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Clinical Trial Risk & Performance
Management vSummit

Sept. 8-10, 2020  |  Early access to pre-recorded sessions beginning Aug. 26, 2020

Speakers

Sagar Anisingaraju

Sagar Anisingaraju

Chief Strategy Officer

Saama Technologies

Named to this year’s prestigious PharmaVOICE 100 list of the most inspiring individuals in life sciences, Sagar Anisingaraju guides the concepts, design, and development of innovative data and analytics solutions at Saama that generate successful business outcomes. Sagar leads Saama’s transformation journey, creating focus areas, business models, and repeatable offerings. His passion is to help pharma and biotech create intelligent analytical solutions to operationalize insights and solve drug development/delivery business challenges.

Sagar holds multiple patents related to AI applications. He has authored and published several technical articles and blogs on how AI-powered solutions can bring about a Pharma version of Moore’s Law that reduces the cost and duration of clinical trials by order of magnitude. His new novel, Kuchela.AI, tells the story of a technologist’s journey of self-awareness that radically advances the world through AI with a higher purpose.

 

 

 
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Frank Berger

Frank Berger

Head of Analytics, Global Clinical Operations

Boehringer Ingelheim

Frank Berger is currently the Head of Analytics, Global Clinical Operations, at Boehringer Ingelheim’s headquarter based in Ingelheim, Germany. He and his team develop and deliver metrics and KPIs as well as ad hoc analyses (operational and financial) to support data-driven business steering and decisions related to hundreds of clinical trials with a total budget of approx one billion Euro per year. Frank is a physician by training and got his M.D. from the Technical University of Aachen, Germany. During the first years of his career in the pharmaceutical industry Frank published frequently in peer-reviewed journals, mostly on dementia research. Frank has more than 10 years’ experience as International Project Leader at Boehringer Ingelheim, successfully advancing projects through all clinical phases, from Phase I to launch.

 

 

 
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Jennifer Campbell

Jennifer Campbell

Clinical Data Analyst

CluePoints

As a Clinical Data Analyst for CluePoints, Jennifer Campbell 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.

 

 

 
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Stephen Crow

Stephen Crow

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.

 

 

 
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Keith  Dorricott

Keith Dorricott

Director

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.

 

 

 
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Kevin Douglass

Kevin Douglass

Associate Director-Process Excellence & Risk Management

DSI

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.

 

 
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Nancy Dynes

Nancy Dynes, MBA

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.

 

 

 
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Amy Jimmerson

Amy Jimmerson, RN BSN, MSHCA, CCRA

Clinical Monitoring Director, Global Monitoring

Medtronic

Amy Jimmerson has more than 18 years experience in the clinical research arena. Amy started her career as a registered nurse (ICU/CCU, Telemetry) then became a clinical research coordinator, worked as a clinical research monitor (CRA) and is now Clinical Director of Monitoring at Medtronic. Today, Amy oversees US clinical monitoring activities for Medtronic’s robust Cardiac and Vascular Solutions (CVG) BU as well as the Spine and Post Approval Studies. Amy is passionate about monitoring quality and leads the Global Monitoring Quality Team and co-leads the centralized Monitoring Visit Report Review Team. In addition, Amy oversees the Risk-Based, Remote and Centralized Data Monitoring Teams. Amy earned a Bachelor of Science degree in Nursing from the University of North Alabama and a Master of Science Degree in Health Care Administration from Bellevue University. Amy is a member of the Tennessee Nurses’ Association, she is a Certified Clinical Research Associate (CCRA) and is a member of the Association of Clinical Research Professionals (ACRP).

 

 

 
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Todd Johnson

Todd Johnson

Principal Consultant

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.

 

 

 
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Nechama Katan

Nechama Katan

Director-Data Science Lead

Pfizer

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.

 

 

 
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Nathaniel  Katz

Nathaniel Katz, MD

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.

 

 

 
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Renuka Kelapure, MD

Central monitoring manager in RBM

Pfizer

Renuka is a physician who has a passion for healthcare, technology and clinical research. Renuka was a practicing family physician whose curiosity to understand methods of clinical research and medicine brought her to the USA. Renuka has a Masters in Health administration graduate degree from the UNC Gillings School of Global Public Health where she started working as Director of clinical research. Renuka has managed numerous complex clinical trials and has extensive experience in clinical operations, regulatory, pharmacovigilance and data management. For the last two years Renuka has been a Central Monitoring Manager with the Pfizer Risked Based Monitoring group. Renuka is a lifelong learner and holds certifications in SAS, R and machine learning from Northeastern University.

 

 

 
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Jennifer Lawyer, RN, BS

Operations Director

Clinical Pathways

Maryann Livolsi

Maryann Livolsi, MSN, RN

GCP Compliance Leader

Bill & Melinda Gates Medical Research Institute

Maryann Livolsi of Bill & Melinda Gates Medical Research Institute is the GCP Compliance Leader and is responsible for fostering and promoting GCP compliant environment, supporting a culture of quality, regulatory compliance and continuous inspection readiness. Over 29 years of experience in clinical research operations and quality assurance at small biopharmaceutical and large pharmaceutical companies.

 

 

 
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 Maria Makarovskaya

Maria Makarovskaya, MA

Global Strategic Sourcing, Clinical Category Management Lead

Corbus Pharmaceuticals

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.

 

 

 

 
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Arturo Morales, PhD

Arturo Morales, PhD

Vice President, Technology Solutions

WCG

Dr. Arturo Morales is an accomplished biopharmaceutical executive who oversees all technical and data science operations at Analgesic Solutions including the ongoing development and commercialization of the Company’s proprietary Quantitative Data Surveillance System (QDSS). Upon completing his Ph.D. with Dr. Paul Schimmel at Massachusetts Institute of Technology (MIT), Dr. Morales started his industry career with Genome Therapeutics as a Senior Computational Biologist. He subsequently led a variety of teams at various companies including the Novartis Institutes for Biomedical Research, where he was Global lead for Biology Platform Informatics. Dr. Morales was also the founder of a digital health company that integrated traditional health metrics with a variety of data feeds in order to better identify trends and improve health outcomes.

 

 

 
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Jean Mulinde

Jean Mulinde, MD

Senior Advisor, Division of Clinical Compliance Evaluation

FDA CDER

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.

 

 

 
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Rachel Oakley

Rachel Oakley

VP RBQM Services

Triumph Research Intelligence

Christine Panetti

Christine Panetti

Sr. Associate Central Monitor

Pfizer

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.

 

 

 
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Vera Pomerantseva

Vera Pomerantseva

Sr. Central Monitoring Lead

Bristol-Myers Squibb

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.

 

 

 
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Johann Proeve

Johann Proeve

Chief Scientific Officer

Cyntegrity

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.

 

 

 
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Jonathan Rowe, PhD

Jonathan Rowe, PhD, MS, MA

Associate Principal

ZS Associates

Since 1996, Jonathan Rowe has worked within the pharmaceutical industry to develop medical therapies from the clinical, operational, and business perspectives. Jonathan currently holds the position of Associate Principal, R&D Excellence at ZS Associates, where he focuses on the pharma sector. From 2014 to 2019, Jonathan was the Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities included 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 was built into all trials. He also held a number of other 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 PhD and MS at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

 

 

 
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Leslie Sam

Leslie Sam

Principal Consultant

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.

 

 

 
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Anamika Sarkar

Anamika Sarkar

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.

 

 

 
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Sandra (SAM) Sather

Sandra Sather, MS, BSN, CCRA, CCRC

Vice President

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.

 

 

 
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Oleg Shevaldyshev

Oleg Shevaldyshev

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.

 

 

 
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Erika Stevens

Erika Stevens, MA

Chief Operating Officer

Wool Consulting Group, Inc.

Erika Stevens leads research transformation advisory and assurance services. In this capacity, she advises sponsors, CROs and sites in process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing, compliance risk management and enterprise management transformation services. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP and GCP. Ms. Stevens has over 20 years of research/ R&D experience, including over 12 years in research management serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations. Ms. Stevens is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Ms. Stevens served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Ms. Stevens is the Vice Chair of the Associate Board of Trustees. Erika serves on the MAGI advisory board and is a director for Brightpoint Health. She is also a frequent speaker on research operations and compliance practices at international conferences. Additionally, she is a published author whose work appears in a variety of peer journals including the American Journal of Obstetrics & Gynecology, The Monitor, Clinical Researcher, Regulatory Focus, Applied Clinical Trials, Clinical and Translation Science and the Journal of Mental Health and Aging

Ms. Stevens holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University. She also holds a Graduate Certificate in Gerontology from Case Western University.

 

 

 
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Linda Sullivan

Linda Sullivan, MBA

Executive Director

WCG MCC

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.

 

 

 
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Elvin Thalund

Elvin Thalund

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.

 

 

 
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Gary Tyson

Gary Tyson

Partner

Pharma Initiatives

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.”

 

 
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Keri Urwin

Keri Urwin, MBA

Principal Consultant, Clinical Operations

Halloran Consulting Group

Keri Urwin has more than 19 years of experience in clinical trial management leading large, global teams through many phase I-IV projects from study start through regulatory submission. Using her ability to see the “big picture,” Keri resolves issues quickly to bring vendors and cross-functional teams together. She has therapeutic experience in neurology, pain management, PE/DVT, sexual dysfunction, CHF, gene therapy and oncology.

Before joining Halloran, Keri spent six years working as a consultant for Pfizer on pain management and PE/DVT trials. She also spent two years at GlaxoSmithKline where she was a lead study manager assigned to various global trials focusing on restless leg syndrome and MS. Earlier in her career, Keri spent five years at Biogen Idec where she focused on multiple sclerosis (MS) trials for Avonex and Tysabri and was part of the submission team responsible for FDA approval of Tysabri.

 

 

 
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Alec Vardy

Executive Director, Clinical Data Management

Jazz Pharmaceuticals

Alec has worked in the pharmaceutical industry for over 40 years. He entered the industry as a Biostatistician, and made the switch to Data Management in 1998. For the last 18 years, Alec has been working in small to medium Biotechnology companies in the San Francisco Bay area in a variety of therapeutic areas, and has been involved in several successful drug approvals. In small companies, with limited resource and seemingly ever-changing timelines, efficiency is critical, and Alec has always made infrastructure building an important component of his work during these last 18 years. At Jazz Pharmaceuticals, he is co-leader of an initiative to implement a Risk-Based Quality Management system, an activity which he feels could be an industry “game changer” if done well and fully adopted.

 

 

 
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Nico Wegener

Nico Wegener

Senior Clinical Project Manager

Merz Pharmaceuticals

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.

 

 

 
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Michael Wilkinson

Michael Wilkinson, MPH

Project Manager

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.

 

 

 
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Liz Wool

Liz Wool, CCRA, CID, CMT

President

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.

 

 

 
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Steve Young

Steve Young

Chief Scientific Officer

CluePoints

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.

 

 

 
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About MCC

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.

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