Faculty – 10th Proactive GCP Compliance

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.

Reetu Dandora
Executive Director, Strategic Quality Oversight Lead, MRL QUALITY ASSURANCE

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Reetu Dandora has over 18 years of experience advising clients in the pharmaceutical and health care industries on a wide array of strategic initiatives. Reetu joined Merck’s Office of General Counsel in 2009 and, since then, has gained expertise in issues arising from clinical research and US regulatory and commercial matters.In particular, since 2014, she has supported a number of clinical trial-related matters with the goal of ensuring that company-sponsored clinical studies are conducted consistent with regulatory and ethical requirements across the globe. She joined MRL Quality Assurance in January 2018 and focuses her efforts on developing strategies that provide end-to-end support related to the overall management of data quality and integrity matters throughout the drug development process. She also supports health authority interactions associated with inspections and data quality and integrity matters. Prior to joining Merck, Reetu was a Partner in Reed Smith LLP’s Philadelphia office where she represented pharmaceutical companies in product liability matters, including mass torts, class actions and personal injury cases. Reetu has a BA in Political Science from the University of Pennsylvania and a JD from the George Washington University Law School.

Greg Dombal

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Greg joined Halloran Consulting Group in 2007.  He focuses on helping emerging companies navigate challenges in product development while establishing appropriate clinical, regulatory, and compliance structures. Greg represents clients to worldwide regulatory agencies and routinely functions as an on-demand Head of Regulatory, Clinical, or Development.

Greg pairs over 25 years’ experience in worldwide regulatory affairs, quality assurance and clinical development with a willingness to challenge conventional, conservative approaches and find the best solution for each company and their products.  Before joining Halloran, Greg was responsible for the regulatory, quality assurance, and clinical groups at ArQule. At its peak, the programs he was responsible for encompassed 17 clinical studies with annual budgets in excess of $25 million.

Over his career, Greg has successfully filed over 45 clinical trial applications (IND, IDE or equivalent), attended over 75 regulatory agency meetings, presented to multiple Advisory Committees and helped companies respond to Warning Letters, 522 Orders, and Clinical Hold notices.  He has obtained Orphan Drug designation and/or Fast Track designation for fifteen individual products, successfully negotiated multiple Special Protocol Agreements, and has extensive involvement with NDA/MAA submissions resulting in multiple product approvals.

Greg holds a Bachelor of Science in Biology from the University of North Carolina at Chapel Hill. He is also a certified PROSCI change management professional from Colorado State University. He is involved with many non-profit organizations; as an advisor to the Fit Girls Foundation a 501(c)(3) building strong, brave and fit young women; as a past president of Marblehead Youth Baseball, and was a founding board member of the TriROK Foundation a 501(c)(3) dedicated to eliminating childhood obesity.

Jason Donnelly
Director, Clinical Quality and Compliance, SCHOLAR ROCK, LLC

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Jason Donnelly is currently Director, Clinical and Quality Compliance at Scholar Rock, a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role. In his role Jason is responsible for building and maintaining Quality Management Systems and guiding GxP compliance risk mitigation and management strategies.

Jason has 14 experience in GxP compliance with the last 5 years focused solely on GCP compliance at Vertex Pharmaceuticals and Merrimack Pharmaceuticals. Jason received an MSc in Drug Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy and Health Science in 2006.

Deb Driscoll
Vice President, Quality Assurance, MERCK RESEARCH LABS

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Deborah Driscoll has more than 20 years of broad experience in academia and the pharmaceutical industry.  She began her career in 1984 working as a research technician at the Boston VA Medical Center and Boston University.  In 1986 she began her career in industry at Hoffmann-La Roche as a pharmacology research scientist working in preclinical neuroscience research.  In 1990 she transitioned from the laboratory to clinical research working as a clinical research associate in oncology and AIDS research.  Deborah has spent the majority of her career at Pfizer, most recently in the role of Vice President of Quality Assurance and  led the group through June 2015.

Deborah joined Merck as the head of Quality Assurance in July 2015, assuming responsibilities for GCP, GLP and GPvP in addition to Animal Welfare oversight within Merck Research Laboratories.  In 2014 Deborah assumed the leadership role for TransCelerate BioPharma Inc. Clinical Quality Management System Team working with 20+ member companies to develop and advance a clinical quality framework to enable consistent and timely delivery of reliable data that may be used by an organization, its partners, regulators, clinicians and patients to make informed decisions.  Deborah holds a B.S. in animal science and an M.S. in biology.

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.

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.

Dr. Jeff Kingsley

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Dr. Jeff Kingsley received his Bachelor of Science degree from the University of Scranton in 1995 with concentrations in biology, chemistry, history, and cultural anthropology, and his Master of Science degree in 1997 in biochemistry. His medical degree was received from the Philadelphia College of Osteopathic Medicine in 2001 and his MBA was received from Emory University’s Goizueta Business School in 2011.

Dr. Kingsley has been faculty with the Columbus Regional Health Family Medicine Residency as well asDirector of Family Medicine and Urgent Care.He currently holds faculty appointments with the Mercer School of Medicine and thePhiladelphia College of Osteopathic Medicine Georgia.

Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices in multiple cities in two states. The family of companies conduct phase Ib through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006.

Dr. Kingsley is the past Chair of the Board of Trustees for the Association for Clinical Research Professionals which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees. Dr. Kingsley obtained his CPI in 2009 and his FACRP in 2017.

He enjoys each day with his wife Christine and four beautiful children.Dr. Jeff Kingsley can be reached at 706-536-6619 and JKingsley@IACTHealth.com

Cheryl McCarthy, RQAP-GCP, CQA, CBA
Associate Director, R&D Quality and Compliance, BIOGEN

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Cheryl McCarthy has over 20 years industry experience in a regulated environment. Her GCP experience includes the development and management of Quality Management Systems, Audit Programs, and Computer System Validation Programs. She is currently at Biogen in the role of Associate Director, R&D Quality and Compliance managing their GCP Audit Program. She is a certified SQA RQAP-GCP and ASQ CQA and CBA. She participates regularly in industry events where she speaks on GCP Topics.

Dawn Niccum, Quality Manager, ENDOCYTE, INC.

Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP
Senior Director, Quality Assurance and Compliance, 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.

Dave Nickerson
Head of Clinical Quality Management, EMD SERONO

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David Nickerson is the Head of Clinical Quality Management at EMD Serono. In this role he has global responsibility for the strategy, implementation and oversight of a risk-based approach to quality planning, control, and improvement for the clinical development portfolio and associated business processes. Prior to joining EMD Seronoin 2016, David was Senior Director in Clinical Development Quality at Pfizer where he was responsible for the development and implementation of a comprehensive approach to quality risk management in clinical trials and for leadership of the Clinical Development Quality organization in China. David was a member of the Expert Working Group that was responsible for the development of ICH E6 R2.

April Rafkind, M.Sc.
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.

Sharon Reinhard, M.S.
Clinical Compliance Solutions, Consultant on Assignment, MERCK

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Sharon Reinhardhas over 20 years of industry experience comprised of a unique blend of roles in clinical development, operations, compliance and quality assurance.She has worked for large companies such as Wyeth, mid-sized companies such as Shire and Endo and small biotech companies like Solstice Neurosciences and iCeutica.

Prior to joining the industry, Sharon spent 4 years working in academic research at the University of Pennsylvania.She has developed expertise in GCP, risk-based approaches, quality by design and inspection readiness.During her career, she has supported 10 NDA filings, over a dozen Sponsor regulatory inspections and performed countless vendor, site, document and process audits.

Sharon has published over a dozen abstracts and articles related to clinical research.She has also served as chair and/or speaker at numerous industry conferences.She earned her undergraduate degree from the University of Pennsylvania in Biology and English and her Masters of Science in Pharmaceutical Sciences from Temple University School of Pharmacy.In 2014, Sharon transitioned to independent consulting to provide “right-sized” clinical development and QMS services to a variety of pharmaceutical and biotechnology companies. In November, 2018, she joined Merckin the Quality Assurance division after supporting the company in a consulting role the previous 2 years.

Karin Rezzonico
Associate Director, Clinical Quality Compliance, INSEPTION GROUP

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Karin Rezzonico is Associate Director, Clincial Quality Compliance for the InSeption Group and responsible QA compliance activites, with a focus on TMF process development to drive quality and efficiency as well as development, implementation, and management of the eTMF. She was formerly at Genentech as a Communication and Change Manager for Clinical Operations. With over 18 years of pharmaceutical and biotech industries experience, Ms. Rezzonico holds a Master’s Degree in Biology, Mini MBA in BioPharma Innovation and is a Prosci certified Change Management Practitioner.

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.

Jolie Weintraub
Executive Director, Quality Assurance, Therapeutic Area Head-Oncology, MERCK

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.

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.

Michael Wieczerak
Associate Director, Clinical Quality Management, EMD SERONO

Jane Wood
Quality Center of Excellence Lead, YOUR ENCORE

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Building on 40 years of industry and leadership experience, Jane brings a wide range of Quality & Compliance experience to Your Encore, tailoring Quality Management Systems, aligning with ICH E6 (R2) and other regulations, developing strategies for weaving the business and R&D quality together, consulting on R&D quality and compliance issues, helping prepare for, mitigate, and resolve global regulatory actions, including mock Inspections, assessments and audits.

Jane most recently led the R&D Quality & Compliance function for Johnson & Johnson, leading a global team of 360 colleagues with broad-based GXP compliance responsibilities across the Pharmaceutical, Medical Device, and Consumer sectors.

Jane began her career in the UK in the Blood Transfusion Service as a GMP Production Manager and then progressed to head up Quality in a Scottish CRO. During her tenure at the CRO Jane assumed leadership across all the GXP QA functions including IT, Animal Health, GMP, GLP, GCP, and ISO 9001. Following these broad-based career experiences in the Quality arena, Jane moved to Italy to gain International experience. During the next several years, along with a succession of mergers and acquisitions, Jane headed up diverse and increasingly large global Quality and Compliance functions including Pfizer and Johnson & Johnson.

Jane has a passion of helping people love quality, she enjoys finding solutions that focus on issues that matter, She also worked actively with the industry and regulators on a Clinical QMS via the TransCelerate BioPharma Consortium.

A frequent speaker at Quality events and conferences and writer of quality articles on LinkedIn, Jane is experienced, business focused and pragmatic.

Liz Wool

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With 37 years in healthcare and 25 years in clinical research, Liz is a recognized industry expert, consultant and international speaker with a focus on solutions and added value results for her clients. Liz’s expertise is in the areas of clinical research, trial management, clinical quality management systems, vendor management and oversight, compliance, operations, personnel training and development, and performance management methods. Therefore, Liz’s services and solutions produce results in both organizational effectiveness and efficiencies (design, re-design, and modifications for growing companies as well as companies after mergers and acquisitions) in support of organizations’ goals.

Liz’s strategic, operational, leadership and facilitation expertise, combined with her spirit of teamwork, brings the ability to swiftly identify the organization’s challenge at both the departmental and enterprise level. In determining solutions for her clients, Liz draws on her experience working with the full range of national and international stakeholders in clinical research for the design, development and deployment of their solutions. She has worked with medium-sized pharma and large pharma; virtual, small and large biotechnology companies; Contract Research Organizations (CROs); National Institutes of Health (NIH); Department of Defense researchers; academic medical centers; and a national healthcare organization. This experience and expertise results in Liz’s ability to provide solutions – focused services and recommendations that are a “right fit” for an organization’s size, scope of business, business plan, business goals and culture.

Liz has provided consulting services to six of the 21 TransCelerate Biopharma, Inc. companies during her consulting tenure in the areas of department-level strategic support, SOPs and performance management (post-merger/acquisitions), vendor program gap analyses, enterprise-wide training strategy and framework gap analyses, training courses, and metrics.