14th Clinical Performance Metrics Summit - Sonesta Philadelphia Rittenhouse Square

14th Clinical Performance Metrics Summit
December 4 - 5, 2017
Sonesta Philadelphia Rittenhouse Square
Philadelphia, PA

Implement, understand, and analyze performance metrics to increase operational efficiencies in clinical trials

Faculty – 14th Clinical Performance Metrics Summit

Christopher Barshick, Ph.D., MBA
Director of Global Clinical Operations, JOHNSON & JOHNSON VISION

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Chris Barshick is Global Director of Clinical Operations at Johnson & Johnson Vision in Jacksonville, FL. He leads a team of associates focused on executing clinical studies in a GCP compliant fashion, on-time and within budget. He holds a Bachelor of Arts in Chemistry from Washington & Jefferson College and a Ph.D. in Analytical Chemistry from the University of Virginia. Chris worked for 9 years at the Oak Ridge National Laboratory in Oak Ridge Tennessee. During this time, he earned an MBA from the University of Tennessee – Chattanooga, attending classes at night and on the weekends. He left ORNL for GE Plastics in 2000 and was the Analytical Technology Manager at 3 U.S. sites until 2006 when he joined JJV as a Master Black Belt. Chris became a certified MBB in 2007 and has held a number of positions in product development, process improvement, and Clinical Operations during his 11 years at J&J. He has over 45 publications in peer-reviewed journals and over 120 presentations at national and international conferences.

Jack Faricelli
Lean Six Sigma Black Belt Clinical Trial and Pharmacology Sampling Program Manager, CLINICAL TRIAL OPERATIONS PERFORMANCE METRICS EXPERT – 25+ YEARS

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Jack has more than 20 years of experience in process improvement, clinical trial operations and project management. He has also held leadership roles within GlaxoSmithKline, Siemens (SMS), the Hospital of the University of PA and a sole proprietorship providing consulting services to the pharmaceutical industry.

Jack is a graduate of Rutgers University and Jefferson Graduate School of Biomedical Sciences.

Wen-Yaw (Alex) Hsieh
Director, Quality Predictive Analytics, PFIZER

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Alex Hsieh is a Director of Clinical Development Quality Analytics in Quality Performance and Risk Management in Pfizer Clinical Development Quality. Alex joined Pfizer in March 1999. During the past 18 years, Alex held progressively responsible roles, moving from positions of Statistician to Master Black Belt, Project Manager, Risk Management facilitator, and most recently, to the director role in Quality Performance and Risk Management responsible for using quality analytics, including utilization of multivariate statistics and machine learning techniques, to drive quality excellence of clinical trials.

Alex has a breadth of experience in Pharmaceutical Sciences and Clinical Development and supported several new product developments as well as other developing compounds. Alex holds a B.S. in Physics from Fu Jen Catholic University, a Master’s Degree in Statistics from Columbia University, and another Master’s Degree in Pharmaceutical Engineering from the University of Michigan. He also is an American Statistical Association (ASA) – Accredited Professional Statistician (PStatÆ), American Society for Quality (ASQ) – Certified Master Black Belt (CMBB), Certified Six Sigma Black Belt (CSSBB), Certified Quality Engineer (CQE), and PMI’s Project Management Professional (PMP) and Risk Management Professional (RMP).

Ram Josyula
Master Black Belt Coach and AI Consultant, BRISTOL-MYERS SQUIBB

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Ram Josyula, Continuous Improvement Master Black Belt Coach, BRISTOL-MYERS SQUIBB

Since 2007, Ram Josyula has been delivering mission critical initiatives in R&D, Manufacturing and Commercial operations at BMS. Ram and his team enable faster, simpler and safer clinical operations during the life cycle of the studies emphasizing patient focus. They employ quantitative technologies such as metric definition, data analytics, statistics, Lean, Six Sigma, simulation, CI and TRIZ. Prior to BMS, Ram coached and trained more than 2,000 project leaders at GE, BP, Ford and Merrill Lynch for breakthrough results. Ram holds Master of Science degree from MIT specializing in system dynamics and a Bachelor of Technology from IIT Madras.

Jeff Kingsley

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

Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and nine wholly owned and integrated clinical research offices throughout Georgia. The family of companies conducts phase I 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 currently serves as 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.

Amine Ouazzani, M.Sc.
Feasibility Specialist, Clinical Trial Analytics, BRISTOL-MYERS SQUIBB

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I am passionate about using analytics concepts, including big data and predictive analytics, to generate actionable insights, drive decision making and optimize processes.

I have completed Two Masters Degrees at the University of Montreal in Canada:  One in Clinical Pharmacology and the second in Pharmaceutical Sciences specialized in clinical research.

I joined BMS in 2005 at the Canadian head office where I held different roles in clinical operations and metrics and reporting.

In July 2016, I have relocated to the BMS global headquarters in Princeton, NJ, with my family to live an extraordinary experience and to pursue my career (and passion) in Clinical Trial Analytics.

Armelde Pitre
Senior Director, Clinical Development Quality, Quality and Performance Risk Management, PFIZER

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Armelde Pitre, MBA has more than 25 years of experience spanning many aspects of drug development. She led clinical projects from feasibility to regulatory submission in all phases and in multiple disease areas. Her experience includes functional line management in biometrics, information technology, benchmarking and metrics, quality assurance, vendor management, and SOPs and training. Currently, Armelde is a Senior Director at Pfizer and the GCP Performance Analytics Group Lead. She is accountable for the advancement and oversight of Pfizer’s GCP Quality Management System and Quality Taxonomy. She provides leadership and expertise in analytics, interpretation and presentation of performance intelligence to drive decision-making, process improvement and delivery in clinical trials.

Kunal Sampat
Senior Manager Clinical Programs, ABBOTT VASCULAR

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Kunal is a Senior Manager, Clinical Research at Abbott Vascular and also the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. You can find him on LinkedIn at https://www.linkedin.com/in/kunalsampat and through the Clinical Trial Podcast at clinicaltrialpodcast.com.

Michelle Spak
Director, Integrated Business Intelligence Services, JOHNSON & JOHNSON

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Michelle Spak is a Director in Integrated Business Intelligence Services within Johnson & Johnson. She is leading a team in creating visualization solutions for operational data and driving data warehouse solutions. Her team is responsible for the creation and governing of metrics. The metrics and reporting focus was initially in the pharmaceutical industry, but has been expanded to other sectors within Johnson & Johnson. Her team is also responsible for medical review capabilities.

Michelle began her, 17-year J&J career, as a Clinical Database Analyst within Data Management. Her last held position within data management was the Director of Data Management for the Immunology Therapeutic Area. Previously she was an IT Consultant for the Pharmaceutical Industry.

Michelle is a graduate of Shippensburg University, with a Bachelor of Science degree in Business Information Systems.

Linda Sullivan

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Linda Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM (MCC)

Ms. Sullivan is Co-Founder and President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management and Clinical Trial Oversight industry meetings.

Ms. Sullivan received a B.S. in biology from Trinity College and a M.B.A. from Dartmouth College, where she was named a Tuck Scholar.

Mayuri Trehan
Associate Director, CELGENE

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Mayuri is a Process Improvement and Change Management leader managing strategic initiatives and clinical development programs in the pharma/biotech industry for over 16 years. She has handled the launch of Key Performance Indicators (KPIs) and created an approach for the identification of Key Risk Indicators (KRI’s) to manage clinical trials more efficiently. She has led the Quality Management System (QMS) governance forum and has managed a PMO with oversight of a portfolio of process improvement projects. Mayuri is a certified Project Management Professional (PMP), Lean Six Sigma Black Belt and Organization Change Management leader. She volunteers for the Project Management Institute New Jersey Chapter (PMINJ) as the Process Excellence Lead. In addition, Mayuri is serving as a Mentor in the 2017 Healthcare Businesswomen’s Association (HBA) Mentoring Program.

Alec Vardy
Senior Director, Data Management, JAZZ PHARMACEUTICALS

Chung Wen (Wendy) Yu
Quality Predictive Analytics Manager, PFIZER

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As a Quality Predictive Analytics Manager at Pfizer, Wendy is responsible to improve and ensure the clinical trial quality by developing and applying advanced machine learning. She identifies business issues and tackles them through different lenses, analyzing and listening to the data. She is effective at creating practical solutions to solve various organizational needs and communicating the information to team members and leaderships. Being in the research and analytics role for five years, Wendy has developed strong quantitative and qualitative skills. Prior to joining Pfizer, Wendy worked at ASCAP as a Data Scientist and also worked at Monell Chemical Senses Center as a research analyst. Her research work was published in Science journal. (Predicting human olfactory perception from chemical features of odor molecules. Science. 2017 Feb 24; 355(6327):820-826. doi: 10.1126/science.aal2014). Wendy holds a Master of Biotechnology from the University of Pennsylvania.

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