Publications in this category are led by a junior investigator in any area of FDA regulatory science. Nominations must have a junior scientist who is first author on the manuscript which must have been accepted or published in a reputable, peer reviewed journal in the last fiscal year and is no more than 7 years from last degree at the time of award submission.
Si Wen, Ph.D. (Visiting Scientist - CDRH)
For the development of a novel, rigorous, and unbiased method to evaluate medical devices and imaging biomarkers with clinicians in the loop.
Journal Name: Statistics in Biopharmaceutical Research
Journal Name: The Journal of Clinical Pharmacology
For developing a quantitative framework to assess exposure-response noninferiority between pediatric and adult populations to support extrapolation of efficacy decision making in drug development
Qunshu Zhang, PhD (CDER)
Journal of Medical Imaging
For publication of a novel in silico method for augmenting artificial intelligence (AI) algorithm training data for improved performance and robustness.
Kenny Cha, PhD (CDRH)
McWilliams et al. show that vaccine pseudo-virus rVSVdeltaG-EBOV-GP infects mouse neurons of the eyes and brains, demonstrating potential neurotropism of candidate Ebola vaccine.
Ian Lee McWilliams, PhD
For publication of a paper describing a multimodal adaptive optics system capable of cellular level visualization across all layers of the retina.
Zhuolin Liu, PhD
Dr. Efe Eworuke is nominated for the Chief Scientist Publication Award to a Junior Scientist for her work in evaluating the effectiveness of a boxed warning for increased risk of bone loss during depo-medroxyprogesterone acetate therapy.
Efe Eworuke, R.Ph. PhD
For publication of a novel and rapid method for predicting osteo-genic biological activity of multi-potent stromal cells.
Ross A. Marklein, PhD
Tracing Origins of the Salmonella Bareilly Strain Causing a Food-borne Outbreak in the United States.
Maria Hoffmann, PhD (visiting Scientist)
For groundbreaking advances in predictive accuracy of diffusion of leachables in a polymeric device material at physiological temperature using atomistic molecular dynamics simulation.
Chris Forrey, PhD, CDRH, First Author
David M. Saylor, PhD, CDRH
Joshua Silverstein, PhD, CDRH
Jack Douglas, PhD, NIST
Eric Davis, PhD, Drexel University
Yossef Elabd, PhD, Drexel University