Mieke Borgs – Global Head Clinical Document Governance and Management, GDO Trial Management
Mieke has over 20 years of experience in global clinical trial management. She holds a Ph.D. in Biomedical Sciences from the Catholic University of Leuven, Belgium. She started her career in 1996 at Janssen Research Foundation (J&J) in Beerse, Belgium, as a CRA. She then moved to Novartis Switzerland in 1998 to take on the role of Clinical Research Scientist. In 2001, Mieke joined F. Hoffmann-La Roche in Basel where she held various roles with increasing responsibilities in the field of Clinical Operations. Mieke re-joined Novartis Basel in 2010 and has since then been working in various roles in Trial Management. As of 2017, Mieke has taken on the role of Global Head Clinical Document Governance and Management.
Martina Duevel – Systems Excellence Project Leader
Martina Duevel has almost 20 years of pharma experience. In her current role as Systems Excellence Project Leader at Bayer she is responsible for eTMF Innovation and its integration into the R&D system landscape and involved in other projects driving digitisation. In 2015 she lead the implementation of Bayer's eTMF and subsequently headed the maturation program.
Martina has started her Industry career in Clinical Quality Assurance where she worked as an auditor for studies, vendors, and systems, as trainer of auditors and as internal GCP consultant for process changes, inspections, and SOP development. In 2008 she moved into Clinical Project Management were she was overseeing operations for clinical development projects in oncology and diagnostic imaging from early planning through submission and inspection. In 2014/15 she led a group of clinical trial coordinators and clinical records coordinators managing study TMFs.
Martina has studied Biochemistry and earned a doctorate (Dr. rer. nat) from Free University Berlin and worked in several research institutions were she gained her first GxP experience. She is a certified Project Manager as well. In her spare time she enjoys spending time with her family, singing in a choir, and gardening.
Director, Medicines Quality Organisation – International- ELI LILLY
Lucy Hampshire – Director, Medicines Quality Organisation – International
Lucy has worked in the pharmaceutical industry since 2001 and is a Quality Director in the Medicines Quality Organisation division of Eli Lilly and Company Limited. Lucy leads teams providing country level quality oversight for activities relating to medical, regulatory and safety across EMEA, Latin America and Asia Pacific. Lucy started her career in industry in pharmacovigilance before moving into a quality oversight role. Lucy provides leadership and expertise in medical and pharmacovigilance quality systems, ensuring the update of processes impacted by EU GvP and GCP. Lucy has a vast experience in GvP inspections and since the beginning of 2015 took on quality oversight responsibilities for clinical activities, hosting a recent MHRA Sponsor and Site GCP inspection as well as providing leadership for other European GCP inspections.
Lucy has a BSc in Biological Sciences (Microbiology) and obtained an MSc Clinical Microbiology from Barts and The London School of Medicine and Dentistry. Lucy previously trained as a clinical scientist researching antimicrobial resistance before moving into the pharmaceutical industry.
Wendy Koç is Senior Manager at Gilead Sciences International, based in the UK. She has 23 years of experience in pharma GCP compliance. During this time she has covered every aspect of clinical trials, worked in both Pharma, CRO and as a consultant.
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as CSO, she leads all Phlexglobal partnering across the clinical space, has key strategic input into the development of our eTMF, PhlexEview and serves as a Board member.
Karen was also responsible for the development of the TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She still chairs the management of the Model – a Model used by the vast majority of Pharmaceutical companies and CROs.
Karen graduated as a Pharmacist in South Africa and entered the Pharmaceutical Industry working for Eli Lilly in Sales. In 1992, she moved into Clinical Research in the UK with Chiltern International, initially managing the Clinical Development Department. Latterly she started up and globally managed a novel group, EDC Solutions, before joining Phlexglobal.
Vittoria Sparacio – Head, Clinical Documentation Operations GSK Pharma R&D Projects, Clinical Platforms and Sciences
Vittoria Sparacio heads up the Clinical Documentation group at GlaxoSmithKline Pharmaceuticals R&D and leads the electronic Trial Master Files implementation program. In her role, she provides strategic direction for evolving the clinical document management space in GSK Pharmaceuticals R&D.
Vittoria previously held clinical research and document management roles at GSK Biologicals, Novartis, Chiron, MSD, and ICON beginning in 2001.
Vittoria established the electronic TMF system and set new processes and standards that transformed document management and archiving capabilities for Novartis Vaccines clinical development. She also led inspection readiness program, clinical operational excellence initiatives and was an early member of the TMF Reference Model working group.
Vittoria is a speaker and advisory board member for TMF conferences and seminars and is a faculty member of the Master Program in Vaccinology & Pharmaceutical Clinical Development from the University of Siena, Italy since 2009. Vittoria holds a master’s in biochemistry & molecular biology from the University of Pisa and had basic research experience in molecular genetics and immunology at the University of Gothenburg and Karolinska Institute of Stockholm, Sweden.
Global Trial Capabilities Leadership- ELI LILLY
William Chesterfield – Global Trial Capabilities Leadership
Competency Development Specialist- NOVO NORDISK
Dorte Christiansen – Competency Development Specialist
Senior Director, Product Management- WINGSPAN TECHNOLOGY, AN IQVIA COMPANY
Kathie Clark – Senior Director, Product Management
WINGSPAN TECHNOLOGY, AN IQVIA COMPANY
Kathie Clark is Senior Director of Product Management for Wingspan Technology, Inc. She oversees the development of the Wingspan eTMF and other Wingspan products servicing the Life Sciences and Pharmaceutical industries. She has more than 20 years of experience in product management, business development, marketing, business analysis, project planning and management and solution/product design and development. Kathie has worked with more than 80 pharmaceutical, biotech, CRO and medical device organizations in the US, Europe, Japan and Israel. Her areas of expertise in life sciences content management include Clinical, Quality and Manufacturing, Regulatory Affairs & Submissions, and Legal Contract systems. Most recently at Wingspan, she has driven the design of the latest generation eTMF solution, which focuses on bringing transparency, insight and efficiency to all types of eTMF users. Previously, Kathie served as Director of Product Management at NextDocs, where she was responsible for the product strategy and roadmap for regulatory and quality products. She previously served as Director of Professional Services at GlobalSubmit working with the FDA to implement eCTD validation rules. Before that, she was a Director at First Consulting Group, where she was instrumental in the development of the suite of FirstDoc solutions and their delivery to dozens of clients, in addition to building and managing the Life Sciences Subject Matter Expert/Business Analyst practice. She is the author of many white papers, blog posts and presentations on content management for eTMF, regulatory and quality systems.
Senior Document Specialist- CHUGAI
Sally Digby – Senior Document Specialist
Associate Director, Global Clinical Operations- BIOGEN
Jane Twitchen – Associate Director, Global Clinical Operations
Jane is currently Associate Director, Systems and Operations for Biogen Idec’s Knowledge, Records and Information Strategies team. In this role, Jane is responsible for the implementation, enhancements and oversight of Biogen’s eTMF repositories and manages associated, peripheral operations. Jane is currently focussed on the successful integration of Biogen’s eTMF with their Strategic Partner’s system.
Jane holds a BSc in medical physics and a postgraduate certificate in management. Her 17+ year career has involved the delivery of complex global technology solutions, and has included stops at Covance, SAS and several software companies that provided services to the pharmaceutical industry. Prior to joining Biogen Idec, Jane worked for six years at Phlexglobal, initially leading the Project Management team implementing eTMF solutions and overseeing the delivery of a range of TMF QC, Remediation and Migration Projects. Her most recent role at Phlexglobal was Head of Quality, where she focused on optimizing Phlexglobal’s eTMF quality processes and workflows. Jane also remains an active member of the TMF Reference Model Quality and Metrics subcommittee.
Principal Competency Development Specialist- NOVO NORDISK
Anne-Mette Varney – Principal Competency Development Specialist
Anne-Mette Varney is working as a Principal Competency Development Specialist and TMF Process Manager within Trial Management Anchor, Clinical Operations at Novo Nordisk A/S where she is responsible for building the TMF maintenance organisation in a global environment and for driving the TMF strategy and collaborate cross functional. Since 2012 she has been LoB PM in TMF Improvement Project optimising the TMF process and Inspection Readiness, supported a TMF IT Project as TMF process expert, conducted pilot on centralised QC and oversight, and leading the change process implementation in the global organisation. As background Anne-Mette holds a bachelor in Nursing and worked as a nurse for several years before moving to Pharmaceutical industry in 2000. During the past 18 years she has been working within Safety and Pharmacovigilance, Project and Program Management in CRO, and Clinical Operations as Senior International Trial Manager and TMF Process Manager.
Andreas Järemo is Associate Director Enablement with AstraZeneca where he is the TMF Global Lead overseeing the framework of the enterprise-wide TMF. In this role, he interacts with internal senior leaders, internal science unit’s implementation leads, external vendors, projects and study teams to make sure that the process, system, and central services set up are in line with expectations and current regulations.
Andreas has more than 20 years of Pharma Industry experience, spending most of his time in AstraZeneca. With a research background in Immunology, Andreas has had several positions as study leader, both globally and locally including monitoring. He has been working with patient safety, authoring protocols, leading phase I to III studies and various improvement projects. Andreas then continued to conduct outcome trials implementing study set-ups and integrations, defining process and systems, and working with CROs and AROs.
Director- HEALTH SCIENCES RECORDS & ARCHIVES ASSOCIATION
Eldin began his records management career in 1986 at Glaxo. He held a variety of information and records management positions of increasing seniority, which continued following his move to Pfizer in 1993. His experience spans most areas of information and records management, including: DMSs and ERMS/EDMSs; file plans and retention schedules; classification schemes and taxonomies; microfilming; disaster recovery; data protection; imaging and workflow solutions; mergers and acquisitions; litigation support; change management; archive and active file management. In 2004, Eldin established Rammell Consulting, a management consultancy specialising in the provision of expert records management support, primarily to the pharmaceutical and biotech industries. He has worked with several companies on the development and implementation of eTMF systems and supporting processes.
Barry Sacks is the Interim Chief Technology Officer at Phlexglobal. Barry is a Partner within Digital Works Group’s Product, Project and Technology team bringing over 25 years of experience leading a variety of start-up, SME, and blue-chip organisations through the design, delivery and management of innovative digital products and services. An accomplished technology entrepreneur, corporate director and consultant having worked throughout the UK, Europe, Australia and the US.
Prior to Digital Works Group, Barry founded a SaaS venture, Homes and Rooms, was the Global CTO for the consumer lending FinTech MyJar (based in Estonia), the CTO (Corporate Venturing) for Diageo and has since enjoyed a varied interim career. He has a B.Eng with honours in Software Engineering for Real-Time Systems from Anglia Ruskin University, Cambridge.
Director and Head of TMF Operations- DAIICHI SANKYO
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the Director/Head of TMF Operations; prior to that, she worked at Covance for 8 years within the Trial Master File space.
Ms. Toth is a Steering Committee member on the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA).
Ms. Toth is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified. She received her Master’s Degree in Clinical Research & Organizational Management from Drexel University, a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and has an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College.
In her spare time, she enjoys family time and watching her kids play soccer, basketball, and football.
Director, Head of TMF Management and Compliance- EISAI
Wendy Trimboli – Director, Head of TMF Management and Compliance
Wendy has more than 20 years of major pharma experience in clinical research and clinical operations and has facilitated cross-functional teams, project teams and process improvement initiatives utilizing lean six-sigma methodology. She is a Steering Committee member of the DIA TMF Reference Model working group and has presented at numerous conferences internationally. In her current role at Eisai, she leads the group responsible for the global oversight of TMF management and archiving, and the quality control review process for clinical trial documents across all therapeutic areas. She is also responsible for oversight of the eTMF vendor and works closely with Eisai’s strategic CRO partners.
Jason Weinstein has worked in the pharmaceutical industry for 5 years. He transitioned to TMF and Document Management in 2014 and is currently the eTMF Business Lead at Regeneron Pharmaceuticals Inc. In his position, Jason works closely with the various system teams to ensure that the eTMF meets business needs for all TMF stakeholders. In addition, as part of this role, Jason has managed multiple migrations and participated in several regulatory inspections. He trains and works with CROs and has been instrumental in developing reports and metrics.