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U.S. Department of Health and Human Services

Science & Research

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FDA CRADAs

 

 

 

FDA/Center Principal Investigator

 

Collaborator(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 Assessment

Development 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 Qualicon

Optimization 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 Qualicon

Optimization 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 Company

 

 

Development 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&D

 

Development of a General Purpose Software Tool that Optimizes Clinical Study Design with Biomarkers

CBER

Sanjay Kumar, Ph.D.

Program for Appropriate Technology in Health

 

Bioassays 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 Washington

 

Development 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 Institution

 

Alexandrium 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 Medical

 

Optical 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 Medicine

 

Systems 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 Limited

 

Development 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 Fayetteville

 

Wireless 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 Laboratories

 

Measurement 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 University

 

Ecology 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 Pennsylvania

 

Biomechanics 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.

 

MultiCASE

 

 

Enhancement 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 Instrument

 

Design 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 Laboratory

 

Toxicity, Trophic Transfer and Persistence of Harmful, Algal Toxins and Metabolites in Shellfish

NCTR
Dwight Miller, Ph.D.
Litmus, LLC

 

Innovative, Static, and Dynamic Chemical Sensors

CBER
Jenny Riemenschneider, Ph.D.
HemaTech, LLC

 

Analysis of Anthrax Antibody Production in Conventional and Transchromosomal Cows

CBER
Carolyn Wilson, Ph.D.
Scripps Research Institute

 

Expression and Function of the Human PERV A Receptor

CBER
Willie Vann, Ph.D.
University of Illinois

 

Rational 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 Cross

 

Transgenic 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.
IBM

 

Development of a Physical Database for Study Data for Clinical and Non-Clinical Data at FDA

CBER
Konstantin M. Chumakov, Ph.D.
Johns Hopkins University

 

Development 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 Institute

 

Porin Gene Variable Region Typing of Neisseria gonorrhoeae

CVM
David G. White, Ph.D.
University of Maryland

 

Characterization of Multiple Antibiotic Resistance Among Enterohemorrhagic E. coli

CDRH
Brian Beard
Mobile Manufacturers Forum

 

Medical 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 Technologies

 

Advanced Analytical Tools for Drug Safety Risk Assessment

CFSAN
Keith Lampel, Ph.D.
Whatman Bioscience

 

Universal 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 Foundation

 

Electronic 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 Plough

 

Identification 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 Rock

 

Effects 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 Association

 

Fluoroquinolone Resistance Among Pathogenic Avian Escherchia coli

 

NCTR
Brian F. Coles

University of Arizona Arizona Cancer Center

 

Dietary 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 Corporation

 

Frequent 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/CASE

 

Multi/CASE Software Program Database Modules to Enhance Their Application for Predicting and Characterizing Toxicity of Pharmaceuticals

CFSAN
Elizabeth Calvey, Ph.D.
University of Maryland

 

Collaboration 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 Association

 

Development 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 Charnwood

 

Development 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 Corporation

 

Testing Human Sera for Total IgE and Specific IgE for Detection and Survey of Allergenic Disease

NCTR
Dr. Julian Leakey
Gentest Corporation

 

Development of Cell Lines Expressing Individual UDP-glucuronosyltransferase Isoforms

CFSAN
Dr. Daniel Benz
CRC Press

 

Food Additives: Toxicology Regulation and Properties

NCTR
C.D. Jackson, Ph.D
Proctor & Gamble

 

Hepatoxicity 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 York

 

Use of Supercritical Fluid Technologies in Analysis and Processing of Allium Species

NCTR
C. Dan Brand
American Institute for Cancer Research

 

Modularity Effects of Caloric Restriction on Toxicological Process

CFSAN
Karen Carson
Illinois Institute of Technology

 

Collaborative Research in Food Safety and Quality (National Center for Food Safety and Technology) and Individual Project Agreements

CBER
Dr. James Vickers
Tulane University

 

Development of Non-Human Primate Model for Krebbe's Disease

 

NCTR
Frederick Beland, Ph.D.
Carl Cerniglia, Ph.D.

Electric Power Research Institute

 

Risk Assessment of Manufactured Gas Plan Residues

 

NCTR
William A. Allaben, Ph.D.

National Grocery Manufacturers of America

 

Effects 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 Associates

 

Evaluation of Animal Bioassay Data Through Use of Computer-Based Statistical Programs

 

NCTR
Merle Paule, Ph.D.

D&M Consulting

 

Improved 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