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  1. About Science & Research at FDA

Excellence in Data and Computational Science

This category recognizes a group involved in a data science collaborative effort which includes, but is not limited to, development and use of innovative or uniquely applied methods of analysis, such as, contaminant profile tracking, device failure analysis, drug interaction analysis, food safety analysis, epidemiological research, predictive modeling, methods correlation and data analysis, data visualization, statistical method development, computational modeling and simulation (CMS), and machine learning or artificial intelligence approaches to support scientific or investigative operations.

2024
Drug Supply Chain Analytics Team (CDER)
For harnessing data science to develop the Supply Chain Analytical Network System and Supply Chain Disruption Model to assess early signs of potential drug shortages.

Reza Kazemi-Tabriz, Ph.D. (CDER)
Andreas Schick, Ph.D. (CDER)
Zachary Tillman, M.S. (CDER)
Jhon Roberto Delhy Nolivos, Ph.D. - Staff Fellow (CDER)
Eric Nichols, M.S. (CDER)
Alvin So, M.S. (CDER)
Fatima Barragan Herrera, M.S. - ORISE Fellow (CDER)
Benjamin Walworth, M.S. (CDER)
Cynthia Leung, M.S. (CDER)
Sarah Nance, M.S. (CDER)
Matthew Rosenberg, M.S. (CDER)
Negar Tavasoli Hozouri, Ph.D. (CDER)

2023
Opioid Systems Model Team (CDER)
For harnessing systems science to develop the SOURCE model (Simulation of Opioid Use, Response, Consequences, and Effects) and a supporting analysis service to inform opioid policymaking.

Sara Lynn Eggers, Ph.D.

Reza Kazemi-Tabriz, Ph.D.

Emily Grace Ewing, M.P.P

Blair Coleman Nesmith, Ph.D., M.P.H.

Grace Chai, Pharm.D., M.P.H.

Jana Katherine McAninch, M.D., M.P.H., M.S.

Lukas Glos, M.A.

2022
The FDA-led Sequencing Quality Control Project Phase 2 (SEQC2) Team (NCTR)
For leading a consortium study to evaluate the analytical performance of next-generation sequencing technologies to advance their applications for precision medicine.


Weida Tong, PhD
Tao Chen, PhD
Weigong Ge, MS
Binsheng Gong, PhD (Visiting Scientist)
Wenjing Guo, PhD (Visiting Scientist)
Tao Han, PhD (Staff Fellow)
Huixiao Hong, PhD
Dan Li, PhD (Visiting Scientist)
Dongying Li, PhD (Staff Fellow)
Zhichao Liu, PhD
Joe Meehan, BA
Baitang Ning, PhD
Bohu Pan, PhD (Staff Fellow)
Barbara L. Parsons, PhD
Qiang Shi, PhD (Visiting Scientist)
Dong Wang, PhD
Leihong Wu, PhD
Joshua Xu, PhD
Yifan Zhang, PhD
Wen Zou, PhD (Visiting Scientist)
Malcolm Moos, MD, PhD (CBER)
Eric F. Donaldson, PhD (CDER)
Shraddha Thakkar, PhD (CDER)
Wenming Xiao, PhD (CDER)
Zivana Tezak, PhD (CDRH)
Samir Lababidi, PhD (OC)

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

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