The Future of UK Life Sciences Regulation 2024

Tim Stonehouse

Vice President International Regulatory Strategy, Vertex Pharmaceuticals

No bio provided

---

Professor Manohar Bance

Professor of Otology and Skull Base Surgery, University of Cambridge

Professor  Bance is the Professor of Otology and Skull Base Surgery at the University of Cambridge. Prior to 2017, he was Chair of the Dept of Otolaryngology, Dalhousie University in Canada.  He is a surgeon-scientist, who runs a basic science lab. He also runs a genetic hearing loss clinic, and has been involved with first in human studies for gene therapy for hearing loss

---

Steve Bates OBE

Chief Executive Officer

No bio provided

: stevebatesuk
: @SteveBatesUK

---

Dr Alison Cave

Chief Safety Officer, MHRA

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.

---

Lucy Chappell

Chief Scientific Adviser, Department of Health and Social Care, And Chief Executive Officer, The National Institute for Health and Care Research (NIHR)

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.

---

Clive Collett

Head of Policy and Engagement, Health Research Authority

Clive Collett is the Head of Policy & Engagement within the Health Research Authority’s Policy & Partnerships Directorate. He has over 25 years of experience of research regulation and research ethics committees within the NHS. He is currently involved in the update to the UK’s Clinical Trials Regulations, including the introduction of new research transparency requirements. He has a biology degree, PgDip in Healthcare Ethics and an MA in Medical Ethics & Law. He is a lay member of the Ministry of Defence Research Ethics Committee (MODREC).

---

Dr Gracy Crane

Regulatory Chapter Lead & Regulatory Science Lead , Roche Pharmaceuticals

Gracy Crane is a cancer biologist by training with a Master in Biomedical Research and a Ph.D. in Cancer Biology. She has also completed post-doctoral training fellowships at Oxford University (UK) and Massachusetts Institute of Technology (USA). 

She has over 12 years of years of experience in the pharmaceutical industry, in varying roles including medical and scientific affairs, clinical development, health outcomes research and real world data. For the past 5 years, she has worked on leading the real world evidence strategy for molecules within the rare cancer space as part of the global Data Science team of the personalized health care department at Roche. Currently, she is the RWD policy lead and Chapter Lead within the Global Regulatory Science team at Roche. She has authored many publications on this topic and has presented in many international conferences.

Gracy is also part of a number of external steering/working groups including the ISPOR RWD transparency Initiative (https://www.ispor.org/strategic-initiatives/real-world-evidence/real-world-evidence-transparency-initiative), the CIOMs working group on RWD/E guidelines, and the Duke Margolis RWE Collaborative, and a member of EFPIA IEGU. She is also a co-author on the HARPER work: https://onlinelibrary.wiley.com/doi/full/10.1002/pds.5507

---

Helen Knight

Director of Medicines Evaluation, National Institute for Health and Care Excellence

Helen Knight is the Director of Medicines Evaluation at the National Institute for Health and Care Excellence (NICE). She is responsible for designing and operating methods and systems to produce national guidance and other advice on medicines and other relevant therapies for the NHS in England. With an academic background in biochemistry and health economics, and over 20 years of experience in Health Technology Assessment, she has extensive knowledge of the principles of evidence-based healthcare, methods and processes of health technology assessment and experience over a wide range of technologies and disease areas.

---

Louise Knowles

Deputy Director, Innovation Accelerator and Regulatory Science, MHRA

Louise has over 17 years of experience working in Scientific roles across the Civil Service, and joined the MHRA in October 2023. The Innovation Accelerator and Regulatory Science team provides innovators enhanced access to MHRA scientific expertise and regulatory guidance, bringing together the work of the Innovation Office, Horizon Scanning functions as well as leading on the delivery of the Innovative Licensing and Access Pathway (ILAP) and the Innovative Devices Access Pathway (IDAP).  She was previously the Head of Research Capacity and Growth at DHSC and part of the leadership team for the National Institute for Health and Care Research, providing the strategic leadership and oversight of the NIHR Translational Research Infrastructure and NIHR Clinical Research Network as well as leading work to deliver on the ambitions set out in the UK Vision for Clinical Research Delivery. Prior to her role in DHSC she was a Foresight Researcher at the Government Office for Science and led a number of Research Programmes for the Food Standards Agency.

---

Puja Myles

Director, Medicines and Healthcare products Regulatory Agency’s (MHRA)

Puja Myles is Director of the Medicines and Healthcare products Regulatory Agency’s (MHRA) specialist real world data research service, the Clinical Practice Research Datalink (CPRD). She is a public health specialist and prior to joining CPRD, was a public health academic at the University of Nottingham, UK. She is a fellow of the Faculty of Public Health (UK), a senior fellow of the Higher Education Academy (UK) and has a doctorate in epidemiology.

---

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.

---

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.

---

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 June Raine DBE

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA)

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.

Kathy Williams

Executive Director Regulatory Policy, Intelligence & Regional Strategy, AstraZeneca

No bio provided

---