2nd European Clinical Quality Oversight Forum -

2nd European Clinical Quality Oversight Forum
26 – 27 February 2018
London, United Kingdom

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

Faculty – 2nd European Clinical Quality Oversight Forum

Pearl Boakye, Ph.D.
Head, Compliance Management, BAYER

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Pearl Boakye, Head, Compliance Management, BAYER HEALTHCARE

Pearl joined Bayer UK in 1993 as a Clinical Research Scientist, and over the years has held positions within Monitoring, Study Management, Line Management, Outsourcing and Operational Support across a variety of therapeutic areas. She spent a year working in Bayer’s New Jersey office.

In April 2011, she was appointed Head, CAPA Management within the Business Excellence Function of Bayer’s Global Development Quality Department, and was responsible for directing the CAPA strategy for Global Development. This included standard setting and the development of a harmonized CAPA process and CAPA Tool. Pearl established and leads a cross-functional CAPA Council that oversees the tracking, collation, analysis and reporting of CAPAs for Pharma R&D (Bayer).

In 2013, Pearl was appointed Head of Compliance Management within Bayer’s Global R&D Quality Department, leading a small team with responsibility for supporting CAPA, Risk Management and Quality Governance for Pharma R&D (Bayer).

Lynette J. Bojko
Director, Sourcing and Vendor Management, PFIZER

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Lynette Bojko is a Sourcing and Vendor Management Lead for Pfizer’s Innovative Health business. In this role, Lynette helps to develop Pfizer’s internal and external sourcing strategy and works closely with clinical teams to ensure successfully delivery of their clinical trials.

She has led the development of Pfizer’s Academic Research Organization (ARO), Pediatrics and Rare Disease sourcing strategies. Lynette supports the oversight and management of some of Pfizer’s preferred vendor relationships. She leads various initiatives within Pfizer including the redesign of Pfizer’s vendor assessment / due diligence processes and champions the process within her organization to ensure proper risk analysis and mitigation is performed prior to contract execution. She partners closely with all of the functional lines within Pfizer including the Clinical Development Quality organization to ensure healthy vendor engagement.

Lynette has over 20 years of experience in clinical research at Pfizer working across numerous functional lines including Data Management, Study Management, Project Management spanning a wide range of therapeutic areas and study types in both Early and Late Development. She has been PMP certified since 2012.

Susan Callery-D’Amico
Vice President, R&D Quality Assurance, ABBVIE

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Susan Callery D’Amico is a seasoned pharma leader and expert with extensive experience in quality assurance and clinical development. Susan is the Vice President, R&D Quality Assurance, AbbVie, Inc. with the mission to drive quality excellence and continuous improvement as a strategic advantage across the life cycle of pharmaceutical products, and to implement, maintain and ensure the effectiveness of a Quality Management System. Susan has held senior management positions in research and development operations and quality assurance at RWJPRD (J&J), Novarits and Reata. She has the breadth of drug development experience from early-man to regulatory approval and launch.

Keith Dorricott

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Keith Dorricott is Director, Dorricott Metrics &Process Improvement Ltd. and an Ambassador for the Metrics Champion Consortium (MCC). He has a background in manufacturing from Kodak Ltd. and has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master Black Belt in Lean Sigma quality and process improvement techniques and is an expert in root cause analysis developing a novel approach for clinical trials. He speaks regularly at conferences such as DIA on various topics and runs a number of different metric work groups for the MCC such as Vendor Oversight, Data Management / Biostatistics, Trial Master File, Site Selection and facilitates the Centralised Monitoring workgroup. He can be contacted via keith@dorricottmpi.com.

Tammy Finnigan

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Tammy has 20 years clinical research experience, having worked in both large Pharma and large CRO companies prior to joining TRI. Her experience both in monitoring, and managing clinical trials have provided valuable insight the way quality management processes and supporting tools should work. Tammy is the business sponsor of TRIs RBM tool, OPRA and is actively involved in supporting multiple RBM projects with TRI clients. For almost 4 years, Tammy has been working with the MCC as a representative on the Risk-Based Monitoring and Central Monitoring working groups.

Gail Francis
Expert Inspector, Good Clinical Practice, MHRA

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Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held various positions in monitoring, Project Management, and more recently in GCP Compliance and Training Management.

Gail was promoted to Senior Inspector in October 2005 and accredited to perform Pharmacovigilance Inspections in November 2007. In June 2010 Gail was promoted to Expert Inspector, GCP.

Gail holds a B.Sc. (hons) in Applied Biology and a certificate in Human Pharmacology

David Fryrear
Senior Director, Research and Development Quality Assurance, ABBVIE

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David W. Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE

David Fryrear is a Senior Director in R&D Quality Assurance at AbbVie. In this role, he is the global head of clinical and pharmacovigilance quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management. He and his team have been focused on implementation of integrated, cross-GxP quality strategies, quality and business process ownership, and advancing AbbVie standards and systems across R&D for documentation, TMF, issue management, and oversight processes.

Prior to joining AbbVie in January of 2013, David had been at Eli Lilly for 23 years, the last 12 in leadership positions in quality assurance. He has a B.S. in Chemistry from Centre College and an M.S. in Pharmaceutical Science from Butler University.

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP
Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC

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Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP is an accomplished clinical quality and regulatory compliance professional with in-depth knowledge of all facets of clinical trial operations and the ability to support management and clinical teams that are conducting compliant clinical trials globally. She excels in the interpretation of the impact of various US and foreign regulatory body regulations and guidelines to clinical functions, clinical trial operations, and the risks and benefits of implementation strategies. Her development of risk-based auditing strategies has earned her the respect of multiple sponsor companies. She brings 20 years of experience in the pharmaceutical, medical devices and animal health arenas to her work and teaching.

Celeste received a bachelor’s degree in animal science from the University of Florida, and an A.S. in veterinary technology from St. Petersburg Junior College. She is a Certified Veterinary Technician, Registered Quality Assurance Professional – GCP, and a Certified Clinical Research Professional.

Karen Hue, FRQA
Associate Director, Quality Assurance Europe, AIMMUNE THERAPEUTICS UK LIMITED

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Karen graduated with a B.Sc. in Applied Biology specialising in pharmacology followed later on with a diploma in total quality management. Her career started in toxicology in preclinical research followed by a short spell working in transplantation in Addenbrooke’s and Papworth Hospitals in Cambridge where she ran an investigator-led clinical trial focussing on population pharmacokinetics on a popular anti-rejection therapy. In 1991 she made the move to SmithKline Beecham in the Regulatory Compliance department and covered all types of auditing in clinical trials, including working on one of the first eCRFs. This led to a move to ADAMAS consulting and time spent covering auditing, inspections and gap analysis for many clients including CSV and of course the year 2000 projects. During this time Karen was a member of the RQA professional teaching team on the CSV courses and is a Fellow in RQA (FRQA). After leaving ADAMAS Karen became a consultant again focussing on CSV activities, inspection readiness and hosting as well as many gap analysis. In 2013 she went back to full-time employment in Optum Lifesciences and worked in the late phase and health economics area. After Optum Lifesciences was acquired by Mapi, Karen moved to Intercept Pharmaceuticals, a biotech company specialising in liver disease and then to Aimmune Therapeutics Inc, a company developing treatments for food allergies using biologic product candidates and a characterized oral desensitization immunotherapy (CODIT™) approach. During her career to-date, she has been involved in inspections from the FDA, Health Canada, the MHRA, Health Products Regulatory Authority (formerly the Irish Medicines Board) and the EMA, both for GCP and GvPV.

Siobhan Hurley
Clinical QA Programme Manager R&D, Quality Assurance, ABBVIE

Bodo Lutz
Global Clinical Quality Assurance, Compliance and Data Integrity Officer, NOVARTIS

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Dr. Bodo Lutz is a trained environmental engineer and biologist by education. He received his Ph.D. from the Technical University of Munich, Germany.

Dr. Lutz is an assigned GCP/GcLP Data Integrity Officer for clinical development and as Clinical Quality Risk Manager is responsible for the audit program as part of the vendor and investigational site management process and for the internal self-inspection program related to the development of biopharmaceutical products within the global clinical Quality Assurance department.

Prior to this he held several positions in clinical quality assurance and management at CROs and biotech, medical device and pharmaceutical companies where he also conducted audits on internal processes and at service providers and investigational sites, and he provided consultancy to improve the cooperation of business partners in clinical research.

Before joining the pharmaceutical industry he worked in several scientific programs — e.g., HIV-infection and AIDS therapies improvements and human cancer research — and performed experimental studies to investigate degradation processes of genetically modified DNA and protein after ingestion.

Milind Nadgouda

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Milind Nadgouda is a seasoned quality and regulatory professional with 19 years of industry experience. He is the Co-founder and Director of RiverArk Limited; a Quality Consultancy providing services in GxP space. His core areas of specialisation are Risk Strategy (Identification; Assessment; Rating; Prevention and Mitigation); Regulatory Agency Inspection Readiness and Quality Management System GAP analysis. Milind has worked on different types of quality projects with methodologies such Six Sigma; Kaizen and Lean. His expertise in quality strategy and regulatory compliance has been derived from hands-on real-world experience. So far in his career, Milind has been in the frontline during GxP inspections and has on several occasions been in the back room supporting the team for inspections. AstraZeneca, Bristol Myers Squibb, Ranbaxy and Eli Lilly are few of the companies Milind has worked at and consulted. He sees himself as a problem solver and a solution provider.

Heike Reinstaedtler
Director, Clinical Operations Quality, GSK VACCINES

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Heike serves as Head of Clinical Development Quality at GSK Vaccines, a global team responsible for quality oversight and support enabling proactive, integrated and risk-based quality management throughout the clinical and epidemiology study processes. Her focus is to partner with the business in ensuring the compliance of clinical and epidemiology studies as well as support the development of a strong quality culture and mindset throughout the organization.

In 2015, she transitioned from Novartis, where she led the Global Clinical Quality Assurance team accountable to monitor and verify regulatory compliance in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Vigilance Practice (GVP) regulated areas as well as provide guidance to non-regulated areas in Research. Prior to joining Novartis in 2006, Heike spent 15 years in different companies in the area of Regulatory Affairs and GCP Auditing.

During her career, Heike has managed various HA inspections in the clinical and pharmacovigilance area facing inspectors from different health authorities including EMA, FDA and PMDA.

Dennis Salotti, M.S., MBA, CCRA
Vice President, Operations, THE AVOCA GROUP

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Dennis Salotti is the executive lead for Operations of The Avoca Group and is head of Avoca’s Industry Research and Diligent™ Centralized RFI Platform divisions. Dennis leads the strategy and execution of bespoke research projects and Avoca’s broader industry-leading research on quality, risk innovation and clinical trial execution. He is also responsible for the strategy and operations of Diligent, the clinical research industry’s first centralized platform for clinical service provider pre-qualification.

With more than 16 years in the pharmaceutical industry as a Sponsor, Provider and Consultant, Dennis has experience that spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations and strategic management.

Prior to joining The Avoca Group, Dennis was Director of Operations for WriteResult, an eCOA clinical research organization, where he was responsible for client delivery across the portfolio of global clinical trials. He has previously held positions in research and clinical operations for Pfizer and Merck.

Dennis is an Adjunct faculty instructor at Drexel University College of Medicine’s graduate program in Clinical Research Organization Management, and a Member of the Board of Trustees for the Diabetes Foundation. His educational credentials include an MS in Clinical Research Organization Management from Drexel University, an MBA in Technology Management from the New Jersey Institute of Technology, and a BS in Biology from Sacred Heart University.

Martin Thorley
Director, Vendor Quality Lead, PFIZER

François Torche

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François Torche, CEO, CLUEPOINTS

François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 17 years in the pharmaceutical industry, he has held positions as a statistical programmer; an SAS and JAVA developer; and an IT project leader for companies such as GSK, UCB and IDDI. During his 10-year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the SMART™ engine, a patented software solution and the underpinning of CluePoints. Francois has served as CluePoints’ Chief Executive Officer since the company’s inception in 2012.

Michele Weitz
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.

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