‘Lola Fashoyin-Aje

Company: FDA

Job title: Director, Office of Clinical Evaluation- cell, tissue, gene therapies

Seminars:

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

Navigating Accelerated Approval of Gene Therapies: The Role of Regulatory Processes & Biomarkers 12:00 pm

• A detailed examination of recent updates in regulatory processes aimed at expediting gene therapy approvals, including insights from successful case studies • Exploration of what makes biomarkers compelling for accelerated approvals, focusing on attributes such as sensitivity, specificity, and relevance to disease progression • A review of gene therapy approvals where biomarkers played a…Read more

day: Day 1 - Regulatory 2

Navigating Accelerated Approval of Gene Therapies: The Role of Regulatory Processes & Biomarkers 12:00 pm

• A detailed examination of recent updates in regulatory processes aimed at expediting gene therapy approvals, including insights from successful case studies • Exploration of what makes biomarkers compelling for accelerated approvals, focusing on attributes such as sensitivity, specificity, and relevance to disease progression • A review of gene therapy approvals where biomarkers played a…Read more

day: Day 1 - Regulatory 1