NIH_SPENDING_CATS: Biotechnology;Immunization;Immunotherapy;Infectious Diseases;Lung;Pediatric;Pneumonia;Pneumonia and Influenza;Prevention

ORG_CITY: Morrisville

ORG_NAME: INHALON BIOPHARMA, INC.

ORG_STATE: NC

PHR: Project Narrative Early treatments against respiratory syncytial virus (RSV), the leading cause of bronchiolitis and pneumonia in the U.S., are sorely needed. To address this need, Inhalon is advancing IN-002, an inhaled monoclonal antibody therapy against RSV that can be dosed with at-home convenience; Inhalon has already manufactured clinical trial materials, and are on schedule to execute a Phase 1 study for IN-002 in the first half of 2024. In this proposal, we seek support to complete the non-clinical elements of the study, including measuring the specific levels of IN-002 over time in the nasal turbinates and blood at different times following inhaled dosing.

PI_NAMEs: HUTCHINS, JEFF T (contact)

PROGRAM_OFFICER_NAME: KIM, SONNIE

PROJECT_TERMS: Address;Adult;Affinity;Age;Animal Model;Anti-viral Agents;Anti-viral Therapy;Antibodies;Antibody Therapy;Award;Back;Binding;Biological Assay;Biometry;Blood;Bronchiolitis;Cells;Cessation of life;Child;Climate;Clinic;Clinical;Clinical Research;Clinical Trials;cost;COVID-19;COVID-19 treatment;cross reactivity;Daughter;Development;Dose;Drug Kinetics;Early treatment;efficacy evaluation;Elderly;Elements;Engineering;Environment;Enzyme-Linked Immunosorbent Assay;Epithelium;expectation;experience;Fc domain;first-in-human;Focal Infection;Funding;Future Generations;Goals;Grant;Guidelines;handheld equipment;Healthcare;Home;Hospitalization;Human;human study;Immunocompromised Host;Immunoglobulin G;immunoprophylaxis;Individual;Infant Mortality;Infection;Infrastructure;Inhalation;lamb model;Lung;manufacture;Measures;Medical;minimal risk;Modeling;Monoclonal Antibodies;Monoclonal Antibody Therapy;Morbidity - disease rate;mortality;Mucins;Mucociliary Clearance;Mucous body substance;nasal swab;Nasal turbinate bone structure;Nebulizer;Necrosis;Neonatal;neutralizing monoclonal antibodies;Nose;Palivizumab;Pharmaceutical Preparations;Phase;phase 1 study;phase 2 study;Phase I Clinical Trials;Phase II Clinical Trials;Pneumonia;Polysaccharides;Population;portability;Positioning Attribute;Premature Infant;prevent;programs;Prophylactic treatment;Rattus;Reporting;respiratory;respiratory pathogen;Respiratory syncytial virus;Respiratory Syncytial Virus Infections;Respiratory syncytial virus RSV F proteins;Respiratory System;Safety;safety and feasibility;Schedule;Series;Serum;Site;Specimen;Structure of parenchyma of lung;Therapeutic;Time;Tissues;Vaccines;Validation;validation studies;vibration;Viral;Viral Load result;Viremia;Virion;virtual;Virus;Vision;Work;Writing

PROJECT_TITLE: Pharmacokinetics analysis from first-in-human study of IN-002, a potent inhaled muco-trapping antibody therapy for RSV


ADMINISTERING_IC: EB

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Pain Research;Patient Safety;Physical Activity;Physical Rehabilitation;Rehabilitation;Rural Health;Telehealth

ORG_CITY: TIMNATH

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: ASSISTIVE TECHNOLOGY DEVELOPMENT, INC.

ORG_STATE: CO

PHR: Project Narrative This project aims to reduce the cost and time of recovery from lower limb orthopedic injury or surgery through the development of a telerehabilitation device that provides motorized exercise modes coupled with blood flow restriction to enhance the effectiveness of low-load exercise while recording data and sharing progress with the patient’s care team, whether the patient is in a clinic or at home. A low-cost telehealth solution will also increase accessibility for those in rural areas. Furthermore, by providing a single device to quantify and record exercise conditions, blood-flow parameters, and progress over time, this project has the potential to contribute to a better scientific understanding of the effects of blood flow restriction on exercise, especially when used for musculoskeletal conditions.

PI_NAMEs: BILLI, FABRIZIO ;WILKINSON, DAVID  (contact)

PROGRAM_OFFICER_NAME: ASHMONT, KARI RICH

PROJECT_TERMS: Address;Affect;Age;Anterior Cruciate Ligament;anterior cruciate ligament reconstruction;Blood flow;Clinic;Clinic Visits;clinical practice;Clinical Trials;commercialization;cost;cost effective;Coupled;Data;Data Aggregation;design;Development;Devices;digital;Effectiveness;Evaluation;Exercise;Expenditure;experience;Feedback;Goals;Growth;health care quality;Healthcare;Home;Impairment;Injury;Intuition;Knee;Knee Injuries;Knee joint;knee replacement arthroplasty;Leg;Ligaments;light weight;Lower Extremity;manufacture;Marketing;Medicare;Mobility decline;mode of exercise;Modeling;Motor;Muscle;muscle strength;Muscular Atrophy;Musculoskeletal;novel;operation;Operative Surgical Procedures;Orthopedic Surgery;Orthopedics;Outcome;Pain;pain reduction;Patient Care Team;Patients;Persons;Phase;Physical Function;physical therapist;Physical therapy;Pilot Projects;Population;pressure;Procedures;prototype;Pump;reconstruction;Reconstructive Surgical Procedures;Recovery;Reflex action;repaired;Research;Retrieval;Risk;Robotics;rural area;Rural Community;Safety;Small Business Innovation Research Grant;Stretching;success;Surveys;System;Technology;telehealth;telerehabilitation;Testing;Thigh structure;Time;Torque;Tourniquets;Training;trend;United States;usability;vein occlusion;Weight

PROJECT_TITLE: A lightweight robotic telerehabilitation device with integrated blood flow restriction for patients with musculoskeletal conditions

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


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Biotechnology;Genetics;Human Genome

ORG_CITY: MADISON

ORG_NAME: SCARAB GENOMICS, LLC

ORG_STATE: WI

PHR: The bacteria Escherichia coli (E. coli) continues to be a major vehicle used in the production of proteins and DNA in the biotechnology and pharmaceutical industry. However, improvements in genetic stability coupled with a reduction in deleterious elements unique to E. coli such as endotoxin would greatly improve and simplify its use. A E. coli strain that would encapsulate enhanced production characteristics and safety would greatly benefit the biopharmaceutical industry.

PI_NAMEs: BLATTNER, FREDERICK R;FRISCH, DAVID A (contact)

PROGRAM_OFFICER_NAME: BILLINGSLEA, EDDIE

PROJECT_TERMS: Address;Antineoplastic Agents;Bacteria;Biological Assay;Biological Products;biopharmaceutical industry;Biotechnology;Carbohydrates;Cell Density;Characteristics;Chimeric Proteins;comparative;cost;Coupled;Data;Denileukin Diftitox;density;Disease;DNA;DNA purification;DNA Transposable Elements;Drug Industry;Elements;Encapsulated;Endotoxins;Engineering;Enzymes;Escherichia coli;FDA approved;Fermentation;flasks;gene therapy;Genes;Genetic;Genetic Enhancement;Genetic Techniques;Genome;Genomics;Goals;Growth;Human papillomavirus 16;Immunoglobulin Fragments;improved;inorganic phosphate;interest;IS Elements;Legal patent;Limulus;Lipid A;Measures;Methods;next generation;Nucleic Acids;Phagocytes;Phase;Phosphoric Monoester Hydrolases;Phosphorylation;Phosphorylation Site;Plant Resins;plasmid DNA;Plasmids;Play;Preparation;Process;Production;protein purification;Proteins;Protocols documentation;Publishing;Reagent;receptor;Recombinant Proteins;Research;RNA vaccine;Role;Safety;Salts;Sampling;scale up;Side;small molecule;success;Testing;Therapeutic;therapeutic protein;Therapeutic Uses;Time;TLR4 gene;Toxic effect

PROJECT_TITLE: An improved low-endotoxin Clean Genome E. coli strain for production of biological products

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-G (15)]


ADMINISTERING_IC: HD

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

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

NIH_SPENDING_CATS: 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;Patient Safety;Pediatric;Prevention;Women's Health Research

ORG_CITY: NEW YORK

ORG_DEPT: NEUROLOGY

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

ORG_STATE: NY

PHR: Public Health Relevance: Strengthening the informed consent process is an important step in attaining authentic participation in clinical research, particularly by the vulnerable populations affected by HIV. We will evaluate a visual informed consent document that uses pictures to aid in achieving better comprehension of the requirements of participation in research. The study is nested in an on-going trial in South Africa among mothers living with HIV and their infants.

PI_NAMEs: KUHN, LOUISE  (contact)

PROGRAM_OFFICER_NAME: ESBER, ALLAHNA LAUREN

PROJECT_TERMS: Adult;Affect;Africa;Age;agricultural region;Agricultural Workers;Agriculture;Area;Attitude;Binding;Breast Feeding;Cartoons;Child;Clinical Ethics;Clinical Research;Clinical Trials;Collaborations;Communication;Comprehension;Conflict (Psychology);Consent;Consent Forms;Contracts;Creativeness;Data;Decision Making;design;Development;efficacy evaluation;efficacy testing;Elements;Eligibility Determination;Enrollment;Ethics;Evaluation;Funding;Future;Goals;Growth;Health;HIV;improved;Individual;Industry;Infant;infant morbidity;Informed Consent;Institution;International;Interview;Knowledge;Legal;Life;literacy;low health literacy;Low Literacy Population;Maternal and Child Health;Measures;Medical center;member;Methods;Minor;Morbidity - disease rate;Mothers;multidisciplinary;National Institute of Child Health and Human Development;Nature;New York;North Carolina;novel strategies;Outcome;Parents;Participant;Perception;perinatal HIV;Persons;Population;Postpartum Period;Postpartum Women;pragmatic trial;Pregnant Women;Procedures;Process;prospective;Province;public health relevance;Randomized;randomized trial;Randomized, Controlled Trials;Recommendation;recruit;Regrets;Research;Research Personnel;Respondent;response;Rights;Self Efficacy;Site;Social Sciences;social stigma;South Africa;Structure;Testing;Text;Trust;Universities;usability;vision development;Visit;Visual;Vulnerable Populations;Woman;Work;Writing

PROJECT_TITLE: Strengthening informed consent for authentic participation in perinatal HIV research

STUDY_SECTION: PPAH

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Arthritis;Autoimmune Disease;Infectious Diseases;Lyme Disease;Tickborne Diseases;Vector-Borne Diseases

ORG_CITY: NEW HAVEN

ORG_NAME: L2 DIAGNOSTICS, LLC

ORG_STATE: CT

PHR: PUBLIC HEALTH RELEVANCE Lyme disease (LD), caused by the spirochete Borrelia burgdorferi, is the most common disease transmitted by tick, affecting an estimated 500,000 people in the United States each year. 10-20% of patients experience long-term clinical manifestations, including Lyme arthritis (LA) and/or Post Treatment Lyme Disease Syndrome (PTLDS), for which better therapeutic agents are urgently needed. Our long-term product goal is a novel secretory leukocyte protease inhibitor (SLPI) based therapeutic indicated for advanced Lyme disease, including potentially both LA and PTLDS.

PI_NAMEs: FIKRIG, EROL  (contact)

PROGRAM_OFFICER_NAME: BOWDEN, NADINE

PROJECT_TERMS: Ache;Affect;Aftercare;Albumins;Amoxicillin;Anti-Bacterial Agents;anti-fungal agents;Anti-Inflammatory Agents;Antibiotic Therapy;Antibiotics;Antiinflammatory Effect;antileukoprotease;antimicrobial;Arthralgia;Arthritis;bactericide;Binding;Biological Assay;Borrelia;Borrelia afzelii;Borrelia burgdorferi;Borrelia garinii;C3H/HeN Mouse;Ceftriaxone;Cells;chemokine;Clinical;clinically significant;cytokine;Data;Development;Diagnosis;Disease;disease transmission;Disease-Modifying Second-Line Drugs;dosage;Dose;Doxycycline;Enzyme-Linked Immunosorbent Assay;Etiology;Europe;Excision;experience;Fatigue;Flow Cytometry;Formulation;Fostering;Foundations;Functional disorder;Goals;Half-Life;Histology;Human;Impaired cognition;In Vitro;in vitro Assay;in vivo;Individual;Infection;Infiltration;Intervention;joint inflammation;Joints;Knock-out;Knockout Mice;Knowledge;Libraries;Lyme Arthritis;Lyme Disease;Macrophage;Measures;Methods;Minimum Inhibitory Concentration measurement;Minority;Modeling;Morbidity - disease rate;mouse model;Mus;Muscle;neutrophil;nonhuman primate;novel;novel therapeutics;Oral;Order Spirochaetales;Pain;pathogen;Pathology;Pathway interactions;Patients;Persons;Phase;pleiotropism;Population;Post Treatment Lyme Disease Syndrome;Proteins;public health relevance;Regimen;Research;Resolution;Serum;Severities;Swelling;Symptoms;Synovial Fluid;Synovial joint;Synovial Membrane;Synovitis;Testing;Therapeutic;Therapeutic Agents;tick bite;tick transmission;Tick-Borne Diseases;Tissues;Toxicology;United States;vaccine efficacy;Viral Physiology;Yeasts

PROJECT_TITLE: A novel therapeutic for Lyme arthritis based on a secretory leukocyte protease inhibitor

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-F (12)]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Brain Cancer;Brain Disorders;Cancer;Neurosciences;Rare Diseases

ORG_CITY: MOUNTAIN VIEW

ORG_NAME: CORDANCE MEDICAL, INC.

ORG_STATE: CA

PHR: PROJECT NARRATIVE The NeuroAccess system utilizes focused ultrasound and microbubbles to non-invasively open the blood-brain barrier, enabling liquid biopsy in brain tumor patients. The proposed study aims to optimize this technique's safety and efficacy, potentially providing new tools for brain tumor diagnosis and management. This innovation addresses the critical need for better brain tumor biopsies, promising significant impact on patient care and outcomes. NCI Phase I SBIR Confidential Page 1 of 12 Aims Page and Research Plan Draft

PI_NAMEs: RAMAMURTHY, BHASKAR  (contact)

PROGRAM_OFFICER_NAME: REGMI, SAROJ GOPAL

PROJECT_TERMS: Address;Adult;American;Animals;Back;Biological Assay;Biological Markers;Biopsy;Blood;Blood - brain barrier anatomy;Blood specimen;blood-brain barrier disruption;blood-brain tumor barrier;Brain;Brain Neoplasms;Brain region;brain tissue;Breakthrough device;Cancer Patient;cell free DNA;Circulation;Clinical Research;commercialization;Contrast Media;Data;design;Detection;Devices;Disease;Edema;Effectiveness;Endothelial Cells;Ensure;Enzyme-Linked Immunosorbent Assay;Epidermal Growth Factor Receptor;Extravasation;FDA approved;Focused Ultrasound;Future;Glial Fibrillary Acidic Protein;Glioma;Goals;Hemorrhage;Histology;Human;human data;improved;innovation;liquid biopsy;Magnetic Resonance Imaging;Malignant neoplasm of brain;Malignant Neoplasms;Manufacturer;Marketing;Measures;Mechanics;Methods;Microbubbles;migration;Modeling;Molecular;Molecular Profiling;mutant;Operative Surgical Procedures;Outcome;overexpression;Patient Care;Patient-Focused Outcomes;Patients;Peripheral;Phase;phase 2 study;Physics;prevent;Procedures;Protocols documentation;Rattus;Research;Risk;Safety;Sensitivity and Specificity;Small Business Innovation Research Grant;Solid Neoplasm;Sonication;Specific qualifier value;Specificity;success;System;Techniques;Testing;Tissues;tool;transmission process;treatment duration;tumor;tumor diagnosis;tumor diagnostic;Tumor Markers;Tumor Volume;ultrasound

PROJECT_TITLE: Optimizing non-invasive focused ultrasound for brain tumor liquid biopsy in a rat glioma model - Phase I

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology

ORG_CITY: TEMPE

ORG_NAME: BIOSENSING INSTRUMENT, INC.

ORG_STATE: AZ

PHR: PROJECT NARRATIVE  This project addresses the significant unmet need for study of membrane protein binding kinetics in their native microenvironment, thereby mitigating costly missteps and false leads in drug development. Plasmonic Scattering Microscopy (PSM) technology will be developed for high throughput label-free analysis of in situ molecular interaction kinetics and binding heterogeneity among hundreds of individually resolved cells simultaneously and is compatible with fluorescence imaging for simultaneous orthogonal validation. PSM will have a large impact on biomedical research of cellular processes, discovery of biomarkers, and screening of drug candidates.

PI_NAMEs: LY, NGUYEN  (contact)

PROGRAM_OFFICER_NAME: YEH, ALVIN TIEN-WEI

PROJECT_TERMS: Acceleration;Address;Adoption;Agglutinins;Area;Arizona;base;Behavior;Binding;Binding Proteins;Biological Markers;Biological Models;biomarker discovery;Biomedical Research;Biosensing Techniques;Cell Density;Cell membrane;Cell Physiology;Cell surface;Cells;Collaborations;commercial prototype;commercialization;contrast imaging;cost;Data;data quality;detection method;detection sensitivity;Development;disease diagnosis;drug candidate;drug development;Drug Industry;Drug Screening;Drug Targeting;Elasticity;Environment;Event;Exhibits;Feedback;Fluorescence;fluorescence imaging;Generations;Heterogeneity;high throughput technology;Image;imaging capabilities;improved;In Situ;Individual;innovation;instrument;interest;Kinetics;Label;Lectin;Ligands;light scattering;Lighting;Lipids;Mainstreaming;Measurement;Measures;Membrane Glycoproteins;Membrane Proteins;Methods;microscopic imaging;Microscopy;Molecular;Noise;novel strategies;Optics;pancreatic cancer cells;Performance;Pharmaceutical Preparations;Pharmacologic Substance;Phase;plasmonics;Play;Population;Process;protein function;prototype;receptor;Refractive Indices;Research;Resolution;response;sensor;Signal Transduction;Small Business Technology Transfer Research;small molecule;success;Surface;Surface Plasmon Resonance;System;Technology;temporal measurement;Testing;Time;United States National Institutes of Health;Universities;usability;Validation;Work

PROJECT_TITLE: Plasmonic Scattering Microscopy for high-throughput in-situ quantification of molecular binding kinetics on single cells

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-S (12)]


ORG_CITY: WEST NEWTON

ORG_NAME: MIXEDLCMEDIA LLC

ORG_STATE: MA

PHR: PROJECT NARRATIVE  Deep proteomic profiling of scarce biological and clinical samples is still a major challenge since no amplification techniques are available for proteins and proteoforms, and current state-of-the-art proteomic techniques based on conventional chromatography columns coupled with mass spectrometry provide suboptimal performance and sensitivity levels. In this study, based on our novel, currently unavailable on the market, chromatographic column technology, we plan to build a reliable, robust, thoroughly evaluated commercialization-ready prototype chromatography platform to enable ultrasensitive proteomic profiling and address the challenges of numerous clinical, academic, and industrial laboratories. If successful, we will commercialize the technology to satisfy current customer needs in high-sensitivity proteomic analysis and tackle numerous biological and pathological phenomena that currently could not be investigated in amount-limited samples.

PI_NAMEs: IVANOV, ALEXANDER R (contact)

PROGRAM_OFFICER_NAME: BARNES, CHARLES ASHLEY

PROJECT_TERMS: Address;Alzheimer's Disease;Animal Model;Area;Biological;Biological Models;Biology;Biomedical Research;Biopsy;Biotechnology;Blood;Businesses;Capillary Electrophoresis;Cardiovascular Diseases;Cell model;Cell Separation;Cell Therapy;Cells;Cellular Phone;Chemistry;Chromatography;Clinical;clinical application;clinical diagnostics;Column Chromatography;commercialization;commercialization readiness;Communicable Diseases;Coupled;detection limit;Device or Instrument Development;Diagnostic;Disease;Disease Pathway;Dryness;Early Diagnosis;Elements;Engraftment;Ensure;experience;Forensic Medicine;Future;Gas Chromatography;General Population;genomic profiling;Genomics;Geometry;Goals;Health Insurance;Heating;Industrialization;instrument;instrumentation;interest;Laboratories;Laboratory Research;Lasers;lipidomics;liquid biopsy;Liquid Chromatography;liquid chromatography mass spectrometry;Liquid substance;Malignant Neoplasms;Marketing;Mass Spectrum Analysis;metabolomics;Modeling;Molecular;Molecular Analysis;Morphology;nano;nanoelectrospray;Needles;Neonatal;Neoplasm Circulating Cells;new therapeutic target;next generation;novel;novel marker;Oligonucleotides;Organelles;Organoids;Outcome;Pathologic;Patients;Peptides;Performance;personalized medicine;Pharmacologic Substance;Phenotype;Physiological;Play;Population;Porosity;Post-Translational Protein Processing;Proteins;Proteome;Proteomics;prototype;Publications;Quality of life;Reproducibility;Research Personnel;Sampling;Signal Transduction;Specimen;Spottings;stem cells;Techniques;Technology;Tissues;transcriptomic profiling;transcriptomics;Traumatic Brain Injury;Tubular formation;wasting;Work

PROJECT_TITLE: Next-generation nanoflow LC column technology to enable high sensitivity proteomics of limited samples

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


ORG_CITY: LOUISVILLE

ORG_DEPT: BIOCHEMISTRY

ORG_NAME: UNIVERSITY OF LOUISVILLE

ORG_STATE: KY

PHR: PROJECT NARRATIVE The proposed research involves the development of a novel statistical phylogenetic tool for identification of pathogen social interactions and its potential application for treatment of HIV as a cooperative biosystem within the human host. Simulated compensatory mutations in a structured population, as well as publicly available, longitudinal genomic data from the SIV-infected macaque model will be used to validate the tool and test the central hypothesis surrounding HIV social behavior. The goal of this study is to improve our understanding of the interactions at the pathogen population level involved in immune evasion and drug resistance that plagues human health.

PI_NAMEs: MAGALIS, BRITTANY  (contact)

PROGRAM_OFFICER_NAME: GEZMU, MISRAK

PROJECT_TERMS: Address;Adopted;Altruism;Anatomy;Anti-retroviral resistance;Anti-viral Therapy;Antibiotic Therapy;Area;Automobile Driving;B-Lymphocyte Epitopes;Bacteria;Bacterial Infections;Behavior;biofilm species;Biological;Characteristics;Chronic;chronic infection;cohort;Communities;Complex;conditional mutant;Cooperative Behavior;Data;design;Development;Drug resistance;Epitopes;Event;Evolution;Exhibits;experience;fitness;Frequencies;Genes;Genome;genomic data;Genomics;Goals;Health;Hepatitis C virus;HIV;HIV Infections;Human;Immune;Immune Evasion;Immune response;Immune system;immunogenic;Immunotherapeutic agent;Immunotherapy;improved;in vivo;Individual;Infection;innovation;Length;lens;Life;Macaca;Maintenance;Measurable;Microbial Biofilms;Modeling;Mutation;mutation correction;Nature;neutralizing antibody;novel;novel therapeutic intervention;Organ;Organism;overpopulation;particle;pathogen;Pathway interactions;Pattern;Phylogenetic Analysis;Phylogeny;Play;Population;Population Dynamics;prevent;Prevention;Prokaryotic Cells;Proteins;Research;Resistance;RNA;Role;Sampling;Shapes;simulation;Site;SIV;social;Social Behavior;Social Interaction;Specific qualifier value;stem;Structure;Subgroup;Systemic infection;Testing;Therapeutic;Time;Tissue Sample;Tissues;tool;treatment strategy;Variant;Vertebrates;Viral;Virus;Virus Diseases;whole genome

PROJECT_TITLE: Description of HIV social behavior using a phylogenetic model of structured co-evolution

STUDY_SECTION: HVCD

STUDY_SECTION_NAME: HIV Molecular Virology, Cell Biology, and Drug Development Study Section[HVCD]


NIH_SPENDING_CATS: Cancer;Cervical Cancer;Clinical Research;Health Services;Infectious Diseases;Prevention;Primary Health Care;Sexually Transmitted Infections;Telehealth;Women's Health Research

ORG_CITY: SAN FRANCISCO

ORG_NAME: TEAL HEALTH INC

PHR: PROJECT NARRATIVE  Limited access to and insufficient uptake of screening remain persistent barriers to cervical cancer elimination as a public health threat. The Teal Health self-collect device (Teal Wand) is designed to help women collect their own vaginal sample for Human Papillomavirus (HPV) testing on FDA approved assays for primary HPV, thereby doubling (or more) participation in screening. FDA approval of at-home screening has the potential to decrease health disparities and improve access to preventive women’s health services among those who experience barriers or are not accessing preventive care in the current system.

PI_NAMEs: DEPEL, TRENA ;FITZPATRICK, MEGAN  (contact)

PROGRAM_OFFICER_NAME: LOU, XING-JIAN

PROJECT_TERMS: 15 year old;Acceleration;Affect;Agreement;Biological Assay;Cell Line;Cervical Cancer Screening;Classification;Clinic;Clinical;Clinical Research;Collection;commercial application;Communication;Computer software;Country;Data;design;Detection;Devices;Dryness;Evaluation;experience;FDA approved;Feedback;girls;Health;Health Personnel;Hela Cells;Home;HPV screening;Human Papilloma Virus Vaccination;Human Papillomavirus;Human papillomavirus 16;Human papillomavirus 18;Improve Access;improved;Income;innovation;Intervention;Link;Malignant neoplasm of cervix uteri;Malignant Neoplasms;Marketing;Methods;novel;Outpatients;Participant;Performance;Persons;Phase;Pilot Projects;pilot test;Polyurethanes;Population;Porifera;Preventive;Preventive care;Preventive screening;Public Health;Reduce health disparities;Research Design;Rotation;sample collection;Sampling;San Francisco;screening;screening program;Shipping;Source;standard of care;Surveys;Suspensions;System;Tampons;telehealth;Testing;Texture;Time;uptake;usability;Vaccinated;Vaccination;Vagina;Viral;Virus;Visit;Woman;Women's Health Services

PROJECT_TITLE: Evaluation of the Teal self-collect device for cervical cancer screening

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CDPT-V (13)]


NIH_SPENDING_CATS: Bioengineering;Nanotechnology

ORG_CITY: MENLO PARK

ORG_NAME: NUMENTUS TECHNOLOGIES INC.

PHR: PROJECT NARRATIVE  Natural biological nanoparticles called exosomes are involved in cancer and neurodegenerative and cardiovascular diseases, as well as in normal physiology. Similar particles from endogenous bacteria called outer membrane vesicles (OMVs) are involved in both infections and normal physiology (maintaining a healthy microbiome) and are implicated in cancer (tumor) development because of an aberrant microbiome. We will develop and test a new technology platform for detailed exosome/OMV analysis that will help to (i) improve methods for diagnosis and prognosis of cancer and other diseases and (ii) monitor host/microbiome health and infections.

PI_NAMEs: FARIS, GREGORY W (contact)

PROGRAM_OFFICER_NAME: GERSHENSON, ANNE

PROJECT_TERMS: Address;Area;Bacteria;Biological;Biological Markers;Biology;Blood;Body Fluids;Breast Cancer cell line;Calibration;cancer cell;Cancer cell line;Cancer Prognosis;Cardiovascular Diseases;Categories;Cells;Clinical;clinically relevant;Communication;Complex;Data;design;Detection;Development;Diagnosis;Diagnostic;Diameter;Disease;Elasticity;Endosomes;Escherichia coli;exosome;experimental study;extracellular vesicles;Feces;fluorescence imaging;Goals;Gram-Positive Bacteria;Health;Heat-Shock Proteins 70;Heterogeneity;high throughput analysis;Homeostasis;Human;Image;imaging platform;Immune response;improved;Infection;innovation;instrument;intercellular communication;interest;Investigational Therapies;Label;Life;Lipid Bilayers;Lipids;Liposomes;Malignant Neoplasms;Masks;Medical;Medicine;Membrane;Membrane Proteins;Methods;microbiome;Monitor;nanoparticle;nanoscale;Nerve Degeneration;Neurodegenerative Disorders;Neurons;new technology;Normal Cell;novel;novel diagnostics;Nucleic Acids;particle;Pathology;Patients;Phase;Physiological;Physiological Processes;Physiology;Plasma;Play;Population;potential biomarker;Process;prognostic;prognostic tool;Proteins;Publications;Research;Role;Saliva;Sampling;Scanning;Serum;Source;Specimen;Speed;Staphylococcus aureus;stem cell biology;Surface;System;technology platform;Testing;Therapeutic;Tissues;tool;tumor;Tumor-Derived;Urine;Vesicle

PROJECT_TITLE: High-Throughput High-Content Nanoscale Extracellular Vesicle Analysis


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Chronic Obstructive Pulmonary Disease;Clinical Research;HIV/AIDS;Infectious Diseases;Lung;Microbiome

ORG_CITY: CHAPEL HILL

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIV OF NORTH CAROLINA CHAPEL HILL

PHR: PROJECT NARRATIVE People living with HIV are at heightened risk of chronic lung diseases. This proposal will investigate the changes in the nasal mucosa, including secreted mediators and nasal microbiome associated with HIV infection and how these changes are associated with adverse pulmonary outcomes.

PI_NAMEs: DRUMMOND, MICHAEL BRADLEY (contact)

PROGRAM_OFFICER_NAME: MONGODIN, EMMANUEL FRANCK

PROJECT_TERMS: Acceleration;Acute;Airway Disease;antiretroviral therapy;Asthma;bacteriome;Biological;Biological Markers;chemokine;Chronic;Chronic lung disease;Chronic Obstructive Pulmonary Disease;Clinical;cohort;Cohort Studies;cytokine;Data;Development;Diagnosis;Disease;disease diagnosis;dysbiosis;Environment;Epidemiology;Event;Functional disorder;Gatekeeping;Health;HIV;HIV Infections;illness length;Immune;Immune system;immunoregulation;Impairment;Individual;Inflammatory;insight;Intervention;Knowledge;Lung;Lung Diseases;lung microbiome;Measures;Mediator;Methodology;microbiome;microbiome alteration;Mucosal Immunity;Mucositis;mycobiome;nasal microbiome;Nose;oral microbiome;Outcome;Participant;pathogen;Pattern;Periodicals;Persons;Phenotype;Pneumonia;Population;Populations at Risk;Predisposition;Prevalence;prospective;pulmonary function;pulmonary function decline;Pulmonary function tests;Research;Research Design;respiratory;Respiratory Disease;respiratory health;respiratory pathogen;Respiratory Tract Infections;Risk;Role;Sampling;Severity of illness;Structure;Structure of mucous membrane of nose;Symptoms;Testing;The Multicenter AIDS Cohort Study;Therapeutic;therapeutic target;Tobacco;Variant;Viral;Virus Diseases;Visit;Vulnerable Populations;Woman;Work

PROJECT_TITLE: HIV-Associated Lung Disease: The Role of Nasal Mucosal Immunity and Microbiome

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IIDB-R (02)]


NIH_SPENDING_CATS: Biotechnology;Breast Cancer;Cancer;Gene Therapy;Genetics;Immunotherapy;Women's Health Research

ORG_NAME: PYROJAS INC

PHR: Narrative Pyrojas has developed PyroTIMER CAR-T cells that express an anti-TGF-β fusion protein to enhance the efficacy of CAR-T cell therapy by inhibiting the TGF-β pathway. In preliminary studies, PyroTIMER CD19 CAR- T cells have demonstrated enhanced cytotoxicity and persistence compared to traditional CD19 CAR-T cells against B cell lymphomas in cellular and animal models. The objective of this proposal is to evaluate the safety and efficacy of PyroTIMER CAR-T cells in preclinical animal models of B-cell lymphoma, breast cancer, and lung cancer. The study aims to provide critical preclinical safety and efficacy data to pave the way for further clinical development of PyroTIMER CAR-T cells in treating human cancers where efficacy is limited by the immunosuppressive TIME.

PI_NAMEs: BAGATI, ARCHIS  (contact)

PROGRAM_OFFICER_NAME: TRIPURANI, SWAMY KRISHNA

PROJECT_TERMS: Adverse reactions;Aftercare;Animal Model;Antigen Targeting;antitumor effect;B-Cell Lymphomas;Benchmarking;Biological Assay;Bioluminescence;bioluminescence imaging;Breast Cancer Cell;Breast Melanoma;burden of illness;Cancer Patient;CAR T cell therapy;CD19 gene;cell killing;Cell Line;Cell model;Cell Proliferation;Cells;chimeric antigen receptor;chimeric antigen receptor T cells;Chimeric Proteins;clinical development;Clinical Trials;Collaborations;comparative;cytokine;cytokine release syndrome;Cytolysis;cytotoxic;cytotoxicity;Data;design;Development;disorder control;Dose;effective therapy;efficacy study;engineered T cells;Ensure;Environment;Evaluation;exhaustion;Exhibits;Flow Cytometry;forging;Future;Hematologic Neoplasms;Human;Immune;Immune response;Immunocompetent;immunogenic;immunogenicity;Immunosuppression;improved;improved outcome;In Vitro;in vitro Assay;in vivo;in vivo evaluation;Infusion procedures;innovation;Investigational New Drug Application;Long-Term Effects;Luciferases;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant Neoplasms;manufacture;Measurement;Measures;Mediating;Mediator;Melanoma Cell;Methodology;Monitor;mouse model;Mus;novel;Outcome;Pathway interactions;patient derived xenograft model;patient safety;Patient-Focused Outcomes;Patients;Peptides;Personal Satisfaction;personalized cancer therapy;Pharmacologic Substance;Phase;phase 2 study;Population;Positioning Attribute;pre-clinical;preclinical efficacy;preclinical safety;Predisposition;Production;Proliferating;Protein Isoforms;Research;resilience;Risk;Safety;Scientific Advances and Accomplishments;Scientific Inquiry;Series;Solid Neoplasm;T cell therapy;T-Lymphocyte;TCR Activation;Technology;Testing;Therapeutic;therapy design;Time;Tissue Stains;Toxic effect;Transforming Growth Factor beta;Treatment Efficacy;triple-negative invasive breast carcinoma;tumor;Tumor Burden;tumor microenvironment;Tumor Volume;tumor-immune system interactions;Validation;Xenograft Model

PROJECT_TITLE: PyroTIMER Technology: Enabling T-Cell Persistence in Immunosuppressive Tumor Microenvironments


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Autoimmune Disease;Digestive Diseases;Inflammatory Bowel Disease;Machine Learning and Artificial Intelligence;Microbiome;Precision Medicine;Prevention

ORG_NAME: FOLI BIO INC.

PHR: NARRATIVE Inflammatory Bowel Disease (IBD) is the most common chronic inflammatory condition of the gastrointestinal (GI) tract, yet major knowledge gaps remain in the temporal processes driving inflammatory states in the gut at disease onset and during flare-ups. Foli Bio Inc. is developing an innovative technology, called Exfo-seq, to precisely and robustly quantify expression of host genes directly from stool RNA (exfoliome), as a non-invasive approach to longitudinally profile dynamic processes occurring within the GI tract. The overarching goal of this study is to validate the functional utility of Exfo-seq by generating unprecedented knowledge regarding the human GI exfoliome at baseline and over time, and examining the local gut immune profile, evaluating heterogeneity in inflammatory states between individuals, identifying early biomarkers, and predicting therapeutic response.

PI_NAMEs: HUANG, YIMING  (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Acceleration;Adult;Adverse effects;analysis pipeline;Automobile Driving;Biological Markers;Biological Process;Biology;Biotechnology;Businesses;cell type;Cells;Chronic;Clinical Pathology;Clinical Trials;cohort;Crohn's disease;Data Set;Disease;DNA;Doctor of Philosophy;drug development;drug efficacy;Drug Modelings;drug response prediction;Drug Targeting;early detection biomarkers;Early identification;Epithelial Cells;Etiology;Feces;Flare;Future;gastrointestinal;Gastrointestinal Agents;Gastrointestinal Diseases;Gastrointestinal tract structure;Gene Expression Profile;Generations;Genes;Genomics;Goals;gut microbiome;Healthcare Industry;Heterogeneity;host-microbe interactions;Human;Immune;Incidence;Individual;Inflammatory;Inflammatory Bowel Diseases;innovative technologies;insight;Intervention;intestinal epithelium;Intestines;Knowledge;machine learning model;Measurement;medication safety;Methodology;Methods;microbiome;mid-career faculty;Modality;Molecular;Monitor;multiple omics;Mus;novel;Onset of illness;participant enrollment;Patients;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Phase I Clinical Trials;Population;precision medicine;Prediction of Response to Therapy;Prevalence;prevent;Process;research and development;Resources;responders and non-responders;response;Risk;RNA;Running;Sampling;Severity of illness;Signal Transduction;stool sample;Technology;Therapeutic;Therapeutic Intervention;Time;timeline;Tissues;tool;Treatment Failure;Ulcerative Colitis;Universities

PROJECT_TITLE: Non-invasive exfoliome platform to accelerate treatment for gastrointestinal disorders

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


NIH_SPENDING_CATS: Cancer;Clinical Research;Lung;Lung Cancer;Precision Medicine;Prevention

ORG_CITY: PALO ALTO

ORG_NAME: EXAI BIO, INC.

PHR: Lung cancer is the leading cause of cancer death in the US (1 in 5 of all cancer deaths). Early detection of lung cancer minimal residual disease (MRD) after treatment improves the effectiveness of therapies and patient survival rates. The goal of this program is to develop a highly sensitive, tumor-naive, blood-based laboratory developed test (LDT) for detecting MRD in stage IB–IIIA non-small cell lung cancer (NSCLC) patients undergoing neoadjuvant therapy.

PI_NAMEs: ALIPANAHI, BABAK  (contact);BEHSAZ, BABAK ;PATEL, SANDIP PRAVIN

PROGRAM_OFFICER_NAME: ZANE, LINDA KARINE

PROJECT_TERMS: Accreditation;Adenocarcinoma;Affect;Aftercare;Algorithms;American Association of Cancer Research;American Society of Clinical Oncology;artificial intelligence model;Biological Assay;Biological Markers;Blood;cancer care;cancer cell;Cancer Center;Cancer Detection;cancer diagnosis;Cancer Etiology;Cancer Patient;cancer therapy;care outcomes;Cessation of life;Characteristics;Clinical;Clinical Research;Clinical Sensitivity;cloud based;cohort;Collaborations;commercial launch;commercialization;Congresses;data analysis pipeline;design;Detection;detection assay;Detection of Minimal Residual Disease;Development;Diagnostic;Diagnostic tests;Disease;Distant;early detection biomarkers;Early Diagnosis;Effectiveness;Enrollment;Evaluation;Excision;Goals;Government;Histologic;improved;improved outcome;In complete remission;individual patient;Laboratories;liquid biopsy;Lung;lung cancer screening;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant Neoplasms;Medical Oncology;Modality;Neoadjuvant Therapy;neoplastic cell;Newly Diagnosed;next generation sequencing;Non-Small-Cell Lung Carcinoma;novel;novel diagnostics;Oncology;Operative Surgical Procedures;Orphan;Pathologic;Patient Care;Patient-Focused Outcomes;Patients;Peer Review;Performance;performance tests;Persons;Phase;Physicians;Positioning Attribute;Postoperative Period;Preparation;professor;programs;prospective;prototype;Publications;Publishing;recruit;Recurrence;Reference Values;Regimen;relapse prevention;Reporting;Resectable;Residual Cancers;Residual Neoplasm;response;Retrospective cohort;Sampling;Screening for cancer;Series;Small Business Innovation Research Grant;Small RNA;Specificity;Squamous cell carcinoma;Stress Tests;Survival Rate;Techniques;Testing;Therapeutic;Time;Tissues;Treatment Effectiveness;Treatment Protocols;tumor;Tumor Burden;tumor DNA;Tumor Subtype;Tumor Tissue;Untranslated RNA;Validation;Whole Blood;Work

PROJECT_TITLE: Orphan Non-coding RNA-based Test for Detecting Minimal Residual Disease in Resectable Non-small Cell Lung Cancer


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Autism;Basic Behavioral and Social Science;Behavioral and Social Science;Bioengineering;Biomedical Imaging;Brain Disorders;Clinical Research;Intellectual and Developmental Disabilities (IDD);Mental Health;Neurosciences;Pediatric;Prevention

ORG_CITY: SAINT LOUIS

ORG_NAME: ESPERIMAGE LLC

ORG_STATE: MO

PHR: Project Narrative: Brain imaging with MRI machines provides non-invasive access to the neural basis of development, degeneration, and disease of the brain. However, the logistics of MRI are ill-suited to many applications in children. This grant will develop a flexible and efficient method for data registration and modeling for high-performance wearable high-density diffuse optical tomography systems and validate it within both adults and children.

PI_NAMEs: TROBAUGH, JASON WAYNE (contact)

PROGRAM_OFFICER_NAME: DURKIN, JACLYN MARIE

PROJECT_TERMS: 3-Dimensional;Adult;Affect;Algorithms;Anatomic Models;Anatomy;Array tomography;Atlases;autism spectrum disorder;autistic;awake;Behavioral;Behavioral Symptoms;Brain;Brain Diseases;Brain imaging;BRAIN initiative;Brain Mapping;Cellular Phone;Child;Child Development;Childhood;Cognitive;cognitive capacity;commercial application;commercialization;commercialization readiness;Communication;Complement;Data;density;Development;Devices;diffuse optical tomography;Disease;dyadic interaction;Early Diagnosis;Early Intervention;Environment;Evaluation;Eye;Fiber;Fiber Optics;flexibility;follow-up;Functional Magnetic Resonance Imaging;functional near infrared spectroscopy;gaze;General Population;Goals;Grant;Hair;Head;Image;image reconstruction;Imaging Device;Impairment;improved;improved outcome;individuals with autism spectrum disorder;Infant;innovation;Institutional Review Boards;instrument;interest;Legal patent;Licensing;Light;Literature;Location;Logistics;Loudness;Magnetic Resonance Imaging;Maps;Market Research;Measurement;Methodology;Methods;Modeling;Modernization;Monitor;Morphologic artifacts;Motion;Motor;neural;Neurodevelopmental Disorder;neuroimaging;Noise;nonhuman primate;optical imaging;Optics;Outcome;Parents;Participant;Performance;Phase;Phenotype;Photogrammetry;Play;Predisposition;Procedures;Process;Prognosis;Protocols documentation;repetitive behavior;Reporting;Resolution;response;Role;Scalp structure;sensor;Sensory;Shapes;Signal Transduction;skill acquisition;skills;Small Business Technology Transfer Research;social;social attachment;social communication impairment;Social Development;Standardization;Surface;System;technological innovation;Technology;Toddler;tomography;tool;Transcend;Translations;treatment response;treatment strategy;Universities;Validation;visual motor;visual tracking;visual-motor integration;Washington;wearable device

PROJECT_TITLE: Flexible, scalable, and generalizable photogrammetric head modeling for high-density diffuse optical tomography


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

ORG_CITY: SEATTLE

ORG_NAME: CYRUS BIOTECHNOLOGY, INC.

ORG_STATE: WA

PHR: NARRATIVE Recombinant uricases used for the treatment of chronic refractory gout suffer from high immunogenicity and the elicitation of anti-drug antibodies, which limits their efficacy and patient usage. By leveraging AI-based computational protein design with extensive experimental validation, this project aims to engineer a recombinant uricase with enhanced stability, reduced immunogenicity, and prolonged half-life in vivo. These objectives are accomplished by integrating serum albumin-binding activity and stability-enhancing modifications with targeted mutagenesis to remove antigenic epitopes in the sequence of a highly active bacterial uricase, ultimately creating a safer and more effective alternative to current gout medications.

PI_NAMEs: CHAN, KUI KIU (contact);PROCKO, ERIK

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Active Sites;Address;Adult;Adverse effects;Affect;Affinity;Albumins;Algorithm Design;Alleles;Anaphylaxis;Antibodies;Antibody Affinity;Antigen Presentation Pathway;Antigen-Presenting Cells;Area;Arthritis;Automobile Driving;B-Lymphocytes;Bacillus;Binding;Biological;Biological Assay;Biological Availability;Biotechnology;Black Box;Body Temperature;CD4 Positive T Lymphocytes;Cell division;Cell surface;Chimeric Proteins;Chronic;clinically relevant;Computer Models;Cysteine;de-immunization;design;Development;Distal;disulfide bond;Disulfides;Dose;drug candidate;Drug Kinetics;Engineering;Enzyme-Linked Immunosorbent Assay;Enzymes;Epitopes;Excision;Excretory function;expectation;experimental study;Family suidae;Flow Cytometry;Generations;Gout;Half-Life;Heart Arrest;Histocompatibility Antigens Class II;HLA Antigens;Human;Hybrids;Immune response;immunogenicity;Immunosuppressive Agents;improved;improved outcome;In Vitro;in vivo;Inbred Mouse;indexing;Inflammatory Arthritis;intense pain;Interferometry;intravenous administration;Intravenous infusion procedures;Joints;Kinetics;Length;Libraries;Life Extension;Marketing;Measures;Mediating;melting;Membrane Proteins;Methods;Methotrexate;Modification;Molecular Chaperones;Mus;Mutagenesis;mutant;Mutation;Names;neutralizing antibody;Organism;Outcome;oxidation;Papio;patient population;Patients;Peptides;Peripheral Blood Mononuclear Cell;Pharmaceutical Preparations;Physiological;Point Mutation;Population;preclinical development;prediction algorithm;Property;Protein Engineering;Proteins;Reaction;Recombinants;Redness;Refractory;Research;Route;Sampling;Scanning;screening;Serum;Serum Albumin;service providers;subcutaneous;Surface;surface coating;Swelling;T-Cell Activation;T-Cell Proliferation;T-Lymphocyte;T-Lymphocyte Epitopes;technology development;Temperature;Testing;Therapeutic;therapeutic protein;therapeutically effective;thermostability;Time;tool;Urate Oxidase;Uric Acid;Validation;Variant;Yeasts

PROJECT_TITLE: Advanced Uricase Engineering for Improved Outcomes in Gout Patients

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


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Machine Learning and Artificial Intelligence;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health;Urologic Diseases;Women's Health Research

ORG_CITY: Chicago

ORG_NAME: RENALIS HEALTH INC.

ORG_STATE: IL

PHR: NARRATIVE Overactive bladder (OAB) is a prevalent and costly health condition that poses a significant public health burden in the United States. Research has shown that the prevalence of OAB in the US is high among Latina women, yet Latina women have less access to behavioral therapy for OAB. As such, this work is aimed at improving the bladder health knowledge of Latina women through adapting and testing a novel, conversational agent-based application for delivering validated, patient-centered OAB behavioral therapy for Latina women.

PI_NAMEs: CHEN, YUFAN BRANDON (contact);NODORA, JESSE

PROGRAM_OFFICER_NAME: SOLIS SANABRIA, CAROLINA VANESSA

PROJECT_TERMS: Acculturation;Address;Adopted;Affect;Age;American;Area;Artificial Intelligence;Awareness;Behavior Therapy;bilingualism;Bladder;Caring;chatbot;clinical efficacy;clinical practice;Clinical Research;Cognitive;Communities;Data;design;diaries;digital;digital treatment;Disproportionately impacts women;Education;efficacy study;English Language;Ethnic Origin;Ethnic Population;evidence base;experience;Face;Feedback;Focus Groups;Health;Health Care Costs;health disparity;Health education;health knowledge;Health Services Accessibility;High Prevalence;Hispanic;hispanic community;Hispanic Women;improved;incontinence symptom;informant;information gathering;innovation;Insurance Coverage;Intervention;Language;Language Development;Latina;Latina Population;Learning;Linguistics;Machine Learning;Managed Care;Mexican Americans;mHealth;Modality;Modification;Multimedia;novel;Outcome;Overactive Bladder;Participant;Pathway interactions;Patient Compliance;patient oriented;patient population;Patients;Pelvic floor structure;Phase;Practice Management;Prevalence;Preventive;Process;programs;Public Health;Quality of life;Questionnaires;Race;racial population;Recommendation;recruit;remote delivery;Reporting;Research;Research Design;Research Personnel;Self Management;Severities;Small Business Innovation Research Grant;social culture;Spanish;Suggestion;Surveys;Symptoms;Target Populations;Techniques;Technology;Testing;Therapeutic Intervention;treatment risk;treatment strategy;United States;Urinary Incontinence;urologic;usability;Voice;Walking;Woman;Work

PROJECT_TITLE: Cultural Adaptation of a Digital Overactive Bladder Behavioral Therapy for the U.S. Latina Population

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


NIH_SPENDING_CATS: Clinical Research;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Patient Safety;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn

ORG_CITY: Eden Prairie

ORG_NAME: NUBORN MEDICAL, INC.

ORG_STATE: MN

PHR: NARRATIVE As many as 90% of preterm infants will suffer from the negative health complications and expensive hospital stays that result from untreated swallowing deficits. nuBorn Medical is developing the first validated SMART bottle system that allows for the non-invasive identification of these deficits during a typical bottle feed. This device will allow clinicians to provide earlier, more effective treatments so that preterm infants can eat safely and leave the hospital sooner.

PI_NAMEs: MCGRATTAN, KATLYN ELIZABETH (contact)

PROGRAM_OFFICER_NAME: ROSS, SHARON A

PROJECT_TERMS: 37 weeks gestation;Accounting;Achievement;Age;Apnea;aspirate;Body System;Bottle feeding;Bradycardia;Cardiopulmonary;Clinical;Clinical assessments;Clinical Data;clinically significant;Collaborations;Communication;Coupled;Data Set;Deglutition;Deglutition Disorders;design;Detection;Development;Devices;Diagnostic;Diagnostic Procedure;Eating;Economic Burden;effective therapy;effectiveness validation;Equilibrium;Event;Exhibits;Expenditure;experience;feeding;Feeds;Functional disorder;Gestational Age;Goals;Health;Hospitalization;Hospitals;Impairment;improved;Infant;infant monitoring;insight;Intervention;Investigation;Ionizing radiation;Length of Stay;Live Birth;Lung;Malnutrition;Manometry;Marketing;Measures;Medical;Methodology;Methods;Modification;Morbidity - disease rate;Neonatal;neonatal health;Nipples;noninvasive diagnosis;novel;Oral;Oropharyngeal;Outcome;Patients;peer;Performance;Pharyngeal structure;Phase;Physiology;Positioning Attribute;premature;Premature Birth;Premature Infant;pressure;product development;Production;Radiation;Research;Resolution;Sampling;sensor;Small Business Technology Transfer Research;societal costs;socioeconomics;Source;standard of care;sucking;Suction;System;Technology;Testing;Time;tool;Treatment Protocols;United States;Validation;verification and validation;Visualization;Work

PROJECT_TITLE: A Novel Non-Invasive Method of Dysphagia Detection in Preterm Infants: Bottle Finalization & Validation


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

ORG_CITY: SAN DIEGO

ORG_NAME: ABWIZ BIO, INC.

PHR: PROJECT NARRATIVE This project will leverage a cutting-edge biotechnology platform to develop neutralizing antibodies to Machupo virus (MACV) by immunization with a first-in-class prefusion stabilized MACV GPC trimer and innovative phage display technologies.

PI_NAMEs: MARUYAMA, TOSHIAKI  (contact);SAPHIRE, ERICA OLLMANN

PROGRAM_OFFICER_NAME: DYALL, JULIE

PROJECT_TERMS: Affinity;Animal Model;Antibodies;antibody engineering;antibody libraries;Antigens;Applications Grants;Arenavirus;Binding;Binding Sites;Biological Assay;Biotechnology;Bolivian Hemorrhagic Fever Virus;Bone Marrow;Cells;Clinical;Clinical Trials;commercial application;Development;Dose;efficacy study;Engineering;Enzyme-Linked Immunosorbent Assay;Epitopes;Evaluation;experimental study;Foundations;gene cloning;Glycoproteins;Goals;GP2 gene;GTPBP1 gene;Health;high throughput screening;Immunization;Immunize;Immunoglobulin G;in vivo;innovation;Laboratory Research;Lassa virus;Legal patent;Libraries;Membrane Glycoproteins;Methods;Mission;Molecular Conformation;Monoclonal Antibodies;monomer;Neutralization Tests;neutralizing antibody;novel;Oryctolagus cuniculus;Outcome;Pathogenesis;Phage Display;Phase;preclinical development;Preparation;prevent;Property;Reagent;receptor binding;Research;safety study;screening;Serum;Site;Small Business Technology Transfer Research;Specificity;Spleen;subcutaneous;Tacaribe Complex Viruses;Techniques;Technology;Testing;TFRC gene;Therapeutic;United States National Institutes of Health;vaccination strategy;Work

PROJECT_TITLE: Development of Neutralizing Antibodies to Machupo Virus

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


ORG_CITY: BLACKSBURG

ORG_NAME: BIOTHERAPEUTICS, INC.

ORG_STATE: VA

PHR: Public Health Relevance Asthma is a chronic, widespread allergic disease with total expenses exceeding $80 billion annually in the U.S. Current therapies for asthma are modestly successful but leave significant subpopulations of patients without adequate response. This SBIR Phase I application will develop a new oral immunoregulatory therapeutic targeting a novel mechanism of action that enhances Treg function for the treatment of asthma.

PI_NAMEs: BASSAGANYA-RIERA, JOSEP  (contact)

PROGRAM_OFFICER_NAME: LIU, QIAN

PROJECT_TERMS: Acceleration;Address;airway hyperresponsiveness;Airway Resistance;Allergic Disease;Animal Model;Asthma;asthma model;asthmatic patient;Autoimmune Diseases;Benchmarking;Biological Availability;Biological Response Modifier Therapy;Biotechnology;Cell Respiration;Cells;chemokine;Chronic;Chronic Disease;Clinical;Clinical Chemistry;Clinical Trials;Coagulation Process;commercial application;Communicable Diseases;Comparative Study;Complex;Computer Models;cytokine;Cytoplasm;Data;design;Development;Disease;Dose;drug candidate;Drug Kinetics;efficacy study;Endocrine;eosinophil;Epithelial Cells;Extrinsic asthma;Fibroblasts;Flow Cytometry;glucose metabolism;Goals;Half-Life;Hematology;Hepatocyte;Histologic;Histopathology;Hypersensitivity;IL17 gene;Immune;Immunity;immunoregulation;improved;Infiltration;Inflammation;Inflammatory;inhibitor;innovation;Interleukin-2;Legal patent;Lesion;Lung;Macrolides;Marketing;Medical;member;Metabolic;Metabolism;Methotrexate;Mitochondria;Modeling;mouse model;Mus;neutrophil;Neutrophil Infiltration;No-Observed-Adverse-Effect Level;novel;novel therapeutic intervention;novel therapeutics;Oral;Outcome;Ovalbumin;Pathogenesis;patient subsets;Patients;Pharmaceutical Preparations;pharmacologic;Phase;Plasma;Positioning Attribute;Precision Health;precision medicine;Program Development;Protein Family;public health relevance;Pyroglyphidae;Rattus;receptor;Regulatory T-Lymphocyte;response;Risk;Route;Safety;safety outcomes;safety study;Sampling;side effect;Signal Transduction;Small Business Innovation Research Grant;small molecule therapeutics;Squamous Epithelium;Stat5 protein;steroid dependence;success;synergism;Target Populations;Testing;Therapeutic;therapeutic target;Therapeutic Uses;Tissues;TNF gene;Toxic effect;Treatment Efficacy

PROJECT_TITLE: Development of Novel Therapeutics for Asthma

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 RCCS-B (11)]


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Basic Behavioral and Social Science;Behavioral and Social Science;Bioengineering;Biomedical Imaging;Brain Disorders;Clinical Research;Dementia;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Prevention;Social Determinants of Health

ORG_CITY: Charlotte

ORG_NAME: AMISSA, INC.

PHR: PROJECT NARRATIVE This collaborative research between Washington University School of Medicine in St. Louis and Amissa Health aims to assess the relationship between health-related data collected from wearable devices and driving behaviors among older adults with and without preclinical Alzheimer’s disease (AD). This Phase I SBIR aims to advance the data and knowledge of the relationships between preclinical AD and biometric/behavioral measures. The proposed research is clinically relevant as it could provide early predictive insights into AD. The goal is to identify and validate digital biomarkers relevant in the classification of AD years before the onset of symptoms while augmenting the use of neuropsychological assessments.

PI_NAMEs: CORKEY, JON ANDREW (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Acceleration;Accidents;Address;Algorithms;Alzheimer disease detection;Alzheimer's Disease;Alzheimer's disease related dementia;American;Amyloid;Apple watch;Attention;Automobile Driving;behavior measurement;Behavior Therapy;Behavioral;Biological Markers;Biometry;Black Box;Blood Pressure Monitors;Cerebrospinal Fluid;Cessation of life;Classification;Clinical;clinical application;clinically relevant;Cognition;Cognitive;cognitive function;cohort;Communities;Consent;cost;cost effective;Country;Coupled;Data;Data Collection;Databases;Dementia;Detection;Diagnosis;diagnostic tool;digital;Digital biomarker;digital health;Disease;driving behavior;driving performance;early detection biomarkers;Early Diagnosis;executive function;explainable artificial intelligence;feasibility research;fitness;Funding;Future;Goals;handheld mobile device;Health;Health behavior;Heart Rate;human old age (65+);Image;Impaired cognition;impaired driving performance;Individual;Injury;innovation;insight;interest;Knowledge;Licensing;Low Income Population;Machine Learning;machine learning method;machine learning model;Measures;Medical Care Costs;medical schools;Memory;Methods;Modeling;Monitor;mortality;Movement;multimodal data;multimodal learning;multimodality;Nervous System Disorder;Neuropsychology;noninvasive diagnosis;novel;novel strategies;older adult;older driver;Oxygen;Parkinson Disease;Participant;Patients;Pattern;Persons;Phase;Physical activity;Plasma;Population;Positron-Emission Tomography;pre-clinical;prediction algorithm;Prevalence;prevent;recruit;remote patient monitoring;Research;Research Personnel;Research Project Grants;Risk;risky driving;Rural;Sampling;Screening procedure;sensor;Series;sleep pattern;sleep quality;Small Business Innovation Research Grant;smart watch;social stigma;Speed;Standardization;Symptoms;Techniques;Testing;Time;tool;Tracer;Uninsured;United States;United States National Institutes of Health;Universities;Vehicle crash;Visuospatial;Washington;wearable data;wearable device;wearable sensor technology;Work

PROJECT_TITLE: Augmented Preclinical Alzheimer's Disease Detection Through Wearable Health and Driving Behavior Data.

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


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Aging;Bioengineering;Chronic Liver Disease and Cirrhosis;Digestive Diseases;Genetics;Liver Disease;Lung;Nanotechnology;Pulmonary Fibrosis

ORG_CITY: Mountain View

ORG_NAME: REJUVENATION TECHNOLOGIES, INC.

PHR: Narrative Rejuvenation Technologies Inc. (RTI) seeks to improve the tools required for clinical translation of intravenously- infused RNA lipid nanoparticle (LNP) therapeutics. RTI will employ as a test case telomerase mRNA LNPs, which they have shown confer substantial therapeutic benefit in multiple mouse models. This project will enable clinical translation of intravenously-infused RNA LNP therapeutics, which have broad potential applicability for protein replacement, gene editing, and other critical unmet medical needs.

PI_NAMEs: RAMUNAS, JOHN  (contact)

PROGRAM_OFFICER_NAME: HAPPEL, CHRISTINE MARIE

PROJECT_TERMS: Acceleration;Acute;adaptive immunity;age-related disease;Aging;aging related disease;Alcoholic Hepatitis;Anaphylaxis;Animal Model;Animal Testing;Apoptosis;Autoimmunity;Automobile Driving;Biodistribution;Biological;Biological Assay;Biology;Bleomycin;Bone marrow failure;brief intervention;Capillary Electrophoresis;Cell division;cell type;Cells;Chemistry;Chromosomes;Chronic;Clinic;Clinical;clinical translation;Clinical Trials;Cryoelectron Microscopy;Data;desensitization;Development;Disease;disease model;DNA;DNA Damage;Dose;Double-Stranded RNA;drug sensitivity;Drug Stability;Evaluation;Extrahepatic;Feedback;first-in-human;Flow Cytometry;Future;Genes;Genomic Instability;Grant;Guidelines;Hepatocyte;idiopathic pulmonary fibrosis;Immune response;improved;innovation;Intravenous;Intravenous infusion procedures;invention;kidney fibrosis;Legal patent;Length;Licensing;Ligands;Ligation;lipid nanoparticle;Lipids;Liver;Liver diseases;Liver Fibrosis;liver inflammation;Lung;Lung Diseases;Malignant Neoplasms;manufacture;Measures;Medical;Messenger RNA;Methods;Modeling;mouse model;mRNA delivery;Mus;nanoparticle delivery;nanoparticle drug;nonhuman primate;novel;Oncogenes;Organ;Pathologic;Patients;Pharmaceutical Preparations;Phase;Plasmids;Poly A;Pre-Clinical Model;prevent;Production;Proteins;Pulmonary Fibrosis;pulmonary function;regenerative approach;Regenerative capacity;Regenerative Medicine;Rejuvenation;Risk;RNA;RNA vaccine;Safety;senescence;single-cell RNA sequencing;Specificity;stem cells;T cell infiltration;targeted delivery;Technology;Telomerase;telomere;Telomere Shortening;Temperature;Testing;Therapeutic;therapeutic nanoparticles;Thioacetamide;Time;Tissues;tool;Transfection;Translating;translational applications;Translations;Universities;Vaccines;Work;wound healing

PROJECT_TITLE: Advanced tools for translation of intravenously-infused RNA LNP therapeutics to the clinic

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 BBBT-F (10)]


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Nutrition

ORG_CITY: SCOTTSDALE

ORG_NAME: SEQUITUR HEALTH CORP.

PHR: PROJECT NARRATIVE The objective of this SB1 work is to complete commercial and regulatory activities to bring an in vitro diagnostic to market for home measurement of a metabolic parameter. In the long term, home use of this device will enable improved care for patients at risk for metabolic decompensation. Improved measurement will enable improve medical outcomes of these vulnerable patients by enabling timely use of known interventions.

PI_NAMEs: THOMAS, MARYLAURA LIND (contact)

PROGRAM_OFFICER_NAME: PARISI, MELISSA

PROJECT_TERMS: Acute;Address;Adult;Age;Ammonia;Award;Blood;Blood Tests;Caregivers;Catabolism;Certification;Cessation of life;Chronic;Clinical;Cognition;commercialization;commercialization readiness;Computer software;Consensus;Data;design;Development;Devices;Diet;Dietary Proteins;Disease;Disinfection;Documentation;Drops;Environment;Event;Fasting;fatty acid oxidation;Foundations;Frequencies;Future;Goals;handheld equipment;Health;Hereditary Disease;high risk;Home;Home environment;Human;Hyperammonemia;Impaired cognition;improved;in-vitro diagnostics;innovation;instrument;Intervention;Knowledge;Label;Laboratories;manufacture;Marketing;Measurement;Measures;Medical;medical attention;Medical emergency;meetings;Metabolic;Metabolic Diseases;Metabolism;meter;mobile application;Modification;Monitor;Neurologic;Neurologic Dysfunctions;Neurologic Symptoms;Outcome;Patient Care;Patients;Performance;Persons;Pharmaceutical Preparations;Phase;Physicians;Plasma;point of care;Prevention;Preventive measure;protein intake;Reporting;Research;Risk;Science;seventh grade;Signal Transduction;software development;Symptoms;System;Technology;Testing;Time;time use;Translating;twelfth grade;United States Food and Drug Administration;United States National Institutes of Health;Update;Urea cycle disorders;virtual;waiver;Whole Blood;Work

PROJECT_TITLE: Whole Blood Point of Care Metabolic Measurement - SB1

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-B (19)]


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Bioengineering;Biomedical Imaging;Breast Cancer;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Estrogen;Pain Research;Patient Safety;Rehabilitation;Women's Health Research

ORG_CITY: PORTLAND

ORG_NAME: MADORRA, INC.

ORG_STATE: OR

PHR: Narrative Vulvovaginal atrophy (VVA) affects an estimated 90% (44.6M) of peri- and postmenopausal women in the US, as well as 75% (1.4M) of breast cancer survivors (BCS). Despite the prevalence of VVA, there is a lack of effective and safe treatment options: the standard of care is hormone therapy, which carries a number of risks (e.g., coronary heart disease, stroke, venous thromboembolism, dementia), whereas Over-the-Counter lubricants and moisturizers are distained by users as messy, temporary, and simply not effective enough for the severity of symptoms endured. Bridging these gaps, the Madorra Therapy System is a non-hormonal, non- invasive, solution that uses therapeutic ultrasound to support vaginal health by increasing vasodilation and blood flow to the vagina, resulting in increased lubrication and improvements in tissue health.

PI_NAMEs: ROCKWEILER, HOLLY  (contact)

PROGRAM_OFFICER_NAME: TINGEN, CANDACE M

PROJECT_TERMS: Abstinence;Address;Adjuvant;Adopted;Affect;Anatomy;arm;Atrophic;Blinded;Blood flow;Breast Cancer survivor;cancer recurrence;cancer therapy;Client satisfaction;Clinical;clinical effect;Clinical Trials;commercialization;Comparative Study;Control Groups;Coronary heart disease;Coupling;Data;Dementia;design;Devices;Double-Blind Method;Dryness;Dyspareunia;efficacious treatment;efficacy study;Ensure;Estrogens;Evaluation;Exercise;Exhibits;Failure;Feasibility Studies;Feedback;Funding;Goals;Health;High Risk Woman;High-Risk Cancer;Home;hormone therapy;improved;Incidence;indexing;Learning;Left;Libido;Lubricants;Lubrication;Measures;Medical Device;Mental Depression;novel;open label;Pain;Participant;Pathway interactions;Patients;Perimenopause;Phase;Physiological;placebo group;Postmenopause;Prevalence;prevent;primary endpoint;Production;prototype;Quality of life;Randomized;Reporting;response;Risk;Safety;safety study;Serious Adverse Event;Severities;sex;sexually active;sham-controlled study;side effect;Small Business Innovation Research Grant;standard of care;Stroke;success;Survivors;Symptoms;System;Technology;Temperature;Therapeutic;Therapeutic Effect;Therapeutic Uses;therapy adherence;Thinness;Time;Tissues;treatment adherence;Treatment-Related Cancer;Ultrasonic Therapy;Ultrasonics;ultrasound;United States National Institutes of Health;Update;usability;Vagina;vaginal dryness;Vasodilation;venous thromboembolism;Visual;Woman;women's treatment

PROJECT_TITLE: At-home, ultrasonic device for treatment of vulvovaginal atrophy

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


NIH_SPENDING_CATS: Bioengineering;Cardiovascular;Contraception/Reproduction;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Hematology;Maternal Health;Maternal Morbidity and Mortality;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Preterm, Low Birth Weight and Health of the Newborn;Prevention;Women's Health Research

ORG_CITY: SPARTANBURG

ORG_NAME: LUCIE MEDICAL INC

ORG_STATE: SC

PHR: Project Narrative Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide. Despite advancements in other medical specialties, innovations in maternal health are lagging and the need for effective, rapid, and accessible interventions for PPH is urgently needed. Lucie Medical is developing a device to prevent hemorrhage and limit blood loss in cesarean sections.

PI_NAMEs: COBB, JENNIFER WEST (contact)

PROGRAM_OFFICER_NAME: GOLDBERG, ILANA GRACE

PROJECT_TERMS: Accounting;Adverse effects;adverse outcome;Anemia;Applications Grants;Balloon Dilatation;biomaterial compatibility;Birth;black women;Blood Transfusion;Cesarean section;Clinical;Contracts;cost;Country;Data;design;design verification;Developed Countries;Device Designs;Devices;Diabetes Mellitus;Discipline of obstetrics;Dose;effective therapy;effectiveness measure;EKG ST Segment Depression;Ensure;Evaluation;experience;fabrication;Family health status;feasibility trial;Freezing;Generations;global health;Goals;hazard;health disparity;Health Professional;Health Technology;Healthcare Systems;hemodynamics;Hemorrhage;Hemostatic function;high risk;Human;Hypertension;Hypotension;Hysterectomy;improved;Incidence;Induced Labor;Industry;innovation;International;Intravenous Bolus;KRAS2 gene;Labor augmentation;Life;low and middle-income countries;manufacturing process;Marketing;Maternal Health;maternal morbidity;Maternal Mortality;maternal safety;Measures;Mechanics;Medical;medical specialties;Mental Health;Methods;Morbidity - disease rate;mortality;Mothers;novel;Operative Surgical Procedures;Oxytocin;Patients;Performance;performance tests;Pharmaceutical Preparations;Phase;physical conditioning;post intervention;postcesarean section;Postpartum Hemorrhage;Preclinical Testing;pressure;prevent;prophylactic;prototype;Public Health;Radiology Specialty;Randomized, Controlled Trials;Readiness;Recommendation;Regimen;Research;Risk Factors;Risk Management;severe maternal morbidity;Small Business Innovation Research Grant;Societies;Specific qualifier value;Sterilization;Structure of internal iliac artery;Surgical sutures;Sustainable Development;System;Tachycardia;technological innovation;Technology;Testing;Therapeutic;Therapeutic Embolization;Third Stage Labor;Tranexamic Acid;Transfusion;United States;Uterine Contraction;Uterine Inertia;Uterine myomectomy;Uterus;Vacuum;Vaginal delivery procedure;Validation;Visualization;Woman;Work;World Health Organization

PROJECT_TITLE: A Novel Device for Uterine Hemostasis Post Cesarean Section


ADMINISTERING_IC: OD

ED_INST_TYPE: ORGANIZED RESEARCH UNITS

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

ORG_NAME: UNIVERSITY OF WASHINGTON

PHR: PROJECT NARRATIVE - OVERALL The pigtail macaque (Macaca nemestrina) is a critical resource for nonhuman primate models of human diseases, particularly HIV/AIDS. The goal of this project is to increase the availability and improve the characterization of this precious resource for the biomedical and behavioral research community.

PI_NAMEs: BASSO, MICHELE A;HOTCHKISS, CHARLOTTE  (contact)

PROGRAM_OFFICER_NAME: SUI, YONGJUN

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Alleles;Anatomy;animal care;Animal Model;Animals;Area;Award;Behavioral;Behavioral Research;Biological;Biomedical Research;biomedical resource;Breeding;Caring;Characteristics;Collaborations;Communities;Complex;cost;design;diagnostic tool;empowerment;Ensure;Epithelium;Exclusion;Exhibits;experience;Exposure to;Faculty;Funding;Genetic;genetic pedigree;genome resource;Genotype;germ free condition;Goals;Grant;Guidelines;Health;high standard;HIV;Housing;Human;human disease;human model;Human Resources;Immune response;Immunologics;improved;Infection;Infectious Agent;Investigation;keratinization;Lentivirus;Macaca;Macaca mulatta;Macaca nemestrina;Maintenance;Major Histocompatibility Complex;member;microbicide;microorganism;Mind;Mission;Modeling;nonhuman primate;novel;pathogen;Pathogenicity;Pathologic;Personal Satisfaction;Physiological;pre-exposure prophylaxis;Primates;Production;Productivity;Research;Research Personnel;Research Project Grants;Resources;Risk;Safety;Sales;Serology;Simian Retroviruses;SIV;social;Source;success;Testing;United States;United States National Institutes of Health;Vagina;vaginal microbiome;Virus;virus testing;Washington

PROJECT_TITLE: WaNPRC Macaca nemestrina SPF Breeding Colony

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 EMS-H (55)]


NIH_SPENDING_CATS: HIV/AIDS;Infectious Diseases

PI_NAMEs: HOTCHKISS, CHARLOTTE  (contact)

PROJECT_TERMS: Animal Model;Animals;Behavioral;behavioral health;Breeding;Caring;Characteristics;Coccidioides posadasii;cold temperature;Conflict (Psychology);cost effective;Disease;Ensure;Environment;Exclusion;Exhibits;experience;Exposure to;Female;Genetic Variation;germ free condition;Health;HIV/AIDS;Housing;Infant;Infrastructure;Lentivirus;Macaca;Macaca mulatta;Macaca nemestrina;Maintenance;male;men's group;microorganism;Modeling;natural hypothermia;nonhuman primate;Occupational Health;Organism;pathogen;Pathogenicity;physical conditioning;Predisposition;prevent;Primates;Production;Productivity;Research;Research Personnel;Resources;Risk;screening;Seasons;SIV;Specific qualifier value;Stress;Trauma;U-Series Cooperative Agreements;United States National Institutes of Health;Virus;Washington;Women's Group

PROJECT_TITLE: HUSBANDRY AND MANAGEMENT


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Rare Diseases;Valley Fever;Vector-Borne Diseases

PI_NAMEs: GRANT, RICHARD  (contact)

PROJECT_TERMS: Accidents;AIDS therapy;animal care;Animals;Antibodies;antibody detection;Antigens;Arizona;Binding;Biological Assay;Body Fluids;Breeding;C-terminal;Cells;Cellular Immunity;Coccidioides;Coccidioides immitis;Coccidioides posadasii;Coronavirus;Cytomegalovirus;Dependence;design;Detection;detection assay;Development;Disease;Disease Outbreaks;Exposure to;Flavivirus;gene therapy;germ free condition;Glycoproteins;Health;Herpesviridae;Human;Immune response;Immunodominant Epitopes;improved;Infection;Infectious Agent;innovation;Interferon Type II;International;Laboratories;latent infection;Lead;Macaca;Macaca nemestrina;Maintenance;Measles;multiplex assay;nonhuman primate;Parasites;pathogen;Pathogen detection;Prevalence;Proteins;Recombinant Proteins;Reporting;Reproducibility;Research;Research Personnel;Research Project Grants;respiratory pathogen;Retroviridae;Risk;Safety;screening;Sensitivity and Specificity;seroconversion;Serology;Serology test;Serotyping;Services;SIV;Specificity;success;Testing;testing services;Trypanosoma;Trypanosoma cruzi;Vaccinated;Vaccines;vector;Virus;Virus Diseases;virus testing;working group

PROJECT_TITLE: Vital Testing Core


PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Alleles;Animal Model;Animals;Breeding;Coccidioidomycosis;Collaborations;Communicable Diseases;Data;Data Analyses;data repository;Disease;Disease Outcome;Disease Progression;Disease Resistance;Disease susceptibility;Encephalitis;Ensure;Foundations;Generations;Genetic;genetic pedigree;Genetic Variation;Genome;genome sequencing;genome-wide linkage;genomic data;genomic tools;Genomics;Genotype;Goals;Haplotypes;Health;HIV;HIV/AIDS;Human;Immune response;Inbreeding;Individual;interest;Investigation;Knowledge;Macaca;Macaca mulatta;Macaca nemestrina;Maintenance;MHC Class I Genes;Modeling;Molecular;Monitor;nonhuman primate;novel;offspring;Outcome;Parents;pathogen;Phenotype;Polymorphism Analysis;Population;Predisposition;Prevention;Records;Reporting;Research;Research Design;Research Personnel;research study;Rhesus;Risk;RNA;Rodent Model;Short Tandem Repeat;Single Nucleotide Polymorphism;SIV;Study models;Study Subject;success;Testing;U-Series Cooperative Agreements;Validation;Variant;Viral Load result;whole genome

PROJECT_TITLE: MHC Genetic Typing Core


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Biotechnology;Brain Disorders;Gene Therapy;Genetics;Human Genome;Intellectual and Developmental Disabilities (IDD);Mental Health;Neurosciences;Pediatric;Rare Diseases;Rett Syndrome;Stem Cell Research;Stem Cell Research - Embryonic - Human;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Non-Human;Women's Health Research

ORG_CITY: NEW YORK

ORG_NAME: EPITOR THERAPEUTICS, INC.

PHR: Narrative Rett Syndrome is a devastating neurodevelopmental disease caused by mutations on the MeCP2 gene located on the X chromosome, with no disease modifying treatments available. Due to the presence of a wild type MeCP2 gene on the inactive X chromosome, targeted reactivation of this gene can rescue disease phenotypes by normalizing MeCP2 expression. Epitor Therapeutics is developing a novel genome editor that can be delivered to the CNS via a single AAV to reactivate MeCP2 gene via epigenetic modification.

PI_NAMEs: TSAI, YI-TING  (contact)

PROGRAM_OFFICER_NAME: GILCHRIST, FLOY ANNETTE

PROJECT_TERMS: adeno-associated viral vector;Adolescent;Affect;BCAR1 gene;Behavior assessment;Biodistribution;Biological Assay;bisulfite sequencing;Body Weight;boys;Brain;Breathing;Cell Line;cell type;Cells;Central Nervous System Diseases;Chimeric Proteins;Clustered Regularly Interspaced Short Palindromic Repeats;cognitive disability;cohort;demethylation;Dependovirus;Development;Disease;disease phenotype;DNA;DNA Binding;DNA Double Strand Break;DNA Methylation;dosage;Encapsulated;Epigenetic Process;epigenetic therapy;epigenome;epigenome editing;ES Cell Line;Female;Gene Activation;Gene Expression;Genes;Genetic Recombination;Genome;genome editor;genome-wide;girls;Guide RNA;Hand;human embryonic stem cell;humanized mouse;In Vitro;in vivo;Induced pluripotent stem cell derived neurons;Language;Liver;loss of function mutation;Methyl-CpG-Binding Protein 2;Methylation;Modification;mosaic;Mosaicism;mouse model;Movement;Mutate;Mutation;Neonatal;Neurodevelopmental Disorder;neuronal cell body;Neuronal Differentiation;Neurons;novel;off-target site;patient derived induced pluripotent stem cells;Patients;Performance;Pharmacology;Phenotype;physically handicapped;primary outcome;promoter;Protein Engineering;protein expression;Protein translocation;Proteins;rational design;Reporter;Residual state;Rett Syndrome;Risk;Sampling;scaffold;secondary outcome;Seizures;single-cell RNA sequencing;skill acquisition;Sleep disturbances;Specificity;System;targeted delivery;targeted treatment;Therapeutic;Therapeutic Effect;Tissues;tool;transcriptome sequencing;Tropism;Validation;Variant;Virus Shedding;whole genome;X Chromosome;X Inactivation

PROJECT_TITLE: Application of a novel dCasNano-based Epigenetic Editing to Treat Rett Syndrome

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


NIH_SPENDING_CATS: Bioengineering;Machine Learning and Artificial Intelligence;Neurosciences

ORG_CITY: CHICAGO

ORG_NAME: BRITESEED, LLC

PHR: PROJECT NARRATIVE Dura and nerve roots are often accidentally damaged during a number of spinal procedures which can lead to debilitating adverse outcomes for the patients, increased operating times, and additional surgeries. The goal of Phase I of this Small Business Innovation Research (SBIR) proposal is to miniaturize an optical sensor for detecting dura and nerve roots for integration into a Kerrison rongeur while Phase II focuses on developing and evaluating this sensor in fully functional multispectral Kerrison rongeur (MKR) during in vivo porcine laminectomies. By incorporating dura and nerve root detection into a familiar surgical tool currently used when these structures are most at risk, the MKR has the potential to bolster surgeon confidence, decrease surgery times, and reduce the incidence of these inadvertent injuries while minimizing barriers to adoption.

PI_NAMEs: THROCKMORTON, GRAHAM ADAIR (contact)

PROGRAM_OFFICER_NAME: GUTOWSKI, STACIE MARIE

PROJECT_TERMS: 3D Print;Accidents;Adoption;adverse outcome;Affect;Area;Biomechanics;Bite;bone;Cervical;Chest;Classification;classification algorithm;commercialization;Custom;Data;design;Detection;Development;Diameter;Dimensions;Dissection;Dura Mater;Ensure;Esthesia;Family suidae;Foundations;Goals;high risk;Histology;Housing;iatrogenic injury;improved;in vivo;Incidence;injured;Injury;Intracranial Hemorrhages;Laminectomy;machine learning algorithm;machine learning classification;Mechanics;miniaturize;Modeling;Monitor;Movement;Nerve;nerve damage;Neurophysiology - biologic function;operation;Operative Surgical Procedures;optical sensor;Optics;Outcome;Paralysed;Patient-Focused Outcomes;Patients;Performance;Persistent pain;Phase;Population;Positioning Attribute;pressure;prevent;Procedures;product development;Property;prototype;Repeat Surgery;Research;Research Proposals;Research Support;Risk;Sampling;sensor;severe injury;Sheep;Signal Transduction;Site;Small Business Innovation Research Grant;Spinal;Spine surgery;Structure;success;support vector machine;Surgeon;Surgical Instruments;Technology;Time;Tissues;tool;Training;Transducers;Validation;Vertebral column;visual feedback;Visualization

PROJECT_TITLE: Development of a Multispectral Kerrison Rongeur for Dura and Nerve Root Detection

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-W (12)]


NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Bioengineering;Biomedical Imaging;Biotechnology;Brain Disorders;Complementary and Integrative Health;Eye Disease and Disorders of Vision;HIV/AIDS;Mental Health;Neurosciences;Substance Misuse

ORG_CITY: NEW HAVEN

ORG_NAME: PANLUMINATE INC.

PHR: Project Narrative Understanding the intricate functions of the brain at a molecular level, particularly how individual cells and complex neural circuits interact over time and space, will provide new insights into the cellular mechanisms disrupted in neurological diseases. In this project, we will develop pan-OptiX S3D, the first automated three-dimensional and subcellular spatial proteomics platform technology, and validate its applicability in mouse brain tissue, including in a mouse model of Alzheimer’s disease. This development is crucial for advancing public health as it aims to transform the way we identify, treat and prevent a range of brain disorders, opening new horizons in neuroscience and medical treatment.

PI_NAMEs: M'SAAD, ONS  (contact)

PROGRAM_OFFICER_NAME: ANDERSON, PAIGE MARIE

PROJECT_TERMS: 3-Dimensional;Achievement;Address;Alzheimer's disease model;Amyloid;Antibodies;Automation;Axon;Beds;Biology;Biotechnology;Brain;Brain Diseases;brain tissue;Cells;Color;commercialization;Complex;Computer software;confocal imaging;Consumption;cost;Deposition;design;Development;Diagnostic;diagnostic strategy;Diffusion;Dimensions;Disease;DNA;Epitopes;Excision;Face;Future;Goals;Grant;Image;imager;imaging capabilities;imaging platform;Imaging technology;Immunofluorescence Microscopy;In Situ;Individual;innovative technologies;insight;Label;Licensing;Lipids;Maps;mass spectrometric imaging;Medical;Methods;Microfluidics;Microscopy;Molecular;Molecular Profiling;mouse model;multiplexed imaging;Mus;Names;Nervous System Disorder;neural circuit;neural network;Neurobiology;Neurosciences;new technology;novel;optical imaging;Outcome;Pathology;Penetration;Periodicity;Pharmacologic Substance;Phase;Preparation;prevent;Prevention strategy;Process;protein distribution;Proteins;Proteome;Proteomics;Protocols documentation;Public Health;Research;Resolution;Rodent;Sampling;Senile Plaques;Signal Transduction;spheroids;Stains;superresolution imaging;targeted imaging;Techniques;Technology;technology platform;Testing;Thick;Three-Dimensional Imaging;Time;Tissue Expansion;Tissue Fixation;Tissues;treatment strategy;ultra high resolution;Work

PROJECT_TITLE: A 3D super-resolved platform for rapid and highly multiplexed proteomics


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Mental Health;Prevention

ORG_CITY: NEW ORLEANS

ORG_NAME: SPOTTED TECH LLC

ORG_STATE: LA

PHR: NARRATIVE HIV remains a global health challenge, necessitating strategies for timely diagnosis and rapid access to care for people living with HIV (PLWH) to curb new transmissions. Enrolling and retaining PLWH in care is particularly significant, yet challenging, in underserved regions with high infection rates. Spotted Tech is developing a home- based mail-in CD4 count test designed to alleviate the need for frequent clinic visits, empowering PLWH to proactively monitor their health status, facilitate early HIV intervention, and ultimately play a role in curbing the spread of HIV.

PI_NAMEs: FAHLBERG, MARISSA  (contact);VACCARI, MONICA

PROGRAM_OFFICER_NAME: RAO, VASUDEV RAMACHANDRA

PROJECT_TERMS: Address;assay development;Blood;Blood capillaries;Blood Cells;Blood specimen;Caring;CD4 Lymphocyte Count;CD4 Positive T Lymphocytes;Cell Count;Cell Extracts;cell injury;Cells;Clinic;Clinic Visits;clinically relevant;cost effectiveness;Coupled;Data;Dedications;design;Development;Diagnosis;Diagnostic Reagent Kits;Dryness;Early Diagnosis;Early Intervention;empowerment;Enrollment;Exposure to;Face;field study;Fingers;Fostering;Foundations;global health;Goals;Health;health management;Health Services Accessibility;Health Status;Healthcare;Healthcare Systems;HIV;HIV Infections;Home;Human immunodeficiency virus test;Improve Access;improved;Incidence;Individual;infection rate;innovation;Intervention;Louisiana;Marketing;Measurement;Measures;Methods;Monitor;Pain;Paper;Participant;Persons;Phase;Play;point of care testing;Process;Protocols documentation;Recovery;Reproducibility;Role;Sampling;social stigma;Spottings;Staging;standardize measure;Surveys;Testing;Time;transmission process;Transportation;Travel;underserved area;United States;usability;Validation;validation studies;Viral Load result;Visit;Whole Blood

PROJECT_TITLE: CD4-LINK: Improving access to HIV care in underserves areas with a home-based, mail-in CD4 count test


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

ORG_CITY: NEWTON

ORG_NAME: AQUINNAH PHARMACEUTICALS, INC.

PHR: Project Narrative Alzheimer’s Disease is a significant burden to society for which there are currently no effective treatments; therefore, there is a dire need for novel therapeutic approaches in this field. This proposal aims to develop a lead drug candidate that will be disease-modifying, and can be tested in the relevant studies to bring it into the clinic.

PI_NAMEs: LARSEN, GLENN  (contact);WOLOZIN, BENJAMIN L

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: abeta accumulation;Affect;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease patient;Alzheimer's disease related dementia;Alzheimer's disease therapeutic;Alzheimer's disease therapy;Amyloid;Animal Model;Applications Grants;Award;Biochemical;Biological Assay;Biological Availability;Blood;Books;Boston;Brain;Canis familiaris;Cardiovascular system;Cells;cerebral atrophy;Chemicals;Chemistry;Clinic;Clinical Chemistry;clinical development;Clinical Trials;cognitive function;Complex;Data;Development;Development Plans;Disease;Disease Management;Disease Progression;Dose;drug candidate;drug development;Drug Kinetics;effective therapy;Ensure;Exposure to;Feedback;first-in-human;Genetic;Genetic Polymorphism;Hematology;high throughput screening;Human;Impaired cognition;improved;In Vitro;in vivo;Laboratories;Laboratory Research;Lead;Link;manufacture;Measures;meetings;Membrane;Memory Loss;Messenger RNA;Metabolic;Molecular;mouse model;Mus;Mutation;Nerve Degeneration;Neurodegenerative Disorders;Neurofibrillary Tangles;neuron loss;Neurons;novel;novel therapeutic intervention;Oral;Organ;Pathologic;Pathology;Patients;Pharmaceutical Chemistry;Pharmaceutical Preparations;Pharmacologic Substance;pharmacophore;Pharmacotherapy;Phase;Phase I Clinical Trials;pre-Investigational New Drug meeting;programs;Property;Proteins;Rattus;Reporting;Research;response;RNA;RNA metabolism;Role;Safety;safety study;Sampling;Senile dementia;Senile Plaques;Serum;Small Business Innovation Research Grant;small molecule;Societies;stem;stress granule;subcutaneous;symptomatic improvement;tau aggregation;tau interaction;tau Proteins;tau-1;Tauopathies;Testing;therapeutic candidate;therapeutic target;Toxic effect;Toxicology;Transgenic Mice;Universities;Work

PROJECT_TITLE: Development of a novel Alzheimer's disease therapeutic targeting tau

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 AN-P (11)]


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer

ORG_CITY: MARLBOROUGH

ORG_NAME: ASSAYQUANT TECHNOLOGIES, INC.

PHR: Narrative: Protein kinases are enzymes essential to human health and are frequently associated with many diseases, including cancer. There is an urgent need to accurately measure kinase activity in complex samples, including lysates from human cells and tissues, to improve our understanding of kinase biology and to monitor the effect of new drugs. A new product from AssayQuant Technologies, Inc., designated as PhosphoSens Lysate, combines several innovations to generate selective sensor peptides that addresses this need and fuels new approaches for discovering and validating life-saving medicines to treat human diseases.

PI_NAMEs: SCHAEFER, ERIK MICHAEL (contact)

PROGRAM_OFFICER_NAME: ZANE, LINDA KARINE

PROJECT_TERMS: Address;Adoption;Biochemical;Biological Assay;Biology;Cell Line;Cells;chelation;clinical candidate;clinically relevant;commercialization;Complex;cost;CSNK1A1 gene;Cysteine;Data;Development;Disease;drug development;drug discovery;Drug Targeting;Enzymes;Family;Feedback;Fluorescence;fluorophore;Goals;Health;Human;human disease;improved;Inflammatory;inhibitor;innovation;interest;Investigational Drugs;kinase inhibitor;Kinetics;Laboratories;Lead;lead optimization;Life;Malignant Neoplasms;manufacture;MAP2K6 gene;MAPK10 gene;MAPK3 gene;MAPK7 gene;MAPK8 gene;Measurement;Measures;Medicine;Methods;Mitogen-Activated Protein Kinases;Monitor;novel strategies;novel therapeutics;Oncogenic;Oncology;Oxyquinoline;Pathway interactions;Peptide Library;Peptides;Phase;phase 2 study;Phenotype;Phosphorylation;Phosphorylation Site;Phosphotransferases;Physiological;PIM1 gene;Play;Process;Proliferating;Protein Isoforms;Protein Kinase;Proteome;Reader;Reagent;Recombinant Proteins;Recombinants;Reporting;Reproducibility;Research;response;Role;Running;S phase;Sampling;screening;sensor;Signal Pathway;Signal Transduction;Site;small molecule;Solid;Specificity;success;Technology;Testing;Therapeutic;Time;Tissue Sample;Tissues;tool;tumor;Validation;Work

PROJECT_TITLE: Activity-based Sensor Peptides for Direct, High-throughput, and Kinetic Quantitation of Oncogenic Protein Kinases in Unfractionated Cell and Tissue Samples

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


ORG_CITY: SEWICKLEY

ORG_NAME: MAGNIFY BIOSCIENCES INC.

ORG_STATE: PA

PHR: PROJECT NARRATIVE Magnify Biosciences Inc. is advancing public health through the development of "Magnify," a cutting-edge Expansion Microscopy technology, aimed at equipping neuroscientists with Multiplex Magnify sample preparation kits for enhanced synapse typing and brain imaging. By enabling detailed 3D nanoscale ultrastructural analysis of brain tissue with molecular specificity using only a light microscope, these kits significantly reduce research costs and time. This innovation will allow researchers to explore the molecular mechanisms behind neural diseases more deeply, paving the way for new treatments and a better understanding of synaptopathies, significantly contributing to advancements in public health and neuroscience.

PI_NAMEs: KLIMAS, ALEKSANDRA  (contact)

PROJECT_TERMS: 3-Dimensional;Adoption;Anatomy;Antibodies;Bar Codes;Biological;Biological Sciences;Biotechnology;Brain;Brain imaging;brain research;brain tissue;Cilia;Collaborations;Complex;Computer software;confocal imaging;cost;Crista ampullaris;Custom;Data;design;Development;Devices;Disease;Electron Microscopy;Ensure;Epitopes;experimental study;Feedback;flexibility;Gel;Goals;Grant;Human;Image;image processing;imaging capabilities;imaging platform;Imaging Techniques;Immunofluorescence Immunologic;Indirect Immunofluorescence;innovation;interest;Label;Left;Letters;Libraries;Light Microscope;Lipids;Maps;Methods;Microscopy;Mitochondria;Molecular;molecular marker;multiplexed imaging;Mus;Names;nanoscale;Nature;neural;Neurons;Neurosciences;Neurosciences Research;next generation;Noise;novel;Nucleic Acids;Oligonucleotides;operation;optical imaging;Optical Methods;Optics;Outcome;Pattern;Phase;Preparation;preservation;Process;protein complex;Proteins;Protocols documentation;prototype;Public Health;Reagent;reagent testing;Research;Research Personnel;Resolution;sample fixation;Sampling;satisfaction;Signal Transduction;Specificity;Specimen;Stains;Standardization;Structure;success;superresolution imaging;Synapses;Techniques;Technology;Testing;Three-Dimensional Imaging;Time;time use;Tissue Expansion;Tissues;tool;ultra high resolution;Validation;Work

PROJECT_TITLE: Multiplex Magnify Protocol and Kit for High Plex, Superresolution 3D Synaptic Imaging and Analysis in Neuroscience


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Brain Disorders;Drug Abuse (NIDA only);Fentanyl Misuse and Addiction;Harm Reduction for Substance Misuse;Lung;Neurosciences;Opioid Misuse and Addiction;Opioids;Physical Injury - Accidents and Adverse Effects;Substance Misuse

ORG_CITY: GAINESVILLE

ORG_NAME: SERODOPA THERAPEUTICS INC

ORG_STATE: FL

PHR: PROJECT NARRATIVE The opioid crisis in the United States has been exacerbated by illicit fentanyl, resulting in a staggering increase in injuries and deaths. Currently available overdose reversal agents have a limited capacity to combat opioid- induced respiratory depression, and repeated, higher doses required to achieve the same effect push the intervention’s safety. Serodopa Therapeutics is developing a novel intranasal formulation of a naloxone derivative that will offer rapid and effective reversal of fentanyl-induced respiratory depression to vastly reduce injury and improve survival rates for opioid overdose.

PI_NAMEs: VORONKOV, MICHAEL V. (contact)

PROGRAM_OFFICER_NAME: NGUYEN, TAM L

PROJECT_TERMS: Acceleration;addiction;analog;aqueous;Blood;Brain;Brain Injuries;Canis familiaris;Cardiovascular system;Cessation of life;Chemicals;Clinical Research;Clinical Trials;combat;COVID-19 pandemic;Data;design;Development;Dose;Dryness;Fentanyl;fentanyl overdose;first-in-human;Formulation;Goals;Hypoxia;improved;In Vitro;Injury;innovation;Intervention;Lead;Life;Long term disability;mu opioid receptors;Naloxone;National Institute of Drug Abuse;novel;novel therapeutics;Opioid;Opioid Antagonist;opioid epidemic;opioid mortality;opioid overdose;Overdose;overdose death;Overdose reversal;Pharmaceutical Preparations;Pharmacology;Pharmacology Study;Phase;Phase I Clinical Trials;Plasma;Population;Powder dose form;pre-clinical;preclinical development;preclinical study;Preclinical Testing;prevent;Process;programs;Property;prototype;Public Health;Rattus;Readiness;receptor;Regimen;Reporting;Resistance;respiratory;Safety;safety assessment;scale up;side effect;Small Business Innovation Research Grant;standard care;Survival Rate;synthetic opioid;Temperature;Testing;Therapeutic;Toxicology;United States;Ventilatory Depression;Work

PROJECT_TITLE: NX90: A Treatment for Overdose Caused by High Potency Opioids

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-S (14)]


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Bioengineering;Brain Disorders;Caregiving Research;Clinical Research;Dementia;Depression;Mental Health;Neurodegenerative;Neurosciences;Palliative Care;Rehabilitation

ORG_CITY: Minneapolis

ORG_NAME: KORONIS BIOMEDICAL TECHNOLOGIES CORPORAT

PHR: Narrative Informal and family caregivers provide three-quarters of the care for America’s dementia population at great economic and emotional cost to themselves. These caregivers experience significant stress due to the burdensome behaviors associated with dementia. The proposed research seeks to develop a cognitive training system to help care recipients with mild cognitive impairment or early-stage dementia preserve their cognition and delay the need for care to reduce these burdens and facilitate greater caregiver independence.

PI_NAMEs: RIEHLE, TIMOTHY H. (contact)

PROJECT_TERMS: Address;Aging;aging related disease;Alzheimer's Disease;Alzheimer's disease related dementia;American;Anecdotes;Behavior;Biomedical Technology;Books;burden of illness;care recipients;Caregiver Burden;caregiver stress;Caregiver support;Caregivers;Caring;Cognition;Cognitive;cognitive testing;cognitive training;Collection;Computer software;Consult;cost;Dementia;design;Development;Doctor of Philosophy;economic value;Economics;Emotional;Endowment;Engineering;Ensure;evidence base;executive function;experience;Family;Family Caregiver;family caregiving;Family member;Feedback;Focus Groups;Friends;functional independence;Goals;Home;Human;Impaired cognition;in-home care;Individual;informal care;informal caregiver;informal support;innovation;Institutionalization;Intervention;Life;Long-Term Care;loved ones;Medical Device;Memory;Mental Depression;mild cognitive impairment;Minnesota;Modeling;Monitor;multidisciplinary;Music;novel;Performance Status;person centered;personalized medicine;Persons;Phase;Population;preservation;Prevalence;prevent;Process;professor;programs;prototype;psychosocial;Public Health Schools;Recommendation;Recording of previous events;Research;Research Personnel;Research Project Grants;Role;Scientist;Series;Services;Short-Term Memory;skills;Stress;System;Tablets;Text;Therapeutic Intervention;Training;Training Activity;Universities;usability;Work

PROJECT_TITLE: Interactive Gaming Platform to Facilitate Cognitive Interventions for Dementia

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