 4:30 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 3:30 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

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