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  1. FDA Technology Transfer Program

FDA CRADAs

FDA CRADAs

FDA/Center Principal InvestigatorCollaborator(s)Title of CRADA
CBER
Zuben Sauna, Ph.D.
Biogen Idec Hemophilia Inc.Immunogenicity of Human-Factor IX-Murine-FC Fusion Protein in the Mouse Hemophilia B Mouse Model
CBER
John Cipollo, Ph.D.
Sapienza Università di RomaCollaborative Study of the Interaction of Glycosylation and Innate Immunity in Caenorhabditis elegans
CBER
Chintamani Atreya, Ph.D.
Toray Industries, Inc.Genomic Biomarkers for Product Quality of Stored Blood Cells
CBER
Hana Golding, Ph.D.
Kyowa Hakko Kirin California, Inc.Use of Bioimaging to Examine Protection Conferred by Monoclonal Antibodies Against Vaccinia Virus
NCTR
Dan Buzatu, Ph.D.
Vivione Biosciences, LLCDevelopment and Adaptation of the RAPID-B Pathogen Detection System
CBER
Konstantin Chumakov, Ph.D.
PATHCalibration of Reagents for ELISA Test for Potency Assay of Inactivated Polio Vaccine (IPV)
OIM
Randy Levin, M.D.
Hiteks SolutionsStructured Product Labeling Indexing Project
CFSAN
Marc Allard, Ph.D.
Lifetech CorporationLife Technologies Real-Time PCR Assay and Sequencing Workflows for Bacterial Strain Typing
CBER
Michael Fauntleroy
Health CanadaUS-Canada Regulatory Cooperation Council Initiative: Common Electronic Submissions Gateway
CBER
Abdu Alayash, Ph.D., D.Sc.
Albert Einstein College of MedicineMechanisms and Modulation of Acellular Hemoglobin A Toxicity
CBER
Konstantin Chumakov, Ph.D.
University of Central FloridaLow Cost Booster Vaccine To Improve Immunity Against All Polio Virus Serotypes
CFSAN
Efstathia Papafragkou, Ph.D.
North Carolina State UniversityBuilding Capacity to Control Viral Foodborne Disease: A Translational, Multidisciplinary Approach
CFSAN
Alison Robertson, Ph.D
Florida Gulf Coast UniversityCiguatera Investigations in the Greater Caribbean Region:  Ecophysiology, Population Connectivity, Forecasting, and Toxicogenesis
CVM
Haile Yancy, Ph.D.
BioGx, Inc.The Development and Evaluation of the Multiplex Real-Time Assay (MRTA)
CFSAN
Sherwood Hall, Ph.D.
Mercury Science, Inc.Immunoassays for the Saxitoxins
CVM
Marylin Martinez, Ph.D.
Simcyp LimitedDevelopment of Physiologically-Based Pharmacokinetic (PBPK) DOJ Support Veterinary Drug Evaluations
CDRH
Srinidhi Nagaraja, Ph.D.
Cordis Corporation
Medical Implant Mechanics, LLC
Dassault Systemes Simlia Corporation
Validation of Multi-Axial Stent Fatigue Stress Calculations
CDRH
Oleg Vesnovsky, Ph.D.
Spectra Medical Devices, Inc.Research Investigation of Chisel Point or Semi-Lancet Non-Coring Needles
CDRH
Oleg Vesnovsky, Ph.D.
Nipro CorporationResearch Investigation of Diamond Point or Lancet Non-Coring Needles
CBER
Willie Vann, Ph.D.
Program for Appropriate Technology in HealthHigh Yield Group X Meningococcal Polysaccharide-Protein Carrier Conjugates and Technology Transfer
CBER
Margaret Bash, Ph.D.
Program for Approprate Technology in HealthEvaluation of Functional Immune Responses to Serogroup A Meningococcal Vaccines Using Human Complement Serum Bacterial
CDRH
Mary Weick-Brady, MSN, RN
Kwikpoint/Gaia LLCUse of Visual Language in Medical Device Safety Publications
CFSAN
Susan McCarthy, Ph.D.
WTI, Inc.Development of Procedure for the Disinfection of Raw Fish
CFSAN
Marc Allard, Ph.D.
Agilent Technologies, Inc.Mass Spectroscopy-Based Genotyping:  New Tools for Food-Borne Pathogen Surveillance and Outbreak Control
NCTR
William Salminen, Ph.D.
Cellular Dynamics InternationalAssessment of Human Induced Pluripotent Stem Cell (iPSC)-Derived Hepatocytes as an In Vitro Model for Hepatotoxicity
CDRH
Cara Krulewitch, CNM, Ph.D. FACNM
American Society of Plastic Surgeons (ASPS)/Plastic Surgery FoundationBreast Implant- Anaplastic Large Cell Lymphoma Registry Collaboration
CDRH
Michelle Tarver-Carr, Ph.D.
American Academy of OphthalmologyDevelopment and Analysis of a Registry for Intraocular Lenses (IOLs)
NCTR
Daniel Doerge, Ph.D.
University of Illinois Urbana-ChampaignBotanical Estrogens: Mechanisms, Dose and Target Tissues
CDER
William H. Doub, Ph.D.
Malvern Instruments, Inc.Morphologically Directed Raman Chemical Microscopy of Pharmaceutical Solids
CBER
Dorothy Scott, Ph.D.
University of Texas Health Science Center at San AntonioInvestigation of the Structure of a1-Proteinase Inhibitor Polymers by Atomic Force Microscopy
ORA
Ian Mayers
United States PharmaceopeiaCollaboration between the United States Pharmacopeia and Office of Regulatory Affairs/Food and Drug Administration
NCTR
Martha Moore, Ph.D.
TERA- Toxicology Excellence for Risk AssessmentDevelopment of a method to use in vivo mutagenicity data to address the question as to whether a specific chemical induces cancer via a mutagenic or a non-mutagenic mode-of-action (MOA)
CBER
Pedro Piccardo, M.D.
The University Court of the University of Edinburgh, Roslin InstituteExperimental Models for the Study of the Pathogenesis of Transmissible Spongiform Encephalopathies
CDRH
Leonardo Angelone, Ph.D.
Imricor Medical Systems, Inc.MR Conditional Device Radiofrequency Safety Assessment Method
CFSAN
Eric Brown, Ph.D.
E.I. du Pont Nemours and Company, DuPont QualiconOptimization of Rapid Methods for Sample Collection and Transport, Molecular Capture Methods, and Molecular RAPD Subtyping
ORA
Kai-Shun Chen, Ph.D.
E.I. du Pont Nemours and Company, DuPont QualiconOptimization of Real Time PCR Assay for Detection of Shigella spp. for Use with the BAX® Instrument
CBER
Luisa Gregori, Ph.D.
Alliance Biosecure Research FoundationInfectivity Titrations of Blood Components from Chimpanzees Infected with the Agent of Gerstmann-Sträussler-Scheinker Syndrome in Mice and Comparison of Sensitivity of Mouse Bioassays
CBER
Willie Vann, Ph.D.
PATH Vaccine SolutionsDevelopment of Conjugation Technology for Pneumococcal Conjugate Vaccines
NCTR
Barbara Parsons, Ph.D.
The Hamner Institutes for Health SciencesEvaluating the Utility of ACB-PCR in Dose-Response Assessment and Mode-of Action Evaluation (Phase II)
CBER
Jakob Reiser, Ph.D.
Muscular Dystrophy AssociationRemote Therapeutic Delivery for Spinal Muscular Atrophy
CBER
Indira Hewlett, Ph.D.
Nanosphere, Inc.Development of a Nano-Particle Influenza Assay
CDRH
Paul Jones
Fraunhofer USA, Inc. - CESESoftware Re-engineering and Forensic Analysis
CDRH
Gerry W. Gray, Ph.D.
Cytel, Inc.Software for Bayesian Clinical Trials
OC/OCPP
Armando Oliva, M.D.
GlobalSubmit, Inc.Study Design Software
CDER
Federico Goodsaid, Ph.D.
Eli Lilly and CompanyDevelopment of Standards, Data Integration, and Applications for Analyzing and Visualizing Heterogeneous Datasets
CDER
Joseph Hanig, Ph.D.
Mosaiques DiagnosticsIdentification and Validation for Urinary Biomarkers for Drug Toxicity
CDRH
Aldo Badano, Ph.D.
Ginzton Technology Center--Varian Medical Systems, Inc.X-ray Detector Models for Imaging Breast Cancer
CDER
Federico Goodsaid, Ph.D.
Adaptive Pharmacogenomics, LLC, and GlaxoSmithKline R&DDevelopment of a General Purpose Software Tool that Optimizes Clinical Study Design with Biomarkers
CBER
Sanjay Kumar, Ph.D.
Program for Appropriate Technology in HealthBioassays to Predict the Biological Activity, Safety, and Virulence of Live Attenuated Plasmodium Falciparum Sporozoite
CDRH
V. Michelle Chenault, Ph.D.
Eyelight Diagnostics, Inc.Non-Invasive Assessment of Individuals at Risk for Diabetes
CBER
Raj K. Puri, M.D., Ph.D.
Protox Therapeutics, Inc.Development and Characterization of Novel Protein Toxin Therapeutics Targeting IL-4 Receptor
CDER
Joga Gobburu, Ph.D.
American Association of Pharmaceutical Scientists (AAPS)Enhancing IND/NDA Review Quality via Quantifying Prior Knowledge
CDER
Felix Frueh, Ph.D.
Federico Goodsaid, Ph.D.
Ingenuity, Inc.Reference Database Exploration Tool for Regulatory Review of Biomarker, Pharacogenomic, and Toxicogenomic Data
CDER
Randy Levin, M.D.
Infrastructures for Information, Inc. (i4i)FACTS@FDA Label and Listing Collaboration System
CDER
Kurt Brorson, Ph.D.
Eli Lilly and CompanyAn Integrated Approach to Evaluation of Viral Clearance for Monoclonal Antibodies
NCTR
Robert H. Heflich, Ph.D.
Teijin Pharma, Ltd.Methods of Development for Determining Pig-A Mutations in Rodents by Flow Cytometry
NCTR
Merle G. Paule, Ph.D.
Univ. Arkansas for Medical SciencesKetamine Pharmakinetics in Children
NCTR
Barbara Parsons
CIIT Centers for Health ResearchACB-PCR in Dose Response Assessment and Mode-of-Action Evaluation
CDER
Mark Avigan, M.D.
John Senior, M.D.
Entelos, Inc.Development of Drug-Induced Liver Injury (DILI) PhysioLab Platform
CDRH
Ronald W. Waynant, Ph.D.
Raydiance, Inc.Medical Applications of a High Energy Femtosecond Laser
CFSAN
Thomas J. Flynn, Ph.D.
In Vitro TechnologiesCryopreserved Human Hepatocytes to Increase Plateability and Extend Culture Life
CFSAN
Jonathan Deeds, Ph.D.
University of WashingtonDevelopment of a Surface Plasmon Resonance-based Biosensor for the Detection of PSP Toxins
CFSAN
Mona S. Calvo, Ph.D.
Mushroom CouncilDiseases Resistance and Vitamin D Rich Edible Mushroom Consumption
CFSAN
Stacey Etheridge, Ph.D.
Woods Hole Oceanographic InstitutionAlexandrium Fundyense Distributions in the Gulf of Maine: Shellfish Toxicity, Verical Toxin Flux, and Bloom Dynamics in a Complex Shelf Sea
CDRH
Ronald Robinson, Ph.D.
Epicor/St. Jude MedicalOptical Techniques for the Non-Invasive 3D Characterization of Biomedical Ultrasound Beams
CDER
Karol Thompson, Ph.D.
Affymetrix, Inc.Toxigenomic Signature Analysis of Drug-Induced Phospholipidosis
CBER
Carol Weiss, M.D., Ph.D.
NovartisEnv-Gp41 Oligomeric Immunogen
NCTR
Fred A. Beland, Ph.D.
BG MedicineSystems Toxicology from the 28-day Rat Study for Prediction of Clinical Liver Toxicology Potential
CDER
James Weaver, Ph.D.
Pfizer, Inc.Evaluation of Biomarkers of Drug-Induced Vascular Injury
CDRH
Aldo Badano, Ph.D.
FIMI/Phillips, Inc.High-Dynamic-Range Display of Medical Images
CBER
Jay Lozier, M.D., Ph.D.
National Hemophilia FoundationGenetics of Inhibitor Antibody Response
CDER
John F. Kauffman, Ph.D.
ChemImageRaman Chemical Imaging of Pharmaceutical Solids
CDER
R. Daniel Benz, Ph.D.
Lhasa LimitedDevelopment of FDA Toxicology Databases Suitable for Human Expert Rule Development and Mechanistic Understanding of Chemical-Induced Toxicity
CDER/CDRH
Felix Frueh, Ph.D., CDER
NovartisCo-Development of Drugs and Pharmacogenomic Tests
NCTR
Merle G. Paule, Ph.D.
Boehringer-Ingelheim PharmaceuticalsLong-term Dopaminergic Receptor Stimulation on Compelx Brain Functions
CBER
Konstantin Chumakov, Ph.D.
U.S. Civilian Research & Development FoundationTest Kit for Quantitative Genotyping of Subtypes of HCV
NCTR
Syed Ali, Ph.D.
University of Arkansas FayettevilleWireless Deep B Stimulation in Non-human Primates with MPTP-Induced Parkinson's Disease
CDER
Peter Lee, Ph.D.
Pharsight CorporationEnhancing IND/NDA Study Data Review Process
CDER
Randy Levin, M.D.
U.S. PharmacopeiaSubstance Registration Project
CDRH
Howard Bassen
Biophan LaboratoriesMeasurement and Computer Modeling to Evaluate the Safety of Medical Implants in the Presence of Electromagnetic Fields from Magnetic Resonance Imaging
CDER
Helen Winkle
LightPharma, Inc.Understanding manufaturing Science to Caprture Opportunities on the Critical Path for Chemistry, Manufacturing, and Controls (CMC)
CBER
Sheldon Morris, M.D.
Albert Einstein College of MedicineCharacterization of Novel Live Attenuated TB Vaccine Strains
CFSAN and CDER
Kirk Arvidson, Ph.D., CFSAN
R. Daniel Benz, Ph.D., CDER
Leadscope, Inc.Development of Toxicology and Clinical Effects Databases
CBER
Vladimir Chizhikov, Ph.D.
American Type Culture Collection (ATCC)Oligonucleotide Microarrays for Identification and Genotyping of Mycoplasma
CDER
Felix Frueh, Ph.D.
Novartis Institutes for Biomedical Research, Novartis, Inc.Criteria for Drug Evaluation of Genomic Biomarkers of Safety
NCTR
Martha Moore, Ph.D.
Toxicology Excellence for Rise Assessment (TERA)Development of a Method to Use In Vivo Mutagenicity Data
NCTR
Bruce D. Erickson, Ph.D.
Pfizer, Inc.Evaluation of Mechanisms of Inactivation and Degradation of Third Generation Cephalosporins by Bovine Intestinal Microflora
NCTR
Daniel R. Doerge, Ph.D.
University of MarylandDevelopment of a PBPK/PD Model for Acrylamide
CBER
Carolyn Wilson, Ph.D.
Meriture, Inc.Development of Analysis or Peptides for Antiviral Effect on Ebola Virus Infection
CDRH
Wolfgang Kainz, Ph.D.
The Foundation for Research on Information Technologies in Society--IT'ISNumerical Models and Tools
CFSAN
William Burkhardt, III
Cepheid, Inc.Specific Reagent for the Detection of Norwalk Virus
OC/OCIO
Mark Gray and Randy Levin
GlobalSubmit, Inc.Common Table of Contents
CDER
Rakhi Shah, Ph.D.
Texas A&M University, KingsvilleCreation of "Design Space" for Novel Targeted Dosage Forms
CFSAN
Angelo DePaola, Ph.D.
North Carolina State UniversityEcology and Control of Pathogenic Strains of Vibrio Vulnificus (Vv) and Vibrio Parahaemolyticus (Vp) in U.W. Gulf Coast Oysters
NCTR
Daniel R. Doerge, Ph.D.
University of IllinoisPhytoestrogens and Aging
NCTR
Merle G. Paule, Ph.D.
University of ArkansasComprehensive Assessment of Motion Sickness and Neurovestibular Disorders
CDER
Mansoor Khan, Ph.D.
Novartis, Inc.Application of PAT Tools During Manufacturing
NCTR Merle G. Paule, Ph.D.Pfizer, Inc.Cognitive Assessments of Certain Psychotropic Compounds Using NCTR Operant Behavioral Test Battery
NCTR
Weida Tong, Ph.D.
SAS Institute, Inc.Development of Array Track Modules to Linking Functionality PI Polymer Structure
CDER
Jonathan Cook
Conformia, Inc.Survey of Pharmaceutical Needs
CBER
Sheldon Morris, M.D.
Aeras Global TB Vaccine FoundationDevelopment of Preclinical Assays for Safe Use of TB Vaccines
CBER
Hana Golding, Ph.D.
Technion Research and Development FoundationUse of Microarray Technology to Identify New Genes
CBER
Raj K. Puri, M.D., Ph.D.
University Michigan Medical SchoolIL-13 Fusion Cytotoxin as a Targeted Therapeutic
CDRH
Ronald W. Waynant
NanoSonic, Inc.Optical Fiber-Based Instrumentation for Monitoring Breath Biomarkers
CDRH
William F. Pritchard, M.D., Ph.D.
Univ. of PennsylvaniaBiomechanics and Genomics of Vascular Dysfunction and Healing
NCTR
Z. Binienda, D.V.M., Ph.D.
Sigma Tau Research, Inc.Development of Biomarkers for Early Detection of Mitochondrial Dysfunction
CBER
Ewa Marszal, Ph.D.
Alpha-1 FoundationInvestigation of Alpha-1-PI Polymer Structure
CBER
Carl Frasch, Ph.D.
Program for Appropriate Technology in Heath (PATH)High Yield Group A Meningococcal Polysaccharide-Tetanus Toxoid Conjugates
CDER
Edwin J. Matthews, Ph.D.
Joseph F. Contrera, Ph.D.
MultiCASEEnhancement of the Performance of the MultiCASE (Q)SAR Software and FDA Toxicology Prediction Models
CDER
Kurt Brorson, Ph.D.
Parenteral Drug Assn.Large Virus Filter Nomenclature Standardization
CDER
Norman Stockbridge, M.D.
Mortara InstrumentDesign and Development of a Customized ECG Warehouse
NCTR
Richard D. Beger, Ph.D.
RxGen, Inc.Metabonomics of Hepatotoxicity in Humans
CBER
Raj Puri, M.D., Ph.D.
NeoPharm, Inc.
NIH/NINDS
Convection-enhanced Delivery of IL13-PE38QQR for Treatment of Diffuse Brainstem Gliomas
CFSAN
Robert W. Dickey, Ph.D.
Mote Marine LaboratoryToxicity, Trophic Transfer and Persistence of Harmful, Algal Toxins and Metabolites in Shellfish
NCTR Dwight Miller, Ph.D.Litmus, LLCInnovative, Static, and Dynamic Chemical Sensors
CBER Jenny Riemenschneider, Ph.D.HemaTech, LLCAnalysis of Anthrax Antibody Production in Conventional and Transchromosomal Cows
CBER
Carolyn Wilson, Ph.D.
Scripps Research InstituteExpression and Function of the Human PERV A Receptor
CBER
Willie Vann, Ph.D.
University of IllinoisRational Design of Anti-Meningococcal Polysaccharide Conjugate Vaccine
CDRH
Stephen Hilbert, Ph.D.
LifeSpan, Inc.Explant Pathology Studies of Small Intestinal Submucosa Fabricated Pulmonary and Mitral Valve Replacements Implanted in Sheep
CBER
Raj K. Puri, M.D., Ph.D.
American Type Culture Collection (ATCC)Analysis of Gene Expression by Microarray on Various Cell Lines
CBER
Raj K. Puri, M.D., Ph.D.
Holland Laboratory, American Red CrossTransgenic Mouse Model for the Study of Variant Creutzfeldt-Jakob Disease
CDER
Robbe Lyon, Ph.D.
Pfizer, Inc.Assessment of On-line or At-line Vibrational Spectroscopy and Chemical Imaging Techniques in Pharmaceutical Manufacturing for Controlling Critical Quality Attributes
CDER
Joseph F. Contrera, Ph.D.
Edwin J. Matthews, Ph.D.
MDL, Inc.Development of Toxicology Prediction Modeling Modules
CDER
Randy Levin, M.D.
IBMDevelopment of a Physical Database for Study Data for Clinical and Non-Clinical Data at FDA
CBER
Konstantin M. Chumakov, Ph.D.
Johns Hopkins UniversityDevelopment of Biochip-Based Technologies for Detection of Pathogenic Bacteria and Viral Agents and Establishment of a Secure Central Repository for Microarray Data
CBER
Margaret C. Bash, M.D., M.P.H.
Research Triangle InstitutePorin Gene Variable Region Typing of Neisseria gonorrhoeae
CVM
David G. White, Ph.D.
University of MarylandCharacterization of Multiple Antibiotic Resistance Among Enterohemorrhagic E. coli
CDRH
Brian Beard
Mobile Manufacturers ForumMedical Device Electromagnetic Interference 
(EMI) from Wireless Data Devices and Interlaboratory Comparison of Radiofrequency (RF) Dosimetry Data from Handheld Transmitters
CDER
Paul Seligman, Ph.D.
Lincoln TechnologiesAdvanced Analytical Tools for Drug Safety Risk Assessment
CFSAN
Keith Lampel, Ph.D.
Whatman BioscienceUniversal Method for the Preparation of PCR Template of Pathogenic Microorganism Using FTA Filters
CDER
Frank Sistare, Ph.D.
OxfordGlycoSciences, Inc.Development of Improved Biomarkers for Early Detection of Mycocardial Injury, Vascular Injury,and Liver Injury
CDER
Randy Levin, M.D.
DataPharm FoundationElectronic Collection, Processing and Distribution of Drug Product Infomation
CVM
David G. White, Ph.D.
University of Georgia Research FoundationSalmonella through Food Chain, a Molecular Approach
CDER
Randy Levin, M.D.
Lincoln Technologies, Inc.Design and Development of a Prototype Integrated Submissions Data Repository and Data Validation and Transformation Tool for eSubmission CRT Data
CDER
Frank Sistare, Ph.D.
Schering PloughIdentification and Evaluation of Vasculitis Induced by SCH351591
CDER
Randy Levin, M.D.
PharmQuest, Inc.Development of Carcinogenicity and Toxicology Data Management System
CBER
Emmanuel Petricoin, Ph.D.
NIH/National Cancer Institute and Correlogic Systems, Inc.Use of Pattern Discovery Technology to Identify Patterns of Protein Expression Associated with Specific Disease States
CDER
Randy Levin, M.D.
PPD Informatics/PPD Development, Inc.Automation of Patient Profiles for Use with Submission Data Interface and Automated Import Screening
CVM
Robert D. Walker, Ph.D.
Clinical Microbiology Institute (CMI)In Vitro Antimicrobial Testing of Clinically Important Antimicrobial Agents
CBER
Serge Beaucage, Ph.D.
Agilent Technologies, Inc.Synthesis of Oligonucleotides on Planar Glass Surfaces
NCTR
Merle Paule, Ph.D.
University of Arkansas Little RockEffects of Prenatal Cocaine on Behavioral Plasticity
CVM
Marilyn Martinez, Ph.D.
Riviere Consulting, Inc.Quality of Animal Drug Submissions
CDER, CBER, CVM
Robert T. O'Neill, CDER
Martin Green, Ph.D., CBER
Marilyn Martinez, Ph.D., CVM
Pharsight Corp.Enhanced Clinical Drug Trial Simulation and Population PK Analysis Software
CBER
Dennis Klinman, M.D., Ph.D.
Coley Pharmaceuticals Group, Inc.CpG Oligonucleotides Optimized for Activity in Humans
CVM
David G. White, Ph.D.
U.S. Poultry and Egg AssociationFluoroquinolone Resistance Among Pathogenic Avian Escherchia coli
NCTR
Brian F. Coles
University of Arizona Arizona Cancer CenterDietary Isothiocyanates, Glutathione S-transferases, and Colorectal Neoplasia
CDER
Moheb Nasr, Ph.D.
U.S. Pharmacopeia (USP)Collaboration Regarding USP Reference Standards
CDRH
Russell D. Owen
Cellular Telecommunications Industry Assn. (CTIA)Health Effects of RF Emissions from Wireless Phones
NCTR
Paul Howard, Ph.D.
Argus Research Labs, Primedica CorporationSkin Tumorigenesis in SKH-1 Mice
CDER
Frank Sistare, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.Immune Biomarkers for Monitoring Drug-Induced Vasculitis
CDRH
Donna Walsh
Program for Appropriate Technology in Health (PATH)Effects of Storage, Materials and Stress on Latex Glove Integrity
CBER
Raj K. Puri, M.D., Ph.D.
Neurocrine Biosciences, Inc.A Circular Permuted IL-4 Pseudomona Exotoxin as an Anti-Cancer Agent
ORA
Kimetha Francis
EduNeering, Inc.Transitioning FDA Basic Law Course to On-line Learning
NCTR
Fred Kadlubar, Ph.D.
Genometrix, Inc.Drug and Cancer Susceptibility Gene Analysis Using Microarray DNA Chip Technology
CVM
Michael H. Thomas
Conservation Fund, Freshwater InstituteBacterial Pathogens in Fluidized Sand Biofilters
CFSAN
Elizabeth Calvey, Ph.D.
University of MarylandFT-NIR Rapid Determination of Food Integrity
CDER
Frank Sistare, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.Transgenic Mouse Model as a Short-term Alternative to Predicting the Carcinogenecity of Pharmaceuticals
CDRH
Vesna J. Tomazic-Jezic, Ph.D.
Safeskin CorporationFrequent Use of C Latex Products that may Play a Role in the Rate of Sensitization and the Intensity of Reaction to Latex Products
CDRH
Paul L. Jones
Institute of Electrical and CDP Electronics Engineers (IEEE)Improvement in the Quality of Software that is Used in Medical Devices to Increase Their Safety and Effectiveness
CDER
Joseph F. Contrera, Ph.D.
Edwin J. Matthews, Ph.D.
Multi/CASEMulti/CASE Software Program Database Modules to Enhance Their Application for Predicting and Characterizing Toxicity of Pharmaceuticals
CFSAN Elizabeth Calvey, Ph.D.University of MarylandCollaboration through Joint Institute of Food Safety and Applied Nutrition (JIFSAN) Regarding Food Safety, Human Nutrition and Animal Health Sciences
NCTR
Daniel Sheehan, Ph.D.
Chemical Manufacturers AssociationDevelopment of a Statistically Robust 3D-QSAR Model to Predict In Vitro Rate Uterine Estrogen Receptor Binding Activity
OC/OMS
Kathryn Huntley, Ph.D.
BDM Federal, Inc.Development of AutoCode CS Software to Facilitate the Processing and Retrieval of Textual Information with Potential Application to Other Fields
CBER
Raj K. Puri, M.D., Ph.D.
NeoPharm, Inc.Interleukin-13 Pseudomonas Exotoxin as Anticancer Agent
NCTR
Jon G. Wilkes, Ph.D.
Scientific Instrument Services, Inc.New Technologies for Improving High Performance Liquid Chromatography Detection
NCTR
Merle G. Paule, Ph.D.
Astra CharnwoodDevelopment of Non-Human Primate Model for Studying Consequences of Long Term Anticonvulsant Medication Function in Developing Animals
OC/OMS
Kathryn Huntley, Ph.D.
BDM Federal, Inc.Development of Autocode 1.0 (Medical Terminology) to Support the Medical Regulatory Products Lifecycle
CDRH, CBER & ORADiagnostic Products CorporationTesting Human Sera for Total IgE and Specific IgE for Detection and Survey of Allergenic Disease
NCTR
Dr. Julian Leakey
Gentest CorporationDevelopment of Cell Lines Expressing Individual UDP-glucuronosyltransferase Isoforms
CFSAN
Dr. Daniel Benz
CRC PressFood Additives: Toxicology Regulation and Properties
NCTR
C.D. Jackson, Ph.D
Proctor & GambleHepatoxicity in Induction of Liver Tumors in Mice Treated with Doxylamine, Pyrilamine and Triprolidine
CDRH
Paul S. Ruggera
Organ, Inc.Rapid and Uniform Heating of Vitrified Organs Under 1000 Atmoshperes of Pressure
CDER
Raymond Lipicky, Ph.D.
Medifacts, Inc.Ambulatory Blood Pressure Monitoring
CFSAN
Elizabeth Calvey, Ph.D.
State University of New YorkUse of Supercritical Fluid Technologies in Analysis and Processing of Allium Species
NCTR
C. Dan Brand
American Institute for Cancer ResearchModularity Effects of Caloric Restriction on Toxicological Process
CFSAN
Karen Carson
Illinois Institute of TechnologyCollaborative Research in Food Safety and Quality (National Center for Food Safety and Technology) and Individual Project Agreements
CBER
Dr. James Vickers
Tulane UniversityDevelopment of Non-Human Primate Model for Krebbe's Disease
NCTR
Frederick Beland, Ph.D.
Carl Cerniglia, Ph.D.
Electric Power Research InstituteRisk Assessment of Manufactured Gas Plan Residues
NCTR
William A. Allaben, Ph.D.
National Grocery Manufacturers of AmericaEffects of Long Term Exposure to Methyl Bromide
NCTR
Lionel Porter, Ph.D.
Best Foods, Inc.Carcinogenic Study: The Effects of Dietary Fat, Carbohydrates and Fiber
CBER
Daniel Liu, Ph.D.
SNS, Inc.Auto On-Line Hydrolysis System
NCTR
Ralph L. Kodell, Ph.D.
Clement AssociatesEvaluation of Animal Bioassay Data Through Use of Computer-Based Statistical Programs
NCTR
Merle Paule, Ph.D.
D&M ConsultingImproved Methods/Measurements of Brain Functions in Response to Environmental Stimuli
NCTR
Dr. Daniel Casciano
Transgenic Sciences, Inc.Research & Development on In Vitro Toxicology Tests
NCTR
Dr. Ritchie Fleurs
G.K. Scientific, Inc.Testing and Evaluation of Electrophoresis Funnel Apparatus