Faculty – 8th Clinical Trials Inspection Readiness Summit

Kristen Bennett
Associate Director, Client Delivery, THE AVOCA GROUP

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A member of the Avoca Group’s integrated consulting and Avoca Quality Consortium® workstreams, Kristen Bennett provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across The Avoca Group.

Kristen has 12 years of clinical trial experience with expertise in clinical trial execution, process development, and strategic management. Her previous professional roles include project, data, and site management.

Kristen’s clinical research career began as a clinical research coordinator at a large academic oncology institution where she was responsible for the recruitment, intervention, data collection, laboratory, and data analysis for studies across multiple therapeutic areas. Kristen transitioned into a research supervisory role with the primary responsibility of developing and providing education, orientation, and continuing education programs relative to conducting research protocols. Kristen has also co-authored several scientific abstracts/poster presentations.

As project manager at various CROs, Kristen ensured operational excellence within the project management group across a portfolio of studies. She participated on the Steering Committee of each study to analyze trial progress and mitigate newly identified trial risks. She also developed and evaluated study performance metrics against agreed-upon budget deliverables and timelines. Additionally, Kristen managed and coordinated the efforts of cross-functional project teams to support milestone achievement while implementing continuous improvement activities for internal and external risk mitigation.

Kristen holds a bachelor’s degree in Biology from Kutztown University of Pennsylvania.

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.

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 (HRPP) at Yale University. Before joining Yale in April 2016, she held several positions at Quorum Review (now Advarra), 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. 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).

Linda is actively involved with several professional organizations and initiatives centered on human subjects research and recently accepted an appointment with the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Some of her areas of involvement include IRB harmonization, decentralized clinical trials, revised Common Rule and single IRB implementation strategies, research data protection, clinical trial process improvement, research quality and compliance, and the use of technology in research. She is also a frequent presenter and educator on a variety of topics such as operations management, research integrity, good clinical practice, research oversight, the operationalization of regulatory and institutional requirements pertaining to research, and global bioethics.

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

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Christina DeLuca is an Associate Director-GCP Inspection Lead for Merck & Co., Inc. and has been in this position since 2016. In this role, her responsibilities include: ensuring that Health Authority inspections are adequately managed, supported, and facilitated; coordinating the preparation, conduct, and follow-up of any Health Authority inspection of a Merck sponsored clinical trial; and implementing processes, activities, and training pertaining to inspection activities. Prior to joining Merck, Christina was an Inspection Manager for Pfizer Inc. In this role, she supported GCP and Pharmacovigilance inspections conducted globally by Health Authorities. Prior to joining Pfizer, Christina was an Investigator/Consumer Safety Officer for the U.S. Food and Drug Administration since 2009, in which she conducted inspections of a variety of types of establishments with concentration in BIMO and Biologics, assuring compliance with the Compliance Programs and Federal Regulations. Christina has prior experience as a Clinical Research Coordinator and earned a B.S. in Biology from Montclair State University.

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 has more than 15 years of experience in Quality Assurance. She began her career at the Dana-Farber/Harvard Cancer Center, where during her 14-year tenure, she served as Director of the Quality Assurance Office for Clinical Trials.

Alyssa joined Yale University in July 2014 and is currently the Associate Director of QA at the Yale Center for Clinical Investigation (YCCI). 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.

Alyssa received her Masters of Public Health from Boston University and is a Certified Clinical Research Professional (CCRP). She has served on national committees including a three-year term on the American Association of Cancer Institutes: Clinical Research Initiative’s Steering Committee. She was the the President of the Boston Chapter of the Society of Clinical Research Associates (SoCRA) from 2010-2014 and is currently the President of the SoCRA Greater New Haven Chapter.

Darshan Kulkarni
FDA Regulatory and Compliance Attorney, THE KULKARNI LAW FIRM

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Dr. Kulkarni is Principal Attorney at the Kulkarni Law Firm and is responsible to help guide policy development and engagement strategies using various methodologies including, but not limited to clinical trial transparency, and patient centricity using technologies like artificial intelligence, blockchain, big data etc. He is also asked to help with regulatory strategy development, clinical trial contract negotiation and responding to titled and untitled letters.

He has multiple patent filings to his name and owns various forms of intellectual property rights including copyrights, trademarks etc.

He is routinely called on because of his almost 20 years of experiences working on the legal and regulatory requirements associated the Food Drugs and Cosmetics Act, state and federal versions of the Anti-Kickback Law, Civil Monetary Penalties Act, False Claims Act, Sunshine Act, HIPAA, 21st Century Cures Act etc.

He regularly works with issues relating to a variety of local, state, federal and international agencies including, but not limited to the United States (US) Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Drug Enforcement Administration (DEA), United States Department of Justice (DOJ) and International Conference on Harmonization (ICH).

Dr. Kulkarni has over 20 years of experience as a clinician having worked in numerous pharmacy settings including retail, hospital, long term care, hospice and others.

He lectures and teaches extensively globally on various issues relating to the life sciences including in academic settings like Johns Hopkins University, Thomas Jefferson University Medical School, Temple Law School and Temple pharmacy school, Drexel University, University of Florida, University of Southern California etc. He is currently Visiting Professor at the University of the Sciences, in their Biomedical Writing Program, where he has taught for over 10 years and received an Outstanding Adjunct Teaching Award and is Visiting Professor at the Children’s Hospital of Colorado. He regularly gives keynote talks at various events including DIA, and AALNC and others.

Dr. Kulkarni serves on various Editorial and Advisory Boards including for FDANews and Applied Clinical Trials. He serves in the American Bar Association where he participates and is actively involved in the Healthcare Fraud Section, Life Sciences Section, and Distance Learning Section. He is a former board member of the National Bar Association’s Health Law Section.

Most recently, Dr. Kulkarni has written several articles, and chapters for textbooks including the chapter on Medical Devices, Drug Advertising, Drug Compounding, and pharmaceutical reimbursement for the Second, Third, Fourth and upcoming Fifth Edition of Pharmaceutical and Medical Device Law – Regulation of Research, Development, and Marketing, Second Edition – the American Bar Association’s flagship textbook for pharmaceutical and medical device law. He is currently working to submit his chapter on FDA Regulated Research for the latest edition of the Research Compliance Professional’s Handbook.

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.

Tian Luo
Clinical Inspection Readiness Leader, SANOFI

Stephanie Mangigian
Commander, United Public Health Service, Certified Bioresearch Monitoring Specialist, FOOD AND DRUG ADMINISTRATION

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Stephanie was hired by the FDA in 2002 and spent the majority of her FDA career as a Consumer Safety Officer working as a Generalist in several program areas, such as: foods, biologics, pharmaceuticals, medical device, radiological health, emergency response, and State Programs. The last three years she concentrated on the bioresearch monitoring program and became certified as a specialist.

Prior to her working for the FDA, Stephanie worked for the Center for Medicaid and Medicare Services, Office of Emergency Preparedness, Bureau of Prisons and the Indian Health Service.

Stephanie served two agencies, the United States Public Health Service (USPHS) as a Commissioned Corps Officer and currently holds an Investigator position within the FDA. She transferred from the U.S. Air Force Reserves into the USPHS in 1996. Prior to her Commissioning as a Corps Officer, she was a flight nurse in the U.S. Air Force Reserves and the U.S. Air National Guard. She has worked as a nurse in the private sector and government for the past 37 years. She has continued her clinical practice by working part time as a home health nurse for Bayada Home Care Specialists.

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.

Eric Rubinson

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Eric Rubinson joined Intra-Cellular Therapies (ITI) in January 2019 as Director of R&D Solutions. In his role, Eric partners with R&D leadership to identify, evaluate, plan, and deploy process and technology improvements. Eric is currently leading an end-to-end TMF Transformation initiative at ITI.

Eric has served on both the sponsor and consulting side of the TMF world. Prior to joining ITI, Eric led the Global TMF Operations and Compliance function at Allergan and served as a TMF SME with CGI. Eric has also been a Steering Committee member for the TMF Reference Model.

Eric lives in NJ with his wife and two boys.

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.

Nelson A. Vega
Manager, Quality Assurance, UNIVERSITY OF MIAMI

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.