Analytical science includes, but is not limited to, development and use of new and/or uniquely applied methods of analysis, e.g., analytical methods development, device failure analysis, drug interaction analysis, epidemiological research, predictive modeling, methods correlation and data analysis, statistical method development, etc.

2021

Collaborators with National Institutes of Health for Accurate SARS-CoV-2 Serology Testing (CDRH)

For scientific excellence, innovation, and dedication in collaborating with National Cancer Institute on a groundbreaking program to ensure accurate serology tests for SARS-CoV-2.

 

Steven R. Gitterman, MD

Brendan J. O'Leary

 

2020

RWE Methods Group

For extraordinary achievements in the timely development and active promotion of novel statistical methods for leveraging real-world evidence to support regulatory decision-making

 

Wei-Chen Chen, PhD

Heng Li, PhD

Nelson Lu, PhD

Ram Tiwari, PhD

Chenguang Wang, PhD (Professor/Collaborator)

Yunling Xu, PhD

Lilly Yue, PhD

 

2019
Liposome Characterization (ORA)
Outstanding performance in the development of an analytical method for quantifying an active pharmaceutical ingredient in liposomal-based drug formulations.

Thilak Mudalige, PhD

Wenlei Jiang, PhD

Sean W. Linder, PhD

Siyam Ansar, PhD (ORISE)

 

2018 
The National Antimicrobial Resistance Monitoring System (NARMS) Bioinformatics Team
For developing powerful web-based tools to analyze and visualize comprehensive antibiotic resistance gene data from bacterial genomic sequences, thereby enhancing global antibiotic resistance surveillance

Heather Tate, PhD, MPH
Claudine Kabera, MPH
Chih-Hao Hsu, PhD
Gregory Tyson, MS, PhD
Shaohua Zhao, DVM, PhD,MS
Emily Crarey, MPH (C)
Daniel Tadesse, DVM, PhD
Michael Grabenstein

2017 
ZikV Reference Reagent Team
For rapid development and characterization of the CBER/FDA ZIKV RNA reference reagent as part of the FDA emergency response to the Zika virus outbreak

Maria Rios, PhD
Caren Chancey, PhD
Evgeniya Volkova, MS, MBA
Andriyan Grinev, PhD

2016 
Exact Mass Measurement Guidance Development Group
For collaborative cross-center analytical sciences research resulting in guidance for confirmation of identity of chemical residues using data produced by High-Resolution Mass Spectrometry

Timothy R. Croley, PhD
Bryan Gamble, PhD
Hiranthi Jayasuriya, PhD
Philip James Kijak, PhD
Hui Li, PhD
Sherry Turnipseed, PhD
Jon W. Wong, PhD

2015
Shell Egg Salmonella Detection Method Development Team, CFSAN
For the development and validation of a new BAM Salmonella culture method for whole shell eggs and validation of 3 molecular methods for the detection of Salmonella in eggs.

Eric Brown, PhD
Narjol Gonzalez-Escalona, PhD
Peter Evans, PhD
Thomas Hammack, MS
Jennifer Hait
Dwayne Roberson
Eve Thau (ORISE Fellow)
Guodong Zhang, PhD
Jie Zheng, PhD

 
2014
Translational Cardiac Electrophysiology Devices
For collaborative cross-center analytical sciences research that involved implementation of a novel translational science approach to answer important regulatory science questions for cardiac devices.

Daniel Caños,PhD, MPH, CDRH
Dulciana Chan, MS, CDRH
Loriano Galeotti, PhD, CDRH
Naomi Herz, MSc,
Lars Johannesen, MS, CDRH
Krystal Lansdowne, RN, CDRH
Zak Loring, MD,
Ileana Piña, MD, MPH, CDRH
William Sanders, MD, MBA, CDRH
Christopher Scully, PhD, CDRH
Kimberly Selzman, MD, M.P.H., CDRH
David Strauss, MD, PhD, CDRH
Jose Vicente, MS, CDRH
Robbert Zusterzeel, MD, CDRH

2013
Influenza Proteomics Team
For development of mass spectrometry-based analytical methods to identify and quantify influenza vaccine components.

Michail Alterman, Ph.D., CBER
Maryna Eichelberger, Ph.D., CBER
Melkamu Getie-Kebtie, Ph.D., CBER
Ishrat Sultana, Ph. D., CBER

 
2012
CBER Pandemic Influenza Preparedness Team, CBER
For the Pandemic Influenza Preparedness:  New molecular tools for better understanding of how different vaccine modalities and novel adjuvants improve protective immunity against influenza.

Hana Golding, Ph.D.
Surender Khurana, Ph.D.

2011
Thorough QT Statistical Research Team
For significant achievement in the analytical science of the design and analysis of thorough QT studies

Yi Tsong, Ph.D.
Joanne Zhang, Ph.D.

2010
BPA in Infant Formula Team, CFSAN
For developing a method and the analysis of bisphenol A (BPA) in infant formula to address the FDA Science Board concerns

Luke K. Lindahl-Ackerman, Ph.D.
Gregory C. Noonan, Ph.D.
John A. Roach, M.S.

2009
PDE-5 Inhibitors and Analogs Analytical Group, ORA
For outstanding performance in characterizing and determining PDE-5 inhibitors and their analogs in illegally marketed dietary supplements.

Cheryl L. Flurer, PhD
Rick A. Fllurer, PhD
Bryan M. Gamble, PhD
Samuel R. Gratz, PhD
Merrie P. Jackson, BS
Elisa A. Nickum, BS
Valerie M. Toomey, BS