Steven E. Kern, PhD
Steven E. Kern, PhD is Deputy Director of Quantitative Sciences at the Bill and Melinda Gates Foundation. The Quantitative Sciences group is focused on quantitative analysis to support program strategies for therapeutic projects that the foundation funds.
Prior to this, he was Global Head of Pharmacology Modeling at Novartis Pharma AG based in Basel Switzerland where he led a team focused on providing model based drug development support to therapeutics in many disease conditions across all stages of drug development. He joined Novartis in 2010 from the University of Utah in Salt Lake City, Utah where he was Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering, and served as co-investigator for their NIH funded Pediatric Pharmacology Research Unit. He has designed, conducted, and served as a principal investigator for clinical pharmacology studies in adults and children that spanned the population from pre-term infants to elderly adults.
Mr Kern will address the SCDM 2018 Annual Conference on the topic of “Global Health Clinical Trials: Challenging Work in Challenging Situations“.
Kaye H. Fendt, MSPH
Kaye Fendt presented her first keynote address: Clinical Data Integrity: A Key Link in the Drug Regulatory System, at The Society of Clinical Data Management annual meeting in October, 1997. Since then she has served the SCDM as a member of the Board, founder of the GCDMP, session chair and presenter at annual meetings. She was the initial FDA liaison to CDISC and subsequently served as a CDISC founding board member. In addition, she has had faculty appointments at UNC-Chapel Hill and Duke University and was the Director of Quality Assurance at the DCRI, Duke University. Currently she is retired but continues to provide consulting on quality and data integrity issues to the medical product development industry and academic institutions.