James Pound

Interim Executive Director, MHRA

James Pound joined the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008. He has worked in a variety of roles within the MHRA and is an executive leader within the Agency with responsibility for our Innovation Accelerator (the home of our innovative pathways for medicines and medical devices), the clinical investigations and trials group and the standards and compliance function which includes our Medicines GXP compliance teams, British Pharmacopoeia and medical devices audit and compliance. James led the cross-Agency response to clinical trial assessment delays in 2023 which were successfully eliminated in Autumn 2023 with sustained performance by the Agency since then.

He holds an honours degree in Chemistry and has previously worked in a variety of roles in development and manufacturing in the pharmaceutical industry.

Dr Martin O'Kane

Regional Head of Regulatory Affairs EU Policy & Liaison, Novartis Pharmaceuticals

Martin O’Kane PhD is Regional Head of Regulatory Affairs EU Policy & Liaison at Novartis Pharmaceuticals, responsible for developing and implementing complex regulatory strategies in global development and enabling regulatory compliance. He is co-chair of the European Federation of Pharmaceutical Industries Associations (EFPIA) Clinical Trials Regulation Pillar and is a member of the BIA Regulatory Affairs Advisory Committee. Martin has seventeen years’ previous experience in medicines regulation working in the Medicines and Healthcare products Regulatory Agency (MHRA), the majority of which was in the clinical trials field including scientific assessment of trial applications and development of policy, guidance, and legislation relevant to the UK’s exit from the EU and the UK response to COVID-19.