The 2018 Programme is now finalised and the speakers will be added here as we confirm their details.
Nadir is as an oral surgeon and worked first, in public healthcare. He holds a university degree in health economics and medical informatics. He has served in global positions at Wyeth, and now at Sanofi, in clinical operations, leading projects in clinical development, and clinical technologies. Nadir is actively engaged in bringing innovation in clinical development and led projects in remote trial (Verkko), wearables trials, digital endpoints trials and recently in EHRs driven clinical trials. He is a member of the Executive Committee of the EHR4CR champion project. Nadir is presently leading a consortium project EHR2EDC aiming at further developing capabilities to conduct trials using EHRs data directly.
Adam has spent 29 years in clinical research and has been with Covance for 10 years. With job roles in pharma, an EDC vendor and several major CROs, he is experienced in 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.
Stephen Brown has over 20 years experience in Clinical Data Management & Programming within both the CRO and Pharmaceutical sector. His experience includes leading the Clinical Programming department at Roche UK & leading a 20 strong Global team through Technical/Strategic solutions in Reporting Visualisations & Medical Data Review. Currently, he is a Senior Manager within the Clinical Data Management department at Roche.
Stephen started his Pharmaceutical career working at the Covance early phase clinical research unit in Leeds supporting healthy volunteers undertaking first-in-humans drug trials for safety, tolerability & efficacy after which he then progressed into Data Management working on later phase studies. Whilst at Covance Stephen spent several years working in the IT dept. First as a Process Analysts & System Specialist, responsible for new system life cycle development, process documentation & system training and later in Clinical programming becoming a founder member of the Oracle Clinical Programming team.
In 2005 Stephen joined Roche as a Clinical Programmer and went on to become the Manager of that team. During his career at Roche he has been involved in many different roles and initiatives including Cross functional Risk Management Analytics Platform projects; Metrics dashboards and platforms implementation, developing and implementing systems such as Oracle Clinical, RAVE EDC System / SDTMv Extraction & Tabulation and Reporting Data Modelling.
Stephen is passionate about supporting the development of Personal Health Care & Real World Data.
Stéphane Chollet is an experienced Senior Project Manager who joined the Pharmaceutical R&D industry in 2004, moving to Keyrus Biopharma in 2005. He has experience working in institutions (French Petroleum institute), in small and mid-size CRO (Therapharm Recherches and Keyrus Biopharma), acting in the Data Management field. Stéphane is currently leading the Innovative Technology Initiative, a working group dedicated to the development of innovative tools for biopharma companies.
During his career in Data Management, Stéphane has been the successful leader of the data management functional service platform for GSK Vaccines, following the international flu pandemic alert in 2009. Showing excellence and efficiency during all phases of the collaboration from set-up to conduct, Stéphane was key in expanding our collaboration with GSK, leading to several other FSPs implementation.
Stéphane is a bachelor in Biology of Populations and Ecosystems and hold a master degree in Management of Data for Biomedical Research.
Richard Davies joined OmniComm in February 2014 and is based in the UK. As Executive Director of Business Solutions his role is to support organizations’ adopting OmniComm solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection programs. Additionally he has product management responsibilities and provides a bridge between customers, prospects and ongoing product development. He has worked for technology vendors for nearly 20 years but prior to this, he worked in data management with Fisons Pharmaceuticals and Astra.
Fabien Didier holds a university degree in Cellular & Molecular Biology as well as in Computer Sciences applied to Life Sciences. He has spent 25 years in clinical research with various positions in Data Management in different therapeutic areas. During this period, Fabien managed a global team, experienced several operating models, developed standards and was involved in some submissions.
In 2010, Fabien joined a Transversal expert team and worked in projects such as the implementation of a new Data Management partnership model with an Indian company, the KPIs, the Clinical Data Management System selection, the data validation strategy & dashboard, the resource algorithm definition….
Currently, Fabien is leading a Data Management expert team dedicated to the Data Management, the DM sourcing models, the standards & the technologies. He is also engaged in bringing innovations in Sanofi clinical trials.
Xavier Gobert, CEO of MyData-Trust has over 20 years’ experience in the Pharmaceutical Industry. He is deeply passionate about delivering exceptional service. Xavier is also a clinical data standards expert leading the French Users Group of CDISC since 2011 and board member of the E3C.
Uppsala Monitoring Centre (UMC)
Malin is Product Strategy Manager for WHODrug dictionary at Uppsala Monitoring Centre (UMC). She is a pharmacist by training and she has been working with WHODrug in different roles for twelve years, from data validation to production and now she is involved in the strategic development of the WHODrug offering. She has been running projects such as the development of the Standardised Drug Queries, the development and introduction of the new dictionary formats and new dictionary type. She is involved in collaborations with US FDA, Japanese PMDA and several other authorities. She is also involved in the ISO group and EU task force for the implementation of the Identification of Medicinal Products, IDMP. Malin is passionate for development of products that make life easier for its users and she always encourages and welcomes input for new developments of UMC offerings
European Institute for Innovation through Health Data and of the EuroRec Institute
Dipak Kalra, PhD, FRCGP, FBCS, is President of the European Institute for Innovation through Health Data and of the EuroRec Institute. He plays a leading international role in research and development of electronic health record interoperability standards, data and privacy protection, interoperability business models and the reuse of EHRs for research. He has led multiple European projects in these areas, including Horizon 2020 and the IMI programme alongside pharma companies, hospitals and ICT companies. Dipak is Clinical Professor of Health Informatics at University College London, visiting professor at the University of Gent, and a member of standards bodies including CEN, ISO and HL7.
Bertrand Le Bourgeois
Silicon Marketing / PharMarketing
Bertrand Le Bourgeois MSc, Dipl. Ing. graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He has spent his career in Management and IT Consulting, in the healthcare and life science industries at major software solution providers for Clinical Research and Data Management.
Now Bertrand runs Silicon Marketing and PharMarketing, two business development and marketing consultancies, dedicated at helping companies develop in the pharmaceutical sector in EMEA. He is speaking regularly at industry conferences in Europe and US, and sits at the Board of Data Management Biomedical and Association for Clinical Data Management.
Marketa has been working in the field of Data Management in the CRO environment since 2007 when she began her career as a Data Manager and Data Entry Clerk. In 2012, she became Manager of Clinical Data Operations for MDSL International in the United Kingdom, a position which she held until the company was acquired by CROS NT in 2013. Marketa then became a Principal Data Manager for global CRO.
She has been the Lead Data Manager on numerous studies and has participated in many kick-off meetings, bid defense meetings and client training. She has an in depth understanding of clinical data management processes from protocol review to database lock. She has extensive knowledge across a number of therapeutic areas. Marketa joined the ACDM conference committee in 2014.
Graduating as a bio-engineer from the Ecole Nationale Supérieure d’Agronomie et des Industries Alimentaires (ENSAIA) and followed with an executive MBA from HEC Paris, Jean-Luc has worked in Clinical Research as Worldwide Managing Director of SGS Clinical Research, European Director of MDS Pharma Services and Strategy Consultant at Arthur D. Little. During these experiences, he has led international teams of up to 500 people.
Recently, Jean-Luc joined AEC-Partners a strategic consulting firm specialised in healthcare. He leads assignments for the pharmaceutical companies to optimize their R&D strategy and supports CROs in putting in place innovative projects. Jean-Luc has established a solid international network within the pharmaceutical sector and with CRO companies, which he has leveraged to support private equity funds as a Senior Advisor.
Earlier in this career, Jean-Luc worked for 13 years with Essilor as a General Manager and a Marketing Director in several European countries
CROS NT Limited
Jo started her career as a Data Manager in Searle back in the 1990’s, where she developed to a high level global data manager role, with particular expertise in new technologies and process improvement. This is also where her career in the ACDM began as part of the website sub-committee and gaining the MSC in Clinical Data Management that the ACDM set up in conjunction with Kingston University. After several mergers and acquisitions Jo left the pharmaceutical company side of the industry and started working with an Entrepreneur in a start-up CRO. Together they grew the company, developing a reputation for quality and expertise in Biometrics and Jo became the Managing Director of MDSL International after 5 years broadening her data management experience into strategic management. In 2013 CROS NT acquired MDSL International and Jo became the UK Country Manager for the global CRO. She has worked on a number of special projects while maintaining her strategic management responsibilities, including Integration, Quality Management Systems, Continuous Improvement, Functional Service Provision, HR, Business Development. Jo joined the ACDM conference committee in 2010, became chair in 2014 and also joined the ACDM board in 2014 as Treasurer.
Roche Products Limited
Ian has been in the industry for around 23 years, and spent most of that time in CDM biometrics. Starting his career at a CRO, Parexel, where he worked as a clinical data manager for 7 years and spent a year as a statistical programmer. Following this, he moved to Roche and worked as a Program Data Leader looking after all the data management activities across many compounds and in a variety of therapeutic areas. However for the last two years he has been working in Roche’s global quality dept, developing global compliance metrics for senior leadership, GCP and GVP councils. Although he has moved away from CDM, he is still passionate and actively involved in the running of the ACDM as a board member.
Dr. Johann Pröve
Past Global Head Data Management, Bayer Healthcare
Dr Johann Pröve studied agro-biology and started his business life in 1980 at Bayer in Clinical Data Management. Between 1990 and 1994 he was Head of Clinical Data Management at Bayer Corp in West Haven, Connecticut, USA.
Since 2000 Johann was the Head Global Data Management at Bayer Healthcare until November 2013 when he was appointed as Global Strategy and Development Advisor in Global Data Sciences and Analytics.
As of Jan 1 2016, Johann offers clinical data management consulting services as a freelance consultant and is also the Chief Scientific Officer at Cyntegrity, an RBM application company.
Andy Richardson has worked in the pharmaceutical and allied industries for more than 25 years. Trained originally in pharmacology, he has worked in both the pharma and CRO sectors for top 10 pharma and leading CROs where he has held senior roles in clinical data management and clinical systems as well as working independently in QA, project team leadership roles and supporting and delivering MSc and other training courses. He is currently a consultant with d-Wise based in the UK, supporting major clinical systems reengineering and process improvement initiatives for pharma with a primary focus on CDISC standards operational implementation across the study lifecycle.
Q-FINITY Quality Management
Marcus has been in the life science industry for more than 20 years, and spent most of that time in IT, Project Management, Technology Quality Management and Assurance. He started his career at a CRO, PAREXEL, where he worked three years as a IS Supervisor and was responsible for IT operation for multiple offices, as well as several IT projects including several roll-outs and the Year-2k project. In 2000 he moved to the University Hospital of Heidelberg and became the Head of IT and Computerized System Validation at the Coordination Centre for Clinical Trials, an academic CRO at the University Hospital of Heidelberg. In this role he introduced state of the art computerized system validation and management practices to an academic environment. He initiated and implemented the first regulatory compliant EDC solution for the support of multi-centric-trials at the University Hospital. Three years later he re-join PAREXEL in a Quality Manager position. Over the last 14 years he was in charge of different leadership positions, which included Head of Global Technology Quality Management and Head of the QA Computer Technology Auditing Group. Marcus has a proven history of getting to the heart of matters impacting IT security and risk, with clear insight into gaps, threats, and remediation solutions. Adept at leading worldwide programs and projects to deploy frameworks, systems, and controls that transform how companies handle risk prevention and mitigation. Recognized for driving continuous improvement at all levels, with a key focus on transformation in project management and systems controls including computerized system validation. Recently, he joined Q-FINITY, a consulting company for risk-based Quality Management, Quality Assurance, GxP-Compliance and Continuous Improvement of Processes, Data and Computerized Systems. As Chief Operation Officer he now takes care of the operational belongings of Q-FINITY.
Jon has 27 years of industry experience in biometrics services in both Pharma & CRO organizations. He lead global data management and biostatistics teams in serving Accelsiors’ Customers. Jon has extensive knowledge across a number of therapeutic areas. He is a recognized expert in data management and serves as the co-Chair of the Association for Clinical Data Management and is an accredited trainer. Jon has previously held leadership positions with GSK, Pfizer and Amgen.