FDA Science Forum 2000

2000 FDA SCIENCE FORUM
SCIENTIFIC ACHIEVEMENT AWARDS

Excellence in Analytical Science
Poliovirus Research Group - Center for Biologics Evaluation and Research: David M. Asher, M.D.
Konstantin M. Chumakov Ph.D.
Eugenia M. Dragunsky, Ph.D.
Joan C. Enterline
Monica L. Parker
Kitty L. Pomeroy
Gennady V. Rezapkin, Ph.D.
Rolf E. Taffs, Ph.D.
For the development of two new reliable methods for control of Oral Poliovirus Vaccine safety: MAPREC - to monitor manufacturing processes and the transgenic mouse model - to replace the use of monkeys for control of neurovirulence.

Excellence in Laboratory Science
Abdu I. Alayash, Ph.D - Center for Biologics Evaluation and Research: For studies that contributed fundamentally to current understanding of the hemoglobin toxicity and potentially to the design of safer second generation blood substitutes.

Excellence in Review Science
Biopharmaceutics Classification System Working Group - Center for Drug Evaluation and Research: Ajaz S. Hussain, Ph.D.
Lawrence J. Lesko, Ph.D.
Ko-yu Lo, Ph.D.
Vinod P. Shah, Ph.D.
D onna Ann Volpe, Ph.D
Roger L. Williams, M.D.
For development and implementation of a Biopharmaceutics Classification System to establish a mechanistic basis for correlating in vitro drug product dissolution and in vivo bioavailability.

Outstanding Intercenter Scientific Collaboration
PCR Feed Methodology Validation Group: Dorothy E. Farrell (CVM)
Sharon Friedman (CVM)
Michael J. Myers, Ph.D. (CVM)
Warren L. Campbell (NCTR)
Carl E. Cerniglia, Ph.D. (NCTR)
Donald D. Paine (NCTR)
Rong-Fu Wang, Ph.D. (NCTR)
Steven C. Madzo (ORA)
For participation in a validation trial of a PCR-based method that detects bovine-derived materials that will be used in support of the feed ban.

2000 Center and Office of Regulatory Affairs
Scientific Achievement Awards

Center for Biologics Evaluation and Research

Poliovirus Research Group - Excellence in Analytical Science
David M. Asher, M.D.; Konstantin M. Chumakov Ph.D.; Eugenia M. Dragunsky, Ph.D.; Joan C. Enterline; Monica L. Parker; Kitty L. Pomeroy; Gennady V. Rezapkin; Ph.D.and Rolf E. Taffs, Ph.D.: For the development of two new reliable methods for control of Oral Poliovirus Vaccine safety: MAPREC - to monitor manufacturing processes and the transgenic mouse model - to replace the use of monkeys for control of neurovirulence.
Abdu I. Alayash, Ph.D. - Excellence in Laboratory Science: For studies that contributed fundamentally to current understanding of the hemoglobin toxicity and potentially to the design of safer second generation blood substitutes.
Infliximab Licensing Group - Excellence in Review Science
Lauren E. Black, Ph.D.; Kurt A. Brorson; John David Finkbohner, Ph.D.; Martin David Green, Ph.D.; Brian Erskine Harvey, M.D., Ph.D.; Christopher Charles Joneckis, Ph.D.; Barbara G. Matthews, M.D.; Teresa Neeman, Ph.D. and Jose Javier Tavarez-Pagan: For innovative application of regulatory policy enabling rapid approval of an effective treatment for Crohn's Disease.

Center for Drug Evaluation and Research

Hsien-Ming James Hung, Ph.D. - Excellence in Analytical Science: For outstanding achievements in the development of new statistical methodologies for clinical trials that significantly enhance the scientific basis of the FDA's regulatory decisions.
Cardiopulmonary Pharmacology Research Team - Excellence in Laboratory Science
Douglas P. Chadwick; Eugene H. Herman, Ph.D. and Jun Zhang, M.D.: For establishing animal models of insidious anthracycline induced cardiotoxicity, discovering a cardioprotective approach, and linking the cardiotoxicity to a monitorable interspecies biomarker.
Biopharmaceutics Classification System Working Group - Excellence in Review Science
Ajaz S. Hussain, Ph.D.; Lawrence J. Lesko; Ph.D.; Ko-yu Lo, Ph.D.; Vinod P. Shah, Ph.D.; Donna Ann Volpe, Ph.D. and Roger L. Williams, M.D.: For development and implementation of a Biopharmaceutics Classification System to establish a mechanistic basis for correlating in vitro drug product dissolution and in vivo bioavailability.

Center for Devices and Radiological Health

S. Lori Brown, Ph.D., M.P.H. - Excellence in Analytical Science: For outstanding intellect and leadership in performing pioneering studies on silicone gel breast implants including a seminal study on breast implant rupture.
Marwood N. Ediger, Ph.D. and Richard P. Weiblinger, M.A., M.P.H. - Excellence in Laboratory Science: For pioneering research contributions on the fundamental action-mechanisms of ultraviolet lasers on human tissue that determine the safety and efficacy of leading-edge surgery devices.<P>
Miriam C. Provost, Ph.D. - Excellence in Review Science: For scientific review excellence and regulatory leadership contributing to the safety of hemodialysis devices through the development of guidance documents and standards.

Center for Food Safety and Applied Nutrition

Adrian Weisz, D.Sc. - Excellence in Analytical Science: For outstanding contributions in separation and purification technology using countercurrent chromatography.
Paul Whittaker, Ph.D. - Excellence in Laboratory Science: For outstanding laboratory research on iron metabolism that has had an impact on the public health effects from iron deficiency and iron toxicity.
Christine J. Lewis, Ph.D. - Excellence in Review Science: For outstanding contributions to the monitoring of folate food fortification.

Center for Veterinary Medicine

Jurgen von Bredow, Ph.D. - Excellence in Analytical Science: For the development and evaluation of methods and protocols for the performance certification of diagnostic screening tests for antibiotic residues in milk.
Joseph Kawalek, Ph.D. - Excellence in Laboratory Science: For sustained research on in vitro drug metabolism assays in food-producing animals to validate their use as alternatives and supplements to whole animal experiments.
Kevin J. Greenlees, Ph.D. - Excellence in Review Science: For development of human food safety standards for New Animal Drug Applications for aquatic food animals.

National Center for Toxicological Research

Mohamed S. Nawaz, Ph.D., Saeed A. Khan, Ph.D., Ashraf A. Khan, Ph.D. - Excellence in Analytical Science: For outstanding scientific achievement in the development of novel biochemical and molecular techniques to detect and characterize antibiotic resistant bacteria isolated from poultry and human clinical samples.
John F. Bowyer, Ph.D. - Excellence in Laboratory Science: For research on substituted amphetamines that provides an understanding of the mechanisms involved in their neurotoxicity and how environmental temperature interacts with the mechanisms and impacts on testing of these FDA relevant agents.
Carl Edward Cerniglia, Ph.D. - Excellence in Review Science: For outstanding scientific leadership in developing novel approaches in the way that the microbiological safety assessment of veterinary drugs are reviewed.

Office of Regulatory Affairs

Karen Colburn Jinneman - Excellence in Analytical Science: For exemplary analytical excellence in detection and classification of human pathogenic microorganisms.
Alice E. Cohen, Ph.D. - Excellence in Laboratory Science: For outstanding performance as a technical expert in food microbiology covering analysis, inspections and training.

Nominees for 2000 FDA Scientific Achievement Award for Outstanding Intercenter Scientific Collaboration

Neurotoxicology Research Group: For exceptional service in the promotion of Intercenter and Interagency scientific collaborations resulting in optimization of applications of emerging technologies to neurotoxicological research.; Jan N. Johannessen, Ph.D. (CFSAN)
David S. Lester, Ph.D. (CDER)
Robbe C. Lyon, Ph.D. (CDER
ICCVAM Immunotoxicology Working Group: For outstanding and dedicated service in review of the first assay accepted as validated by the Interagency Coordinating Committee for the Validation of Alternative Methods.; Hui-Chen Chang, Ph.D. (CFSAN)
Kenneth L. Hastings, Ph.D., M.P.H. (CDER)
David G. Hattan, Ph.D. (CFSAN)
Dennis Hinton, Ph.D. CFSAN)
John J. Langone, Ph.D. (CDRH)
Marilyn Lightfoote, Ph.D. (CDRH)
Anne M. Pilaro, Ph.D. (CBER)
Maryann C. Principato, Ph.D. (CFSAN)
Lynnda L. Reid, Ph.D. (CDER)
Susan D. Wilson, D.V.M., Ph.D. (CDER)
Wen-Chic Josie Yang, D.V.M., Ph.D. (CDER)
PCR Feed Methodology Validation Group: For participation in a validation trial of a PCR-based method that detects bovine-derived materials that will be used in support of the feed ban.; Dorothy E. Farrell (CVM)
Sharon Friedman (CVM)
Michael J. Myers, Ph.D. (CVM)
Warren L. Campbell (NCTR)
Carl E. Cerniglia, Ph.D. (NCTR)
Donald D. Paine (NCTR)
Rong-Fu Wang, Ph.D. (NCTR)
Steven C. Madzo (ORA)

BEST POSTER AWARDS
Presented by the FDA Chapter of Sigma Xi

	Abstract A19 Detection of Peanut Agglutinin in Chocolate and Cookies by Enzyme-Linked Immunosorbent Assay T.Y. Yi, A.W. Smallwood, T.W. Brueggemeyer and R.D. Satzger
	Abstract B17 Quantitative, Biologically Relevant Parameters for Testing and Standardization of Skin Response to UV The FDA Photosciences Network
	Abstract B03 Predicting the Neurovirulence Potential of Viral Vaccines for the Human CNS: The Use of Mumps Virus for Model Development S. A. Rubin, M. Pletnikov, R. Taffs, P. Snoy and K. Carbone