Genome Editing and Regulatory Harmonization: Progress and Challenges

3:00 PM - 4:00 PM, Wednesday, June 5, 2019 ・ 118A, Level 100
Genome editing offers the potential of new and effective treatments for genetic diseases. As companies work to develop these treatments, regulators are focused on ensuring that any such products meet applicable safety and efficacy requirements. This panel will discuss how European Union and United States regulators are approaching therapeutic use of genome editing, issues in harmonization between these two – and other - jurisdictions, challenges faced by industry as regulatory positions evolve, and steps that organizations and companies can take to facilitate approval and continued efforts at harmonization.
Acting Gene Therapy Branch Chief, Division of Cell and Gene Therapy
Center for Biologics Evaluation and Research (CBER), FDA
Counsel, Food, Drug and Medical Device Regulatory Life Sciences
Sidley Austin LLP
SVP and Head of Regulatory Affairs
Spark Therapeutics
Senior Vice President of Regulatory Affairs