Publications in this category report on a new or refined non-laboratory method and/or a new, innovative, or otherwise exceptional study design or analysis that addresses one or more public health challenges. This award recognizes the development and demonstration of an outstanding or exceptional approach to solving a public health problem. Nominations must have an FDA staff member as the first or last author on the manuscript which must have been accepted or published in a reputable, peer reviewed journal in the last fiscal year.
Journal Name: Nature Biotechnology
For study design in establishing performance matrices, reference samples, and data-sets using whole-genome, whole- exome, and single cell sequencing, resulting in three publications.
Wenming Xiao, PhD (CDER)
Journal: Diabetes Care
For Study Design in investigating the risk of breast cancer among insulin glargine users.
Marie C. Bradley, PhD (CDER)
JAMA Network Open
For publishing a landmark paper describing the first-of-a-kind fully virtual clinical trial that replicated an actual trial performed for FDA evidence generation.
Aldo Badano, PhD
For the publication “predicting Opioid Receptor binding affinity” which highlights development of a novel multi-component modeling approach to assess the risk that some new opioid poses to public safety
Naomi Kruhlak, PhD
Edward Hawkins, PhD
Christopher Ellis, PhD (Staff Fellow)
Lidiya Stavitskaya, PhD
Marlene Kim, PhD
For her publication, ‘Designing therapeutic cancer vaccine trials with delayed treatment effect, an exceptional manuscript with immediate impact that may speed availability of cancer therapies.
Zhenzhen Xu, PhD
This published human PBPK model is the gold standard used by public health organizations for assessing BPA exposures from foods and the environment.
Xiaoxia Yang, PhD
Daniel R. Doerge, PhD
Justin G. Teeguarden, PhD
Jeffrey W. Fisher, PhD
Genetic understanding of the underlying determinants controlling the development of anti-FIX inhibitory antibodies in Hemophilia B patients
Zuben E. Sauna, PhD (Fellow)
For outstanding scientific research concerning the under representation of women in medical device clinical trials and appropriate use of cardiac resynchronization therapy.
Kathryn O’Callaghan, BSE
Daniel Caños, MPH, PhD
Jamie Carpenter, MSPH
Ilean Piña, MD, MPH (Contractor)
William Sanders, MD, MBA
Kimberly Selzman, MD, MPH
David Strauss, MD, PhD
Robbert Zusterzeel, MD (ORISE Fellow)