Company: Sigilon Therapeutics
Job title: Senior Director, Regulatory Affairs
Angela N. Johnson, MSE, PMP, RAC is currently the Senior Director of Regulatory Affairs at Sigilon Therapeutics, and previously was Director of Strategic Development at IQVIA, where she led clinical development strategy for a range of advanced therapy products across the globe. She holds a Master’s in Materials Science and Engineering from North Carolina State University and leads a biomedical innovation research project at Texas Tech University. Angela is a multi-year faculty of the Regulatory Affairs Professionals Society (RAPS) and author of multiple presentations and publications on gene therapy, including the 2019 RAPS Fundamentals textbook chapter on regenerative medicine cell and gene therapy. She serves as a Government Relations Board Committee member for American Society of Gene & Cell Therapy (ASGCT), working with FDA, global health authorities, and payors to advance gene and cell therapy development.
Gaining Insights into a Successful Hemophilia Gene Therapy Trial 10:00 am
Overview standard outcomes measures and recent surrogate endpoints, safety measures, and patient important outcomes (PIOs) and patient reported outcomes (PROs) Understand logistical considerations for early trial clinical development and scalable clinical product management Examine patient selection and retention in hemophilia advanced therapy trialsRead more
day: Day Two