Developing endpoints for regenerative medicine: an interview with Stephen Westover

In this interview, Stephen Westover (Cook MyoSite, PA, USA) discusses how Cook MyoSite worked with regulators to ensure the most appropriate endpoint for their autologous cell therapy for female stress incontinence. Can you introduce yourself and tell us a little about your role at Cook Myosite? I am the Director of Regulatory Affairs at Cook MyoSite, Inc. and I am the point of contact for interactions with the health authorities regarding clinical investigations and product development. As we chart a path towards commercial licensing of our cellular therapy products, I oversee communications with and submissions to health authorities including Food...