Lord James O'Shaughnessy

Senior Partner, Newmarket Strategy

James is co-founder and Senior Partner of Newmarket Strategy, a consultancy dedicated to improving access to health innovation by providing strategic advice and technical support to the healthcare, life sciences and health tech sectors. He is also a non-executive director at HDR-UK and the Albion Development VCT plc. In early 2023 James was commissioned by the Government to carry out an independent review of commercial clinical trials in the UK, which was published in May. James has operated at the highest levels of government, including as a Minister at the Department for Health & Social Care, as Director of the No.10 Policy Unit, and as an advisor to DHSC Ministers during the COVID-19 crisis. As Minister his responsibilities included implementing the Life Science Industrial Strategy, delivering a new pricing scheme with the pharmaceutical industry, chairing the National Genomics Board, and driving the digital transformation of the NHS. He was also responsible for preparing the health and social care sectors for Brexit and helping to design the post-Brexit regulatory regime.

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.