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Kaye H. Fendt
Kay Obenshain
David Christiansen
Imogene McCanless Grimes
Jennifer A. Powell
William A. Sollecito
Kaye H. Fendt, MSPH
Founder and Scientific Director
Kaye H. Fendt is a Research Associate Professor and Director of the Data Coordinating Center for the North Carolina Center for Children’s’ Healthcare Improvement within the University of North Carolina School of Medicine in Chapel Hill, North Carolina. She served for four years as a Regulatory Health Information Specialist in CDER, Food and Drug Administration and was a Fellow and a Co-Coach in the Council for Excellence in Government. Ms. Fendt has been an independent consultant for the pharmaceutical industry, was a founding director of CDISC and served on the Board of Directors for 4 years. She served on the Board of Trustees of the Society of Clinical Data Management where she initiated the Good Clinical Data Management Practices Document. She is currently the liaison between the GCDMP committee and the FDA and has developed and presented GCDMP training for FDA inspectors.
Kay Obenshain
Board Member and Project Leader
Kay Obenshain is an independent consultant. Most recently, she was Public Sector Program Manager for Analytics and Information Quality at SAS. After teaching mathematics and statistics at Francis Marion College she served in several R&D capacities at Burroughs Wellcome Co. She administered and coordinated clinical research including developing case report forms; initiation, monitoring, editing and closing studies, ensuring that sites meet and follow FDA and company regulations and guidelines; and expediting acquisition and transfer of data from clinical trials. She negotiated, selected and coordinated contract research organization services; coordinated interactions with Aids Clinical Trial Groups personnel, performed pharmacokinetic and statistical analyses and authored various documents for NDA submissions.
David Christiansen, Dr.P.H.
Board Member
Dr. Christiansen is a consultant specializing in pharmaceutical regulatory electronic submissions. He earned his Masters and Doctorate of Public Health in Biostatistics from UNC. He is co-founder of CDISC and leader of the Analysis Dataset Modeling (ADaM) Team. He co-developed and taught a graduate level course entitled “Clinical Trial Information Management” to FDA medical reviewers through the University of North Carolina at Chapel Hill. As Principal Biostatistician at Genentech, Inc, he developed new technologies and processes for drug development and electronic regulatory submissions. Dr. Christiansen was Research Assistant Professor of Biostatistics at UNC, specializing in statistical computing and research data management.
Imogene McCanless Grimes, Ph.D.
Board Member
Imogene Grimes, Vice President, Statistical Services, for Regeneron Pharmaceuticals, in Tarrytown, NY, has over 20 years in the pharmaceutical industry spanning all clinical trials research tasks. She served as an Adjunct Assistant Professor in the School of Public Health, Department of Biostatistics, UNC, Chapel Hill, NC, chaired the Board of Directors for the Durham Mathematics Council, served as author and editor of the Good Clinical Data Management Practices Guideline Committee. She has been an active member of the American Statistical Association, the Biometrics Society, the Institute of Mathematical Statistics, the Society for Clinical Trials, and the Drug Information Association where she has provided seminars on many aspects of Drug Development Research and has an active publication record.
Jennifer A. Powell
Board Member
Jennifer A. Powell has 20 years of experience in diverse health care settings; her past clients and employers include Kaiser Permanente, Beth Israel Hospital in Boston, the NC Department of Health and Human Services, and the University of North Carolina at Chapel Hill, appointed a faculty appointment in the School of Medicine in 2000. She has worked extensively in the areas of building infrastructure for rapid growth, developing and marketing products and taking strategic initiatives to the next level of tactical application. Since February, 2004 she has opened a consulting practice in areas of health care infrastructure, workforce excellence and project leadership. She has recently been appointed to the Board of Directors of the Data Quality Research Institute. She completed a joint medical school/business school advanced degree program at the University of Rochester, awarded an MBA and an MPH in 1986. Jennifer is a co-founder of the National Initiative for Children’s Healthcare Quality (NICHQ) and has served the last 3 years as the National Director of Public Events. Jennifer also contracts as a Director of the Leadership Program for the Institute for Healthcare Improvement, whose mission is to drive the improvement of health by advancing the quality and value of health care through working with over 200 premier health care organizations across the world.
William A. Sollecito, Dr.P.H.
Board Member
Dr. Sollecito is a Research Professor and Director of the Public Health Leadership Program in the School of Public Health at the University of North Carolina at Chapel Hill. He teaches research methods, management and leadership courses in both residential and distance learning formats. He received a Doctor of Public Health degree in Biostatistics in 1982 from the School of Public Health at UNC Chapel Hill. After working for ten years in public health and health services research, Dr. Sollecito worked in the contract research industry at Quintiles Transnational Corporation from 1982-1996. As President of Quintiles Americas, he was responsible for all clinical operations in Canada and South America, as well as the United States. He also served as a member of the Quintiles Transnational Board of Directors during 1995 and 1996. His primary areas of interest include continuous quality improvement, project management, and leadership in public health and clinical research; his recent publications include evaluative research on the impact of distance education on public health practice, and the application of continuous quality improvement approaches in the clinical contract research industry and in pediatric care.
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