Faculty – 7th Clinical Trials Inspection Readiness Summit

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.

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.

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.

Elias Dorfman
Director, Headquarters Clinical Quality Management, MERCK

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Elias Dorfman is the Headquarters Clinical Quality Manager leading ID & Vaccines at Merck & Co., responsible for implementing risk based quality management via development of Risk Assessments and implementation Quality Plans, as well as working with teams to ensure ongoing inspection readiness, providing quality oversight of trial conduct, managing significant quality issues and supporting both inspection preparation and inspection conduct.

Elias has over 20 years experience in various aspects of the pharmacuetical industry, including pharmaceutical, biotech and CRO. During that time he has held clinical operations roles as CRA, Project Manager as well as Clinical Quality Management roles at the Country-level and now within Headquarters operations. Elias has supported numerous inspections at clinical investigator sites and Sponsor during that time. In addition to clinical research-related roles Elias also has extensive experience in bioanalytical assay development and validation (HPLC, LC/MS, GC/MS), and in computer systems validation and implementation of computerized systems in the laboratory setting.

Elias earned a degree in Biochemistry from Concordia University in Montreal, Quebec (Canada) and is a PMP-certified Project Manager.

Kathy Goldstein
Sr. Director, Quality Management Lead, REGENERON PHARMACEUTICALS

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Kathy Goldstein is currently the Sr. Director, Head, Quality Management Lead at Regeneron Pharmaceuticals. In this position, Dr. Goldstein leads a team of Quality Management Leads who ensure quality and compliance for all global clinical study activities. The quality management lead team is responsible for providing guidance, interpretation, support, training and key input to clinical study teams on GCP regulations, guidelines, corporate standards and policies. The team also participates in GCP inspections and leads inspection preparation activities with clinical study teams.

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 and compliance, and project management. Prior to joining Regeneron Pharmaceuticals, she has held quality / compliance roles, along with extensive operational experience as a CRA and clinical program manager where she managed study teams, timelines and deliverables to ensure the overall success of sponsor programs.

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.

Gerry Grove
Director, Clinical Operations, Respiratory, Inflammatory and Autoimmunity, MEDIMMUNE

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Gerry is a Director of Clinical Services at MedImmune, a subsidiary of AstraZeneca and is responsible for cross therapeutic, process improvement initiatives in Clinical Biologics. She has 25 years of experience in a variety of Clinical Development and Clinical Operations roles and has extensive experience of all stages of trial development and processes to support the conduct and oversight of clinical trials. Gerry has a degree in Physiology (B.Sc. Sp Hons) and a Ph.D. in Nutrition.

Sheila Gwizdak

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Sheila joined Halloran Consulting Group in 2018. She has over 18 years of experience in the biotechnology and pharmaceutical industry. Her career has focused on quality, process improvement, and training including the execution of corporate and department-level quality assurance initiatives such as SOP development, compliance, gap analyses and remediation, inspection readiness, audits, and training. Sheila also has specific experience in inspection readiness activities (FDA, EMA, MHRA, and PMDA) including storyboard development, coaching, and conducting mock inspections.

Before joining Halloran, Sheila was a director at Alexion where she supported the development and implementation of a quality management framework that included the standardization of procedures, systems, training, and processes. Before joining Alexion, Sheila held a series of progressive positions with Pfizer, Inc. in clinical quality, operations, and training.

Sheila earned a Bachelor of Science in education from Central Michigan University and a Master of Science in management from Rensselaer Polytechnic Institute.

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.

Carrie Lauer
Senior Manager Clinical Operations, GE HEALTHCARE

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Carrie Lauer has 14 years’ research experience, with nearly 12 years in the drug and medical device industry. She currently leads the Clinical Affairs Operations team at GE Healthcare – one of the world’s largest medical device companies.

Carrie has a Master’s degree in Biology and began her post-graduate career studying the NCE potential of fungal secondary metabolites. Throughout her career, she has held positions ranging from bench scientist and study coordinator to director of research and analysis and clinical study manager. Before joining GE Healthcare, she was a QM process lead and implemented a risk-based QM model for her department.

In her current role, Carrie leads a global team of medical writers, biostatisticians and data scientists, data managers, and monitors. This incredible team designs, conducts, and reports on GE-sponsored trials that support commercialization of GE Healthcare medical devices. Her team’s mission is improving lives in moments that matter by delivering quality clinical research with transparency, compliance, accountability, and integrity.

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.

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.

Sarah O’Hora
Director, Vault Clinical, VEEVA

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In her role as Director, Vault Clinical, Sarah is responsible for growing Veeva’s clinical market by providing thought leadership and sales support to teams in the field and driving product development and market strategy for eTMF, SSU and CTMS. She also has a keen focus on educating the market on Veeva’s strategy in the clinical content management and trial execution space and helping Veeva customers improve how they use Vault Clinical products. Prior to joining the clinical strategy team, Sarah spent three years in professional services at Veeva and was responsible for the successful eTMF implementations of several top 20 pharma companies. She brings over 10 years experience in the clinical operations space and has held a variety of roles in research site, CRO, and sponsor settings; experience that she leverages to help the industry think about solving challenges in new ways through the use of technology. Sarah holds a B.S. in psychology and a B.A. in women’s studies from Tulane University.

Vaishali Shukla
Head of Clinical QA and Product Quality Management, UNIQURE

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Vaishali Shukla is the Head of Clinical QA and Product Quality Management at uniQure. Vaishali is a Quality Compliance leader with over 14 years’ of experience in the biopharmaceutical industry, with expertise in a broad variety of subjects ranging from early clinical development (IND/NDA/ANDA/BLA) to commercialization of biologics & small molecules (solid oral dosage forms/liquid/inhaled). Vaishali started her career in Quality Assurance at BioVest Internationals, where she implemented novel processes for continuous development. She went on receive recognition for her contributions to the Quality systems at both Takeda and Shire Pharmaceuticals. In her current role at uniQure she is leading Quality Management and Clinical QA Teams responsible for Clinical Quality, Quality Systems, Partnerships, and Continuous Improvement. Vaishali holds a BS in Biology, a Masters in Botany, a Masters in Regulatory Affairs for Drugs, Biologics and Medical Devices, MS in Pharmaceutical Economics and Policy and is currently a Ph.D. candidate for Pharmaceutical Science.

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.

Ann Taylor
Inspection Readiness Lead, Director, PFIZER

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Ann Taylor has 20 years of experience within 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 driving proactive inspection readiness across many clinical teams as well as when there is a high likelihood of a regulatory inspection. She interfaces with each team to complete inspection readiness tools which help identify gaps and potential inspection risks in addition to ensuring they are current with recent inspection experiences. She leads teams through pre-submission inspection readiness deep dives and storyboarding. Ann supports and leads key activities in the control rooms as required during regulatory inspections and provides input during 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.

Katherine Taylor
Director, GCP Inspection Lead/ 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.

Rick Ward
VP, Commercial Operations, TRIFECTA CLINICAL

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Rick is the Vice President of Commercial Operations at Trifecta responsible for delivering strategic growth via comprehensive leadership across business development, sales operations and marketing. In his role at Trifecta, Rick serves as a key member of the executive team to deliver innovative results, including his active pursuit to help clients achieve a perpetual state of inspection readiness across their entire research portfolio. Rick’s deep industry experience combined with his goal-oriented, passionate and highly collaborative nature have delivered results across the board for sponsors, CROs and biotechnology companies in areas ranging from patient recruitment, clinical trials, post marketing studies and outsourced services.

Prior to joining Trifecta, Rick held various leadership positions within the healthcare industry including PAREXEL, MedAvante and Greenphire. Among his many accomplishments as Vice President of Business Development at Greenphire include his role in driving growth from a company of sixteen employees with less than a million in sales to a company of 120 with more than $25 million in sales.

Rick is a graduate of Penn State University and remains an active alumnus serving the Smeal College of Business. Rick also serves as an Advisory Board Member for the Society for Clinical Research (SCRS).

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.