U.S. flag An official website of the United States government
  1. Home
  2. Science & Research
  3. About Science & Research at FDA
  4. Excellence in Laboratory Science Group Award 2009--Present
  1. Science & Research

Excellence in Laboratory Science Group Award 2009--Present

Excellence in Laboratory Science Group Award 2009--Present

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.

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 affects 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