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.
Associate Director, Document Control and Training- DYNAVAX TECHNOLOGIES
Robin Farmer – Associate Director, Document Control and Training
Robin has over 15 years’ experience working directly in the Records Management space. She gained her experience working as a paper TMF processer at Amgen. Within that role she was able to gain the experience of transitioning from a paper based system to an eTMF system.
For the past 7 years Robin has held positions of leadership in various roles and worked with companies managing TMF records on various projects that range from: mergers and acquisitions, converting paper TMF to eTMF, helping records teams organize their work space to be more productive and create better process flows, as well as inspection readiness activities.
In her current role she owns the eTMF process and works closely with CRO vendors to help maintain a contemporaneous eTMF. She also manages documents outside of the TMF such as Clinical Operations Training records and non-TMF documentation for proper storage.
Robin received her Doctorate from the University of La Verne in 2013 with a focus in Organizational Leadership and Management. Her dissertation, entitled: Elements of Teamwork in Biotechnology Companies focused on the need for strong leadership practices within the Biotech workspace.
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.
David Katzoff brings more than 25 years of software product development, applications engineering, systems integration, project management and compliant business solutions design experience to his role. Much of that experience is concentrated in enterprise-class research, manufacturing and business and marketing systems for premier clients in the life sciences, financial services and manufacturing sectors.
As a co-founder of Valiance, David led the initial development of Valiance’s core software products TRUcompare and TRUmigrate. His thorough understanding of the supported platforms, user interface design and novel testing techniques directly resulted in Valiance’s unique product direction path.
David earned a B.S. in Electrical Engineering from the University of Rochester in New York and is a member of the Phi Beta Kappa Society.
Lisa has 10 years of experience working in Clinical Trial Master Files at small to medium sponsor companies in the San Diego area. She has assisted two companies in moving from paper to electronic TMF systems. Currently, she is at Xencor, Inc. where she directs of a group of five TMF professionals. At Xencor, she has led the implementation of Veeva Vault eTMF including system configuration, development of TMF policies and procedures and stewarding the partnership of a shared Sponsor/CRO TMF. Lisa is familiar with working with limited resources and with wearing many clinical hats, as is common at smaller companies. Lisa current initiatives at Xencor include developing a Sponsor TMF Oversight program and developing a more mature reporting and metrics program within Veeva Vault.
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.
Scott is an experienced clinical research professional with more than 13 years of life sciences industry experience. Scott Is Director of GCP Quality, a CRO located In San Francisco. Scott Is a member of The Reference Model’s Steering Committee. He also serves on the advisory board The Academy of Good Clinical Practice, a member organization that he founded In In January 2018.
Scott’s professional career began within a global CRO working in several different roles, learning to follow Good Clinical Practices (GCP) from study start-up to study close-out. After spending several years working in various CROs and learning from experienced peers about the life cycle of product development, Scott was attracted to the ever-developing, electronic side of the industry. Scott contributed to European operations, strategy and growth for two major eClinical service providers, specializing in electronic Trial Master File (eTMF) solutions.
Working for organizations that provide services to product sponsor organizations, it was important for him to understand how best to do so. Over the past few years (2013-2016), Scott invested in his personal development and is now a Black Belt within the Six Sigma methodologies. As well as this, every year Scott undergoes an ICH-GCP refresher course.
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.
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 Scientist, Clinical Research- MERCK
Jolanta Strus – Associate Principal Scientist, Clinical Research
Jolanta has worked in clinical research for over 13 years and is currently a Clinical Scientist in the Clinical Sciences & Study Management (CSSM) organization at Merck. Jolanta began her career with Merck in 2005. She has held various roles related to clinical trial development and has worked on Phase 2 and 3 clinical trials, regulatory submissions, as well as prepared for and participated in several FDA Advisory Committee meetings. She has been a functional area (FA) TMF subject matter expert for over 10 years with the last 3 years spent as CSSM TMF Subject Matter Expert (SME) co-lead. As a TMF SME she is a point of contact for TMF in the CSSM organization and as TMF SME Co-Lead works with cross-functional teams to ensure TMF completeness and readiness.
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.
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.