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.
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.
Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner for eTMF implementation across the organization. In this capacity, she interacts with internal senior level management, external vendors, collaboration partners, and clinical study and other internal personnel to ensure compliance with Regeneron business practices and clinical research program objectives.
Prior to March 2017, Joanne was the Director of Clinical Research & Development Process Management at Purdue Pharma she was responsible for research quality, data integrity and continuous improvement in clinical research. At Purdue Pharma, she was responsible for the Trial Master File and FDA submission and inspection readiness beginning in 2008. She and her team worked with a TMF vendor and successfully implemented an eTMF based on the industry standard Reference Model which is currently used by the internal teams and CROs. As part of her inspection readiness responsibilities, she has been actively pursuing quality improvements in site preparation and the TMF.
Joanne received her bachelor’s degree from Notre Dame College in New Hampshire and went on to get her master’s in microbiology from the University of Connecticut in Storrs. Additionally, she attended Lesley College in Cambridge, MA and received a master’s degree in applied management. She has worked in R&D at various biotech, device, CRO and pharmaceutical companies.
Manager, Clinical Support and Quality Documentation- BOEHRINGER INGELHEIM
Joy Mehlenbacher-Mohamed – Manager, Clinical Support and Quality Documentation
Joy Mehlenbacher-Mohamed, BSc, is currently working as the manager of the Administration Group at Boehringer Ingelheim Previously she was the as the Clinical Oversight and Quality Documentation Manager at Boehringer Ingelheim and is based in Ontario Canada. She has been working in clinical research for 22 years and with Boehringer Ingelheim since 2003.
Joy’s teams are responsible for overall clinical trial support and the quality of eTMF for inspection readiness.
In addition, her experience includes global TMF governance, global vendor relations and CRO TMF management, white papers on global quality control processes, and regulatory inspection readiness.
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.
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.
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.
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.
Ivan Walrath – Head of Audit and Inspection Quality
In his capacity as Head of Audit and Inspection Quality, Ivan Walrath is responsible for driving GCP with inspection readiness, audit, management that uses TMF and Operational data. Previously, Ivan was the Business Process Owner for the Trial Master File and Study Execution Processes at Pfizer. As Business Process Owner, he was responsible for end-to-end process design across the entire portfolio of clinical trials including implementation of process, standards and controls,, technology, and measurement.
Ivan has been at Pfizer for more than 23 years in the clinical trial arena, including monitoring, study management, clinical project management and records management, where he worked on the development and implementation of Pfizer’s first electronic Trial Master File in 2000 as well as the more recent implementation of Pfizer’s current TMF process and eTMF system. With his extensive knowledge of clinical trial execution, TMF processes and eTMF systems, Ivan is looked on as an industry leader in this field.
Before joining Pfizer, he coordinated clinical trials in Philadelphia, where he managed trials conducted in depression, anxiety and schizophrenia. He holds a Master of Science degree in Organizational Management from Eastern Connecticut State University and a Bachelor of Arts degree in Psychology from the University of Pennsylvania.
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.
Head Site Management, NA, Acquisition Integration and Clinical Records Management- ALLERGAN
Alana Wriggins – Head Site Management, NA, Acquisition Integration and Clinical Records Management
Alana has more than 20 years of clinical research experience, and has led both regional and global cross-functional staff across project teams and facilitated numerous process improvement initiatives. She has been involved at the front-line of numerous FDA inspections. In her current role at Allergan, she leads the group responsible for the global oversight of TMF management and archiving, as well as, inspection readiness and acquisition activities. She is also responsible for site management activities in North America. Alana received her Bachelor of Science degree in Nursing from the University of South Carolina and her Master’s degree in Health Science, Clinical Research Administration from George Washington University. She is a member of ACRP and the Regulatory Affairs Professional Society.