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FDA
Jan. 24, 2005
| FDA/Center Principal Investigator |
Collaborator(s) | Title of CRADA |
|---|---|---|
| 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 | Development of Biomarkers for Early Detection of Mitochondrial Dysfunction |
| CBER Ewa Marszal, Ph.D. |
Alpha-1 Foundation | Investigation of Alpha-1-PI Polymer Structure |
| CBER Carl Frasch, Ph.D. |
Program for Appropriate Technology in Health (PATH) |
High Yield Group A Meningococcal Polysaccharide-Tetanus Toxoid Conjugates |
| CDER Edwin J. Matthews, Ph.D. Joseph F. Contrera, Ph.D. |
MultiCASE, Inc. | 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 hepatoxicity 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 |
| CBER Jenny Riemenschneider, Ph.D. |
HemaTech, LLC | Analysis of Anthrax Antibody Production in Conventional and Transchromosomal Cows |
| CBER Willie Vann, Ph.D. |
University of Illinois | Rational design of anti- meningococcal Polysaccharide Conjugate Vaccine |
| CBER Carolyn Wilson, Ph.D. |
Scripps Research Institute | Expression and Function of the Human PERV A Receptor |
| NCTR Dwight Miller, Ph.D. |
Litmus, LLC | Innovative, Static, and Dynamic Chemical Sensors |
| 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 Puri, M.D., Ph.D. |
American Type Culture Collection (ATCC) |
Analysis of Gene Expression by Microarray on various cell lines |
| CBER Pedro Piccardo, Ph.D. |
Holland Laboratory, American Red Cross |
Transgenic mouse model for the study of variant Creutzfeldt-Jakob Disease |
| CDER Joseph Contrera, Ph.D. |
MDL, Inc. | Development of Toxicology Prediction Modeling Modules |
| 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 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 |
University of Maryland | Characterization of Multiple Anti- biotic Resistance among Enterhem- orrhagic E. coli |
| CDER Paul Seligman, Ph.D. |
Lincoln Technologies | Advanced Analytical Tools for Drug Safety Risk Assessment |
| CDRH Brian Beard |
Mobile Manufacturers Forum |
Medical Device Electromagnetic Interference (EMI) from wireless data devices and interlaboratory comparison of Radiofrequency (RF) dosimetry data from hand- held transmitters |
| 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 Bio- markers for Early Detection of Mycocardial Injury, Vascular Injury, and Liver Injury |
| 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. Office of the Commissioner/OMS and Office of Regulatory Affairs John D. Gugliotti |
PPD Informatics/PPD Development, Inc. Federal Express Corp. |
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 Oglinucleotides Optimized for activity In humans |
| CVM David G. White, PhD. |
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 neoplasoa |
| 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 |
| CDER Randy Levin, M.D. |
DataPharm Foundation | Electronic Collection, Processing and Distribution of Drug Product Information |
| CVM David G. White, Ph.D. |
University of Georgia Research Foundation |
Salmonella 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 |
| NCTR Paul Howard, Ph.D |
Argus Research Labs, Primedica Corporation |
Skin 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 Puri, M.D., Ph.D. |
Neurocrine Biosciences, Inc. | A Circular Permuted IL4 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 Institute |
Bacterial pathogens in fluidized Sand Biofilters |
| CFSAN Elizabeth Calvey, Ph.D. |
University of Maryland | FT-NIR Rapid Determination of Food Integrity |
| CDER Frank Sistare, Ph.D. |
Boehringer Ingelheim Pharmaceuticals, Inc. | Transgenic Mouse model as a short-term alternative to prediciting the carcinogenicity 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 for 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 Rat 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-13Pseudomonas 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, Incorporated |
Development of Autocode 1.0 (Medical Terminology) to support the Medical Regulatory Products Lifecycle |
| CDRH, CBER & ORA | Diagnostic 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 an triprolidine |
| CDRH Paul S. Ruggera |
Organ, Inc. | Rapid and Uniform Heating of Vitrified Organs under 1000 Atmospheres 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 Dr. Merle Paule |
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 & Evaluation of Electyrophoresis Funnel Apparatus |