Outsourcing in Clinical Trials 2020 A Virtual Experience

Biography: Andrew Thompson is the Director of Therapy and Analysis at GlobalData Healthcare, responsible for data collection and forecasting within the Medical Devices portfolio. Andrew is passionate about developing innovative approaches to the world of medical devices industry research. Andrew joined the team in 2012, following 20 years working within the academic and industry sectors, developing a specialty in advanced diagnostics for infectious disease. With multiple patents in molecular detection technologies, publications’ covering a breadth of topics and leading product development teams, Andrew has established a strong reputation within molecular diagnostics. Having worked on the frontline, Andrew can share a global understanding of the medical device industry, with both a highly developed understanding of the technologies, new and emerging, and of the business dynamics fueling medical device usage in healthcare. Responsible for the content and direction of global medical device portfolios, GlobalData forward-looking approach generates stimulating analysis and reports, to explore what these changes mean for GlobalData’s clients and their customers.

Session Details: Impact of the Medical Device Regulation on Device Approvals 27-05-2020, 1:05 pm View In Agenda

Biography: Professor of Clinical Diabetes and Metabolism, Cardiff University School of Medicine. Professor of Endocrinology and Diabetes, University of Bristol. Colin Dayan trained in medicine at University College, Oxford, and Guy’s and Charing Cross Hospitals in London, UK before obtaining a PhD in the immunology of Graves’ Disease in Laboratory of Marc Feldmann. He then spent a year as an endocrine fellow at the Massachussetts General Hospital in Boston, USA before completing his specialist training in diabetes and endocrinology as a Lecturer in Bristol. He became a consultant senior lecturer in medicine (diabetes/endocrinology) at the University of Bristol in 1995 and Head of Clinical Research at the Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology in Bristol in 2002. In 2010, he was appointed to the Chair of Clinical Diabetes and Metabolism and Head of Section at Cardiff University School of Medicine. He served as Director of the Institute of Molecular and Experimental Medicine in 2011 – 2015. In 2017 he was appointed to the post of Professor of Endocrinology and Diabetes at the University of Bristol, UK as a joint post with Cardiff. He has a long established interest in translational research in the immunopathology of type 1 diabetes and is currently conducting early phase clinical trials in the development of antigen specific immunotherapy as well as leading multicentre phase 2 studies. His clinical interests in diabetes include management of poor compliance in type 1 diabetes, public health measures in the prevention of type 2 diabetes and models of community care in diabetes. He is the lead for diabetes in the Cardiff whole pancreas transplantation programme and with colleagues leads an All Wales anonymised data linkage programme for monitoring childhood type 1 diabetes. He has been part of 2 major EU FP7 programme grants in type 1 diabetes (and coordinator on one), a member of the Juvenile Diabetes Research Foundation Medical and Scientific Committee and the Welsh Diabetes Research Unit. Prof Dayan currently leads the Clinical Engagement and Training Core of the Diabetes UK funded type 1 diabetes UK immunotherapy Consortium which aims to coordinate and support combined efforts to bring immunotherapy for type 1 diabetes into clinical practice. He also chairs the UK Clinical Studies Group for the prevention, targets and therapies in type 1 diabetes.

Session Details: How can disease consortia help recruitment into clinical trials: experience from the UK Type 1 diabetes immunotherapy consortium 27-05-2020, 11:55 am View In Agenda

Biography:

Session Details: Case Study: Can Choosing an Adaptive Approach Lead to Increased Efficiency in a Clinical Trial? 27-05-2020, 2:15 pm View In Agenda

Biography: Global Development Operations Process Improvement lead responsible for Clinical Study Start up and Informed consent processes in Amgen. As of Jan 2019 responsibilities expanded to study conduct and closeout processes. Implementation lead for eConsent Amgen representative to the TransCelerate Biopharma organization for eConsent. Was Amgen Shared Investigator Platform (SIP) implementation lead and Amgen representative in TransCelerate SIP team during 2018.

Session Details: Bolstering Patient Enrolment Rates by Focusing on the Needs of the Patient in Order to Ensure Positive Feedback both During and Post-Trial 27-05-2020, 4:35 pm View In Agenda

Biography: John Shillingford, PhD is an experienced clinical researcher whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years.  John has both lived and worked in a number of European Countries as well as the USA.   He is now lives in Germany. His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes. John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH. Currently John is Clinical Operations Director and a member of the Board of Afon Technology Ltd, a UK based Medical Device Company, Consultant to International Research Companies  and additionally continues to run a number of training courses in Vendor and Project Management.

Session Details: Strategies for Efficient Conflict Resolution between Trial Sponsors and CROs 27-05-2020, 2:50 pm View In Agenda

Biography: Barbara is Director, Quality and Risk Management, at GSK. This includes ensuring GSK’s global processes, procedures and training meet current and future regulatory requirements and GCP, and supporting GCP inspection readiness. She has recently taken on responsibility for quality at GSK’s phase 1 unit and for Human Biological Sample Management within clinical trials. Barbara has a PhD in Physiology and Pharmacology from the University of Nottingham. She started in clinical research 25 years ago as a Clinical Research Associate, subsequently working in clinical trial management, training, and various quality roles, for pharmaceutical companies including GSK and Roche. She is a visiting lecturer at Kings College London and an Honorary Fellow of the Institute of Clinical Research.

Session Details: Exploring Approaches to ICH E8(R1) Compliance 27-05-2020, 10:45 am View In Agenda

Biography: Currently, working as Head of Clinical Operations for Mereo BioPharma, a small UK-based biopharma company specialising in rare diseases, Ian has approx. 20 years’ experience in clinical development. Working for small, medium, large pharma and CROs, including Takeda oncology, Shire, ICON, Sanofi in clinical science and operational roles he has a broad therapeutic and operations experience in early & late phase development which has supported successful registrations in US, EU and Japan. He has been successful in operationalising complex programs in orphan and specialty indications and has a PhD in Medical Microbiology from the University of Edinburgh and Queen Margaret University College.

Session Details: The changing communication interfaces in clinical trials: Are we navigating the new normal? 27-05-2020, 10:10 am View In Agenda

Biography: Having graduated from University with a degree in biochemistry , I have worked in the pharmaceutical industry for 30+ years most of these in clinical development. For the last 10 years I have had the role of Director of clinical operations within the anti-infectives portfolio first at AZ then latterly at a small biotech company F2G. I have also had a similar tole within the oncology and CNS portfolio and have worked across all phases of development from FTiM to phase 4 and post approval commitment studies. I am very interested in the difference between small and large pharma and the way these different entities interact and partner with CROs.

Session Details: Analysing the differences in CRO relationship management when working in biotech vs big pharma environments 27-05-2020, 3:25 pm View In Agenda

Biography:

Session Details: Unlocking the Potential of Hospital Study Sites to Achieve True Patient Centricity 27-05-2020, 4:00 pm View In Agenda

Biography:

Session Details: Unlocking the Potential of Hospital Study Sites to Achieve True Patient Centricity 27-05-2020, 4:00 pm View In Agenda

Biography: Nick Rich joined Novotech business development in March 2017. With a strong passion for Business Development, and a results orientated approach, he brings over 25 years of experience across the life science space. Nick’s specialty is clinical full service outsourcing of pharmaceutical and biotechnology products across Asia Pacific. In his previous roles, he has managed a team of account directors in Asia Pacific based in India, China, Singapore and Japan. Nick holds a Bachelor of Science with Honours from the University of Warwick.

Session Details: Running Global Trials with Regional CRO Specialists 27-05-2020, 12:30 pm View In Agenda