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Douglas Peddicord, Ph.D.

Dr. Peddicord is Chair of the CDISC Board of Directors and serves as Executive Director of the Association of Clinical Research Organizations (ACRO), which has been a major supporter of CDISC and the move toward clinical data standards to improve the quality and efficiency of clinical trials. He is also President of Washington Health Strategies Group, LLC, which provides a full range of strategic consulting, government affairs and association management services to healthcare organizations. His particular areas of expertise include health information technology and medical privacy, clinical trials, medical informatics, and Medicare coverage and payment policy.

 

Jonathan Zung, Ph.D.

Dr. Zung is a seasoned pharmaceutical industry executive with over 25 years’ development experience. He is Chair Elect of the CDISC Board Chair and currently serves as Advisor to the CEO of WCG and President of Clintrax. Prior to this, Dr. Zung was Group President, Clinical Development & Commercialization Services for Covance, where he led a global organization of over 8,000 employees in 60 countries, spanning all phases of development, along with global market access services. Dr. Zung also served as Vice President and Head of Global Clinical Sciences and Operations at UCB, with responsibility for clinical operations, data management, statistical sciences, contracting, medical writing and operational excellence across the United States, Europe and Asia. Before joining UCB, he was Vice President and Head of Global Development Operations at Bristol-Myers Squibb, where he led a 1,400-person organization that managed clinical trials from Phase II through registration. He has held several positions at Pfizer Global Research and Development. Dr. Zung serves on the Clinical Advisory Board for Saama Technologies. He received his doctorate in analytical chemistry from Emory University.

 

Stephen Pyke

Mr. Pyke is Past Chair of the CDISC Board of Directors and Senior Vice President, Clinical Projects & Quantitative Sciences at GlaxoSmithKline (GSK). He leads a multi-disciplinary group providing end-to-end support for the planning, conduct and delivery of clinical trials and observational studies across Pharmaceutical R&D. He trained as a statistician, and began his career in academia before moving to join the pharmaceutical industry in 1996, since when he held various clinical and non-clinical roles, both at GSK and at Pfizer. Mr. Pyke has held a number of honorary professional positions including: Chair, PSI (2009-11); Vice President, RSS (2013-2016); CDISC Board Member (2013-15). He studied Mathematics and Statistics at, respectively, University of York and Imperial College, London. He is a Chartered Statistician.

 

Chris Decker, MS

Chris Decker is Vice President, Life Sciences Practice at d-Wise, a technology and process consulting company focused on empowering innovation for a healthier world.  Chris leads a large team of domain and technical expertise, delivering clinical systems integration, standards implementation, and adoption of technology within the clinical trial lifecycle.  He served on the PhUSE Board of Directors for four years and, since 2005, as a volunteer across various CDISC teams, including co-lead of the ADaM Training sub-team. In addition, Chris co-led the creation and implementation of the FDA PhUSE Computational Sciences Collaboration where he serves as FDA PhUSE Liaison and co-lead of the PhUSE Computational Science Steering Committee.  Prior to d-Wise, he  was a Life Sciences Consultant at SAS Institute, leading customer implementations of SAS solutions and a Senior Statistician with Glaxo Wellcome responsible for delivering Phase IV clinical trials across a range of therapeutic areas and leading a range of data integration and process improvement initiatives. Chris received his BS in Statistics from Virginia Tech and his MS in Statistics from NC State. 

 

David Evans, MS

David Evans is Principal Director, Global Head of Quality Governance and Regulatory Compliance for Accenture Research and Development Services. With over 35 years’ experience in the clinical research, regulatory and healthcare industries, he is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions. Mr. Evans was the architect and developer of the first electronic drug submission to the FDA in 1985, and has been responsible for more than 100 electronic regulatory submission and complex clinical data warehouse systems. He holds a master’s degree in Biomedical Engineering and has previously held executive-level positions (CIO, CTO, COO, CQO) at software development, clinical research, regulatory and industry consulting companies.

 

Masanori Fukushima, M.D., Ph.D.

Dr. Fukushima is a Professor Emeritus at Kyoto University and Director and Chairman of Translational Research Informatics Center (TRI), Japan. An oncologist, he has over 25 years’ experience engaging in the practice and dissemination of standard cancer treatment and reforming Japan’s medical care system. Dr. Fukushima actively contributes to building the clinical trial infrastructure, with a focus on translational research. He promotes using CDISC Standards in academic research toward the goal of complete, harmonized data standardization. Dr. Fukushima also supervises the national translational research promotion programs conducted by the government of Japan, which led to the formation of the Academic Research Organization (ARO) Council.

 

David Hardison, Ph.D.

Dr. Hardison focuses on helping life science organizations optimize evidence planning, generation and management throughout the product life cycle. This includes leveraging his extensive global experience in the healthcare ecosystem to develop strategies, tactics, and technologies for gaining optimal insights across proprietary research data, public data and Real World Data that help companies embrace Precision Medicine and Value-based Reimbursement. He has served as a strategic advisor to healthcare executive teams, physician organizations and boards of trustees on continuous quality improvement and served the dual role of Vice President of Continuous Improvement and CIO of a health system. Dr. Hardison has served in several industry leadership positions and is current Past - Chairman of the CDISC Board of Directors and remains on the Board as Board Member Emeritus.

 

Pam Howard, MS

Pam Howard is Vice President of Biostatistics and Programming and Medical Writing at ICON. Prior to this role, she held a number of senior positions within ICON, including Vice President,  Data Management, Vice President, Clinical Operations and Global Business Lead for Metrics and Process Improvement Initiatives.  Ms. Howard has always had an interest in standards, and has actively promoted the application of standards, in particular, to promote data-driven decision making, to increase the quality and productivity of clinical projects, and decrease their costs. She recently completed a diploma and certificate in Company Direction from the Institute of Directors, Ireland. Ms. Howard received her MS in Biostatistics from the University of Reading, UK, an MS in Biotechnology from University College Galway, Ireland and a BS in Industrial Chemistry from the University of Limerick, Ireland.

 

Margaret Keegan

Ms. Keegan is President of Data Sciences, Safety, and Regulatory for IQVIA. She leads the divisions of Central Monitoring, Data Management, Biostatistics, Medical Writing, Safety and Regulatory. Ms. Keegan is also a member of the IQVIA Executive Committee. Prior to this, she held senior leadership positions as Global Head of Data Management, Head of North America Clinical Operations, Global Head of Integrated Processes and Technologies and Global Head of Enterprise Solutions Development. Ms. Keegan has over 25 years’ biopharmaceutical industry experience, holding leadership roles at large pharmaceutical and CRO companies. She has led statistics, programming, data management, late phase and clinical functions, and has worked in Europe and the United States. Ms. Keegan holds a Bachelor of Science degree in Pure and Applied Mathematics and is a Chartered Statistician.

 

Pandu Kulkarni, PhD

Dr. Pandu Kulkarni is the Chief Analytics Officer and Vice President of Biometrics and Advanced Analytics at Eli Lilly and Co. Dr. Kulkarni leads a division of nearly 600 people composed of statisticians from discovery to commercialization, advanced analytics, data management, data standards and technology. He joined Eli Lilly in 2000 and has held numerous leadership positions, including technical and management positions within, and outside of, statistics.

Dr. Kulkarni received several grants from the US Air Force to develop techniques that evaluate and study the effects of environmental contaminants, such as dioxin on humans. He also received grants from NASA to study the effects of microgravity to see the effectiveness of exercise countermeasures in minimizing the effects of microgravity on astronauts. 

A tenured professor at the University of South Alabama, Dr. Kulkarni has given numerous invited presentations across the globe to provide training, continuing medical education, and workshops on the use of statistics in medical research and has published over 50 articles in statistics and medical areas in peer-reviewed journals.

He earned his Ph.D. in Statistics at LaTrobe University in Melbourne, Australia.

 

Zhengqing Li, PhD

Dr. Zhengqing Li is Global Vice President and Head of MSD China R&D at Merck.  He leads a development team whose primary mission is to bring innovative medicines and vaccines effectively and efficiently to meet the unmet medical needs of Chinese patients. Dr. Li also plays a leadership role in building Merck’s global capabilities in China in the area of quantitative sciences and in establishing external collaborations with research institutes, professional societies and industry partners.  Under his leadership, the MSD China R&D Center has grown dramatically with more than 600 scientists.

Previously, Dr. Li held leadership roles with Bristol-Myers Squibb and worked with increasing responsibility in drug development at Pfizer and Procter & Gamble Pharmaceuticals. He has authored and co-authored more than 40 scientific and clinical trial methodology papers and abstracts. Additionally, Dr. Li has played a leadership role in the development and approval of more than 20 drugs or new indications in China and United States.

Dr. Li received his undergraduate education at University of Science and Technology of China and his PhD in Biostatistics from University of Wisconsin-Madison. Upon completion of his PhD, he took a faculty position in the School of Public Health at State University of New York at Albany.

 

Hiroshi Masumoto, PhD

Hiroshi Masumoto is Vice President of Biostatistics and Data Management at Daiichi Sankyo. Hiroshi leads the function, supervising clinical epidemiology, biostatistics, data management, and clinical data system and standards. His focus is to contribute to informed decision-making and value proposition through data-driven sciences. Hiroshi has broad experience and expertise in the pharmaceutical industry, including non-clinical research, global project management, corporate strategy and brand strategy. He received his Ph.D. in Bio-Organic and Medicinal Chemistry and BS in Pharmaceutical Chemistry from the University of Tokyo.

 

Steve Rosenberg

Steve Rosenberg is Senior Vice President and General Manager of Oracle Health Sciences. He has over 30 years’ experience in the life sciences and healthcare arenas, leading development, services, support, and consulting. Mr. Rosenberg possesses a unique ability to address and influence the changing life sciences landscape, using his deep domain understanding, customer relationships, and technology vision.  He served as the visionary and lead evangelist for the integrated clinical technology suite introduced by Phase Forward. As senior vice president of Software and Services at Phase Forward, Mr. Rosenberg was an integral member of the senior management team and championed the integrated technology approach.

 

Joyce Sensmeier, MS, RN

Ms. Sensemeier is the Vice President of Informatics at the Healthcare Information and Management Systems Society (HIMSS). She has made contributions to enabling health information exchange through standards profiling, testing and harmonization initiatives. Ms. Sensmeier led the advancement, and currently serves as President of, Integrating the Healthcare Enterprise (IHE) USA. IHE USA is a regional deployment committee of IHE International, a standards profiling organization, which over the past decade has achieved both national and international adoption of its public domain technical framework. She is a fellow in the American Academy of Nursing, and has led consortia that include industry, government and clinical leaders in efforts to advance widespread adoption of interoperable electronic health records.

 

Névine Zariffa, M. Math

Ms. Zariffa is Vice President of Biometrics and Information Sciences at AstraZeneca Pharmaceuticals. Prior to this role, she held a number of positions at GlaxoSmithKline Pharmaceuticals across all phases of drug development. Ms. Zariffa is a pharmaceutical executive with 20 years' experience across all phases of drug development. She is an expert in statistics, drug development, portfolio-level decisions, regulatory interactions, strategy, innovation, bridging the discovery/development interface, and business development. Ms. Zariffa received her B.S. in Mathematics from McGill University in 1987, and her M. Math from the University of Waterloo in 1988.