COMPARABILITY STRATEGIES FOR CELL AND GENE THERAPIES
MONDAY, AUGUST 21, 2017 | 9:00 – 11:30 am


Instructor:
Christopher Bravery, Ph.D., Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Change is inevitable and necessary both in development and over the post-approval product lifecycle. Whenever changes are made it is necessary to confirm they do not adversely impact the quality, and therefore safety and efficacy, of the product; this requires data beyond meeting current specifications.

Concerns about comparability undertaken during development are common issues raised during review and often delay market approval or contribute to failure. This course explains what comparability is and how to develop a successful comparability protocol.

  • What is comparability?
  • Why is meeting existing specifications not comparability?
  • How do I apply the principles of comparability to highly variable products?

Instructor Bio:

Christopher_BraveryChristopher Bravery, Ph.D., Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. CAB Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialization of regenerative medicine. Christopher has spent most of his career working in regenerative medicine: starting with a PhD in xenotranplantation immunology he first moved into industry in 1998 when he joined Imutran Ltd (A Novartis Pharma AG Co.) developing novel transgenic pigs to treat human organ failure. Following the closure of Imutran, Christopher moved to Intercytex and subsequently made the transition to regulatory affairs by joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.