EXCELLENCE IN ANALYTICAL SCIENCE

For promotion of vaccine safety through the development of in vivo assays for the preclinical assessment of the risk for virus vaccine neurovirulence

EXCELLENCE IN LABORATORY SCIENCE

For developing a world renowned research program focused on porcine endogenous retroviruses to inform the regulatory oversight, including safety assessment, of porcine xenotransplantation products

EXCELLENCE IN REVIEW SCIENCE

For developing innovative analytical methodologies for quantifying the dose-response relationships and estimates of risk of Listeria monocytogenese in a number of foods that has served as the basis for critical risk management decisions

OUTSTANDING JUNIOR INVESTIGATOR

For conducting groundbreaking research on the evolution of bacterial pathogens through the use of bioinformatic analyses of DNA sequences to probe genetic change

OUTSTANDING SUPPORT SCIENTIST

For outstanding scientific and quality achievements that led to the first laboratory in FDA to acquire accreditation by the American Association for Laboratory Accreditation

OUTSTANDING NEW REVIEWER

For outstanding scientific contribution in the area of neurology, and exemplary performance as a new reviewer

CENTER AWARDS

EXCELLENCE IN ANALYTICAL SCIENCE

Steven A. Rubin, M.S
Center for Biologics Evaluation and Research (CBER)

For promotion of vaccine safety through the development of in vivo assays for the preclinical assessment of the risk for virus vaccine neurovirulence

James J. Chen, Ph.D.
National Center for Toxicological Research (NCTR)

For significant contributions toward the resolution of statistical issues associated with gene microarray data relative to regulatory review and decision-making by FDA

DNDP Suicide Rates in Trials of Antidepressants Team
Center for Drug Evaluation and Research (CDER)

Tarek A. Hammad, M.D., Ph.D.
Andrew D. Mosholder, M.D., M.P.H.
Gerard Boehm, M.D., M.P.H.
Paul A. David, RPh
Judith A. Racoosin, M.D., M.P.H.
Thomas P. Laughren, M.D.

For developing and applying a novel approach to the analysis of NDA safety data in order to explore a vexing ethical dilemma in antidepressant trial design

Joseph L. Ferreira, Ph.D.
Office of Regulatory Affairs (ORA) Southeast Regional Laboratory

For development and validation of a refined ELISA for the detection of type A, B, E, and F Clostridium botulinum toxins

Pak-Sin Chu, Ph.D.
Center for Veterinary Medicine (CVM)

For the development of sensitive methods for the detection and confirmation of animal drug residues in meat, milk and eggs

Gracia A. Perfetti, Ph.D.
Center for Food Safety and Applied Nutrition (CFSAN)

For outstanding contributions in developing analytical methods for determining sulfites and polynuclear aromatic hydrocarbons in foods in response to FDA regulatory needs

EXCELLENCE IN LABORATORY SCIENCE

Carolyn A. Wilson, Ph.D.
Center for Biologics Evaluation and Research (CBER)

For developing a world renowned research program focused on porcine endogenous retroviruses to inform the regulatory oversight, including safety assessment, of porcine xenotransplantation products

Merle G. Paule, Ph.D.
National Center for Toxicological Research (NCTR)

For demonstrating the neurotoxic potential of agents that block sodium channels and NMDA receptors during development utilizing a nonhuman primate model of complex learning

*Palmer Orlandi, Ph.D. and Keith A. Lampel, Ph.D.
Center for Food Safety and Applied Nutrition (CFSAN)

In recognition of developing and demonstrating the utility of a novel method to detect and identify microbial pathogens in foods

EXCELLENCE IN REVIEW SCIENCE

Review Committee for Original BLA of Aventis Behring L.L.C. for Alpha-1-Proteinase Inhibitor (Human)

Pankaj Amin, B.S., CBER
Mahmood Farshid, Ph.D., CBER
John Godshalk, M.B.A., CBER
Paul Hshieh, Ph.D., CBER
J. Lloyd Johnson, Pharm.D., CBER
Elena Karnaukhova, Ph.D., CBER
Ewa Marszal, Ph.D., CBER
Anita M. O'Connor, Ph.D., CBER
L. Ross Pierce, M.D., CBER
Anil K. Rajpal, M.D., CBER
Kathryn D. Smith, B.S., CBER
Mark Shield, Ph.D., CBER
Andrew Shrake, Ph.D., CBER

For a fast track response review for a life-threatening inherited disease

Erica Brittain, Ph.D. and Daphne Lin, Ph.D.
Center for Drug Evaluation and Research (CDER)

For outstanding contribution to the statistical review process through innovative approaches in the design and the analysis of clinical trials for antimicrobial drug products

William Childress, Ph.D.
Office of Regulatory Affairs (ORA) Winchester Engineering and Analytical Center, Winchester, MA

For exceptional contribution to protecting public health through the development of regulatory protocols for self monitoring blood glucose devices

Clark D. Carrington, Ph.D.
Center for Food Safety and Applied Nutrition (CFSAN)

For developing innovative analytical methodologies for quantifying the dose-response relationships and estimates of risk of Listeria monocytogenese in a number of foods that has served as the basis for critical risk management decisions

*James P. Reeves, Ph.D.
Center for Devices and Radiological Health (CDRH)

For scientific and technical contribution that facilitated bringing diagnostic assays for markers used to diagnose cancer to market to meet a critical public health need

OUTSTANDING JUNIOR INVESTIGATOR

Siobhán Clare Cowley, Ph.D.
Center for Biologics Evaluation and Research (CBER)

For outstanding progress in understanding the cellular basis of non-interferon mediated control of intracellular bacterial infections, leading to improved correlates of protection for bacterial vaccines

Charles Gieseker, M.S.
Center for Veterinary Medicine (CVM)

For outstanding performance which resulted in developing new techniques, trouble-shooting procedures and working independently to provide incurred residue tissues of multiple drugs in multiple fish species

Eric Wayne Brown, Ph.D.
Center for Food Safety and Applied Nutrition (CFSAN)

For conducting groundbreaking research on the evolution of bacterial pathogens through the use of bioinformatic analyses of DNA sequences to probe genetic change

OUTSTANDING SUPPORT SCIENTIST

Chia-Yun Lo, B.S., M.S.
Center for Biologics Evaluation and Research (CBER)

For outstanding scientific contributions to the public health made possible by her professional expertise, scientific curiosity and sophistication, critical thinking, and generous assistance of colleagues

Cathy L. Burns, BS.
Office of Regulatory Affairs (ORA) Denver District

For outstanding scientific and quality achievements that led to the first laboratory in FDA to acquire accreditation by the American Association for Laboratory Accreditation

Cristina B. Nochetto
Center for Veterinary Medicine (CVM)

For outstanding performance, as evidenced by working independently, improving existing procedures, innovating new techniques, and demonstrating enthusiasm and teamwork

Diana S. Stewart, B.S., M.S.
Center for Food Safety and Applied Nutrition (CFSAN)

For technical excellence and outstanding laboratory management in support of microbiological food safety and security research at the National Center for Food Safety and Technology

OUTSTANDING NEW REVIEWER

Ping He, M.D.
Center for Biologics Evaluation and Research (CBER)

For outstanding efforts directly contributed to a timely review of a highly complex application of a red cell leukoreduction filter and storage set

Carlos Peña, Ph.D.
Center for Devices and Radiological Health (CDRH)

For outstanding scientific contribution in the area of neurology, and exemplary performance as a new reviewer

John Kendall Harshman, M.S., D.V.M.
Center for Veterinary Medicine (CVM)

For efficient and effective recommendations to approve eleven generic animal drug products, and for exceptional scientific insight and response to citizen petitions

Kimberly A. Smeds, Ph.D.
Center for Food Safety and Applied Nutrition (CFSAN)

For exceptional performance as a new FDA scientific reviewer, in one year becoming fully productive and contributing substantially to the mission of the FDA

	Sigma Xi Outstanding Poster Award - 2004 FDA Science Forum Board A-62 Solid-phase immunosensor for quantitative rapid detection of antibiotic residues in raw unprocessed milk N.A.Anis1, J.C. Gotthardt1, M.S. Khalil2, L.H. Stanker3, D.E. Menking4, J. J. Valdes4, J. Park4,   1FDA, CVM, Rockville MD, 2University of Maryland, Baltimore MD, 3USDA, Albany CA, 4U.S. Army, ABG, Aberdeen, MD Abstract
	Sigma Xi Outstanding Poster Award - 2004 FDA Science Forum Board C-16 Microarray analysis of Bacillus cereus group virulence factors N. Sergeev1 , M. Distler2 , V. Chizhikov3 , A. Rasooly1 , 1OST, CDRH, FDA, Silver Spring, MD, 2JIFSAN - University of Maryland, Silver Spring, MD, 3FDA, Silver Spring, MD Abstract
	Sigma Xi Outstanding Poster Award - 2004 FDA Science Forum Board E-49 Carrier Albumin's Binders in Serum (CABs): Enhancing Disease Detection A.I. Mehta1, M. Lowenthal2, D. Johann2, V. Pajapakse2, V. Fusaro2, S. Hoatson2, H. Asmussen2, J. Roberts2, C. Butler2, R. Papas2, S. Ross2, D.A. Fishman3, E.F. Petricoin2, L.L. Liotta2,    1FDA-NCI. Clinical Proteoimic Program, 2NIH-CBER & Howard Hugh Medical Institute, 3Northwestern University Medical School, Chicago IL
	Sigma Xi Runner Up Poster Award - 2004 FDA Science Forum Board B-05 Local Delivery of Estrogen Inhibits Stenosis Following Angioplasty Balloon Injury in a Swine Model: A Preliminary Report on the Safety and Effectiveness of a Trans-Vascular Needle Injection Catheter J.A. Karanian1, R. Virman2, D. Wray-Cahen1, A.E. Ashby1, S.L. Hilbert1, W.F. Pritchard2,    1OST, CDRH, FDA Laurel MD, 2Armed Forces Institute of Pathology, Washington DC Abstract
	Sigma Xi Runner Up Poster Award - 2004 FDA Science Forum Board I-06 Multiplex DIG-ELISA for the Detection of Clostridium botulinum Toxin Types A, B, E, and F J.L. Ferreira1, S.K.Sharma2, S.B.Eblen2,    1ORA, FDA, Atlanta, GA, 2CFSAN, FDA, College Park, MD
	Clear Science Communication Award - 2004 FDA Science Forum Board A-44 Hand-held microfluidics multi-channel immunosensor for detection of multiple microbial toxins simultaneously I. Treisel1, M. Manion1, N. Sergeev2, B. Shapiro1, A. Rasooly2,    1JIFSAN-University of Maryland, 2OST, FDA, Silver Spring, MD Abstract
	Clear Science Communication Award - 2004 FDA Science Forum Board B-15 Adverse events (AEs) among patients receiving autologous cultured chrondocytes M.A.Malek, A.K. Mohan, J. Polder, M.M. Braun, T.R. Cote,   CBER, FDA, Rockville, MD Abstract
	Clear Science Communication Award - 2004 FDA Science Forum Board G-05 Consumer's Use of Food and Restaurant Labeling: Focus Group Results A.M. Lando, J.M. Labiner, R.A.Williams,   CFSAN, FDA, College Park MD Abstract
	Clear Science Communication Award - 2004 FDA Science Forum Board M-04 Study Pregnant Women? Yes, You Can! K. Uhl1, M.A. Miller2, D.L. Kennedy2,   1CDER, OND, FDA, Rockville, MD, 2OC, FDA, Rockville MD