Speakers

Prof 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.

Dr Mark Treherne	Biography: Dr Mark Treherne was appointed Chief Executive of the UKTI LSO in August 2012. Mark is a qualified research scientist with a PhD in Pharmacology from Cambridge University and has over 25 years’ experience in the discovery of novel treatments for diseases of the nervous system. Formerly at Pfizer in Sandwich, UK, and responsible for research into neurodegenerative diseases before leaving Pfizer in 1997 to set up Cambridge Drug Discovery (CDD) as Chief Executive, which was sold to BioFocus in 2001 for Ł28 million. Mark has helped to raise over Ł140 million for various early-stage biotechnology companies and has now served on the Boards of over 14 private and public biopharmaceutical companies.

Dr Peter Wilmshurst	Biography: Peter Wilmshurst is a consultant cardiologist at the Royal Stoke University Hospital. When a junior doctor, he reported misconduct by a pharmaceutical company that falsify research in the UK and marketed an ineffective and unsafe drug in developing countries. His actions caused worldwide withdrawal of the drug. Since then he has investigated cases of misconduct in research in the UK and abroad. He has defended three legal cases resulting from him raising concerns about a medical device before the company went into liquidation. l. He was described in a BMJ editorial as “British medicine’s champion whistleblower” and in Private Eye as “the godfather of NHS whistleblowers”. In 2003 he was awarded the Annual Health Watch Award “for courage in challenging misconduct in medical research” and in 2012 he was the first recipient of the BMJ Editors Award “for persistence and courage in speaking truth to power”.

Dr Janet Wisely	Biography: Janet Wisely is the Chief Executive of the Health Research Authority. Janet obtained a degree and PhD in Physics from the University of London, joined the NHS in 1992 and has spent her entire working career associated with research and the NHS. Janet is an innovative leader with a track record of successful change management who, as the Director of the National Research Ethics Service, has transformed the UK ethics service into an internationally recognised system for ethical review. She has also been instrumental in delivering wider change through the provision of the Integrated Research Application System which streamlines the application processes for researchers. As Chief Executive of the Health Research Authority, Janet is leading work to further improve the environment for research to make it easier to do good quality ethical research in the UK. Janet is an honorary fellow of the faculty of pharmaceutical medicine and in July 2013 was selected onto the inaugural HSJ Inspirational Women list.

Jonathan Fennelly-Barnwell	Biography: Jonathan Fennelly-Barnwell is the Head of Collaboration and Development at the HRA. Jonathan obtained a Masters in Medical Ethics and Law, and has been at the HRA since its inception in 2011 having joined the National Research Ethics Service as a regional manager. Before this, Jonathan has spent his working career primarily in public and mental health, in service development, professional education and commissioning. Jonathan now leads a small team in the HRA which develops and promotes joint working practices and agreements both within the HRA, and more widely; his team also assists researchers with complex or novel regulatory requirements using resolution as evidence to inform service and policy development. Jonathan retains academic interests in ethics and the law, and is currently a doctoral candidate at the London School of Hygiene and Tropical Medicine, in the area of ethics and legal embodiment in public health policy.

Dr Michael D Leek	Biography: Michael is CEO of TC BioPharm, developing phase II/III T cell-based cancer immunotherapies. He has previously worked as CEO of an orthobiologicals company, and with a clinical team developing an autologous infusion of stem cells to initiate regeneration of new hepatic tissue. Jointly responsible for moving Intercytex from a pre-clinical research company, to an AIM-listed biotech with several cell therapy products in the clinic, Michael has developed over 10 cell-based products from concept to clinic in an ever-evolving clinical, commercial and regulatory landscape.

Prof 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 and clinical research. In 2009 he won the Lily Prize of the British Pharmacology Society. In 2000 he established the Barts and The London Genome Centre which now underpins over 40 programmes of research. Since 2008 he directs the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit. Mark was appointed Director of the William Harvey Research Institute in 2002 and was elected a Fellow of the Academy of Medical Sciences in 2008. He led on fundraising towards the Ł25m William Harvey Heart Centre which created a translational clinical research centre. Mark served on the NICE Guideline Group for hypertension and leads the Joint UK Societies’ Working Group and Consensus on Renal Denervation and was President of the British Hypertension Society (2009-2011). In 2013 he became an NIHR Senior Investigator and was appointed as the Chief Scientist for Genomics England (NHS 100K Sequencing Project) 2013-2017.

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 was a member of the European Pharmacopoeia Commission’s Working Party on Cell Therapy Products. He moved to the MHRA Clinical Trials Unit (CTU) as a Pharmaceutical Assessor in 2007 and was involved in the assessment of chemical and biological CTA applications for all phases of study. He became Head of CTU in November 2015 and is currently involved in European Medicine Agency and UK projects to prepare for implementation of the new clinical trials Regulations.

Nicola Colson	Biography: Nicola Colson is Policy Adviser for EU and International medical device policy at the MHRA. Nicola has been working on negotiation of the new EU Regulations for medical devices and IVDs, and prior to joining the civil service, Nicola worked in EU health policy for private and non-profit interest groups.