Catarina Bergman leads the TMF implementation and adoption work in Global Medicine Development at AstraZeneca, she is accountable for the actions and implementation of the new eTMF with more than 5000 users. Catarina previously for several years lead the Nordic organization in Site Management and Monitoring (Clinical Operations).
During the years in the pharmaceutical business she has been working in several leading positions in both sales, marketing, price & market access and payer evidence roles.
Catarina Bergman holds a bachelor’s in pediatric nursing and worked as a nurse for several years before she moved to the pharmaceutical industry in 1995.
Clinical Operations Manager UK Country Head
Christopher Betts – Clinical Operations Manager UK Country Head
Christopher is the UK country head for clinical operations on a FSP program; responsible for overseeing country performance and compliance whilst working to sponsor SOPs and within sponsor systems including eTMF.
Previous to this role Christopher was an eTMF Manager at Covance for almost four years. During his time as an eTMF Manager Christopher was a core team member in the implementation of a new eTMF, ongoing review of SOPs and associated documents, MHRA inspections and the development of eTMF metrics and reporting. In addition Christopher was aligned to key sponsors, providing input and assistance to establish their eTMF and/or procedures.
Christopher holds a Bachelor of Science in Medical Biochemistry from Brunel University.
Global Head Clinical Document Governance and Management, GDO Trial Management
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, AN IQVIA 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 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.
Francis P. Crawley is the Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) in Brussels, Belgium. He is the founder and Director of the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). He coordinates the GCPA-SIDCER European Fellowship in Research Ethics (EFRE). He is a philosopher specialised in ethical, legal, and regulatory issues in health research, having taught at several European, Asian, and Middle East universities. He is the past Secretary General, Ethics Officer, and Chairman of the Ethics Working Party at the European Forum for Good Clinical Practice. He currently chairs the methodologies sub-group of the Real Word Data Working Group at the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians. He has acted as an author or expert for the leading international and European research ethics and GCP guidelines, as well as for several guidelines in Asia, Africa, the Americas, and Europe.
He was for 15 years the Chairman of the Ethical Review Committee of the International Network for Cancer Treatment and Research (INCTR); a member of the INCTR Tissues Committee; and a member of the Ethics Committee of the European Organization for Research & Treatment of Cancer; Consultant to the Peking University Institutional Review Board; and a member of the Steering Committee of the Chinese Ethics Committee of Registering Clinical Trials (ChECRCT). He has been a member of the joint EMVI-AMVTN Ethical Review Committee; a Permanent Liaison Officer to the International Bioethics Committee of UNESCO; and a Contact Officer for CIOMS. In 2006 he was Visiting Expert in research ethics at the Ministry of Health, Singapore.
He the committee chairman of the WHO guidelines on ethics committees and data monitoring committees; and he was a member of the Scientific Advisory Committee for the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). He also served for four years on the UNAIDS Ethical Review Committee. He is a co-founder and past Steering Committee Member of the Global Forum for Bioethics in Research; a past member of the Committee of Interested Parties of the Centre for the Management of Intellectual Property in Health Research & Development; a past member of the European Science Foundation’s Education Working Group, and a past member of the WHO GCP Handbook drafting committee. In addition, he is a member of the Ethics Working Group, European Academy of Paediatrics (UEMS-EAP); and an investigator in several European Commission projects, including ‘The Development of European Standards on Confidentiality and Privacy in Healthcare among Vulnerable Patient Populations’, ‘Ethical Function in Hospital Ethics Committees’, & ‘Ethical Considerations in Clinical Trial Collaboration with Developing Countries’, ‘European Network for Expertise for Rare Paediatric Neurological Disorders (nEUroped)’ and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials (RESPECT). He is also a member of past Vice-Chairman of the Ethics Committee of the International Society for Medical Publication Professionals.
He was the Co-facilitator for the Ethics Roundtable at the Africa Centre for Health & Population Studies in South Africa where he taught a modular GCP course and where he was a member of a DSMB for an HIV vertical transmission study. He is also a member of several regional organizations for ethics in research in Central and Eastern Europe, Asia, Africa, and Latin America. He founded the AfroGuide Project: Developing Guidelines for Health Research in Africa, with the UN Economic Commission for Africa and the African Union. He serves on several editorial boards for international journals.
Sarah Curno has worked in a GCP environment in the pharmaceutical industry for 30 years as a CRA, Project Manager, Line Manager and Project Director before specialising in TMFs and Records Management in 2005. As Director of Records Management in a medium sized CRO, Sarah set up an eTMF to handle over 80 TMFs, engaging with all departments to ensure a fit for purpose final product. Sarah is currently a Contract TMF Specialist for Hedian Records Management and a member of the Health Sciences Records and Archives Association (HSRAA).
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 and eTMF Process Owner Representative.
Director, Trial Capabilities, Trial Master File and Records Management
Tonya Edison – Director, Trial Capabilities, Trial Master File and Records Management
Tonya Edison is Director of Trial Capabilities, Trial Master File (TMF) and Records Management, at Eli Lilly and Company. She is accountable for the development and execution of business processes governing the TMF and records management. In her role, she collaborates with senior leaders across the Lilly Clinical Development organization, Quality, Information Technology (IT) and other functional areas to ensure TMF regulatory compliance, maintain study-level inspection readiness, and drive strategy for continuous improvement of the TMF system.
Paul Fenton holds a degree in management from London Metropolitan University as well as an MBA in Technology Management from the Université du Québec à Montréal.
Paul has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005. He has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards as well as in the integration of systems and processes for clinical trials. He is a regular speaker at industry events and is actively involved in several projects for the development of clinical research standards and platforms.
Andy has a BSc (Hons) in Biology and an MSc in Medical Statistics and IT.
Andy worked as a Medical Statistician after gaining his MSc, primarily working in clinical trial design and data analysis. Andy also undertook some data management activities. After three years in this role, Andy moved into clinical research and became a Clinical Research Associate (CRA) at the start of 1996 and progressed to be a Clinical Project Manager. During these seven years Andy was involved in a broad range of clinical trial activities for pharmaceutical and medical device trials. Andy also had a part-time role during his time as a CRA as an ISO9001 internal auditor. Andy’s last two years in industry prior to joining the MHRA were spent as a Compliance and Training Manager within clinical research.
Andy has been with the MHRA GCP Inspectorate since August 2005 and has inspected numerous commercial and non-commercial organisations, contract research organisations, phase 1 clinical units and investigator sites as part of MHRA and EMA inspections. MHRA inspections request TMFs for selected trials and Andy and MHRA GCP colleagues have had numerous experiences inspecting TMFs. Andy was part of the authoring team for the MHRA GCP Guide. Andy also works with EU GCP inspector colleagues in the EMA and GCP Inspectors Working Group sub-groups on Quality Risk Management, TMFs and Source Data, which were responsible for the respective EU reflection papers.
William Hamilton is a Senior Product Integrator with over twenty years of experience in the Life Sciences division of DXC Technologies. Working out of Philadelphia, Pennsylvania, he has been involved with custom and enterprise content management systems for multiple verticals exclusively for the pharmaceutical industry. Working primarily in a technical capacity, he has participated in all phases of software development such as application design and development, testing, delivery, requirement gathering, and end user training.
In his current role at DXC Technology, he is serving as the Business Analyst for the eTMF Tracker application.
Director, Medicines Quality Organisation – International
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 Document Quality Centre EU
Martin Hausten – Head of Global Document 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.
Manager — TMF Management and Compliance, Global Regulatory Services and Operations
Alison Hussain – Manager — TMF Management and Compliance, Global Regulatory Services and Operations
Alison is currently TMF Manager at Eisai, overseeing the daily QC management activities associated with the TMF business process focusing on continuous process improvement activities working across the functional areas and CRO stakeholders to ensure consistent processes and procedures are followed.
Alison is CRO Lead to the largest CRO vendor providing guidance to CRO management and Eisai functional groups. She generates KPI performance metrics analyzing and identifying trends across the portfolio to share with the CROs.
Prior to Eisai, Alison worked at Phlexglobal Ltd as Operations Manager focusing on implementation and delivery of projects with a focus on quality, cost and efficiency.
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.
Gergana graduated as a physician in Sofia, Bulgaria and started working as a doctor at the Cardiology ward at the National Hospital for CV diseases, Sofia.
In 2002, Gergana moved into clinical research starting as a monitor and a local study lead in AstraZeneca. In 2008 she took the role of a Clinical Process manager, responsible for SOP management, training and quality control of the clinical operations department in the local organization.
In 2012, Gergana started her journey in the electronic management of Trial Master Files, and since 2016 is in a leading role for the design and implementation of the New Strategy reengineering entirely the TMF management at AZ.
In her role as a Global TMF Process Owner, Gergana is responsible for ensuring a TMF process applicable to all science units at AZ and aligned with regulatory expectations.
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.
Manager IGC, Quality and Enterprise Learning
Antonio Lio – Manager IGC, Quality and Enterprise Learning
Gerard has over 20 years of R&D experience in the biopharmaceutical business. Having obtained a BSc degree in pharmacology, Gerard started his career in pre-clinical cardiovascular pharmacology, assessing the potential of candidate drugs for clinical development. On moving into Clinical Development, he worked in pharmacovigilance where he was lead scientist for several investigational and marketed drugs. Subsequently, he was appointed Global Lead for Clinical Trial Transparency at AstraZeneca with responsibility to monitor global external requirements to advise on company policy and for establishing and maintaining the governance framework to ensure compliance with company policy. From there he took on management of the Informed Consent group within Clinical Operations for several years before joining Biogen in 2015 where he now works in a similar capacity.
R&D Personal Data Protection Specialist
Jeppe Manuel – R&D Personal Data Protection Specialist
Jeppe G. Manuel works as the R&D Personal Data Protection Specialist in Novo Nordisk A/S and is responsible for driving and aligning Novo Nordisk’s privacy by design efforts across the global R&D organisation. Hereunder, ensuring the clinical processes and systems are aligned with personal data protection regulations. Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting.
Jeppe has 12+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation and Information Management. Jeppe holds a Master degree in Library and Information Science.
former Medicines Inspector
DANISH MEDICINES AGENCY
Philip Lange Møller is a former Medicines Inspector at the Danish Medicines Agency inspecting clinical trials on medicines and medical devices. He has worked at the Danish Medicines Agency since 2006 first on national inspections and since 2007 also inspecting clinical trials requested by EMA (CHMP) in Europe and the rest of the world. He is a member of the EMA GCP Inspectors Working Group.
Prior to joining the Danish Medicines Agency, Philip has led a clinical research team and been the principal investigator — coordinating investigator — investigator-sponsor for clinical trials as well as medical advisor and clinical project leader in pharmaceutical companies.
Philip is a graduated physician of 1988 from Aarhus University in Denmark and trained in internal medicine and anaesthesia until 1997.
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.
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
Mark started his career at Beecham Research Laboratories, in anti-infective discovery programmes where he was involved in development of high throughput screening systems for drug discovery and in the isolation and identification of naturally produced active components. The discovery research involved antibacterial, antimycoplasmal, antiviral and antiparasite research. After 17 years in the lab, Mark then moved into Clinical Research where he worked as a global Programme Manager. In this role, Mark worked for a number of different pharmaceutical companies (British, French, American and Japanese) and has managed different trials in many therapeutic areas on a global basis. In this time Mark was involved in all aspects of research from drug development planning, management and reporting of trials and submitting trial data to authorities.
After 13 years in clinical research, Mark moved to the MHRA, where he was a GCP Inspector and was involved in all aspects of GCP inspection in the UK and overseas. He was involved in the non-commercial inspection process and also the bioequivalence inspection process. In addition, he was part of the inspectorate training team, and also managed a number of GCP Consultative meetings. After 5 years as an inspector, Mark joined ADAMAS Consulting in October 2011 where he was involved in a number of different audit types in different areas of the world, having performed most aspects of GCP, laboratory aspects of GLP and IMP manufacturing aspects of GMP audits. In the past year, Mark has moved onto Clovis Oncology where he is Senior Manager QA and has a global role managing and overseeing all aspects QA GCP for the company.
Mark has a degree in Applied Biology, specialising in Microbiology and is a member of Research Quality Assurance (RQA).
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.
Leanne joined GSK in 1992 as a statistician, having graduated from the London School of Hygiene & Tropical Medicine with an MSc in Medical Statistics. Leanne worked on clinical trials and was involved in protocol writing, statistical analysis & report writing. Her role expanded to include a variety of different activities including document management, Investigator Sponsored Studies oversight, SOP management, statistical training and performance metrics. Over the last couple of years, Leanne worked on the implementation of GSK’s electronic TMF, as well as being involved in the TMF Reference Model group within GSK. In October 2017 she made the move into the Clinical Documentation Operations team at GSK, with responsibility for the Third Party TMF Activities at GSK.
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.
Principal Competency Development Specialist
Annebeth Siø Jensen – Principal Competency Development Specialist
Annebeth Sioe Jensen is working as a Principal Competency Development Specialist within Trial Management Anchor, Clinical Operations at Novo Nordisk A/S where she is involved in TMF Improvement Project optimising of the TMF process and has contributed to a pilot on centralised QC and oversight of TMF. As background Annebeth holds a degree in BsNursing, Ba Ling. Merc. and NLP Master. She has 19 yrs of experience working with different R&D aspects of the pharma industry.
Annebeth has been with Novo Nordisk A/S since 2005 working as Clinical Trial Manager and as Competency Development Specialist.
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.
Vice President Product and General Manager
Perry Steinberg – Vice President Product and General Manager
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.
Director and Head of TMF Operations
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
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
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 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.
Stephanie Viscomi is Head of TMF at ImmunoGen in Boston. She has more than a decade of experience that predominately pertains to TMF. In that time, Stephanie has gained a unique understanding of the TMF from both views from CRO to sponsor. In her role at ImmunoGen, she is working to enhance the TMF platform while building an operational infrastructure to improve study conduct and resource allocation. Prior to her current role, Stephanie worked with and managed multiple global TMF teams providing support to large volume TMF’s all while meeting global standards and internal processes. Also during Stephanie’s tenure, her experience includes the development of effective metrics and cross-departmental training programs, extensive enhancements to TMF oversight processes, inspection readiness compliance, and creation of a cross-functional project coordination department.
Vincent has worked in the pharmaceutical industry since 2005 and is a Compliance Senior Manager in Global R&D Audit of Amgen Inc. During his time in Amgen, he was responsible for a number of high profile and complex audits.
Vincent had worked in the MHRA between 2005 and 2015 as a Senior GCP Inspector and GCP Operations Manager. During his time in the MHRA, he had been involved in a number of EMA and UK National Inspections, the development of the MHRA GCP Guide, EMA and GCP Inspectors Working Group, Clinical Trial Collaboration Group, the development of reflection papers. He was the chair of the PICS GCP/PV sub-group.
Vincent has a Ph.D. in Pharmaceutical Science from King’s College London and MBA from Durham University. He was a member of the Research Ethics Committee and an honorary Senior Lecturer at the University of London.