Christina Allen – Senior TMF Specialist, TMF Operations
Christina has over ten years of experience in the Pharmaceutical industry. Currently working in Daiichi Sankyo’s TMF Ops group, serving as a TMF SME to project teams and functional areas. She is a core team member responsible for the launch of a new eTMF system, with an interest and expertise in the creation, implementation, and training of functional QC processes and procedures. Christina leads the compilation of the TMF Management Plan in association with the TMF Owner and acts as a point of contact for audits and inspections related to the Trial Master File processes and activities and assists with the development of corrective action plans related to Trial Master File findings. She is uniquely positioned in managing CRO/Sponsor relationships, working with industry leaders such as Covance and Novo Nordisk before joining Daiichi three years ago.
eClinical Manager eTMF and Collaboration- CSL BEHRING
Jennifer Arters – eClinical Manager eTMF and Collaboration
Jen has a vast array of systems development and process improvement in the pharmaceutical industry by supporting the R&D and healthcare delivery systems. She has contributed most recently to the implementation of goBalto study startup solution and the upgrade of the Veeva Vault eTMF, supporting clinical system integrations. Her knowledge of technology has assisted to streamline current clinical systems within CSL Behring. Her past 20 years in the industry has contributed with her innovative strategic management across companies. She is a results focused individual with global knowledge across multiple functional areas. Her recent design of an access management system has supported a robust training solution for the companies external service providers. Jen has increased efficiency through restructuring processes with alignment of business requirements to technological user requirements. Jen is based in King of Prussia, PA and is currently working on road mapping project to broaden the business knowledge of the technologies 5 year plan.
Evelin Baez is a Clinical Management Document Specialist with more than thirteen years of experience in quality control and records management. She has been in her current position at BD in Tempe, Arizona for over five years. Prior to BD, 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 within her division 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. Evelin has been present at our TMF Summits since 2014.
Clinical Document Management and Inspection Readiness- SHIRE
Wendy Beeby – Clinical Document Management and Inspection Readiness
Document Center Manager- PSI PHARMA SUPPORT AMERICA
Bio Kristen has worked for 20 years in the pharmaceutical industry. She presently serves as a Document Center Manager at PSI Pharma Support America, Inc. in charge of Trial Master File operations for the U.K., Australia, New Zealand and North and Latin America. She has spent a great portion of her time working on bridging the gap between sponsor and CRO expectations in TMF functionality as well as assisting in the development and deployment of client based eTMF services for her current company. She is a recognized expert in the field of clinical Trial Master Files and specializes in finding customer orientated solutions to risk management and compliance in a global environment.
Director, Regulatory Affairs – Regulatory Systems Strategy- BIOGEN
Andy Chu – Director, Regulatory Affairs – Regulatory Systems Strategy
Andy has worked across the Life Sciences and Pharma Industry over the past 25 years, across the multiple disciplines, businesses, and capabilities of R&D. As the Head of Regulatory Information Management and Data Sciences (RIM DS) at Biogen, he drives how the regulatory function brings together its technology, data, processes and people to enable strategic objectives by developing the vision of RIM, evolving the Regulatory core capabilities against this vision, and providing an operating framework supporting the use of these capabilities.
Senior Director, Product Management- WINGSPAN TECHNOLOGY, AN IQVIA COMPANY
Kathie Clark – Senior Director, Product Management
WINGSPAN TECHNOLOGY, AN IQVIA COMPANY
Kathie Clark is Senior Director of Product Management for Wingspan Technology, Inc. She oversees the development of the Wingspan eTMF and other Wingspan products servicing the Life Sciences and Pharmaceutical industries. She has more than 20 years of experience in product management, business development, marketing, business analysis, project planning and management and solution/product design and development. Kathie has worked with more than 80 pharmaceutical, biotech, CRO and medical device organizations in the US, Europe, Japan and Israel. Her areas of expertise in life sciences content management include Clinical, Quality and Manufacturing, Regulatory Affairs & Submissions, and Legal Contract systems. Most recently at Wingspan, she has driven the design of the latest generation eTMF solution, which focuses on bringing transparency, insight and efficiency to all types of eTMF users. Previously, Kathie served as Director of Product Management at NextDocs, where she was responsible for the product strategy and roadmap for regulatory and quality products. She previously served as Director of Professional Services at GlobalSubmit working with the FDA to implement eCTD validation rules. Before that, she was a Director at First Consulting Group, where she was instrumental in the development of the suite of FirstDoc solutions and their delivery to dozens of clients, in addition to building and managing the Life Sciences Subject Matter Expert/Business Analyst practice. She is the author of many white papers, blog posts and presentations on content management for eTMF, regulatory and quality systems.
Grace Crawford – VP Clinical Quality and Compliance
Grace joined MedImmune in April 2015 as head of the Clinical Quality & Compliance function responsible for supporting the Clinical Biologics area within MedImmune. Prior to that, Grace spent over 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in industry participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium, and Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science Degree in Clinical Microbiology at the Medical College of Pennsylvania.
Director Quality Assurance Strategic Advice- Science Unit QA, GCP and PV- ASTRAZENECA
Sheryl Crean – Director Quality Assurance Strategic Advice- Science Unit QA, GCP and PV
Sheryl Crean, RQAP GCP is Director of Quality Assurance, Strategic Advice at AstraZeneca in Gaithersburg, MD. Sheryl has served in various GXP Quality roles in Pharma & CROs with GCP and PV expertise including system, routine and submission triggered Inspections across various Health Authorities: FDA, EMA, MHRA, PMDA, Health Canada & Ministries of Health. Her current responsibilities include operational, tactical and strategic quality aspects including Inspection readiness preparation and execution. Sheryl has led inspection activities as host, anteroom lead, QA support, helping teams and functional areas prepare for successful Inspection outcomes and implementation of follow up & lessons learned.
QA Consultant, QA-Product Research and Development- ELI LILLY
Sonja Davis – QA Consultant, QA-Product Research and Development
Sonja Davis has over twenty-eight years of experience across various roles in analytical development, clinical supply planning and execution, clinical data management, and Quality. As a Six Sigma Black Belt, she led complex, cross-functional projects to redesign quality systems, improve accuracy and cycle-time for investigational medicinal product label approvals, and improve document retention processes for batch records. Since her Black Belt assignment, she has worked to continuously improve processes to reduce variability and complexity by building standardization and systematization into the quality culture. This focus, along with her expertise in the area of overlap between GMP and GCP requirements, has allowed her to contribute to Lilly’s TMF harmonization project over the last four years.
Donna is a business consultant who has more than 25 years of experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management and TMF management. Her vast experiences dealing with small to large pharma companies, academic centers, regulatory agencies, CROs and investigator sites provide her with the knowledge needed to assist research organizations in all areas of clinical compliance. She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations. In 2005 Donna founded DWD & Associates. In her capacity as President, she has led several large projects performing operational gap analysis and implementing process improvement initiatives for sponsors, CROs and clinical sites. She is an experienced auditor and has expertise in SOP development for both investigator and sponsor organizations. She has led the implementation of eSource and electronic Trial Master File solutions, and has expertise in clinical validation of these systems. In June 2015, DWD & Assoc became Just in Time GCP to better describe the services and capabilities of the organization. Donna remains as President.
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.
Senior Director, Content Management and Authoring- PFIZER
Mary Emanoil – Senior Director, Content Management and Authoring
Mary has been with Pfizer for over 25 years and has held a variety of positions in information management with extensive experience in document and records management. She is currently Senior Director and Lead of the Content Management and Authoring team within the Information Management Center of Excellence. In this role Mary is accountable for management and support of Pfizer’s core content management and authoring solutions including the Pfizer Trial Master File (pTMF) and the Global Document Management System (GDMS). With a mission to increase quality and usability of content through automation and collaboration, the Content Management and Authoring team is delivering cutting-edge solutions and services to Clinical, Regulatory and Safety teams across Pfizer. Mary has an MS in Information and Library Science and a BA in Liberal Arts from the University of Michigan.
Liz is a Sr. Manager within in the TMF organization at Biogen and currently oversees TMF process and quality for phase I-IV trials to ensure ongoing compliance across the organization. During Liz’s 5+ years at Biogen, she has supported numerous regulatory inspections (FDA, MHRA, PMDA), has supported development of a TMF metrics program and has worked cross-functionally on TMF management with CROs. Additionally, Liz has driven implementation of a global eTMF at Biogen, and built a team of TMF Study Owners to support day-to-day TMF activities on the SMT level. She obtained a BE in biomedical engineering from Vanderbilt University, and is currently an MBA candidate at Worchester Polytechnic Institute.
Prior to her work at Biogen, Liz was a research coordinator at Vanderbilt University Medical Center’s Clinical Research Center, and held clinical trial and TMF management roles at Lantheus Medical Imaging and Aveo Oncology.
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.
Karen has 34 years of experience in the pharmaceutical industry, in TMF and in inspection support. She worked at Schering-Plough for 25 years, leading their global, Clinical Documentation department and supporting Regulatory Authority inspections from the TMF perspective. Since the Merck/Schering-Plough merger, Karen has been an Essential Document Lead, supporting various aspects of the TMF including in/out-licensing projects, outsourced trials, and Regulatory Authority inspections.
Karen holds a bachelor’s degree in Biology from the University of Scranton, and a master’s degree in Biology/Business Administration from Seton Hall University.
Patty Fulton is the Quality Consultant for the Trial Master File at Eli Lilly and Company. In this role she participates in strategic planning to integrate quality into the business process, provides guidance to trial teams and implements quality initiatives to ensure compliance and inspection readiness. She has worked with functions across Lilly Research Laboratories to help drive quality expectations for the TMF globally. Patty is also the Business Quality Leader for the eTMF IT System leveraging system knowledge to create solutions that are efficient and compliant.
Susan Groth is a Headquarters Clinical Quality Manager currently working in ID & Vaccines at Merck & Co., responsible for implementing risk based quality management via development of Risk Assessments and implementation of Quality Plans, as well as working with teams to ensure ongoing inspection readiness, providing quality oversight of trial conduct, managing significant quality issues, and supporting both inspection preparation and inspection conduct. Susan has a BS from Rutgers University, a MS from Drexel University, a Six Sigma Yellow Belt Certification, and over 20 years of experience across both large and small pharmaceutical, biotech, and CRO organizations. During that time she has held both internal and external auditing roles, CAPA Management positions, as well as Clinical Quality Management roles, now within Headquarters operations. She has extensive expertise in CAPA management, risk assessment, process improvement, and site and process audit management.
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.
Rebecca Halbur is the business system owner of the TMF system at Biogen. Her nine years of experience in TMF spans various levels and operating models from document processing in both paper and eTMF, to people management of TMF teams, project management and system oversight and development in both the CRO and biotech environments. Included in this is significant experience in helping pharmaceutical and biotech companies setup and navigate the complex global TMF environment where she assisted with implementing and migrating to new systems, training teams around the globe, and implementing bespoke QC processes. She holds a BSc in Biological Sciences from North Carolina State University and a Masters of Liberal Arts in Extension Studies with a Concentration in Sustainability from Harvard University.
As Senior Consultant with The Avoca Group -the driving force behind continuous improvement of outsourced clinical research, Janis developed many of the quality oversight tools within the Avoca Quality Consortium® Knowledge Center. Through Avoca’s industry research expertise, 62 plus Consortium Members, and body of over 250 tools that empower and enable drug development teams, Avoca helps bring medicines to patients in a more effective manner. Janis has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO, and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), she was responsible for R&D sourcing, contracting, and supplier alliance management. As the primary point of contact to health authorities for inspection readiness for strategic sourcing, she developed and successfully implemented an end-to-end process for inspection readiness of the sourcing organization. She is also the mastermind behind the Oversight Capability and Maturity Model (OCMM) and Prequalification work streams, and a key contributor to Avoca’s Diligent® Vendor Qualification Platform. Janis has been a chair, invited speaker, and panelist at numerous conferences. She holds an MBA from the University of Delaware and a BS in Chemistry from Towson University.
Nela Hayes – Senior Manager, Clinical Documentation
Nela Hayes is a Senior Manager of Clinical Documentation Center Operations at AbbVie, managing a team responsible for oversight of AbbVie’s eTMF system business processes, including overseeing implementation of eTMF system enhancements, providing day to day operational support, creating and maintaining eTMF training and managing quality control processes in relation to eTMFs. She has worked at AbbVie (formerly a part Abbott) for over 15 years and has spent a great deal of her time in the Clinical Operations space working with trial management and operations, quality document management systems, as well as sponsor and site regulatory inspection support. Nela is passionate about diversity and inclusion, specifically the advancement of underrepresented groups into leadership roles and is the current Co-Chair of AbbVie’s Women’s Employee Resource Group and a member of Healthcare Businesswomen’s Association (HBA). She holds a Bachelors of Philosophy in Communications from Northwestern University.
Associate Director, Clinical Operations- Duke Clinical Research Institute
Kathy is a core member of the TMF implementation team at DCRI. She is accountable for the actions and implementation of the new eTMF system with more than 3000 users. She is the Associate Director for Clinical Operations department, overseeing Project Management, Site Management and Monitoring.
Kathy’s has over 20 years of experience in global clinical trial management in both the commercial and academic environments. Kathy also holds a degree in nursing and worked as a nurse for several years before she moved to the pharmaceutical industry in 1994.
Victoria Ho has more than 25 years of experience in the pharmaceutical/biotechnology industry. She has been at Gilead for 18 years. She heads up the Central Records team at Gilead as well as the Learning and Knowledge Management function within Clinical Operations. She served as the TMF Business Owner during the implementation of Gilead’s eTMF and continues to work with the TMF System Owner and other administrators on its ongoing improvement. Her responsibilities include the continuous improvement of the TMF process to better ensure TMF compliance and quality. Prior to her current role at Gilead, Victoria was responsible for leading various drug development programs at Gilead as well as managing clinical trials at other companies.
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.
Senior Manager, Process, Training and Compliance- TAKEDA
Lisa Joseph – Senior Manager, Process, Training and Compliance
Lisa Joseph, CCRA has been working in the clinical research industry for over 25 years, working her way through roles as a site study coordinator, CRA/Lead CRA, study manager, line manager, training manager and her more recent roles in clinical training and compliance in academic, CRO and sponsor companies. In her most recent position at Takeda Pharmaceuticals, Lisa has focused on clinical trial SOP management, clinical compliance, process improvement, change management, and GCP inspection readiness. One major project over the past few years has been the implementation of a vendor agnostic eTMF platform suitable for Takeda’s global and varied portfolio; current process improvement activities include definition of cross functional sponsor oversight and documentation in support of proactive inspection readiness.
Clinical Research Oversight Specialist; Assistant Administrative Director- TEXAS HEART INSTITUTE
Aryn Knight – Clinical Research Oversight Specialist; Assistant Administrative Director
TEXAS HEART INSTITUTE
Aryn is a Certified Clinical Research Professional (CCRP) with more than 16 years of direct experience in clinical research in academia and hospital environments. Since 2013, Ms. Knight has also served as the active Chapter Chair for Houston/Galveston Society of Clinical Research Associates (SoCRA). Additionally, she is a member of the Texas Medical Center’s Institutional Review Board through Western IRB.
Aryn’s research experience has included research compliance, research coordination, protocol development, grant writing and submissions, budget development, IRB submission and all regulatory maintenance, Sub-Investigator, research operation development and management, supervision and training of other research coordinators and development of clinical research programs. Additionally, Ms. Knight has direct clinical research experience 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, and clinical study and other internal personnel to ensure compliance with Regeneron business practices and clinical research program objectives.
Prior to March 2017, Joanne was the Director of Clinical Research & Development Process Management at Purdue Pharma she was responsible for research quality, data integrity and continuous improvement in clinical research. At Purdue Pharma, she was 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 received her bachelor’s degree from Notre Dame College in New Hampshire and went on to get her master’s in microbiology from the University of Connecticut in Storrs. Additionally, she attended Lesley College in Cambridge, MA and received a master’s degree in applied management. She has worked in R&D at various biotech, device, CRO and pharmaceutical companies.
Director, Clinical Operations, Head of Clinical Document Control- PHARMACYCLICS
Alex Markiel – Director, Clinical Operations, Head of Clinical Document Control
Alex Markiel has more than sixteen 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 Portals. Alex’s experience working across companies and studies in a variety of roles has provided him with a varied, in-depth knowledge of clinical system processes, implementation and management. Alex is based in San Francisco and currently manages a Clinical Records Department, where he leadsTMF Specialists, technicians and study team personnel in the effective and efficient management of TMF records.
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.
Director, Process Excellence and Risk Management Clinical Development Operations- DAIICHI SANKYO
Ann McCabe – Director, Process Excellence and Risk Management Clinical Development Operations
Ann McCabe is currently the Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked in the areas of Clinical Operations, Quality, Process Improvement and Training and is PROSCI certified. She is currently leading implementation efforts for Risk Based Quality Management (ICH E6 R2) and study/partner metrics for Daiichi Sankyo. She has Bachelor’s degrees in Biology and Medical Technology from the University of Delaware.
Director Consulting Services- CGI CONSULTING
Christopher McSpiritt – Director Consulting Services
Manager, Clinical Support and Quality Documentation- BOEHRINGER INGELHEIM
Joy Mehlenbacher-Mohamed – Manager, Clinical Support and Quality Documentation
Joy Mehlenbacher-Mohamed, BSc, is currently working as the manager of the Administration Group at Boehringer Ingelheim Previously she was the as the Clinical Oversight and Quality Documentation Manager at Boehringer Ingelheim and is based in Ontario Canada. She has been working in clinical research for 22 years and with Boehringer Ingelheim since 2003.
Joy’s teams are responsible for overall clinical trial support and the quality of eTMF for inspection readiness.
In addition, her experience includes global TMF governance, global vendor relations and CRO TMF management, white papers on global quality control processes, and regulatory inspection readiness.
Associate Director of Document Management- ADVANCED CLINICAL
JP Miceli – Associate Director of Document Management
JP Miceli is an Associate Director of Document Management for Advanced Clinical. JP started work at Advanced Clinical in September 2018 managing all TMF activities and staff, and supporting business development opportunities, budgeting, and inspection readiness events. Prior to joining Advanced Clinical, JP spent 15 years working with the TMF at sponsor companies including Shire Pharmaceuticals, Vertex Pharmaceuticals and Takeda Pharmaceuticals. JP has been a member of the TMF Reference Model group since 2010, and is currently a member of the Change Control Board, where all suggested changes to the Reference Model are submitted and reviewed. In addition to sitting on the Change Control Board, JP also leads and participates in multiple Reference Model Zone subgroups, and is a member of the Framework for the Destruction of Paper team.
Global Quality Manager- NOVELLA CLINICAL
Pat Miesner – Global Quality Manager
Manager, Clinical Supply Planning and Execution- ELI LILLY
Thomas Miller – Manager, Clinical Supply Planning and Execution
Thomas has over 22 years of experience in various biotech/biopharma businesses in the Midwestern US, Northeastern US, and in Germany – sixteen years focused on Clinical Supply Planning and Execution. He has helped manage, design, and implement clinical supplies and supply plans for all phases of trials and for numerous indications. Thomas also spent six years as a Co-Facilitator, then Course Director, for a non-profit educational organization, providing training on the basics of clinical supplies. Thomas’ background in training, biotech, and vendor relations has given him the diverse perspective and tools needed to find common ground when working with cross functional partners. He has been working on Lilly’s TMF harmonization project for more than two years and looks forward to gaining more expertise in this area.
Owner and Principal Consultant- MULCAHY CONSULTING
Lisa Mulcahy has 25+ year career in the pharmaceutical industry, in the areas of Clinical Operations and Quality Management with specialty in process for the management of records created and maintained in support of the clinical trial process. More than 10 years ago, she became an independent consultant, focusing solely on the Trial Master File management. She has very deep experience assisting clients with assessment and improvement of their current state and associated processes, development of future design, writing of process-related documentation, and implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs.
Lisa is co-founder of the team of industry representatives that created, maintains, and expands the TMF Reference Model and remained its co-leader through 2015. She continues to contribute to the team’s leadership and initiatives as a TMF RM Steering Committee member. Lisa recently lead a team of industry representatives to review and revise the Framework for the Destruction of Paper, v2.0.
Curran Murphy is of has been in the pharmaceutical industry almost 20 years. She began in scientific research and has been in clinical operations for the last decade.
Curran has a passion for operational process improvement. In all of her clinical operations assignments, she has volunteered or been elected as a prominent person to facilitate department process improvements and to make work streams more efficient. Currently, she is the process owner of the Trial Master File Initiative within Cerulean.
Her previous companies include Cerululan Pharma and most recently Syros Pharmaceuticals where she was Associate Director of Clinical Operations. She was also with with Millennium Pharmaceuticals and Alkermes. Curran holds a Bachelor of Administration degree from Syracuse University.
Elisa has been in the pharmaceutical industry for over 17 years and has held a variety of positions implementing and supporting clinical applications on both the Vendor and Sponsor side. Her current role is Senior Information Manager within the Information Management Center of Excellence at Pfizer which includes the responsibility of Business System Owner for the Trial Master File. Elisa is responsible for collaborating with business and technical groups to define requirements and ensure the system meets business needs. In addition, she works to improve new and existing business and support processes in the TMF space. To achieve these goals, Elisa’s team is exploring automation, predictive analytics and artificial intelligence as Pfizer looks to increase quality and gain efficiencies. Elisa has a Bachelor of Arts from the State University of New York at Geneseo.
TMF Operations, Clinical Development Operations Function- DAIICHI SANKYO
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 joined Daiichi Sankyo as the Manager of TMF Operations in 2016.
Laura has become quite an expert in launching eTMF systems over the years and has participated in five eTMF system launches in the past 5 years. She especially likes diagnosing system issues and process improvement. She holds her Masters of Science of Jurisprudence in Pharmaceutical and Medical Device Law and Compliance from Seton Hall Law School.
Senior Director of QA and Compliance- INSEPTION GROUP
Dawn Niccum – Senior Director of QA and Compliance
Dawn Niccum is the Sr. Director of QA and Compliance at the inSeption Group, where she is responsible for all quality and compliance areas for the company including SOP development, deviation & CAPA management, oversight of computer system validation, audit conduct and support, and GxP training. Ms. Niccum has worked in the pharmaceutical industry and with clinical trials for more than 20 years. Starting as a clinical study coordinator, she then moved to monitoring followed by training and compliance. Ms. Niccum holds a Master’s Degree in Regulatory Affairs and Quality Compliance from Purdue University, holds certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP) and Project Management (PMP), and is a registered nurse.
Senior Manager, Clinical Operations- KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
Barbara Novak – Senior Manager, Clinical Operations
KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
Barbara has more than fifteen years of experience in Clinical Development and Clinical Research. She has been at Kyowa Kirin for the past ten years. In her role as Senior Manager in Clinical Operations, Barbara is the regional eTMF business administrator for the US and Europe regions.
She oversees a team of six Clinical Trial Managers and Trial Coordinators in all areas of assigned trial execution, implementation and conduct of open-label and double-blind, randomized multi-center, Global Phase I/II/III oncology and CNS – Parkinson’s disease clinical research trials. Barbara provides training and support to CROs and internal teams world-wide in collaboration with IT and other functions. Barbara collaborates with quality administrators at Kyowa Kirin’s headquarters in Japan to create SOPs that she continues to develop. Her other responsibilities range from site selection, vendor management, and study start-up to achieve successful project delivery. Of late, Barbara was charged with selecting and implementing an eTMF system that satisfied her company’s marketing and business needs.
Barbara’s prior roles have included time as a Clinical Trial Manager at Johnson & Johnson Pharmaceutical Research & Development and Clinical Research Associate at several different companies.
Barbara was also an Adjunct Instructor in Foundations of Clinical Research and Study Design. She received her Bachelor of Science degree from Rutgers University’s Douglas College. Barbara enjoys swimming, biking, gardening and nature.
Sabrina Owens is the US Clinical Trials Administrator responsible for US specific clinical trial documentation knowledge. In this role she has been responsible for review and implementation of working procedures related to US run trials, including specification of the retention of appropriate TMF documentation, and best practices in building TMF matrices and plans. In prior CRO experience, Sabrina became a specialist in eTMF practices and the DIA Reference Model, and works to continually expand and enrich that knowledge.
Senior Manager, Global CTA Management- PHARM-OLAM INTERNATIONAL
Jelena Pavlovic – Senior Manager, Global CTA Management
Being an engineer, Jelena was teaching students applied mathematics and soil mechanics at the University and by pure chance have joined Pharm-Olam more than 16 years ago thinking it will be just for a few months. It turned out it was a destiny and lifetime profession!
Working in a CRO was always very dynamic, starting in a role of Clinical Trial Associate supporting CRAs with the study conduct and TMF maintenance, moving on to the role of the Global Clinical Trial Associate supporting Sponsors and Project Managers in the study conduct and TMF organization on a global study level. As TMF expert and Senior Manager Jelena is currently responsible for organization and resourcing of global clinical administration department, development and improvement of TMF processes to ensure TMF inspection readiness in Pharm-Olam globally which is a big challenge considering Pharm-Olam’s presence in 40 countries across all continents.
Miriam has thirteen years of experience in research with six in the pharmaceutical industry. Prior to joining Mylan in 2013 as a CRA, she worked on investigator initiated trials as a research coordinator for populations with Spinal Cord Injury, Stroke, Upper Extremity Amputation and Traumatic Brain Injury. Currently, Miriam is a Clinical Research Manager and monitor for Phase I BA/BE trials and working to implement eTMF for these.
Miriam holds a Masters degree in Clinical Research Organization and Management from Drexel University and a Bachelors of Science degree in Psychology from Syracuse University.
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.
Advisor, Quality Systems and Compliance Management- ELI LILLY
Minette Pugh – Advisor, Quality Systems and Compliance Management
Minette has 24 years of pharma industry experience, which range from small start-up to large pharma. These experiences span multiple disciplines including QC Laboratories, Commercial Manufacturing QA, Development QA, CT Supply Chain, and Compliance. She is currently managing a group that is focused on compliance related projects and initiatives within the Clinical Supply Planning organization including deviation, Change and CAPA management, Quality systems that manage & support the business, internal/external cGMP & GCP inspection support, and TMF functional harmonization across Lilly.
Mark Romano is an R&D Customer Success Manager for Veeva with a focus on Vault Clinical applications, namely eTMF, CTMS, and Study Startup. Mark is responsible for aligning with customers to promote strategic focus and strong program management, supporting customers through education on new and enhanced Vault functionality, evaluating how customers manage their Vault applications to identify efficiency and effectiveness gains, and guiding customers on industry trends and best practices.
Prior to joining Veeva, Mark worked in the pharmaceutical industry for over 18 years at multiple pharmaceutical companies and contract research organizations. In that time, he held a variety of positions in Clinical Operations – including Clinical Research Associate and Quality Assurance Auditor – and spent more than a decade working in a variety of clinical trial/project management positions, including director-level roles.
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.
Casey joined BD two years ago as part of the Legacy C.R Bard Corporate Clinical Affairs team, and is now part of the BD Global Clinical Development group following the acquisition of Bard in 2017. Prior to joining BD she attended James Madison University in Harrisonburg, Virginia and moved on to work with a mid-size Life Sciences company in their Clinical Operations department. Her current responsibilities range from global eTMF Management, working closely with the clinical study teams to support daily operations, and assisting with eTMF system administrator responsibilities.
Barry Sacks is the Chief Technology Officer at Phlexglobal. Barry was previously 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 organizations through the design, delivery, management and growth 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, was the Global CTO for the FinTech MyJar, the CTO (Corporate Venturing) for Diageo, as well as enjoying a varied interim career.
TMF Project Manager- LMK CLINICAL RESEARCH CONSULTING
Ruby began her career in TMF management in 2005 at a large CRO amidst their global records management centralization project. She has worn many hats during her fourteen year tenure within this specialized field including Subject Matter Expert, Steering Committee Member, Help desk, process developer, systems tester, and trainer. She has been a pilot participant/contributor for three major eTMF upgrades/implementations and has provided training on three continents. She is a Six Sigma white belt and maintains GCP certification. When she isn’t at her computer, she enjoys gardening, crafts, and spending time outdoors with her furkids—a blue heeler named Bandit and a smooth coat border collie who sometimes responds to Mojo.
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.
Regulated Content Management, General Manager and Product Leader- MEDIDATA
Perry Steinberg – Regulated Content Management, General Manager and Product Leader
Perry Steinberg is the General Manager and Product Leader for Edge eTMF and the Regulated Content Management Platform at Medidata Solutions. He has led the business and technology development for multiple products across the Medidata Clinical Cloud, collaborating across tech and the business, focusing on overall platform unification, processes, and quality, as well as the culture of success. He has over 20 years of experiencing leading artifact, document and data initiatives for Fortune 500 companies. Perry holds a BA in economics and computing from UCLA and an MBA in marketing and corporate strategy from the University of Michigan, Ross School of Business.
Mindy Taback is a Clinical Trial Associate (CTA) in the Clinical Operations division at Aerie Pharmaceuticals, Inc. Mindy is part of a core team, responsible for supporting the Clinical Trial Managers and study teams in the administration of clinical trials. Prior to joining Aerie, Mindy spent more than 20 years at Schering Plough, where she started as an administrative assistant, moved on to become a Clinical Documentation Specialist, responsible for the review and processing of all CRF/TMF documents across therapeutic areas, and then became a training coordinator. She earned her bachelor’s degree in Education from Kean University.
Laura joined Xcovery in May 2018 as the companies first Trial Master File (TMF) Manager. She works closely with the internal clinical team and vendors to ensure the integrity of the clinical TMF’s. Prior to Xcovery, Laura helped pilot a new TMF Quality department at IQVIA which is still thriving today. Laura holds a Bachelor’s of Science in Respiratory Therapy from the University of Kansas Medical Center.
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.
Senior Manager, Process, Training and Compliance- TAKEDA
Melissa Umbehauer Chiasson – Senior Manager, Process, Training and Compliance
Melissa Umbehauer Chiasson is a Senior Manager within Clinical Development Services at Takeda Pharmaceuticals. Melissa has over 10 years of experience in the pharmaceutical industry. In her current role, Melissa leads Trial Master File (TMF) strategy, oversight and inspection readiness. She was the business lead for the Takeda eTMF implementation and has led TMF readiness for MHRA and FDA GCP inspections. In addition, Melissa works with Takeda’s CRO partners to develop and implement TMF Strategy Plans that outline standards and serve as the foundation for TMF inspection readiness with our partners. She also serves as the subject matter expert for TMF acquisitions and divestures. Prior to her current role within Clinical Development Services, Melissa has held various leadership roles ranging from implementation of a clinical trial management system and end user support model to providing management for a global clinical operations study support team primarily focused on TMF oversight. Melissa holds a Bachelor’s degree in Business Administration from Rowan University and a Master’s degree in Leadership from Northeastern University.
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.
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.
Senior Director GCP, Compliance Operations- CLOVIS ONCOLOGY
Michele Weitz – Senior Director GCP, Compliance Operations
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.
Debra Wells is a manager in the TMF Compliance group at Eisai. Previously, Debra was a Senior Project Manager and Program Manager at Bayer where she led the eTMF implementation and the associated integrations. Debra has over 15 years of experience delivering IT solutions in pharmaceutical companies, including Johnson and Johnson, Roche, Novartis and Allergan. Before entering into the pharmaceutical industry, Debra was a co-founder and owner of a private software development firm specializing in manufacturing. She has recently joined the Reference Model team as a contributor to the Exchange Mechanism.
Karen Whitson – Assistant Director, Clinical Documentation Center
Karen Whitson is an Assistant Director of the Clinical Documentation Center at AbbVie Inc. She has 29 years of clinical Trial experience which includes areas of data management, system configuration, and project management. Her current responsibilities include leading the Clinical Documentation Centers Operations Team. The team responsibilities include identifying and implementing enhancements to the functionality of AbbVies eTMF. Karen has been working as an eTMF subject matter expert at AbbVie Inc since 2016.
Robert has been with Merck for over 17 years with 15 years focusing on IT architecture and delivering enterprise content management solutions supporting R&D and Quality processes. Over these years, he has witnessed the industry transition from custom legacy solutions to the latest generation of solutions that are built for scale and rapid implementation. He is focused on bridging the gap between business value realization and the exponential rate of changing technology. He is currently leading the R&D IT Cyber Resiliency program where his team focuses on implementing emerging technologies to ensure the availability, security, and integrity of mission-critical data.
Head Site Management, NA, Acquisition Integration and Clinical Records Management- ALLERGAN
Alana Wriggins – Head Site Management, NA, Acquisition Integration 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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