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.
Director, Regulatory Affairs – Regulatory Systems Strategy
Andy Chu – Director, Regulatory Affairs – Regulatory Systems Strategy
Vice President, Product Management
WINGSPAN TECHNOLOGY, AN IQVIA COMPANY
Kathie Clark is Vice President of Product Management for Wingspan Technology, Inc. She oversees the development of the Wingspan eTMF and other Wingspan products servicing the Life Sciences and Pharmaceutical industries. She has more than 20 years of experience in product management, business development, marketing, business analysis, project planning and management and solution/product design and development. Kathie has worked with more than 80 pharmaceutical, biotech, CRO and medical device organizations in the US, Europe, Japan and Israel. Her areas of expertise in life sciences content management include Clinical, Quality and Manufacturing, Regulatory Affairs & Submissions, and Legal Contract systems. Most recently at Wingspan, she has driven the design of the latest generation eTMF solution, which focuses on bringing transparency, insight and efficiency to all types of eTMF users. Previously, Kathie served as Director of Product Management at NextDocs, where she was responsible for the product strategy and roadmap for regulatory and quality products. She previously served as Director of Professional Services at GlobalSubmit working with the FDA to implement eCTD validation rules. Before that, she was a Director at First Consulting Group, where she was instrumental in the development of the suite of FirstDoc solutions and their delivery to dozens of clients, in addition to building and managing the Life Sciences Subject Matter Expert/Business Analyst practice. She is the author of many white papers, blog posts and presentations on content management for eTMF, regulatory and quality systems.
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
Sheryl Crean – Director Quality Assurance Strategic Advice- Science Unit QA, GCP and PV
QA Consultant, QA-Product Research and Development
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.
Elias Dorfman is the Headquarters Clinical Quality Manager leading ID & Vaccines at Merck & Co., responsible for implementing risk based quality management via development of Risk Assessments and implementation 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.
Elias has over 20 years experience in various aspects of the pharmacuetical industry, including pharmaceutical, biotech and CRO. During that time he has held clinical operations roles as CRA, Project Manager as well as Clinical Quality Management roles at the Country-level and now within Headquarters operations. Elias has supported numerous inspections at clinical investigator sites and Sponsor during that time. In addition to clinical research-related roles Elias also has extensive experience in bioanalytical assay development and validation (HPLC, LC/MS, GC/MS), and in computer systems validation and implementation of computerized systems in the laboratory setting.
Elias earned a degree in Biochemistry from Concordia University in Montreal, Quebec (Canada) and is a PMP-certified Project Manager.
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 joined the pharmaceutical industry seventeen years ago working first in the Clinical Quality Assurance department at Schering AG in Berlin and then in clinical project management at Bayer. In January 2015, she was assigned as Clinical Project Leader for eTMF implementation and maturation. Martina is now Systems Excellence Project Leader and eTMF Process Owner Representative.
Senior Director, Content Management and Authoring
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.
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.
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.
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 TMF models from document processing in paper TMF, to people management, and system oversight 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.
Senior Manager, Clinical Documentation
Nela Hayes – Senior Manager, Clinical Documentation
Director, Clinical Operations
Victoria Ho – Director, Clinical Operations
Senior Manager, Process, Training and Compliance
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 – Center for Clinical Research
TEXAS HEALTH INSTITUTE
Aryn Knight – Clinical Research Oversight Specialist; Assistant Administrative Director – Center for Clinical Research
TEXAS HEALTH 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.
Senior Clinical Research Coordinator
ROWE NEUROLOGY INSTITUTE
Leigh Kreshel – Senior Clinical Research Coordinator
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.
Director, Clinical Operations, Head of Clinical Document Control
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 is currently working on the implementation and rollout of an eTMF program at a local biotech as well managing a TMF team in the effective and efficient archiving 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
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.
Manager, Clinical Supply Planning and Execution
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.
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.
Senior Information Manager
Elisa Murphy – Senior Information Manager
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 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.
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.
Senior Manager, Clinical Operations
KYOWA KIRIN PHARMACEUTICAL
Barbara Novak – Senior Manager, Clinical Operations
KYOWA KIRIN PHARMACEUTICAL
Barbara has more than fifteen years of experience in Clinical Development and Clinical Research. She has been at Kyowa Kirin for ten years. In her role as Senior Clinical Trials Manager in Clinical Operations, Barbara is the regional business administrator for the US and Europe. She manages 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 trainings and support to CROs and internal teams world-wide in collaboration with IT and other functions. Barbara worked with 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, study start-up to 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 in included Trial Manager at Johnson & Johnson Pharmaceutical Research & Development and Clinical Research Associate at several other companies.
Barbara is also an Adjunct Instructor in Foundations of Clinical Research and Study Design. She received her bachelors of science from Rutgers University’s Douglas College. Barbara enjoys swimming, biking, hiking, gardening and nature.
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
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 graduated as a pharmacist in South Africa and entered the life science industry working for Eli Lilly. In 1992, she moved into clinical research in the UK with Chiltern International, initially managing the Clinical Development Department across Europe. Latterly she started and globally managed a novel group, EDC Solutions.
In 2007, Karen joined Phlexglobal as Chief Business Development Officer and in 2015 she moved into the role of Vice President, Client Solutions. With her clinical and EDC background, Karen has also taken on a lead role in Phlexglobal’s electronic Trial Master File initiative, to promote, develop and implement support of Client eTMF systems as well as Phlexglobal’s eTMF Solution – PhlexEview.
Karen’s most recent role is that of Chief Strategy Officer where she is focussing on the strategic priorities for the company. Karen focuses on four key areas, being Key Clients, CROs, TMF Expertise and PhlexEview eTMF, in order to support the continued strong growth of Phlexglobal.
Karen also co-chairs the TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files.
Clinical Trial Document Specialist, Global Clinical Development
Casey Ryan – Clinical Trial Document Specialist, Global Clinical Development
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 Interim Chief Technology Officer at Phlexglobal. Barry is a Partner within Digital Works Group’s Product, Project and Technology team bringing over 25 years of experience leading a variety of start-up, SME, and blue-chip organisations through the design, delivery and management of innovative digital products and services. An accomplished technology entrepreneur, corporate director and consultant having worked throughout the UK, Europe, Australia and the US.
Prior to Digital Works Group, Barry founded a SaaS venture, Homes and Rooms, was the Global CTO for the consumer lending FinTech MyJar (based in Estonia), the CTO (Corporate Venturing) for Diageo and has since enjoyed a varied interim career. He has a B.Eng with honours in Software Engineering for Real-Time Systems from Anglia Ruskin University, Cambridge.
Bryan Souder is Director, TMF Head at Merck & Co., INC., USA. He has a BS from Radford University, a Six Sigma Greenbelt, and 22 years of clinical trial research experience. His current focus is being TMF Head. Prior to leading the department Bryan was the eTMF “Global Implementation Lead” Merck & Co., Inc. He has conducted eTMF application & process training in 18 countries and has hosted multiple sponsor inspections.
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 Tenbrink – TMF Manager
Director and Head of TMF Operations
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She has been with Daiichi Sankyo, Inc. since 2016 as the Director/Head of TMF Operations; prior to that, she worked at Covance for 8 years within the Trial Master File space.
Ms. Toth is a Steering Committee member on the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA).
Ms. Toth is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified. She received her Master’s Degree in Clinical Research & Organizational Management from Drexel University, a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and has an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College.
In her spare time, she enjoys family time and watching her kids play soccer, basketball, and football.
Senior Manager, Process, Training and Compliance
Melissa Umbehauer Chiasson – Senior Manager, Process, Training and Compliance
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
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.
Assistant Director, Clinical Documentation Center
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.
Merck Research Labs IT
Robert Willis – Merck Research Labs IT
Head Site Management, NA, Acquisition Integration and Clinical Records Management
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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