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.
Director, Clinical Operations- PRA HEALTH SCIENCES
Molly Brock – Director, Clinical Operations
PRA HEALTH SCIENCES
Director, TMF Operations- SYNEOS HEALTH
Colleen Butler – Director, TMF Operations
Global Trial Capabilities Leadership- ELI LILLY
William Chesterfield – Global Trial Capabilities Leadership
Dorte Christiansen – Competency Development Specialist
In her capacity as Competency Development Specialist at Novo Nordisk, Dorte is responsible for the technical and process matters related to Novo Nordisk’s eTMF implementation, including migration of several million trial master file documents. Previously she was Systems Support Specialist at Novo Nordisk until October 2018. Prior to joining Novo Nordisk, Dorte was Principal Consultant at NNIT A/S. Dorte has years of hands-on experience with trial master files and has gained her process insight from working in trial management on large multinational trials. Dorte has a broad project experience, working both with TMF process optimisation, change management and eTMF system implementation. Dorte has been involved in the TMF Reference Model in various working groups. Supplementing her process knowledge, Dorte also has hands-on experience with different eTMF systems and takes a keen interest in bridging the business requirements with the supporting IT system.
Vice President, 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.
Has held various positions with Glaxo over 22 year, mainly working on the development of the CTMS system. Was also in charge of the archiving for the Clinical UK Division.
Then moved to GE Healthcare as a Principle CTA assisting Project Managers with the setup and management of the global studies.
I am now currently working at Chugai Pharma Europe as a Senior Document Specialist primarily assisting Project Managers with the documentation for their studies and working with Head Quarters in Japan on the implementation of our eTMF.
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.
Head of Global Documentation Quality Centre EU- BOEHRINGER INGELHEIM
Martin Hausten – Head of Global Documentation Quality Centre EU
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.
Renee Heuser – Director, Clinical Documentation Center
Renee started her career at Abbott Laboratories and continued with AbbVie after the separation in 2013. Over the years she held various positions in Clinical Operations and Project Management across several Therapeutic Areas, with experience spanning early to late stage drug development. A few years ago, Renee transitioned from the clinical operations area into a direct leadership role for a functional area, managing a global team of 100+ individuals responsible for AbbVie’s clinical documentation. Since taking over responsibility of the Master Files, she has redefined how AbbVie handles clinical documents and conducts TMF oversight. Renee and her team have implemented many enhancements to their eTMF system and have significantly improved stakeholder engagement. These efforts have impacted the R&D organization’s culture to think about the TMF as a study management tool versus a document repository. Renee actively participates in agency inspections as the Business Process Owner for all things related to Artifact Management. This year she is a co-lead of AbbVie’s cross-functional “Inspection Readiness” efforts.
Renee has over 28 years of pharmaceutical industry experience, primarily in planning and executing clinical trials and project management of Therapeutic Area clinical programs. She has a Bachelor’s degree in Finance.
Clinical Trials Coordinator- DUKE UNIVERSITY MEDICAL CENTER
Etienne Hinton – Clinical Trials Coordinator
DUKE UNIVERSITY MEDICAL CENTER
Manager, Information Governance and Compliance- PPD
Michelle Ingraham – Manager, Information Governance and Compliance
Michelle Ingraham is the Manager of Information Governance and Compliance (IGC) over the TMF group at PPD. As one of the core team members in developing and implementing eTMF at PPD in 2012, she is one of the foremost experts on PPD’s TMF systems and processes. Michelle has focused her leadership efforts on process improvements in Records Management and Information Governance and brings this expertise to the TMF group, which are PPD’s TMF process owners and provide global operational and strategic support to PPD as well as Sponsors with their TMF development. As manager, she is responsible for ensuring inspection support as well as evaluating impacts of new processes and technologies to support Clinical Trails, such as robotics, on TMF systems and processes.
Michelle holds a Bachelor of Science in Electronic Media, Arts, and Communication with a minor in Management from Rensselaer Polytechnic Institute and has eleven years of experience in the Clinical Research industry.
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.
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.
Sue Murray is VP, Head of Quality at Agios in Cambridge. Agios is a biopharmaceutical company passionately committed to applying scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. Sue is a Quality and Regulatory professional with over 20 yrs of experience. Prior to Agios, Sue spent the majority of her career at Biogen in escalating leadership roles in Technical Development, Quality and Regulatory CMC. Sue’s focus is on fostering a risk-based Quality culture across all GXP functions at Agios and continuous improvement of the Quality Management System. Sue has expertise in leading global regulatory inspections and agency meetings, CMO oversight, product release/ recall, and establishing and managing all aspects of the Quality Management Systems. Sue holds a B.S. and M.S. in Chemical Engineering from the University of Massachusetts, Lowell.
Head of Clinical Operations and Data Management- CANCER RESEARCH UK
Stephen Nabarro – Head of Clinical Operations and Data Management
CANCER RESEARCH UK
Stephen Nabarro has 15 years experience in oncology research and drug development. He completed a PhD in paediatric oncology at University College London, followed by a Postdoctoral Fellowship at the Medical Research Council Laboratory of Molecular Biology in Cambridge. In 2007 Steve joined Cancer Research UK, the largest funder of cancer research in Europe. In his role as Head of Clinical Operations and Data Management in the CRUK Centre for Drug Development his team have successfully adopted a risk based monitoring approach, implemented EDC and eTMF systems to improve quality and operational efficiency, and they are currently exploring novel approaches to patient involvement in clinical trials.
RDQA Area Head, EEMEA- ABBVIE
Patricia Pengelly – RDQA Area Head, EEMEA
Senior Director – Head of TMF Solutions – Quality Management- IQVIA
Helen Price – Senior Director – Head of TMF Solutions – Quality Management
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.
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.
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.
Bryan Souder is Director, TMF Head at Merck & Co., INC., USA. He has a BS from Radford University, a Six Sigma Greenbelt, and 22 years of clinical trial research experience. His current focus is being TMF Head. Prior to leading the department Bryan was the eTMF “Global Implementation Lead” Merck & Co., Inc. He has conducted eTMF application & process training in 18 countries and has hosted multiple sponsor inspections.
Vittoria Sparacio – Head, Clinical Documentation Operations, 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 Head, Compliance and Regulatory Affairs Quality- NOVARTIS
Rebecca Stanbrook – Global Head, Compliance and Regulatory Affairs Quality
Global Document Specialist- BOEHRINGER INGELHEIM
Carina Teufel – Global Document Specialist
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.
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.
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.
Matthias has over 15 years of experience in Information Technology within the Life Science Industry. He holds a Masters Degree in Business Administration as well as a Bachelor Degree in Information Technology. He started his career in Finance and Banking in 1997 and moved to Life Science in 2004 by joining F. Hoffmann-La Roche AG, Switzerland. There he held various positions, including Team Manager for Integrated Document Management. In 2016, Matthias joined nnit as Principal Consultant in their Swiss Office and decided to become an independent consultant in summer 2018 via ARCONDIS AG Switzerland. As of 2017, Matthias is working at Novartis and is currently the Business Migration Lead for the “Subway C-Line Artificial Intelligence” Migration Project.
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