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Speakers
Dr Marc Bailey
Dr Marc Bailey leads the scientific, research and innovative work of the agency. Marc is a molecular biologist with a PhD in Pathology. Marc has had a varied career starting with academic research on infectious diseases before establishing a team developing physical standards for biotechnology at the National Physical Laboratory and then leading research into Digital Health for a multinational corporation. Marc joined the Agency in 2017 at the South Mimms Laboratory initially as a Head of Division and then as interim Director of NIBSC.
Steve Bates OBE
What does your role at BIA involve?
Steve Bates is the CEO of the UK Bioindustry Association, the UK’s Trade Association for innovative life science companies with over 550 members. Steve is the visible face of the vibrant UK life sciences industry to government and media. He serves on the UK Government’s Life Sciences Council and the UK Biosecurity Leadership Council. Steve was a founder member of the UK Government’s Vaccine Taskforce in the Covid crisis, sitting on its steering Board alongside Kate Bingham. He is active member and former chair the International Council of Biotech Associations and has been a board member of EuropaBio since 2015.
Previous experience & achievements
Steve has championed, with government, effective industrial incentives like the Biomedical Catalyst, which have crowded in private sector investment into UK SMEs. He is a driving force behind the scale up agenda, spearheading policy agenda to unlock UK pension fund capital into productive UK growth in life sciences. He has forged several links for the sector across the USA, Europe and in China. In his time at the BIA, Steve has developed new member groups focused on cell and gene therapy, genomics and engineered biology. A strong advocate of partnership working, Steve champions sector collaboration with research charities and academia. Proud to lead an organisation with a diverse Board with over 40% female representation, Steve is committed to next generation talent and developing the skills needed for the sector to flourish. Before joining the BIA in 2012, Steve worked for Genzyme and was advisor to the UK Government of Tony Blair working on NHS reform and the Northern Ireland peace process. He was made OBE for services to innovation in 2017 and became a Fellow of the Academy of Medical Science in 2020.
Dr Alison Cave
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.
Professor Lucy Chappell
Professor Lucy Chappell is Chief Scientific Adviser to the Department of Health and Social Care and Chief Executive Officer of the National Institute for Health and Care Research (NIHR), the UK’s largest funder of health and care research. The Chief Scientific Adviser has overall responsibility for DHSC research and development and for supporting analysis and life sciences across the Department. Prof Chappell provides science advice to ministers across the range of health topics and is involved in cross-government science policy. Prof Chappell is also Professor of Obstetrics at King’s College London, working mainly in clinical trials in pregnancy, and a practising Consultant Obstetrician at Guy’s and St Thomas’ NHS Foundation Trust.
Nick Crabb
Nick had a 20-year career in analytical science, process technology and general management in the chemical, pharmaceutical and contract laboratory industries prior to joining NICE in 2010. His initial role was to establish and manage the Diagnostics Assessment Programme and he was later appointed Programme Director, Scientific Affairs. Nick currently oversees NICE’s Science, Evidence and Analytics Directorate. He has broad scientific and policy interests relating to the evaluation of technologies and interventions to support the development of clinical, public health and social care guidance. His experience includes consideration of Health Technology Assessment (HTA) issues arising from the availability of novel new products such as cell and gene therapies and work on methods issues relating to the evaluation of antimicrobials. Nick was the NICE lead on a collaborative pilot project with NHS England to develop and test innovative models for the evaluation and purchase of antimicrobials. Nick also has interests around the alignment of regulatory and HTA processes and collaborates closely with national and international regulators.
Alastair Denniston
Professor Alastair Denniston is an NIHR Senior Investigator, Consultant Ophthalmologist and Hon Professor in the evaluation and regulation of AI health technologies, based at University Hospitals Birmingham NHS Foundation Trust, and the Centre for Regulatory Science and Innovation, University of Birmingham, UK. With Dr Xiaoxuan Liu, he leads a Research and Policy Group which explores how we can ensure that AI health technologies are effective, safe and equitable, and improve patient care in the ‘real world’. The group has a particular focus on ethical data architecture, and ensuring that the data foundations of AI are inclusive and representative, such as through the STANDING Together initiative. Alastair was co-founder of INSIGHT, the UK’s Health Data Research Hub for Eye Health, jointly leads the international reporting guidelines for clinical trials of AI health technologies (SPIRIT-AI and CONSORT-AI) and is a Member of the UK Government’s Regulatory Horizons Council.
Camilla Fleetcroft
Camilla has a wealth of knowledge and experience across the MedTech sector. After qualifying as a medical doctor, she worked for 9 years at the Medicines and Healthcare products Regulatory Agency (MHRA) and recently joined BSI to lead on strategy and innovation within the Regulatory Services team. In 2023 she supported the UK Government as a champion for the Pro-Innovation Regulation of Technologies Review. Working hand-in-hand with Sir Patrick Vallance and Sir John Bell, the review set out key recommendations to accelerate development and deployment of emerging technology in the UK.
Dr Janet Messer
Janet Messer is Director of Approvals at the Health Research Authority. She is responsible for the Research Ethics, Confidentiality Advice, Assessment and Assurance services, alongside the supporting guidance and advice. Her team also works collaboratively with a wide range of partner organisations to fulfil the HRA’s aims to coordinate and standardise practice in research regulation, to make it easier to do good trustworthy ethical research in the UK. She sits on the cross-sector Recovery, Resilience and Growth Programme Board. She led the implementation of HRA Approval, and more recently has worked closely with MHRA, the devolved administrations and NIHR in the development of the combined review process for clinical trials which completed its roll out at the start of 2022. She is working closely with MHRA on the development and implementation of the new clinical trial regulations. She has a PhD in biochemistry from University of Cambridge and a Masters in Medical Law, along with many years’ experience of clinical research in the pharmaceutical industry, NHS R&D and the NIHR Clinical Research Network.
Dr Martin O'Kane
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.
Lord James O'Shaughnessy
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 June Raine DBE
Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a Master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development within the UK national authority. She was elected in 2012 as the first chair of the European Pharmacovigilance Risk Assessment Committee, and is also co-Chair of the WHO Advisory Committee on Safety of Medicinal Products. Her special interests are in monitoring the outcomes of regulatory action, risk communication and patient involvement in the regulatory process.
Jörg Schläpfer
Dr Jörg Schläpfer is the Chief of Staff & Head Sector External Relations at Swissmedic, the Swiss Agency for Therapeutic Products. Dr Schläpfer studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine, completing his PhD and undertaking 12 years of academic research, he was employed by a number of companies in various roles within the pharmaceutical industry from 2002 to 2015. From 2015 to 2019, Dr Jörg Schläpfer was Head of Division Process Development and Support in the Authorisation sector at Swissmedic as well as Deputy Head of the sector. In March 2019, Dr Schläpfer was appointed as Chief of Staff & Head Sector External Relations.
Jon Sisson
Jon is a pharmaceutical physician with extensive knowledge of medicines development and regulation across the whole product lifecycle. Since joining tranScrip in January 2022, Jon has led multiple projects, advised on all phases of clinical development, regulatory strategy and on multiple types of UK/EU/US regulatory application. Before moving to tranScrip, Jon was a medical assessor at the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for 22 years. Initially Jon worked in the post-licensing division across all therapeutic areas, with a focus on license variations, safety reviews and advertising issues. After 10 years in post-licensing, he moved to the licensing division, to assess new license applications (new chemical entities and generics) and provide national scientific advice to companies. This mainly covered products for cardiovascular conditions and diabetes, but Jon gained cumulative experience in a wider range of therapy areas, particularly when serving as a UK representative on the Committee for Medicinal Products for Human Use (CHMP) Scientific Advice Working Party. Previously, following clinical training in internal medicine, Jon worked in the Hoechst and GlaxoWellcome clinical pharmacology units, including as Principal Investigator in first-in-man studies. Jon has a particular interest in clinical pharmacology and pharmacokinetics, bioequivalence studies and structured risk: benefit assessment. He is a fellow of the UK Faculty of Pharmaceutical Medicine and serves on their Board of Examiners for the Certificate and Diploma in Pharmaceutical Medicine.
Shannon Thor
Cmdr. Shannon Thor is the Deputy Director of the FDA Europe Office based in Brussels, Belgium. Cmdr. Thor brings a wealth of experience as a pharmacist, policy advisor, and public health leader. During her FDA tenure, she has been responsible for providing leadership and technical expertise on international public health initiatives and U.S.-European relations, with a particular focus on maternal health projects such as improving information on the safe use of medicines in pregnancy and during breastfeeding. She has held policy advisor roles in FDA’s Office of Health and Constituent Affairs and Office of New Drugs where she advised on cross-cutting issues such as over-the-counter monograph reform, drug and device user fee programs, and patient-focused drug development. Since her commissioning in the U.S. Public Health Service in 2015, she has deployed with various government agencies in support of public health emergencies, most notably to support the COVID-19 pandemic response.
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