Faculty – 6th Clinical Trials Inspection Readiness Summit

Stacey L. Basham, Assistant Director, R&D GCP Quality Assurance, ABBVIE

Stacey L. Basham
Assistant Director, R&D GCP Quality Assurance, ABBVIE

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Stacey Basham is currently the Assistant Director of Clinical Quality Assurance at AbbVie, Inc. in North Chicago, Illinois, where she oversees and supports clinical quality efforts for study activities across several therapeutic areas, as well as post marketing safety study surveillance. Ms. Basham has had a distinguished, compliance-focused career. She has more than 17 years of experience in the pharmaceutical, biologics and medical device industries, where she has held positions in quality assurance, pharmacovigilance and project management. Prior to joining AbbVie, Stacey worked as an independent GCP consultant. She has also served as Director of Quality Assurance/Regulatory Compliance for a mid-size CRO; Drug Safety Officer in Europe for a biopharmaceutical company; and GCP Quality Assurance Auditor.

Ms. Basham was trained as a registered nurse at Mary Lanning Memorial Hospital School of Nursing, holds a Bachelor of Science degree in health care studies, and is currently enrolled in an MSHS program in regulatory affairs through George Washington University. Stacey is also RQAP-GCP certified.

Angela Berns
Director and Head of Vendor Management, UCB BIOSCIENCES INC.

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Angela Berns has worked in Clinical Research for 23 years. She is currently the Director and Head of the Vendor Management in the Clinical Quality Assurance group at UCB Biosciences Inc. located in Research Triangle Park, NC since 2006.
Before moving to the east coast Angela worked for six years as Manager of the Global GCP Computer Compliance Group at Amgen, Inc. located in Thousand Oaks, California. Angela has worked in preclinical research at The Charing Cross and Westminster Medical School in London, England. She also worked for six years at a multinational CRO as a Data Management Team Leader and Senior Quality Assurance Auditor. She has spoken at numerous industry conferences and published several articles in industry publications and contributed to a book entitled Biomarkers in clinical drug development – quality assurance and regulatory compliance.

Angela holds a Bachelor of Science degree (Analytical Science) from Dublin City University and an Advanced Diploma in Information Technology from The Dublin Institute of Technology. She is certified as an Auditor of Suppliers of Computer Products and Services using the audit process model defined in PDA technical Report no. 32 and holds the US Regulatory Affairs Certification (RAC). Angela has served on the Board of Directors for the North Carolina Chapter of The Society of Quality Assurance.

Nancy Bitters
GCP/GVP Inspection Management Lead, 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.

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).

Stephanie deRijke, Director, Clinical Trials Audit and Compliance, EMORY UNIVERSITY

Stephanie deRijke
Director, Clinical Trials Audit and Compliance, EMORY UNIVERSITY

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Stephanie has 10 years of clinical research experience, and is currently serving as the director of an internal, clinical trial quality assurance and improvement program at Emory University. In this role, her responsibilities include managing not-for-cause and for-cause audits and providing on-site, individual, large group and electronic GCP training to numerous clinical research professionals at all stages of their careers. Prior to her current role, she developed and managed a new quality assurance program at the Emory Institutional Review Board.

In 2010, Stephanie became a site visitor for the Association for the Accreditation of Human Research Protections Programs and obtained a Certified IRB Professional certificate.

Before moving to the administrative side of research, Stephanie spent two years working as a nurse practitioner co-investigator at the NIH Clinical Center in Bethesda, MD. She obtained both a BSN and MSN from the Nell Hodgson Woodruff School of Nursing at Emory University and began her nursing career in Labor and Delivery at Emory University Hospital Midtown.

Rachael Easton
Senior Director, Translational Medicine and Clinical Pharmacology, SANOFI

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Rachael has 10 years of experience in the design and implementation of first-in-human through proof-of-concept clinical studies. Within Sanofi, she currently leads a group in the U.S. and Asia which is responsible for developing and executing early development strategies across therapeutic areas. Rachael received her MD and Ph.D. degrees from Washington University School of Medicine and trained in Endocrinology, Diabetes and Metabolism at the University of Pennsylvania.

Betsy Fallen
Regulatory and Clinical Process Consultant, BAFALLEN CONSULTING, LLC

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Ms. Fallen is an authority on the business processes and associated use of information technology in drug development. A passionate advocate for moving life sciences business online, Betsy is an expert on IT in regulatory and clinical operations, data management, and ancillary supply chains, among other areas.

Betsy recently left Merck after two decades of outstanding contributions. She has participated in many industry initiatives and SIACs, including the TMF Reference Model, Chair of the SAFE-BioPharma Global Business and Regulatory Group, PhRMA Electronic Regulatory Submissions Working Group, NCI caBIG CRIX and the IRISS Steering Committee Chair.

Currently, Betsy is an independent consultant providing expertise to industry. She is an active member of DIA and frequently participates in conferences and meetings as program chair, speaker or session chair. She has also presented globally on diverse topics in clinical and regulatory areas for many conferences.

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.

Andreas Kateifides
Compliance Oversight Systems, VERTEX PHARMACEUTICALS

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Andreas has 5 years of clinical research experience and is currently serving currently a manager at Vertex Pharmaceuticals in the Process Management and Business Analytics group. In this role, Andreas is responsible for providing strategic input, leadership, and support to various functions across clinical development to address process needs for compliance with regulatory requirements.

He has collaborated with stakeholders within regulatory affairs and GCP QA groups to establish processes and governance for assessing global GCP intelligence to comply with updated GCP requirements.

Andreas has received an MBA from Boston University School of Management, with concentrations in Health Sector Management, Business Strategy, and Finance. Prior to this, he studied Medicine and completed an M.Sc. and Ph.D. in Molecular Medicine at the University of Crete, Greece.

Tipsuda Kongtong
Manager, Clinical Quality Assurance, EISAI

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Tipsuda joined Eisai in 2012 and has held positions in clinical operations and clinical quality assurance. In her current role, she is responsible for GCP audits and leading inspection readiness activities. Tipsuda has 13 years of clinical research experience in neurology, oncology and infectious diseases. She holds a Bachelor of Science in Public Health and a Master of Public Health Epidemiology from Rutgers University.

Dawn Niccum, Quality Manager, ENDOCYTE, INC.

Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP
Director, Quality Assurance, INSEPTION GROUP

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Dawn Niccum is Director, Quality Assurance for the inSeption Group and responsible for all areas of QA including compliance, Policies and SOPs, and training. She was formerly with Endocyte, Inc. as Associate Director, QA. With over 20 years of pharmaceutical experience, Ms. Niccum holds a Master’s Degree in Regulatory Affairs and Quality Compliance, certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP) and Project Manager (PMP), and is a registered nurse.

Lou Pasquale
Customer Success, Content Management Solutions, WINGSPAN, A QUINTILESIMS COMPANY

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Lou Pasquale heads up Customer Success for Content Management Solutions at Wingspan. Lou is responsible for helping customers achieve their goals through the use of Wingspan applications. Along with his team, Lou defines and implements Wingspan’s client engagement practices and application support processes. He brings with him more than 20 years of experience in Life Sciences, ensuring Wingspan has an ear to the customer and their needs.

Jonathan Rowe, Ph.D., M.S., M.A.
Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

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Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Susan Seroskie, RN, BSN
Senior Manager, Global Quality Management, OTSUKA PHARMACEUTICAL COMPANIES

Ann Taylor
Clinical Quality Manager, Associate Director, PFIZER

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Ann Taylor has 19 years in the pharmaceutical industry. Her career began in Data Management, followed by positions in Clinical Quality Assurance, Global Compliance and Training with emphasis on Inspection Readiness, 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 provides support for all types of regulatory inspections and is involved in the inspection response process.

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.

Ivan Walrath
Head of Audit and Inspection Quality, PFIZER

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Ivan Walrath is the Business Process Owner for the Trial Master File and Study Execution processes at Pfizer. As Business Process Owner, he is responsible for end-to-end process design across the entire portfolio of clinical trials sponsored by Pfizer. This includes design and implementation of process, standards and technology as well as measurement and process controls.

Ivan has been at Pfizer for more than 19 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 in 1995, 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.

Steven Whittaker
Senior Consultant, THE AVOCA GROUP

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Steven Whittaker currently serves as senior consultant for The Avoca Group. He also is an independent consultant for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution plans. Whittaker has served for sixteen consecutive years on the Advisory Board for the annual Partnerships in Clinical Trial program, chairing the board for two years. In addition, he regularly moderates quarterly Clinical Research Consortium forums, developing strategic agendas and facilitating the exchange of leadership concepts between clinical development executives across several top-tier pharmaceutical and biotech organizations.

Whittaker retired from Eli Lilly and Company where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform.