Faculty – 9th Clinical Quality Oversight Forum

Kenneth A. Getz, MBA
Chairman, CISCRP


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Kenneth A. Getz is the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategies and tactics, outsourcing, and global investigative site and patient recruitment practices and policies. He is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise.  Ken is also the founder and owner of CenterWatch, a leading publisher in the clinical trials industry, and a board member of the Metrics Champion Consortium, LLC.

A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press.  He is the author of two nationally recognized books for patients and their advocates entitled Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation, and he is the recipient of several awards for innovation and scholarship.  Ken has held a number of board appointments in the private and public sectors including serving on the Institute of Medicine’s Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative. He is on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science, writes a bi-monthly column nominated for a Neal Award in 2010 for Applied Clinical Trials, and has been twice nominated for Tufts University’s Distinguished Service award.

Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Ken worked for more than seven years in management consulting where he assisted biopharmaceutical companies develop and implement business strategies to improve clinical development performance.

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.

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.

Miah Jung, Pharm.D., M.S.
Pharmacologist, Office of Scientific Investigations, Office of Compliance, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), FDA

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Miah Jung is a Pharmacologist in the Good Clinical Practice Team, Compliance Enforcement Branch, Office of Scientific Investigations, Center for Drug Evaluation and Research (CDER), FDA. She has been with FDA for 5 years. In her work, she is responsible for helping to ensure human subject safety and data integrity in clinical studies as part of FDA’s BIMO program. Prior to FDA, she has worked in academia coordinating clinical research studies.

Maryann Livolsi, MSN, RN

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Accomplished leader in R&D Quality Assurance with effective management experience worked in small, mid-sized, large pharmaceutical/bio-pharmaceutical and a non-profit bio-pharmaceutical company, in depth knowledge in clinical trial management, GXP auditing, process gap analysis, SOP development and regulatory inspections. Effectively lead process for Quality and Performance Metrics Dashboards for R&D Compliance, adjunct professor for Drexel University Clinical Pharmacology Master’s Program, presents at industry related conferences including Linking Leaders and Exl Pharma. Over 25 years of clinical research experience. Six Sigma Graduated Rutgers University with a Bachelor’s Degree in Nursing and received a Masters of Nursing Administration from University of Pennsylvania and The Wharton School.

Marion Mays
VP Client Solutions and Quality Assurance, PHLEX GLOBAL

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Marion Mays has worked for 23 years in the pharmaceutical industry and eight years as a leader in the Information Management division. She has implemented global records management processes, cloud-based and secure document management solutions for the Trial Master File (TMF), along with adoption of the DIA model. Throughout these technical advances, she continues to be an advocate for essential information management practices and competent training for all contributors and consumers of the TMF, and she understands the vast potential for rigor managing the TMF to advance clinical outcomes.

Cheryl McCarthy, RQAP-GCP, CQA, CBA
Director, Research Quality Assurance, IRONWOOD PHARMACEUTICALS

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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.

Jonathan Rowe, Ph.D., M.S., M.A.
Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

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Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Christine Sahagian, Head of Registries and Late Phase QA and Compliance, SHIRE

Christine Sahagian
Head of Registries and Late Phase QA and Compliance, SHIRE

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Christine has more than 20 years of experience in the clinical trial industry. She began her clinical research career at Parexel in the data management group, followed by a move to a small CRO (CareStat/Battelle CRO), where she expanded her career into clinical monitoring and project management. After more than 12 years of working for CROs, she decided it was time to test the waters working at sponsor companies. Christine has had roles in outsourcing, clinical compliance, and clinical QA and compliance at Vertex, Biogen and Cubist. At Cubist, she established the Clinical Trial Oversight and Compliance group and led process improvement efforts in areas such as clinical vendor oversight, site/monitoring quality oversight, clinical quality systems (issue management and CAPAs) and inspection readiness. She is currently the Head of Registries and Late Phase QA and Compliance at Shire, where she is leading an effort to establish a compliance framework for management and oversight of registries and other late phase research. She has a B.S. in chemistry and an M.S. in nutrition from Tufts University and is a lifelong resident of the greater Boston area.

Dennis Salotti, M.S., MBA, CCRA
Chief Operating Officer, THE AVOCA GROUP

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Dennis Salotti is COO of The Avoca Group and lead for the Diligent® Qualification Platform, the clinical research industry’s first centralized platform for clinical service provider qualification.

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

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

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

Stacy St. John
Director, Clinical Development Quality – Vendor Quality and Quality Culture, 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.

Krista Tibbs
Specialist, Clinical Development, HALLORAN CONSULTING GROUP

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Krista Tibbs has over 15 years of clinical development experience focused on strategic planning and project execution. Her therapeutic expertise includes oncology, pulmonology, and neurology, and her product knowledge includes monoclonal antibodies, cell replacement, gene therapy, small molecules, and xenotransplantation.

Before joining Halloran, Krista held roles of increasing responsibility with Genzyme Corporation, monitoring and managing early phase studies for rare conditions and neurodegenerative diseases. As Associate Director of Clinical Research, she led a cross-functional development team through early phase acquisition and subsequent stage gates and participated in task forces for due diligence, protocol feasibility, and case report form design. With the clinical research organization PAREXEL International, she worked as a cross-functional project leader for U.S. and global studies. Most recently, she served the site management organization Center for Biomedical Research working with oncology and pulmonology patients and executing Phase I, II, and III studies with over 20 industry sponsors and a variety of CROs, vendors, and systems.

Michael Torok, Ph.D.
Clinical Quality Assurance Head, ASTELLAS

Shelly Weeks-Townsend, M.S., CQA
Director, Quality Assurance, ZYNERBA PHARMACEUTICALS

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Shelly Weeks-Townsend is the Director of Quality Assurance at Zynerba Pharmaceuticals. Shelly has worked in the pharmaceutical industry for more than 27 years with experience spanning from bench chemist through product launch and post marketing surveillance. Over the past year with Zynerba Shelly is continuously building and sustaining a quality culture both internally and with external contract service providers. Her latest endeavors include leading the revisions to Zynerba’s Quality Plan, Role of the Quality Unit Procedure and Contract Service Provider Quality Oversight processes. As the QA Director, Shelly is accountable for establishing and driving systems to ensure GMP production and release of clinical trial materials, GCP Quality support for clinical trials and vendor management auditing program. Shelly developed a breadth experience with International and US Regulatory bodies. She has hosted MHRA and FDA inspections with her former employers and developed inspection ready procedures as well as conducted mock inspections and mock recalls.

Shelly is a Magna Cum Laude graduate of Virginia State University, where she earned a Bachelor of Science degree in Chemistry. She received her Master of Science degree in Organic Chemistry from The Ohio State University.

Jane Wood
Quality Center of Excellence Lead, YOUR ENCORE

Former Vice President and Head, BioResearch and Quality Compliance, JOHNSON & JOHNSON

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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.

Steve Young
Chief Operations Officer, CLUEPOINTS

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Steve holds a Masters degree in Mathematics from Villanova University. He worked for three biopharmaceutical companies over a span of 15 years, where he assumed leadership positions in clinical data management and led the successful enterprise roll-out of EDC at both J&J and Centocor. He spent an additional six years with Medidata and then OmniComm, leading the development of analytics and risk-based monitoring (RBM) solution portfolios and providing RBM and clinical operations consulting to many organizations. He also led a pivotal RBM-related analysis in collaboration with TransCelerate and has co-authored two patents related to RBM methods.