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  1. About Science & Research at FDA

Excellence in Laboratory Science, Engineering, or Analytical Science–GROUP

This category recognizes a group involved in a laboratory science collaborative effort which includes but is not limited to, applied research to investigate biological, chemical, medical product interactions, including interactions between the human body and medical devices or radiation-emitting products, or pharmacological phenomena, e.g., mechanistic studies to assess carcinogenic risk of specific chemicals, mechanism of disease pathogenesis, interaction of immune function and drug metabolism, study of emerging pathogens, toxicity profile identification, manufacturing science, materials science, method development and advancement of laboratory techniques, analysis of chemical contaminants in food, cosmetics, and dietary supplements, etc.

Bioassay Assessment Group (CDER)
For innovative contributions to assess quality and potency of bispecific antibodies against SARS-CoV-2 variants through the development of functional bioassays for these products.

Baolin Zhang, Ph.D.
Alexis Dean. M.S. (ORISE Fellow)
Shen Luo, Ph.D.
Julianne Twomey, Ph.D.

Carol Weiss Laboratory Group (CBER)
For contributions to the US government COVID-19 response effort to evaluate the potency of clinical-stage therapeutic antibodies against emerging SARS-CoV-2 variants. 

Carol D. Weiss, MD, PhD
Russell Vassell, MS
Wei Wang, PhD
Sabrina Lusvarghi, PhD (Staff Fellow)
Naga Venkata Sabarinath Neerukonda, PhD (Fellow)
Rachel Herrup, MS (Fellow)
Richard Wang, BS (Fellow)

Development of human TK6-derived cell lines for genotoxicity testing (NCTR)
For excellence of research to develop fourteen TK6-derived cell lines that stably expressing a single human cytochrome P450 for potential application in genotoxicity testing. 

Tong Zhou, PhD
Nan Mei, PhD
Xiaoqing Guo, PhD
Mugimane G. Manjanatha, PhD
Xilin Li, PhD (ORISE Fellow)
Lei Guo, PhD
Si Chen, PhD (Staff Fellow)
Qiangen Wu, PhD (Visiting Scientist)
Xiaobo He, PhD (Visiting Scientist)
Matthew S. Bryant, PhD

Doxorubicin Cardiotoxicity Evaluation Team
The group has identified early predictive biomarkers in nonclinical and clinical samples that may facilitate identification of patients at risk for anthracycline-induced cardiotoxicity.

Laura K. Schnackenberg, PhD
Varsha Desai, PhD
James C. Fuscoe, PhD
Vikrant Vijay, PhD
Carrie Moland
Bounleut Phanavanh, PhD
Tao Han, PhD (Staff Fellow)
Richard D. Beger, PhD
Lisa Pence, PhD
Jinchun Sun, PhD (Visiting Scientist)
Li-Rong Yu, PhD (Staff Fellow)
Zhijun Cao, PhD (Staff Fellow)
William Mattes, Ph.D., DABT
Julia T. Lathrop, PhD
Jinong Li, PhD, DABCC
Jane P.F. Bai, PhD
Kelly Norsworthy, MD
Ashutosh Rao, PhD
Baikuntha Aryal, PhD
Nicholas Richardson, DO, MPH
Margret Merino, MD
Laleh Amiri-Kordestani, MD

Hepatitis C Neutralizing Antibodies Research Group
For discovery of molecular mechanisms that explain how human neutralizing and non-neutralizing antibodies interact with hepatitis C virus (HCV). These findings shed light on historical failures of Hepatitis C Immune Globulin in clinical trials, and provide a path forward for use antibody therapies to prevent or treat HCV.

Pei Zhang, MD
Evi Budo Struble, PhD
Lu Deng, PhD
Lilin Zhong, MS
Hailing Yan, MS
Maria Luisa Virata-Theimer, PhD

Immunogenicity risk of innate immune response modulating impurities: assessment and control
Identified the contribution of process-related innate immune response modulating impurities to immunogenicity risk of peptides and proteins, developed animal studies to model the effect, and in vitro assays to assess the risk. The findings contributed to guidance on assessment of immunogenicity risk for heparins, synthetic peptides and proteins.

Daniela Verthelyi, MD, PhD
Lydia Haile, PhD
Vivian Wang, MS
Ashutosh Rao, PhD
Montserrat Puig, PhD
Roshni Rao, PhD (Orise)
Swamy Polumuri, PhD (Orise)
Cynthia Sommers, PhD
Eduardo Mufarrege, PhD (Orise)

Contamination Analysis Group
For development of new, fast, efficient, and adaptable methods for detecting adulterated heparin and endotoxin contamination in FDA regulated medical products.

David Keire, PhD
Hongli Li, PhD
Peter Nemes, PhD
Samanthi Wickramasekara, PhD

Bio-Control Development Team
For sustained achievement in discovering and developing for farm use, an unprecedented
biological control schema aimed at preventing the contamination of fresh-market tomatoes with

Rebecca L. Bell, PhD
Eric W. Brown, PhD
Timothy R. Croley, PhD
Christina Ferreira, (Fellow)
Darcy E. Hanes, PhD (C)
Ann Marie Knolhoff, PhD
Yan Luo, PhD (Fellow)
Elizabeth Reed, MS, (Fellow)
Robert L. Sprando, PhD
Jie Zheng, PhD (Fellow)

Green Flourescent Protein Control Strain, CFSAN
For the innovative use of recombinant DNA technology to create green fluorescent protein microbiological control strains for the microbiological analysis of regulatory samples.

Rachel Binet, PhD
Maria Hoffman, PhD (ORISE Fellow)
Steven Monday, PhD
Emily Pettengill, PhD (ORISE Fellow) 

FDA/IFSH Low-Moisture Foods Research Team
For outstanding research achievements at FDA/IFSH leading to the safety of low-moisture foods and ingredients.

Nathan M. Anderson, PhD, CFSAN
Gregory J. Fleischman, PhD, CFSAN
Elizabeth M. Grasso, PhD, CFSAN
Stephen F. Grove, PhD
Susanne E. Keller, PhD, CFSAN
Haiping Li, PhD
Naharika Mishra, PhD, OSPD
Christina N. Stam, PhD, CFSAN

Bioprocess Research Group
For establishing a model monoclonal antibody manufacturing process from cell banking to final dosage form to provide a basis for CDER research on bioprocess improvement.

Kurt Brorson, Ph.D., CDER
Scott Lute, M.S., CDER
Erik Read, Ph.D, CDER
Cyrus Agarabi, Pharm.D., Ph.D., M.S., CDER
Rakhi Shah, Ph.D., M.S., CDER
David Awotwo-Otoo, Ph.D., CDER
Huiquan Wu, Ph.D., M.S., CDER
Michael Boyne, Ph.D., CDER

Genomics Group, CFSAN
For FDA implementation of genomic approaches to molecular epidemiology has produced far reaching effects on traceback of foodborne pathogens, regulatory decision-making, and evolutionary knowledge.

Marc W. Allard, Ph.D.
Charles Wang, B.S.
Errol Strain, Ph.D.
David Melka, B.S.
Christine E. Keys, M.S.
Andrea Ottesen, Ph.D.
Dwayne Roberson, B.S.
Shashi Sharma, Ph.D.
Steven M. Musser, Ph.D.
Eric W. Brown, Ph.D.

Modern Analytics for Heparin Characterization Laboratory Team
This team examined novel approaches for characterization of heparin demonstrating the value of modern analytics and computational methods to assess quality of complex drug substances.

Lucinda Buhse, Ph.D.
Ali Al Hakim, Ph.D.
David Keire, Ph.D.
Richard Kolinski
Christine Moore, Ph.D.
Moheb Nasr, Ph.D.
Mike Trehy, Ph.D.
Hongping Ye, Ph.D.

CVM-Melamine Research Group, CVM
For outstanding proactive investigation of melamine related renal pathology which provided the Agency with time critical information during FDA’s melamine risk assessment.

Eric Evans
Charles M. Gieseker, M.S.
Nicholas R. Hasbrouck
Tamara Mayer
Cristina Nochetto
Renate Reimschuessel, Ph.D., V.M.D.
Steven Rill
Cynthia B. Stine, M.S., Ph.D.
Elizabeth Tall, M.S.
Jeffrey L. Ward, D.V.M., M.S., Ph.D.

CBER Malaria Research Group
For the CBER Malaria Research Group for novel assays improving safety and efficacy of candidate malaria vaccines and detecting malaria-infected donors of blood and tissues.

K. Kumar, PhD, CBER
Babita Mahajan, PhD, CBER
Victoria Majan, MS, CBER
Hong, Zheng, MS, CBER

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