Faculty – 8th Proactive GCP Compliance

Katie Alberta
Global Head, Clinical and Pharmacovigilance Quality, ALKERMES

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Katie transitioned from a career in critical care nursing into the pharmaceutical and biotech industry in the 1990s.  Katie spent her first eight years in the industry developing the Clinical Quality Assurance department at Amgen, Inc.  From Amgen Katie moved to Cephalon, Inc., where she spent the next 14 years building a global Clinical and Pharmacovigilance Compliance Program incorporating the industry trends of Risk Management and Vendor Oversight. Katie has also experienced the start up of Coastal Compliance, LLC whereby she assisted pharma companies in corporate compliance investigations and due diligence activities. Currently Katie is the Global Head of CQA for GCP and GPvP standards at Alkermes, Inc in Boston, MA.

Catherine Arthey

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Catherine Arthey founded DArcy Consulting in 2014 to focus on R&D compliance for pharma/biotech companies. Catherine is passionate about compliance and the benefits unlocked by having a compliance culture. Having worked in R&D compliance for most of her career, first with PA Consulting Group and more recently with Deloitte, Catherine has come to realize that proactive compliance is not only common sense but is a key enabler to better business performance. The benefits of proactive compliance are easily demonstrable and if communicated in the right way can switch the focus from “Are we being compliant?” to “How well are we performing?” This is what a culture of compliance means and this is the vision of DArcy Consulting.

Catherine has a Bachelor of Science in biotechnology and a Master in Business Administration from Manchester Business School.

Nathalie Bourgouin, PMP
Director, SKILLPAD

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With more than 25 years of experience in pharmaceuticals and biotech in North America, Nathalie Bourgouin is a leader in compliance, quality and project management with a solid background in risk-based clinical quality assurance processes, training and auditing. She has planned and audited numerous sites and vendors as part of several global studies. At Skillpad, Nathalie leads the Compliance Consulting group with a focus on clinical trials and research compliance. She is the content expert of the new Premium Suite of Clinical Inspection Readiness e-Lessons supporting sponsors. Nathalie did her B.Sc. at McGill University and her M.Sc. at the University of Guelph and is a certified Project Management Professional (PMP).

Dwayne Brazelton
Director, Clinical Quality Assurance, MACROGENICS, INC.

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Dwayne Brazelton has more than 24 years experience in the pharmaceutical industry.  He serves as the Director of Clinical Quality Assurance at MacroGenics, Inc.  In this role Dwayne is responsible for the design and execution of all company GCP quality assurance processes and initiatives, as well as ensuring their effectiveness in satisfying the quality and compliance objectives of this novel biotechnology company.

Prior to working at MacroGenics, Dwayne served as the Director, Clinical Quality and Compliance at Covidien.  In this role, he built a new quality assurance organization capable of supporting the GLP, PV and GCP needs of the Covidien Pharmaceutical’s R&D organization.

Dwayne’s experience also includes more than 16 years of non-clinical and clinical quality assurance experience with Pfizer.  He began his GCP career as a clinical project auditor, serving as a GCP and quality advisor, as well as performing domestic and international clinical audits.  Those audits included investigator site, in-licensing, for cause, regional office, vendor, document, as well as internal systems audits.  He assumed roles of increasing responsibility before managing a team of clinical quality assurance professionals.  In this role he ensured the development of appropriate project-level risk assessments, audit plans and the effective delivery of the portfolio of QA activities across more than 20 major clinical projects/products.  He also provided a leadership role in multiple FDA sponsor-monitor inspections.

Dwayne holds a B.S. degree in Biology from the University of Evansville.

Conference speaker Dr. Kathy Goldstein

Kathy Goldstein, PharmD, RPh, CCRA
Senior Director, Development Quality Operations, R&D Quality and Compliance, ALEXION PHARMACEUTICALS

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Kathy Goldstein is currently the Director, Clinical Quality Operations at Alexion Pharmaceuticals. In this position, Dr. Goldstein leads the clinical quality operations team to ensure quality and compliance for all global clinical study activities. The quality operations team is responsible for providing guidance, interpretation, support, training and key input to  clinical operations on GCP regulations, guidelines, corporate standards and policies. The team also manages GCP inspections and leads inspection preparation activities.

Dr. Goldstein has more than 20 years of experience in the biotech, pharmaceutical and medical device industries, with positions in pharmacokinetics and drug metabolism research, clinical operations, quality assurance, and project management. Prior to joining Alexion, she managed the Clinical Operations department at a CRO. In this role, she also served as a program manager where she managed study teams, timelines and deliverables to ensure the overall success of sponsor programs. Dr. Goldstein has monitored or managed clinical research programs in a wide range of therapeutic indications including ICU-based septic shock, dermatology, cardiovascular, asthma, oncology, sexually-transmitted diseases, sickle cell anemia, analgesia, wound healing, burns, fecal incontinence and rare skin disorders.

Dr. Goldstein holds a B.S. in pharmacy from the University of Minnesota and a doctor of pharmacy from the University of Florida. She has also completed a Pharmacy Practice residency program accredited by the American Society of Health-System Pharmacists (ASHP). Dr. Goldstein has also earned ACRP’s Certified Clinical Research Associate (CCRA) designation.

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.

Joseph F. Gotowko
Assistant Director, RDQA Quality Systems, ABBVIE

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Joe joined AbbVie in September 2015 as the Assistant Director of R&D Quality Systems in Lake County, IL. His current role as the process owner of quality risk management is to provide guidance and oversight on changing regulations, such as the ICH E6 Addendum for clinical, and to establish cross-functional quality systems for risk management in R&D.

Prior to joining AbbVie, he was the Internal Audit and Risk Manager for an AstraZeneca commercial vaccine operations site in Philadelphia, PA. He also held positions including Senior R&D GMP Quality Assurance Specialist at GlaxoSmithKline and Lead Engineer at Merck.

Joe attended Rensselaer Polytechnic Institute and received his bachelor’s degree in chemical engineering. He is currently attending the Temple Fox School of Business OMBA program.

Tipsuda Kongtong, MPH
Manager, Clinical Quality Assurance, EISAI, INC.

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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.

Maryann Livolsi, Head of Clinical QA and Compliance Programs, R&D Quality Assurance and Compliance, SHIRE

Mary Ann Livolsi, MSN, RN, RQAP-GCP
Head Quarters Clinical Quality Management (HQ CQM), Quality and Continuous Improvement (QCI), SQAC, LLC CONTRACTED TO MERCK RESEARCH LABORATORIES

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Mary Ann Livolsi is an accomplished leader in R&D quality assurance with effective management experience. She has worked in small, mid-sized and large pharmaceutical/bio-pharmaceutical companies and possesses in-depth knowledge of clinical trial management, GXP auditing, process gap analysis, SOP development and regulatory inspections. She effectively leads processes for quality and performance metrics dashboards for R&D compliance; is an adjunct professor for Drexel University Clinical Pharmacology Master’s Program; and presents at industry-related conferences, including Linking Leaders and events hosted by ExL Pharma. She possesses more than 25 years of clinical research experience, is Six Sigma certified, graduated from Rutgers University with a bachelor’s degree in nursing, and received a master’s of nursing administration from University of Pennsylvania and The Wharton School.

Suzanne Lukac
Associate Director, Risk-Based Monitoring Implementation, MERCK

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Suzanne Lukac has more than 15 years of experience in the pharmaceutical industry.  She is currently the Project Lead for Merck’s Risk-Based Monitoring (RBM) Implementation Initiative, overseeing the Work Stream and Sub Team activities that will shape the adoption of RBM at Merck using TransCelerate methodology.

Prior to assuming this role, Suzanne was an Associate Director in Clinical Quality Management supporting oncology at Merck. She was responsible for assisting clinical teams in implementing Quality by Design (QbD) into their trials and guiding teams through risk assessment and mitigation exercises to formulate study quality plans.  Suzanne has also held roles in clinical research in both early and late stage development as a Protocol Lead and has also worked as a medical writer.

Suzanne holds a B.S. in biology from Temple University.

Dawn Niccum, Quality Manager, ENDOCYTE, INC.

Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP
Associate Director, Quality, ENDOCYTE

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Dawn Niccum has worked in the pharmaceutical industry and with clinical trials for more than 20 years. She started as a clinical study coordinator, moved to monitoring, and then to training and compliance. Currently she is Associate Director, Quality for a small biopharmaceutical company located in West Lafayette, Indiana. She has responsibilities for compliance in the clinical group, SOP development, Computer System Validation oversight, training and safety. She is certified as a CCRA, Project Manager; is a registered nurse; and holds a master’s in regulatory affairs and quality compliance.

Jennifer J. Poulakos, Ph.D.
Director, Development Quality Assurance, AGENSYS, INC., AN AFFILIATE OF ASTELLAS PHARMA, INC.

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Jennifer Poulakos is currently the Director of Development Quality Assurance at Agensys, Inc., a small biotechnology company owned by Astellas Pharma, Inc. Jennifer began her career in (biotech) drug development more than 20 years ago, overseeing early and late phase clinical programs. She worked on two programs through BLA submission and developed a strong relationship with and appreciation for clinical quality assurance. She transferred to a clinical quality assurance role approximately 10 years ago developing audit strategies for clinical programs, service providers and internal processes in which identified compliance risks were escalated and process improvement initiatives implemented. In addition, she led global inspection preparedness activities and managed sponsor and pharmacovigilance inspections.

April Rafkind, MSc
Director, Pharma Clinical Quality Assurance, NOVARTIS

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April Rafkind joined Novartis (East Hanover, NJ) Pharma Clinical Quality Assurance on May 2, 2016 and is currently Development Unit Head Clinical Quality, Respiratory.

Previously, April held various QA roles with increasing responsibility at Merck, Pfizer and Covance; as a champion for quality she has gained substantial quality management system experience, including clinical quality assurance, audit, regulatory compliance, inspection management and risk mitigation.

April holds an M.S. in clinical research organization & management from Drexel University College of Medicine, Pennsylvania, and a B.A. in psychology and sociology from Rutgers University, Rutgers College, New Jersey.

Patricia Santos-Serrao, RAC
Market Segment Director, Global Pharmaceutical, Blood and Biologics, MASTERCONTROL

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Patricia entered the life sciences industry more than 20 years ago, starting her career in industry working in regulatory and clinical at Schering-Plough and Boehringer Ingelheim Pharmaceutical. She later transitioned into the solutions provider sector, assisting various-sized life sciences organizations during her time at CDC Solutions, Liquent, CSC and QUMAS in implementing various business process solutions to global pharmaceutical, biotech and medical device organizations. She has taken a leading role in transitioning various organizations business processes around regulatory operations and clinical operations from paper to electronic systems for various business functions. Patricia is now a Director of Pharmaceutical and Biotech Solutions at MasterControl, a leading provider of quality management systems for manufacturing, clinical and regulatory areas of life sciences.

Stacy St. John, MBA
Director, GCP Quality Management System Strategy, Clinical Development Quality, PFIZER

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Stacy St. John has more than 15 years of experience in the pharmaceutical industry. Stacy joined Pfizer in 2007, where she focused on building and sustaining a quality culture, evolved Pfizer’s approach to quality standards, and led change management in clinical development. Over the past year, she led the development of Pfizer’s GCP Quality Manual and Vendor Quality Oversight. Stacy is a Director, GCP Quality Management System Strategy Lead with Clinical Development Quality, where she is accountable for establishing and driving a strategy and system to ensure a highly functioning Pfizer GCP Quality Management System (QMS) across clinical development.

Stacy attended Assumption College and received a bachelor’s degree in marketing, communication and economics. She received her Master of Business Administration from Quinnipiac University.

James Streeter
Global Vice President, Life Sciences Product Strategy, ORACLE HEALTH SCIENCES

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As the global head of life sciences product strategy for Oracle, James Streeter collaborates closely with Oracle customers, regulatory agencies, analysts and industry thought leaders to develop and help execute the overall business and product strategy for Oracle Health Sciences. He previously held leadership roles at PPD in both operations, as the Global Head of Global Clinical Technical Operations and EDC and recently in IT, as Global Head of Systems Development, Business Operations Teams, and eClinical Strategy and Innovation.

James has 29 years of data acquisition and analysis experience utilizing computerized systems and has focused on eClinical systems and processes for trials for the last 19 years. James’ experience includes implementing end-to-end eClinical Solutions and processes across all therapeutic areas and all phases of studies.

James’ early experience in eClinical was gained at Pfizer Inc., where he was Senior Director of Global Clinical Data Services, heading the global data acquisition department for the company’s global research and development organization. Prior to joining Pfizer, he was a Senior Hardware, Software and Systems Engineer for the U.S. Navy Underwater Sound Laboratory with a focus in data acquisition and analysis.

Liz Szczesniak
Director of Compliance, Vaccines Clinical Research and Development, PFIZER

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Liz Szczesniak has worked in the clinical trial space for more than 25 years.  From the laboratory bench to SOP and policy writing to quality and compliance, the journey has been filled with adventures in learning.  Liz is currently the Director of GCP Compliance with Pfizer Vaccine Research and Development, where she is responsible for driving compliance throughout all aspects of activities conducted by Vaccines Clinical Research and Development.

Steven Talerico, Associate Director, Clinical Quality Management, Inspections Lead, MERCK

Steven Talerico, M.S.
Director, GCP Inspection Management (GIM), Global Inspections Lead, Global Clinical Trial Operations (GCTO), MERCK

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Steve has more than 25 years of experience in the pharmaceutical industry. Starting as a co-op student working on his bachelor’s degree in biology, he has worked with Pennwalt, Wyeth, Astra-Zeneca, Schering-Plough and Merck. He has worked in the areas of pharmacology and toxicology pre-clinical research, clinical quality assurance, clinical corporate compliance and GCP inspection readiness and management. Presently, he is the Inspection Lead with the Clinical Quality Management Group at Merck. He has a bachelor’s degree in biology from Rochester Institute of Technology, a master’s degree in toxicology/environmental studies from University of Rochester School of Medicine and Dentistry, and a second master’s degree in pharmaceutical science from Temple University.

Mike Townsley
Director, Clinical Quality Assurance, TREVENA

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Mike Townsley is a highly skilled and accomplished QA professional with 18 years of increasing responsibilities across multiple functions, including clinical operations, QA, QC, Global Supply Chain and Safety. His therapeutic area experiences include oncology, cardiovascular, infectious disease, pulmonary, gastro intestinal auto-immune neurology and pain management. He has a bachelor’s degree in nursing by education and training. Mike has extensive experience in global quality assurance and quality compliance activities. He has more than 10 years of management and oversight of the Clinical Quality Assurance/Quality Compliance departments, including phase I-III domestic and international clinical trials audits. During his career, he has prepared, hosted, followed up and trained activities related to the FDA, MHRA and EMA GCP inspections. Mike has experience in large pharma and small startup activities, including the development of a Quality Management System (QMS); usage GXP regulatory knowledge and training to support the implementation of a Learning Management System (LMS). In addition, he has experience in the development and implementation of risk management assessment tools to identify, analyze and mitigate risk factors and experienced in CAPA management and execution of effective CAPA management tools. Mike is a strong leader who is personable, collaborative and driven to foster and support a team approach to influence others and build strong professional relationships.

Anne Verrocchi
Senior Associate Director/Principal Auditor, BOEHRINGER INGELHEIM

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Anne Verrocchi has worked in the pharmaceutical industry for 29 years. She began her career at Bayer Corporation in clinical data management before moving on to clinical quality assurance. After spending 13 years at Bayer, Anne joined Boehringer Ingelheim Pharmaceuticals, Inc. where she held several positions in Clinical Quality Assurance and Auditing. During her tenure at BI she has conducted QA audits of investigator sites (in the US, Canada, Latin America and Europe), CROs and internal systems, and has coordinated the internal system audit program at BI. Anne also has extensive experience in preparing investigator sites for health authority inspections and has participated in sponsor inspections by the FDA and EMA. In her current role as Senior Associate Director/Principal Auditor, Anne serves on an internal governance council empowered to make decisions on requests and updates to global standard operating procedures and is leading a project to develop an audit management system.

Dan Walsh
Director, Clinical Oversight, MYLAN

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Daniel Walsh is currently Director, Clinical Oversight at Mylan. Daniel has worked in clinical research in academic, CRO and sponsor settings within the areas of clinical operations, project management, training and development, and quality oversight. He has maintained a focus on systems, process, technology and training as drivers of quality and innovation. He holds a master’s degree in quality assurance/regulatory affairs. Daniel serves as an instructor within Temple University’s School of Pharmacy Regulatory Affairs and Quality Assurance Program.

Steve Whittaker
Senior Consultant, THE AVOCA GROUP


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Steven B. Whittaker is Executive Director for The Avoca Quality Consortium and Senior Consultant for the Avoca Group, where he conducts Quality Workshops, Executive Level Consulting for Pharmaceutical Quality, Clinical Development, Project Management, Sourcing, Alliance and Relationship Management. The Avoca Group is the driving force behind continuous improvement of outsourced clinical research. Through Avoca’s industry research expertise, 62 plus Consortium Members, and body of over 250 tools that empower and enable drug development teams, Avoca helps bring medicines to patients in a more effective manner..

Steve 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. His wealth of experience through years of drug development leadership roles and his established network with professionals across these industries provide a unique and valuable combination of insights for organizational leaders. Whittaker has served for 12 consecutive years on the Advisory Board for the annual Partnerships in Clinical Trials program, chairing the board for 2 years. In addition, Whittaker has moderated numerous 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 in December 2009 where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform. As the leader of the Global Clinical Research Sourcing Office, Whittaker established Lilly’s first corporate strategy and operational design for outsourcing global clinical development to CRO preferred partners. This included the selection and initial implementation of the preferred partner approach for global, full-service CRO capabilities. Whittaker also led Lilly’s Project Management Center of Excellence, establishing standards for leaders of project development.

Cheri Wilczek

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Cheri A. Wilczek, M.S., B.S., is the founder and President of ClinAudits, LLC, a recognized leader and independent, niche provider of domestic and international Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP) and Good Tissue Practice (GTP) auditing services and has managed its growth since the company’s inception in 1994. She has more than 35 years in the regulated pharmaceutical industry. ClinAudits assists clients in the pharmaceutical, biotechnology, tissue engineering, medical device industries, OTC, RX, gene therapy, and medical universities and institutions, and is focused on meeting end-to-end FDA and other governmental authority compliance requirements around the world.

The company operates strictly within the regulations/guidelines set forth by the FDA and other governmental authorities; regulations/guidelines designed to bring products to market which have demonstrated adherence to exacting standards in terms of manufacturing and production, field-proven efficacy and patient safety. Because we do not conduct or manage clinical trials (e.g., IVRS and EDC processes), ClinAudits is well positioned to emphasize our 100% objectivity and independence across a comprehensive portfolio of critical services.

ClinAudits is proud to have attained a Women-Owned Business Enterprise Certification.

Cheri obtained her Bachelor of Science degree from the University of Delaware and her Master of Science in Genetics from the University of Maryland.

Prior to founding ClinAudits, Cheri had prior positions with The Upjohn Company and Hoffmann La Roche.