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.
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.
Manager, Information Governance and Compliance- PPD
Michelle Ingraham – Manager, Information Governance and Compliance
Michelle Ingraham is the Manager of Information Governance and Compliance (IGC) over the TMF group at PPD. As one of the core team members in developing and implementing eTMF at PPD in 2012, she is one of the foremost experts on PPD’s TMF systems and processes. Michelle has focused her leadership efforts on process improvements in Records Management and Information Governance and brings this expertise to the TMF group, which are PPD’s TMF process owners and provide global operational and strategic support to PPD as well as Sponsors with their TMF development. As manager, she is responsible for ensuring inspection support as well as evaluating impacts of new processes and technologies to support Clinical Trails, such as robotics, on TMF systems and processes.
Michelle holds a Bachelor of Science in Electronic Media, Arts, and Communication with a minor in Management from Rensselaer Polytechnic Institute and has eleven years of experience in the Clinical Research industry.
Clinical Research Associate- XENCOR
Lisa Leete – Clinical Research Associate
Director, Clinical Operations, Head of Clinical Document Control- PHARMACYCLICS
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 currently manages a Clinical Records Department, where he leadsTMF Specialists, technicians and study team personnel in the effective and efficient management of TMF records.
Owner and Principal Consultant- MULCAHY CONSULTING
Lisa has a 20+ year career in the pharmaceutical industry, primarily in the areas of clinical operations and quality management. More than seven years ago she became an independent consultant, focusing solely on Trial Master File process and management assisting clients with the assessment and improvement of their current state, the development of future design, and the 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 workshop 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.
Emily Roberts-Thomson is Vice President and Head of Clinical Operations at Acerta Pharma (Acerta), a majority owned company of AstraZeneca, delivering new heme-oncology medicines to patients. Over the last 2.5 years, Emily’s work at Acerta has involved the transformation and organization of the Clinical Operations groups in USA and Netherlands, stabilizing the department through creation of process, training and implementation of systems. She actively participated in leading the direction of the company and her drive for clinical operations quality and inspection readiness enabled the successful US approval and launch of Calquence in 2017. Emily reported directly into the CEO of Acerta.
A clinical operations leader with 30 years of experience in education and pharmaceutical industries, Emily graduated in Medical Science from the Universities of Sydney and Newcastle in Australia. She educated students at a university level in the disciplines of pharmacology and biochemistry, before entering the pharmaceutical industry.
Prior to moving to Acerta Pharma, she has led and represented global teams supporting operational deliverables at both contract research organizations, as well as in large corporations – working in offices in USA, Australia and Canada. In addition to her department leadership, she has a proven track record in establishing complex study models to operationalize multiple and parallel protocols in hematology, solid tumors in adults and pediatrics, across company portfolios.
She moved to Acerta in 2016, now located in South San Francisco CA, just following the acquisition by AZ earlier in 2016 with a $7 billion valuation – the largest exit of a privately held European biotech.
Associate Principal Clinical Scientist- Merck
Jolanta Strus – Associate Principal Clinical Scientist
Director, Head of TMF Management and Compliance- EISAI
Wendy Trimboli – Director, Head of TMF Management and Compliance
Wendy has more than 20 years of major pharma experience in clinical research and clinical operations and 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 Eisai, she leads the group responsible for the global oversight of TMF management and archiving, and the quality control review process for clinical trial documents across all therapeutic areas. She is also responsible for oversight of the eTMF vendor and works closely with Eisai’s strategic CRO partners.
Senior Manager, Process, Training and Compliance- TAKEDA
Melissa Umbehauer Chiasson – Senior Manager, Process, Training and Compliance
Melissa Umbehauer Chiasson is a Senior Manager within Clinical Development Services at Takeda Pharmaceuticals. Melissa has over 10 years of experience in the pharmaceutical industry. In her current role, Melissa leads Trial Master File (TMF) strategy, oversight and inspection readiness. She was the business lead for the Takeda eTMF implementation and has led TMF readiness for MHRA and FDA GCP inspections. In addition, Melissa works with Takeda’s CRO partners to develop and implement TMF Strategy Plans that outline standards and serve as the foundation for TMF inspection readiness with our partners. She also serves as the subject matter expert for TMF acquisitions and divestures. Prior to her current role within Clinical Development Services, Melissa has held various leadership roles ranging from implementation of a clinical trial management system and end user support model to providing management for a global clinical operations study support team primarily focused on TMF oversight. Melissa holds a Bachelor’s degree in Business Administration from Rowan University and a Master’s degree in Leadership from Northeastern University.
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.
Senior Director GCP, Compliance Operations- CLOVIS ONCOLOGY
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.
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