Niamh Kinsella

Company: Biogen

Job title: Global Regulatory CMC Early Development Gene Therapy Lead

Seminars:

Highlighting How to Best Demonstrate Comparability in Your Manufacturing Processes 11:30 am

What is comparability and how does it impact the overall development plan of the product? How to demonstrate comparability to regulators during development Best practices: how to prepare early to meet authority expectationsRead more

day: Day One

Panel Discussion: The Challenges Associated With Scaling-Up to Commercial Manufacturing 11:00 am

Personal experiences in building gene therapy manufacturing facilities Weighing up the choice between in-house manufacturing and outsourcing to CMOs Considerations for deciding between scaling up and scaling out Understanding how to demonstrate comparability when scaling up manufacturing processes Integrating technology into modern gene therapy manufacturing approachesRead more

day: Day One