Faculty – 8th Clinical Trials Inspection Readiness Summit

Kristen Bennett
Associate Director, Client Delivery, THE AVOCA GROUP

Nancy Bitters
Inspection Management Lead, Biopharma, Global Research and Development Quality, EMD SERONO

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Nancy Bitters has more than 20 years of experience in the pharmaceutical industry. Nancy is currently employed by EMD Serono Inc.

She is an Inspection Management Lead for EMD Serono.

In her role within the Research & Development Quality Assurance Department, Nancy oversees and/or facilitates Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections worldwide for EMD Serono/Merck KGaA. This includes GCP inspections of clinical investigator sites worldwide, GCP and/or PV sponsor inspections of EMD Serono and inspections related to GCP components of vendors used by EMD Serono. Nancy has overseen and/or facilitated over 100 inspections in her career.

Nancy has been at EMD Serono as a GCP/GVP Inspection management lead since February 2017. Previously, Nancy was an Inspection Management Lead at Pfizer.

Nancy has a B.S. in microbiology from the University of Connecticut and an MBA from the University of New Haven.

Jamie Bridges
Director, GDMS, Operational Excellence, MERCK

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Jamie Bridges has 20 years of pharmaceutical experience in Data Management and Epidemiology. She began her career at Pfizer and spent the past 19 years with Merck and Co in Upper Gwynedd, PA.

Jamie is currently the Head of Operational Excellence, which is one of the functional areas within Data Management. In this role, Jamie is the process owner of Data Management processes, oversees the PMO for strategic and continuous improvement initiatives as well as managing quality and compliance for Data Management. This includes serious quality incidents, internal audits as well as worldwide health authority inspections across the Merck portfolio. Jamie has actively participated in several inspector interviews, responses and CAPAs.

She received her Bachelor of Science in Public Health from Rutgers University and her Masters of Public Health in Epidemiology from Rutgers School of Public Health. Jamie is also a member of Avoca and holds her PMP certification.

Sharon Brower
Director, Training and Process and Continuous Improvement, BRISTOL-MYERS SQUIBB

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Sharon Brower is a 25 year veteran of the BioPharma industry and has a bachelor’s in Philosophy and a Master’s in Linguistics from the University of Madrid. She is currently the Head of Clinical Training, Process & Continuous Improvement at Bristol-Myers Squibb based in Princeton, NJ. She was previously the Head of Training & Auditing at Roche and the Head of Training and Compliance at BioClinica. Sharon has spent 25 years developing and implementing programs to improve processes around Training, Auditing, Documentation, and Continuous Improvement. She is a frequent keynote speaker at industry conferences sharing her experiences with building effective document management systems, role-based training programs, and continuous improvement models which all aim to reduce audit findings, increase efficiency, and promote a proactive approach to dealing with issues as opposed to reactive “fire-fighting.”

Linda M. Coleman
Director, Human Research Protection Program, YALE UNIVERSITY

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Linda Coleman is the Director of the Human Research Protection Program at Yale University. Prior to joining Yale in April 2016, she held several positions at Quorum Review, an independent IRB and consulting company that serves institutional, independent, and international sites. From January 2016 – March 2016, Ms. Coleman served as Quorum’s Vice President of Regulatory & Legal Affairs of Kinetiq, a division of Quorum. Prior to 2016, she served as Quorum’s Director of Regulatory Affairs & General Counsel from 2011 – 2015, and its Director of Regulatory Affairs from 2007 – 2010.

From 2011 to the present, Ms. Coleman has been a Task Force Member of the Industry Pharmacogenomics Education Task Force, a subcommittee of the Industry Pharmacogenomics Working Group (I-PWG). Ms. Coleman is also the Team Lead for the Mobile Clinical Trials working group of the Clinical Trials Transformation Initiative (CTTI), and actively participates on other committees related to research, health law, and education.

Prior to joining Quorum, Ms. Coleman was an attorney at Bennett, Bigelow & Leedom where her practice focused on regulatory compliance, Medicare and Medicaid reimbursement, health care litigation, business/transactional, behavioral health, employment law, and general patient care delivery matters.

In addition to her law degree, Ms. Coleman holds the following certifications: CHC (Certified in Healthcare Compliance), CHRC (Certified in Healthcare Research Compliance), CCEP-I (Certified Compliance & Ethics Professional – International), and CIP (Certified IRB Professional).

Grace Crawford
VP Clinical Quality and Compliance, MEDIMMUNE

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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.

Christina Deluca
Associate Director, GCP Inspection Management, MERCK

Alyssa K. Gateman
Associate Director, Yale Center for Clinical Investigations, Director Office of Quality Assurance and Training, YALE UNIVERSITY

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Alyssa K. Gateman is an Associate Director at the Yale Center for Clinical Investigation (YCCI) and the Director of YCCI’s Quality Assurance and Training Office at Yale University. She joined Yale in July 2014 from the Dana-Farber/Harvard Cancer Center, where she served as Director of the Quality Assurance Office for Clinical Trials (QACT).

Throughout her 14-year tenure at Dana-Farber/Harvard Cancer Center, she provided oversight of all protocol registration, data collection design of investigator-initiated clinical trials, and management of the internal auditing program. As Director of the QACT, she provided leadership and management for data and safety monitoring and auditing services to all of Dana-Farber/Harvard Cancer Center, which is composed of five clinical institutions: Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, and Boston Children’s Hospital.

Ms. Gateman served as the President of the Boston Chapter of the Society of Clinical Research Associates (SoCRA) from 2010–2014. She also served a three-year term on the American Association of Cancer Institutes: Clinical Research Initiative’s Steering Committee.

At YCCI, she oversees the Office of Quality Assurance and Training, which is a centralized shared resource that provides data and safety monitoring, auditing, monitoring, consultations with investigators and research staff regarding compliance with Good Clinical Practices, and training and educational instruction to improve the quality of clinical research at Yale.

Vinita Leslie
Director, Trial Master File Process Owner, Regulatory Operations, BIOGEN

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Vinita Leslie is the Trial Master File Process Owner at Biogen. In this role, Ms. Leslie is responsible for TMF life cycle governance and oversight for clinical trials sponsored by Biogen. This includes setting enterprise-wide vision, strategy and performance objectives for end-to-end TMF life cycle management. In this role she is also responsible for partnering with key business and functional leaders and other process owners to collect process feedback and to communicate and implement strategy and objectives.

Prior to joining Biogen, Vinita spent 10 years working at Wyeth and Novartis Vaccines & Diagnostics in the clinical trial arena. Her early years were in clinical research at Georgetown University Medical Center and Massachusetts General Hospital. Ms. Leslie holds a Master of Arts degree in counseling from George Washington University and a Bachelor of Arts degree in psychology from Randolph-Macon Woman’s College.

Ann McCabe
Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO

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Ann McCabe is currently the Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked in the areas of Clinical Operations, Quality, Process Improvement and Training and is PROSCI certified. She is currently leading implementation efforts for Risk Based Quality Management (ICH E6 R2) and study/partner metrics for Daiichi Sankyo. She has Bachelor’s degrees in Biology and Medical Technology from the University of Delaware.

Lydia Milne
Director Quality Systems Inspection Program, ASTELLAS

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Lydia Milne is Director, Quality Systems Inspection Program at Astellas. Prior to joining Astellas, she held various positions in quality and compliance at Abbott in support of medical devices and pharmaceuticals. She has a B.A. in Biology from Purdue University, an M.A. in Instructional Leadership from Marquette University and a Graduate Certificate in Medical Bioethics from the Medical College of Wisconsin. She is a certified ISO 9000 Lead Auditor, ASQ CQA and on the AVOCA Quality Consortium Inspection Readiness Leadership Board. She has more than 30 years of experience in the pharmaceutical industry.

Julia Moore
Associate Director, Clinical Operations, SANGAMO THERAPEUTICS

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Julia Moore has attained 20+ years of experience in drug and combo product development inclusive of rare and ultra-rare therapeutics. She also has worked as a registered nurse and as a family nurse practitioner in private practice and in the academic research environment. Most recently, she joined Sangamo therapeutics in 2017 as an Associate Director, Clinical Operations to lead the genomic medicine interventions for severe hemophilia A and hemophilia B. Over the past 14 months, Julia has developed and is implementing a multi-phase clinical oversight and optimization platform of processes focused on clinical operational excellence dedicated to compliance to ICH E6 (R2) changes and project lifecycle inspection readiness. Julia has worked her way through entry level clinical support role to advanced leadership roles in Clinical Operations across multiple organizations with global experience across each phase of study. She has a strong focus on emerging talent, process improvement and patient safety with a deep appreciation for the importance of attention to quality by intention in each facet of trial execution.

Laura Naranjo
Manager, TMF Operations, DAIICHI SANKYO

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Laura began her career out of college working as an investigator for the federal government, conducting background investigations for individuals looking for national security clearance. Laura has since made the move to the pharma industry and has been working in TMF since 2009. She has worked on both the sponsor and vendor sides throughout her career and joined Daiichi Sankyo as the Manager of TMF Operations in 2016.

Laura has become quite an expert in launching eTMF systems over the years and has participated in five eTMF system launches in the past 5 years. She especially likes diagnosing system issues and process improvement. She holds her Masters of Science of Jurisprudence in Pharmaceutical and Medical Device Law and Compliance from Seton Hall Law School.

Johanna Stamates
Executive Director, Research Compliance and Quality Assurance, UNIVERSITY OF MIAMI

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Johanna Stamates holds a master’s degree and a bachelor’s degree in hospital economics and nursing and completed several certifications for the conduct of research and research compliance. She has over 30 years of combined experience in healthcare, healthcare and research compliance, and management. Her expertise ranges from nursing, study and site management to research compliance and the development and delivery of research and compliance related training. Certified by the International Organization for Standardization (ISO) 9000, she is experienced in the creation, implementation, and oversight of total quality management systems (QMS) and was vital in the implementation of QMS in the Vienna Hospital Association. Johanna Stamates currently directs the Office of Research Compliance and Quality Assurance (RCQA) at the University of Miami. This includes the oversight of human subject research compliance programs such as Quality Assurance, Clinical Trials Disclosure, Corrective and Preventive Action System and research compliance-related education. She maintains memberships with ACRP, SQA, the University of Miami Bio Ethics Committee and HCCA.

Katherine Taylor
Director, GCP Inspection Management, MERCK

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Katherine is Director at Merck in the GCP Inspection Management Department. In her role as GCP Inspection Lead for the Oncology Therapy area, she coordinates the preparation, notification, conduct, and follow-up of any Health Authority inspection related to clinical studies sponsored by Merck worldwide. She also implements processes, activities (inspection preparation and mock inspections) and training to ensure that Merck Headquarters, Clinical Investigator sites and Vendors are prepared for an inspection.

Katherine has 20 years’ experience within the pharmaceutical industry, working within both pharmaceutical companies and a CRO. She started her career in data management before moving into clinical operations working as a CRA, and then moved into CRO management (of data management deliverables) before transitioning to Quality Assurance.

Katherine worked as an international GCP auditor for 13 years at Schering-Plough Research Institute (SPRI), Sanofi-Aventis, and Morphotek, Inc. and functioned as a QA project lead. Her experience includes developing QA plans, performing risk-based analyses, completing root cause analysis of identified issues, and overseeing CAPA development and assessment. She has expertise in databases and electronic records and is considered a Global Expert User for QAAD (Quality Assurance Auditing Database). She has significant experience with both sponsor-monitor, and investigator site FDA Inspections, preparing global inspection teams and has supported a multitude of clinical investigator site inspections.

Katherine holds a B.S. in Natural Science/Biology from the Indiana University of Pennsylvania and an MBA from Eastern University.

Ann Taylor
Director, Inspection Readiness Lead, Clinical Development Quality, PFIZER

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Ann Taylor has 20 years in the pharmaceutical industry. Her career began in Data Management, followed by positions in Clinical Quality Assurance, Global Compliance and Training, and Clinical Quality Management before moving to her current role leading Inspection Readiness (IR) activities. She is employed by Pfizer. Her current responsibilities include serving as an inspection readiness contact to provide guidance and focused support to study teams both proactively and when there is a high likelihood of a regulatory inspection. This includes addressing compliance with processes and aiding in identifying potential risks during IR discussions. Ann supports the inspection leads during regulatory inspections by leading key activities in the control room. She’s involved in CAPA management for inspection commitments.

She holds a B.S. in biology from Pennsylvania State University, a Medical Technology certification from Medical College of Pennsylvania, and a Master’s in Regulatory Affairs and Quality Compliance from Temple University.

Michele Weitz
Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.

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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.

Michael Wieczerzak
Associate Director, Clinical Quality Management, EMD SERONO

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Michael Wieczerzak is an Associate Director, Clinical Quality Management at EMD Serono. His main responsibilities are within inspection readiness and quality risk management. Prior to joining the Clinical Quality Management department, he was a Clinical Trial Lead running immunology trials. Michael holds both a BS and MS degree in Biomedical Engineering from the University of Connecticut as well as an MBA from the University of Massachusetts. In addition, he is a member of SOCRA and is CCRP certified.