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, Clinical Document Management, Inspection Readiness and Trial Support- TAKEDA
Wendy Beeby – Director, Clinical Document Management, Inspection Readiness and Trial Support
Wendy Beeby is Director of Clinical Document Management, Inspection Readiness and Trial Support at Takeda, responsible for the strategic direction of clinical document management, Trial Master File and Trial Support working in collaboration with functional leads to implement effective inspection readiness and support plans.
With a career of over 25 years working in the pharmaceutical industry, Wendy has enjoyed building customer focused teams which provide expert guidance and support on trial support, records management and inspection preparedness.
In collaboration with TMF expert vendors, Wendy has developed innovative models for TMF quality review which can adapt quickly to fast growing organization. Having implemented eTMF, she more recently focused on an eTMF migration solutions to support outsourced trials. Wendy has enjoyed working with core team experts in company acquisitions and has implemented strategies for the integration of clinical records, systems and teams.
Senior Manager, Audit and Inspection Readiness, Specialty Clinical Development and Global Medical Affairs- TEVA
Tatsiana Brady – Senior Manager, Audit and Inspection Readiness, Specialty Clinical Development and Global Medical Affairs
Kristen Bretzius has worked for 20 years in the pharmaceutical industry. She presently serves as the Manager, Trial Master File Governance within Teva’s Specialty R&D Systems and Standards Group, working with internal stakeholders to produce compliant, consistent and inspection ready Trial Master Files. She also brings 14 years of CRO experience which includes oversight of global TMFs in multiple TMF systems. She’s 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. She is a recognized expert in the field of clinical Trial Master Files specializing in finding client orientated solutions to risk management and compliance in a global environment.
June is an experienced professional with 15+ years of global research experience and knowledge of both Pharmaceutical and CRO environments. She began working in GMP and GLP labs, then moved into GCP Quality Assurance as a Document Manager and GCP Auditor. In her current role as Director of Clinical Operations at TESARO, she provides program-level oversight and leadership for the portfolio of ovarian oncology trials. Also in this role, June oversees the eTMF and has successfully implemented changes in management of related systems and personnel.
June received an MBA and attained ASQ CQA certification while working as a GCP Auditor.
Deborah Castellana is Associate Director, Regulatory Affairs at Celgene, a Bristol-Myers Squibb company responsible to work with cross-functional colleagues on operational standards and processes related to TMF such as quality goals, oversight methods, good document management practice and the approach to TMF Plans and Indexes. Deborah acts as the company TMF Archivist for paper and electronic records. In this position, Deborah works closely with the CRO partners on TMF Strategic Plans to ensure a robust, collaborative approach to planning, managing, closing out and archiving TMF documents is in place.
Prior to joining Celgene, Deborah provided TMF Consultancy to pharmaceutical companies working with integration experts on the migration and archiving of TMF documents and systems in company acquisitions. At Novartis, Deborah managed the business, strategic and operational activities for a global clinical document management team for over 10 years.
Jessica Chamberlain – Records Analyst, Central Medical Files
Jessica has worked in clinical research specializing in the Trial Master File for 7 years. She participated in transitioning her organization from a paper based TMF model to an eTMF model utilizing the Framework for the Destruction of Paper. She has additional experience in aligning to the TMF Reference Model and implementing a new eTMF system within her organization. In her role as Records Analyst she generates metrics for the management of TMF quality and productivity, and currently leads an effort to outline a risk based approach to TMF Reconciliation to further support inspection readiness.
Jessica is a member of the TMF Reference Model group and contributed to the User Guide sub-group and deliverables. She holds her Master's degree in Library and Information Sciences from the University of Illinois. She has attended the TMF Summit in the past, and this is her first year presenting.
Dorte Christiansen – Competency Development Specialist
In her capacity as Competency Development Specialist at Novo Nordisk, Dorte is responsible for the technical and process matters related to Novo Nordisk’s eTMF implementation, including migration of several million trial master file documents. Previously she was Systems Support Specialist at Novo Nordisk until October 2018. Prior to joining Novo Nordisk, Dorte was Principal Consultant at NNIT A/S. Dorte has years of hands-on experience with trial master files and has gained her process insight from working in trial management on large multinational trials. Dorte has a broad project experience, working both with TMF process optimisation, change management and eTMF system implementation. Dorte has been involved in the TMF Reference Model in various working groups. Supplementing her process knowledge, Dorte also has hands-on experience with different eTMF systems and takes a keen interest in bridging the business requirements with the supporting IT system.
Manager, Regulatory TMF- BIOGEN
Dawn Clowes – Manager, Regulatory TMF
Global Head of Clinical Quality and Compliance- ASTRAZENECA
Grace Crawford – Global Head of Clinical Quality and Compliance
As the Global Head of Clinical Quality & Compliance, Grace is accountable for the development, implementation, maintenance and adoption of quality management services for Development Operations, R&D. Grace has extensive experience leading global teams accountable for quality management systems, compliance, and delivery of high quality, GCP inspection ready clinical studies. She is passionate about creating a quality mindset and raising awareness to make a positive impact to the quality culture in organizations. Before the AstraZeneca re-organization in 2019, Grace was the head of Clinical Quality & Compliance at MedImmune (the Biologics science unit within AstraZeneca) since April 2015 responsible for supporting the Clinical Biologics department. 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, often chairing or presenting at conferences, and participates in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium, and Linking Leaders Clinical “Quality” Roundtable discussion.
Associate Senior QA Consultant, QA-Product Research and Development- ELI LILLY
Sonja Davis – Associate Senior 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.
Brian has spent 23 years in clinical research, working at CROs, Biotech and Medical Device companies. He began his career as a CRA before advancing to monitoring management, then study and program management. In addition to managing multi-national studies, Brian has a firsthand perspective on the global nature of clinical trial operations, having lived and worked in Europe, Canada and now the United States. He is a native of the city of Liverpool, UK and a graduate of Brunel University, London, UK. He currently holds the position of Clinical Affairs Director at Endologix, Irvine, CA. Where he is responsible for Abdominal Aortic Aneurysm global clinical operations. Brian is an enthusiastic advocate of TMF and has extensive experience in the implementation and operation of the eTMF systems.
Clinical and TMF Operations Manager- TG THERAPEUTICS
Ashlyn Deshaies – Clinical and TMF Operations Manager
Ashlyn Deshaies serves as the Clinical and TMF Operations Manager at TG Therapeutics overseeing the planning and execution of TMF processes, quality reviews, and TMF scoped deliverables. Ashlyn has driven implementation TMF maintenance guidelines based on the 'three Es,' essential, effective, and efficient processes. The development of these processes has allowed for the implementation of measured quality reviews and further standardization in TMF processes and outsourced TMF oversight.
In addition to TMF management, Ashlyn also leads a team of study start-up and maintenance specialists giving her a unique viewpoint as both a functional group owner and TMF owner. This viewpoint has allowed her to develop successful methods to drive TMF contribution and completeness across other functional groups.
Prior to her current role, Ashlyn worked as a Site Regulatory Manager at TG Therapeutics and Research Assistant at Duke Family Medicine and Community Health.
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.
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 35 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.
Director, Clinical Documentation Center, Strategic Clinical Operations- ABBVIE
Renee Garrett – Director, Clinical Documentation Center, Strategic Clinical Operations
Renee started her career at Abbott Laboratories and continued with AbbVie after the separation in 2013. Over the years she held various positions in Clinical Operations and Project Management across several Therapeutic Areas, with experience spanning early to late stage drug development. A few years ago, Renee transitioned from the clinical operations area into a direct leadership role for a functional area, managing a global team of 100+ individuals responsible for AbbVie’s clinical documentation. Since taking over responsibility of the Master Files, she has redefined how AbbVie handles clinical documents and conducts TMF oversight. Renee and her team have implemented many enhancements to their eTMF system and have significantly improved stakeholder engagement. These efforts have impacted the R&D organization’s culture to think about the TMF as a study management tool versus a document repository. Renee actively participates in agency inspections as the Business Process Owner for all things related to Artifact Management. This year she is a co-lead of AbbVie’s cross-functional “Inspection Readiness” efforts.
Renee has over 28 years of pharmaceutical industry experience, primarily in planning and executing clinical trials and project management of Therapeutic Area clinical programs. She has a Bachelor’s degree in Finance.
Gillian is responsible for accelerating value for IQVIA content management customers and ensuring an exceptional experience, while driving retention and growth for the business. Gillian works with customers to develop and redefine business processes to align with the implementation and use of Wingspan-developed applications. With over 20 years TMF and eTMF experience in Operations, Project Management, Business Development and Marketing; across a wealth of systems and companies, Gillian has worked with the TMF Reference Model since its inception including a spinoff initiative on paper destruction. She has presented at conferences, written articles and authored whitepapers as a TMF SME.
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.
Nick Hargaden – Associate Director, Clinical Systems
Nick Hargaden is Associate Director, Clinical Systems at Agios Pharmaceuticals. In his current role he has responsibility for managing clinical operations system selection, implementation and support including eTMF, IRT, operational data reporting and portfolio resource planning. Nick has worked in the application of software technology in clinical trials since 1998 at CRO, eClinical vendor, and sponsor organizations. He has held leadership positions with global responsibilities in operational, business development, and quality management functions. He ran his own consulting practice and cofounded, built and sold Algorics, a data analytics software company.
Clinical Trial Coordinator- DUKE CLINICAL RESEARCH INSTITUTE
Etienne Hinton is a Clinical Trials Coordinator at Duke Clinical Research Institute. He has been in the clinical research industry since 2007. He has worked at CROs, Quintiles and Health Decisions, and has been at an ARO, the DCRI for the past 5 years. His focus has been the SharePoint Electronic Trial Master File. He has created classes, conducted training, and provided hands on guidance in use of the SharePoint TMF. Most recently, he has been assisting with implementation of the Phlexglobal TMF solution for DCRI, PhlexEview.
Administrative Director, Center for Clinical Research- TEXAS HEART INSTITUTE
Aryn Knight – Administrative Director, Center for Clinical Research
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.
Hobson Lopes is currently the Manager of the Clinical Archive at Regeneron Pharmaceuticals and primarily focuses on the storage paper and electronic TMF records and TMF inspection preparation. Prior to coming to Regeneron, he worked in the TMF group at Boehringer Ingelheim. He has 8+ years’ experience in document management and is a member of several industry groups including the TMF Reference Model and HSRAA, where he serves on the operating committee as the Finance Coordinator.
Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations- PHARMACYCLICS
Alex Markiel – Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations
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.
James E. Martin leads the TMF Quality, Governance and Compliance departments within the TMF Business Unit at Syneos Health, a leading Top 3 CRO. Since graduating in Biomedical Science, James has accrued over 11 years of industry experience across multiple organisations and fields including Pre-clinical, Process Optimisation, Clinical Project Management, and most recently Trial Master File. This breadth of experience enables him to view challenges from a variety of perspectives in order to develop new and innovative solutions. While working in TMF, he has touched almost all aspects of the function, and is currently focused on supporting internal and external inspection readiness.
James is inspired every day by the impact his team and the wider industry have on helping those in need to get and stay healthy, a passion he takes into his personal life through an avid interest in personal fitness and regular participation in sponsored charity events.
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.
Product Delivery Consultant - Design Hub- ELI LILLY
Thomas Miller – Product Delivery Consultant - Design Hub
Thomas has approximately 25 years of experience in various biotech/biopharma businesses in the Midwestern US, Northeastern US, and in Germany – most of that time 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 has a 25+ year career in the pharmaceutical industry, primarily in the areas of clinical operations and quality management. Over 10 years ago she became an independent consultant, focusing solely on TMF process and management assisting biopharmaceutical R&D companies large and small with the assessment and improvement of their current state, establishing process where there is none, improving process to align with current standards, and the selection-implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs. She is a frequent speaker and experienced, accomplished workshop/course leader at TMF-related professional meetings.
Lisa is co-leader, with Karen Roy of Phlexglobal, as well as a Steering Committee member of the volunteer team of industry representatives through the DIA that created, maintains and expands the TMF Reference Model. She is the Chairperson of the DIA Document & Records Management Community.
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.
Laura Naranjo – Associate Director, TMF Operations
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.
Practice Head — Life Sciences- PHARMA TEK SOLUTIONS
Vinay is an accomplished leader with 20 years of diversified experience in Life Sciences IT with extensive functional and technical expertise in R&D, Manufacturing and Quality functions. His vast experience includes providing IT strategic consulting in Pharma industry in the areas of cloud infrastructure, clinical operations, data management, GxP systems implementation through risk-based approach.
He began his career as software test engineer and transitioned into CSV engineer role and worked for Genentech, Gilead and major biotech companies in San Francisco Bay Area. In 2017, Vinay founded Pharma Tek Solutions. He leads both on-shore and off-shore teams that provides validation managed services. He is an experienced CSV auditor and completed multiple audits with focus on implementing IT/GCP processes, Information Security and Infrastructure Qualification. His experience includes qualifying emerging cloud-based technologies, Software as a Service (SaaS) applications, infrastructure, enterprise applications and system integrations.
Senior Director, Head of TMF and Registry Operations- PFIZER
Marie-Christine Poisson-Carvajal – Senior Director, Head of TMF and Registry Operations
Marie-Christine Poisson-Carvajal is the Head of TMF & Registry Operations and the TMF Business Process Owner at Pfizer. She has been in the TMF space since 2011. 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 35 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.
Lori Ridge has 20 years of Pharma Industry experience. With a background in Nursing, she was a Site Clinical Research Coordinator for 10 years before moving into the CRO industry as a Regulatory Officer, Sr. CRA, Sr. and now a TMF Expert. Her Therapeutics areas range from Phase I, II & III — Asthma & Allergy, Cardiology, Endocrinology & Oncology.
Lori began her career at the Texas Heart Institute as a Research Coordinator for the Cardiovascular Anesthesia Research Intensive care unit. She then took several contract positions as a research coordinator in the Texas Medical Center. After 10 years, she moved into the CRO industry starting as a document specialist and quickly finding herself as a Sr. Regulatory Officer for US Oncology located in Houston, TX for Phase I — Therapeutic Oncology Products Program. Escalating into a CRA role, she found her place as an in-house CRA specializing in TMF SWAT & Rescue with Pharm-Olam International located in Houston Texas.
Currently, Lori capacitates as a contract rescue TMF Expert for CROs and Sponsors worldwide by implementing processes for TMF oversight, metrics for completeness, risk mitigation, and inspection readiness. She has assisted design teams for major eTMF system vendors with the five main phases of the system(s) validation process. Lori has vast experience with Sponsor TMF Audits as well as Sponsor Site Audits. By experiencing and hosting over 22 TMF-focused FDA Audits and remotely hosting two EMEA TMF-focused audits, her experience and expertise in the industry are well received.
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.
Jay Russak, MBA is currently a Clinical Team Lead at Dicerna Pharmaceuticals where he is primarily focused on clinical development strategy, trial design, and execution. Together with the team, he is also heavily involved in clinical vendor selection and management of a clinical stage program in a rare disease. Jay has over 12 years of experience in the field of clinical research, nine of which have been spent directly managing clinical trials in small and large biotechnology companies. He has experience planning for and being a part of FDA, MHRA, and EMA inspections. Before his current role with Dicerna, Jay held roles of increasing responsibility at Finch Therapeutics (Somerville, MA), Sage Therapeutics (Cambridge, MA), Biogen (Cambridge, MA), and Dana-Farber Cancer Institute (Boston, MA). Jay has a BS in Biology from Northeastern University, MA in Medical Sciences from Boston University School of Medicine, and a MBA from Worcester Polytechnic Institute.
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.
Director, Clinical Design, Delivery and Analytics- ELI LILLY
Nicole Sheetz – Director, Clinical Design, Delivery and Analytics
Nicole Sheetz serves as a Director at Lilly within the Clinical Design, Delivery and Analytics organization where she is the Global Process Owner for the Trial Master File and Records Management and serves as the System Owner for Vault Clinical (eTMF, Study Start-Up, and Global Directory). She has nearly 20 years of experience including clinical development operational leadership, business and IT solutions, and complex internal and external global communication and change management strategies. She serves on multiple external boards and committees including both pharma and non-profit sectors, each focused on patients, caregivers, health care providers, innovation, and/or creativity. Nicole holds a PharmD from the University of North Carolina.
Supriya Shoroff is a subject matter expert and Clinical Documents Manager at MediVector Inc. based in Boston.
Supriya oversees the TMF operations in-house and the CRO’s management of eTMFs. Supriya has successfully implemented the electronic Trial Master File solution at MediVector and is the TMF process owner.
Currently, Supriya is working on data migration projects and leading the migrating effort of about 200,000 + documents into the new eTMF solution.
Trial Master File and Institutional Review Board Specialist- PATH
Shannon Simpson is currently responsible for the development, implementation and management of the Trial Master File (TMF) system for clinical trials performed by the PATH Office of Essential Medicines, a global nonprofit dedicated to research in vaccines for the developing world. She has led the transition from maintaining TMFs in a homegrown system to managing TMFs in a recently acquired eTMF application. Shannon has spearheaded the advancement of in-house TMF operations for the past 5 years. Prior to that, she spent 4 years leading institutional IRB compliance with PATH’s Malaria Vaccine Initiative, which partnered with GSK in developing the world’s first malaria vaccine.
Jay Smith – Senior Director, Product, Trial Interactive
Jay Smith is Head of Product for TransPerfect’s Trial Interactive E-Clinical platform. Jay brings 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. Previously, Jay has led product efforts for Medidata, Sparta Systems, Cureatr, VenueNext, Apogy, and Liquent. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College.
Joaquin Sosa has 18 years of clinical research experience: 7 years at clinical research organizations (CRO) as a Clinical Research Associate (CRA) for Phase I-IV studies, 3 years in Technical Operations at the Phase I site/CRO level, and 1 year of experience in an acute care, clinical setting (Intensive Care Unit). Additionally, he has 5 years of experience in clinical and corporate operations management at the site level, and 3 years of experience as a Project Manager at the CRO level. Most recently, he is in a leadership role within the Syneos Health TMF Operations department as a Director.
Joaquin has significant regulatory and data management experience, at the CRO level via monitoring, project management, and as a director in a functional department, and through management of the regulatory and data management departments at the site level.
Joaquin holds an Associates of Applied Science: Nursing, a Bachelors of Arts: Business Administration, and a Masters in Business Administration, and resides in Austin, TX.
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.
GM & VP, Product- MEDIDATA, a Dassault Systèmes company
Perry Steinberg is the General Manager and Vice President Product at Medidata Solutions. He has led the business and technology development for multiple products across the Medidata Clinical Cloud while collaborating across tech and business to improve the market offering for the platform, to improve processes and to develop a culture of success. He has over 20 years of experience leading payment processing, regulated content and eTMF 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.
Kyle Stephenson is a clinical product manager for Veeva, dedicated to delivering features and functionalities to enhance eTMF, Study Start-up, CTMS, and CRO processes.
Kyle first decided to join the software industry after working with the Veeva Vault eTMF application at Johnson & Johnson. After spending many years implementing Veeva’s Clinical Suite as a consultant, Kyle made the transition into product management.
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.
Former Director TMF Operations, Inspection and Strategy- JUST IN TIME GCP
Wendy Trimboli – Former Director TMF Operations, Inspection and Strategy
JUST IN TIME GCP
Wendy has extensive pharma experience in clinical research and operations with expert knowledge of the end-to-end drug development process and current regulatory authority requirements in a global environment. She has facilitated cross-functional teams, project teams and process improvement initiatives utilizing lean six-sigma methodology. She is a Steering Committee member of the DIA TMF Reference Model working group and has presented at numerous conferences internationally.
In her current role at Just in Time GCP, she provides leadership in areas of TMF Management, Inspection Readiness, and Organizational Strategy, managing the TMF and Inspection Readiness Leads. She also serves as a company subject matter expert in areas of inspection readiness and TMF management, conducting continuous improvement activities of both systems and operational processes that support company services.
Director, Central Medical Files- ASTELLAS
Allison Varjavandi – Director, Central Medical Files
Principal Competency Development Specialist- NOVO NORDISK
Anne-Mette Varney – Principal Competency Development Specialist
Anne-Mette is TMF process and product owner at Novo Nordisk where she is responsible for building the TMF maintenance organisation in a global environment and for driving the TMF strategy and collaborate cross functional. Anne-Mette is currently responsible for roll-out and onboarding new studies in a brand new eTMF system. Anne-Mette has been 20 years in the pharma industry. The past 8 years dedicated to TMF where she has been project manager in multiple TMF projects with the aim of improving and optimising the TMF process and system, centralised TMF quality control and oversight and inspection readiness. As background Anne-Mette holds a bachelor in nursing and worked as a nurse for several years before moving to pharmaceutical industry.
Associate Director, TMF Compliance and Education- ALEXION
Stephanie Viscomi – Associate Director, TMF Compliance and Education
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.
Sr. Manager, Global Regulatory Systems and Process Management- EISAI
Debra Wells – Sr. Manager, Global Regulatory Systems and Process Management
Debra Wells is a Sr. manager in the Global Regulatory Systems and Process Management Group at Eisai, working closely with the TMF Management group. 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.
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.
Senior Business Analyst, TMF Operations- DAIICHI SANKYO
Keith Win – Senior Business Analyst, TMF Operations
Keith has worked at Daiichi Sankyo Inc for over two years. Prior to DSI, Keith worked for Janssen R&D. At DSI, Keith is responsible for managing eTMF Vault system enhancement projects, business analysis, and data analysis of eTMF metrics.
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