Speakers

Adam Baumgart	Biography: Adam has spent 29 years in clinical research and has been with Covance for over 10 years. With job roles in pharma, an EDC vendor and several major CROs, he is experienced in ICH GCP E6 revision 2, risk-based monitoring, process excellence, project management, clinical data management and clinical monitoring. Adam’s role is Senior Director, Xcellerate Monitoring Solutions Development in Covance’s risk based monitoring (RBM) and central monitoring organization. He leads the cross-functional, transformational project team responsible for the implementation of RBM, central monitoring and risk management tools, processes, roles and services. Adam is passionate about the opportunity these capabilities bring to the way we work, our roles and the improvements in data integrity, patient safety and regulatory compliance.

Ross Davenport	Biography: Ross Davenport is a Senior Lecturer in Trauma Sciences at C4TS and consultant trauma and vascular surgeon at the Royal London Major Trauma Centre, Bart’s Health NHS Trust. His research focus is on trauma-induced coagulopathy, acute response to injury and the treatment of major trauma haemorrhage. He has previously worked in prehospital care for both London and Essex & Herts Air Ambulances. Currently he is a personal tutor and module lead for the online Masters programme in Trauma Sciences at QMUL.

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.

Paula Walker	Biography: Paula Walker has been a GCP inspector for the MHRA since 2009. She is now an Inspectorate Operations Manager, and a Senior GCP inspector, with responsibility for the GCP Inspectorate team, a post that she has held for the past five years. Prior to joining the Agency Paula worked in research governance and clinical trials regulation in the non-commercial sector. She started in the NHS working in research and development in a number of roles including ethics management and training, and subsequently worked as a research manager in the higher education sector. Following this she moved back into clinical research and trials regulation working in a number of universities, providing operational and regulatory support for sponsored trials.

Dr Mark Wright	Biography: Dr Wright has experience in basic research and clinical drug development (Phases I - IV) with significant experience of creation, direction, management and reporting of clinical trials from first-into-man through to post-marketing authorisation and has held senior positions (incl. Head of Phase I Unit; International Clinical Team Leader; Director, Clinical Development, Europe) in pharmaceutical companies ranging in size from start-up to global, including European, Japanese and US-based. Most recent experience concerns EHR-enabled clinical studies including comparative effectiveness research, targeted study platform development, and related studies at CPRD where he is Head, Real-world Clinical Studies.

Dr Graham Wylie	Biography: Dr Graham Wylie, CEO for Medical Research Network (MRN) has more than 25 years’ experience in the pharmaceutical industry working for Pfizer, PAREXEL and Healthcare at Home. He was also named as one of the most influential leaders in the pharmaceutical industry by PharmaVOICE 100 in 2014. Graham joined Healthcare at Home in 2005 to set up their trial division and led the management buy out to create MRN in 2006.