Laboratory science includes, but is not limited to, research to investigate biological, chemical, 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, etc.

2021

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

 

2020

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

 

2019

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

 

2018

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)

 

2017

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

 

2016

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
Salmonella.

 

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)

 

2015

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) 

 

2014

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

 

2013

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

 

2012

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.

 

2011

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.

 

2010

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.

 

2009

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