Richard Keane

Richard has more than 20 years’ experience in Regulatory Chemistry Manufacturing and Controls (Regulatory CMC) in the pharma/biotech industry. He is currently the head of commercial products Regulatory CMC at Biogen, having worked previously in Regulatory CMC roles at GlaxoSmithKline and Wyeth Europa. He has been responsible for the global development, registration and life cycle of a wide range of small molecules and biological products, including multiple accelerated programs. He has led a number of regulatory CMC focused Agency scientific advice meetings and represented his company and the pharmaceutical industry on a number of occasions in various meetings and workshops, including presenting at the 2018 EMA Workshop with stakeholders on support to quality development in early access approaches (i.e. PRIME, Breakthrough Therapies).

Richard is active in the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing and Quality Expert Group, including the sub-team working on continuation of the concepts developed as the 2018 EMA Workshop. At EFPIA he also co-chairs the ATMP manufacturing sub-team. Richard is a member of the CASSS CMC Strategy Forum Europe Program Committee and the organising committee of the organization for professionals in regulatory affairs (TOPRA) masterclass on “Registration of Biological, Biotechnology and Advanced Therapy Products”.