Clinical Data Analyst
As a Clinical Data Analyst for CluePoints, Jennifer works with customers to develop and implement data surveillance and risk management within the CluePoints Central Monitoring Platform, along with providing guidance to customers in RBQM methodology and best practices. Jennifer has lead training workshops on conducting RBM analyses within the organization and in collaboration with customers, and is currently participating in RBQM best-practice initiatives for several industry stakeholders. She holds a Bachelor of Science degree in Astrophysics from Haverford College.
Associate Director-Performance & Training/Clinical Operations
GW Pharmaceuticals (Greenwich Pharmaceuticals)
Over a 16-year career with GW Pharmaceuticals, Steve Crow has 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.
Dorricott Metrics & 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.
Associate Director-Process Excellence & Risk Management
Kevin Douglass is an Associate Director with the Process Excellence & Risk Management team at Daiichi-Sankyo, partnering with Clinical Operations and other functional areas to optimize clinical trial processes and tools. The team takes a specific focus on risk-based quality management including risk assessment, risk-based/centralized monitoring, and metrics oversight. PERM members participate in process improvement projects, usually in collaboration with CRO partners. Kevin has more than 30 years’ pharma experience with firms including Wyeth, Rhone-Poulenc Rorer, Pfizer, and Shire.
Metrics Consultant, Medicines Quality Organization
Eli Lilly & Co.
In her role as a quality consultant in the Medicines Development Unit at Lilly, Nancy Dynes provides in-depth analyses of medical audit, deviation, inspection and root cause investigation data to identify trends and evaluate performance using data visualization tools and analytics. She has been recognized as a Top Innovator for developing a deviation analysis tool for business partners. In earlier roles, she oversaw the development and implementation of a decision support data warehouse of clinical trial management data, managed productivity metrics for the global clinical trial operations organization, and analyzed internal and external databases to develop accurate enrollment predictions for the Global Enrollment Optimization group.
Halloran Consulting Group, Inc.
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.
Director-Data Science Lead
As the “Data Wizard with Personality,” Nechama Katan blends an ability to write code and provide prototypes with a talent for driving the business conversation, and helps organizations use data to drive business decisions. In addition to working with various organizations, she also serves as an instructor in Statistics, Operations, Data Presentation and Metrics Development.
Chief Scientific Officer
WCG Analgesic Solutions
Dr. Nathaniel Katz is a leading expert in treatment and clinical study design in pain clinical trials. He is a neurologist and pain management specialist with a distinguished career at Harvard Medical School, Brigham & Women’s Hospital and Dana Farber Cancer Institute. From 2000-2004 he served as Chair of the Advisory Committee, Anesthesia, Critical Care, and Addiction Products Division, FDA. He founded Analgesic Solutions with the mission of modernizing the design and conduct of pain clinical trials to advance the scientific quality of pain clinical research and empower effective treatments for patients. He has been an Associate Editor at the Clinical Journal of Pain, and Associate Editor (Pain) for the Encyclopedia of Neurological Sciences.
Global Strategic Sourcing, Clinical Category Management Lead
Maria Makarovskaya has 20+ years of experience in clinical business operations in Pharmaceutical/Biotech industry. Areas of expertise include: strategic outsourcing, vendor and relationship management, contract management, financial analysis, global procurement and project management with emphasis on clinical research. She started her career at a site at Rhode Island Hospital and continued at various biotech/pharmaceutical and device companies, including Vertex, Sepracor, Molecular Insight Pharmaceuticals, Boston Scientific, Cubist, Infinity, Akebia, Tesaro/GSK company. She also provided consulting and advisory services to Voyager, Vigeo and Loulou Foundation.
She holds a Master’s Degree in Education and Linguistics from Moscow Linguistic University and Paralegal Diploma from National Academy for Paralegal Studies from Albertus Magnus College, CT.
Currently Maria is Clinical Category Management Lead, Global Strategic Sourcing at CORBUS Pharmaceuticals, Inc.
Senior Advisor, Division of Clinical Compliance Evaluation
Dr. Jean Mulinde is Senior Advisor for Policy in the Office of Scientific Investigations, CDER. Previously she was a Clinical Team Leader in the Division of Anti-Infective Products in CDER’s Office of New Drugs. She received her M.D. and completed a residency in Internal Medicine at the University of South Alabama School of Medicine, followed by a fellowship in Infectious Diseases at the University of Maryland School Of Medicine. Before joining the FDA, she was an Assistant Professor of Medicine at the University of Maryland’s R. Adams Cowley Shock Trauma Center.
Sr. Associate Central Monitor
As a Pfizer Sr. Associate Central Monitor, Christine Panetti facilitates learning for her team to be effective communicators in the RBM arena. With 25 years of Healthcare service, she has built strong working relationships using tools and strategies for interest-based negotiations. Christine is certified in mediation and has a master’s degree in Leadership and Negotiation. She lectures and provides coaching to teams and individuals interested in conflict resolution, negotiation and communication best practices that will develop their team for success.
Sr. Central Monitoring 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.
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.
Wool Consulting Group
Leslie Sam is Principal Consultant, Wool Consulting Group, supporting development/refinement of clinical quality management systems, issue management, and clinical trial risk management in clinical research. Accomplished, results-driven, passionate clinical research and quality professional with 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate certification (issued by the American Society for Quality), conflict management and high learning agility] in regulated, fast-paced, global biopharmaceutical company, clinical development research and quality divisions. Co-author of 3 TransCelerate Group, peer-reviewed journal articles on the topics of Clinical Quality Management Systems and Issues Management Systems.
Business Relationship Manager, Global Development Systems (Clinical Operations)
Regeneron Pharmaceuticals, Inc.
Anamika Sarkar is working as Business Relationship Manager in Global Development System, focusing on Global Clinical Operations at Regeneron since June 2017. Prior to Regeneron she worked at Paragon Solutions (currently CGI) where she had been providing strategy consulting in clinical and regulatory operations spaces for both Biotechs and CROs. Some of her past experience in consulting includes as IT consulting role at Daiichi Sankyo Pharma and Domain Consultant for big Pharma Companies at Wipro Technologies. She is passionate about bringing right drug to right patient.
Anamika is a PhD and MBA (Pharma Industry Management from Rutgers University), who started her scientific career as Computational Biologist, after her PhD, in the same field, from IITD (Indian Institute of Technology Delhi, India). She has worked as scientist both in academia (University of Washington Seattle, Memorial Sloan Kettering Cancer Center, Mt. Sinai School of Medicine) as well as pharma industry (Novartis Inc.). She has been consulting as a bridge between business, technology and Science since 2012 till she joined Regeneron in 2017.
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.
Associate Director, Quality Assurance
PRA Health Sciences
Dr. Oleg Shevaldyshev has more than 17 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 an Associate Director Quality Assurance at PRA Health Sciences, based in Moscow, Russia.
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.
Director, Industry Strategy
Oracle Health Sciences
Elvin Thalund is a recognized industry expert in clinical trials, having over twenty 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 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 Universitet.
Gary Tyson is an expert on clinical operations with more than 30 years consulting to biopharma and CRO clients. His track record includes major change initiatives, rapidly implementing process, technology and organizational improvements. He formed Pharma Initiatives in 2014 around a central premise: "People Support What They Create.”
Senior Clinical Project Manager
Nico Wegener is in his 11th year with Merz Pharmaceuticals. His focus is multinational clinical studies in the drug and device fields. His experience running clinical studies, especially in China, has taught him the crucial importance of implementing RBQM.
Tufts Center for the Study of Drug Development
Michael Wilkinson is a project manager for the Sponsored Research program at Tufts, with more than five years of experience in protocol complexity, clinical data management and the vendor qualification process. Specialties include data collection, study database management and statistical analysis.
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 CluePoints COO, Steve Young is responsible for ensuring successful adoption of the CluePoints platform. His 15-year biopharma experience includes leadership positions at J&J, Centocor, Medidata and OmniComm with responsibilities in clinical data management, EDC, analytics and risk-based monitoring (RBM) and clinical operations methodology. He also led a pivotal RBM-related analysis in collaboration with TransCelerate, and is currently leading RBM best-practice initiatives for several industry RBM consortiums. He has co-authored two patents related to RBM methods.
Leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. Founded in 2006, MCC is the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. MCC provides the collaborative environment for biopharmaceutical and device sponsors, service providers and sites to improve clinical-trial development through use of MCC standardized performance metrics.