Deputy Director of the Office of Medical Policy
Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama, as well as a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health.
Artem Andrianov, PhD, serves as CEO for Cyntegrity. He graduated with Ph.D. in Mathematical Modelling, and executive Master of Business Administration from Cass Business School, London.
- 25+ year of experience in data quality projects, RBQM and biostatistics for pharmaceutical industry. Special expertise in such topics as: Spirometry, ECG, Oncology, ePROs, clinical data management.
- Life passion: do clinical trials safer and more reliable, improving clinical research with Risk-based Quality Management (RBQM) and drive the concepts of RBQM to new frontiers.
- In 2013 he founded the RBQM company — Cyntegrity, which focuses on data-driven risk management in clinical trials
Associate Director, Performance & Training (ECO Team), Clinical Operations
Jazz Pharmaceuticals (formerly GW Pharma)
Steve Crow has over a 16-year career with GW Pharmaceuticals and spent five years as a CRA, five as a Clinical Project Manager and four managing programs of clinical trials. He is currently responsible for the framework, tools and processes relevant to performance and training within the Excellence in Clinical Operations team at GW.
Senior Director, Clinical Oversight, Systems and Training
United Therapeutics Corporation
As a Senior Director in Clinical Operations at United Therapeutics, Maureen Cunningham leads teams responsible for Clinical Oversight, CTMS and RBQM Systems and Informatics, and Training and Standards of UT Clinical Studies. Maureen has held a number of roles throughout the years encompassing monitoring, quality, project management, process improvement, TMF and quality risk-based management. A lifelong learner, Maureen’s educational background consists of medical lab technology, nursing, liberal studies, PMP certification and most recently a Master of Management in Clinical Informatics from Duke University School of Medicine.
Dorricott Metrics and Process Improvement Ltd
Keith Dorricott, Contractor for the Metrics Champion Consortium and Director, Dorricott Metrics & Process Improvement Ltd., has a background in manufacturing with Kodak Ltd. He worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs.
Halloran Consulting Group
John Ferraro has more than 28 years of experience in Clinical Operations/Development within the biotechnology and pharmaceutical industry. During this time, he has been successful in all sizes and types of organizations as well as a myriad of therapeutic areas most recently oncology, hematology, immune-oncology, and rare disease. John is an expert clinical operations leader who excels at operational strategic planning, oversight, and delivery of clinical development programs.
Prior to joining Halloran, John led his own consulting firm, JnC Clinical, where he was engaged with organization types including a global CRO, a medical device startup, and a generic company as their Vice President of Clinical Operations or expert Clinical Advisor. Before, JnC Clinical, John was the Vice President of Clinical Operations for Fate Therapeutics, Inc. While at Fate, John rebuilt the Clinical Operations and Data Management Departments while being accountable for strategy, planning, and execution of all clinical programs in all phases of development. John spent over 8 years at GlobeImmune, Inc. as Senior Director of Clinical Operations. He was brought onboard by the founding scientists as one of the company’s first six employees. John was tasked to create and implement the infrastructure of the Clinical Operations Department globally. He was accountable for operational oversight of all clinical development programs. John spent his early career as a regional CRA for SmithKline Beecham and a Clinical Trial Manager at Pfizer where he performed all site management activities as well as managed the pivotal Inhaled Insulin Trials. He was also a clinical research coordinator at a clinical research site.
Chief Operating Officer
Triumph Research Intelligence
Vice President of Clinical Operations
Matt Healy has over 24 years of clinical research experience, spanning both academia and the CRO industry. For the last 15 years, Matt has been focused on supporting the development and management of clinical operations across a variety of global clinical programs. He has extensive experience in the implementation of processes and procedures used by the clinical operations teams to successfully manage clinical studies across all stages of development from Phase I through Phase IV.
Head of Customer Success
Todd Johnson claims more than 20 years’ experience in pharmaceutical development and clinical systems. He is knowledgeable in ICH/GCP and boasts clinical operations experience across multiple therapeutic areas, including participation in several successful IND and NDA submissions. Before joining Halloran, Todd led Clinical Information and Informatics groups at Astellas and PPD, with emphasis on operational performance metric/KPI assessment, data quality, benchmarking, dashboard development and reporting. In addition to degrees in biology, epidemiology and biostatistics, he holds an MBA in entrepreneurship and econometrics and statistics from the University of Chicago Booth School of Business and is currently enrolled in Northwestern University’s Master of Science program in predictive analytics.
Associate Director, Oncology Risk Management
Joe Kunakorn has 20+ years of experience in the Biopharma industry as a quality professional with expertise in auditing, QMS, GCPs, GMPs, and medical devices. In his current role with Janssen Research & Development, LLC, Joe leads the clinical quality oversight, risk management, and inspection readiness efforts for the CAR-T oncology compound at the program and trial level.
As the operations director at Clinical Pathways, Jennifer Lawyer’s focus is on implementing processes to improve quality and on-time delivery for eLearning development and project management. As an eLearning project manager, she ensures the day-to-day processes run efficiently and products are high-quality and completed on time. Prior to joining Clinical Pathways, Jennifer worked as a clinical research professional and a private duty nurse. She holds a B.S. in psychology, an A.S. degree in nursing, and two clinical trials research associate certificates (core competencies and advanced topics). She is a member of the Association of Clinical Research Professionals (ACRP) and is working on her professional certification.
Keith Morgenstern has been a client-facing, operations leader in the clinical trials industry for the past 20 years. He is currently a Portfolio Director at Medable where he helps clients develop their own DCT studies using Medable’s SaaS platform. Prior to Medable, Keith was a Relationship Manager at ERT overseeing eCOA portfolios of approximately 50 projects across multiple service lines for his top-30 clients. Before joining ERT, Keith was a consultant to the MCC where he facilitated the development of eCOA metrics, helped design and develop MCC’s Risk Assessment & Mitigation Management Tool (RAMMT) and helped author several of MCC’s eLearning courses on metrics development.
Senior Director, QA & Compliance
With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn Niccum provides our clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance and auditing, inspection readiness activities, SOP development, computer system validation, quality document management, training, and safety.
As the Sr. Director, Quality Assurance and Compliance for the inSeption Group, she assists companies in the development, management, and oversight of their quality systems. She has presented at numerous conferences on the clinical quality systems, trial master file, risk management, and inspection readiness. Dawn holds a Master’s degree in Regulatory Affairs from Purdue University, has certifications in clinical research, GCP quality assurance, and Project Management, and is a registered nurse.
Risk and Quality Management Lead
Vera Pomerantseva has years of pharmaceutical industry experience combining analytics, clinical operations and project management. A Certified Project Manager (PMP) with an MS in Management and post-graduate training in Risk Management and Clinical Trials Conduct, she has published widely on pharma-related topics.
Executive Director, Data & Analytics
Jennifer Price is an accomplished professional with 25+ years of clinical research management and technology implementation experience. Jennifer has proven success with strategic planning, project management, data management, quality, and resource planning in many therapeutic areas. Jennifer is a passionate advocate for eSource, Clinical Data Standards, Clinical Data Sciences, Direct-to-Patient technologies and Direct Data Capture.
Jennifer is a emeritus Board Member and Secretary of the Society of Clinical Data Management (SCDM) and has been involved with the development of the metrics section of the Good Clinical Data Management Practice (GCDMP), involved with Trancelerate eSource consortium and has been active with CDISC since 2006.
Chief Scientific Officer
Johann Proeve's employer, Cyntegrity, offers RBQM applications and services to pharma clients. His 40-year career in pharma data management includes heading global strategy and development for both Bayer Healthcare and Global Data Sciences & Analytics.
RBQM Operations Consultant
Clinical Pathways, LLC
Sandra "Sam" Sather’s consultancy promotes clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. With a background in nursing and education, she has specialized in training and performance improvement over a career of 30+ years. Specific client services include quality system gap analyses, cost containment and audit readiness. She is a subject matter expert in GCP areas including monitoring, auditing, risk management, and GCP regulations and regulatory guidelines.
Clinical Pathways, LLC
Charles “Chuck” Sather’s current focus of consulting is to promote efficiency in remote and on-site Monitoring and Auditing in a balanced, fair and amiable manner. He has over 30 years of clinical experience with a Bachelor of Science Degree in Nursing and has been certified by the Association for Clinical Research Professionals (ACRP) as a CCRA for approximately 15 years. He is a frequent speaker at industry conferences, has authored multiple courses for clinical research training programs in various functional areas and has been an Item Writer on ACRP’s Exam Committee. He specializes in:
- The remote and on-site monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials
- Regulatory inspection preparation and post audit Root Cause Analysis, Gap Analysis and CAPA development
- SOP and monitoring tool development
- And in compliance and data management auditing.
In 2002 he co-founded Clinical Pathways (CP), LLC with Sandra “Sam” Sather.
Director Quality and Compliance
ICON (formerly PRA Health Sciences)
Dr. Oleg Shevaldyshev has more than 18 years of experience in the CRO industry, that includes more than 8 years in Quality Assurance (QA) roles, and also monitoring and project management experience. His main QA interests include global non-compliance and serious breach management, auditing, process improvement and risk management. In 2017, Oleg received the MCC Champion award; and he continues his active participation in some of MCC activities. Prior to joining the industry, he used to be a physician in an intensive stroke unit.
Currently, Oleg is Director of Quality & Compliance at ICON (formerly PRA Health Sciences), based in Moscow, Russia.
Senior Director, RBQM customer success
Kristin Stallcup brings extensive industry experience in various trial management capacities. Currently she serves as senior director responsible for implementation and adoption of risk-based quality management technology into business process. Kristin has held other industry positions ranging from clinical operations, project management and central monitoring operations. Kristin received her MSHS in clinical research management from George Washington University, her BS in molecular biology from Vanderbilt University, and has Project Management Professional (PMP) certification.
Linda Sullivan is Co-Founder & Executive Director of WGC’s Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has more than 30 years of experience helping healthcare and clinical research organizations improve processes that strengthen financial and quality outcomes.
Chief Scientific Officer
Dr. Pam Tenaerts is on a mission to improve evidence generation in medicine, She believes we need new models to facilitate and scale the evidence generation system for health by creating re-usable, responsible and more effective ways to understand and treat disease.
Dr. Tenaerts will direct research at Medable to help identify, implement and make ubiquitous responsible decentralized trial strategies. Dr. Tenaerts brings more than 30 years of experience in clinical trials, as a researcher and academic, in medical device research operations, a hospital-based site administrator, and physician, most recently serving as executive director of the Clinical Trials Transformation Initiative (CTTI) at Duke University. She sits on the board of the Society of Clinical trials, the Scientific Leadership Council of the Digital Medicine Society, participates on the Good Clinical Trial Collaborative, and is a member of the National Academies of Science and Medicine: Forum on drug discovery, development and translation.
She received her MD from the Catholic University in Leuven and her MBA from the University of South Florida.
Director, Industry Strategy
ElvinThalund is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences’s effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in industrial engineering from Aalborg University.
Gary Tyson is an expert on clinical operations with over 30 years of experience consulting to the biopharma and CROs industry. Gary has led a wide range of major change initiatives, rapidly implementing process, technology and organizational improvements. Gary and his teams have successfully embedded RBQM in a range of CROs and biopharma companies.
Gary formed Pharma Initiatives in 2014 around a central premise: "People Support What They Create.” Gary, his partner and staff at Pharma Initiatives view their role as partner, driver and supporter of major operational change but always with the client owning and leading the change initiatives. Only in that way does change become successfully embedded.
President, Vendor Management and Training Practice Lead
Wool Consulting Group, Inc.
Liz Wool boasts 29 years’ experience in clinical operations, compliance, CRO-Vendor oversight and training. A recognized industry expert on CRO-Vendor oversight/management, she has presented on this topic in the U.S. and EU since 2010. She is a certified CRA (ACRP), instructional designer and master trainer, and a member of the National Speakers Association.
Chief Scientific Officer
As Chief Scientific Officer for CluePoints, Steve Young oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical 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 6 years with eClinical solution providers Medidata and OmniComm, leading the development of analytics and risk-based quality management (RBQM) solutions and providing RBQM consultation to many organizations. Steve also led a pivotal RBM-related analysis in collaboration with TransCelerate, and is currently leading RBQM best-practice initiatives for several industry consortiums. Steve holds a Master’s degree in Mathematics from Villanova University.