Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification to trials of all sizes. Her division covers a wide variety of therapeutic areas. She works across FDA on patient focused drug development and rare disease initiatives, master protocols, and other programs. Prior to working at the FDA, she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.

Dr. Selena Daniels serves as a Team Leader in the Division of Clinical Outcome Assessment at the Food and Drug Administration (FDA). She leads a team of expert analysts who provide consultation and advice on clinical outcome assessment (COA) endpoint development and validation, including considerations for clinical trial design, conduct, analysis, interpretation, and reporting for regulatory determinations of medical product benefit. Prior to joining the FDA in 2015, Dr. Daniels worked in the Health Economic and Outcomes Research (HEOR) group at Allergan, Inc for almost five years, where she developed and executed HEOR strategies, as well as developed and implemented innovative COA strategies and endpoints for clinical trials.

Lili Garrard is a statistical reviewer on the Clinical Outcome Assessment (COA) Statistical Support Team at the Division of Biometrics III, Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Garrard primarily supports the Division of Gastroenterology and Inborn Errors Products (DGIEP) by providing statistical consultations and reviews related to the use of COAs. Dr. Garrard joined the FDA in 2016 from the University of Kansas Medical Center where she received a PhD in Biostatistics.

Monica Morell is a statistical reviewer on the Patient-Focused Statistical Support (PFSS) Team at the Division of Biometrics III, Office of Biostatistics (OB), OTS, CDER, FDA. Dr. Morell’s team provides statistical and psychometrics reviews on the development and use of clinical outcome assessments (COAs) across multiple therapeutic areas. Prior to joining FDA, Dr. Morell was a clinical research coordinator at the Sylvester Comprehensive Cancer Center’s Department of Radiation Oncology. Dr. Morell received a PhD in Measurement, Statistics, and Evaluation from the University of Maryland, and both an MSE degree in Research, Measurement, and Evaluation and a BA degree in Psychology from the University of Miami.