ORG_CITY: FREDERICK

ORG_NAME: DYNPORT VACCINE COMPANY, LLC

PI_NAMEs: SHOCKEY, GRAIG  (contact)

PROJECT_TERMS: carbapenem resistance;clinical trial implementation;Clinical Trials;Clinical Trials Unit;Communicable Diseases;early phase clinical trial;Infection;Intervention;Investigation;National Institute of Allergy and Infectious Disease;New Agents;Phase 0 Clinical Trial;Phase I Clinical Trials;Prevention;Study Subject;Therapeutic

PROJECT_TITLE: Task B1: Phase I Clinical Trial to Evaluate a Therapeutic for Carbapenem-resistant Enterbacterales (CRE) Infections


ADMINISTERING_IC: AI

ARRA_FUNDED: N

FUNDING_MECHANISM: NON SBIR/STTR CONTRACTS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_STATE: MD

PROJECT_TERMS: antibiotic resistant infections;carbapenem resistance;clinical trial implementation;Clinical Trials;Clinical Trials Unit;Combating Antibiotic Resistant Bacteria;Communicable Diseases;early phase clinical trial;Intervention;Investigation;National Institute of Allergy and Infectious Disease;New Agents;Phase 0 Clinical Trial;Phase I Clinical Trials;Prevention;Study Subject;Therapeutic

PROJECT_TITLE: Task B1: Phase I Clinical Trial to Evaluate a Therapeutic for Carbapenem-Resistant Enterbacterales (CRE) Antibiotic-Resistant Infections


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Cancer;Cervical Cancer;Clinical Research;Clinical Trials and Supportive Activities;HPV and/or Cervical Cancer Vaccines;Immunization;Infectious Diseases;Prevention;Primary Health Care;Sexually Transmitted Infections;Vaccine Related;Women's Health Research

ORG_CITY: SAN JOSE

ORG_COUNTRY: COSTA RICA

ORG_FIPS: CS

ORG_NAME: FUNDACION INCIENSA

PI_NAMEs: ROMERO, BRYON  (contact)

PROJECT_TERMS: 14 year old;aged;Antibody Response;Antibody titer measurement;Blinded;Blood;Cancer Burden;Cervical;cervical cancer prevention;Cervical Cancer Screening;chronic infection;Collection;Communities;Costa Rica;Development;Diagnostic;Dose;Eligibility Determination;Enzyme-Linked Immunosorbent Assay;Exposure to;follow-up;girls;HPV screening;Human papilloma virus infection;Human Papilloma Virus Vaccination;Human Papilloma Virus Vaccine;Human Papillomavirus;Human papillomavirus 16;Human papillomavirus 18;Infection;Licensure;Malignant neoplasm of cervix uteri;Manuals;novel;Participant;Phase;premalignant;Prevention Research;prisma;Procedures;prophylactic;Public Health;Randomized Controlled Clinical Trials;randomized, clinical trials;Training;unvaccinated;Update;Vaccination;vaccine trial;Visit;Woman

PROJECT_TITLE: PRISMA AND EXTEND 2.0 FOLLOW-UP OF STUDY PARTICIPANTS


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Prevention

ORG_CITY: KANSAS CITY

ORG_NAME: MIDWEST RESEARCH INSTITUTE

ORG_STATE: MO

PI_NAMEs: AILLON, KRISTIN  (contact)

PROJECT_TERMS: 3-Dimensional;Adverse effects;Alcohols;Analytical Chemistry;analytical method;Biological;Chemicals;Chemistry;Contractor;Contracts;Curcumin;Development;disorder prevention;Dose;dose information;Dyes;Environmental Exposure;Evaluation;Exposure to;Formulation;Ginkgo biloba extract;Goals;Hazard Identification;Hazardous Chemicals;Health;Heightened Cancer Risk;Human;Individual;interest;Liver;National Institute of Environmental Health Sciences;National Toxicology Program;Organ;Outcome;Process;programs;public health research;Reporting;Research;Risk Assessment;Risk Factors;Rodent;screening;Services;Solubility;sound;Source;Specific qualifier value;spheroids;superfund site;Testing;Toxic effect;Toxicity Tests;Toxicology;Translational Research;Triclosan;Validation;Water;Work;Writing

PROJECT_TITLE: General Chemistry Support for Translational Toxicology


PROJECT_TERMS: Adverse effects;Agrochemicals;Analytical Chemistry;Biological;Chemicals;Chemistry;Contracts;Development;Dimethyl Sulfoxide;disorder prevention;Dose;dose information;Economics;Environmental Exposure;Equipment and supply inventories;Evaluation;Exposure to;Formulation;Gases;Goals;Hazard Identification;Hazardous Chemicals;Health;Heightened Cancer Risk;High Pressure Liquid Chromatography;Human;In Vitro;Individual;Laboratories;liquid chromatography mass spectrometry;Manufacturer;Mass Fragmentography;Methods;National Institute of Environmental Health Sciences;National Toxicology Program;NMR Spectroscopy;Organ;Outcome;Phase;Process;programs;public health research;Qualifying;Research;research facility;Risk Assessment;Risk Factors;screening;Services;sound;Specific qualifier value;Testing;Toxic effect;Toxicity Tests;Toxicology;Translational Research;validation studies;Work;Zebrafish;zebrafish development

PROJECT_TITLE: High Throughput Toxicological Screening Support


NIH_SPENDING_CATS: Endocrine Disruptors;Health Effects of Indoor Air Pollution;Prevention

PROJECT_TERMS: Adverse effects;Analytical Chemistry;analytical method;Biological;Cardiovascular system;Chemicals;Chemistry;cohort;Contracts;Corn Oil;Development;diphenyl;disorder prevention;Dose;dose information;Environmental Exposure;Evaluation;Exposure to;Flame Retardants;Formulation;Goals;Hazard Identification;Hazardous Chemicals;Health;Heart;Heightened Cancer Risk;High Pressure Liquid Chromatography;Human;Individual;inorganic phosphate;Liver;Methods;Mus;National Institute of Environmental Health Sciences;National Toxicology Program;Organ;Organophosphates;Outcome;Perinatal;Phosphorylation;phthalates;Plasma;Process;programs;Protocols documentation;public health research;Qualifying;Research;Risk Assessment;Risk Factors;Sampling;Services;sound;Specific qualifier value;Sprague-Dawley Rats;tandem mass spectrometry;Testing;Toxic effect;Toxicity Tests;Toxicokinetics;Toxicology;Translational Research;Urine;Work

PROJECT_TITLE: Chemistry Services Supporting NTP Flame Retardant Studies


NIH_SPENDING_CATS: Complementary and Integrative Health;Dietary Supplements;Natural Products;Nutrition;Prevention

PROJECT_TERMS: Adverse effects;Aerosols;Aristolochia;Ashwagandha;Asian;Biological;Botanical dietary supplements;Botanicals;Caulophyllum thalictroides;Charge;Chemicals;Chemistry;Chromatography;Comfrey;Contracts;Coupled;Detection;detector;Development;dietary supplements;Dimethyl Sulfoxide;disorder prevention;Dose;dose information;Ensure;Environmental Exposure;Ephedra;Ephedra sinica;Ethanol;Evaluation;Exposure to;Formulation;Ginseng Preparation;Goals;Goldenseal;Government Agencies;Green tea;Hazard Identification;Hazardous Chemicals;Health;Heightened Cancer Risk;High Pressure Liquid Chromatography;Human;Individual;Industry;instrument;Kava;Lichen - organism;member;Methods;Michigan;Milk Thistle;National Institute of Environmental Health Sciences;National Toxicology Program;Natural Products;Oregon;Organ;Outcome;Privatization;Procedures;Process;programs;public health research;repository;Research;Research Personnel;Risk Assessment;Risk Factors;Safety;Services;Solubility;sound;Specific qualifier value;Standardization;System;Testing;Toxic effect;Toxicity Tests;Toxicology;ultraviolet;Universities;Usnea;Work;Yohimbe

PROJECT_TITLE: General Chemistry Support - Botanicals and Dietary Supplements


NIH_SPENDING_CATS: Cardiovascular;Heart Disease;Prevention

PROJECT_TERMS: Adverse effects;Analytical Chemistry;Biological;Blinded;Cardiac health;Cardiotoxicity;Cardiovascular Diseases;cardiovascular health;Cardiovascular system;Chemicals;Chemistry;Chlorides;Collaborations;Contracts;Coupled;Detection;Development;Dimethyl Sulfoxide;diphenyl;Disease Outcome;disorder prevention;Dose;dose information;Environmental Exposure;Environmental Risk Factor;Ephedra sinica;Evaluation;Exposure to;Formulation;Goals;Hazard Identification;Hazardous Chemicals;Health;Heightened Cancer Risk;High Pressure Liquid Chromatography;Human;In Vitro;in vivo;Individual;inorganic phosphate;Modeling;National Institute of Environmental Health Sciences;National Toxicology Program;NMR Spectroscopy;Organ;Outcome;Parents;Process;programs;Protocols documentation;public health research;Rattus;Research;Risk Assessment;Risk Factors;Sampling;Sampling Studies;screening;Services;sound;Specific qualifier value;Testing;Toxic effect;Toxicity Tests;Toxicokinetics;Toxicology;tributyltin;Work

PROJECT_TITLE: CHEMISTRY SERVICES FOR THE NTP - Cardiovascular Health


NIH_SPENDING_CATS: Neurosciences;Prevention

PROJECT_TERMS: Adverse effects;Behavioral;Biological;Botanicals;Chemicals;Chemistry;Collaborations;Contracts;Development;developmental neurotoxicity;Dimethyl Sulfoxide;Disease Outcome;disorder prevention;Dose;dose information;Drosophila melanogaster;Environmental Exposure;Environmental Risk Factor;Europe;Evaluation;Exposure to;Formulation;Goals;Hazard Identification;Hazardous Chemicals;Health;Heightened Cancer Risk;Human;Indiana;Individual;International;liquid chromatography mass spectrometry;machine vision;Mass Fragmentography;Mass Spectrum Analysis;National Institute of Environmental Health Sciences;National Toxicology Program;neurotoxicology;NMR Spectroscopy;Organ;Outcome;Phase;phase 2 testing;Process;programs;public health research;Research;Risk Assessment;Risk Factors;Services;Solubility;Solvents;sound;Specific qualifier value;Support Contracts;System;Testing;Toxic effect;Toxicity Tests;Toxicology;Translational Research;Tube;United States;Universities;Work;Zebrafish

PROJECT_TITLE: CHEMISTRY SERVICES FOR THE NTP - Developmental Neurotoxicology


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Gene Therapy;Genetics

ORG_CITY: PHILADELPHIA

ORG_NAME: UNIVERSITY OF PENNSYLVANIA

ORG_STATE: PA

PI_NAMEs: JOHNSTON, JULIE  (contact)

PROJECT_TERMS: Adenovirus Vector;animal tissue;Area;Biodistribution;Biological;Biological Assay;Capsid;Cells;Codon Nucleotides;CRISPR/Cas technology;Dependovirus;design;Detection;detection assay;DNA;DNA cassette;Endotoxins;enzyme linked immunospot assay;gene product;Gene Silencing;gene therapy;Genes;Genome;Glycoproteins;good laboratory practice;Immunology;in vivo;Induced Mutation;interest;Laboratories;Lentivirus Vector;MicroRNAs;Mycoplasma;National Heart, Lung, and Blood Institute;neutralizing antibody;Neutralizing antibody assay;next generation sequencing;Non-Viral Vector;overexpression;particle;pre-clinical;programs;Proteins;Quality Control;Regulation;Research Personnel;Resources;Retroviridae;Sequence Analysis;Serotyping;Services;Small Interfering RNA;Sterility;Structure;System;T cell response;Testing;testing services;therapeutic gene;Transcript;Transgenes;vector;vector biodistribution;vector genome;Viral;Virus

PROJECT_TITLE: GENE THERAPY RESOURCE PROGRAM (GTRP): TASK AREA B FOR PRECLINICAL VECTOR CORE LABORATORY SCIENTIFIC ACTIVITIES


NIH_SPENDING_CATS: Aging;Atherosclerosis;Biomedical Imaging;Cardiovascular;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Heart Disease;Prevention;Social Determinants of Health

ORG_CITY: BALTIMORE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

PI_NAMEs: POST, WENDY  (contact)

PROJECT_TERMS: abdominal aorta;Address;African American;Age;aged;Aging;Air Pollution;Ancillary Study;Ankle;Aorta;Area;Atherosclerosis;Behavioral;Biological;brachial artery;Brain;cardiac magnetic resonance imaging;Cardiovascular Diseases;cardiovascular disorder risk;Cause of Death;Characteristics;Chinese;Clinical;clinical examination;cohort;Collaborations;Collection;Communities;Contracts;Coronary Arteriosclerosis;Correlation Studies;Data;Diabetes Mellitus;Disease;disease disparity;Disease Marker;Disease Outcome;Disease Progression;Dyslipidemias;Ethnic Origin;Event;Extramural Activities;follow-up;Fostering;Functional disorder;Funding;Genetic;genetic variant;Goals;Heart;Heart failure;heart function;Hispanic;Hypertension;improved;Incidence;indexing;insight;interest;Investigation;Kidney;Laboratories;Lung;Magnetic Resonance Imaging;Measurement;Measures;Mediating;men;mortality;Multi-Ethnic Study of Atherosclerosis;Myocardial;National Heart, Lung, and Blood Institute;Neighborhoods;Obesity;operation;Organ;Paper;Participant;Persons;Photography;Policies;Population;population based;Population Heterogeneity;predict clinical outcome;Prevalence;Process;psychologic;Publishing;Race;radial artery;recruit;Research Personnel;response;Retina;Risk Factors;Risk Marker;Sampling;sex;Smoking;Socioeconomic Factors;socioeconomics;Subgroup;tonometry;trend;ultrasound;United States;United States National Institutes of Health;vascular bed;Vascular Diseases;Woman;Writing;X-Ray Computed Tomography

PROJECT_TITLE: TASK AREA A - MESA CORE OPERATIONS, FIELD CENTER.


NIH_SPENDING_CATS: American Indian or Alaska Native;Cardiovascular;Clinical Research;Health Disparities and Racial or Ethnic Minority Health Research;Heart Disease;Prevention;Racial and Ethnic Minority Health Research;Rural Health

ORG_CITY: EAGLE BUTTE

ORG_NAME: MISSOURI BREAKS RESEARCH, INC.

ORG_STATE: SD

PI_NAMEs: JOLLY, STACEY  (contact)

PROJECT_TERMS: American Indians;Ancillary Study;Arizona;Cardiovascular Diseases;cardiovascular disorder risk;Clinical;clinical examination;clinical predictors;cohort;Cohort Studies;Collaborations;Communities;community engagement;Disease;epidemiology study;Etiology;Event;Family;Family Study;follow-up;Fostering;Functional disorder;Funding;Heart;high risk;Investigation;Longitudinal, observational study;Morbidity - disease rate;mortality;Native Americans;Natural History;Oklahoma;Participant;platform-independent;prospective;recruit;Research Personnel;Risk Factors;Special Population;Training Support;tribal community;tribal leader;tribal Nation

PROJECT_TITLE: STRONG HEART STUDY (SHS)- FIELD CENTER, TASK ORDER 001


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Biotechnology;Neurosciences

ORG_CITY: ALBANY

ORG_NAME: ALBANY MOLECULAR RESEARCH, INC.

ORG_STATE: NY

PHR: Overall management of projects to develop therapies for neurological disorders

PI_NAMEs: REILLY, JOHN  (contact)

PROJECT_TERMS: Acceleration;analytical method;Clinical Trials;Contractor;Contracts;Data;Development;Documentation;Dosage Forms;drug candidate;drug development;drug distribution;early phase clinical trial;efficacy study;Formulation;good laboratory practice;Good Manufacturing Process;Grant;Investigational Drugs;Investigational New Drug Application;Label;manufacture;method development;Nervous System Disorder;novel therapeutics;Pharmaceutical Preparations;Pharmacologic Substance;preclinical efficacy;Preparation;Process;programs;Regulation;small molecule;support network;therapy development;United States Food and Drug Administration;United States National Institutes of Health;Validation;Work

PROJECT_TITLE: IGF::OT::IGF DRUG MANUFACTURING AND FORMULATION PROGRAM (DMFP) TASK ORDER #01:  PERFORMANCE ACTIVITY 1 TECHNICAL SUPPORT (1/15/15 / 1/14/16)


NIH_SPENDING_CATS: Mental Health

PI_NAMEs: SMITH, TIMOTHY  (contact)

PROJECT_TERMS: Communities;Contracts;Data;data archive;data ecosystem;data ingestion;data repository;Databases;Ecosystem;Ensure;Exercise;experience;Funding;Goals;Hour;human centered design;Human Resources;improved;Information Systems;National Institute of Mental Health;Neurosciences;Personally Identifiable Information;Privacy;programs;Research;Research Project Grants;Secure;Security;Support System;System;United States National Institutes of Health

PROJECT_TITLE: 1) EXERCISE ADDITIONAL "UP-TO HOURS" DURING OPTION YEAR TWO (2)2) REVISE ATTACHMENT 2: OTHER TERMS AND CONDITIONS, P.4, HHSAR 352.237-75 KEY PERSONNEL TO SUPPORT THE NIMH NDA WHICH IS A SINGLE DATA


ORG_CITY: VIENNA

ORG_STATE: VA

PHR: This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management.

PI_NAMEs: PREUGSCHAT, FRANK  (contact)

PROJECT_TERMS: Address;assay development;Biochemical;Biological Assay;Biological Products;Biological Testing;Cells;Clinical;clinical pain;Clinical Research;Collaborations;Consultations;Contractor;design;Development;Development Plans;Electronic Mail;evaluation/testing;experimental study;Helping to End Addiction Long-term;in vitro Assay;Individual;Investigational Drugs;Lead;lead optimization;Logistics;manufacture;Measures;member;Pain;Pain management;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;pre-clinical;preclinical evaluation;Principal Investigator;product development;programs;Published Comment;Qualifying;Recommendation;Resources;Role;safety study;safety testing;Serum;Services;Speed;Strategic Planning;Telephone;therapeutic development;timeline;Tissue Sample;Toxicology;United States National Institutes of Health;Validation;validation studies

PROJECT_TITLE: BIOACTIVITY ASSAY DEVELOPMENT CONSULTING SERVICES


NIH_SPENDING_CATS: Infectious Diseases;Rare Diseases;Vector-Borne Diseases

ORG_CITY: ROCKVILLE

ORG_NAME: BIOMEDICAL RESEARCH INSTITUTE

PI_NAMEs: MENTINK-KANE, MARGARET  (contact)

PROJECT_TITLE: Task C16: Production and Development of Schistosomiasis Research Reagents


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Digestive Diseases;Emerging Infectious Diseases;HIV/AIDS;Hepatitis;Hepatitis - B;Hepatitis - C;Infectious Diseases;Liver Disease;Orphan Drug;Rare Diseases;Tuberculosis

ORG_CITY: MANASSAS

ORG_NAME: AMERICAN TYPE CULTURE COLLECTION

PI_NAMEs: RASHID, SUJATHA  (contact)

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Area;Award;base;Basic Science;Biological;Chemicals;Clinical Trials;Collaborations;Communicable Diseases;Communities;Contracts;Development;Devices;Extramural Activities;Hepatitis B Virus;Hepatitis C virus;HIV;Investigational New Drug Application;Investigator-Initiated Research;Licensure;Maintenance;Mycobacterium tuberculosis complex;National Institute of Allergy and Infectious Disease;novel therapeutics;Organism;pre-clinical;Private Sector;product development;Production;programs;Reagent;repository;Research;research clinical testing;research study;Resources;Services;Therapeutic;therapeutic development;Translational Research;United States Food and Drug Administration;Work

PROJECT_TITLE: Reagent Program for HIV and other Infectious Diseases


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Emerging Infectious Diseases;Immunization;Infectious Diseases;Orphan Drug;Prevention;Rare Diseases;Vaccine Related;Vector-Borne Diseases

ORG_CITY: GALVESTON

ORG_NAME: UNIVERSITY OF TEXAS MED BR GALVESTON

ORG_STATE: TX

PI_NAMEs: BEASLEY, DAVID  (contact)

PROJECT_TERMS: Contracts;Dengue Vaccine;Dengue Virus;Development;Evaluation;infectious disease model;mouse model;therapeutic development;therapeutic evaluation;Vaccines

PROJECT_TITLE: Task A63: Evaluation of Therapeutics and Vaccines in Mouse Models of Dengue Virus


ADMINISTERING_IC: HD

IC_NAME: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

ORG_CITY: MENLO PARK

ORG_NAME: SRI INTERNATIONAL

ORG_STATE: CA

PI_NAMEs: BUNIN, DEBORAH  (contact)

PROJECT_TERMS: Area;Bioinformatics;Biological Testing;Clinical;Clinical Trials;Collaborations;Contraceptive Agents;Contraceptive Availability;Contraceptive Devices;contraceptive target;Data;Databases;design;Development;Devices;drug discovery;Drug Formulations;drug testing;efficacy evaluation;Evaluation;Friends;In Vitro;in vivo;Internet;Investigational New Drug Application;Knowledge;Maintenance;Medicine;next generation;novel;novel strategies;Pharmaceutical Preparations;Phase;pre-clinical;Preparation;Process;reproductive;Research Personnel;Safety;stability testing;System;Toxicology;Update;user-friendly;web app;web site;Work

PROJECT_TITLE: BIOLOGICAL TESTING FACILITY - CONTRACEPTIVE TARGET DATABASE AND APPLICATION


NIH_SPENDING_CATS: Aging;Congenital Structural Anomalies;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Osteogenesis Imperfecta;Osteoporosis;Pediatric;Prevention;Rare Diseases

ORG_NAME: IQ SOLUTIONS, INC.

PI_NAMEs: ROBINSON, NATE  (contact)

PROJECT_TERMS: Adolescent;Aging;Asian;Asian Women;Awareness;Bone Diseases;bone health;Dedications;Early Diagnosis;Early treatment;Education;General Population;Health Professional;Hispanic Women;Hyperparathyroidism;Individual;Information Dissemination;Knowledge;Language;Link;Low Literacy Population;men;Metabolic Bone Diseases;Osteitis Deformans;Osteogenesis Imperfecta;Osteoporosis;outreach;Pamphlets;Patients;Physicians;Populations at Risk;Prevention;Resources;Spanish;United States Dept. of Health and Human Services;United States National Institutes of Health;Visual impairment

PROJECT_TITLE: TASK ORDER FOR TWO NATIONAL INFORMATION CLEARNINGHOUSES


NIH_SPENDING_CATS: Aging;Atherosclerosis;Cardiovascular;Clinical Research;Heart Disease;Heart Disease - Coronary Heart Disease;Prevention;Social Determinants of Health

ORG_CITY: WINSTON-SALEM

ORG_NAME: WAKE FOREST UNIVERSITY HEALTH SCIENCES

ORG_STATE: NC

PI_NAMEs: WAGENKNECHT, LYNNE  (contact)

PROJECT_TERMS: Adult;African American;aged;Amyloid deposition;Ancillary Study;Area;arterial stiffness;Atherosclerosis;Atherosclerosis Risk in Communities;Atrial Fibrillation;Biochemical;Biological Assay;Blood specimen;Blood Vessels;Brain;Candidate Disease Gene;Cardiovascular Diseases;Case/Control Studies;caucasian American;Clinical;clinical development;clinical examination;clinical predictors;Cognition;cohort;Cohort Studies;Collaborations;Communities;Contracts;coronary artery calcification;Coronary heart disease;County;Cryopreservation;Data;Data Collection;data sharing;Death Rate;Dementia;Diabetes Mellitus;DNA;EFRAC;Electrocardiogram;Environmental Risk Factor;Event;follow-up;Fostering;Funding;Genetic;Genome Scan;Geographic Locations;Goals;Grant;Heart failure;Hospitalization;Injury;Investigation;Lymphocyte;member;middle age;Monitor;Myocardial Infarction;Natural History;novel;Participant;Policies;preservation;Process;Prospective, cohort study;Publications;Qualifying;recruit;Research Personnel;residence;Risk Factors;rural setting;Subgroup;suburb;Technology;trend;United States National Institutes of Health;Ventricular Dysfunction;Vital Status;Washington

PROJECT_TITLE: THE ATHEROSCLEROSIS RISK IN COMMUNITIES (ARIC) STUDY - FIELD CENTER - TASK ORDER 01, TASK AREA A


ED_INST_TYPE: SCH ALLIED HEALTH PROFESSIONS

NIH_SPENDING_CATS: Aging;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Heart Disease;Prevention;Women's Health Research

ORG_CITY: AMHERST

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: STATE UNIVERSITY OF NEW YORK AT BUFFALO

PI_NAMEs: WACTAWSKI-WENDE, JEAN  (contact)

PROJECT_TERMS: Aging;Ancillary Study;Cardiovascular Diseases;Cardiovascular system;Classification;cohort;Data;Discipline;epidemiology study;Event;follow-up;Funding;Goals;innovation;Knowledge;Life;older women;Participant;platform-independent;power analysis;Prevention trial;Qualifying;Quality of life;Research;Research Personnel;resilience;Resources;sample collection;Women's Health

PROJECT_TITLE: WOMEN'S HEALTH INITIATIVE (WHI) - REGIONAL CENTER (RC) - EXERCISING TASK AREA A1 AND A2


ORG_CITY: NEW YORK

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

PI_NAMEs: SHEA, STEVEN  (contact)

PROJECT_TITLE: TASK AREA A - MESA CORE OPERATIONS, FIELD CENTER


NIH_SPENDING_CATS: Aging

ORG_CITY: CAMDEN

ORG_NAME: CORIELL INSTITUTE FOR MEDICAL RESEARCH

ORG_STATE: NJ

PI_NAMEs: NORA, ENGEL  (contact)

PROJECT_TITLE: SELECTION, PRODUCTION, CHARACTERIZATION AND DISTRIBUTION OF CULTURED CELLS FOR RESEARCH ON AGING; PERIOD OF PERFORMANCE


NIH_SPENDING_CATS: Networking and Information Technology R&D (NITRD);Neurosciences

ORG_CITY: BURLINGAME

ORG_NAME: COLLABORATIVE DRUG DISCOVERY, INC.

PHR: Information Technology support for development of treatments for neurological disorders. Storage of data and reports for the development of investigational new drug (IND) packages.

PI_NAMEs: ERNST, SYLVIA  (contact)

PROJECT_TERMS: analog;Biological Assay;Chemical Structure;Chemicals;Computer software;Contractor;Data;Data Storage and Retrieval;Databases;Development;Drug Packaging;Funding;Information Systems;Information Technology;Investigational Drugs;member;Nervous System Disorder;Online Systems;Pharmacology;Reporting;therapy development;Toxicology;United States National Institutes of Health;user-friendly;Visualization

PROJECT_TITLE: EXERCISE OPTION PERIOD 1


NIH_SPENDING_CATS: Infectious Diseases

ORG_CITY: WILMINGTON

ORG_NAME: PPD DEVELOPMENT LP

PI_NAMEs: KIRKBY, MATTHEW  (contact)

PROJECT_TERMS: Clinical;Clinical Research;clinical research site;Clinical Trials;Communicable Diseases;Conduct Clinical Trials;Contractor;Contracts;Dedications;Funding;Future;Grant;Individual;Industry Collaboration;Principal Investigator;programs;Regulatory Affairs;Research Personnel;Services;U-Series Cooperative Agreements

PROJECT_TITLE: REGULATORY MANAGEMENT CENTER (RMC) - Infectious Diseases


NIH_SPENDING_CATS: Infectious Diseases;Prevention

ORG_CITY: HINCKLEY

ORG_NAME: ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC.

ORG_STATE: OH

PI_NAMEs: SPITZ, ROBERT  (contact)

PROJECT_TERMS: clinical trial implementation;Clinical Trials;Clinical Trials Unit;Communicable Diseases;Development;early phase clinical trial;Intervention;Investigation;National Institute of Allergy and Infectious Disease;New Agents;Prevention

PROJECT_TITLE: Task A: Early Phase Clinical Trial Units (EPCTU)


NIH_SPENDING_CATS: Biotechnology;HIV/AIDS;Immunization;Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_CITY: KANSAS CITY

ORG_NAME: MIDWEST RESEARCH INSTITUTE

PI_NAMEs: KENNEDY, MICHELLE  (contact)

PROJECT_TERMS: Address;Area;Contractor;Contracts;Development;Documentation;Equipment and supply inventories;flexibility;HIV;Investigational Drugs;Label;National Institute of Allergy and Infectious Disease;Phase;pre-clinical;Preclinical Testing;Process;product development;Production;programs;research and development;research clinical testing;Services;Shipping;vaccine development;Vaccines

PROJECT_TITLE: Preclinical and Translational Vaccine Development for HIV and Other Candidate Agents (PTVDS)


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Patient Safety

ORG_NAME: FISHER BIOSERVICES, INC.

PI_NAMEs: MAHZAD, MEHRINFAR  (contact)

PROJECT_TERMS: Cancer Therapy Evaluation Program;Clinical;Clinical Distribution;Conduct Clinical Trials;Contract Services;Contracts;drug development;Pharmaceutical Preparations;Pharmacologic Substance;Program Development;repository

PROJECT_TITLE: STORAGE AND DISTRIBUTION OF CLINICAL AGENTS


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;Prevention

ORG_CITY: MORRISVILLE

ORG_NAME: HEALTH DECISIONS, INC.

PI_NAMEs: DART, CLINT  (contact)

PROJECT_TERMS: Award;Clinical;Clinical Research;Clinical Trials;Clinical Trials Design;Clinical Trials Network;condoms;Conduct Clinical Trials;Contraceptive Agents;contraceptive efficacy;Contraceptive methods;Couples;Data;Data Analyses;Data Collection;data exchange;Databases;Dose;drug development;Enrollment;Evaluation;first-in-human;follow-up;Food and Drug Administration Drug Approval;Gel;Goals;Gonadotropins;Good Clinical Practice;Guidelines;Hormonal;International;male;Male Contraceptive Agents;men;Mission;Monitor;Monitoring Clinical Trials;Multi-Institutional Clinical Trial;National Institute of Child Health and Human Development;Nestorone;New Drug Approvals;novel;Pharmaceutical Preparations;Phase;Preparation;Process;Production;programs;Protocols documentation;Qualifying;recruit;Regulation;Reporting;research clinical testing;Safety;Services;Site;Specific qualifier value;sperm cell;Testosterone;Time;Vasectomy;Woman;Work

PROJECT_TITLE: COORDINATION, MONITORING, FOLLOW-UP, AND EVALUATION OF A CLINICAL TRIAL OF NESTORONE TESTOSTERONE GEL FOR MALE CONTRACEPTION


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Genetics;HIV/AIDS;Immunization;Nanotechnology;Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_CITY: DURHAM

ORG_NAME: DUKE UNIVERSITY

PI_NAMEs: BERES, WENDELL  (contact)

PROJECT_TERMS: Address;Antigens;Area;Biological Assay;Clinical Trials;Contracts;Cyclic GMP;Development;Documentation;Encapsulated;flexibility;Generations;Genetic Transcription;Good Manufacturing Process;HIV;In Vitro;Investigational Drugs;Label;lipid nanoparticle;Lipids;manufacture;Manufactured Materials;Messenger RNA;National Institute of Allergy and Infectious Disease;Phase;pre-clinical;Preclinical Testing;Process;product development;Production;programs;Reaction;research clinical testing;Services;stability testing;Testing;vaccine development;Vaccines

PROJECT_TITLE: cGMP Manufacture, Fill-Finish, Release, Analytical and Stability Testing and Stability Program of mRNA, Lipid Nanoparticle Based HIV Immunogens


NIH_SPENDING_CATS: Biotechnology;Genetics;Human Genome

ORG_CITY: RESEARCH TRIANGLE PARK

ORG_NAME: SCIOME, LLC

PI_NAMEs: SHAH, RUCHIR  (contact)

PROJECT_TERMS: Aging;aqueous;Bioinformatics;Biological Assay;cell free DNA;Chemical Exposure;Chemicals;cheminformatics;comparative;Contractor;Data;Data Analyses;Databases;differential expression;DNA analysis;DNA Methylation;epigenomics;Film;Genes;Genetic Transcription;Genomics;high throughput screening;In Vitro;in vitro Model;Informatics;innovation;Liver;Measures;metaplastic cell transformation;method development;Microarray Analysis;Mouse Strains;Mus;Output;Pharmaceutical Preparations;Placenta;programs;Reproducibility;Research Design;Sampling;Series;spheroids;Support Contracts;Technology;Three-dimensional analysis;Tissue-Specific Gene Expression;Toxic effect;toxicant;Toxicogenomics;Update

PROJECT_TITLE: BIOINFORMATICS SUPPORT FOR DNTP & DIR


NIH_SPENDING_CATS: Biotechnology;HIV/AIDS;Immunization;Infectious Diseases;Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_CITY: KENSINGTON

ORG_NAME: ADVANCED BIOSCIENCE LABORATORIES, INC.

PI_NAMEs: FOUTS, TIMOTHY  (contact)

PROJECT_TERMS: Antigens;Clinical Trials;Contractor;Contracts;Databases;Development;Documentation;efficacy study;Equipment and supply inventories;Good Manufacturing Process;HIV;HIV vaccine;HIV-1;Human;immunogenicity;In Vitro;Investigational Drugs;Laboratories;Laboratory Animals;manufacture;Monoclonal Antibodies;National Institute of Allergy and Infectious Disease;Phase;plasmid DNA;preclinical development;Preclinical Testing;Preventive vaccine;product development;Production;Proteins;Protocols documentation;prototype;quality assurance;Quality Control;research clinical testing;Shipping;stability testing;Testing;Toxicology;Vaccines;Viral Vector

PROJECT_TITLE: cGMP Manufacturing of Monoclonal Antibodies (mAbs) Against HIV


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;Nutrition;Obesity;Prevention;Women's Health Research

ORG_CITY: DAVIS

ORG_NAME: UNIVERSITY OF CALIFORNIA AT DAVIS

PI_NAMEs: MICHAEL, CREININ  (contact)

PROJECT_TERMS: Adherence;Age;Body mass index;Clinical;Clinical Practice Guideline;Clinical Trials;Clinical Trials Network;Contraceptive Agents;contraceptive efficacy;Contraceptive methods;Contractor;Data;Development;Dose;Drug Kinetics;Enrollment;Estrogens;Evaluation;Female Contraceptive Agents;follow-up;Free Will;Goals;Good Clinical Practice;Government;Implant;Injectable;Injections;International;Intramuscular;Intrauterine Devices;Lactation;Levonorgestrel;Mission;Monitor;National Institute of Child Health and Human Development;Non obese;Obesity;Pharmacodynamics;pill;Population;Progestins;protocol development;Protocols documentation;Public Health;Recording of previous events;Records;recruit;Regimen;Regulation;reproductive;Risk;Risk Reduction;Route;Safety;subcutaneous;symposium;Time;United States Food and Drug Administration;venous thromboembolism;Woman

PROJECT_TITLE: PHARMACOKINETIC/PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION - UC DAVIS


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Orphan Drug;Prevention;Rare Diseases;Vaccine Related

ORG_CITY: COLUMBUS

ORG_NAME: BATTELLE CENTERS/PUB HLTH RES & EVALUATN

PI_NAMEs: RUDGE, THOMAS  (contact)

PROJECT_TERMS: Area;Biological;Biological Products;Bioterrorism;Clinical;Communicable Diseases;Contracts;Development;Educational workshop;efficacy testing;Emerging Communicable Diseases;evaluation/testing;Feasibility Studies;immunogenicity;Immunology procedure;Investigational New Drug Application;Licensing;Marburgvirus;novel vaccines;Office of Administrative Management;product development;Qualifying;Reporting;Safety;Sampling;Services;Site Visit;Testing;testing services;Toxicity Tests;Toxicology;Training;vaccine candidate;vaccine development;Vaccines;Validation

PROJECT_TITLE: Task V11: General Safety Toxicity Testing


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Clinical Trials and Supportive Activities;Emerging Infectious Diseases;Infectious Diseases;Orphan Drug;Rare Diseases;Vector-Borne Diseases

ORG_CITY: BETHESDA

ORG_NAME: ABVIRO, LLC

PI_NAMEs: RAMSTEDT, URBAN  (contact)

PROJECT_TERMS: Advanced Development;biodefense;candidate selection;Chemistry;Clinical assessments;Clinical Trials;Dengue Virus;efficacy evaluation;Emerging Communicable Diseases;Evaluation;Infection;lead optimization;manufacture;pathogen;Phase II Clinical Trials;pre-clinical;product development;research and development;Research Support;safety assessment;Therapeutic;therapeutic candidate;therapeutic development

PROJECT_TITLE: Development of Therapeutic Candidates for Biodefense, Infections and Emerging Infectious Diseases


PROJECT_TERMS: Area;assay development;Biological;Biological Products;Bioterrorism;Clinical;Communicable Diseases;Contracts;Development;Educational workshop;efficacy testing;Emerging Communicable Diseases;evaluation/testing;Feasibility Studies;immunogenicity;Immunology procedure;Investigational New Drug Application;Licensing;Monkeypox;novel vaccines;Office of Administrative Management;product development;Qualifying;Reagent;Reporting;Safety;Sampling;Services;Site Visit;Testing;testing services;Toxicology;Training;vaccine candidate;vaccine development;Vaccines;Validation

PROJECT_TITLE: Task V15: Development of Assays and Reagents for mpox Vaccines


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Clinical Trials and Supportive Activities;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

PI_NAMEs: MOODY, TONY  (contact)

PROJECT_TERMS: Biological Assay;Clinical Research;Clinical Trials;design;Development;efficacy testing;Evaluation;Immunity;immunogenicity;Immunologics;In Vitro;in vivo;influenza virus strain;influenza virus vaccine;innovation;Reagent;universal influenza vaccine;vaccine candidate;vaccine delivery;Vaccine Design;Vaccines

PROJECT_TITLE: Collaborative Influenza Vaccine Innovation Centers (CIVICs): Component A: Vaccine Center


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related


NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Comparative Effectiveness Research;Drug Abuse (NIDA only);Opioid Misuse and Addiction;Opioids;Substance Misuse

ORG_CITY: ROCKVILLE

ORG_NAME: THE EMMES COMPANY, LLC

PHR: The public health relevance of this contract includes addressing research gaps in the treatment of opioid use disorder by conducting clinical trials evaluating established or novel medications and behavioral interventions, or the combination thereof, in diverse patient populations. This contract is part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis.

PI_NAMEs: JELSTROM, EVE  (contact)

PROJECT_TERMS: Address;Behavior Therapy;Behavioral;Clinical;Clinical Investigator;Clinical Research;Clinical Treatment;Clinical Trials;Clinical Trials Network;community based treatment;Conduct Clinical Trials;Consultations;Contracts;Data;Drug abuse;drug testing;Funding;Goals;Grant;Health Personnel;Helping to End Addiction Long-term;improved;Individual;Intervention;Logistics;Medical;medical specialties;Monitor;Multi-Institutional Clinical Trial;National Institute of Drug Abuse;novel;Opiate Addiction;Opioid;opioid epidemic;opioid misuse;opioid use disorder;Patient Participation;patient population;Patients;Pharmaceutical Preparations;Pharmaceutical Services;pharmacologic;Pharmacological Treatment;Physicians;protocol development;Protocols documentation;Provider;Public Health;public health relevance;Research;Research Personnel;research study;Research Training;Resources;Speed;statistics;Substance Use Disorder;substance use treatment;Treatment Effectiveness;United States National Institutes of Health

PROJECT_TITLE: CTN CLINICAL COORDINATING CENTER TASK ORDER 8. POP 2/24/23 – 2/23/24


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: NEW TAIPEI CITY

ORG_COUNTRY: TAIWAN

ORG_FIPS: TW

ORG_NAME: PHARMACOLOGY DISCOVERY SERVICES TAIWAN, LTD.

PI_NAMEs: MIESEL, LYNN  (contact)

PROJECT_TERMS: Bacterial Antibiotic Resistance;Bacterial Drug Resistance;Bacterial Infections;bacterial resistance;Combating Antibiotic Resistant Bacteria;Contracts;Development;Evaluation;infectious disease model;mouse model;therapeutic development;therapeutic evaluation

PROJECT_TITLE: Task A87: Therapeutic Testing in Murine Models of Antibiotic-Resistant Bacterial Infection


NIH_SPENDING_CATS: Biotechnology;Neurosciences

PHR: Subject matter expert support for projects developing therapies for neurological disorders

PI_NAMEs: YOUNG, STEVEN  (contact)

PROJECT_TERMS: Biological Products;Nervous System Disorder;Pharmaceutical Chemistry;Services;small molecule;therapy development

PROJECT_TITLE: SMALL MOLECULES AND/OR BIOLOGICS MEDICINAL CHEMISTRY CONSULTANT SUPPORT SERVICES


NIH_SPENDING_CATS: American Indian or Alaska Native;Cardiovascular;Clinical Research;Health Disparities and Racial or Ethnic Minority Health Research;Heart Disease;Prevention;Racial and Ethnic Minority Health Research;Rural Health

ORG_CITY: HYATTSVILLE

ORG_NAME: MEDSTAR HEALTH RESEARCH INSTITUTE

PI_NAMEs: UMANS, JASON G (contact)

PROJECT_TERMS: American Indians;Ancillary Study;Arizona;base;Cardiovascular Diseases;cardiovascular disorder risk;Clinical;clinical examination;clinical predictors;cohort;Cohort Studies;Collaborations;Communities;community engagement;Disease;epidemiology study;Etiology;Event;Family;Family Study;follow-up;Fostering;Functional disorder;Funding;Heart;high risk;Investigation;Longitudinal, observational study;Morbidity - disease rate;mortality;Native Americans;Natural History;Oklahoma;Participant;platform-independent;prospective;recruit;Research Personnel;Risk Factors;Special Population;Training Support;tribal community;tribal leader;tribal Nation

PROJECT_TITLE: STRONG HEART STUDY (SHS) - FIELD CENTER, TASK ORDER 001, BASE PERIOD, FEBRUARY 15, 2019 TO FEBRUARY 14, 2020


NIH_SPENDING_CATS: Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Rare Diseases

ORG_CITY: MC LEAN

ORG_NAME: MITRE CORPORATION

PHR: Rare Diseases Research

PI_NAMEs: HUSTON, PAULA  (contact)

PROJECT_TERMS: Complex;Contractor;Discipline;Equity;Health;health disparity;health equity;Individual;medical specialties;National Center for Advancing Translational Sciences;pre-clinical research;preclinical development;Rare Diseases;Research;Surveys;Therapeutic Research

PROJECT_TITLE: NCATS DPI TDB INFUSE HEALTH EQUITY PRECLINICAL DEVELOPMENT


NIH_SPENDING_CATS: Cancer;Cancer Genomics;Cervical Cancer;Genetics;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Human Genome;Infectious Diseases;Prevention;Sexually Transmitted Infections;Social Determinants of Health;Women's Health Research

ORG_CITY: FREDERICK

ORG_NAME: LEIDOS BIOMEDICAL RESEARCH, INC.

PHR: Public Health Relevance: Developing new screening and triage tools for cervical cancer prevention that can be adapted to low-resource settings and self-sampling will allow to extend the reach of current screening approaches to underserved populations and reduce mortality of cervical cancer.

PI_NAMEs: FREEDMAN, LEONARD  (contact)

PROJECT_TERMS: Acceleration;Area;Automation;Biological Assay;Cancer Control;cervical cancer prevention;Cervical Cancer Screening;Clinical;Collection;data management;Databases;Development;Division of Cancer Epidemiology and Genetics;Funding;Genomics;Genotype;Human Papillomavirus;Laboratories;Liquid substance;Malignant neoplasm of cervix uteri;Methylation;Molecular Biology;mortality;new technology;Nucleic Acids;Preparation;Process;Protocols documentation;public health relevance;Resource-limited setting;Resources;Sampling;screening;Specimen;technical report;Testing;tool;Triage;Underserved Population;Viral

PROJECT_TITLE: NCI Moonshot: Accelerate Cervical Cancer Control


PI_NAMEs: BAVARVA, JASMIN  (contact)

PROJECT_TERMS: Genomics;refractory cancer

PROJECT_TITLE: Refractory Cancers Biospecimen Acquisition and Genomic Characterization


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Contraception/Reproduction;Nutrition;Obesity;Patient Safety;Prevention;Women's Health Research

ORG_CITY: BOSTON

ORG_NAME: BOSTON MEDICAL CENTER

ORG_STATE: MA

PI_NAMEs: WHITE, KATHARINE O'CONNEL  (contact)

PROJECT_TERMS: Adherence;Age;Body mass index;Boston;Clinical;Clinical Practice Guideline;Clinical Trials;Clinical Trials Network;Contraceptive Agents;contraceptive efficacy;Contraceptive methods;Contractor;Data;Development;Dose;Drug Kinetics;Enrollment;Estrogens;Evaluation;Female Contraceptive Agents;follow-up;Free Will;Goals;Good Clinical Practice;Government;Implant;Injectable;Injections;International;Intramuscular;Intrauterine Devices;Lactation;Levonorgestrel;Mission;Monitor;National Institute of Child Health and Human Development;Non obese;Obesity;Pharmacodynamics;pill;Population;Progestins;protocol development;Protocols documentation;Public Health;Recording of previous events;Records;recruit;Regimen;Regulation;reproductive;Risk;Risk Reduction;Route;Safety;subcutaneous;symposium;Time;United States Food and Drug Administration;venous thromboembolism;Woman

PROJECT_TITLE: CCTN-PHARMACOKINETIC / PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION - BOSTON


NIH_SPENDING_CATS: Breast Cancer;Cancer;Complementary and Integrative Health;Dietary Supplements;Women's Health Research

ORG_CITY: NEW YORK

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

PI_NAMEs: DAMOCI, CHRISTOPHER  (contact)

PROJECT_TERMS: Anabolism;Breast Cancer Cell;cancer therapy;Coenzyme Q10;Collaborations;Contractor;efficacy testing;Human;In Vitro;in vivo;in vivo evaluation;inhibitor;Lead;Modeling;mouse model;National Center for Advancing Translational Sciences;Running;Series;Services;SKBR3;small molecule inhibitor;Testing;Xenograft Model

PROJECT_TITLE: IN VIVO TESTING OF A LEAD COQ10 BIOSYNTHESIS INHIBITOR IN AN SK-BR-3 XENOGRAPH MOUSE MODEL


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;Estrogen;Nutrition;Obesity;Prevention;Women's Health Research

ORG_CITY: PORTLAND

ORG_NAME: OREGON HEALTH & SCIENCE UNIVERSITY

ORG_STATE: OR

PI_NAMEs: JENSEN, JEFFREY  (contact)

PROJECT_TERMS: Adherence;Age;Body mass index;Clinical;Clinical Trials;Clinical Trials Network;Contraceptive Agents;contraceptive efficacy;Contraceptive methods;Data;Drug Kinetics;Enrollment;Estrogens;Evaluation;Female Contraceptive Agents;Formulation;Free Will;Implant;Injectable;Injections;Intramuscular;Intrauterine Devices;Lactation;Levonorgestrel;Mission;National Institute of Child Health and Human Development;Non obese;Obesity;Oregon;Pharmacodynamics;pharmacokinetics and pharmacodynamics;pill;Population;Progestins;Public Health;Recording of previous events;recruit;Regimen;reproductive;Risk;Risk Reduction;Route;Safety;subcutaneous;Time;United States Food and Drug Administration;venous thromboembolism;Woman

PROJECT_TITLE: CCTN-PHARMACOKINETIC / PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION - OREGON


NIH_SPENDING_CATS: Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_NAME: INTERNATIONAL AIDS VACCINE INITIATIVE

PI_NAMEs: SAGAR, SANGEETHA  (contact)

PROJECT_TERMS: Adjuvant;Biological Products;Clinical Research;Communicable Diseases;Contracts;Cyclic GMP;Development;Development Plans;Human;influenza virus vaccine;influenzavirus;manufacture;novel vaccines;Phase;product development;research clinical testing;Services;System;United States Food and Drug Administration;vaccine delivery;vaccine development;Vaccines

PROJECT_TITLE: Task V32: Manufacture of Influenza Virus Human Challenge Material for Phase I/II Clinical Testing


NIH_SPENDING_CATS: Burden of Illness;Cancer;Prevention;Social Determinants of Health

ORG_CITY: MENANDS

ORG_NAME: HEALTH RESEARCH INC, NEW YORK STATE DOH

PI_NAMEs: SCHYMURA, MARIA  (contact)

PROJECT_TERMS: Annual Reports;anti-cancer research;Cancer Control;Cancer Patient;cancer statistics;Data;Diagnosis;Disease;Geography;Incidence;Infrastructure;insight;Malignant Neoplasms;Monitor;National Cancer Institute;Patients;Population;Prevalence;SEER Program;Social Characteristics;Subgroup;Time;treatment pattern;trend

PROJECT_TITLE: SEER Core Infrastructure Support


NIH_SPENDING_CATS: Neurosciences

ORG_CITY: BOULDER

ORG_STATE: CO

PHR: Subject matter expert support for developing therapies for neurological disorders

PI_NAMEs: FRANKLIN, RONALD  (contact)

PROJECT_TERMS: Address;assay development;Chemistry;Clinical Research;Contractor;Data;Data Analyses;design;Development;drug development;drug discovery;Drug Kinetics;drug metabolism;Electronic Mail;Experimental Designs;Formulation;Investigational Drugs;Lead;lead optimization;Nervous System Disorder;programs;Protocols documentation;Recommendation;Reporting;Services;Telephone;therapy development;United States National Institutes of Health

PROJECT_TITLE: SUBJECT MATTER EXPERT CONSULTANT FOR DRUG METABOLISM PHARMACOKINETICS [DMPK].


ORG_CITY: EAST SETAUKET

PI_NAMEs: ARALDI, GIAN  (contact)

PROJECT_TERMS: Address;Biological Assay;Chemicals;Chemistry;Clinical;Clinical Research;Contractor;Contracts;Data Analyses;Development;Development Plans;Electronic Mail;Feedback;Guidelines;Human Resources;innovative technologies;Knowledge;Lead;manufacture;manufacturing process;manufacturing scale-up;member;National Institute of Neurological Disorders and Stroke;Nervous System Disorder;Plants;pre-clinical;Process;programs;Protocols documentation;Recommendation;Regulation;Reporting;Research;Role;scale up;Services;Site;small molecule;Strategic Planning;symposium;technology development;Technology Transfer;Testing;therapy development;timeline;United States National Institutes of Health;Writing

PROJECT_TITLE: PROCESS CHEMISTRY CONSULTING SERVICES. KEY PERSONNEL CONSULTANT: DR. GIAN ARALDI.


ORG_CITY: AUSTIN

ORG_NAME: TOXSTRATEGIES, INC.

PI_NAMEs: WOOD, MARCIE  (contact)

PROJECT_TERMS: Address;Biological Assay;Biological Products;Clinical;clinical pain;Clinical Research;Collaborations;Contractor;Data Analyses;design;Development;Development Plans;drug development;drug discovery;Electronic Mail;Feedback;Helping to End Addiction Long-term;in silico;In Vitro;in vivo Model;lead optimization;Logistics;member;model development;National Institute of Neurological Disorders and Stroke;Nervous System Disorder;Neurosciences;Oligonucleotides;Pain;Pain management;pharmacokinetics and pharmacodynamics;Pharmacology;Pharmacology and Toxicology;Pharmacology Study;pre-clinical;Program Development;programs;Recommendation;Resources;Role;safety study;screening;Services;Speed;Strategic Planning;symposium;Testing;Toxicology;United States National Institutes of Health

PROJECT_TITLE: NINDS, NIH BPN, NIH HEAL AND OTHER NIH NEUROSCIENCE-FOCUSED DRUG DISCOVERY AND DEVELOPMENT PROGRAMS WITH TOXICOLOGY CONSULTING SERVICES


PROJECT_TERMS: Address;Biological Assay;Biological Products;Clinical;Clinical Research;Collaborations;Contractor;Data Analyses;design;Development;Development Plans;drug development;drug discovery;Electronic Mail;Feedback;healing;in silico;In Vitro;in vivo Model;lead optimization;Logistics;member;model development;National Institute of Neurological Disorders and Stroke;Nervous System Disorder;Neurosciences;Oligonucleotides;pharmacokinetics and pharmacodynamics;Pharmacology;Pharmacology and Toxicology;Pharmacology Study;pre-clinical;Program Development;programs;Recommendation;Resources;Role;safety study;screening;Services;Strategic Planning;Study Subject;symposium;Testing;therapy development;Toxicology;United States National Institutes of Health

PROJECT_TITLE: NINDS TOXICOLOGY CONSULTING SERVICES (NIH BPN, NIH HEAL AND OTHER NIH NEUROSCIENCE-FOCUSED DRUG DISCOVERY AND DEVELOPMENT PROGRAMS)


NIH_SPENDING_CATS: Cancer

PI_NAMEs: DMITROVSKY, ETHAN  (contact)

PROJECT_TITLE: FY22 Facilities Task Order B – Refurbishment and Infrastructure Projects focused on Facility Improvements within the NCI at Frederick Campus


PROJECT_TITLE: FY22 CONSOLIDATED FACILITIES TASK ORDER C


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Clinical Trials and Supportive Activities;Coronaviruses;Coronaviruses Therapeutics and Interventions;Emerging Infectious Diseases;Infectious Diseases;Prevention

ORG_NAME: DYNPORT VACCINE COMPANY, LLC

PI_NAMEs: LONG, CASEY  (contact)

PROJECT_TERMS: clinical trial implementation;Clinical Trials;Clinical Trials Unit;Communicable Diseases;COVID-19 therapeutics;Dose;Double-Blind Method;early phase clinical trial;Intervention;Investigation;National Institute of Allergy and Infectious Disease;New Agents;phase 1 study;Phase I Clinical Trials;Placebo Control;Prevention;Randomized;Study Subject

PROJECT_TITLE: Task C1: A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Phase 1 Study of SARS-CoV-2 Therapeutics


ORG_CITY: MORRISVILLE

ORG_NAME: HEALTH DECISIONS, INC.

PI_NAMEs: DART, CLINT  (contact)

PROJECT_TERMS: Adherence;Age;Body mass index;Clinical;Clinical Trials;Clinical Trials Network;Contraceptive Agents;contraceptive efficacy;Contraceptive methods;Dose;Drug Kinetics;Enrollment;Estrogens;Female Contraceptive Agents;follow-up;Formulation;Free Will;Hepatotoxicity;Implant;Injectable;Injections;Intramuscular;Intrauterine Devices;Lactation;Levonorgestrel;Mission;Monitor;National Institute of Child Health and Human Development;Obesity;pill;Population;Progestins;Public Health;Recording of previous events;recruit;Regimen;reproductive;Risk;Risk Reduction;Route;Safety;service coordination;Services;subcutaneous;Time;United States Food and Drug Administration;venous thromboembolism;Woman

PROJECT_TITLE: A STUDY TO EVALUATE THE PK AND PD OF IM OR SQ INJECTIONS OF LEVONORGESTREL BUTANOATE (LB) FOR FEMALE CONTRACEPTION


PI_NAMEs: DATTA, KIRAN  (contact)

PROJECT_TERMS: coronavirus vaccine;Data;Development;Goals;National Institute of Allergy and Infectious Disease;next generation;novel vaccines;Phase;Phase I Clinical Trials;Phase II Clinical Trials;phase II trial;Series;Standardization

PROJECT_TITLE: Phase 1 and Phase 2 Clinical Trials for Next-Generation Coronavirus Vaccines


NIH_SPENDING_CATS: Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Obesity;Racial and Ethnic Minority Health Research

ORG_CITY: CHAPEL HILL

ORG_NAME: UNIV OF NORTH CAROLINA CHAPEL HILL

PI_NAMEs: CAI, JIANWEN  (contact)

PROJECT_TERMS: Adult;Ancillary Study;Anthropometry;Area;Blood Pressure;Cardiometabolic Disease;Cardiovascular system;Central American;Chicago;Clinic;cohort;Contracts;Cuban;data sharing;Disease;Dominican;Enrollment;epidemiology study;Funding;Heart Diseases;High Prevalence;Hispanic;Hispanic Community Health Study/Study of Latinos;Hispanic Populations;Laboratories;Latino;Latino Population;Lung;Measurement;Medical;Mexican;Morbidity - disease rate;mortality;National Heart, Lung, and Blood Institute;Obesity;Onset of illness;operation;Phase;pilot test;Plasma;Policies;Prevalence;protocol development;Puerto Rican;Risk;Risk Factors;Sampling;Serum;South American;Stroke;Testing;Training;United States;United States National Institutes of Health;Urine;Visit;Whole Blood

PROJECT_TITLE: HCHS-SOL COORDINATING CENTER TASK AREA B2 EXAM YEAR 3


ORG_CITY: CLIFTON

PI_NAMEs: SCHULTZ, CLYDE  (contact)

PROJECT_TERMS: Address;analytical method;Antibodies;Antisense Oligonucleotides;Area;Biochemistry;Biological;Biological Process;Biological Products;Biological Response Modifier Therapy;Cell Therapy;Cells;Chemistry;Clinical Research;Collaborations;Complex;Contractor;Contracts;Data;design;Development;Electronic Mail;Ensure;evaluation/testing;Feedback;Formulation;Government;Guidelines;improved;Investigational Drugs;Investigational New Drug Application;Label;Leadership;Lentivirus;Liposomes;manufacture;meetings;member;method development;Methodology;Methods;Modality;nanoparticle;oligonucleotide therapeutics;operation;Peptides;Performance;Polymers;preclinical evaluation;Preparation;Principal Investigator;Process;product development;programs;protein purification;Protocols documentation;Published Comment;quality assurance;Recombinant Proteins;Regulation;Regulatory Affairs;Reporting;research clinical testing;Risk;Role;Running;safety testing;scale up;Services;Site;Small Interfering RNA;Specific qualifier value;Strategic Planning;symposium;Telephone;Testing;Therapeutic;therapeutic development;timeline;Toxicology;United States National Institutes of Health;Viral;Viral Vector;Visit;Work

PROJECT_TITLE: BIOLOGICS SUBJECT MATTER EXPERT (SME) CONSULTING SERVICES


ORG_CITY: BURLINGTON

PI_NAMEs: VANAGS, DAINA  (contact)

PROJECT_TERMS: Address;ADME Study;Affect;Amendment;Animal Model;Area;Biological Assay;Biological Products;Clinical;Clinical Protocols;Clinical Research;Collaborations;Contractor;Data;Data Analyses;design;Development;Development Plans;drug development;drug discovery;efficacy study;Electronic Mail;Ensure;Experimental Designs;Familiarity;Feedback;Formulation;Guidelines;in silico;In Vitro;in vivo;in vivo Model;Industry;Lead;lead optimization;Logistics;Medical;member;model development;Nervous System Disorder;Oligonucleotides;Pamphlets;Performance;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;Pharmacology;Pharmacology and Toxicology;Pharmacology Study;pre-clinical;Preparation;Process;programs;Protocols documentation;Quality Control;Recommendation;Research Design;Research Personnel;Resources;Role;safety study;screening;Services;Strategic Planning;Study Subject;symposium;Testing;timeline;Toxicology;United States National Institutes of Health;Work;Writing


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Coronaviruses;Coronaviruses Vaccines;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_NAME: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

PI_NAMEs: KRAMMER, FLORIAN  (contact)

PROJECT_TERMS: 2019-nCoV;Biological Assay;Clinical Research;Clinical Trials;COVID-19 vaccine;design;Development;efficacy testing;Evaluation;Immunity;immunogenicity;Immunologics;In Vitro;in vivo;influenza virus strain;influenza virus vaccine;innovation;Reagent;SARS-CoV-2 immunity;SARS-CoV-2 infection;universal influenza vaccine;vaccine candidate;vaccine delivery;Vaccine Design;Vaccines

PROJECT_TITLE: Collaborative Influenza Vaccine Innovation Centers (CIVICs): Component A: Vaccine Center, SARS-CoV-2


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

PROJECT_TERMS: Biological Assay;Clinical Research;Clinical Trials;design;Development;efficacy testing;Evaluation;Immunity;immunogenicity;Immunologics;In Vitro;in vivo;influenza virus strain;influenza virus vaccine;innovation;Reagent;universal influenza vaccine;vaccine candidate;vaccine delivery;Vaccine Design;Vaccines

PROJECT_TITLE: Collaborative Influenza Vaccine Innovation Centers (CIVICs): Component A: Vaccine Center


ORG_CITY: HOUSTON

ORG_NAME: BAYLOR COLLEGE OF MEDICINE

PI_NAMEs: RIVES, MICHELLE  (contact)

PROJECT_TERMS: Area;catalyst;Cells;Contractor;Data;database of Genotypes and Phenotypes;Databases;Development;Disease;functional genomics;Funding;genome sequencing;genomic data;Goals;Heart;Hematological Disease;Lung;Multiomic Data;National Heart, Lung, and Blood Institute;Phase;precision medicine;Process;programs;Research Personnel;Resolution;Resources;Sleep Disorders;Trans-Omics for Precision Medicine;whole genome

PROJECT_TITLE: NHLBI TRANS-OMICS FOR PRECISION MEDICINE (TOPMED) FOR THE CENTRALIZED OMICS RESOURCE (CORE) - TASK AREAS 2, 3, AND 4


NIH_SPENDING_CATS: Biotechnology;Gene Therapy;Genetics;Orphan Drug;Rare Diseases

ORG_CITY: ALBUQUERQUE

ORG_NAME: LOVELACE BIOMEDICAL RESEARCH INSTITUTE

ORG_STATE: NM

PI_NAMEs: ROBERTSON, MIKE  (contact)

PROJECT_TERMS: Behavioral Assay;Biodistribution;Biological;Biological Assay;Biometry;Collaborations;Contractor;Data;Dependovirus;design;Development;Disease;efficacy evaluation;efficacy study;enzyme activity;Evaluation;gene therapy;Generations;Genotype;Government;IACUC;in vivo;Injections;ketotic hyperglycinemia;Lead;Measurement;Measures;method development;Methods;methylmalonyl-CoA decarboxylase;mouse model;Mus;National Center for Advancing Translational Sciences;National Human Genome Research Institute;pharmacologic;Physiological;Preparation;Procedures;programs;Protocols documentation;Reporting;Safety;Sampling;scale up;Therapeutics for Rare and Neglected Diseases;transgene expression;Transgenic Mice;Weight

PROJECT_TITLE: EFFICACY AND SAFETY EVALUATION OF A LEAD GENE THERAPY CANDIDATE IN PROPIONIC ACIDEMIA (PA) DISEASE MOUSE MODELS AND BIOANALYTICAL ASSAY METHODS DEVELOPMENT.


ORG_CITY: KANSAS CITY

ORG_NAME: MIDWEST RESEARCH INSTITUTE

PI_NAMEs: SLADE, DESMOND  (contact)

PROJECT_TERMS: Adverse effects;Aerobic;Affect;Aminoglycoside Antibiotics;analytical method;Antibiotic Therapy;Antibiotics;Auditory;Cessation of life;Data;Disease;Dizziness;Equilibrium;Hair Cells;hearing impairment;Impairment;Infection;Inner Hair Cells;Labyrinth;method development;mycobacterial;Natural Killer Cells;ototoxicity;Patients;pre-clinical;side effect;small molecule;Validation;vestibular system

PROJECT_TITLE: ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDY OF ORC-13661


NIH_SPENDING_CATS: Infectious Diseases

ORG_CITY: MENLO PARK

ORG_NAME: SRI INTERNATIONAL

PI_NAMEs: MIRSALIS, JON  (contact)

PROJECT_TERMS: Biological;Chemistry;Clinical Trials;Communicable Diseases;Development;Development Plans;Drug Kinetics;Evaluation;In Vitro;in vivo;Interventional Agent Development;Lead;manufacture;pathogen;pre-clinical;product development;programs;Safety;Services;Therapeutic;therapeutic development;Toxicology;Toxin

PROJECT_TITLE: Task C13: GMP Manufacturing of Oxfendazole Clinical Trial Material and Stability Study


NIH_SPENDING_CATS: Anthrax;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Rare Diseases

ORG_CITY: SALISBURY

ORG_COUNTRY: UNITED KINGDOM

ORG_FIPS: UK

ORG_NAME: UK HEALTH SECURITY AGENCY

PROJECT_TERMS: Amoxicillin;Bacillus anthracis;Clavulanate;Contracts;Development;Evaluation;infectious disease model;Label;nonhuman primate;Sampling;therapeutic development

PROJECT_TITLE: Task B11: Sample Storage to Support a Label Change for Amoxicillin and Amoxicillin-Clavulanate


NIH_SPENDING_CATS: Biotechnology;Immunization;Infectious Diseases;Orphan Drug;Prevention;Rare Diseases;Transplantation;Vaccine Related

ORG_CITY: FREDERICK

PI_NAMEs: YARAMOLU, RAGHUVEERA  (contact)

PROJECT_TERMS: Allergic Disease;Asthma;Autoimmune Diseases;Basic Science;Biological Products;Cell Transplantation;Clinical;Clinical Research;Clinical Trials;Contracts;Disease;Equipment and supply inventories;Food;Funding;Immune;infectious disease treatment;Intervention Studies;manufacture;Manufacturer;Mediating;National Institute of Allergy and Infectious Disease;Opioid;Organ Transplantation;Pharmacologic Substance;Placebos;Prevention;Product Labeling;programs;Rare Diseases;Role;Schedule;Services;Site;Solid;Tissue Transplantation;vaccine trial

PROJECT_TITLE: CLINICAL PRODUCTS CENTER (CPC) for IMMUNE-MEDIATED DISEASES


PI_NAMEs: DEVASAHAYAM, ANBU  (contact)

PROJECT_TERMS: Allergic Disease;Asthma;Autoimmune Diseases;Basic Science;Biological Products;Cell Transplantation;Clinical;Clinical Research;Clinical Trials;Contracts;Food;Funding;Immune;Intervention Studies;Mediating;National Institute of Allergy and Infectious Disease;Opioid;Organ Transplantation;Pharmacologic Substance;programs;Rare Diseases;Schedule;Services;Solid;Tissue Transplantation;vaccine trial

PROJECT_TITLE: NIAID DAIT CLINICAL PRODUCTS CENTER (CPC)


PROJECT_TERMS: Biological Products;Clinical;Clinical Research;Clinical Trials;Contracts;Equipment and supply inventories;Funding;infectious disease treatment;manufacture;National Institute of Allergy and Infectious Disease;Pharmacologic Substance;Placebos;Prevention;Product Labeling;programs;Role;Schedule;Services;vaccine trial


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Health Disparities and Racial or Ethnic Minority Health Research;Immunization;Infectious Diseases;Pediatric;Prevention;Racial and Ethnic Minority Health Research;Vaccine Related;Women's Health Research

ORG_CITY: ROCKVILLE

ORG_NAME: WESTAT, INC.

PI_NAMEs: DRIVER, BARBARA  (contact)

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adolescent;Adolescent Development;adolescent health;Adolescent Medicine Trials Network;Agreement;AIDS clinical trial group;Area;Award;Biological Assay;Brazil;care coordination;care systems;Child;Childhood;clinical center;Clinical Management;Clinical Research;clinical research site;Clinical Trials;Clinical Trials Network;Communicable Diseases;Conduct Clinical Trials;Contractor;Contracts;Country;Data Analyses;data management;Diagnostic Procedure;Epidemiology;Equipment;Ethnic Origin;Evaluation;Family;flexibility;Funding;Grant;Healthcare;HIV;HIV Infections;HIV prevention trials network;HIV vaccine;HIV Vaccine Trials Network;HIV-infected adolescents;HIV/AIDS;Human Development;Human Resources;Immunologics;improved;Infectious Diseases Research;Infrastructure;inner city;International;International Maternal Pediatric Adolescent AIDS Clinical Trials;Investigational Therapies;Laboratories;laboratory equipment;laboratory facility;Lead;Maintenance;Mediation;Medical;meetings;Methodology;minority children;Mission;Monitor;Mothers;National Institute of Allergy and Infectious Disease;National Institute of Child Health and Human Development;Natural History;operation;patient population;pediatric human immunodeficiency virus;pediatric human immunodeficiency virus infection;Performance;pharmacologic;Pharmacy facility;Prevention;Prevention strategy;programs;protocol development;Protocols documentation;quality assurance;Quality Control;racial minority;Recurrence;repository;Reproductive Health;Research;Research Activity;Research Personnel;Resources;Safety;Sampling;Security;Services;Shipping;Site;South Africa;Specific qualifier value;Specimen;Specimen Handling;System;Testing;Therapeutic;Therapeutic Research;Training;Translations;United States National Institutes of Health;vaccine trial;Woman;Work

PROJECT_TITLE: SUPPORT SERVICES OF THE HIV AIDS CLINICAL TRIAL NETWORKS


NIH_SPENDING_CATS: Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Preterm, Low Birth Weight and Health of the Newborn;Women's Health Research

ORG_NAME: FISHER BIOSERVICES, INC.

PI_NAMEs: MANDACI, OGUZ  (contact)

PROJECT_TERMS: Biological Specimen Banks;clinical center;Collection;Data Coordinating Center;Equipment and supply inventories;Human;Maternal-Fetal Medicine Units Network;Monitor;National Institute of Child Health and Human Development;repository;Services;Specimen;System;Temperature;United States

PROJECT_TITLE: REPOSITORY SERVICES FOR THE MATERNAL-FETAL MEDICINE UNITS NETWORK (MFMU)


NIH_SPENDING_CATS: Cardiovascular;Chronic Obstructive Pulmonary Disease;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Lung;Obesity;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

PROJECT_TERMS: Adult;Ancillary Study;Area;Asthma;Cardiometabolic Disease;cardiovascular health;Cardiovascular system;Central American;Chicago;Chronic Obstructive Pulmonary Disease;Clinic;Clinical;cohort;Contracts;Cuban;Diabetes Mellitus;Disease;Dominican;Enrollment;epidemiology study;Event;follow-up;Funding;Funding Mechanisms;Future;Health;health care service utilization;Heart Diseases;High Prevalence;Hispanic;Hispanic Community Health Study/Study of Latinos;Hispanic Populations;Latino;Latino Population;Left Ventricular Hypertrophy;Lung;Lung Diseases;lung health;Measures;Medical;Mexican;Morbidity - disease rate;mortality;National Heart, Lung, and Blood Institute;National Institute on Minority Health and Health Disparities;Obesity;Onset of illness;operation;Participant;Phase;power analysis;Prevalence;protocol development;Puerto Rican;Risk;Risk Factors;Socioeconomic Factors;South American;Stroke;Training;United States

PROJECT_TITLE: HISPANIC COMMUNITY HEALTH STUDY - STUDY OF LATINOS (HCHS-SOL) - COORDINATING CENTER


NIH_SPENDING_CATS: Clinical Research;Neurosciences

PHR: support to develop novel therapies for neurological disorders

PI_NAMEs: ANDERSON, PAUL  (contact)

PROJECT_TERMS: Address;Chemical Structure;Chemistry;Clinical Research;Collaborations;Contractor;Data;design;Development;drug development;drug discovery;Electronic Mail;Feedback;Helping to End Addiction Long-term;Individual;Lead;lead optimization;member;Methodology;Nervous System Disorder;novel therapeutics;Pharmaceutical Chemistry;Principal Investigator;Process;programs;Reporting;Research;Research Contracts;Role;Services;Strategic Planning;symposium;Telephone;Testing;United States National Institutes of Health;Visit

PROJECT_TITLE: MEDICINAL CHEMISTRY CONSULTING SERVICES


PHR: Support development of non-addictive therapies for pain

PROJECT_TERMS: Address;Chemical Structure;Chemistry;Clinical Research;Collaborations;Contractor;Data;design;Development;drug development;drug discovery;Electronic Mail;Feedback;Helping to End Addiction Long-term;Individual;Lead;lead optimization;member;Methodology;Pain;Pain management;Pharmaceutical Chemistry;Principal Investigator;Process;Program Development;programs;Reporting;Research;Research Contracts;Role;Services;Strategic Planning;symposium;Telephone;Testing;United States National Institutes of Health;Visit


NIH_SPENDING_CATS: Autoimmune Disease;Microbiome;Pediatric;Prevention;Primary Immunodeficiencies;Rare Diseases

ORG_CITY: Durham

ORG_NAME: RHO FEDERAL SYSTEMS DIVISION, INC.

PI_NAMEs: MILLIN, CHRISTINA  (contact)

PROJECT_TERMS: Autoimmune Diseases;Biological Markers;Clinical;Clinical Management;Clinical Research;Clinical Trials;Collaborations;congenital immunodeficiency;design;Development;Disease;Genetic study;Immunology;innovation;Manuscripts;microbiome research;Mucous Membrane;pharmacovigilance;Phase;Preparation;Prevention;protocol development;repository;Safety;Sampling;Support Contracts;Surveys

PROJECT_TITLE: IPP: AUTOIMMUNE DISEASES STATISTICAL AND CLINICAL COORDINATING CENTER (ADSCCC)


NIH_SPENDING_CATS: Infectious Diseases;Prevention

PI_NAMEs: SAVIOLAKIS, GEORGE  (contact)

PROJECT_TERMS: clinical trial implementation;Clinical Trials;Clinical Trials Unit;Communicable Diseases;Development;early phase clinical trial;Intervention;Investigation;National Institute of Allergy and Infectious Disease;New Agents;Prevention

PROJECT_TITLE: Task A: Early Phase Clinical Trial Units (EPCTU)


ORG_CITY: CARY

ORG_NAME: ALLUCENT GOVERNMENT SERVICES (US) LLC

PI_NAMEs: MCKEE, KELLY  (contact)


NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Brain Disorders;Conditions Affecting the Embryonic and Fetal Periods;Fetal Alcohol Spectrum Disorders (FASD);Infant Mortality;Infectious Diseases;Intellectual and Developmental Disabilities (IDD);Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Prevention;Rare Diseases;Sleep Research;Substance Misuse;Sudden Infant Death Syndrome

PROJECT_TERMS: adverse pregnancy outcome;Alcohols;Biological;Child Health;Childhood;Collection;Communicable Diseases;Contracts;Coupled;Equipment and supply inventories;Fetal Alcohol Exposure;Fetal Alcohol Spectrum Disorder;Human;Human Development;Intramural Research;Monitor;National Institute of Child Health and Human Development;Perinatology;population health;Pregnancy;prenatal;repository;Research;Research Activity;Role;sample collection;Services;Specimen;stillbirth;Sudden infant death syndrome;System

PROJECT_TITLE: REPOSITORY SERVICES FOR THE SAFE PASSAGE STUDY (PASS)


ORG_CITY: Chicago

ORG_NAME: UNIVERSITY OF ILLINOIS AT CHICAGO

ORG_STATE: IL

PI_NAMEs: DAVIGLUS, MARTHA  (contact)

PROJECT_TITLE: HISPANIC COMMUNITY HEALTH STUDY-STUDY OF LATINOS (HCHS-SOL)- CHICAGO FIELD CENTER


ADMINISTERING_IC: VA

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: Veterans Affairs

ORG_CITY: DURHAM

ORG_NAME: DURHAM VA MEDICAL CENTER

PHR: There are currently only 2 FDA-approved medications for the treatment of PTSD, both of which were approved more than 15 years ago and resulted in only moderate-effect sizes in FDA registration trials. The development of effective pharmacological treatments for Iraq/Afghanistan-era Veterans with PTSD is especially urgent, as Veterans returning from deployments experience high rates of PTSD often resulting in debilitating symptoms and reduced quality of life. Converging data suggest that pregnenolone is a promising pharmacological agent for treating PTSD symptoms. We thus propose to conduct a randomized clinical trial investigating the potential efficacy of pregnenolone for PTSD and commonly co-occurring symptoms such as pain and depression. Pregnenolone has a favorable side-effect profile, and our prior research demonstrates that pregnenolone is well-tolerated in Veteran cohorts. Treatment with pregnenolone could thus be an efficacious, inexpensive, and safe new therapeutic for Iraq/Afghanistan-era Veterans with PTSD.

PI_NAMEs: NAYLOR, JENNIFER C (contact)

PROJECT_TERMS: Acute;Address;Afghanistan;Aftercare;Allopregnanolone;Anti-Anxiety Agents;anti-depressive agents;Anti-Inflammatory Agents;anxiety-like behavior;associated symptom;Biological Psychiatry;Bipolar Depression;Brain;Brief Pain Inventory;candidate marker;chronic pain;Clinical;Clinical Data;cohort;Communication;comparison control;Data;debilitating symptom;depressive symptoms;Development;dual diagnosis;efficacious treatment;efficacy evaluation;Emotional;Emotions;experience;FDA approved;Focus Groups;follow-up;Foundations;Fright;Functional disorder;Hamilton Rating Scale for Depression;improved;inflammatory marker;Intervention;Investigation;Iraq;Low Back Pain;Mass Spectrum Analysis;Mental Depression;mild traumatic brain injury;military veteran;Neurobiology;neurogenesis;neuroimaging;neuroprotection;neurosteroids;novel therapeutics;Pain;Pain Disorder;pain reduction;pain symptom;Participant;Patients;Pharmaceutical Preparations;pharmacologic;Pharmacological Treatment;Pharmacotherapy;phase 3 study;Placebos;post intervention;Post-Traumatic Stress Disorders;pre-clinical;Prediction of Response to Therapy;Pregnenolone;primary endpoint;Process;Property;Quality of life;Randomized;randomized, clinical trials;Randomized, Controlled Trials;Recommendation;Refractory;Research;Rodent;Rodent Model;Role;secondary endpoint;Serum;side effect;Stress;symptomatic improvement;Symptoms;Techniques;Therapeutic;treatment duration;Veterans;working group

PROJECT_TITLE: Neurosteroid Intervention for PTSD in Iraq/Afghanistan-era Veterans


ADMINISTERING_IC: GM

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Building Research Capacity at Institutions with Limited NIH Funding;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: GRAND FORKS

ORG_NAME: UNIVERSITY OF NORTH DAKOTA

ORG_STATE: ND

PI_NAMEs: BRISSETTE, CATHERINE AYN;NOOKALA, SUBA  (contact)

PROGRAM_OFFICER_NAME: CUPIT, PAULINE

PROJECT_TERMS: Adipose tissue;Antibiotic Therapy;Bacteria;design;Down-Regulation;Genetic;Homeostasis;Impairment;improved;Information Dissemination;Knowledge;Ligands;lipid biosynthesis;Metabolic;mouse model;novel diagnostics;Outcome;pathogen;personalized therapeutic;Skin;Soft Tissue Infections;Streptococcal Infections;Streptococcus pyogenes;Therapeutic

PROJECT_TITLE: Skin-Adipose axis in HLA-II mouse models of Group A Streptococcus infection


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Brain Disorders;Dementia;Genetics;Neurodegenerative;Neurosciences

ORG_CITY: SEATTLE

ORG_NAME: SEATTLE INST FOR BIOMEDICAL/CLINICAL RES

ORG_STATE: WA

PHR: Project Narrative Abnormally folded, phosphorylated and aggregated tau accumulates in several neurodegenerative diseases including Alzheimer's Disease. We have discovered mutations in tubulin genes that suppress neuronal tau-induced toxicity in Caenorhabditis elegans model. The aims within this proposal will elucidate the mechanisms underpinning mutant tubulin-mediated suppression of tau toxicity, tau-microtubule interactions, and aid in the discovery of new therapeutic strategies.

PI_NAMEs: BENBOW, SARAH JEAN ZIMMERMAN (contact)

PROGRAM_OFFICER_NAME: YANG, AUSTIN JYAN-YU

PROJECT_TERMS: Address;Affect;age-related disease;aging population;Alzheimer's Disease;Axonal Transport;Behavioral;Biochemical;Biology of Aging;biophysical techniques;Caenorhabditis elegans;career;career networking;chronic traumatic encephalopathy;Clinical;Clustered Regularly Interspaced Short Palindromic Repeats;Communities;Cytoskeleton;Defect;Development;Disease;Disease Progression;Economics;experimental study;Frontotemporal Lobar Degenerations;gain of function;gene conservation;Genes;genetic approach;Goals;Healthcare;Healthcare Systems;Human;improved;In Vitro;interest;Journals;Knowledge;Laboratories;Leadership;live cell imaging;MAPT gene;Measures;Mediating;Medical;meetings;Methods;Microtubule Polymerization;Microtubules;Modeling;Molecular;Motility;Motor;mutant;Mutant Strains Mice;Mutation;Nerve Degeneration;Neurodegenerative Disorders;Neuronal Dysfunction;Neurons;new therapeutic target;novel therapeutic intervention;Pathologic;Pathology;Phase;Phenotype;Phosphorylation;Play;Point Mutation;Prevalence;Principal Investigator;Process;Property;protein aggregation;Proteins;reconstitution;Research;Research Personnel;Resistance;Resources;Role;skills;social;sound;System;tau aggregation;tau Proteins;tau-microtubule interaction;Tauopathies;Testing;Toxic effect;Training;Transgenic Organisms;Translating;Translations;Tubulin;United States Department of Veterans Affairs;Universities;Washington;Work

PROJECT_TITLE: Mutant Tubulins Confer Resistance to Pathological Tau

STUDY_SECTION: NSS

STUDY_SECTION_NAME: NSS


FUNDING_MECHANISM: OTHERS

NIH_SPENDING_CATS: Aging;Cancer;Cancer Genomics;Colorectal Cancer;Digestive Diseases;Genetics;Human Genome;Microbiome;Prevention;Social Determinants of Health

ORG_CITY: TRENTO

ORG_COUNTRY: ITALY

ORG_FIPS: IT

ORG_NAME: UNIVERSITY OF TRENTO

PI_NAMEs: SEGATA, NICOLA  (contact)

PROGRAM_OFFICER_NAME: UMAR, ASAD

PROJECT_TERMS: Address;adenoma;Adenomatous Polyps;Age;Animal Model;anti-cancer research;Biological;Biological Factors;Biological Models;biological specimen archives;Birth;Blood;cancer initiation;Cells;Characteristics;cohort;Collaborations;Colorectal Cancer;colorectal cancer risk;Colorectal Neoplasms;Computational Biology;Data;data harmonization;Development;Dimensions;Discipline;early onset;early onset colorectal cancer;Ecosystem;Electronic Health Record;Environmental Risk Factor;Epidemiologic Factors;Epidemiology;Ethnic Origin;Etiology;Feces;Future;Generations;Genomics;Geography;Goals;high risk;Homeostasis;Immunology;Incidence;Individual;innovation;Lesion;Life Cycle Stages;life span;Life Style;lifestyle intervention;Link;Malignant Neoplasms;Mediating;Metagenomics;microbial signature;microbiome;microbiome research;Mind;Modeling;novel;Pathway interactions;pharmacologic;Population;Positioning Attribute;prevent;Prevention;Process;Prospective Studies;Questionnaires;Race;Research;Resolution;Risk;Risk Assessment;Risk Factors;small molecule;social determinants;stem cell biology;Technology;Tissues;Translating;Vision;Work

PROJECT_TITLE: PROSPECT - Microbiome Studies. (PATHWAYS, RISK FACTORS, AND MOLECULES TO PREVENT EARLY-ONSET COLORECTAL TUMOURS)


ADMINISTERING_IC: EB

ED_INST_TYPE: BIOMED ENGR/COL ENGR/ENGR STA

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Bioengineering;Nanotechnology;Obesity

ORG_CITY: CHAMPAIGN

ORG_DEPT: ENGINEERING (ALL TYPES)

ORG_NAME: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN

PHR: NARRATIVE Classification of cells within human tissues is essential for understanding states of health and disease. In this proposal, we will develop a new class of fluorescent label that increases the number of molecular classification markers for cells by an order of magnitude. These labels function within intact, three-dimensional tissue, an attribute that we will use to map the local environments of adipose tissue immune cells that are thought to determine comorbid outcomes of obesity.

PI_NAMEs: SMITH, ANDREW MICHAEL (contact)

PROGRAM_OFFICER_NAME: ATANASIJEVIC, TATJANA

PROJECT_TERMS: 3-Dimensional;Address;Adipose tissue;Animal Model;Applications Grants;Binding;Biological;Biological Sciences;Biomedical Engineering;biomedical imaging;Biophysics;Categories;cell dimension;cell type;Cells;Cellular Immunology;Characteristics;Chemicals;Classification;Code;Color;comorbidity;Computer software;Cytometry;Cytoplasm;deep learning algorithm;design;Dimensions;Disease;Disparity;Dyes;Electronics;Engineering;Environment;Exhibits;Flow Cytometry;Fluorescence;fluorescence imaging;Fluorescent Probes;fluorophore;Goals;Health;Heart Diseases;high dimensionality;human tissue;Image;Immune;Immunoglobulin Fragments;Immunophenotyping;improved;In Situ;Individual;insight;Label;Light;Location;Maps;Measurement;Measures;Membrane;Methods;Microscope;Microscopy;Molecular;molecular marker;Molecular Probes;nanocrystal;Nature;Non-Insulin-Dependent Diabetes Mellitus;Nucleic Acids;Obesity;optical imaging;Optics;Outcome;Pattern;Property;Proteins;Proteomics;Quantum Dots;Research Personnel;Research Project Grants;Resolution;Rodent Model;Scientist;Semiconductors;Signal Transduction;Specificity;Stains;Technology;technology platform;Testing;Thick;Thinness;Time;Tissue imaging;Tissues;tool;tumor-immune system interactions;Validation;Work

PROJECT_TITLE: Hyperplexed Quantum Dots for Multidimensional Cell Classification in Intact Tissue

STUDY_SECTION: EBIT

STUDY_SECTION_NAME: Enabling Bioanalytical and Imaging Technologies Study Section[EBIT]


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Immunotherapy;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_CITY: AMSTERDAM

ORG_COUNTRY: NETHERLANDS

ORG_FIPS: NL

ORG_NAME: NETHERLANDS CANCER INSTITUTE

PI_NAMEs: SCHUMACHER, TON  (contact)

PROGRAM_OFFICER_NAME: HOWCROFT, THOMAS K

PROJECT_TERMS: Address;algorithm development;algorithm training;Algorithms;Antigen Presentation;Antigen Targeting;Antigens;Binding;Biochemical;Biological;cancer therapy;cancer type;Clinical;Collection;combinatorial;Complex;Computer Models;Computing Methodologies;cytotoxicity;Data;Data Set;design;Development;Engineering;Epitopes;Event;extend lifespan;Face;Feedback;Generations;Genetic Screening;Goals;Grant;Human;immune checkpoint blockade;Immune response;Immune system;Immunity;Immunodominant Antigens;Immunology;Immunotherapy;improved;insight;Institution;interest;large scale data;Libraries;Machine Learning;Malignant neoplasm of lung;Malignant Neoplasms;Maps;Melanoma;method development;Methods;Modeling;Molecular;mouse model;neoantigens;next generation;novel;novel drug class;pathogen;Patients;Peptide/MHC Complex;Peptides;personalized medicine;Pharmaceutical Preparations;Phase;prediction algorithm;Productivity;Proxy;quantum;Receptor Signaling;Research Personnel;Resolution;response;Sampling;Source;Specificity;structural biology;Structure;System;T cell response;T cell therapy;T-Cell Antigen Receptor Specificity;T-Cell Receptor;T-cell receptor repertoire;T-Cell Receptor Therapy;T-Lymphocyte;Technology;Testing;Therapeutic;therapy design;Toxic effect;Training;training data;tumor;Tumor Antigens;Uncertainty;Validation;Variant;Virus;Vision;Work

PROJECT_TITLE: MATCHMAKERS


ADMINISTERING_IC: EY

ED_INST_TYPE: SCHOOLS OF PHARMACY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Aging;Eye Disease and Disorders of Vision;Neurodegenerative;Neurosciences

ORG_CITY: FORT WORTH

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF NORTH TEXAS HLTH SCI CTR

PHR: Project Narrative (Parent Award) Age-related neurodegenerative diseases like glaucoma have no cure and are a significant public health burden. Our research has shown that glaucoma is associated with loss of cellular energy that is amenable to metabolism-based intervention. Findings from this study will inform the development of novel therapeutics that manipulate cellular metabolism to prevent or slow the progression of glaucoma.

PI_NAMEs: INMAN, DENISE M (contact)

PROGRAM_OFFICER_NAME: SONG, HONGMAN

PROJECT_TERMS: Acceleration;age related neurodegeneration;Animals;Astrocytes;axonal degeneration;Biochemical;Bioenergetics;Cell Physiology;Cell Survival;cell type;Cells;Chronic;Complex;conditional knockout;Coupling;Data;Dependence;design;Detection;Development;Disease;Elements;Equilibrium;Etiology;functional decline;Functional disorder;Gene Expression;Gene Expression Regulation;gene repression;Genes;Glaucoma;Glycolysis;Goals;high intraocular pressure;Homeostasis;Human;human tissue;Hypoxia;in vivo;Incidence;Injury;innovation;insight;Intervention;Investigation;Knockout Mice;Maintenance;Mediating;Metabolic;Metabolic dysfunction;metabolic profile;Metabolism;metabolomics;Mitochondria;mitochondrial dysfunction;Modeling;mouse model;Muller's cell;Nerve Degeneration;neural;Neuroglia;Neurons;new therapeutic target;novel therapeutics;Ocular Hypertension;Optic Disk;Optic Nerve;Oxidative Phosphorylation;Oxygen;parent project;Pathology;Perfusion;Physiologic Intraocular Pressure;Physiological;Positioning Attribute;prevent;protein expression;Public Health;Recycling;Regulation;Research;resilience;Retina;retinal ganglion cell degeneration;Retinal Ganglion Cells;Stress;stressor;Testing;Therapeutic Intervention;transcriptomics;Up-Regulation;Vision;Work

PROJECT_TITLE: Metabolic Vulnerability as a Diseased Target for Glaucoma


ED_INST_TYPE: SCHOOLS OF MEDICINE

NIH_SPENDING_CATS: Behavioral and Social Science;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Lung;Lung Cancer;Prevention;Racial and Ethnic Minority Health Research;Rural Health;Social Determinants of Health

ORG_CITY: CHARLESTON

ORG_NAME: MEDICAL UNIVERSITY OF SOUTH CAROLINA

ORG_STATE: SC

PHR: HOLLINGS CANCER CENTER: OVERALL PROJECT NARRATIVE The Hollings Cancer Center at the Medical University of South Carolina coordinates scientific research to promote interdisciplinary collaborations and translation of cancer research from the bench to the bedside to the community. Through the funding of the P30 Cancer Center Support Grant, the center provides research resources in support of its scientists, and impactful engagement with its catchment area with the goal of reducing the cancer burden for the 5.2 million residents of South Carolina.

PI_NAMEs: DUBOIS, RAYMOND N. (contact)

PROGRAM_OFFICER_NAME: ROBERSON, SONYA

PROJECT_TERMS: Acceleration;Achievement;Address;Affect;African American;African American population;anti-cancer research;Automobile Driving;Awareness;Basic Science;bench to bedside;Black race;Cancer Biology;Cancer Burden;Cancer Cachexia;cancer care;Cancer Center;Cancer Center Support Grant;Cancer Control;cancer education;cancer health disparity;cancer prevention;CAR T cell therapy;career;career development;Caring;Catchment Area;Cause of Death;Cervical;Characteristics;Childhood;Classification;Clinic;Clinical Data;Clinical Protocols;Clinical Sciences;Clinical Trials;Collaborations;college;Colorectal;Communities;community based research;community engagement;Community Outreach;data management;Death Rate;Development;Diagnosis;Diagnostic;Disease;Doctor of Philosophy;Education;Ensure;equity, diversity, and inclusion;ethnic minority;Evaluation;Extramural Activities;Fostering;Funding;Future;Genetic;Geography;Goals;Grant;Grant Review;Head and neck structure;health disparity;high school;innovation;Institution;inter-institutional;interdisciplinary collaboration;Interdisciplinary Study;Intervention Studies;Investments;Journals;Kidney;Leadership;life span;Lung;Malignant Breast Neoplasm;Malignant neoplasm of pancreas;Malignant Neoplasms;Medical;member;Mission;Monitor;Morbidity - disease rate;mortality;National Cancer Institute;next generation;novel strategies;Obesity;Outcome;outreach;Participant;Patients;Peer Review;Persons;Physicians;Policies;Population;Population Heterogeneity;Population Sciences;Poverty;prevent;Preventive;Productivity;Professional Education;programs;Prostate;Protocols documentation;Public Policy;Publications;Qualifying;racial disparity;racial minority;recruit;Research;Research Infrastructure;Research Personnel;Resource Sharing;Resources;Role;Rural;Rural Community;Science;Scientist;Screening for cancer;Services;Shapes;Smoking;socioeconomics;South Carolina;Strategic Planning;Technology;Therapeutic;Therapeutic Clinical Trial;Thinking;tobacco control;Training;Training and Education;Translating;translational cancer research;translational pipeline;Translations;tumor immunology;Underrepresented Minority;Universities;US State;Vocation

PROJECT_TITLE: Medical University of South Carolina - Cancer Center Support Grant

STUDY_SECTION: NCI

STUDY_SECTION_NAME: Cancer Centers Study Section (A)[NCI-A]


NIH_SPENDING_CATS: Cancer;Childhood Leukemia;Clinical Research;Clinical Trials and Supportive Activities;Hematology;Pediatric;Pediatric Cancer;Prevention;Rare Diseases

ORG_CITY: MEMPHIS

ORG_NAME: ST. JUDE CHILDREN'S RESEARCH HOSPITAL

ORG_STATE: TN

PHR: PROJECT NARRATIVE The five multidisciplinary research Programs and nine Shared Resources in the SJCCC work together to find cures for pediatric cancer, while minimizing the long-term side effects of treatment. With strong institutional and philanthropic support, for 56 years we have served as a national and international resource for health care providers, children with cancer, and their families.

PI_NAMEs: ROBERTS, CHARLES  (contact)

PROJECT_TERMS: Acceleration;Address;aged;American;anti-cancer research;Area;Automobile Driving;Basic Cancer Research;Basic Science;biomedical referral center;Brain Neoplasms;Budgets;Cancer Biology;Cancer Center;Cancer Center Support Grant;Cancer Control;Cancer Patient;cancer prevention;Cancer Survivor;Cancer Survivorship;care providers;Caring;Catchment Area;Cessation of life;Charities;Child;childhood cancer survivor;Childhood Cancer Treatment;Classification;Clinical;Clinical Research;clinical trial enrollment;Collaborations;Communities;Comprehensive Cancer Center;Country;curative treatments;data centers;Dedications;design;Development;Developmental Biology;Direct Costs;Disease;Education;Enrollment;experience;Extramural Activities;Faculty;Family;Fostering;Funding;Genomics;Goals;graduate school;Growth;Guidelines;Health Resources;Heart;Hematologic Neoplasms;Housing;improved;improved outcome;Infrastructure;innovation;Inpatients;Institution;inter-institutional;Interdisciplinary Study;International;Intervention Studies;Investigation;investigator-initiated trial;Investments;Journals;Laboratories;Laboratory Research;Location;Longterm Follow-up;Malignant Childhood Neoplasm;Malignant Neoplasms;Manuscripts;member;Mission;National Cancer Institute;NCI Center for Cancer Research;Neurobiology;next generation;novel;novel therapeutic intervention;Outcomes Research;Outpatients;outreach;Paper;Pediatric Hematology;Pediatric Oncology;pediatrician;Peer Review;precision medicine;programs;Protocols documentation;Publications;Publishing;Quality of life;recruit;Research;Research Infrastructure;Research Personnel;Resource Sharing;Resources;Saint Jude Children's Research Hospital;Science;side effect;Site;Solid Neoplasm;Strategic Planning;student training;Survivors;survivorship;Therapeutic;Therapeutic Clinical Trial;Translating;translational goal;translational pipeline;Translational Research;Translations;Treatment Side Effects;United States National Institutes of Health;Work;World Health Organization;young adult

PROJECT_TITLE: Cancer Center Support Grant (CCSG)


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Biotechnology;Clinical Research;Digestive Diseases;Gene Therapy;Genetics;Infant Mortality;Liver Disease;Organ Transplantation;Orphan Drug;Pediatric;Precision Medicine;Rare Diseases;Transplantation

ORG_CITY: PHILADELPHIA

ORG_NAME: CHILDREN'S HOSP OF PHILADELPHIA

ORG_STATE: PA

PHR: PROJECT NARRATIVE Inherited disorders of metabolism, including phenylketonuria (PKU), urea cycle disorders (UCDs), and organic acidemias (OAs), often cause debilitating and even life-threatening medical problems as early as birth. We seek to establish an unprecedented platform to efficiently create personalized gene-editing therapies for patients with these diseases, using a CRISPR technology called prime editing to directly and permanently correct each patient’s disease-causing gene variant in the liver. This “one-and-done” treatment strategy could substantially improve the long-term health and survival of these patients who currently have severely limited treatment options.

PI_NAMEs: AHRENS-NICKLAS, REBECCA CLARE (contact);MUSUNURU, KIRAN

PROGRAM_OFFICER_NAME: BROOKS, PJ

PROJECT_TERMS: Acceleration;Accounting;Address;adenovirus mediated delivery;Adult;Affect;Ammonia;autosome;Biochemical Pathway;biomedical referral center;Birth;Brain;Catabolism;Citrullinemia;Clinical;Clinical Trials;cohort;Communities;community engaged research;CRISPR/Cas technology;Dependovirus;Development;Disease;Dose;Drug Kinetics;Enrollment;Enzymes;Ethics;experience;Genes;genetic variant;Guide RNA;Health;Hepatic;Hereditary Disease;Impairment;improved;improved outcome;in vivo;Inborn Errors of Metabolism;Individual;innovation;Institution;Intervention;Interview;Lead;Life;Liver;liver transplantation;Mediating;Medical;meetings;Metabolic;Metabolic Control;Metabolic Diseases;Morbidity - disease rate;mortality;Mus;Mutation;Neonatal;Neonatal Screening;neonate;Nervous System Trauma;neurotoxic;nonhuman primate;Organ;organic acid;Outcome;Pathogenesis;Pathogenicity;Patients;personalized approach;personalized medicine;pharmacologic;Pharmacology and Toxicology;Phenotype;Phenylalanine;Phenylalanine Hydroxylase;Phenylketonurias;Play;post-transplant;pre-Investigational New Drug meeting;preclinical study;prime editing;prime editor;programs;Protocols documentation;Risk;RNA Sequences;Role;Safety;Scientist;Series;System;Target Populations;Therapeutic;therapeutic genome editing;therapy development;Time;Transplantation;treatment strategy;uptake;Urea cycle disorders;Variant

PROJECT_TITLE: Personalized prime editing as a platform for hepatic inborn errors of metabolism

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MGG-S (70)]


NIH_SPENDING_CATS: Brain Disorders;Down Syndrome;Intellectual and Developmental Disabilities (IDD);Lung;Pediatric

ORG_CITY: TORRANCE

ORG_NAME: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER

PHR: Project Narrative Down syndrome (DS) is the most prevalent chromosomal abnormality worldwide, with an incidence of approximately 1 in 700 live births. Our preliminary studies suggest that increased type I IFN signaling, which is known to play a critical role in cell differentiation, proliferation, as well as extracellular matrix (ECM) production, in DS lungs may cause impaired fetal lung development, resulting in dilated airways and aberrant ECM expression. In this proposal we use human fetal lung cultures to define how increased IFN signaling in the developing DS lung leads to compromised lung development, which may ultimately provide a foundation for potentially new therapies that target the type I IFN pathway for compromised lungs in DS individuals.

PI_NAMEs: DANOPOULOS, SOULA ATHANASIA  (contact)

PROGRAM_OFFICER_NAME: SOOD, BEENA G

PROJECT_TERMS: Adult;Affect;airway muscle;Apoptosis;Arteries;Body System;Cell Differentiation process;Cell Proliferation;Cells;Childhood;Chromosome 21;Chromosome abnormality;Coculture Techniques;Congenital Abnormality;Data;Defect;Deglutition Disorders;Development;Dilatation - action;Disease;Down's Syndrome;Epithelium;Event;Exhibits;Extracellular Matrix;Fetal Development;Fetal Lung;Fibronectins;Foundations;gain of function;gene regulatory network;Genes;Genetic;Goals;Growth;Heart Diseases;Human;IFNAR1 gene;IFNAR2 gene;impaired driving performance;Impairment;improved;in utero;Incidence;Individual;innovation;insight;Interferon Receptor;Interferon Type I;Interferons;Intervention;Live Birth;loss of function;Lung;lung development;Lung Diseases;Lymphatic;Mesenchymal;Mesenchyme;Methods;Modeling;Molecular;Molecular Abnormality;Morbidity - disease rate;Morphology;mortality;Muscle;Muscle Tonus;new therapeutic target;Newborn Infant;novel;Organoids;Pathogenesis;Pathway interactions;Physiological;Play;Pregnancy;prenatal;prevent;Production;Proliferating;Proteins;Publishing;Regulatory Pathway;Reporting;Role;Signal Transduction;single cell sequencing;single-cell RNA sequencing;Structure;Testing;Three-Dimensional Imaging;translational potential;type I interferon receptor;Work

PROJECT_TITLE: Type I IFN signaling during lung development in Down Syndrome

STUDY_SECTION: LIRR

STUDY_SECTION_NAME: Lung Injury, Repair, and Remodeling Study Section[LIRR]


ADMINISTERING_IC: OD

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Data Science

ORG_CITY: CAMBRIDGE

ORG_DEPT: SOCIAL SCIENCES

ORG_NAME: HARVARD UNIVERSITY

PI_NAMEs: KING, GARY  (contact)

PROJECT_TERMS: Adopted;Architecture;Awareness;collaborative approach;Data;Data Commons;data ecosystem;data management;data resource;data reuse;Data Science;data sharing;data submission;Ecosystem;FAIR principles;Funding;generalist repository;Infrastructure;Mission;Modernization;Reporting;repository;Research Personnel;Services;social;Strategic Planning;Training;United States National Institutes of Health;Vision;Work

PROJECT_TITLE: The Harvard Dataverse repository: A generalist repository integrated with a Data Commons


ORG_CITY: CHAPEL HILL

ORG_DEPT: GENETICS

ORG_NAME: UNIV OF NORTH CAROLINA CHAPEL HILL

PHR: NARRATIVE Genetic exchange between homologous chromosomes is essential to ensure that they segregate accurately in meiosis, the specialized cell division that gives rise to eggs and sperm. Errors in recombination can lead to an incorrect number of chromosomes, which is the most common cause of birth defects and miscarriage. However, the same type of exchange in other cells can lead to cancer. This proposal seeks to understand how exchange is promoted in cells undergoing meiosis but avoided in other tissues, in terms of both regulation and molecular mechanisms of recombination processes.

PI_NAMEs: SEKELSKY, JEFF J. (contact)

PROGRAM_OFFICER_NAME: MACARTHUR, LINDA

PROJECT_TERMS: Aneuploidy;Biochemistry;Biology;career;Cell division;Cell Proliferation;Cells;Cellular biology;Chromosome Segregation;Chromosomes;Congenital Abnormality;CRISPR gene drive;Dangerousness;Defect;design;DNA Damage;DNA Double Strand Break;Double Strand Break Repair;Drosophila genus;egg;experimental study;gene drive system;Genetic;Genetic Crossing Over;Genetic Recombination;Genomic Instability;Genomics;Germ Cells;Investigation;Laboratories;Malignant Neoplasms;mathematical model;Meiosis;Meiotic Recombination;Mitotic;Mitotic Recombination;model organism;Molecular;Outcome;Pattern;Pregnancy loss;Process;Regulation;repaired;Research;Scientist;segregation;sperm cell;Spontaneous abortion;Sterility;Time;Tissues;Training;Trisomy;tumorigenesis

PROJECT_TITLE: Mechanisms of meiotic and mitotic recombination

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-CB-K(55)R]


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Autism;Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Building Research Capacity at Institutions with Limited NIH Funding;Clinical Research;Disability Research;Intellectual and Developmental Disabilities (IDD);Mental Health;Neurosciences;Pediatric

ORG_CITY: OXFORD

ORG_DEPT: OTHER HEALTH PROFESSIONS

ORG_NAME: MIAMI UNIVERSITY OXFORD

PHR: PROJECT NARRATIVE One in 44 American children is diagnosed with autism spectrum disorder (ASD), a condition which entails significant challenges with language and social communication. This project aims to understand if: (a) Deaf parents of autistic children differ from hearing parents of autistic children in their attention-regulating behaviors during interactions with their children, and (b) such differences in parent behavior result in more episodes of joint attention with their autistic children, leading to more favorable conditions for language development.

PI_NAMEs: SHIELD, AARON M. (contact)

PROGRAM_OFFICER_NAME: STORKEL, HOLLY LYNN

PROJECT_TERMS: American;Attention;autism spectrum disorder;autistic children;Behavior;Caregivers;Child;Child Rearing;Childhood;Code;Cognitive;cognitive development;Communication;comorbidity;comparative efficacy;Data;deaf;design;Development;Diagnosis;dyadic interaction;Educational Intervention;Educational process of instructing;Effectiveness;Environment;Equipment and supply inventories;Exhibits;Eye;Future;gaze;Hearing;Hearing problem;Impairment;Intervention;joint attention;Language;Language Development;language impairment;Link;Methods;Modality;Parent-Child Relations;parenting intervention;Parents;Protocols documentation;Regulation;Research;Sampling;skills;social;social communication;Social Development;Social Interaction;Structure;Techniques;Time;Visual;Visual attention;Work

PROJECT_TITLE: Attention Regulation Strategies Used by Deaf and Hearing Parents of Autistic Children

STUDY_SECTION: CPDD

STUDY_SECTION_NAME: Child Psychopathology and Developmental Disabilities Study Section[CPDD]