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June Buchanan – Associate Director, Clinical Operations
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.
Senior Specialist, Clinical Document Management and Inspection Readiness- TAKEDA
Heidi Dildine is Sr. Specialist, Clinical Documentation Management & Inspection Readiness at Takeda (formally Shire) where she drives and manages TMF quality review activities for clinical trials, oversees CRO management of TMF records, contributes to process improvement initiatives, provides training and guidance on TMF processes and systems, and supports audits and inspections.
Prior to joining Takeda in April 2017, Heidi was Medical Writing Operations Specialist at Biogen, where she represented Medical Writing as a founding member of the TMF Core Team – a group of functional area representatives and subject matter experts focused on selecting and implementing an eTMF; and developing, analyzing, and improving processes and systems in support of TMF quality management and inspection readiness.
Heidi received her bachelor’s degree in psychology with concentrated studies in ecology and evolutionary biology from the University of Connecticut. She has worked at various biotechnology and pharmaceutical companies in the Boston area in both commercial and development roles, and has participated in several FDA, MHRA, and PMDA inspections.
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.
Wendy Kelly, M.A., has been working in clinical research and development for 13 years. She has experience at site, CRO and Sponsor level and is currently Manager for TMF and Safety Reporting process at pharmaceutical company. Wendy has worked as a subject matter expert for several system implementation projects. She has developed and implemented processes to ensure proper sponsor oversight of TMFs and Safety Reporting. She has worked as the business point person with project teams, vendors for process alignment, system build and implementation.
She is responsible for several integral functions related to clinical trial conduct, including overseeing the management and review of Trial Master Files, Rest of World Safety Reporting and vendor global operations and performance.
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.
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.
Senior Manager, Clinical Operations- KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
Barbara Novak – Senior Manager, Clinical Operations
KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT
Barbara has more than fifteen years of experience in Clinical Development and Clinical Research. She has been at Kyowa Kirin for the past ten years. In her role as Senior Manager in Clinical Operations, Barbara is the regional eTMF business administrator for the US and Europe regions.
She oversees a team of six Clinical Trial Managers and Trial Coordinators in all areas of assigned trial execution, implementation and conduct of open-label and double-blind, randomized multi-center, Global Phase I/II/III oncology and CNS – Parkinson’s disease clinical research trials. Barbara provides training and support to CROs and internal teams world-wide in collaboration with IT and other functions. Barbara collaborates with quality administrators at Kyowa Kirin’s headquarters in Japan to create SOPs that she continues to develop. Her other responsibilities range from site selection, vendor management, and study start-up to achieve successful project delivery. Of late, Barbara was charged with selecting and implementing an eTMF system that satisfied her company’s marketing and business needs.
Barbara’s prior roles have included time as a Clinical Trial Manager at Johnson & Johnson Pharmaceutical Research & Development and Clinical Research Associate at several different companies.
Barbara was also an Adjunct Instructor in Foundations of Clinical Research and Study Design. She received her Bachelor of Science degree from Rutgers University’s Douglas College. Barbara enjoys swimming, biking, gardening and nature.
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.
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.
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.