Regulating Cell Therapy

Speaker: Dr Christopher Bravery # Director, Consulting on Advanced Biologicals Ltd

7th Oct 2011

15:00 - 16:00

Seminar Rm 1.06, Old Surgeons' Hall, HSY

Medicinal products are probably the most highly regulated products on the market, with regulation spanning the raw materials used to make them, through to marketing and reimbursement. The primary purpose of safeguarding public health can at times seem contradictory when products that promise to address unmet clinical need are apparently held up by what is perceived to be an overly burdensome regulatory process. Furthermore, as the field shifts from chemical pharmaceuticals to more complex biopharmaceuticals and even more complex gene and cell therapies, there is increasing concern that the traditional biopharmaceutical model doesn't fit these more novel advanced therapies. This talk will reflect on whether this perception is fair, and whether the regulatory framework in the EU is flexible enough to meet the challenges of new approaches like cell therapy.

Biography

Christopher Bravery founded CAB 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 commercialisation 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 also involved through his participation in the CHMP's cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

For further information about accessibility please contact Angela McEwan on 0131 650 9113 or Angela.McEwan@ed.ac.uk