Donna A. Messner, PhD, is a Research Director at the Center for Medical Technology Policy (CMTP), where she has been deeply involved in CMTP’s efforts to use a transparent, stakeholder-driven process to improve the evidence base for clinical and policy decision-making. She collaborated with an expert technical working group and other advisors to coauthor the CMTP Effectiveness Guidance Document, Evaluation of Clinical Validity and Clinical Utility of Actionable Molecular Diagnostic Tests in Adult Oncology. She was a project leader on CMTP’s stakeholder-driven process to develop a “translation table” algorithm for matching comparative effectiveness research questions with appropriate methods, publishing a series of papers with collaborators on the process and results. She was a senior editor on a methods compendium published by the National Pharmaceutical Council entitled Making Informed Decisions: Assessing the Strengths and Weaknesses of Study Designs and Analytic Methods for Comparative Effectiveness Research, A Briefing Document for Stakeholders.
Dr. Messner was a postdoctoral fellow in the Penn Center for the Integration of Genetic Health Care Technologies in the University of Pennsylvania’s Division of Medical Genetics, and was the Gordon Cain Fellow in Technology, Policy, and Entrepreneurship at the Chemical Heritage Foundation in Philadelphia. She also has extensive previous experience as a laboratory and project manager, and a senior project scientist. She holds a PhD in Science and Technology Studies from the University of Edinburgh, UK, and was a visiting doctoral student in the School of Policy, Georgia Institute of Technology. Her doctoral work focused on changing standards of evidence related to the FDA’s Fast Track and accelerated approval procedures for drugs. She additionally holds an MSc by Research (with distinction) from the University of Edinburgh, an MA from George Mason University, and an undergraduate degree in chemistry from Virginia Tech. She has published on FDA regulation, FDA-CMS parallel review, direct-to-consumer genetic testing, the role of stakeholders in gene patenting, and other topics.