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.
Liz is a Manager within in the TMF organization at Biogen and currently manages the TMF process for phase I-IV trials to ensure ongoing TMF quality and compliance across the organization. During Liz’s three years at Biogen, she has supported numerous regulatory inspections from a TMF perspective, has supported a growing TMF metrics program and has worked cross-functionally on TMF management with CROs. 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.
Renee Fate – Director, Clinical Records Management
Renee Fate has more than 13 years of clinical record management experience. At Allergan, she leads the TMF Compliance Specialists team responsible for providing program-level support to ensure compliance with global TMF standards and internal processes. She collaborates with TMF stakeholders to integrate inspection readiness activities into daily processes. Prior to Allergan, Renee worked at Kythera Biopharmaceuticals and Amgen specializing in TMF compliance, inspection readiness, and transitioning paper-based TMFs to be eTMFs.
Laura Forcade – Clinical Trial Master File Specialist
Laura has a broad background and expertise with GxPs from her 20 years’ experience in the pharma/biotech industry, including regulatory Inspection experience for GMP and GCP. In her current role as Clinical Trial Master File Specialist, Laura is responsible for maintaining eTMFs for multiple global clinical trials. She also led the study team’s implementation of the Electronic Document Management system. She continues to provide systems support for cross-functional teams.
Prior to working at Alexion Pharmaceutical, Laura held Scientist/QA and Medical/Regulatory Affairs SOP Manager at Boehringer Ingleheim.
Director, Head of TMF CoE
The Janssen Pharmaceutical Companies of Johnson and Johnson
Shayna Lambert – Director, Head of TMF CoE
The Janssen Pharmaceutical Companies of Johnson and Johnson
Jennifer Maier – Associate Director, R&D Quality Compliance
Jen has worked in the pharmaceutical industry since 2006 and is an Associate Director in the Research & Development Quality Compliance division of Alexion. Jen provides quality oversight for activities relating to pharmacovigilance, regulatory, and medical. Jen has led teams responsible for creating and implementing processes for TMF Safety Documentation, process improvement initiatives and training compliance. Jen’s experience within industry includes pharmacovigilance compliance, auditing, case processing, and patient support program delivery, design and compliance oversight. Jen’s 13 years of medical experience includes orthopaedics, pediatric – outpatient, urgent care, intensive care, transport and emergency care, and pediatric endrocrinology clinical trials.
Jen has a BS and AS in Nursing from Indiana University Purdue University of Indianapolis. She is a Multiple Sclerosis Certified Nurse. Jen is Green Belt certified and holds a DIA Certification in Clinical Safety & Pharmacovigilance.
Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner for eTMF implementation across the organization. In this capacity, she interacts with internal senior level management, external vendors, collaboration partners, clinical study and other internal personnel to ensure compliance with regulations, Regeneron business practices and clinical research program objectives.
Prior to March 2017, Joanne was the Director of Medical Research Process Management at Purdue Pharma where she was responsible for research quality, data integrity and continuous improvement in clinical research. She was also responsible for the Trial Master File and FDA submission and inspection readiness beginning in 2008. She and her team worked with a TMF vendor and successfully implemented an eTMF based on the industry standard Reference Model which is currently used by the internal teams and CROs. As part of her inspection readiness responsibilities, she has been actively pursuing quality improvements in site preparation and the TMF. Joanne also has expertise in implementing computerized systems and computer system validation and served on the core committee for DIA’s Peach initiative in 2009 which published Computerized Systems In Clinical Research: Current Data Quality and Data Integrity Concepts
Lisa 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 process. 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.
Kate has worked in the biopharmaceutical industry for 20+ years. In her role as Senior CTA – Clinical Systems, Kate manages the TMF process as well as clinical trial disclosure. Kate recently managed a full-scale project to revamp Alkermes’ TMF processes, including adopting the DIA Reference Model and moving into an electronic TMF. This is Kate’s third TMF Summit.
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
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.
Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She joined Daiichi Sankyo in February 2016 after working at a CRO for 8 years within the Trial Master File space.
Ms. Toth is a Steering Committee member for the DIA TMF Reference Model Working Group and on the Board for the Scientific Archivist Group (SAG) as well as on the SAG-GCP Executive Board.
Ms. Toth is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified. She received her Master’s Degree in Clinical Research & Organizational Management from Drexel University, a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and has an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College. In her spare time, she enjoys family time and watching her kids play soccer, basketball and football.
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.