Speakers

Dr Gary Acton	Biography: Gary Acton is a medical oncologist based in London. He became a doctor by accident, having originally gone to university to do something completely different. However, after inadvertently ending up at Oxford and London medical schools he decided to give it a go and found to his surprise (and everyone else’s) that he was actually quite good. After a long period wandering the wards of London hospitals, he eventually left clinical practice, as his hypochondria was getting worse and worse. Following a spell studying mediaeval theology (don’t try this at home) he moved into research and development and has been working on new anti-cancer drugs ever since. He is currently Senior Medical Advisor to Cancer Research UK and is also medical advisor to the UK government’s cancer cellular therapy initiative. Additionally he provides strategic cancer drug development consultancy to a number of US and European biotechnology companies and academic institutions.

Professor Mark Caulfield	Biography: Mark Caulfield graduated in Medicine in 1984 from the London Hospital Medical College and trained in Clinical Pharmacology at St Bartholomew’s Hospital where he developed a research programme in molecular genetics of hypertension which has discovered over 1000 gene loci for blood pressure. He was appointed Director of the William Harvey Research Institute in 2002 and was elected a Fellow of the Academy of Medical Sciences in 2008. Between 2010 and 2015 he co-led the merger of three hospitals in North London to create the new Ł400 million Barts Heart Centre which provides 80,000 cardiovascular patient episodes. He has won the Lily Prize of the British Pharmacology Society, the Bjorn Folkow Award of the European Society of Hypertension 2016 and the Franz Volhard Award of the International Society of Hypertension in 2018. In 2013 he became an NIHR Senior Investigator and was appointed as the Chief Scientist for Genomics England (100,000 Genomes Project). He was appointed Interim Chief Executive Officer for Genomics England from January to September 2019. Sir Mark was awarded a Knighthood in the June 2019 Queen’s Birthday Honours List for services to the 100,000 Genomes Project.

Dr David J Collier	Biography: David trained in medicine at Barts, won one of the first Wellcome Trust Prize Studentships to do a PhD in physiology during his medical degree, led the research team on the British Mount Everest Medicial Expedition in 1994 and has worked on clinical trials since 1997. He is Clinical Director - William Harvey Clinical Research Centre, Clinical and Public and Patient Involvement/Engagement Lead - Barts Cardiovascular Clinical Trials Unit, Public and Patient Involvement & Engagement Strategy Lead - Barts Biomedical Research Centre and Interim Director - Barts CTU (UKCRC registered Clinical Trials Unit). His Clinical Research Centre has recruited large numbers of patients (such as 1157 patients for ASCOT) for 22 years and working with those patients they have influenced the development of many new therapies and also patient collaborations such as Chiaroscuro- marking the 70th Anniversary of the Nuremberg Trials.

Gary Cook	Biography: Gary Cook is Deputy Director in the Office for Life Sciences (OLS) responsible for three areas of core Government policy. Firstly, the strategy, vision and policy for genomics, the use of a person’s DNA to help prevent or cure illness. Secondly, data policy for OLS, improving the health of the nation through better use of NHS data by partners developing innovative treatments. Thirdly, specific responsibilities concerning resilience in the supply chain, ensuring continuity of supply into the UK and appropriate risk mitigation. Gary has nearly eight years’ experience in the Civil Service across five Government Departments, and five years’ experience in the private sector working in digital and data. Gary has an MSc in Public Policy from LSE, an MSc in Information Technology for e-Commerce from the University of Sussex and a BSc in Information Systems from the University of Newcastle-upon-Tyne.

Matt Cooper	Biography: The National Institute for Health Research Clinical Research Network is the research delivery arm of the NHS. It invests some Ł300m each year into an infrastructure of clinical research professionals across England, to support rapid study set-up and patient recruitment into clinical research studies (academic and commercial). The Network has demonstrated year-on-year improvements in patient recruitment numbers and delivery times for commercial studies. In 2018/19 the NIHR CRN supported the recruitment of 46,064 patients into commercial contract clinical trials from1523 open and recruiting studies. Demonstrating efficient and effective set up and delivery of clinical trials at scale in our single healthcare provider - the National Healthcare Service. Matt has been involved in the Network since 2006 and an Executive Director at the Clinical Research Network Coordinating Centre since 2014 and brings a wealth of experience to the post. Matt plays a key role in promoting the UK as a prime destination of choice for clinical research at the frontier of innovation and technology. In previous roles Matt worked in the Clinical Research Group of AstraZeneca UK for a number of years and in the NHS coordinating clinical trials.

Stuart Evans	Biography: Stuart Evans is a Pharmacology graduate from the University of Bath with over 10 years of experience in Clinical Research. He has worked at both large and small CROs before joining AMO Pharma, a small, virtual biopharmaceutical company. His experience includes pharmacovigilance, quality systems, monitoring and study management in various therapeutic areas; now focusing on paediatric neurodevelopmental rare diseases as Associate Director of Clinical Development at AMO Pharma.

Sarah Fryer	Biography: Sarah Fryer, founder of the independent consultancy QRC Consultants, has over 30 years’ experience in the pharmaceutical industry, primarily in the management of clinical research programmes, GCP QA auditing and Quality Systems Management and with a particular interest in the development of advanced therapies. A graduate from Surrey University with an MSc in Toxicology, Sarah moved from pre-clinical research into clinical drug development working in both small company and CRO environments. As Managing Director for the UK office of the international CRO Harrison Clinical Research, she facilitated the attainment of ISO certification for the company. In 2003, she was co-founder of Gregory Fryer Associates. Sarah is now Director of QRCC, based in St Ives, Cambridgeshire, leading a team of QA, regulatory and clinical research consultants.

Alex Gage	Biography: Alex graduated from the University of Nottingham with a BSc (Hons) and has over 20 years’ experience within the pharmaceutical industry, working primarily within clinical operations managing clinical trials and project teams both within the UK and globally. Alex has held numerous positions at a large pharmaceutical company, worked as an independent consultant and for a UK-based Contract Research Organisation. Alex has experience of a wide range of therapeutic areas within clinical research across different phases of development.

Dr Matthew Hallsworth	Biography: Dr Matthew Hallsworth is Head of External Relations for the NIHR Office for Clinical Research Infrastructure (NOCRI). He leads on external stakeholder relations, including engagement with the bio-pharma industry. NOCRI works with companies to support collaboration with the expert investigators and research facilities funded by the UK Department of Health, from early-phase translational medicine through to later-phase clinical trials. Prior to NOCRI Matthew was Head of Communications at the UK Clinical Research Collaboration – a partnership of government, charities, industry, the NHS, academia, regulators and patients focused on improving the clinical research environment in the UK. Matthew has had Research Management roles at the medical charity Asthma UK and for the Department of Health’s National R&D Programme. During his earlier career Matthew was a Research Fellow in Respiratory Medicine at Guy’s & St Thomas’ Hospitals, London, where he completed his PhD on inflammatory mechanisms in asthma and allergic disease.

Dr Ali Hansford	Biography: Dr Hansford is the Head of Regulatory Strategy at the Association of the British Pharmaceutical Industry (ABPI), a role which covers the policy areas of clinical research, regulation of trials and medicines, licensing and access schemes. Prior to this, Dr Hansford was the Head of Science Policy at the ABPI. Before moving to the ABPI, Dr Hansford worked in the Policy & Knowledge team at Prostate Cancer UK. Dr Hansford holds a PhD in the immunology of asthma and allergy from King’s College London and an M.Sci in Pharmacology from the University of Bristol.

Steve Hoare	Biography: Steve trained as an analytical chemist and has experienced the medicines lifecycle as a QC or QA Lead from early discovery through to marketing approval, manufacture and distribution, driving compliance in pretty much every “x” in GxP. Steve’s team at ABPI work with members’ expert communities to develop and advocate Brexit and Brexit-agnostic policies that increase the attractiveness of the UK for investment in R&D and Manufacturing.

Paul Bowers Isaacson	Biography: Paul is a professional educator working in the areas of curriculum development and assessment nationally, for example developing the Extended Project Qualification for sixth form students. He is also an experienced facilitator and offers facilitation and presentation training for various voluntary groups. Some years ago Paul joined a clinical trial overseen at the William Harvey Clinical Research Centre. Paul’s interest in clinical trials had started a few years earlier in the context of developing A Level Science and Society with the Nuffield Curriculum Centre. He has since worked with David Collier at William Harvey to create TrialsConnect as a voluntary organisation of patients inspired by the power of ‘Patient Story’.

Professor Atholl Johnston	Biography: Professor Atholl Johnston is Professor of Clinical Pharmacology at Barts and The London School of Medicine and Dentistry, Queen Mary’s, University of London, visiting Professor of Forensic Pharmacology and Toxicology at St George’s, University of London, and the Director of the laboratory of Analytical Services International Ltd. He is a Fellow of the British Pharmacological Society, the Royal College of Pathologists, the Royal Society of Medicine, the Faculty of Pharmaceutical Medicine, and the Royal Statistical Society. He is a Chartered Scientist, a European Registered Toxicologist, and a state registered Clinical Scientist. Professor Johnston has more than 35 years’ experience in the measurement of drugs as a guide to therapy. He has published over two hundred and sixty articles in peer-reviewed journals. Professor Johnston was a Founder member of CCRA and is currently its President.

Ian King	Biography: Ian is the Deputy Director of the EU & International Policy team at MHRA, heading up the Agency’s EU Exit work, having previously been responsible for leading the Agency’s Brexit No Deal readiness. Prior to this Ian worked on EU carbon pricing negotiations at BEIS/DECC and was part of the DECC strategy team. He has a PhD in solid-state analytical chemistry, and worked as a research scientist in the pharmaceutical industry at the start of his career.

Emma Lewis	Biography: Emma graduated with a BSc (Hons) in Applied Biology from Brunel University before joining the pharmaceutical Industry as a CRA in 1995. Since then Emma has had a diverse career within large pharma and both large and small CROs. Currently Emma is a Senior Director of Clinical Operations with PRA Health Sciences responsible for the recruitment, training and development of clinical operations staff and the delivery of clinical studies across multiple countries including the UK. Emma represents Clinical Operations on the PRA Health Sciences Brexit task force.

Emma Lowe	Biography: Emma works within the Science, Research and Evidence Directorate at the Department of Health and Social Care, leading on research policy for industry relations and growth. Her role includes supporting the implementation of the Life Sciences Industrial Strategy, enhancing the NIHR’s offer for Industry, and other areas of policy which contribute to making the UK the destination of choice for life sciences research. Working with the Office for Life Sciences, Emma led the Clinical Research workstream of the Life Sciences Sector Deal 2. Emma has an MSc in People and Organisational Development from the Roffey Park Institute, has held a variety of roles within the NHS and previously led the design and delivery of learning and workforce development programmes in the NIHR Clinical Research Network, including the NIHR’s Good Clinical Practice (GCP) programme.

Liz Madichie	Biography: Liz Madichie is a senior bio-pharmaceutical executive passionate about influencing change to improve health equality worldwide and enable patients and consumers live longer healthier lives. She has extensive experience in global regulatory, pharmacovigilance and product development strategies, both in the biopharmaceutical and CRO industry. As an active industry advocate, and TOPRA Board member, Liz proactively pursues opportunities to advance the regulatory paradigm. She is a recognised thought leader, delivering several presentations, publications and engages in various industry forum. An experienced leader of global regulatory functions, Liz most recently led the PPD global regulatory affairs function providing consultancy and operational delivery across all elements of the product development and commercialization continuum. Liz holds a doctorate in analytical chemistry from the University of Hull and previously held leadership roles with Taro Pharmaceuticals, Élan Pharmaceuticals and GlaxoSmithKline.

Dr Janet Messer	Biography: Janet Messer is Director of Approvals Service at the Health Research Authority. She is responsible for the Research Ethics, Confidentiality Advice, Assessment and Assurance services, alongside the supporting guidance, advice and learning functions. Her team works collaboratively with a wide range of partner organisations to fulfil the HRA’s aims to make it easier to do good quality ethical research in the UK. Prior to working at the HRA she was Head of Research Management and Governance at the NIHR Clinical Research Network. 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 and working with NHS R&D.

Dr Martin O’Kane	Biography: Dr Martin O'Kane MRPharmS is Head of the Clinical Trials Unit at the Medicines and Healthcare products Regulatory Agency (MHRA). He studied pharmacy at University of Aston and after completing a PhD and post-doctorate research project at the University of Glasgow, moved to Japan to work within the pharmaceutical industry. He joined the MHRA in 2005 as a Pharmacopoeial Scientist within the British Pharmacopoeia and moved to the MHRA Clinical Trials Unit as a Pharmaceutical Assessor in 2007. He became Head of the Clinical Trials Unit in November 2015 and is actively involved in European and UK projects to prepare for implementation of the new clinical trials Regulations as well as the UKs exit from the EU.

Sarah Testori	Biography: Sarah Testori works within the Science, Research and Evidence Directorate at the Department of Health and Social Care and is responsible for Brexit policy in relation to health research and clinical trials. Prior to that she held science and healthcare policy roles at Cancer Research UK and the Human Fertilisation and Embryology Authority. Sarah also has a PhD in Molecular Genetics.

Dr Lincoln Tsang	Biography: Dr Lincoln Tsang is a partner of Arnold & Porter Kaye Scholer LLP’s Global Life Sciences Practice. His legal practice is concentrated on regulatory, compliance, enforcement, litigation and legislative public policy matters relating to the life sciences sector. He has served as a Commissioner of the British Pharmacopoeia Commission; a non-executive board member of the National Institute for Biological Standards and Control (now part of the MHRA); and as a non-executive member of the Regulatory Oversight Committee of the Health Protection Agency. He spent nearly 13 years in the UK regulatory agency and was latterly head of biologicals and biotechnology. He has served as an advisor to the European Medicines Agency, the European Commission and the WHO concerning international trade of medicines. He was appointed recently by the Council of Europe as a special advisor on the development of the MediCrime Convention to combat counterfeit healthcare products. He was a member of the UK Ministerial Industry Strategic Group for pharmaceuticals.