The focus of this session will be on outlining the regulatory framework and challenges of translating the exciting basic science discoveries related to molecular and cellular biology into novel, commercial gene and cellular therapies. It aims to bring together leading experts from Regulatory Agencies like EMA and FDA with expert academic and industrial scientists in this area for a fruitful interaction. It also aims to ensure that representatives of patients and those with an ultimate need for these products will be actively included in the meeting in line with an aim of ESOF2012 which is to bring science to the public.