Speakers

Dr Nay Aung	Biography: Dr Nay Aung is a Cardiologist with a special interest in cardiac imaging at Barts Heart Centre, London, which is the largest dedicated academic clinical unit for cardiovascular medicine in the UK providing world-class care to 6.1 million people in central and east London. He has been accredited with a Level-3 certification for cardiovascular magnetic resonance (CMR) by European Association of Cardiovascular Imaging and a Level-2 certification for cardiac computed tomography (CCT) by British Society of Cardiovascular Imaging. He was awarded with a Wellcome Trust Clinical Research Training fellowship to pursue a doctoral degree, investigating the genetic architecture of cardiovascular structural phenotypes in the UK Biobank population imaging study. He has expertise in handling large multi-omics datasets, working with high-performance computing clusters and predictive modelling techniques using high-level programming languages such as Python and R. His research interests include population genetics, advanced machine learning to gain insights into common and complex diseases, and automation of image analysis by deep learning.

Sarah Beeby	Biography: Sarah Beeby is a Global leader in the life sciences industry with over 20 years of experience focused in delivering strategic growth, products and business objectives combined with leadership to executive level. Sarah joined Clinithink in 2017 to bring technology, in particular AI, to Lifescience projects. The opportunities and business changes that accompany disruptive technology are of particular interest as is the potential outcome of delivering clinical trials and novel treatments to wider patient populations. With a diverse background in life sciences, in roles ranging from CRA, Global Program Manager, VP to COO in Pharmaceutical, CRO, Medical Device and Investigator Site companies, Sarah has a wide range of commercial, operational, therapeutic and regulatory expertise with a focus on collaborative working opportunities to enhance delivery and patient experience.

Shiyan Caan	Biography: Shiyan Caan has been heavily involved in the development of SQN’s recent innovative technology. With a degree in Psychology, Shiyan approaches patient centricity from a cognitive perspective, understanding what is required both for compliance and for patient engagement. With a drive to improve clinical research through innovation, he works alongside the SQN management team and SQN development team to ensure that SQN remain at the forefront of this evolving paradigm.

Dr Ignazio Di Giovanna	Biography: Ignazio earned a PhD in Biophysics at Guys Hospital, based on the development of non-invasive cardiovascular diagnosis techniques. He’s worked in the CRO field since 1990 and the pharmaceutical industry as a whole since 1986. Previous owned manager of CCA Clinical Research, from 1999 until its acquisition by ARG in Dec 2018. Ignazio was a board member at the Institute of Clinical Research (1999-2006) and Chair from 2004 – 2006 and is a past-President of the Clinical & Contract Research Association (CCRA) and a member of the Biotechnology & Pharmaceuticals Sector Advisory Group (BPSAG), advising and influencing UKTI on trade and investment matters for the sector to help improve the UK market. Ignazio was co-editor of “Principles in Clinical Research,” published in 2001, and in April 2004 was awarded an Honorary Fellowship by the Institute of Clinical Research. Ignazio is now ARG’s Vice-President of European Operations.

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.

Simon Lee	Biography: Simon Lee has over 30 years’ experience in the healthcare, pharmaceutical and drug delivery industry. He is currently Chief Compliance Officer for Quotient Sciences, which provides CRO and CDMO services to the pharmaceutical and biotech industry. In this role he has global responsibility for Quality Assurance, Regulatory, Legal, and Health and Safety. He is a member of Quotient’s Executive Leadership Team covering the sites in the UK and USA. Externally I have extensive interactions with the UK regulatory bodies and participate in the Health Research Authority’s Phase I Advisory Group and Transparency Forum as well as with being Quotient’s lead contact person with the MHRA. I am also actively involved in the activities of the Clinical & Contract Research Association in the UK and serve as Secretary on the Executive Board of the European CRO Federation (EUCROF). I represent EUCROF in stakeholder meetings at the European Medicines Agency focused on the Clinical Trial Information System and the EU Clinical Trial Regulation.

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.

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.

Jonathan Mogford	Biography: Jonathan Mogford is the Director of Policy at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA Policy Division, which Jonathan heads, helps the Agency carry out its public health mandate in alignment with wider UK Government priorities and requirements. The Division leads for the Agency, and the UK Government, in the management of EU and International business relating to pharmaceuticals and medical devices regulation. Prior to joining the Agency, Jonathan held a wide variety of policy posts since joining the UK Department of Health in 1990, including secondments to the Foreign Office and to the European Commission in Brussels; he has also headed policy teams in the UK Department of Health responsible for pharmaceutical industry policy and for private sector provision of healthcare services for NHS patients; he was also the Department's Head of European Affairs for 4 years to 2009.

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, he 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 (CTU) as a Pharmaceutical Assessor in 2007. He became acting Head of CTU in May 2014 and Head in November 2015 and is actively involved in European Medicine Agency and UK projects to prepare for implementation of the new clinical trials Regulations.

Dr Elizabeth Robertson	Biography: Elizabeth is Director of Research and joined Diabetes UK in April 2016. Elizabeth is responsible for ensuring Diabetes UK is driving forward understanding, diagnosis, prevention and treatment of diabetes, through investing in the best research minds and projects. Before joining Diabetes UK, Elizabeth was the first Director of Research for Breast Cancer Now, formed from the merger of Breakthrough Breast Cancer and Breast Cancer Campaign in April 2015. Prior to the merger, she was the Director of Research, Policy and Information at Breakthrough Breast Cancer. Previous roles include Director of Operations at Cancer Research UK, Dean of the Graduate Research School at Teesside University and Post-doctoral Research Associate in the Department of Biology at York University. Elizabeth completed her PhD at Queen Mary, University of London and Sloan Masters in Leadership and Strategy from London Business School in 2014. Elizabeth is a Trustee of the national volunteering charity, TimeBank and King’s College Hospital Charity.

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.

Dr Mark Wright	Biography: Mark Wright has 30 years’ experience in clinical R&D, holding positions, with responsibilities for the design and conduct of clinical trials ranging from first-into-man to post marketing-authorisation, either single-site or multi-site and multinational, in a number of pharmaceutical companies. Most recently he was Head of Real-world Clinical Studies at CPRD (part of the UK MHRA) where access to primary care electronic health records enables the exploration of the transformative potential that real-world data (RWD) and the real-world evidence (RWE) derived from them could bring to healthcare.

Dr Calum Yacoubian	Biography: Having trained and worked as a Doctor in Glasgow, taking time to undertake a BSC in developmental medicine, Calum took his knowledge from clinical practice to working as a clinical terminologist at Clinithink in 2015. Having worked on a variety of projects, he moved into Clinithink’s newly formed Life Science department in 2018. He was a core part of team, including geneticists, statisticians and software engineers that collaborated at Rady Children’s Hospital to create an automated pipeline from blood spot to diagnosis in children with rare disease. This resulted in a Guinness World Record for the fastest ever genetic diagnosis in a patient with a rare disease. For this work, he and his colleagues were recently awarded as Champions of Hope in Science and Technology at the Global Genes Conference.