Sharon Ames is Director, Client Solutions for Phlexglobal. Sharon is an industry leader in Trial Master File and electronic Trial Master File management. With more than 25 years of experience in the clinical research industry, Sharon has extensive knowledge of clinical trial processes and cross functional relationships as they relate to essential document requirements during the conduct of clinical trials.
As a Registered Dietitian, Sharon began her clinical career at the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio. In 2011 her clinical experience expanded to Kendle International, now INC Research. During this time Sharon held many clinical leadership roles in project management and global TMF management as well as for study/site start-up activities. Her more recent experience is with eTMF system implementations and integrations in the vendor space.
Sharon is an active member of both the TMF Reference Model group and the TMF Reference Model Steering Committee.
Clinical Training and Systems Manager
Dina Antonacci – Clinical Training and Systems Manager
As the Clinical Training and Systems Manager for Mallinckrodt Pharmaceuticals, Dina Antonacci leads training initiatives and clinical trial related process improvement, which included the initial implementation of the eTMF System and subsequent re-configuration and re-launch, overseeing eTMF operations and applying procedures to improve the functionality of the eTMF System, making the system more user friendly for Mallinckrodt.
Mrs. Antonacci started her career as an educator, teaching students at the college level, the fundamentals of Biology, to the details of Human Anatomy and Human Physiology. Mrs. Antonacci continues to innovate education and training practices within the Pharmaceutical industry, she has taught Medical and Laboratory Technicians how to operator and identify circulating tumor cells using tumor detecting diagnostic instrumentation. Mrs. Antonacci has achieved implementing an effective clinical onboarding program for field based Clinical Service Educators and implemented a successful training program that effectively taught Physicians and Nurses how to operate and safely deliver Photopheresis therapy to patients on two different generations of extracorporeal Photopheresis medical devices. Currently Dina drives training initiatives and is responsible for analyzing, developing, implementing, tracking, and ensuring the continuous improvement of clinical trial-related processes, systems, and SOPs.
Dina has over 11 years in the pharmaceutical industry, specializing in the field of clinical training and development for 9 of those years. Dina has a Master’s degree in the field of Neurophysiology from the University of California in Northridge, where she studied the neuro-protective effects CREB in the spastic Han-Wistar neurodegenerative rat model.
Systems Administrator, Developmental Sciences Quality
Melissa Asare-Aboagye – Systems Administrator, Developmental Sciences Quality
Evelin Baez is a Clinical Management Document Specialist with more than twelve years’ experience in quality control and records management. She has been in her current position at Bard Peripheral Vascular in Tempe, Arizona for over four years. Prior to Bard, Evelin worked at Honor Health as a Data Coordinator and at Medicis Pharmaceutical as the Knowledge Management Technician. She has experience piloting the eTMF process, including conversion from paper to eTMF. Evelin currently owns twelve studies and continuously tests process efficiencies for best presentation in an audit. Evelin also participates in specialized groups for decisions regarding Clinical Operations. In addition to document management, Evelin manages investigational product inventory and accountability for new IDE trials.
Director, Professional Services
As the Director of Professional Services, Terri leads the Wingspan Business Analysis team in the elicitation and documentation of requirements (functional and user) and associated business processes for Wingspan systems. Additionally, Terri leads the Wingspan eTMF Expert Services team that supports clients in the use of the Wingspan eTMF. This includes the creation of the list of required documents for study, maintenance of the list of required documents, and filing and quality control of the documents submitted to the TMF.
Terri graduated from Washington University in St. Louis with a BS in Biomedical Engineering. She also has a MBA with a concentration in Pharmaceutical Management from the Fox School of Business at Temple University and over 15 years of Health Sciences and Health Sciences IT related experience.
Brenda R. Brown of Pfizer has been in her current position since November 2011 as the TMF Business Support and CAPA Management Lead. She has broad familiarity leading efforts to manage cross-organizational collaboration to support study TMF transition and to ensure inspection readiness in supporting clinical project teams with records management and compliance issues. Additionally, she has extensive experience and knowledge integrating electronic and paper TMFs associated with acquisitions, collaborations and divestitures (ACDs).
Brenda joined Pfizer in 1988 and her experience spans many aspects of drug development. She has worked in the clinical and development operations arenas through much of her career, with accountability for supporting senior management, business operations, global resourcing and other clinical trial management activities. She earned her Bachelor of Science degree in business administration with a minor in accounting, and an MBA from the University of New Haven.
TMF Quality Management and Inspection Readiness Consultant
Mark Choe – TMF Quality Management and Inspection Readiness Consultant
Mark is an Inspection Readiness Consultant at Daiichi Sankyo where he plies his experience conducting inspections for coaching and audit preparation His responsibilities also include conducting gap analysis of study documentation Process review of taxonomy and document life cycle.
His two decades of experience in clinical operation, business process management, agency audit preparation, and document management gives him an in-depth and granular understanding of eCTD development.
Mark currently serves as faculty for the RAPS advanced eCTD program.
In his capacity of partner at auCONCORDIA, Mark, is a SharePoint developer who has created a cloud application that manages Common Technical Document development from authoring to validation and agency submission. Mark uses a state of the art interactive eLearning system with compliance and competency tracking to maximize training efficacy and adoption.
Grace Crawford – VP Clinical Quality and Compliance
Grace joined MedImmune in April 2015 as head of the Clinical Quality and Compliance function responsible for the Quality Management Framework that supports Clinical Biologics. Prior to joining MedImmune, Grace spent more than 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in the industry, participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium and the Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory (Special Chemistry and Immunology) at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science in clinical microbiology at The Medical College of Pennsylvania.
Mike Czaplicki – Clinical Documentation Operations Manager
Mike Czaplicki is a Clinical Documentation Operations Manager in the Quality and Risk Management department of GSK’s Pharmaceutical R&D division. Mike is part of a core team that is leading the implementation of an eTMF system across Pharma R&D at GSK and is responsible for a matrix team that maintains the GSK Pharma mapping to the TMF Reference Model and TMF Plan templates. Mike also is a member of the TMF Reference Model Steering Committee and a leading an effort to deliver an updated User Guide and Implementation Toolkit. Prior to working on eTMF Implementation, Mike worked as a Business Analyst for the Records Management Archive Group at GSK and an Information Management Associate at Merck.
Mike holds a Master of Science in Quality Assurance and Regulatory Affairs from Temple University, as well as a Bachelor of Science in Biology.
Senior Global Clinical Project Manager
Martina Duevel – Senior Global Clinical Project Manager
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. She has a bachelors degree in biochemistry and a Ph.D. in the natural sciences.
President and CEO
LMK CLINICAL RESEARCH CONSULTING
Sholeh is President and CEO of LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. She is also the Facilitator of the Metric Champion Consortium’s (MCC) TMF initiative; a cross-industry working group defining standard metrics and key risk indicators that support the TMF. She is recognized as an innovative professional with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert. Her experience includes the TMF reference model member, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations/CRO management, electronic document management, regulatory submissions, quality control processes and implementation, IRB communications, and regulatory inspection participation and preparation. When she is not consulting on TMFs, she enjoys spending quality time with her family.
Catharine Espanhol has over 6 years of experience working with Clinical Research and Trial Master File. She is currently the Regional eTMF Coordinator for Latin America (LATAM) countries at Boehringer Ingelheim in Brazil. She coordinates the regional eTMF team activities and oversees the internal and external partners to guarantee a TMF with quality, accuracy and completeness to be inspection ready. She actively participated in the creation and implementation of metrics and Key Performance Indicators to evaluate the CRO performance and support the harmonization of new eTMF process within LATAM region. She also has worked with metrics to harmonize internal staff performance using Six Sigma Methodology and increase productivity with quality and accuracy. Catharine graduated as Pharmacist in Brazil, Green Belt Certification and actually she is holding a Master Business Administration from Fundação Getúlio Vargas in São Paulo.
Special Topics Consultant
SAFE BIOPHARMA ASSOCIATION
Betsy is an authority on the business processes and associated use of information technology in drug development. A passionate advocate for moving life sciences business online, Betsy is an expert on IT in regulatory and clinical operations, data management, and ancillary supply chains, among other areas.
Betsy recently left Merck after two decades of outstanding contributions. She has participated in many industry initiatives and SIACs, including the TMF Reference Model, Chair of the SAFE-BioPharma Global Business and Regulatory Group, PhRMA Electronic Regulatory Submissions Working Group, NCI caBIG CRIX and the IRISS Steering Committee Chair.
Currently, Betsy is an independent consultant providing expertise to industry. She is an active member of DIA and frequently participates in conferences and meetings as program chair, speaker or session chair. She has also presented globally on diverse topics in clinical and regulatory areas for many conferences.
Renee Fate – Director, Clinical Records Management
Renee Fate has more than 13 years of clinical record management experience. At Allergan, she leads the TMF Compliance Specialists team responsible for providing program-level support to ensure compliance with global TMF standards and internal processes. She collaborates with TMF stakeholders to integrate inspection readiness activities into daily processes. Prior to Allergan, Renee worked at Kythera Biopharmaceuticals and Amgen specializing in TMF compliance, inspection readiness, and transitioning paper-based TMFs to be eTMFs.
Janice has over eight years of experience in Clinical Research with a specific interest in TMF Management. She has worked across multiple functional areas with exposure to both federal and commercial programs. Supporting Rho through the acquisition and implementation of an eTMF and leading the charge for a new TMF Business Process, Janice has an insightful perspective on the keys to successful TMF implementation and management.
In her role as a Senior TMF Project Manager, Janice cultivates an environment of teamwork and collaboration with the support of an amazing core team who together to continue to lead change and innovation in the area of TMF Management at Rho.
Senior Associate, TMF Management and Compliance
Allison Grosik – Senior Associate, TMF Management and Compliance
Pharmaceutical professional with 5+ years of global TMF management. Experienced with managing a paper/electronic TMF from a Sponsor and CRO perspective. Currently part of the TMF Management and Compliance group at Eisai. Team lead for TMF reference model updates, eTMF query process and CRO strategic partner metrics. Prior to Eisai, worked at Quintiles in Clinical Operations. Has a Bachelor of Science from Rutgers School of Engineering focusing on Chemical and Material Science.
Certified Clinical Research Coordinator
UNIVERSITY OF FLORIDA
Amy Gunnett – Certified Clinical Research Coordinator
UNIVERSITY OF FLORIDA
Amy M. Gunnett is a Certified Clinical Research Coordinator and the Lead Research Nurse for the University of Florida’s Department of Anesthesiology Research Office. Mrs. Gunnett is responsible for training research staff, periodical reviews of all procedures and policies to ensure compliance with research and nursing standards and practices, protocol development, regulatory management for investigator-initiated and industry-sponsored protocols, development and implementation of standard operating procedures, direct patient care in clinical trials, and collaboration with the research staff to provide the best service for the department’s research faculty. Prior to this role, Mrs. Gunnett worked under the University of Florida’s Department of Medicine’s Division of Gastroenterology, Hepatology, and Nutrition for 15 years as a regulatory coordinator and a certified nurse research coordinator primarily focusing on coordinating industry-sponsored trials in inflammatory bowel disease and hepatitis C. She received her nursing degree from Santa Fe College in Gainesville, FL; is certified through The Association of Clinical Research Professionals (ACRP) and is an active member in her local chapter; serves as the Co-Chair for the local pilot chapter of International Association of Clinical Research Nurses (IACRN), and is the registry manager for the North American Malignant Hyperthermia Registry (NAMHR) with the Malignant Hyperthermia Association of the United States (MHAUS), which has just moved to the University of Florida.
Louise Hawkins – Clinical Operations Manager, Clinical Operations
Louise Hawkins has worked in clinical research for 10 years and is the TMF subject matter expert at Agios Pharmaceuticals. In this role, she works with cross-functional study teams and vendors to ensure the successful conduct of TMF audits according to pre-defined TMF audit schedules, ensures application of lessons learned across programs, and develops, pilots and implements streamlined and efficient workflows and processes.
Prior to Agios, Louise earned her BSC in nursing, she began her career in industry as a Study Nurse in the Phase 1 Clinical Trial Unit at Roche in the UK. From there, she progressed to full-time study management as a Trial Manager/Senior Research Nurse at the NHS Blood and Transplant (NHSBT) unit. She moved to the US in 2011, where she worked as a Clinical Trial Coordinator at UCSF and Cerexa as a Clinical Trial Assistant and then as a Global Study Manager at Genentech. Louise is currently Clinical Operations Manager at Agios where she is not only responsible for TMF efforts, but is also responsible for overseeing quality and compliance activities for Clinical Operations. She also supports process development, process improvement, and inspection readiness throughout the Clinical Development organization.
Wendy Kelly, M.A., has been working in clinical research and development for 13 years. She has experience at site, CRO and Sponsor level and is currently Manager for TMF and Safety Reporting process at pharmaceutical company. Wendy has worked as a subject matter expert for several system implementation projects. She has developed and implemented processes to ensure proper sponsor oversight of TMFs and Safety Reporting. She has worked as the business point person with project teams, vendors for process alignment, system build and implementation.
She is responsible for several integral functions related to clinical trial conduct, including overseeing the management and review of Trial Master Files, Rest of World Safety Reporting and vendor global operations and performance.
Clinical Research Oversight Specialist
TEXAS HEALTH INSTITUTE
Aryn Knight – Clinical Research Oversight Specialist
TEXAS HEALTH INSTITUTE
Aryn is a Certified Clinical Research Professional (CCRP) with more than a decade of direct experience in clinical research in academia and hospital environments. Her experience has included: research coordination, protocol development, grant writing and submissions, budget development, IRB submission and all regulatory maintenance, supervision and training of other research coordinators, and proficient knowledge of research regulations in FDA/GCP/ICH guidelines. Additionally, she has over 16 years experience in pediatric clinical research within the specialties of cardiology, pediatrics, gastroenterology, NICU, psychiatry, psychology and neurology.
Amy is an experienced research manager with extensive experience in gastroenterology trials. Throughout her research career, Amy has focused on educating participants on the importance of their roles in clinical trials and in the development of improved medications for their indications. As a manager, she works at maximizing efficiency at her site by standardizing the organization of trial files and by streamlining the workflow for research staff.
Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner for eTMF implementation across the organization. In this capacity she interacts with internal senior level management, external vendors, collaboration partners, clinical study and other internal personnel to ensure compliance with regulations, Regeneron business practices and clinical research program objectives.
Prior to March 2017 Joanne was the Director of Medical Research Process Management at Purdue Pharma where she was responsible for research quality, data integrity and continuous improvement in clinical research. She was also responsible for the Trial Master File and FDA submission and inspection readiness beginning in 2008. She and her team worked with a TMF vendor and successfully implemented an eTMF based on the industry standard Reference Model which is currently used by the internal teams and CROs. As part of her inspection readiness responsibilities she has been actively pursuing quality improvements in site preparation and the TMF. Joanne also has expertise in implementing computerized systems and computer system validation and served on the core committee for DIA’s Peach initiative in 2009 which published Computerized Systems In Clinical Research: Current Data Quality and Data Integrity Concepts.
Director, Clinical Operations, Head of Clinical Document Control
Alex Markiel – Director, Clinical Operations, Head of Clinical Document Control
Alex Markiel has more than fourteen years of experience implementing and managing a broad array of clinical systems for both large and small global companies in the pharmaceutical industry. He has contributed to the setup and long-term management of clinical system programs including eTMF, IxRS, CTMS and Investigator Portal. Alex’s experience working across companies and studies in a variety of managerial roles has provided him with a varied, in-depth knowledge of clinical system processes, implementation and management. Alex is based in San Francisco and is currently working on the implementation and rollout of an eTMF program at a local biotech.
Colleen has 20+ years of experience in information management, stewardship, and trial master file in the pharmaceutical industry. She is currently the Director, Trial Master File in Clinical Quality & Compliance at MedImmune, a member of the AstraZeneca Group. Colleen is responsible for global TMF operations, strategy and compliance. She has led the implementation of processes, metrics and several eTMF systems. She is a member of the DIA TMF Reference Model group and in the past served on the Steering Committee. She has implemented a TMF Master Index based the DIA Trial Master File Reference Model across numerous functions. Colleen received a B.S in Medical Technology from Fairleigh Dickinson University. She is also a Green Belt Certified Lean Sigma Instructor and is a Master Coach.
Associate Director, Development Sciences Quality
Scott McCulloch – Associate Director, Development Sciences Quality
Scott is an experienced clinical research professional with more than 12 years life sciences industry experience. Scott’s professional career started within a global CRO working in several different roles, learning to follow Good Clinical Practices (GCP) from study start-up to study close-out.
After spending several years working in various CROs and learning from experienced peers about the life cycle of product development, Scott was attracted to the ever-developing, electronic side of the industry. Scott contributed to European operations, strategy and growth for two major eClinical service providers, specializing in electronic Trial Master File (eTMF) solutions.
Working for organizations that provide services to product sponsor organizations, it was important for him to understand how best to do so. Over the past few years (2013-2016), Scott invested in his personal development and is now a Black Belt within the Six Sigma methodologies. As well as this, every year Scott undergoes an ICH-GCP refresher course.
Jason Methia serves as vice president for Vault and is responsible for growing and sustaining the market within the Enterprise market for Vault Clinical applications, including CTMS, eTMF, Study StartUp, and SiteExchange. Jason is focused on ensuring that Veeva delivers market-leading clinical business operations solutions and that Veeva customers are successful. He previously served as Veeva’s director for Vault eTMF strategy.
Prior to joining Veeva, Jason was the clinical documentation department head and TMF process owner at Vertex Pharmaceuticals. His team was responsible for the adoption of standards and adherence to quality control processes that ensured TMF compliance across the clinical development portfolio. Jason was also the business owner for Vertex’s Study Startup Management System, a web-based application that was developed from the ground up to support the study start-up and site activation process.
Jason has held a variety of roles ranging in clinical operations, regulatory affairs, and inspection readiness at organizations such as the Dana Farber Cancer Institute and Wyeth Research. He earned a bachelor’s degree in psychology from The University of Vermont and a master’s degree in regulatory affairs from Northeastern University.
JP Miceli is an Associate Director of Clinical Document Management for Shire Pharmaceuticals. JP started work at Shire in January 2015 managing TMF outsourcing activities, inspection readiness events, contracts management, archiving and records retention, and implementation of the Veeva Vault eTMF. Prior to joining Shire, JP spent more than 10 years between Vertex Pharmaceuticals and Millennium Pharmaceuticals managing the TMF and working on other initiatives such as CTMS implementation, Investigator Safety Letter Management and Investigator Portals.
Director of Clinical Operations
LMK CLINICAL RESEARCH CONSULTING
Jackie Morrill is the Director of Clinical Operations at LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. She is a Lean Six Sigma Green Belt certified clinical research professional with nearly a decade of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries. For the past five years, her dedicated focus has been on all things Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration and integration projects, development of robust metrics and training programs, enhancement and development of TMF processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections.
Lisa has a 20+ year career in the pharmaceutical industry, primarily in the areas of clinical operations and quality management. More than seven years ago she became an independent consultant, focusing solely on Trial Master File process and management assisting clients with the assessment and improvement of their current state, the development of future design, and the implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs. She is a frequent speaker and experienced workshop leader at TMF-related professional meetings.
Lisa is co-leader, with Karen Roy of Phlexglobal, as well as a Steering Committee member of the volunteer team of industry representatives through the DIA that created, maintains and expands the TMF Reference Model.
TMF Operations, Clinical Development Operations Function
Laura Naranjo – TMF Operations, Clinical Development Operations Function
Laura began her career out of college working as an investigator for the federal government, conducting background investigations for individuals looking for national security clearance. Laura has since made the move to the pharma industry and has been working in TMF since 2009. She has worked on both the sponsor and vendor sides throughout her career and recently joined Daiichi Sankyo as the Manager of TMF Operations. Laura has become quite an expert in launching eTMF systems over the years and has participated in four eTMF system launches in just the past 3.5 years. She especially likes diagnosing system issues and process improvement.
She is a member of the TMF Reference Model Project Team and participated in the review and update to Version 3.0 of The Reference Model. She holds a B.A. in theatre arts from Lehigh University and is working on completing her Master of Jurisprudence in pharmaceutical and medical device law and compliance from Seton Hall Law School.
Dawn Niccum has worked in the pharmaceutical industry and with clinical trials for more than 20 years. She started as a clinical study coordinator, moved to monitoring, and then to training and compliance. Currently she is Associate Director, Quality for a small biopharmaceutical company located in West Lafayette, Indiana. She has responsibilities for compliance in the clinical group, SOP development, Computer System Validation oversight, training and safety. She is certified as a CCRA, Project Manager; is a registered nurse; and holds a master’s in regulatory affairs and quality compliance.
Director of Professional Services
DATA REDUCTION SYSTEMS CORPORATION
James (Jim) Peters is the Director of Professional Services and is responsible for the TMF Practice at DRS Corp. Jim’s responsibilities include, eTMF document processing, mitigation and oversight as well as TMF Audit Services.
Jim has 40 years of experience in document and information management. Recently Jim spent 5 years as the DRS Manager responsible for the global clinical documentation operation of a top 5 multinational pharmaceutical company. Jim’s vast experience provides a unique perspective on document collection, capture, review and filing.
Marie-Christine Poisson-Carvajal – Head of TMF Operations
Marie-Christine Poisson-Carvajal is the Head of TMF Operations and the TMF Business Process Owner at Pfizer. She has been in the TMF space since 2011 as TMF Operations Lead. She is responsible for developing and executing strategy for continuous TMF quality and efficiency improvements, driving execution and performance data for all TMF roles and activities. ensuring TMF functions operate and perform to the level expected to contribute to high quality and inspection-ready TMF. For more than 25 years Marie-Christine has worked with different pharmaceutical companies and CROs in a variety of roles such as CRA, SOP and training manager, GCP quality auditor and project manager. Her experience has provided her with in-depth knowledge of clinical trials and their documentation. Besides her passion for TMF, Marie-Christine is always planning for a next travel or visit to her family in Europe.
Jennifer Poulakos – Director, Development Quality Assurance
Jennifer Poulakos is currently the Director of Development (GCP & GLP) Quality Assurance at Agensys, Inc., a small biotechnology company that is an affiliate of Astellas Pharma, Inc. Jennifer began her career in (Biotech) drug development, over 25 years ago, overseeing early and late phase clinical programs. She worked on two programs through BLA submission and developed a strong appreciation for Clinical Quality Assurance. She transferred to a Clinical Quality Assurance role approximately 15 years ago developing audit strategies for clinical programs, service providers and internal processes. These strategies were designed to identify compliance risks, establish escalation paths and implement process improvement initiatives. In addition, she led global inspection (GCP and PV) preparedness activities and managed sponsor- and pharmacovigilance-inspections.
Clinical Trial Project Manager
ELI LILLY AND COMPANY
Prior to joining Lilly, Tyler worked at a multi-therapeutic community research center. With nearly ten years of clinical research experience, he now works in oncology as a study manager. In addition to his trial management duties, he serves as the TMF subject matter expert at Lilly, which consists of piloting and implementing new TMF management processes, training users in the use of eTMF, and liaising between leadership and users to ensure proper SOP execution. Tyler has a Bachelor of Science degree in Integrated Leadership and is currently pursuing a Master’s degree in Business Administration.
Kelley Robinson – Repository Management Lead, Content Management and Authoring
Kelley currently holds the position of Repository Management Lead at Pfizer where she is responsible for assessing and improving processes and performance for Pfizer’s core content management systems, and is a primary point of contact for the TMF during Regulatory Inspections. Previously she was the system owner for Pfizer’s eTMF and the TMF Process Analyst responsible for metrics and reporting across Pfizer’s enterprise in quality and compliance and operational metrics.
Kelley began her career with Pfizer in 2002 where she has held various roles in the clinical trial support arena, including Pfizer’s CTMS and Information and Records Management where she helped create a global, harmonized Investigator Initiation Package process that helped drive down discrepancy rates and reduce study start up cycle times.
Kelley holds a Bachelor of Science degree in Healthcare Administration and a Master of Business Administration.
Head of eTMF in LATAM and Clinical Operations Manager
BOEHRINGER INGELHEIM BRAZIL
Fabio Rodrigues – Head of eTMF in LATAM and Clinical Operations Manager
BOEHRINGER INGELHEIM BRAZIL
Fabio Rodrigues is currently the Head of TMF for Latin America (LATAM) countries at Boehringer Ingelheim in Brazil, where he directs and oversees the TMF operations and executes strategies to improve compliance and the documentation quality of the TMF in order to ensure it is complete, accurate, updated and inspection-ready. He manages TMFs for trials insourced and outsourced to CROs. In LATAM, he implemented an electronic process to receive documents from CROs and established metrics and KPIs to evaluate CRO performance during the trial’s life. He also has worked with metrics to harmonize internal staff performance using Six Sigma Methodology and increase productivity with quality and accuracy. In addition, his experience includes global TMF governance and collaboration on global TMF working groups.
He has more than 13 years working with clinical research, working as Regulatory Specialist, CRA, Trainer, Quality, CRA Manager and Clinical Operational Manager.
Fabio graduated as Pharmacist in Brazil and he holds a Master of Science degree in Pharmacology from Sao Paulo University, a Master of Business Administration degree from IMES University and Black Belt Certification. He is also an Executive Professional Coach.
Karen Roy – Senior Vice President, Client Solutions
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 moved into her current role as Senior Vice President, Client Solutions in 2015. 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 also co-chairs the DIA TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files.
Eric Rubinson – Associate Director, R&D Consulting
Eric Rubinson leads the cross-functional Trial Master File strategy at Actavis’ subsidiary, Forest Research Institute. Eric is responsible for ensuring and enforcing standards for TMF record management and archival in support of a high-quality and inspection-ready TMF. Eric is also responsible for the archival processes of regulatory submissions and correspondence. Eric is currently serving as a Zone Lead for Regulatory (Zone 3) for the TMF Reference Model.
Eric joined FRI in 2005 as a Business Analyst in Informatics/IT. Prior to FRI, Eric spent several years with Accenture/Andersen Consulting as a process improvement consultant.
When not dreaming about flawless TMFs, Eric is active in his community, coordinating charitable running initiatives, and is pending completion of certification as a running coach.
Clinical Trial Manager, Clinical Systems and Documentation
Kate Santoro – Clinical Trial Manager, Clinical Systems and Documentation
Kate has worked in the biopharmaceutical industry for 20+ years. In her role as Senior CTA – Clinical Systems, Kate manages the TMF process as well as clinical trial disclosure. Kate recently managed a full-scale project to revamp Alkermes’ TMF processes, including adopting the DIA Reference Model and moving into an electronic TMF. This is Kate’s third TMF Summit.
Supriya Shoroff is a subject matter expert and Clinical Documents Manager at MediVector Inc. based in Boston.
Supriya oversees the TMF operations in-house and the CRO’s management of eTMFs. Supriya has successfully implemented the electronic Trial Master File solution at MediVector and is the TMF process owner.
Currently, Supriya is working on data migration projects and leading the migrating effort of about 200,000 + documents into the new eTMF solution.
IRB and Clinical Trials Documentation Specialist
PATH’S CENTER FOR VACCINE INNOVATION AND ACCESS
Shannon Simpson – IRB and Clinical Trials Documentation Specialist
PATH’S CENTER FOR VACCINE INNOVATION AND ACCESS
Shannon Simpson is currently responsible for the implementation and maintenance of the Trial Master File system for clinical trials and other relevant studies for PATH’s Center for Vaccine Innovation and Access (CVIA), which makes lifesaving vaccines globally available to women, children, and communities, particularly in low resource settings. She also serves as an Institutional Review Board Specialist for CVIA’s clinical trial teams and clinical research sites. For the past year, Shannon has served as an Alternate Board Member on the Maryland Department of Health and Mental Hygiene (DHMH) Institutional Review Board (IRB).
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.
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.
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-functionally. 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 the Pharmaceutical industry in 2000. During the past 17 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.
Associate Director, TMF, Clinical Training and Records Management
Stephanie Viscomi – Associate Director, TMF, Clinical Training and Records Management
Stephanie Viscomi, Head of TMF at ImmunoGen, Inc. based in Boston, with over a decade of industry experience predominately pertaining to TMF. In that time, she 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.
Michele Weitz has more than 20 years of experience in drug and device development, and has recently joined Clovis Oncology, located in San Francisco, CA, as Director of GCP Compliance Operations. In this role at Clovis, and with previous employers including Roche and FibroGen, she has been tasked with fostering and promoting a GCP-compliant environment through the development and management of a quality-focused infrastructure that includes: standard operating procedures, GCP process evaluations, training, compliance advice, the review of clinical documents, and responses to inspections and audits. She has extensive experience preparing sponsor companies and sites for regulatory inspections, and has successfully led both “front room” and “back room” inspection activities — including being the main point of contact with the FDA Investigator during inspection. She is a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP), and was part of the first group of ACRP-Certified Clinical Research Associates (CCRA) to achieve 10-year certification status. She began her career in the laboratory performing discovery research, then transitioned into clinical research, where she found her calling. She has held positions as a Site Monitor, International Clinical Auditor, and Training Manager; has been head of several clinical quality assurance groups; and has consulted for more than 20 industry clients. Her professional passions are employee motivation and growth, program development, research ethics, and innovative approaches to quality management.
Assistant Director, Clinical Documentation Center
Karen Whitson – Assistant Director, Clinical Documentation Center
Executive Director, THE AVOCA QUALITY CONSORTIUM; Senior Consultant
THE AVOCA GROUP
Steve Whittaker – Executive Director, THE AVOCA QUALITY CONSORTIUM; Senior Consultant
THE AVOCA GROUP
Steven B. Whittaker is Executive Director for The Avoca Quality Consortium and Senior Consultant for the Avoca Group, where he conducts Quality Workshops, Executive Level Consulting for Pharmaceutical Quality, Clinical Development, Project Management, Sourcing, Alliance, and Relationship Management.
Steve is an independent consultant for the pharmaceutical, biotech, and CRO industries who provides expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution plans. His wealth of experience through years of drug development leadership roles, combined with his established professional network across these industries, provides unique and valuable insights for organizational leaders.
Steve has served for 12 consecutive years on the Advisory Board for the annual Partnerships in Clinical Trials program, chairing the board for two years. In addition, he has moderated numerous quarterly Clinical Research Consortium forums, developing strategic agendas and facilitating the exchange of leadership concepts between clinical development executives across top-tier pharmaceutical and biotech organizations.
In 2009, Steve retired from Eli Lilly and Company, where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform. As the leader of the Global Clinical Research Sourcing Office, Steve established Lilly’s first corporate strategy and operational design for outsourcing global clinical development to CRO preferred partners. This included the selection and initial implementation of the preferred partner approach for global, full-service CRO capabilities. Steve also led Lilly’s Project Management Center of Excellence, establishing standards for leaders of project development.
Exec. Director, Site Management Operations, Acquisition Integrations and Clinical Records Management
Alana Wriggins – Exec. Director, Site Management Operations, Acquisition Integrations and Clinical Records Management
Alana has more than 20 years of clinical research experience, and has led both regional and global cross-functional staff across project teams and facilitated numerous process improvement initiatives. She has been involved at the front-line of numerous FDA inspections. In her current role at Allergan, she leads the group responsible for the global oversight of TMF management and archiving, as well as, inspection readiness and acquisition activities. She is also responsible for site management activities in North America. Alana received her Bachelor of Science degree in Nursing from the University of South Carolina and her Master’s degree in Health Science, Clinical Research Administration from George Washington University. She is a member of ACRP and the Regulatory Affairs Professional Society.
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