Quality Defects and Methods of Reproducibility in Biomedical Research

Michael Lauer, MD

Michael Lauer, M.D., is the Deputy Director for Extramural Research at the National Institutes of Health (NIH), where he serves as the principal scientific leader and advisor to the Director of the NIH on all matters relating to the substance, quality, and effectiveness of the NIH extramural research program and administration. He received education and training at Rensselaer Polytechnic Institute, Albany Medical College, Harvard Medical School, Harvard School of Public Health, and the NHLBI’s Framingham Heart Study. He spent 14 years at Cleveland Clinic as Professor of Medicine, Epidemiology, and Biostatistics. During his tenure at the Clinic, he led a federally funded internationally renowned clinical epidemiology program that applied big data from large-scale electronic health platforms to questions regarding the diagnosis and management of cardiovascular disease. From 2007 to 2015 he served as a Division Director at the National Heart, Lung, and Blood Institute (NHLBI), where promoted efforts to leverage big data infrastructure to enable high-efficiency population and clinical research and efforts to adopt a research funding culture that reflected data-driven policy. He has received numerous awards including the NIH Equal Employment Opportunity Award of the Year and the Arthur S. Flemming Award for Exceptional Federal Service in recognition of his efforts to grow a culture of learning and accountability.

Ivan Oransky, MD

Ivan Oransky, MD, is co-founder of Retraction Watch, editor in chief of The Transmitter, and distinguished journalist in residence at New York University’s Arthur Carter Journalism Institute. Ivan previously was president of the Association of Health Care Journalists and vice president of editorial at Medscape. He has also held editorial leadership positions at MedPage Today, Reuters Health, Scientific American and The Scientist. He is the recipient of the 2015 John P. McGovern Medal for excellence in biomedical communication from the American Medical Writers Association, and in 2017 was awarded an honorary doctorate in civil laws from The University of the South (Sewanee). In 2019, the judges for the John Maddox Prize, which promotes those who stand up for science in the face of hostility, gave him a commendation for his work at Retraction Watch.

Nathalie Percie du Sert, PhD

Head of Experimental Design and Reporting, UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs)

Nathalie Percie du Sert (she/her) leads the NC3Rs’ work to improve the reliability of preclinical and basic research, both in terms of the work funded by the centre, and work funded elsewhere. The NC3Rs provides training for researchers and stakeholders at all stages of the research process, and an extensive library of freely available, online resources. This includes the Experimental Design Assistant, an online expert system to guide researchers through the design of in vivo experiments and the ARRIVE guidelines to improve the design and reporting of animal research in scientific publications.

Nathalie holds a PhD from St George’s University of London. Prior to joining the NC3Rs, she worked as a post-doctoral researcher in the field of nausea and emesis at the University of California, San Francisco and at the Chinese University of Hong Kong, where she developed expertise in in vivo research and systematic reviews and meta-analysis of animal models.

Chris Winchester

Chris Winchester is CEO of Oxford PharmaGenesis, an award-winning HealthScience communications consultancy with over 500 employees in Europe, North America and Asia Pacific. Chris studied Biochemistry at St Catherine’s College, Oxford, leaving with a doctorate in 1997. He has co-authored observational studies, systematic reviews and Delphi consensus development processes, including studies on the role of pharmaceutical companies and communications consultancies in transparency and reporting. Chris is a Co-founder of Open Pharma, a Director of Oxford Health Policy Forum, an Associate Fellow of Green Templeton College, Oxford, a Director of the Friends of the National Library of Medicine and a past Chair of the International Society for Medical Publication Professionals.