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.
Vice President, Product Management
WINGSPAN TECHNOLOGY, a QUINTILESIMS COMPANY
Kathie Clark is Vice President 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 Exper/Business Analyst practice. She is the author of many white papers, blog posts and presentations on content management for eTMF, regulatory and quality systems.
GOOD CLINICAL PRACTICE ALLIANCE – EUROPE
Martina Duevel – Systems Excellence Project Leader
Martina Duevel joined the pharmaceutical industry seventeen years ago working first in the Clinical Quality Assurance department at Schering AG in Berlin and then in clinical project management at Bayer. In January 2015, she was assigned as Clinical Project Leader for eTMF implementation and maturation. Martina is now Systems Excellence Project Leader. She has a bachelor's degree in biochemistry and a PhD in the natural sciences
Director, Trial Capabilities, Trial Master File, Records Management, Metrics
Lucy Hampshire – Director, Medicines Quality Organisation — Europe
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 a team providing country level quality oversight for activities relating to medical, regulatory and safety across Europe. 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.
Team Lead Global Document Specialist, Head of Global Document Quality Content
Martin Hausten – Team Lead Global Document Specialist, Head of Global Document Quality Content
Martin Hausten has been with Boehringer Ingelheim (Germany) since 2004.
He facilitated the set up of the BI TMF Governance Structure starting in 2013 and has been the Chair of the TMF Governance Committee since 2015, a global team of TMF SMEs, business process owners and Global Document Quality Centre leads.
Since March 2016, Martin has been the Head of the Global Document Quality Centre and has led the German team of Global Document Quality Specialists. He is active in the development, implementation and maintenance of Trial Master File (TMF) strategies.
He is experienced in setting up and maximizing outsourcing efficiency and efficacy models and best practices pertaining to TMFs.
Martin collected deep insight into clinical trial processes and CROs' quality management systems during his role as a GCP Auditor and Project Compliance Manager. Before that he was responsible for applying Computer System Validation Standards to systems used in GCP and GMP environments.
Martin studied Business Administration (Dipl. Betriebswirt), is a certified Auditor (DIN EN ISO 19011) and a certified Quality Manager (ISO DIN EN ISO 9000 family), and likes to practise sports.
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.
Ute Kohlhaas, MSc, heads the Gynecology group within Clinical Project Management at Bayer AG. Ute currently leads a comprehensive cross-functional initiative on process improvement and implementation for eTMF workflows across the Bayer Clinical Development organization in an outsourced setting. She has 15+ years of experience in clinical development. She has worked in expert roles, project management and line management functions with various pharmaceutical companies and CROs. Her experience covers all clinical phases, different geographies and several functional areas including data management and quality assurance. Ute is a mathematician by training. She lives in Germany with her husband and the younger of her two sons. In her spare time, she enjoys mountain hiking, horseback riding and traveling.
Meredith started her document wrangling career at Pasteur Mérieux Connaught in Toronto 20 years ago and has not stopped since, with a foray into electronic document publishing for regulatory submissions after her move to what is now Sanofi Pasteur France in 2006. Meredith has been intensely involved as a project member or co-leader in the design, implementation, training, and administration of the Sanofi Pasteur clinical electronic document management system, the P2 publishing tool, and the eTMF management system. She established the clinical publishing group at Sanofi Pasteur and led the implementation of TMF Reference Model 3.0. Meredith’s current responsibilities include activity development and operational management of the TMF QC group at Sanofi Pasteur.
Senior Clinical Trial Administrator
Anna Lundsgaard – Senior Clinical Trial Administrator
Maria Nymann Jensen – Competency Development Professional
Maria Nymann Jensen works as Competency Development Professional within Clinical Operations at Novo Nordisk A/S. She started in Novo Nordisk as Clinical Trial Administrator in 2008 and transferred to her current position in 2012.
Previously, Maria has been involved in two TMF pilot- and optimisation projects and has also taken part in regulatory sponsor inspections from EMA and FDA.
Currently, Maria works full-time with the TMF and is responsible for the TMF support for the global organisation. This includes training and support of the global TMF super- and end-users. Further she takes actively part in audits and inspections.
Before joining Novo Nordisk, Maria was working in the Consulting Engineering industry – also with filing and archiving – and totally Maria has approx. 25 years’ experience with document management and retention. Maria’s educational background is office clerk and bi-lingual correspondent
Karen graduated as a pharmacist in South Africa and entered the life science industry working for Eli Lilly. In 1992, she moved into clinical research in the UK with Chiltern International, initially managing the Clinical Development Department across Europe. Latterly she started and globally managed a novel group, EDC Solutions.
In 2007, Karen joined Phlexglobal as Chief Business Development Officer and in 2015 she moved into the role of Vice President, Client Solutions. With her clinical and EDC background, Karen has also taken on a lead role in Phlexglobal’s electronic Trial Master File initiative, to promote, develop and implement support of Client eTMF systems as well as Phlexglobal’s eTMF Solution – PhlexEview.
Karen’s most recent role is that of Chief Strategy Officer where she is focussing on the strategic priorities for the company. Karen focuses on four key areas, being Key Clients, CROs, TMF Expertise and PhlexEview eTMF, in order to support the continued strong growth of Phlexglobal.
Karen also co-chairs the TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files.
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.
Jenny Savva is a Clinical Operations Manager at Cancer Research UK, based in London. She started in the industry as a CTA and now has eight years of experience managing TMF processes for early phase oncology trials, including TMF quality reviews, document management and archiving. She is continuously driving process improvements to support TMF inspection readiness. Her team is responsible for supporting study teams and coordinating all TMF activities including TMF and ISF set up, filing, TMF quality reviews, and closedown activities.
Jenny leads the recently formed TMF Champions group, which aims to improve TMF quality and completeness, and is the TMF subject matter expert within Clinical Operations. She holds a BSc in applied psychology.
Vittoria Sparacio – Head, Clinical Documentation Operations, GSK R&D Processes, Clinical Compliance Platforms and Sciences
Vittoria Sparacio leads the Clinical Documentation Operations group at GlaxoSmithKline Pharmaceuticals R&D, where she is accountable for the tactical implementation of a sustainable TMF delivery strategy. Vittoria previously established the Novartis Vaccines electronic Trial Master Files system as well as processes and standards in document management and archiving for quality and compliant clinical studies. She also led inspection readiness programs, clinical operational excellence initiatives and contributed to the DIA TMF Reference Model working group. Prior to that, Vittoria held operational and scientific roles in clinical R&D, in the pharmaceutical and CRO industry beginning 2001. Vittoria holds a master’s in molecular biology from the University of Pisa, Italy, and had basic research experience in molecular genetics and immunology at the University of Gothenburg and Karolinska Institute of Stockholm, Sweden.
Regulated Content Management – General Manager and Product Leader
Perry Steinberg – Regulated Content Management – General Manager and Product Leader
Perry Steinberg is the General Manager and Product Leader for Edge eTMF and the Regulated Content Management Platform at Medidata Solutions. He has led the business and technology development for multiple products across the Medidata Clinical Cloud, collaborating across tech and the business, focusing on overall platform unification, processes, and quality, as well as the culture of success. He has over 20 years of experiencing leading artifact, document and data initiatives for Fortune 500 companies. Perry holds a BA in economics and computing from UCLA and an MBA in marketing and corporate strategy from the University of Michigan, Ross School of Business.
Paul Stewart – Associate Director, Clinical Quality & Compliance
Paul is Associate Director, Clinical Quality & Compliance at Medimmune Ltd. where he is supports the Quality Management System within the Clinical Biologics department.
Paul has 18 years’ experience in the biotech, CRO, non-commercial and pharmaceutical industries, has conducted a number of TMF audits; including leading a Global TMF systems audit and has supported CAPA development and implementation following audits and inspections.
He has been a member of Research Quality Association (RQA) for 16 years, where he currently chairs the Quasar Group, has been the Editor of the RQA publication Quasar for the past 5 years and is co-authoring an RQA booklet on TMF, scheduled for publication in 2019.
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She joined Daiichi Sankyo in February 2016 after working at a CRO for 8 years within the Trial Master File space.
Ms. Toth is a Steering Committee member for the DIA TMF Reference Model Working Group and on the Board for the Scientific Archivist Group (SAG) as well as on the SAG-GCP Executive Board.
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.
Wendy Trimboli – Head of TMF Process Management and QC
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 member of the DIA and the TMF Reference Model working group and has presented at numerous conferences and eTMF User group meetings 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.
Associate Director, Global Clinical Operations
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
Anne-Mette Varney – Principal Competency Development Specialist
Anne-Mette Varney is working as a Competency Development Manager and TMF Process Manager within Trial Execution, 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 cross-functional collaboration. During the past two years she has been LoB PM in the TMF Improvement Project optimising the TMF process and Inspection Readiness. Currently she is supporting a TMF IT Project as a TMF process expert.
Anne-Mette holds a bachelor’s in nursing and worked as a nurse for several years before moving to the pharmaceutical industry in 2000. During the past 14 years she has been working within safety and pharmacovigilance, project and program management in CROs, and in clinical operations as Senior International Trial Manager and TMF Process Manager.