NIH_SPENDING_CATS: Acute Respiratory Distress Syndrome;Bioengineering;Lung;Rare Diseases

ORG_CITY: SAN FRANCISCO

ORG_NAME: LIBERANDUM TECHNOLOGIES, INC.

PHR: Many respiratory diseases and traumas result in Acute Respiratory Distress Syndrome (ARDS), and patients must use a ventilator. Conventional ventilators force oxygen into the lung and, while this can be life-saving, the process is also damaging to the lung. We are developing a new ventilator, VENTSAFETM, that creates two-way airflow so that the lungs aren’t overextended; our system is designed to reduce damage and lower the need for sedation, making ventilation safer for ARDS patients.

PI_NAMEs: BARKER, DEAN ANTONY (contact);DEGMETICH, SEAN

PROGRAM_OFFICER_NAME: SHENOY, SIDDHARTH KAUP

PROJECT_TERMS: Acute Respiratory Distress Syndrome;Adult;Air Movements;Alveolar;Blood Gas Analysis;Carbon Dioxide;Cessation of life;Clinic;Computer Analysis;Computer software;conventional therapy;Data;design;Devices;Dysbarism;endotracheal;Frequencies;Gases;Geometry;Goals;high risk;High-Frequency Ventilation;Histology;improved;Life;Liquid substance;Lung;lung injury;Marketing;Methods;Michigan;Modeling;Morbidity - disease rate;mortality;Oleic Acids;Oxygen;pandemic disease;Paralysed;Patients;Pattern;Phase;Physics;Population;porcine model;pre-clinical;pressure;prevent;Process;prototype;rational design;respiratory;Respiratory Disease;Respiratory Failure;Risk;Sedation procedure;Small Business Innovation Research Grant;Structure of parenchyma of lung;symposium;System;Technology;Testing;Time;time interval;Translating;Trauma;Tube;ventilation;Ventilator;Ventilator-induced lung injury;Volutrauma

PROJECT_TITLE: VENTSAFE™ Life Saving Ventilation for the Treatment of ARDS


ADMINISTERING_IC: AG

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Autoimmune Disease;Digestive Diseases;Immunotherapy;Inflammatory Bowel Disease

ORG_CITY: HOUSTON

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: BIOPROVAR CORPORATION

ORG_STATE: TX

PHR: Project Narrative  One million Americans live with Ulcerative Colitis (UC), a debilitating disease presently not medically curable. More than a quarter of UC patients are aged, and prevalence in the over 65 is increasing at an annual rate of 2.8%. UC is an immune-mediated colon disorder driven by an excess inflammation from an overactivated primary-immune response. We have identified BioTremvarTM, a natural blood constituent regulating the primary immune response that has shown solid efficacy in inhibiting deadly excess inflammation in another disease with a deregulation of the primary immune response. We aim to evaluate its therapeutic effectiveness in treating UC. BioTremvarTM therapy is anticipated to alleviate UC excess inflammation and symptoms, allowing recovery to clinical-free symptoms for thousands of afflicted people.

PI_NAMEs: ROUSSEL, EUGENE  (contact)

PROGRAM_OFFICER_NAME: FOX, JENNIFER THERESA

PROJECT_TERMS: Acute;Affect;age-related disease;aged;American;Animal Model;Animals;Anti-Tumor Necrosis Factor Therapy;Antibodies;Binding;Biological;Biological Response Modifier Therapy;Blood;Blood Platelets;Businesses;Cell surface;Cells;Chronic;Clinical;Colitis;Colonic Diseases;commercialization;comparative;Complex;Conduct Clinical Trials;cost;Crohn's disease;Custom;cytokine;Data;dextran sulfate sodium induced colitis;Diagnosis;Digestive System Disorders;Disease;Elderly;experimental study;Funding;gut inflammation;gut microbiota;healing;Human;Hyperactivity;Immune;Immune response;Immunity;Immunologic Memory;Immunotherapy;Infiltration;Inflammation;Inflammation Mediators;Inflammatory;inhibitor;Injections;innovation;Interleukin-12;interleukin-23;Intestines;Intravenous;Ligands;Lymphocyte;Macrophage;male;Measurement;Mediating;Molecular;Monoclonal Antibodies;mouse model;Mus;Myeloid Cell Activation;Myeloid Cells;Natural Immunity;neutralizing monoclonal antibodies;neutrophil;novel therapeutic intervention;old mice;Operative Surgical Procedures;Pathogenesis;Pathway interactions;Patients;Persons;Pharmacology;Phase;Population;pre-clinical;Prevalence;Process;Production;receptor;Receptor Activation;Recombinants;Recovery;Recurrence;Regimen;Regulation;Research;Research Priority;response;RNA Splicing;Role;Safety;Sepsis;Small Business Innovation Research Grant;Sodium Dextran Sulfate;Solid;subcutaneous;success;Symptoms;System;targeted treatment;Testing;Therapeutic;Therapeutic Effect;therapeutic effectiveness;Time;tissue injury;Tissues;TNF gene;Treatment Efficacy;Ulcerative Colitis;United States;Variant;Women's cohort

PROJECT_TITLE: An Innovative Immune Therapy Targeting the TREM1-Inflammation Pathway to Alleviate Excess Inflammation in Ulcerative Colitis of Geriatric Patients

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (10)]


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

ORG_NAME: PUPIL BIO, INC.

PHR: PROJECT NARRATIVE There are currently no biomarkers for the early, highly specific detection of β cell death during the pathogenesis of Type 1 Diabetes (T1D). Islet autoantibodies, the only available T1D biomarkers, can only predict disease risk with limited specificity, and cannot inform on the rate of β cell loss. The goal of this proposal is to build a diagnostic test for the early detection of T1D with high specificity and sensitivity, via the NGS-based identification of hundreds (up to 1,000) of methylation markers in cell-free DNA (cfDNA) that are ultra-specific to β cells.

PI_NAMEs: PINTO, ALESSANDRO  (contact)

PROGRAM_OFFICER_NAME: ARREAZA-RUBIN, GUILLERMO

PROJECT_TERMS: Address;advanced disease;Affect;Algorithm Design;Algorithms;American;Autoantibodies;Beta Cell;Biological Assay;Biological Markers;biomarker identification;Blood;Blood Volume;candidate identification;candidate marker;candidate selection;Cell Death;cell free DNA;cell type;Cells;Cessation of life;Chemistry;chronic autoimmune disease;Clinical Sensitivity;Collaborations;commercialization;Custom;Data;design;Detection;detection limit;detection test;Development;Diagnosis;Diagnostic tests;diagnostic tool;dimer;Disease;disorder risk;DNA;DNA methylation profiling;early detection biomarkers;Early Diagnosis;Early Intervention;Genes;Genomic DNA;Genomic Islands;Goals;Hybrids;Hyperglycemia;Immune system;Injury;Insulin;insulin dependent diabetes mellitus onset;Insulin-Dependent Diabetes Mellitus;islet;islet cell antibody;Islets of Langerhans;Laboratories;methylation biomarker;methylation pattern;next generation sequencing;novel;Output;Pathogenesis;Pathogenicity;Patients;Pattern;Performance;Phase;Plasma Cells;Process;Production;Pupil;Reaction;Sampling;Sensitivity and Specificity;Small Business Innovation Research Grant;Specific qualifier value;Specificity;Symptoms;Technology;Testing;Therapeutic immunosuppression;Tissues;Validation;validation studies

PROJECT_TITLE: Development of an early detection test for Type 1 Diabetes via NGS-based analysis of β cells-specific methylation patterns in cfDNA

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 EMS-S (10)]


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

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

ORG_CITY: San Diego

ORG_NAME: QUANTITATIVE BIOSCIENCES, INC.

ORG_STATE: CA

PHR: Developing effective and safe therapeutics is critical to our quality of life, and novel approaches are needed to improve the speed and accuracy of detection biological contamination and other quality control parameters. Edge DNA and RNA sequence computational capability will provide point-of-production and point-of-care support for analysis of biological contamination that will be essential for effective mon- itoring and gating of biological contaminants in water and therapeutic supplies. The main objective of this SBIR is to create a neural network-accelerated DNA and RNA sequence processing node suitable for ﬁeld, clinical, and industrial use, making it of great utility to monitoring efforts aimed at tracking and assessing potential hazardous exposures, as well as highly marketable to a wide range of end-users. 1

PI_NAMEs: MATHER, WILLIAM  (contact)

PROGRAM_OFFICER_NAME: YU, GUOQIN

PROJECT_TERMS: Acceleration;base;Base Sequence;Biological;biopharmaceutical industry;Clinical;cluster computing;Communication;computational platform;computerized data processing;Computers;Consensus Sequence;cost;cost effective;data format;Detection;Development;Diagnostic;DNA Sequence;DNA sequencing;Emerging Technologies;Future;Generations;improved;Industrialization;innovation;Libraries;manufacture;Maps;Methods;Modernization;Monitor;Monoclonal Antibodies;Mutation;nanobodies;nanopore;neural network;next generation sequence data;novel strategies;Nucleic Acids;Output;outreach;Pharmacologic Substance;point of care;Process;Production;Proteins;Quality Control;Quality of life;Resources;RNA Sequence Analysis;RNA Sequences;Sampling;sensor;sensor technology;Sequence Analysis;Services;Site;Small Business Innovation Research Grant;Specific qualifier value;Speed;Swelling;Techniques;Technology;Therapeutic;Time;tool;transcriptome sequencing;Viral;Water;Work

PROJECT_TITLE: CLEdgeSeq: Advanced sequence analysis and communication for edge applications

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-B (14)]


ADMINISTERING_IC: AI

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Antimicrobial Resistance;Clinical Research;Genetics;HIV/AIDS;Human Genome;Infectious Diseases;Patient Safety;Pediatric;Pediatric - AIDS;Precision Medicine

ORG_CITY: ACCRA

ORG_COUNTRY: GHANA

ORG_FIPS: GH

ORG_NAME: UNIVERSITY OF GHANA MEDICAL CENTRE

PHR: PROJECT NARRATIVE Majority of persons living with HIV are prescribed with fixed dosage formulations of dolutegravir (DTG)-based antiretroviral globally irrespective of predictors of therapeutic outcomes and undesirable effects such as drug resistance mutations, adverse drug events and virologic failure. Young people living with HIV (10-24 years) in Ghana are prescribed with DTG/3TC/TDF fixed dosage formulations with no assuring data from studies involving this age group. This study proposes to work to provide data on drug resistance mutations, pharmacogenetic variations and pharmacokinetic profiles that can affect the disposition and exposure of DTG/3TC/TDF in young people living with HIV in Ghana which can support dosage appropriate formulations for this age group.

PI_NAMEs: THOMFORD, NICHOLAS EKOW (contact)

PROGRAM_OFFICER_NAME: CHIOU, CHEN-CHIA CHRISTINE C

PROJECT_TERMS: Adherence;Adolescent and Young Adult;Adopted;Adult;Adverse drug event;Adverse event;Affect;Africa;Africa South of the Sahara;age group;aged;Anti-Retroviral Agents;antiretroviral therapy;artemether;benflumetol;biobank;Biological Assay;Blood;Blood specimen;CCL21 gene;CD4 Lymphocyte Count;Characteristics;Child;Clinic;Clinical;cohort;Combined Modality Therapy;Country;Cytochrome P450;Data;Databases;dosage;Drug Interactions;Drug Kinetics;drug metabolism;Drug resistance;Dryness;Effectiveness;Enzymes;experience;Failure;Formulation;Funding;Genes;Genetic;genome database;Genotype;Ghana;Health;HIV;HIV drug resistance;HIV Genome;Hyperglycemia;Immunologics;improved;individual variation;Kidney;Lamivudine;Liver;mathematical model;Measurement;medication compliance;metabolic profile;Metabolism;Mood Disorders;Mutation;Neural Tube Defects;novel therapeutics;Obesity;Outcome;Participant;Patients;Peptide Hydrolases;Personal Satisfaction;Persons;Pharmaceutical Preparations;pharmacogenetic variants;Pharmacogenomics;pharmacokinetic characteristic;Phase;Plasma;Population;Recommendation;recruit;Regimen;Reporting;Resistance;Resistance development;resistance mutation;Resources;Restriction fragment length polymorphism;Risk;RNA-Directed DNA Polymerase;Sampling;side effect;Spottings;Statistical Models;Techniques;Testing;therapy outcome;Time;Treatment Failure;Treatment Protocols;Universities;Variant;Vertebral column;Viral;Viral Load result;viral resistance;Work;World Health Organization;Zidovudine

PROJECT_TITLE: PHARMACOKINETICS AND PHARMACOGENOMICS OF DOLUTEGRAVIR-BASED ANTIRETROVIRAL THERAPY IN YOUNG PEOPLE LIVING WITH HIV IN GHANA (PHARMA-YOUNG-HIV)

STUDY_SECTION: HCCS

STUDY_SECTION_NAME: HIV Comorbidities and Clinical Studies Study Section[HCCS]


ORG_CITY: Mansfield

ORG_NAME: ACCELERATED MUSCLE BIOTECHNOLOGIES CONSULTANTS, L.L.C.

ORG_STATE: MA

PHR: Project Narrative Small-angle X-ray diffraction is a specialized tool that allows for the most direct study of muscle motor proteins in living, functioning cells. However, the research tools used to wield this technology are not yet refined and so do not meet its potential to study diseases or potential treatment strategies. The research conducted in this project will improve this technique and expand access to more research scientists, accelerating the study of muscle in basic science, clinical science, and drug discovery industries.

PI_NAMEs: HARRIS, SAMANTHA P;HESSEL, ANTHONY LAWRENCE CAPOZZI;NGUYEN, KHOI DAC (contact)

PROGRAM_OFFICER_NAME: GERSHENSON, ANNE

PROJECT_TERMS: Academia;academic standard;Acceleration;Actomyosin;Address;Adoption;Apple;Area;Arizona;Back;base;Basic Science;beamline;Benchmarking;Binding Proteins;Biological;Biological Sciences;Biomedical Research;Biopsy;Biotechnology;bone imaging;Businesses;Cardiac;career;Cell Physiology;Chicago;Clinical;clinical application;Clinical Research;Clinical Sciences;Collaborations;connectin;Data;data quality;data standards;Development;Disease;drug candidate;drug development;drug discovery;Ensure;experience;experimental study;FDA approved;flexibility;Foundations;Funding;Future;Goals;Grant;Healthcare;Hospitals;Housing;Hypertrophic Cardiomyopathy;Image;Improve Access;improved;Industry;industry partner;Infrastructure;innovation;Lead;Letters;Light;Long Island;Measures;Mechanics;Methods;Molecular;molecular scale;Motor;Muscle;muscle physiology;Musculoskeletal Diseases;Myocardial;Myocardium;Myopathy;Myosin ATPase;myosin-binding protein C;Nerve Tissue;operation;Pain;Pharmaceutical Preparations;Phase;Photons;Physiological;Proteins;Protocols documentation;Publications;Renal Tissue;Reproducibility;Research;research clinical testing;Research Personnel;Reservations;Roentgen Rays;Sampling;Science;Scientist;Services;Site;Skeletal Muscle;Source;Standardization;success;synchrotron radiation;Synchrotrons;Techniques;Technology;Testing;Time;tissue preparation;Tissues;tool;Toxic effect;Training;Translating;treatment strategy;Trust;Universities;volunteer;Work;X ray diffraction analysis

PROJECT_TITLE: Expanding synchrotron applications in biomedical research: Myocardial and skeletal muscle imaging at Brookhaven National Labs

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-J (10)]


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

ORG_CITY: MIDDLETON

ORG_NAME: IMGGYD LLC

ORG_STATE: WI

PHR: Project Narrative: Image guided minimal invasive surgery (MIS) techniques are seeing a rapidly growing number of applications. Neurosurgery is an especially good candidate for this approach, especially when the surgery target is deep or near delicate structures. More widespread use of this valuable technique is limited by lengthy procedure times, challenging technical issues, and the need for a large, well-supported team of clinicians and researchers. We propose to extend development of our neurosurgical device guide, AccuGyd. The principle was demonstrated in a Phase I project. In this Phase II project we will develop the software and hardware devices necessary for clinical use.

PI_NAMEs: OAKES, TERRENCE R (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: 3-Dimensional;Ablation;Acceleration;Adoption;Area;Back;base;Bite;Brain;Cadaver;Calibration;Catheters;Childhood;Climacteric;Clinical;Complex;Computer software;Consumption;cranium;deep brain stimulator;design;Development;Devices;Dimensions;Disincentive;Drug Delivery Systems;Epilepsy;experience;falls;FDA approved;gene therapy;Genetic Diseases;Goals;Gold;Head;high resolution imaging;Hour;Human;Human Resources;Image;image guided;Image-Guided Surgery;Imaging Techniques;improved;indexing;innovation;Interview;Lateral;Lead;Length;Life;Location;Magnetic Resonance Imaging;Malignant neoplasm of brain;Measures;Methods;minimally invasive;Monitor;Neurosurgeon;neurosurgery;Operative Surgical Procedures;Outcome;Output;Phase;Positioning Attribute;Procedures;Protocols documentation;Radial;Recurrent tumor;Research Personnel;Resources;Rotation;sample fixation;Scalp structure;Scanning;Schedule;software development;Structure;Surgeon;System;Techniques;Technology;Theft;Therapeutic;Time;Toddler;Training;United States National Institutes of Health;Validation;X-Ray Computed Tomography

PROJECT_TITLE: AccuGyd: Accelerated Guidance for Accurate MRI-Guided Neurosurgery

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-Z (10)]


NIH_SPENDING_CATS: Bioengineering;Biotechnology

ORG_CITY: BILLERICA

ORG_NAME: NIRRIN TECHNOLOGIES INC

PHR: Project Narrative Manufacturing biopharmaceuticals relies on bioprocessing which is comprised of multiple steps including synthesis of components, purification to remove contaminants, and the addition of supporting excipients in very precise concentrations. Ensuring that products are consistent from batch to batch is not only essential to safety and effectiveness but is required by regulatory agencies such as the Food and Drug Administration. Biopharmaceuticals found to be out of compliance can lead to massive costs for manufacturers to dispose of the adulterated product, as well as rebuild bioprocessing practices to eliminate errors in the future. Nirrin has developed the NXT system, a tunable laser spectrometry system which has been evaluated by numerous biopharmaceutical companies for bioprocessing quantitation of APIs and excipients. Here, we will optimize the system, prepare it for commercialization and perform an external validation study, testing the system’s capabilities at multiple biopharmaceutical manufacturers.

PI_NAMEs: HASSELL, BRYAN  (contact)

PROJECT_TERMS: Acceleration;Adherence;analytical method;Arginine;Back;Biological Products;Biomanufacturing;biopharmaceutical industry;bioprocess;case-by-case basis;commercial launch;commercialization;Computer software;Computers;Consumption;Contractor;cost;Data;design;Development;Documentation;Effectiveness;Ensure;Evaluation;Excipients;experience;feasibility testing;Formulation;Future;Goals;graphical user interface;High Pressure Liquid Chromatography;Histidine;improved;instrument;International;Laboratories;laser spectrometry;Lasers;Letters;manufacture;Manufacturer;manufacturing environment;Mass Spectrum Analysis;Measurement;Measures;Methods;Monitor;Monoclonal Antibodies;Nucleic Acids;Peptides;Performance;Pharmacologic Substance;Phase;Polysorbates;Preparation;Process;programs;Proteins;Protocols documentation;prototype;Publishing;Raman Spectrum Analysis;real time monitoring;Reporting;Safety;Sampling;Scanning;Site;Small Business Innovation Research Grant;Spectrum Analysis;Standardization;success;Sucrose;surfactant;System;Technology;Testing;Time;touchscreen;Trehalose;United States Food and Drug Administration;Validation;validation studies;Variant;verification and validation;volunteer;wasting

PROJECT_TITLE: A tunable laser scanning system for rapid analysis of biopharmaceutical formulations


ED_INST_TYPE: SCHOOLS OF MEDICINE

ORG_CITY: BALTIMORE

ORG_DEPT: RADIATION-DIAGNOSTIC/ONCOLOGY

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

ORG_STATE: MD

PHR: Exercise is now seen as an effective therapy for many diseases. In pregnant mothers, the benefits of exercise can extend beyond the womb, to affect the health of children long into adulthood. This research develops tools that uses body scanning methods to measure the benefits of exercise in pregnant mice and their offspring.

PI_NAMEs: SON, JUNSEOK ;TEE, SUI SENG  (contact)

PROGRAM_OFFICER_NAME: TSAP, LEONID V

PROJECT_TERMS: 3-Dimensional;Administrative Supplement;Adult;Affect;alpha ketoglutarate;APLN gene;Bicarbonates;Biochemistry;Biology;Brown Fat;Carbon;Cells;Child Health;Childhood;Citric Acid Cycle;Clinical Trials;combat;Contrast Media;Data;Detection;Development;Diet;diet-induced obesity;Disease;effective therapy;Ensure;Epigenetic Process;Exercise;experimental study;FAT3 gene;Fatty acid glycerol esters;fetal;Fetal Development;frailty;Fructose;Gene Modified;Goals;Grant;Half-Life;Health;Health Status;healthspan;Hormones;Image;imaging modality;imaging platform;imaging probe;Imaging Techniques;Imaging technology;in vivo;indexing;innovation;Isotopes;Label;Life;Liver;Long-Term Effects;Longitudinal Studies;Magnetic Resonance Imaging;Magnetic Resonance Spectroscopy;Maryland;mass spectrometric imaging;Maternal Health;Measurement;Measures;Mediating;Medicine;Metabolic;Metabolic Activation;metabolic imaging;Metabolism;metabolomics;Methods;minimally invasive;Modality;Mothers;mouse model;Mus;Muscle;Non-Invasive Detection;non-invasive imaging;offspring;Organ;Outcome;Personal Satisfaction;Physical Exercise;Physiologic pulse;Placentation;Plasma;Positron-Emission Tomography;Pregnancy;pregnant;Pregnant Women;protective effect;Pyruvate;Radioactive;Research;Scanning;sedentary;serial imaging;Signal Transduction;success;Supplementation;Surrogate Markers;Techniques;Technology;Testing;Therapeutic;Three-Dimensional Imaging;Tissues;tool;Translations;Universities;Uterus;Water;western diet;whole body imaging;Work

PROJECT_TITLE: Administrative Supplement: Longitudinal Imaging of Maternal Exercise and Exerkine Effects on Offspring Metabolism

STUDY_SECTION: POMD

STUDY_SECTION_NAME: Pathophysiology of Obesity and Metabolic Disease Study Section[POMD]


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Dissemination and Implementation Research;Drug Abuse (NIDA only);HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Hepatitis;Hepatitis - C;Infectious Diseases;Liver Disease;Social Determinants of Health;Substance Misuse

ORG_CITY: PROVIDENCE

ORG_NAME: RHODE ISLAND HOSPITAL

ORG_STATE: RI

PHR: PROJECT NARRATIVE  As nearly two-thirds of people who inject drugs (PWID) experience incarceration, jails offer a missed opportunity to address the public health needs of this population, particularly treating hepatitis C virus (HCV) and HCV co-infection among people living with HIV. This research seeks to introduce a novel low-barrier HCV treatment program (MINMON-J) in a statewide jail setting to provide critical knowledge on HCV treatment to help guide the newly announced national plan for HCV elimination. Given the challenges in community HCV treatment access, low-barrier HCV treatment in a jail could offer a paradigm shift in achieving HCV elimination, particularly among PWID.

PI_NAMEs: BERK, JUSTIN  (contact)

PROGRAM_OFFICER_NAME: WEBB, CANDACE KARONDELETTE

PROJECT_TERMS: Address;Administrator;Adoption;Anti-viral Agents;arm;Caring;Cellular Phone;Clinic;clinical trial implementation;co-infection;Coin;Collaborations;Communicable Diseases;Communities;Community Health Aides;Community Healthcare;Community Services;cost estimate;Data;Drug usage;Effectiveness;effectiveness outcome;effectiveness/implementation trial;Epidemic;epidemic virus;experience;follow-up;formative assessment;Funding;future implementation;General Population;Goals;Grant;Guidelines;Health;Health Services Accessibility;Hepatitis C;Hepatitis C co-infection;Hepatitis C Therapy;Hepatitis C virus;high risk;HIV;HIV Seroprevalence;HIV/HCV;Home;Hospitals;Human;Hybrids;implementation determinants;implementation outcomes;implementation/effectiveness;Imprisonment;Individual;infection rate;Injecting drug user;injection drug use;innovation;Intervention;Interview;Jail;Justice;Knowledge;Life;Link;Maintenance;Medical;Medical Staff;Modeling;Monitor;Morbidity - disease rate;mortality;novel;Outcome;Participant;patient navigation;patient population;Patient Recruitments;Patients;peer;peer support;Persons;Pharmaceutical Preparations;Pilot Projects;pilot trial;Population;pragmatic implementation;Prevalence;Prisons;Protocols documentation;Public Health;Reach, Effectiveness, Adoption, Implementation, and Maintenance;Research;Resources;response;Rhode Island;Seroprevalences;Services;side effect;Site;Societies;Structure;success;System;Testing;Transportation;treatment program;treatment strategy;United States;United States National Institutes of Health;Universities;uptake;Viral;Visit;Work

PROJECT_TITLE: Implementing a Low-Threshold Hepatitis C Treatment in a Jail Setting

STUDY_SECTION: HCAC

STUDY_SECTION_NAME: HIV Coinfections and HIV Associated Cancers Study Section[HCAC]


NIH_SPENDING_CATS: Digestive Diseases;Infectious Diseases

ORG_CITY: ANN ARBOR

ORG_DEPT: PATHOLOGY

ORG_NAME: UNIVERSITY OF MICHIGAN AT ANN ARBOR

ORG_STATE: MI

PHR: Project Narrative Combination antiretroviral therapy results in the elimination of nearly all actively HIV infected cells. However, the small reservoir of remaining cells causes substantial morbidity due to chronic inflammation that has been linked to defects in the intestinal barrier. A better understanding of the fundamental causes of inflammation in HIV infected people will lead to the development of new therapies that will alleviate chronic inflammation and improve the health of PLWH.

PI_NAMEs: COLLINS, KATHLEEN L.;PARKOS, CHARLES A (contact)

PROGRAM_OFFICER_NAME: NGUYEN, KHOA DINH DANG

PROJECT_TERMS: Address;antiretroviral therapy;Area;Biology;bone;Cardiovascular Diseases;CD4 Positive T Lymphocytes;Cell Line;Cell Physiology;Cells;Chronic;Collaborations;comorbidity;cytokine;Data;Defect;Development;Epithelial Cells;Epithelium;experimental study;Exposure to;Functional disorder;Funding;Gastrointestinal tract structure;Goals;gut inflammation;Health;HIV;HIV Infections;HIV-1;HIV/AIDS;Homeostasis;Human;Immune;immune activation;Impairment;improved;Individual;Infection;Inflammation;Inflammatory;insight;Interleukin-1 beta;Interleukin-6;intestinal barrier;intestinal epithelium;Intestines;Lamina Propria;Lead;Link;Metabolic syndrome;Methodology;microbial;Molecular;Morbidity - disease rate;mortality;nef Protein;neurocognitive disorder;novel therapeutics;Pathway interactions;Permeability;Persons;premature;Prevention;Process;Production;Research;Research Personnel;response;Signal Transduction;Source;synergism;T-Lymphocyte;Testing;therapeutic target;TNF gene;trafficking

PROJECT_TITLE: Molecular mechanisms underlying HIV related intestinal epithelial barrier dysfunction


NIH_SPENDING_CATS: Autoimmune Disease;Crohn's Disease;Dietary Supplements;Digestive Diseases;Inflammatory Bowel Disease;Microbiome;Nutrition;Prevention

ORG_CITY: ATLANTA

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: EMORY UNIVERSITY

ORG_STATE: GA

PHR: Project Narrative Inflammatory Bowel Disease is multifactorial and caused by the interplay of genetics, the microbiome and environmental factors. Diet is one of the most prominent environmental factors influencing IBD, however the major challenge for implementing dietary therapy for IBD is the lack of understanding of detailed mechanistic pathways to explain the impact of dietary interventions. The overall goal of this project is to discover relevant dietary fiber-microbe-immune cell interactions that prevent, induce or alter the course of gut inflammation.

PI_NAMEs: CERVANTES BARRAGAN, LUISA  (contact)

PROGRAM_OFFICER_NAME: PERRIN, PETER J

PROJECT_TERMS: Address;Affect;American;Bacteria;Behavior;Body Weight decreased;C57BL/6 Mouse;Carbon;CD4 Positive T Lymphocytes;Cell Communication;Cell Physiology;Cells;Chronic;Citrobacter rodentium;Colitis;Colon;Complex;Consumption;Crohn's disease;cytokine;design;Development;Diet;Diet therapy;dietary;dietary constituent;Dietary Fiber;Dietary Intervention;Disease;Disease Progression;Energy-Generating Resources;Environment;Environmental Risk Factor;epidemiology study;Europe;experimental study;feeding;Fiber;Flow Cytometry;Food;gain of function;Genetic;Germ-Free;Goals;gut inflammation;gut microbiota;Gut Mucosa;Health;Histologic;Human;human microbiota;IL17 gene;Ileitis;Immune;immune cell infiltrate;Immune response;Immune system;immunoregulation;Individual;Inflammation;Inflammatory;Inflammatory Bowel Diseases;Intake;interest;Intervention;Intestinal Mucosa;Intestines;intraepithelial;Lamina Propria;Large Intestine;LCN2 gene;Macronutrients Nutrition;Measures;Mediating;member;Metabolic;Metabolic Pathway;Metagenomics;Microbe;microbial;microbiome;microbiome composition;microbiota;microbiota composition;Modeling;mouse model;Mucositis;Mucous Membrane;Mus;nutrition;nutritional approach;Pathogenesis;Pathology;Pathway interactions;Persons;Population;prevent;Process;programs;Regulation;Regulatory T-Lymphocyte;Research;response;Rest;Risk;Role;Series;Severities;Severity of illness;Small Intestines;stool sample;Structure;Supplementation;T-Cell Development;T-Lymphocyte;Toxoplasma gondii;Ulcerative Colitis;Volatile Fatty Acids

PROJECT_TITLE: Role of dietary fiber-microbiota Interactions in the development and function of small intestinal T cells


FUNDING_MECHANISM: TRAINING, INDIVIDUAL

ORG_CITY: WASHINGTON

ORG_NAME: GEORGE WASHINGTON UNIVERSITY

ORG_STATE: DC

PHR: PROJECT NARRATIVE The existence of latent reservoirs of HIV-infected cells constitutes the major impediment against viral eradication. To that end, strategies that can boost immune effector functions could enhance the efficacy of current strategies aimed towards HIV eradication. This application seeks to evaluate the role of PTPN1/PTPN2 in NK cell cytolytic activity against HIV-infected cells with the goal of using this knowledge to develop effective HIV cure strategies.

PI_NAMEs: MELO, CLAUDIA  (contact)

PROGRAM_OFFICER_NAME: MOITRA, KAROBI

PROJECT_TERMS: Activated Natural Killer Cell;Aftercare;Anti-Retroviral Agents;antibody-dependent cell cytotoxicity;antiretroviral therapy;Autologous;Blood;career;Catalytic Domain;CD4 Positive T Lymphocytes;CD8-Positive T-Lymphocytes;Cell model;Cell Physiology;Cell-Mediated Cytolysis;Cells;Chronic;Clustered Regularly Interspaced Short Palindromic Repeats;Collection;CRISPR/Cas technology;Critical Thinking;cytokine;cytotoxic;cytotoxicity;Development;Dimethyl Sulfoxide;Effector Cell;Engraftment;Enzyme-Linked Immunosorbent Assay;exhaustion;Facial vein structure;Flow Cytometry;Gene Expression;genetic approach;Goals;Harvest;HIV;HIV Infections;HIV-1;Immune;Immune checkpoint inhibitor;immunodeficiency;Immunotherapy;improved;In Vitro;in vivo;Individual;Infection;Inflammation;inhibitor;insight;Interleukin-15;Interruption;Intraperitoneal Injections;Investigation;Janus kinase;Knock-out;Knowledge;Laboratories;latent HIV reservoir;Liver;Lymphocyte;memory CD4 T lymphocyte;Monitor;mouse model;Mus;Natural Killer Cells;novel;Pathologic;Pathway interactions;Persons;pharmacologic;Phosphoric Monoester Hydrolases;Plasma;Play;Positioning Attribute;Postdoctoral Fellow;Production;Proliferating;protein activation;Protein Dephosphorylation;Protein Tyrosine Phosphatase;Proteins;PTPN1 gene;Reporting;Research;Research Personnel;Role;Shock;Signal Pathway;SIV;skills;small molecule;Spleen;STAT protein;Testing;tumor progression;Tyrosine;Viral;Viral Genes;Viral Load result;Viral Physiology;viral rebound;Viral reservoir;Viremia;virology;Virus

PROJECT_TITLE: PTPN1 and PTPN2 as targets to improve NK function against HIV

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F17A-G (20)]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Biomedical Imaging;Biotechnology;Cancer;Comparative Effectiveness Research;Immunotherapy;Lung;Lung Cancer;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Precision Medicine

ORG_CITY: SAN CARLOS

ORG_NAME: ONC.AI, INC.

PHR: Narrative The $10B immunotherapy checkpoint inhibitors (ICI) category has transformed cancer treatment with the PD-(L)1 class demonstrating durable responses and survival increases in metastatic non- small cell lung cancer and melanoma for some patients. Despite these successes, PD-(L)1 ICI therapy is plagued by several shortcomings: unpredictable patient response rates in many cancer types, extremely high total treatment cost ($150,000 per year) and serious adverse events which can often result in patient hospitalization and stoppage of treatment. In this project, Onc.AI aims to develop the first radiomic-based multi-modal Machine Learning solution to the problem of unpredictable response to PD-(L)1 ICI therapy to improve outcomes for patients and reduce the cost burden on healthcare systems and public/private payers. Achieving accurate prediction of PD-(L)1 ICI therapy response will enable a host of high-impact clinical applications such as -- identification of hyper-progressing patients (patients where tumor growth accelerates as a result of PD-(L)1 ICI); improved selection of patients (predicted non-responders) who would benefit from chemotherapy or additional immunotherapy added to a PD-(L)1 ICI backbone; appropriately de- escalating combination therapy to minimize toxicity for predicted responders (switching patient from PD-(L)1/chemo to PD-(L)1 monotherapy); and informing continuation of PD-(L)1 therapy at the 12 to 24 month mark based on radiomic signatures more advanced than tumor shrinkage. Each of these applications has the potential to either significantly improve patient outcomes and/or optimize the health-economic profile of PD-(L)1 ICI treatment.

PI_NAMEs: JORDAN, PETR  (contact)

PROGRAM_OFFICER_NAME: ZHAO, MING

PROJECT_TERMS: Acceleration;adjudication;Adoption;Biological;Biological Assay;Biological Markers;Biopsy;blood-based biomarker;Board Certification;cancer immunotherapy;Cancer Patient;cancer therapy;cancer type;Categories;Cells;Cessation of life;Characteristics;checkpoint therapy;chemotherapy;Clinic;Clinical;clinical application;clinical decision-making;Clinical Management;clinical practice;Clinical Research;Combined Modality Therapy;commercialization;community clinic;Computer Vision Systems;Computerized Medical Record;cost;CTLA4 gene;Data;data harmonization;Data Set;Disadvantaged;Disease;Disseminated Malignant Neoplasm;Early identification;efficacy validation;Epidermal Growth Factor Receptor;Europe;Exhibits;FDA approved;Feasibility Studies;genomic signature;Genomics;Goals;Health;health economics;Healthcare Systems;Hospitalization;Image;imaging biomarker;Immune checkpoint inhibitor;immune-related adverse events;Immunofluorescence Immunologic;immunogenicity;Immunohistochemistry;Immunotherapy;improved;improved outcome;Incidence;inhibitor;inhibitor therapy;Institution;Inter-tumoral heterogeneity;ipilimumab;Laboratories;Lesion;liquid biopsy;Lung;Machine Learning;machine learning model;Malignant neoplasm of lung;Malignant neoplasm of urinary bladder;Malignant Neoplasms;Marketing;Melanoma;model generalizability;Modeling;Molecular;multimodal learning;multimodal modeling;multimodality;Mutation;Nivolumab;Non-Small-Cell Lung Carcinoma;novel;Observational Study;Oncology;Outcome Measure;Pathway interactions;patient response;Patient Selection;Patient-Focused Outcomes;Patients;Pattern;PD-1/PD-L1;pembrolizumab;Performance;Phase;Platinum;predicting response;predictive modeling;Predisposition;Privatization;Probability;Production;programmed cell death ligand 1;programmed cell death protein 1;Progression-Free Survivals;prospective;Proteomics;Protocols documentation;radiologist;Radiology Specialty;radiomics;Records;Research Personnel;research study;response;Risk;Scanning;secondary outcome;serial imaging;Serious Adverse Event;side effect;Small Business Innovation Research Grant;Specificity;Stains;standard of care;success;Techniques;Testing;Therapeutic;Time;Tissues;Toxic effect;Training;Treatment Cost;treatment planning;treatment response;tumor;Tumor Burden;tumor growth;tumor heterogeneity;United States;Validation;Vertebral column;Work;X-Ray Computed Tomography

PROJECT_TITLE: Prospective validation of a radiomics-based multi-modal predictive model for metastatic non-small cell lung cancer patients treated with PD-1 immunotherapy


ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

ORG_CITY: SAN ANTONIO

ORG_NAME: UNIVERSITY OF TEXAS SAN ANTONIO

PI_NAMEs: VEDANAYAGAM, JEFFREY  (contact)

PROGRAM_OFFICER_NAME: ADKINS, RONALD

PROJECT_TERMS: Ablation;Address;arms race;Biology;Breeding;Bypass;catalyst;Collaborations;Comparative Genomic Analysis;Conflict (Psychology);CRISPR/Cas technology;Culicidae;Cytology;Data;Defense Mechanisms;Drosophila genus;Evolution;Extinction;Family;fitness;fly;Foundations;Gametogenesis;Gene Expression;Genes;Genetic;genetic element;Genetic study;Genome;genomic signature;Genomics;Germ Lines;Grant;Impairment;innovation;Insecta;interdisciplinary approach;Knock-out;Laws;Link;male;Mammals;Maps;Measures;Meiosis;Meta-Analysis;model organism;Molecular;Molecular Biology;Mus;mutant;Mutant Strains Mice;Nature;novel;Pathway interactions;Phase;Phylogenetic Analysis;Population;Postdoctoral Fellow;pressure;Process;Production;Property;Proteins;Recurrence;Research;Resources;RNA;RNA Interference;Role;segregation;Selfish Genes;Sex Chromosomes;Sex Ratio;Shapes;Sister;Small Interfering RNA;Small RNA;Source;sperm cell;Spermatogenesis;Sterility;Study models;System;Testing;Testis;tool;Training;Transcript;transcriptome sequencing;transcriptomic profiling;Transgenes;transmission process;Work;X Chromosome;Y Chromosome

PROJECT_TITLE: Selfish meiotic drive and the role of RNAi in defending intragenomic conflict

STUDY_SECTION: NSS

STUDY_SECTION_NAME: NSS


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;HIV/AIDS;Health Services;Infectious Diseases

ORG_CITY: BRISTOL

ORG_COUNTRY: UNITED KINGDOM

ORG_FIPS: UK

ORG_NAME: UNIVERSITY OF BRISTOL

ORG_ZIPCODE: BS8 1TH

PHR: PUBLIC HEALTH RELEVANCE/ PROJECT NARRATIVE In the modern era of antiretroviral therapy (ART) for HIV, mortality and morbidity is much rarer than the pre- ART era so very large studies of people with HIV (PWH) are required to address current research questions. To enable such research, data from multiple cohort studies of PWH (HIV cohorts), often from many countries, need to be combined in HIV cohort collaborations. Such collaborations have evolved with increasing awareness of the need to protect research participants’ privacy, international data protection laws and more widespread use of data use agreements to govern data transfers. This project will develop a novel, secure, data-sharing platform, which will anonymize and safely contain data, and allow international collaborators to conduct secure, privacy-protecting analytics using open science principles. Research conducted through this platform will improve understanding of cause-specific mortality and cause-specific hospitalizations, develop prognostic models for less-studied subgroups of PWH, and investigate the comparative effectiveness of novel treatment strategies.

PI_NAMEs: INGLE, SUZANNE ;STERNE, JONATHAN  (contact);TRICKEY, ADAM

PROGRAM_OFFICER_NAME: MCKAIG, ROSEMARY G

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adult;Age;aged;Aging;Agonist;Agreement;antiretroviral therapy;Awareness;Big Data;Blood Transfusion;Body mass index;Canada;Cardiovascular system;Caring;Cause of Death;Cessation of life;Classification;clinical practice;Code;cohort;Cohort Studies;Collaborations;collaborative approach;comparative effectiveness;compare effectiveness;Computer software;Controlled Environment;Country;COVID-19 pandemic;Data;data exchange;data harmonization;data platform;Data Protection;Data Set;data sharing;Death Rate;Development;Drug usage;Effectiveness;Epidemic;Epidemiology;Europe;Event;Failure;Fostering;Geography;glucagon-like peptide 1;Goals;Health Status;Healthcare;Hepatitis D;Heterogeneity;HIV;HIV therapy;Hospitalization;Improve Access;improved;Income;interest;International;Intervention;Kidney Transplantation;Lamivudine;large datasets;Laws;Life Expectancy;Life Insurance;Link;liver transplantation;Methodology;Methods;Migrant;Modeling;Modernization;Morbidity - disease rate;mortality;Mortality Decline;North America;novel;open data;open source;Oral;Output;Overweight;Ownership;Participant;Pattern;Perinatal transmission;Persons;Policy Maker;Population;pre-exposure prophylaxis;Privacy;privacy protection;Prognosis;Prognostic Marker;prognostic model;Pseudonym;public health relevance;Quality of life;Regimen;Reproducibility;Research;Research Personnel;Research Priority;response;Science;Secure;sex;sharing platform;Source;standard care;Standardization;Strategic Planning;Subgroup;Training;transgender;Treatment Protocols;treatment strategy;United States National Institutes of Health;Universities;Update;Viral;Viremia;Weight Gain;Woman;Work

PROJECT_TITLE: A secure analytics platform to study the prognosis of people with HIV in the USA, Canada and Europe and comparative effectiveness of treatment regimens: the Antiretroviral Therapy Cohort Collaboration

STUDY_SECTION: PPAH

STUDY_SECTION_NAME: Population and Public Health Approaches to HIV/AIDS Study Section[PPAH]


ORG_CITY: NEW HAVEN

ORG_DEPT: PHARMACOLOGY

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: Project Narrative Non-nucleoside inhibitors of HIV reverse transcriptase (RT) remain successful components of combined antiretroviral therapy regimens and have newly discovered HIV-specific cell killing activity, which makes them potential components of future HIV cure strategies. The aim of this proposal is to examine the allosteric networks which allow these inhibitors to block viral replication by inhibiting nucleotide incorporation and kill HIV-infected cells by enhancing RT homodimerization. This work provides the foundation for the development of novel inhibitors which take better advantage of synergy with nucleoside inhibitors and have more potent cell killing activity.

PI_NAMEs: HOLLANDER, KLARISSA  (contact)

PROGRAM_OFFICER_NAME: ZHOU, YAN

PROJECT_TERMS: Active Sites;Adherence;Allosteric Site;Anti-Retroviral Agents;antiretroviral therapy;Area Analyses;Binding;Binding Sites;Biochemical;Catalysis;cell killing;Cell membrane;Cells;cellular targeting;Cessation of life;Characteristics;Chemicals;Chronic Disease;Complex;Cryoelectron Microscopy;DBL Oncoprotein;design;Development;Dimerization;DNA;Drug Interactions;Drug resistance;ds-DNA;Enhancers;experimental study;falls;Fingers;flexibility;Foundations;Future;Glean;global health;HIV;HIV-1;Homodimerization;hydroxyl group;In Vitro;in vivo;Infection;Inflammasome;inhibitor;insight;Kinetics;Knowledge;Measurement;Mediating;Methodology;Molecular;Molecular Conformation;Molecular Probes;Molecular Structure;Monitor;monomer;mutant;non-nucleoside reverse transcriptase inhibitors;novel;nucleoside inhibitor;Nucleosides;Nucleotides;pandemic disease;particle;Patients;Peptide Hydrolases;Persons;pol Gene Products;Polymerase;Polyproteins;preclinical study;premature;prevent;Process;Protein Conformation;Proteins;Proteolysis;Regimen;Reverse Transcriptase Inhibitors;Reverse Transcription;RNA-Directed DNA Polymerase;Series;Shock;Structure;synergism;Techniques;therapeutic development;Treatment Protocols;Vertebral column;Viral;viral DNA;Viral Genome;Viral Load result;Viral Proteins;Viral reservoir;Virus;Virus Integration;Virus Latency;Virus Replication;Work;X-Ray Crystallography

PROJECT_TITLE: Probing Molecular Mechanisms of Allosteric Inhibition of HIV-1 Reverse Transcriptase


ED_INST_TYPE: GRADUATE SCHOOLS

NIH_SPENDING_CATS: Genetics;Neurodegenerative

ORG_CITY: Princeton

ORG_DEPT: BIOCHEMISTRY

ORG_NAME: PRINCETON UNIVERSITY

ORG_STATE: NJ

PHR: PROJECT NARRATIVE Many events during animal development require that proteins are made at particular cellular locations where they are needed; often cells accomplish this by moving messenger RNAs (mRNAs) that code for proteins to the locations where they are needed and applying controls to ensure that protein is produced only there and only at the right time. Impairment of such mechanisms is associated with cancer metastasis, neurodegenerative disorders, and infertility. The proposed studies use sophisticated microscopy methods, innovative biochemical strategies, and genomic approaches to investigate how gathering mRNAs together in structures called germ granules positions mRNAs within an embryo and controls the production of proteins needed for cells that form in this region to follow the right developmental programs.

PI_NAMEs: GAVIS, ELIZABETH R (contact)

PROGRAM_OFFICER_NAME: WELLS, MELISSA LYNN

PROJECT_TERMS: Animals;Behavior;Binding;Biochemical;Biological;Body Patterning;Cells;Client;Code;cohort;Complex;Cytoplasmic Granules;Defect;Development;Disease;Drosophila genus;egg;Embryo;Embryonic Development;Event;Foundations;Genes;Genetic;Genomic approach;Germ;Germ Lines;Goals;high resolution imaging;Impairment;Infertility;innovation;insight;Lead;Location;Maintenance;Malignant Neoplasms;Maternal Messenger RNA;Messenger RNA;Methods;Microscopy;Modeling;Neoplasm Metastasis;Nerve Degeneration;Neurodegenerative Disorders;novel;Oocytes;Phase Transition;Play;Positioning Attribute;posttranscriptional;Prevalence;Production;programs;Proliferating;protein distribution;Proteins;recruit;Regulation;Research;Ribonucleoproteins;RNA;RNA metabolism;Role;self organization;Structure;Structure of primordial sex cell;Time;Transcript;Translations;Work

PROJECT_TITLE: Mechanisms of mRNA localization and translational control in Drosophila development

STUDY_SECTION: MRAC

STUDY_SECTION_NAME: Maximizing Investigators' Research Award C Study Section[MRAC]


ADMINISTERING_IC: CK

IC_NAME: National Center for Emerging and Zoonotic Infectious Diseases

ORG_CITY: CEDAR PARK

ORG_NAME: TARAWA LABS INC

PHR: PROJECT NARRATIVE In the United States alone, nearly 2 million people contract healthcare-acquired infections annually, resulting in 98,000 American deaths a year, with the number of deaths likely to increase due to the emergence of antibiotic resistant bacteria. Although hand washing and the use of gloves have been described as the major deterrents of healthcare-acquired infections, the nonsterile disposable gloves used by healthcare workers may indeed be the source of bacterial transmission between patients. Tarawa Labs has developed an innovative glove product that will dramatically decrease the occurrence of healthcare-acquired infections, and thus, change the delivery of healthcare to improve the quality of patient care globally.

PI_NAMEs: HALL, SARA  (contact)

PROJECT_TITLE: SBIR, Phase I, Preventing healthcare-acquired, antibiotic-resistant bacterial infections with single dispense gloves.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 HSS-J (10)]


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Genetics

ORG_CITY: WORCESTER

ORG_NAME: CODOMAX INC.

PHR: NARRATIVE Intracellular protein aggregation and retention of misfolded proteins in the endoplasmic reticulum is a universal issue plaguing secretory recombinant protein production in Pichia pastoris across all sectors of the biomanufacturing industry. Codomax has developed the Epi-MAX platform, a strain and gene engineering technology that leverages cellular stress responses to enhance protein production and enable the efficient expression of difficult-to-express biologics. Here we propose to use the Epi-MAX platform to boost the efficiency of secreted recombinant therapeutic proteins from Pichia by enhancing stress mRNA translation of three secretory pathway chaperones required to prevent intracellular aggregation and promote assembly and secretion of the polypeptides into functional recombinant protein.

PI_NAMEs: BYRNE, SHANE  (contact);FRIED, STEPHEN DAVID

PROGRAM_OFFICER_NAME: SHARMA, KARLIE ROXANNE

PROJECT_TERMS: Address;Aldesleukin;Biological;biological adaptation to stress;Biological Products;Biomanufacturing;Biotechnology;Calnexin;cancer therapy;Cells;Cellular Stress;Chaperone Gene;Clinical;Codon Nucleotides;commercialization;Computer software;cost;Coupled;CRISPR/Cas technology;Data;Endoplasmic Reticulum;Engineered Gene;Engineering;Enzymes;Escherichia coli;exhaustion;Foundations;Genes;Goals;Heat shock proteins;Human;IL2 gene;Impairment;Industrialization;Industry;innovation;insight;Interleukin-2;Literature;manufacture;manufacturing cost;Mass Spectrum Analysis;Messenger RNA;misfolded protein;Modeling;Modification;Molecular Chaperones;mRNA Translation;overexpression;Pain;Pathway interactions;Pattern;Phase;phase 2 study;Pichia;Pilot Projects;Plasmids;polypeptide;prevent;Production;Productivity;protein aggregation;Protein Disulfide Isomerase;protein expression;Protein Overexpression;Protein Secretion;Proteins;Proteolysis;Proteomics;prototype;Reagent;Recombinant Interleukin-2;Recombinant Proteins;Recombinants;Reporting;response;secretory protein;Series;Stress;stressor;System;Technology;therapeutic protein;tool;transcription factor;transcriptome sequencing;Transfer RNA;Translating;Translations;Work

PROJECT_TITLE: Designer Pichia Strains That Enable Difficult-To-Express Biologics Production by Addressing Limitations in Secretory Protein Expression

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MBBC-G (10)]


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Burden of Illness;Caregiving Research;Clinical Research;Clinical Trials and Supportive Activities;Health Services;Mental Health;Palliative Care;Prevention;Social Determinants of Health;Telehealth

ORG_CITY: MAPLE GROVE

ORG_NAME: ADVANCED MEDICAL ELECTRONICS CORPORATION

ORG_STATE: MN

PHR: Project Narrative In the United States, two-thirds of the 5.4 million people with memory concern (PWMC) live in their homes in the community, reflecting the growing desire of Americans to age in place. The complexity of needs of PWMC including medical, behavioral, and social needs, make it one of the most expensive chronic conditions in the United States, and a strong candidate for improving care through care management support. Navigating fragmented systems of health care, long-term services and supports, and community or social supports to meet the diverse needs of PWMC is challenging. Currently, family, and unpaid caregivers provide the bulk of support PWMC receive to continue living in their homes. Caregiver burden, measured objectively (count of hours) or subjectively (caregiver’s perception of impact on themselves), is associated with poorer outcomes among people living with dementia. Given most PWMC live in their homes, people are concentrating on the home setting as an effective way to identify and address a broader set of unmet needs (e.g., social, and environmental determinants of health) and provide more comprehensive “family-centered” support. This approach aligns with value-based care principles and bridges the health care with community setting.

PI_NAMEs: HAVEY, GARY D (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Activities of Daily Living;Address;aging in place;American;Anxiety;Appointment;Behavioral;care burden;care coordination;care providers;care systems;Caregiver Burden;caregiver stress;Caregiver support;Caregivers;Caring;Cellular Phone;Chronic;Communities;community setting;Computer software;Coupled;Dementia;design;Development;Evaluation;Face;Family;Feedback;Friends;health determinants;Healthcare;Healthcare Systems;Home;Hour;improved;Individual;Informatics;Interview;Location;Managed Care;Measures;Medical;medical appointment;member;Memory;Modification;Monitor;Names;next generation;Notification;Nursing Homes;older adult;Outcome;Participant;Perception;Persons;Phase;phase 2 study;Play;premature;Randomized, Controlled Trials;Reminder Systems;remote monitoring;Reporting;Reservations;response;Risk;Running;Safety;Schedule;Security;Services;Small Business Innovation Research Grant;smartphone application;social;social engagement;social integration;Social Interaction;Social isolation;Social support;Stress;System;Tablet Computer;Tablets;Technology;Testing;Time;tool;Trust;United States;uptake;Visit;Work

PROJECT_TITLE: A Mobile Informatics Solution to Assist Caregivers with Care Coordination and Social Engagement

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 SCIL-D (10)]


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Eye Disease and Disorders of Vision;Networking and Information Technology R&D (NITRD);Neurosciences;Physical Rehabilitation;Rehabilitation;Telehealth

ORG_CITY: MILWAUKEE

ORG_NAME: UBITRIX INTERNATIONAL, INC.

PHR: Narrative: More than a third of adults over 40 suffer from concurrent dizziness secondary to vestibular dysfunction. Real-time teleassessments of vestibular disorders patients remain a challenge. We will develop and demonstrate the performance of a smartphone-based platform (mVOR) using a mobile Gaze Stabilization Test (mGST) protocol as a rehabilitation tool to cost-effectively track and assess vestibular dysfunction patients. Clinicians would receive a real-time assessment report to guide further treatment.

PI_NAMEs: AHAMED, SHEIKH IQBAL (contact)

PROGRAM_OFFICER_NAME: MILLER, ROGER

PROJECT_TERMS: Acoustic Neuroma;Adult;Affect;Algorithms;Bilateral;Biometry;Cellular Phone;Clinic;Clinical;Clinical assessments;clinical efficacy;clinical outcome measures;Clinical Trials;Complex;computer human interaction;Computer Vision Systems;computerized;computerized data processing;Conduct Clinical Trials;cost;cost effective;COVID-19 pandemic;Data;data management;design;Devices;Dizziness;equilibration disorder;Equilibrium;Excision;Eye;Eye Movements;fall risk;falls;Foundations;Friends;gaze;Goals;handheld mobile device;Head;Head Movements;Health system;Home;Human;human subject;Human Subject Research;Institution;instrumentation;Measurement;Measures;Methods;mHealth;microphone;millisecond;Mobile Health Application;Modeling;Monitor;Motion;Musculoskeletal Equilibrium;novel;Online Systems;Outcome;Patient Care;Patients;Performance;Peripheral;Phase;Physical therapy;postoperative recovery;posture instability;Practice Guidelines;Process;processing speed;Protocols documentation;Psychophysics;Qualifying;Recommendation;recruit;Rehabilitation therapy;Reporting;Research;Resources;Role;Secondary to;Self Administration;sensor;shared decision making;software as a medical device;Structure;System;Technology;telehealth;telerehabilitation;Testing;Time;tool;Universities;usability;user-friendly;Vestibular Diseases;Vestibular dysfunction;Vestibular function;Vestibular loss;vestibular system;vestibulo-ocular reflex;Virginia;virtual reality;Vision;Visual Acuity;visual processing;visual tracking;Visualization

PROJECT_TITLE: mVOR: An mHealth Approach to the Clinical Assessment of Gaze Stability and Telerehabilitation of Vestibular Dysfunction

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-M (12)]


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Complementary and Integrative Health;Pediatric

ORG_CITY: DENVER

ORG_NAME: EDIFY

ORG_STATE: CO

PHR: Project Narrative MusiQuest STEAM is an interactive digital media program that combines hands-on STEM technical components with guided lessons that address Next Generation Science Standards for grades K-5. By incorporating audio (music, sound, hearing, etc.) in every lesson, MusiQuest STEAM will present artistic connections to STEM that help build students' knowledge of key concepts, and inspire their interest in learning more about biomedical science and related research. The long-term impact on public health of improved outcomes in STEM education is greater participation in health-related professions, especially from groups that are currently underrepresented in these fields.

PI_NAMEs: ZAX, JACOB  (contact)

PROGRAM_OFFICER_NAME: BECK, LAWRENCE A

PROJECT_TERMS: Address;Animals;Area;Attitude;Brain;career;commercialization;Data;Data Analyses;design;Development;digital media;Education;Educational Assessment;Educational Curriculum;Educational Models;elementary school;Engineering;Ensure;Feasibility Studies;Feedback;fifth grade;first grade;fourth grade;Future;Genetic;Health;Health Occupations;Hearing;Human;improved outcome;Industrialization;Instruction;instrument;interest;kindergarten;Knowledge;Learning;learning engagement;learning outcome;Mathematics;Measurement;Measures;Music;National Institute of General Medical Sciences;Next Generation Science Standards;Outcome;Output;Participant;Phase;Polishes;Process;product development;programs;prototype;Public Health;Randomized;Reporting;Research;Research Personnel;Resources;response;Sales;Schools;Science;Science, Technology, Engineering and Mathematics Education;second grade;Small Business Innovation Research Grant;sound;STEM student;Students;Summary Reports;teacher;Technology;Testing;third grade;Underrepresented Populations;usability;Vocation;Work

PROJECT_TITLE: MusiQuest STEAM: interactive digital media for K-5 STEM education integrating audio and music


NIH_SPENDING_CATS: Biotechnology;Breast Cancer;Cancer;Digestive Diseases;Orphan Drug;Pain Research;Rare Diseases;Stomach Cancer;Women's Health Research

ORG_CITY: SAN FRANCISCO

ORG_NAME: SHASQI, INC.

PHR: Narrative High levels of toxicity plague the efficacy of many different drugs proposed for anti-cancer therapies, leaving patients with the choice of foregoing treatment or dealing with painful side effects. Shasqi proposes a new method of initial administration of localized activators, followed by administration of a prodrug that becomes efficacious within proximity of the tumor localized activator. Shasqi’s solution promotes spatiotemporal control of drug activation, characterizing a platform that could reinvigorate studies into previous therapies that were shelved in clinical trials due to high systemic toxicity.

PI_NAMEs: MCFARLAND, JESSE MISCHA;MEJIA ONETO, JOSE M (contact)

PROGRAM_OFFICER_NAME: EVANS, GREGORY

PROJECT_TERMS: Acceleration;Address;advanced system;Adverse drug effect;Adverse drug event;Adverse Drug Experience Report;analog;Anti-Inflammatory Agents;Antibiotics;Antibodies;antibody conjugate;Antibody-drug conjugates;Antigen Targeting;Antigens;Attenuated;Autoimmunity;Biology;Biopolymers;Breast Cancer Model;Cancer Model;cancer therapy;Chemistry;chemotherapy;Clinic;Clinical Trials;cohort;Conjugating Agent;cost;Cyclooctenes;design;Development;Disease;Dose;Dose Limiting;Doxorubicin;drug candidate;Drug Controls;drug development;Drug Kinetics;drug repurposing;Effectiveness;ERBB2 gene;Exatecan;Exhibits;Failure;Future;Generations;Hospitalization;improved;in vivo;Infection;inhibitor;Injectable;Injections;Investigation;Lead;Liver Dysfunction;Location;Lysosomes;Malignant Neoplasms;malignant stomach neoplasm;manufacture;Maximum Tolerated Dose;Measures;Medical;Methods;Modality;Modeling;Morbidity - disease rate;mortality;mouse model;neoplastic cell;Neutropenia;new technology;novel;Pain;Pain management;Pathologic;Patients;Penetration;Pharmaceutical Preparations;Phase;phase 2 study;Plague;Plasma;Price;Prodrugs;Quality of life;Rattus;Reaction;receptor;Risk Reduction;Safety;side effect;Site;Sodium Hyaluronate;Solid Neoplasm;spatiotemporal;Specificity;Sprague-Dawley Rats;Structure;success;System;systemic toxicity;Testing;Therapeutic;Therapeutic Index;therapeutically effective;Topoisomerase;Topoisomerase-I Inhibitor;Toxic effect;Toxicity Attenuation;Toxicokinetics;Toxicology;trafficking;Trastuzumab;tumor;Xenograft Model;Xenograft procedure

PROJECT_TITLE: Antigen-targeted activation of Topo1 inhibitors via click chemistry

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-R (12)]


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Bioengineering;Pediatric

ORG_CITY: CAMBRIDGE

ORG_NAME: PENDAR TECHNOLOGIES, LLC

PHR: Narrative There is a serious lack of hemodynamic monitoring tools for neonates in critical care. Reliable markers of impaired oxygen delivery and impending shock would give healthcare providers valuable time to react. We will develop a new probe that measures oxygen delivery to tissues as a marker of systemic hemodynamics.

PI_NAMEs: KHEIR, JOHN NAGI;VAKHSHOORI, DARYOOSH  (contact)

PROGRAM_OFFICER_NAME: GUMINA, DIANE LAURA

PROJECT_TERMS: absorption;Advanced Development;Affinity;Animal Model;Assessment tool;Blood capillaries;Blood Pressure;Blood Vessels;Clinical Trials;clinically relevant;Collection;Critical Care;Critical Illness;Death Rate;deprivation;Development;Devices;Diameter;Early identification;Esophagus;Exhibits;Fatty acid glycerol esters;Fiber;Filtration;flexibility;Goals;Head;Health Personnel;Heart Rate;hemodynamics;Hemoglobin;Hemorrhage;Hypotensives;Hypoxia;Impairment;improved;In Vitro;in vivo;Infection;Lactic acid;Lasers;lens;Location;Low Cardiac Output;manufacture;Measurement;Measures;Metabolic;Methods;miniaturize;Modeling;Monitor;Neonatal;neonate;Newborn Infant;Optics;Organ;Oxygen;Oxyhemoglobin;Pacifiers;patient population;Patients;Performance;Perfusion;Peripheral;Physiology;Positioning Attribute;prototype;Raman Spectrum Analysis;Reaction;Reproducibility;Resuscitation;Rodent Model;Safety;sensor;Serum;Shock;skin color;Sterilization;subcutaneous;Surface;System;Testing;Time;Tissue Model;tissue oxygenation;Tissues;Tongue;tool;Triage;Vascular blood supply;Venous;ventilation

PROJECT_TITLE: Monitoring of Oxygen Delivery and Tissue Oxygenation Deprivation in Critically Ill Neonates Using Resonance Raman Spectroscopy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (11)]


NIH_SPENDING_CATS: Biotechnology;Cancer

ORG_NAME: TAMBO, INC.

PHR: Narrative Tambo is developing a platform to activate drugs at a specific site in the body, thus enhancing their efficacy while minimizing systemic toxicity and adverse drug events. Phase I synthesized a selection of protodrugs, demonstrating favorable solubility in formulation, tolerability in mice, and effective action in a murine tumor model, and Phase II will advance the platform and demonstrate its modularity using several additional classes of therapeutic agents. Ultimately, Tambo’s platform could be used for site-specific activation of drugs to improve the efficacy and reduce the side effects of treatment for a wide variety of diseases and conditions.

PI_NAMEs: ROYZEN, MAKSIM ;YEE, NATHAN  (contact)

PROGRAM_OFFICER_NAME: BALAKRISHNAN, KRISHNA B

PROJECT_TERMS: Address;Adverse drug event;Adverse Drug Experience Report;Animal Model;Anti-Inflammatory Agents;Antibiotics;Antineoplastic Agents;aqueous;Area;Attenuated;Biochemical;Biological;Biological Assay;Biological Process;biomarker selection;Biopolymers;Branched-Chain Amino Acids;Buffers;Cell model;Cells;Charge;Chemistry;cost;Cremophor;Cyclooctenes;design;Disease;Dose;Doxorubicin;drug candidate;drug development;drug repurposing;ERBB2 gene;Ethanol;Exatecan;Exhibits;Failure;Formulation;Hospitalization;Hydrophobicity;Immunotherapy;improved;In Vitro;in vivo;in vivo evaluation;Infection;Injectable;Investigation;Lead;Local Therapy;Maximum Tolerated Dose;Medical;Methods;Modeling;Morbidity - disease rate;mortality;Mus;New Agents;novel drug class;novel therapeutics;Paclitaxel;Pain management;Pathologic;Patients;Pharmaceutical Preparations;Phase;Physiological;preclinical efficacy;Price;Prodrugs;Property;Proteins;Quality of life;Reaction;Reactive Oxygen Species;Side;side effect;Site;Small Business Innovation Research Grant;Sodium Hyaluronate;Solid Neoplasm;Solubility;Specificity;Staurosporine;Steroids;success;System;systemic toxicity;targeted agent;Testing;Therapeutic;Therapeutic Agents;Therapeutic Index;therapeutically effective;Tissues;Toxic effect;Toxicity Attenuation;Toxicology;Translating;Treatment Side Effects;tumor;Universities;Variant

PROJECT_TITLE: Discovery of solubilizing side chains for in vivo release of diverse drug classes using the Click Activated Protodrugs (CAP) platform


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease Related Dementias (ADRD);Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Biomedical Imaging;Brain Disorders;Cardiovascular;Cerebrovascular;Clinical Research;Dementia;Neurodegenerative;Neurosciences;Prevention;Vascular Contributions to Cognitive Impairment and Dementia (VCID)

ORG_CITY: Calabasas, CA

ORG_NAME: SAGE CEREBROVASCULAR DIAGNOSTICS, INC.

PHR: NARRATIVE Vascular injury to the brain increases the risk of stroke and directly contributes to cognitive impairment and dementia. Sage Cerebrovascular Diagnostics, Inc. developed and prototyped a robust panel-based assay measuring multiple inflammatory molecules circulating in the bloodstream that can identify individuals with a high likelihood of vascular injury to the brain. This project aims to validate the performance of this novel blood test for patient results reporting and adapt it to an at-home testing platform for ease of use.

PI_NAMEs: EBRAHIMZADEH PUSTCHI, SADAF  (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: Adoption;Alzheimer's Disease;Alzheimer's disease care;Alzheimer's disease diagnosis;Alzheimer's disease related dementia;Award;Benchmarking;biobank;Biological;Biological Assay;Biological Markers;Blood;Blood Circulation;Blood specimen;Blood Tests;Blood Vessels;blood-based biomarker;Brain;brain health;Brain imaging;Brain Injuries;cardiovascular risk factor;care costs;Cause of Death;cerebrovascular;Cerebrovascular Disorders;cerebrovascular health;Cerebrovascular Trauma;Characteristics;Chronic;Clinical;Clinical Laboratory Improvement Amendments;cohort;Collaborations;Collection;commercial application;commercialization;cost;Data;Dementia;dementia burden;dementia risk;Detection;detection limit;Development;Devices;Diabetes Mellitus;Diagnosis;Diagnostic;diagnostic accuracy;diagnostic assay;diagnostic biomarker;diagnostic tool;disability;Disease;Dryness;Early Diagnosis;Environment;epidemiologic data;Evaluation;Fasting;Goals;Health;healthcare burden;Home;home test;human old age (65+);Hypertension;Image;imaging study;Immunoassay;Impaired cognition;improved;Individual;Inflammation;Inflammatory;Injury;innovation;insight;Laboratories;Link;Liquid substance;Magnetic Resonance Imaging;Measures;Methodology;Methods;middle age;minimally invasive;Multiple Sclerosis;Neurologic;novel;novel diagnostics;novel marker;Outcome;Pathogenesis;Pathologic;Pathway interactions;Patients;Performance;performance tests;Persons;Phase;phase 1 study;Plasma;Population;Positioning Attribute;prehypertension;Prevalence;Prognosis;prospective;Proteins;prototype;Provider;Public Health;Reporting;Reproducibility;Risk;Sample Size;Sampling;Sensitivity and Specificity;Serum;Signal Transduction;Small Business Innovation Research Grant;Specificity;Specimen;Spottings;Stratification;Stroke;stroke risk;Symptoms;Testing;tool;treatment planning;Validation;validation studies;Vascular Cognitive Impairment;vascular contributions;Vascular Dementia;vascular injury;Venous blood sampling

PROJECT_TITLE: Development and Validation of a Quantitative Diagnostic Biomarker for Silent Brain Injury

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-H (13)]


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Orphan Drug;Patient Safety;Pediatric;Pediatric - AIDS;Rare Diseases;Tuberculosis

ORG_CITY: GAINESVILLE

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF FLORIDA

ORG_STATE: FL

PHR: NARRATIVE The accelerated rollout of dolutegravir (DTG)-based antiretroviral therapy (ART) as a universal regimen for the treatment of human immunodeficiency virus infection (HIV) in children and adolescents in low- and middle- income countries (LMICs) was done with limited research data in that population. There is currently limited data on the pharmacokinetics of the pediatric DTG formulations, drug-interactions in the settings of treatment of active or latent tuberculosis (TB) as well as long-term outcomes in children and adolescents in real-world settings. This proposal will address these fundamental research gaps and provide relevant data to inform optimization of DTG-based ART in children and adolescents in LMICs.

PI_NAMEs: KWARA, AWEWURA JACOB (contact)

PROGRAM_OFFICER_NAME: LOMBO RODRIGUEZ, TANIA

PROJECT_TERMS: 15 year old;Acceleration;Acquired Immunodeficiency Syndrome;active method;Address;Adherence;Adolescent;Adopted;Adoption;Adult;Affect;Africa;African;antiretroviral therapy;Body mass index;Body Weight;Cessation of life;Child;Childhood;clinical effect;co-infection;comorbidity;Country;Data;Development;Dose;Drug Interactions;Drug Kinetics;Dyslipidemias;Effectiveness;European;experience;falls;Formulation;Frequencies;Friends;fundamental research;Generations;Genetic;Goals;Guidelines;Health;Hepatic;HIV;HIV drug resistance;HIV Infections;HIV-infected adolescents;Household;Hyperglycemia;improved;Incidence;Infant;inhibitor;Integrase;isoniazid;Kidney;Knowledge;Lipids;low and middle-income countries;Medicine;Metabolic syndrome;Names;novel;Outcome;Persons;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;pill;Plasma;Population;Prevalence;Preventive therapy;programs;Property;Recommendation;Regimen;Reporting;Research;Resistance;response;rifapentine;Safety;scale up;Tablets;Toxic effect;treatment guidelines;Treatment Protocols;Tuberculosis;United States Food and Drug Administration;Update;Viral Load result;Virus Diseases;Weight;Weight Gain;World Health Organization

PROJECT_TITLE: Addressing Research Gaps to Optimize Dolutegravir-based ART in Children and Adolescents


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Assistive Technology;Behavioral and Social Science;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Patient Safety;Physical Injury - Accidents and Adverse Effects;Physical Rehabilitation;Rehabilitation

ORG_CITY: SOLANA BEACH

ORG_NAME: ACTIVE4D, INC.

PHR: PROJECT NARRATIVE Rotator cuff tears are the most common tendon injury observed in adults, and failing to receive adequate care for a torn rotator cuff can lead to severe long-term consequences, including chronic pain, muscular weakness, and limited range of motion. To address the current lack of technology to continuously monitor shoulder muscle activity during after rotator cuff repair, Active4D is developing the MyoGuard system as a wearable device to be incorporated into existing rehabilitation programs as a tool to enable adaptive, data-driven, and patient- personalized decision-making by providing continuous monitoring and real-time biofeedback on joint angle and muscle activity. The objectives of this Phase II SBIR project are to optimize the MyoGuard device and smart phone application user interface to better facilitate independent use of the device in the home and decrease manufacturing costs, and to collect human factors data from patients after rotator cuff repair to inform the design of a future clinical trial that will aid in regulatory approval and support rapid commercialization of MyoGuard, thereby making this product accessible to the more than 500,000 patients undergoing rotator cuff repair every year in the United States.

PI_NAMEs: SHEEAN, GEOFFREY  (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Acceleration;Address;Adherence;Adhesives;Adoption;Adult;Affect;Age;Age Years;Aged, 80 and over;Area;Arthroscopic Surgical Procedures;Articular Range of Motion;Benchmarking;Biofeedback;Bluetooth;Caring;Cellular Phone;chronic pain;Classification;Clinical;Clinical Trials;Collection;commercialization;Computer software;Contractor;cost;Custom;Data;data access;Decision Making;deltoid muscle;design;Device Designs;Devices;digital;Direct Costs;Effectiveness;efficacy testing;Electrodes;Electromyography;Engineering;Exercise;exercise rehabilitation;Failure;Feedback;flexible electronics;Funding;Future;Goals;handheld mobile device;healing;Health Insurance Portability and Accountability Act;Home;Hour;Human;human subject;Human Subject Research;Hydrocolloid;improved;improved outcome;Incidence;innovation;Joints;Left;manufacture;manufacturing cost;Marketing;Measurement;Medical;miniaturized device;Monitor;monitoring device;Movement;Muscle;Muscle Weakness;novel;Older Population;Operative Surgical Procedures;Outcome;Ozone;Participant;Patient Compliance;Patients;personalized decision;Phase;Phase I Clinical Trials;physical therapist;Postoperative Period;Preparation;prevent;Procedures;Process;programs;prototype;Reading;Recovery;Recovery of Function;Rehabilitation therapy;repaired;Reproducibility;retention rate;Risk;Risk Reduction;Rotator Cuff;rotator cuff injury;rotator cuff tear;sensor;Shapes;Shoulder;Skin;Small Business Innovation Research Grant;smartphone application;Speed;standard of care;Study Subject;success;Surface;System;Technology;technology development;Telephone;Tendon Injuries;Tendon structure;Time;tool;United States;usability;wearable device;wearable monitor;wearable sensor technology

PROJECT_TITLE: Wearable Monitoring System for Enhancing Rehabilitation Following Rotator Cuff Repair

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MSOS-A (11)]


ADMINISTERING_IC: OH

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

IC_NAME: NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

ORG_CITY: HOUSTON

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON

PI_NAMEs: GUILLOT-WRIGHT, SHANNON PAIGE (contact)

PROGRAM_OFFICER_NAME: GARRETT, BRIDGETTE E

PROJECT_TITLE: Commercial Fishing Occupational Safety Research Cooperative Agreement (U01) - 2022


NIH_SPENDING_CATS: Clinical Research;Genetics;HIV/AIDS;Infectious Diseases;Microbiome;Sexually Transmitted Infections;Women's Health Research

ORG_CITY: BOSTON

ORG_NAME: MASSACHUSETTS GENERAL HOSPITAL

PHR: PROJECT NARRATIVE Of the 1.2 million new HIV infections each year, almost 70% occur in sub-Saharan Africa and most occur in young women of reproductive age following heterosexual sex; the female genital tract (FGT) therefore plays a pivotal role in the acquisition of HIV infection in women. In this project, we will utilize innovative multi-omic characterization of vaginal bacteria and host measures of genital inflammation using samples from a unique clinical cohort of South African women living in an area of extraordinarily high HIV incidence and prevalence. This research has the potential to inform novel strategies for reducing HIV infections in women, particularly for those living in sub-Saharan Africa.

PI_NAMEs: HANDLEY, SCOTT A.;KWON, DOUGLAS  (contact)

PROGRAM_OFFICER_NAME: SHANKAR, UDAY K

PROJECT_TERMS: Address;Africa South of the Sahara;African Women;Age;Anaerobic Bacteria;Area;Bacteria;bacterial community;Bacterial Infections;Behavioral;Biological Models;Biostatistical Methods;Blood;CD4 Positive T Lymphocytes;Cells;Cervical;Cervix Uteri;chemokine;Clinical;cohort;Collaborations;Communities;Complement;Complex;Contracts;cytokine;Data;Data Set;Education;Environment;Epithelial Cells;experience;Exposure to;Female;female reproductive tract;Genetic Transcription;genital secretion;Genitalia;Health;Heterosexuals;high risk;HIV;HIV Infections;HIV-2;human disease;humanized mouse;Immune;Immunology;In Vitro;in vivo Model;Incidence;Infection;Inflammation;Inflammatory;inhibitor;innovation;Knowledge;Lactobacillus;Libraries;Measures;Mediating;Mediator;Membrane;men;metabolomics;Metadata;Metagenomics;metatranscriptomics;Microbial Genome Sequencing;microbial genomics;microbial host;microbiome;microbiome analysis;microbiota;microbiota composition;Modality;Modeling;Modernization;mouse model;Mucositis;Mucous Membrane;Multiomic Data;multiple omics;novel;novel strategies;organ on a chip;Organoids;Participant;Pathogenesis;Pathway interactions;Phenotype;Play;Predisposition;Prevalence;prevent;Productivity;Quality Control;Recording of previous events;reproductive;Research;Resolution;Resources;Risk;Risk Factors;Role;Sampling;Seminal;sex;single-cell RNA sequencing;Site;South African;Techniques;Testing;Tissues;transmission process;Vagina;vaginal infection;vaginal microbicide;vaginal microbiome;vaginal microbiota;Visualization;Woman;Work;young woman

PROJECT_TITLE: Identifying drivers of genital inflammation and HIV acquisition in women living in sub-Saharan Africa

STUDY_SECTION: HIVD

STUDY_SECTION_NAME: HIV Immunopathogenesis and Vaccine Development Study Section[HIVD]


NIH_SPENDING_CATS: Autoimmune Disease;Biotechnology;Digestive Diseases;Immunotherapy;Inflammatory Bowel Disease;Prevention

ORG_CITY: San Diego

ORG_NAME: VIVREON BIOSCIENCES, LLC

PHR: Vivreon Biosciences, LLC 4940 Carroll Canyon Rd., Ste. 110  San Diego, CA 92121 milton@vivreonbiosciences.com NIAID PA-23-230 Project Narrative Ulcerative colitis (UC) is the most common form of inflammatory bowel disease and imposes large quality of life and financial cost burdens on the patient. Additional effective therapeutics that operate via novel mechanisms are needed to control the disease and provide relief. Vivreon’s small molecule therapeutic candidate compound, which blocks a novel target appropriate for the fight against UC, will be advanced into a full clinical development program as an oral therapy option for these patients.

PI_NAMEs: GREENBERG, MILTON L (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: absorption;Affect;Animal Disease Models;animal efficacy;Animal Model;Anti-Inflammatory Agents;Antigens;autoimmune inflammation;Award;Bacteria;Biological;Biological Sciences;Capital;Cardiovascular system;Cells;channel blockers;Chemicals;Chemistry;Chronic;clinical candidate;clinical development;Colitis;Colon;commercialization;Crohn's disease;Development;Disease remission;disorder control;Dose;drug action;drug candidate;Drug Kinetics;Drug Side Effects;efficacy study;Excretory function;Exhibits;expectation;Exposure to;Feedback;fighting;Financial cost;follow-up;Funding;Gastrointestinal tract structure;Gene Expression;Genes;Genetic Transcription;genotoxicity;Goals;good laboratory practice;immunoregulation;Immunosuppression;improved;Individual;Inflammation;Inflammatory;Inflammatory Bowel Diseases;Inflammatory Response;inhibitor;interest;Intestines;Investigational Drugs;Investigational New Drug Application;Investments;Lead;Lesion;leukocyte activation;Leukocytes;Life;Maintenance;manufacture;Mediating;Metabolism;Mission;monocyte;National Institute of Allergy and Infectious Disease;next generation;novel;novel therapeutic intervention;nuclear factors of activated T-cells;Oral;Oral Administration;Pathogenicity;Pathologic;Pathway interactions;Patients;Pharmaceutical Preparations;pharmacologic;Pharmacology and Toxicology;Phase;physical property;Plasma;Preparation;prevent;Process;Program Development;programs;Property;Quality of life;receptor;Rectum;respiratory;response;Running;Safety;safety assessment;safety practice;Signal Transduction;Skin;Small Business Innovation Research Grant;small molecule;small molecule therapeutics;T cell therapy;T-cell inflamed;T-Lymphocyte;targeted treatment;Telemetry;Therapeutic;therapeutic candidate;therapeutically effective;Time;Topical agent;Toxic effect;Toxicogenetics;Toxicology;Treatment Efficacy;Ulcerative Colitis;United States Food and Drug Administration;Writing

PROJECT_TITLE: Predevelopment of VV8220, a Gut-selective CRAC Channel Therapeutic for Ulcerative Colitis

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (10)]


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Digestive Diseases;Gene Therapy;Genetics;Liver Disease

ORG_CITY: Brooklyn

ORG_NAME: MIRIMUS, INC.

ORG_STATE: NY

PHR: Narrative RNA interference (RNAi) – a natural biological mechanism by which eukaryotic cells control gene expression – can be used to target and silence with high specificity virtually any expressed gene, making it a potentially powerful therapeutic approach if the appropriate intracellular delivery vehicle can be deployed to reach tissues of interest. Here, we aim to establish an in vivo pipeline for scalable evaluation of novel RNAi therapeutics using established delivery platforms conjugated to our RNAi payloads. We will perform in vitro and in vivo assessment of select RNAi nucleic acid based therapeutics (NBTs) to evaluate biodistribution, systemic effects, and the inhibitory potential of a target gene using our dual fluorescence reporter model – the Optimus model – and their potential for future clinical use to treat human diseases.

PI_NAMEs: PREMSRIRUT, PREM KHOVABUTR (contact)

PROGRAM_OFFICER_NAME: KODURI, SAILAJA

PROJECT_TERMS: Acceleration;Adenocarcinoma Cell;Algorithms;Animals;aptamer;Binding;Biodistribution;Biological;Biological Availability;Biological Products;Biological Response Modifier Therapy;Cell Line;Cell Transplantation;Cells;Chemical Injury;Clinical;Collaborations;Combined Modality Therapy;Coupled;Coupling;delivery vehicle;DNA;DNA cassette;dosage;Dose;drug development;Elements;Engineering;Enzymes;Eukaryotic Cell;Evaluation;Event;experimental study;extracellular vesicles;Family;Feasibility Studies;Fluorescence;Future;Gene Expression;Gene Silencing;Gene Targeting;Genes;Hepatic Stellate Cell;human disease;improved;In Vitro;in vivo;in vivo evaluation;in vivo Model;innovation;interest;International;Intravenous;Ligands;lipid nanoparticle;Liver diseases;Liver Fibrosis;Lung Adenocarcinoma;lung cancer cell;Measures;Methods;MicroRNAs;Modality;Modeling;Monitor;mouse model;next generation;novel;novel therapeutics;nucleic acid-based therapeutics;oligonucleotide delivery;Oligonucleotides;particle;Penetration;Peptide Hydrolases;Peptides;Pharmaceutical Preparations;Pharmacotherapy;Phase;Phosphotransferases;preclinical development;Process;Protein Family;Protein Inhibition;Proteins;Recombinant adeno-associated virus (rAAV);Reporter;Reporter Genes;Research;RNA Interference;RNA Interference Therapy;RNA Sequences;scaffold;Schedule;Screening procedure;Serotyping;Small Business Innovation Research Grant;Small Interfering RNA;small molecule;small molecule inhibitor;Specific qualifier value;Specificity;subcutaneous;synthetic lethal interaction;System;Technology;Testing;Therapeutic;Therapeutic Uses;Tissues;tool;Toxic effect;trafficking;uptake;Validation;Vertebral column;Viral Interference;Viral Vector;virtual;Whole Organism;Work

PROJECT_TITLE: Creation of the Next Generation RNAi Therapeutics and an in vivo model for their study


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Prevention;Social Determinants of Health

ORG_CITY: CORAL GABLES

ORG_NAME: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE

PHR: Narrative We propose a trial comparing two social network strategies for engaging current PrEP clients to distribute HIV self-test (HIVST) kits and PrEP information to their social network contacts. The study evaluates the strategies' reach, implementation, and effectiveness among 320 PrEP clients. By leveraging trusted networks, this research aims to overcome barriers and contribute to combating the HIV epidemic in priority areas.

PI_NAMEs: DOBLECKI-LEWIS, SUSANNE  (contact)

PROGRAM_OFFICER_NAME: POLLARD-BRANCHARD, SUZANNE LEE

PROJECT_TERMS: acceptability and feasibility;Address;Adoption;AIDS prevention;Area;barrier to testing;Black race;Caring;Client;Clinic;Collaborations;combat;Communities;community partners;compare effectiveness;Consolidated Framework for Implementation Research;Consultations;contextual factors;cost;County;design;Diagnostic Reagent Kits;Effectiveness;effectiveness evaluation;effectiveness-implementation RCT;effectiveness/implementation hybrid;efficacy/implementation trial;Ego;Ensure;Epidemic;epidemiologic data;Equity;experience;Florida;Health;Hispanic;HIV;HIV diagnosis;Hour;Human immunodeficiency virus test;Hybrids;implementation determinants;implementation science;Incidence;Individual;Knowledge;Latino;Location;Mediator;meetings;member;men who have sex with men;Modeling;Neighborhoods;Participant;pilot test;Population;Positioning Attribute;pre-exposure prophylaxis;primary outcome;Privacy;Randomized;Reach, Effectiveness, Adoption, Implementation, and Maintenance;recruit;Reporting;Research;Resources;response;secondary outcome;self testing;Services;Sexual Health;Site;social culture;social engagement;Social Network;social stigma;Social support;success;Testing;theories;Training;trial comparing;Trust;United States;uptake

PROJECT_TITLE: Test-to-PrEP: A Randomized Hybrid Implementation/Effectiveness Trial of a Social Network Strategy to Increase Equitable Reach of HIV Testing and PrEP Information


ADMINISTERING_IC: AA

ED_INST_TYPE: SCHOOLS OF EDUCATION

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Pediatric;Pediatric - AIDS;Prevention;Sexually Transmitted Infections;Social Determinants of Health;Substance Misuse;Underage Drinking

ORG_CITY: Nashville

ORG_DEPT: SOCIAL SCIENCES

ORG_NAME: VANDERBILT UNIVERSITY

ORG_STATE: TN

PHR: PROJECT NARRATIVE The proposed research is relevant to public health by developing novel intervention strategies to reduce heavy alcohol use and increase HIV/STI prevention behaviors among adolescents and young adults in an HIV- endemic setting. The proposed research is relevant to NIAAA Research Priorities to develop “effective prevention and treatment strategies that address the risks for the physical, behavioral, and social consequences that result from excessive drinking,” preventing “children and adolescents from beginning and continuing to drink alcohol” and “offering effective intervention for problem alcohol use at all ages.” The proposed research is also relevant to NIAAA HIV/AIDS Research Priorities to “improve HIV testing and entry to treatment for women and men who drink across a range of severity, including multi-level interventions and measures that impact at the population level”, and addressing health disparities among young women in international settings.

PI_NAMEs: PERKINS, JESSICA M (contact)

PROGRAM_OFFICER_NAME: FREEMAN, ROBERT

PROJECT_TERMS: Address;Adolescent;Adolescent and Young Adult;Adult;Affect;Africa;Age;AIDS prevention;Alcohol abuse;Alcohol consumption;Alcohols;Behavior;Behavioral;Biological Markers;boys;Child;Cohort Studies;Country;Data;Eastern Africa;effective intervention;Enrollment;Focus Groups;Foundations;Gender;girls;Health;Health behavior;health disparity;Heavy Drinking;HIV;HIV Infections;HIV risk;HIV/AIDS;HIV/STD;Human immunodeficiency virus test;improved;Income;innovation;instrument;International;Intervention;intervention effect;intervention refinement;Interview;Measures;Mediating;men;Methods;modifiable risk;National Institute on Alcohol Abuse and Alcoholism;novel;Outcome;Parameter Estimation;peer;Peer Group;Perception;personalized normative feedback;phosphatidylethanol;Population;population based;Population Study;prevent;Prevention;Prevention strategy;Public Health;Publishing;Qualitative Methods;Randomized, Controlled Trials;Research;Research Priority;response;Risk;Risk Behaviors;Risk Factors;Rural;Sampling;Schools;Secondary Schools;Severities;sex;social;Southern Africa;STI prevention;Structural Models;Surveys;Testing;transmission process;treatment strategy;Uganda;UNICEF;uptake;women's treatment;young adult;young woman

PROJECT_TITLE: Perceived Norms About Alcohol Use and HIV/STI Prevention among Adolescents and Young Adults in Rural Uganda

STUDY_SECTION: HIBI

STUDY_SECTION_NAME: HIV/AIDS Intra- and Inter-personal Determinants and Behavioral Interventions Study Section[HIBI]


NIH_SPENDING_CATS: Chronic Liver Disease and Cirrhosis;Digestive Diseases;Hepatitis;Liver Disease;Nutrition;Obesity

ORG_NAME: FUNCTION THERAPEUTICS, INC.

PHR: PROJECT NARRATIVE In this project, a new class of anti-inflammatory small molecules called parmodulins will be investigated for the potential treatment of metabolic dysfunction-associated steatohepatitis (MASH). Novel compounds will be synthesized, tested in vitro, and tested in a model of advanced MASH in mice. This progressive liver disease affects a significant fraction of people worldwide, and safe and effective medications for MASH with new modes of action could be widely beneficial.

PI_NAMEs: DOCKENDORFF, CHRISTOPHER  (contact)

PROGRAM_OFFICER_NAME: DENSMORE, CHRISTINE L

PROJECT_TERMS: activated Protein C;Adult;Adverse effects;Affect;analog;antagonist;Anti-Inflammatory Agents;Antiinflammatory Effect;Apoptosis;Basic Science;Benchmarking;beta-arrestin;Biological Assay;Bleeding time procedure;Blood Platelets;Carbon Tetrachloride;Cavia;Cell model;Cholesterol;Chronic;Coagulation Process;Collaborations;Contractor;Cytoprotection;cytotoxicity;Cytotoxin;Dangerousness;Data;design;Diet;Dioxins;Disease;Disease Progression;Dose;Drug Industry;Drug Kinetics;drug standard;Endothelium;Equilibrium;experience;Fatty acid glycerol esters;fatty liver disease;FDA approved;Fibrosis;Future;Glucose;Hemorrhage;Hemostatic Agents;Hemostatic function;Hepatocyte;Hepatotoxicity;High Fat Diet;improved;In Vitro;in vitro testing;Inflammation;Inflammatory;inhibitor;Insulin Resistance;Investments;Lead;lead optimization;Ligands;Link;Lipids;Liver;Liver diseases;Liver Fibrosis;liver inflammation;liver injury;Liver Microsomes;Measures;Mediating;Metabolic;Metabolic dysfunction;metabolic profile;Michigan;Modality;Modeling;mouse model;Mus;nonalcoholic steatohepatitis;novel;novel strategies;Obese Mice;Obesity;Oral;PAR-1 Receptor;Pathogenesis;Peptide Hydrolases;Persons;Pharmaceutical Chemistry;Pharmaceutical Preparations;Pharmacology;Phenotype;Plasma;pre-clinical;preclinical development;Property;protective effect;Publishing;Relative Risks;Reporting;Research Personnel;scaffold;Series;Signal Transduction;small molecule;Solid;Solubility;Staurosporine;Steatohepatitis;sugar;Testing;Tetrachlorodibenzodioxin;Therapeutic;Thrombin;Thrombin Receptor;thromboinflammation;Tissues;TNF gene;unpublished works;Variant

PROJECT_TITLE: Small Molecule PAR1 Ligands for the Treatment of MASH


NIH_SPENDING_CATS: Autoimmune Disease;Biotechnology;Digestive Diseases;Inflammatory Bowel Disease;Microbiome

ORG_CITY: NEW YORK

ORG_NAME: ANCILIA, INC.

PHR: Project Narrative Live biotherapeutic products (LBPs) clinical success depends on successful engraftment within a recipient microbiome. Ancilia Biosciences is developing a novel class of LBPs by leveraging the natural function of CRISPR-Cas to immunize E. coli Nissle against viruses found in the IBD intestinal tract. Strains with engineered immunity will more efficiently and stably colonize patients with IBD thereby improving clinical outcomes and the risk of relapse. Insights gained from the proposed research will ultimately improve our ability to better prevent, and treat intestinal disease, thereby contributing to the success of NIH’s mission.

PI_NAMEs: BARRANGOU, RODOLPHE ;FOLEY, MATTHEW HARRISON (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Acute;adaptive immunity;Address;Adrenal Cortex Hormones;Adverse effects;Bacteria;Bacterial Genome;Bacteriophages;Biological Response Modifier Therapy;Biological Sciences;burden of illness;Clinic;Clinical;Clustered Regularly Interspaced Short Palindromic Repeats;Colitis;Collaborations;commercialization;Communicable Diseases;Crohn's disease;Cytolysis;Development;dextran sulfate sodium induced colitis;Disease;distinguished professor;DNA;Economic Burden;Engineering;Engraftment;Environmental Risk Factor;Escherichia coli;experimental study;fitness;Functional disorder;Genetic;Genome engineering;Goals;gut colonization;gut microbiome;Hemorrhagic colitis;Human;immune modulating agents;Immunity;Immunize;improved;In Vitro;in vivo;Inflammation;Inflammatory Bowel Diseases;insight;intestinal barrier;Intestinal Diseases;Intestines;Lytic;Methods;microbiome;microbiome components;mid-career faculty;Mission;Modality;mouse model;Mus;new technology;novel;Outcome;Pathogenesis;Patients;portability;Predatory Behavior;Prevalence;prevent;rational design;Recording of previous events;reduce symptoms;relapse risk;Research;Role;stool sample;success;System;Therapeutic;translational impact;Treatment Efficacy;Ulcerative Colitis;United States National Institutes of Health;Universities;Virus;Work

PROJECT_TITLE: Enhancing E. coli Nissle colonization with CRISPR-Cas immunity


NIH_SPENDING_CATS: Bioengineering;Brain Disorders;Clinical Research;Epilepsy;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Prevention

ORG_NAME: SOTERYA, INC.

PHR: Project Narrative Sudden Unexpected Death in Epilepsy (SUDEP) is the leading cause of death in young patients with epilepsy that typically occurs during sleep and in prone (face-down) position after a convulsion. The goal of this SBIR Phase 2 application is to utilize the body position sensors and the expandable cells developed in the Phase 1 project to develop the fully autonomous repositioning mattress-KORUS to prevent the prone position after a seizure and significantly decrease the risk of SUDEP.

PI_NAMEs: BANSAL, PRANAV  (contact);LEE, JONG WOO

PROGRAM_OFFICER_NAME: FORBES, JESSICA CARLENE

PROJECT_TERMS: 3-Dimensional;Address;Admission activity;Adult;Advocate;Anatomy;Apnea;Applications Grants;Arousal;Articulation;Asphyxia;Beds;Biomechanics;body map;body position;Breakthrough device;Caring;Cause of Death;Cell surface;Cells;Cellular Phone;Central Sleep Apnea;Cessation of life;Child;Clinical Trials;commercialization;Communication;Computer software;Convulsions;cost;Dangerousness;Data;design;Detection;Development;Devices;digital;digital twin;Electroencephalography;Environment;Epilepsy;Evaluation;Event;Expert Systems;Face;family burden;Generations;Goals;high volume manufacturing;Home;Hospitals;Impairment;improved;Individual;innovation;Intervention;Life;lifetime risk;Lifting;Machine Learning;Maps;Marketing;Mattresses;Mechanics;Medical;Medical Device;Mission;Monitor;Neurologic;Neurologist;operation;Patients;Performance;Phase;Positioning Attribute;post stroke;pressure;prevent;Prone Position;prototype;rapid detection;Recording of previous events;Recovery;recruit;Resistance;Resolution;Respiration;Risk;Risk Reduction;Seizures;sensor;Services;Shapes;simulation;simulation environment;Sleep;Small Business Innovation Research Grant;software development;sudden unexpected death in epilepsy;Supervision;Surface;System;Tablets;Technology;Testing;Time;Tonic - clonic seizures;Woman

PROJECT_TITLE: A Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP)

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-C (10)]


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Bioengineering

ORG_CITY: Eugene

ORG_NAME: NEMAMETRIX, INC.

ORG_STATE: OR

PHR: NARRATIVE  The zebrafish (Danio rerio) is a widely used animal model for discovery of disease mechanisms and for therapeutic drug development. However, zebrafish caretaking and husbandry is currently a subjective, inefficient and time-consuming endeavor which introduces variability into zebrafish studies. This SBIR project funds the development of a health monitoring system which can be deployed at zebrafish facilities worldwide.

PI_NAMEs: BROCK, TRISHA  (contact);MCCORMICK, KATHRYN E;PRESTON, MARY A.

PROGRAM_OFFICER_NAME: CONTRERAS, MIGUEL A

PROJECT_TERMS: Achievement;Adult;Affect;Agar;Algorithmic Software;Algorithms;animal imaging;Animal Model;Animals;Aquaculture;Area;automated algorithm;Behavioral;Caenorhabditis elegans;Consumption;cost;cost effective;Data;Data Analyses;data management;Databases;design;Development;Disease;drug development;Ensure;Environmental Monitoring;Ethical Issues;experimental study;feeding;Fishes;Funding;Genes;global health;Health;healthspan;Height;Hour;Human;human disease;human model;Image;image processing;Imaging Device;imaging system;improved;insight;Laboratories;Length;life span;Monitor;Morphology;Movement;Mus;Nematoda;nutrition;Orthologous Gene;Pattern;Phase;Phenotype;Population;product development;prototype;Provider;Reporting;Reproducibility;Research;response;Rest;Scientist;screening;Site;Small Business Innovation Research Grant;software development;Standardization;System;Systems Analysis;Temperature;Testing;Therapeutic;Time;tool;United States;Veterinarians;Visual;wasting;water quality;Work;Zebrafish

PROJECT_TITLE: Improving Husbandry and Data Reproducibility Through Automated Health Monitoring in Zebrafish Facilities


FUNDING_MECHANISM: TRAINING, INSTITUTIONAL

NIH_SPENDING_CATS: HIV/AIDS;Infectious Diseases

ORG_DEPT: BIOSTATISTICS & OTHER MATH SCI

ORG_NAME: HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH

PHR: Narrative The Biostatistics and Epidemiology in AIDS Training Program at the Harvard T. H. Chan School of Public Health prepares predoctoral and postdoctoral trainees in the application of biostatistics and epidemiology to HIV/AIDS research. The Program combines first class training in the development of theory and methods in the fields of biostatistics, epidemiology, computational biology/bioinformatics and health data science relevant to HIV research, with practical experience in HIV research collaborations in multidisciplinary team science settings. The Program also provides trainees with the skills necessary for scientific leadership in interdisciplinary settings, focusing on skills for collaboration, communication, grant writing and career development.

PI_NAMEs: HUGHES, MICHAEL DAVID (contact)

PROGRAM_OFFICER_NAME: REFSLAND, ERIC WILLIAM

PROJECT_TITLE: Biostatistics/Epidemiology Training Grants in AIDS

STUDY_SECTION: AIDS

STUDY_SECTION_NAME: Acquired Immunodeficiency Syndrome Research Study Section[AIDS]