Speakers

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.

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 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.

John Hladkiwskyj	Biography: John began his career in clinical research in 1987. Since then he has held a variety of roles which have allowed him to become a very accomplished and experienced manager of clinical research projects, teams and personnel across many different disciplines and therapeutic areas. John’s international experience in running studies in Europe, the USA, Asia, the Middle East and Africa for a variety of International clients from the pharmaceutical, biotechnology and medical devices industries has allowed him to develop a strong international network of quality researchers and investigational sites. John has been a key member of study management teams and a has provided support to many CROs and companies. An active member of CCRA since 2006, he has championed the UK as a location for excellence in clinical research.

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: ...

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 he has extensive interactions with the UK regulatory bodies and participates in the Health Research Authority’s Phase I Advisory Group and Transparency Forum, as well as being Quotient’s lead contact person with the MHRA. He is actively involved in the activities of the Clinical & Contract Research Association in the UK, and serves as Secretary on the Executive Board of the European CRO Federation (EUCROF). He represents EUCROF in stakeholder meetings at the European Medicines Agency focused on the Clinical Trial Information System and the EU Clinical Trial Regulation.

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 Alison McMorn	Biography: Dr. Alison McMorn is a clinical development researcher with over 20 years of industry experience and a strong focus in CNS and paediatric drug development. She has worked for both Pharma and CROs holding positions at SAR Monitoring Services, Mundipharma and Shire. Starting her career at SAR as a CRA she subsequently moved to Mundipharma where she was responsible for the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed paediatric and adult clinical development programs including psychiatry, pain, gastrointestinal and hepatology across all phases of development. In addition, she was responsible for harmonizing CTA working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma, a virtual pharmaceutical company focused on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

Alastair Nicholson	Biography: Before joining the HRA in 2014 as Policy Development Lead for HRA Approval, Alastair was Lead Research Management and Governance Manager for Central and East London CLRN. Alastair joined the NHS in 2001 as R&D Coordinator at his local secondary care Trust, before joining the Cancer Research Network as a research facilitator in 2006 and moving to the CLRN in 2008.

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.

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.