Laurie Burke, MPH, collaborates with pharmaceutical research and medical product development organizations to promote best practices in patient-focused drug development, outcomes research, regulatory strategy, product labeling and advertising. She was a career US Public Health Service officer with the US Food and Drug Administration, Center for Drug Evaluation and Research, where she maintained regulatory policy development and oversight responsibilities related to prescription drug labeling and outcome measurement in clinical trials. She was the lead author of the FDA Patient-Reported Outcomes Guidance published in 2009. She worked extensively on regulatory issues related to the use of clinical outcome assessments to support labeling with the European Medicines Agency, the National Institutes of Health, other US Department of Health and Human Services agencies. She is an Affiliate Associate Professor at the University of Maryland School of Pharmacy. Her academic degrees include a Master of Public Health in Epidemiology from the Uniformed Services University of the Health Sciences and a bachelor of science in pharmacy from the University of Kansas.