ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Bioengineering;Clinical Research;Comparative Effectiveness Research;Diabetes;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Patient Safety;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: PHILADELPHIA

ORG_NAME: VIORA HEALTH INC

PHR: Narrative: Vulnerable and underserved populations often suffer the greatest health risks while facing significant barriers, largely due to social and behavioral factors that hinder continued participation in disease prevention and management protocols. Viora Health’s wraparound digital health support system will support public health scaling of evidence-based protocols by using technology to identify and rank such risks while leveraging existing community based resources to support patients in mitigating these factors.

PI_NAMEs: DUTTA, DEBOLEENA  (contact)

PROGRAM_OFFICER_NAME: MUJURU, PRISCAH

PROJECT_TERMS: acceptability and feasibility;Algorithms;behavior change;Behavioral;behavioral outcome;Behavioral Sciences;Biological;Blinded;Body Weight decreased;Caring;case control;Characteristics;clinical risk;Code;commercialization;Communication;Communities;community partners;Community Services;Confidential Information;cost;Data;Data Collection;Data Science;Databases;design;Devices;Diabetes prevention;diabetes prevention program;diabetic patient;digital;digital health;Disease Management;disorder prevention;Drops;Education;Emergency department visit;Enrollment;ethnic minority;evidence base;experience;Feedback;food insecurity;Fund Raising;General Population;Health;Health behavior and outcomes;health care service;health care service organization;health literacy;Health Personnel;Health Promotion;Health Services;Healthcare;Home;hospital readmission;Human;human subject;improved;Individual;innovation;Institution;Intellectual functioning disability;Intervention;large datasets;Lesbian Gay Bisexual Transgender Queer;Letters;Life Style;lifestyle factors;literacy;Long-Term Care;Managed Care;Marketing;Measurement;Measures;Medical;Medicare;Minority;Minority Groups;Modeling;Needs Assessment;Non-Insulin-Dependent Diabetes Mellitus;Outcome;Participant;participant enrollment;Patient Triage;Patients;peer;Performance;personalized intervention;Phase;Philadelphia;physically handicapped;Population;Prediabetes syndrome;prevent;Program Effectiveness;programs;prospective;Protocols documentation;prototype;Public Health;racial minority;research study;Resource Sharing;Resources;Risk;risk prediction model;Risk Reduction;risk stratification;Savings;Schedule;Self Management;service gap;Side;social;social culture;social disparities;social health determinants;Socioeconomic Factors;socioeconomics;Study Subject;success;Support System;Surveys;System;Technology;Testing;Time;Transportation;Underserved Population;Vulnerable Populations;web app;Woman;Work

PROJECT_TITLE: Wraparound digital health support system to improve engagement and health outcomes of minority populations who are disadvantaged by social determinants of health in evidence-based protocols

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


ADMINISTERING_IC: GM

ARRA_FUNDED: N

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Infectious Diseases

ORG_CITY: DURHAM

ORG_COUNTRY: UNITED STATES

ORG_DEPT: CHEMISTRY

ORG_FIPS: US

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PHR: Project Narrative The copper (Cu) homeostasis mechanisms of Candidia albicans are critical for virulence in a human host, which creates niches of Cu-deficiency and excess as part of the immune response. Despite an understanding of the metalloproteins involved in Cu homeostasis, the mechanism of activation of the transcription factor that controls the Cu-deficient response is still unknown. We propose a wide array of biochemical techniques to investigate the location and metalation state of CuZnSod1 and its involvement in activating the transcription factor under Cu-deficient conditions induced by antifungal treatment; these results will advance our understanding of Mac1’s activation in C. albicans under Cu-deficient conditions and inform our understanding of developing better antifungal treatments exploiting metal-specific weaknesses.

PI_NAMEs: VACCARO, FRANCESCA  (contact)

PROGRAM_OFFICER_NAME: JONES, LATAISIA CHERIE

PROJECT_TERMS: anti-fungal agents;Antioxidants;Azoles;Binding;Biochemical;Biological;Biological Assay;biophysical techniques;Calorimetry;Candida albicans;CEBPE gene;Cell Fractionation;Cell Nucleus;Cells;Copper;copper zinc superoxide dismutase;Cytosol;Data;Dependence;design;DNA Binding;Environment;Equilibrium;Event;Exposure to;Fluconazole;fungus;Gel;Genes;Goals;Growth;Homeostasis;Human;human pathogen;Immune response;Immunocompetent;Immunocompromised Host;Inductively Coupled Plasma Mass Spectrometry;Infection;insight;Investigation;Ions;Location;Mass Spectrum Analysis;Metalloproteins;Metals;Micronutrients;Mitochondria;Molecular;Molecular Sieve Chromatography;Monitor;novel;Nuclear;Nutritional Immunity;Organism;pathogen;Pathogenesis;Pathogenicity;Pathway interactions;Pharmaceutical Preparations;Physiologic pulse;Play;Population;Proteolysis;Reactive Oxygen Species;Regulon;Repression;resistant strain;response;Risk;Risk Factors;Role;Route;Saccharomyces cerevisiae;Signal Transduction;SOD2 gene;Stress;Superoxide Dismutase;superoxide dismutase 1;Techniques;Testing;Titrations;Toxic effect;transcription factor;Transcriptional Activation;Virulence;Western Blotting;Work;Zinc deficiency

PROJECT_TITLE: Investigation of the role of CuZnSod1 in sensing Cu-deficient conditions in Candida albicans

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F04-S (20)]


ADMINISTERING_IC: NS

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Brain Disorders;Clinical Research;Emergency Care;Neurosciences;Physical Injury - Accidents and Adverse Effects;Traumatic Brain Injury (TBI);Traumatic Head and Spine Injury

ORG_CITY: Portland

ORG_NAME: HEMEX HEALTH, INC.

ORG_STATE: OR

PHR: Project Narrative Using an Inclined Plane System to Triage TBI Patients Traumatic brain injury (TBI), such as that experienced in blast injuries and collisions, can vary in severity and be difficult to detect. Mild TBI makes up the majority of brain injuries, but it is the hardest to diagnose; many cases go undiagnosed because these mild brain injuries are not detectable on a CT scan. Further, laboratory diagnostic tests require expensive instrumentation and can take a long time to process and coordinate, making this information difficult to obtain in bedside and emergency situations. We need a point-of-care device that can quickly detect elevated biomarker levels to diagnose and monitor the severity of TBI. To address this need, Hemex Health is proposing to adapt its existing technology combined with micro-engineering methods (microbeads and microfluidic channels) to capture specific TBI biomarkers for identification and monitoring of TBI.

PI_NAMEs: GALEN, PETER  (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: Accident and Emergency department;Address;Affect;Ambulances;Area;Athletic;automated algorithm;Biological Assay;Biological Markers;Blast Injuries;Blood;Blood specimen;Blood Tests;Brain;Brain hemorrhage;Brain Injuries;Cancer Etiology;Caring;Chemistry;circulating biomarkers;Clinical;Cold Chains;cost effective;Craniocerebral Trauma;Data;Department of Defense;design;Detection;Development;Devices;Diagnosis;Diagnostic;diagnostic accuracy;Diagnostic Procedure;Diagnostic tests;Diameter;Disease;Drops;Emergency Situation;emotional symptom;Engineering;Ensure;Environment;Evaluation;experience;Financial cost;Funding;Future;Glial Fibrillary Acidic Protein;Health;Height;Hospitals;Immunoassay;injured;Injury;innovation;instrumentation;Judgment;Label;Laboratories;Lead;Measures;Medicine;Methods;Microfluidics;Microspheres;mild traumatic brain injury;Monitor;novel;Optics;patient response;Patients;Penetration;Performance;Persons;Pharmaceutical Preparations;Pharmacotherapy;Phase;physical symptom;Pilot Projects;Plasma;point of care;point of injury;Point-of-Care Systems;portability;Positioning Attribute;Process;protein biomarkers;Protein C;Proteins;Quality of life;Quantum Dots;Radiation;Reader;Reagent;Recovery;Refrigeration;Reporting;Research;Resource-limited setting;Resources;response;Risk;rural health clinic;Sampling;Scanning;Severities;Small Business Innovation Research Grant;Sports;Symptoms;System;TBI Patients;Technology;Temperature;Testing;Time;Translating;Trauma;Traumatic Brain Injury;Traumatic intracranial hemorrhage;treatment planning;Triage;ubiquitin C-terminal hydrolase;United States Food and Drug Administration;Whole Blood;Work;X-Ray Computed Tomography

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


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Liver Cancer;Liver Disease;Networking and Information Technology R&D (NITRD);Radiation Oncology;Rare Diseases

ORG_CITY: BURLINGTON

ORG_NAME: NE SCIENTIFIC, INC.

ORG_STATE: MA

PHR: Project Narrative: This program aims at validating clinically a software to support physicians in percutaneous microwave ablation of liver tumors. In this form of treatment physicians insert a needle-shaped probe in the tissues which applies heat and destroys the malignancy. As physicians do not have a direct view of the tissues, they use images to track the position of the probe in the body, but there are challenges in evaluating from the images which tissues have been killed and which not – a situation that leads to incomplete treatment of the tumor. The software developed in this research program simulates the physics taking place and indicates on images, during the procedure, which part of the tumor has been killed and which not. Availability of this computerized aid should result in a much more consistent treatment of the tumor volume.

PI_NAMEs: BORSIC, ANDREA  (contact)

PROGRAM_OFFICER_NAME: EVANS, GREGORY

PROJECT_TERMS: Ablation;Achievement;Address;Adopted;algorithm development;Algorithms;Animals;Award;Awareness;base;Benchmarking;cancer therapy;Chemotherapy and/or radiation;Clinic;Clinical;clinical center;clinical translation;Clinical Trials;commercialization;Computer Assisted;Computer software;computerized;Computers;Data;Decision Making;Development;Ensure;Feedback;Fire - disasters;follow-up;Geometry;Goals;graphical user interface;Heating;Image;image guided;image registration;Image-Guided Surgery;improved;innovation;Institutional Review Boards;Intervention;Knowledge;Lead;Left;Libraries;liver ablation;Liver neoplasms;liver tumor ablation;Malignant - descriptor;Malignant neoplasm of liver;Malignant neoplasm of lung;Malignant Neoplasms;Manuals;Manufacturer;Mechanics;Medical center;Medicine;microwave ablation;microwave electromagnetic radiation;Microwave Tumor Ablation;minimally invasive;Minor;Monitor;navigation aid;Needles;novel;Operative Surgical Procedures;Outcome;Patient Recruitments;Patients;Phase;Physicians;Physics;Positioning Attribute;Printing;Procedures;Process;programs;Radiofrequency Interstitial Ablation;radiologist;recruit;Recurrent tumor;Reporting;Research;response;Safety;Shapes;side effect;simulation;Skin;Small Business Innovation Research Grant;software development;Solid;Speed;success;System;Technology;Thinking;Time;Tissues;tool;tumor;tumor progression;Tumor Volume;Visual;Visualization;X-Ray Computed Tomography

PROJECT_TITLE: Computer Guided Microwave Liver Ablation

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Biotechnology;Cardiovascular;Heart Disease;Heart Disease - Coronary Heart Disease;Nanotechnology;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Nonembryonic - Human

ORG_CITY: JOHNS CREEK

ORG_NAME: 5M BIOMED, LLC

ORG_STATE: GA

PHR: PROJECT NARRATIVE  This STTR Phase I project is to develop an MRI-guided, theranostic extracellular vesicle (EV) platform for treating myocardial diseases, such as myocardial infarctions (MI). We anticipate that our innovative theranostic EV platform will emerge as a safe and effective cell-free regenerative therapy with capability for treatment monitoring and response prediction. The successful development of proposed EV platform will open a new horizon for treating various cardiovascular diseases.

PI_NAMEs: LI, YUANCHENG  (contact);LIU, GUANSHU

PROGRAM_OFFICER_NAME: DANTHI, NARASIMHAN

PROJECT_TERMS: Acute;Address;Adult;angiogenesis;Animal Model;Animal Testing;Animals;Anti-Inflammatory Agents;Apoptosis;Benchmarking;Biodistribution;Cardiac;Cardiac Myocytes;cardiac repair;Cardiomyopathies;cardioprotection;Cardiovascular Diseases;Cause of Death;Cell Survival;Cell Therapy;Cells;Cessation of life;Clinic;Clinical;clinical translation;Clinical Trials;Collaborations;Consumption;Contrast Media;cytotoxicity;Detection;Development;Diagnostic;Dilatation - action;dosage;Drug Kinetics;Effectiveness;efficacy evaluation;Engraftment;Ethics;extracellular vesicles;Fibrosis;first-in-human;Formulation;Goals;Growth;Heart;Heart Diseases;Heart failure;heart function;human stem cell-derived;Image;image guided;imaging modality;Immune response;Impairment;In Vitro;in vivo;Incidence;indexing;Infarction;Inflammation;Injections;injured;innovation;Inpatients;interest;Investigational New Drug Application;iron oxide;Ischemia;Label;Length;magnetic beads;Magnetic Resonance Imaging;Magnetism;manufacturing scale-up;Marketing;Measures;Mechanics;Mediating;Methods;Monitor;Morphology;mouse model;myocardial infarct sizing;Myocardial Infarction;myocardial injury;Myocardium;nanomaterials;nanomedicine;nanorod;nanosized;Natural regeneration;non-invasive imaging;novel;novel therapeutics;paracrine;Patients;Phase;phase 1 study;phase 2 study;pre-clinical;preclinical study;predicting response;Preparation;Procedures;Production;Property;Public Health;Quality Control;Recurrence;regenerative;Regenerative Medicine;regenerative therapy;repair function;repaired;Reperfusion Therapy;Reproducibility;Research;Rodent Model;Safety;scale up;side effect;Small Business Technology Transfer Research;stem cell therapy;stem cells;success;Surface;System;targeted delivery;technology platform;Testing;theranostics;Therapeutic;therapeutically effective;Time;Tissues;Toxic effect;Translating;translational potential;Translational Research;Translations;treatment effect;Treatment Efficacy;treatment response;treatment strategy;Ultracentrifugation;Universities;uptake;Width

PROJECT_TITLE: Multi-functional magnetic nanorods for constructing theranostic extracellular vesicles for treating myocardial infarction


ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

NIH_SPENDING_CATS: Neurosciences

ORG_CITY: CHICAGO

ORG_DEPT: PHYSIOLOGY

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

ORG_STATE: IL

PHR: NARRATIVE The proposed research on motor cortex circuits is relevant to public health, both for advancing fundamental neuroscience knowledge about mammalian brain circuits and because a wide spectrum of common disorders affect these circuits in humans. The proposed research is thus relevant to those aspects of the NIH mission aimed at improving health through understanding pathophysiological mechanisms in disorders causing disability.

PI_NAMEs: SHEPHERD, GORDON M (contact)

PROGRAM_OFFICER_NAME: CHEN, DAOFEN

PROJECT_TERMS: Activities of Daily Living;Address;Affect;Anatomy;Area;arm movement;awake;Axon;Behavior;Behavior Control;Behavioral;Biological Assay;Brain;cell type;Communication;Data;disability;Disease;dynamic system;Electrophysiology (science);Environment;Ethology;experimental study;Food Handling;Forelimb;Functional disorder;Goals;Hand;Health;Human;improved;in vivo;insight;kinematics;Knowledge;Label;Link;Mediating;Methods;Mission;model organism;Modeling;Motor;motor control;Motor Cortex;Motor Pathways;Movement;Mus;neural circuit;Neurons;Neurosciences;Neurosciences Research;novel;optogenetics;Output;Parietal;Pathway interactions;Primates;Process;programs;Property;Public Health;Qualifying;Reporting;Research;Rest;Rodent;Sensory;sensory feedback;Series;Shapes;Signal Transduction;skills;Slice;somatosensory;Somatosensory Cortex;Stream;Synapses;Systems Analysis;Testing;tool;United States National Institutes of Health;Viral;Whole-Cell Recordings;Work

PROJECT_TITLE: Synaptic circuit organization of motor cortex

STUDY_SECTION: SMN

STUDY_SECTION_NAME: Sensory-Motor Neuroscience Study Section[SMN]


NIH_SPENDING_CATS: Cardiovascular;Clinical Research;Contraception/Reproduction;Genetic Testing;Genetics;Human Genome;Hypertension;Maternal Health;Maternal Morbidity and Mortality;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Prevention;Women's Health Research

ORG_CITY: SCOTCH PLAINS

ORG_NAME: KANONA, INC.

ORG_STATE: NJ

PHR: PROJECT NARRATIVE Preeclampsia is a devastating pregnancy complication which current prediction algorithms cannot precisely predict. Kanona, Inc is developing a cell-free DNA based algorithm that relies on utilizing placental epigenetic signatures contained within low-pass whole genome sequencing data routinely generated for prenatal aneuploidy screening. This project will refine the current prediction algorithm by correcting for pre-analytical variables, identify relevant epigenetic signatures with placental tissue sequencing and deeper sequencing of cell-free DNA, and perform validation on an external cohort enriched for preeclampsia.

PI_NAMEs: REICHEL, JONATHAN  (contact)

PROGRAM_OFFICER_NAME: VARAGIC, JASMINA

PROJECT_TERMS: Address;Affect;Algorithms;Aneuploidy;Aspirin;ATAC-seq;Biological Assay;Biological Markers;blood pressure control;Blood specimen;Body System;cardiovascular disorder risk;cell free DNA;Chromatin;Circulation;Classification;Clinical;clinical risk;clinical sequencing;cohort;computational platform;computer framework;Computing Methodologies;Custom;Data;Dedications;Detection;diagnostic criteria;DNA sequencing;Dose;early onset;Ecosystem;Elements;Epigenetic Process;Evaluation;experience;First Pregnancy Trimester;follow-up;Functional disorder;Generations;genome sequencing;high risk;Hypertension;Incidence;Individual;Infrastructure;insight;Intervention;Laboratories;Life Experience;liquid biopsy;machine learning model;Maternal and Child Health;Measures;Methodology;Methods;Methylation;Modification;Monitor;Morbidity - disease rate;mortality;Mothers;novel therapeutic intervention;Nucleic Acids;Nucleosomes;offspring;Onset of illness;Patau's syndrome;Pattern;Performance;performance tests;Phase;Phenotype;Placenta;Plasma;Plasma Cells;Population;Positioning Attribute;Pre-Eclampsia;precision medicine;prediction algorithm;predictive marker;Predictive Value;Pregnancy;Pregnancy Complications;pregnant;premature;prenatal;Prenatal care;prenatal testing;prevent;Prevention;programs;Reporting;Reverse Transcription;Risk;Risk Factors;risk mitigation;risk prediction;Risk Reduction;risk stratification;RNA;Role;Sampling;screening;screening program;Serum;Severities;Site;standard of care;Testing;Therapeutic Intervention;Time;Tissues;ultrasound;United States;Validation;validation studies;whole genome;Work

PROJECT_TITLE: Epigenetic phenotyping from liquid biopsy for preeclampsia risk classification during the first trimester

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


NIH_SPENDING_CATS: Brain Disorders;Clinical Research;Fragile X Syndrome;Genetics;Intellectual and Developmental Disabilities (IDD);Neurodegenerative;Neurosciences;Rare Diseases

ORG_CITY: LAWRENCE

ORG_DEPT: PSYCHOLOGY

ORG_NAME: UNIVERSITY OF KANSAS LAWRENCE

ORG_STATE: KS

PHR: PROJECT NARRATIVE Fragile X-associated tremor/ataxia syndrome (FXTAS) is caused by premutation alleles of the FMR1 gene and defined by deterioration of motor abilities and pathology of the cerebellum. Despite their primary roles in FXTAS, motor abilities and cerebellar processes in FXTAS are understudied, and objective, quantitative approaches for tracking their degeneration are needed to understand key mechanisms and track disease onset and progression. Comparing premutation carriers with FXTAS, premutation carriers without FXTAS, and healthy controls, the proposed studies will characterize cerebellar structural and functional degeneration in FXTAS, their relationships with genetic/molecular causes and clinical decline, and their variation across male and female premutation carriers.

PI_NAMEs: MOSCONI, MATTHEW W (contact)

PROGRAM_OFFICER_NAME: RIDDLE, ROBERT D

PROJECT_TERMS: 5' Untranslated Regions;Address;Age;aging population;Alleles;Alzheimer's Disease;Apolipoprotein E;Ataxia;Behavior;Behavioral;biobehavior;Biological Markers;Brain;brain pathway;Cells;Cerebellar Cortex;Cerebellar degeneration;Cerebellum;Cessation of life;CGG repeat;Clinical;Data;Degenerative Disorder;density;Deterioration;Development;Diffusion;Diffusion Magnetic Resonance Imaging;Disease;Disease Pathway;Disease Progression;effective therapy;fall risk;Female;FMR1 gene;Functional Magnetic Resonance Imaging;FXTAS;Gait;Gene Mutation;Genes;Genetic;Genetic Risk;genetic variant;grasp;High Prevalence;human old age (65+);Image;Individual;Knowledge;Lead;Length;Lesion;Lobular;Lower Extremity;male;Manuals;Measures;Messenger RNA;Molecular;molecular marker;Molecular Target;Motor;motor behavior;Movement;Musculoskeletal Equilibrium;Mutation;mutation carrier;Nerve Degeneration;Neurites;novel therapeutics;Onset of illness;Output;Participant;Pathology;Pathway interactions;Patients;premature;Process;Prospective Studies;Quality of life;Rest;Risk;Role;sex;Structure;Symptoms;task analysis;Testing;therapeutically effective;Time;Transcript;Variant;Visual;Visual Cortex;white matter

PROJECT_TITLE: Mechanisms and biomarkers of disease progression in Fragile X-associated tremor/ataxia syndrome (FXTAS)

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 BP-P (02)]


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Eye Disease and Disorders of Vision;Gene Therapy;Genetics;Orphan Drug;Prevention;Rare Diseases;Transplantation

ORG_CITY: CHAPEL HILL

ORG_NAME: BEDROCK THERAPEUTICS, INC.

PHR: Project Narrative Corneal transplantation rejection in high-risk patients occurs at an alarming rate of 70% within 10 years of the surgery. Bedrock Therapeutics has developed a single dose gene therapy specifically for the corneal donor tissue that prevents high-risk acute rejection in an animal model. The work proposed here in seeks to de-risk this approach for applications in human that require corneal transplantation. Successful application of this approach in the corneas may also prevent rejection of other transplanted organs including heart, liver, lung, and kidney.

PI_NAMEs: GILGER, BRIAN C (contact);HIRSCH, MATTHEW LOUIS

PROGRAM_OFFICER_NAME: GOVER, TONY DOUGLAS

PROJECT_TERMS: Accounting;Acute;Address;Adverse event;Age related macular degeneration;Allogenic;Animal Model;assay development;Bilateral;Blindness;Clinical;clinical application;clinical development;clinical translation;Cornea;Corneal Diseases;Data;Dependovirus;Development;Disadvantaged;Disease;Distress;Dose;Dose Limiting;economic impact;efficacy study;fall risk;Frequencies;gene therapy;Gene Transfer;Genes;Genetic;Goals;graft failure;Graft Rejection;Health Care Costs;Heart;high risk;Homeostasis;Hospitals;Human;IGBP1 gene;Immune;Immune response;Immune Tolerance;Immunologics;immunoregulation;Immunosuppression;Immunosuppressive Agents;improved;Individual;Industry Standard;Insulin-Dependent Diabetes Mellitus;Investments;Keratoplasty;Kidney;lead candidate;Liver;Lung;Maintenance;manufacture;Methods;Modeling;mortality;novel;Operative Surgical Procedures;Organ;Organ Transplantation;Oryctolagus cuniculus;Patients;Persons;Pharmaceutical Preparations;Phase;Phase I/II Clinical Trial;pre-Investigational New Drug meeting;prevent;Prevention;Production;Prognosis;protein complex;Protocols documentation;Quality of life;Risk;Safety;safety study;side effect;Small Business Technology Transfer Research;Solid;standard of care;success;Technology;Therapeutic;Tissue Donors;Tissue Transplantation;Transplantation;Transplantation Surgery;United States;Vascularization;vector;Work

PROJECT_TITLE: Prevention of corneal transplant rejection using AAV-BDRK-401 therapy

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cardiovascular;Gene Therapy;Genetics;Heart Disease;Heart Disease - Coronary Heart Disease;Prevention

ORG_CITY: WOODBINE

ORG_NAME: RITHIM BIOLOGICS, INC.

ORG_STATE: MD

PHR: Project Narrative Cardiac arrest is the leading cause of death in the United States and other developed countries. In public discussions, these deaths are often called “heart attacks,” but in reality, they most often occur as a result of lethal ventricular arrhythmias. We previously identified unique elements of the electrical circuits that cause these ventricular arrhythmias. We developed a gene therapy catheter that would allow us to target the heart attach skar. This proposal focuses on developing a gene therapy to prevent the unique elements of the electrical circuit from causing ventricular tachycardia, thereby eliminating these arrhythmias.

PI_NAMEs: ANDERSON, RONALD LEE (contact)

PROGRAM_OFFICER_NAME: TINSLEY, EMILY

PROJECT_TERMS: Abbreviations;Action Potentials;adeno-associated viral vector;adenovirus mediated delivery;Animals;Arrhythmia;Atrial Fibrillation;Attenuated;Autopsy;Biodistribution;Catheters;Cause of Death;Cell Physiology;Cessation of life;Chest;Cicatrix;clinical development;clinically relevant;Coronary Arteriosclerosis;Data;Dependovirus;design;Developed Countries;Development;Devices;Disease;Ectopic beats;efficacy evaluation;efficacy study;Electrophysiology (science);Elements;Environment;Event;experience;experimental study;Family suidae;Future;Gene Combinations;gene therapy;gene therapy clinical trial;Gene Transfer;Genes;Goals;Grant;healing;Heart;Heart Arrest;Heart Atrium;Heterogeneity;Infarction;Investigational Drugs;Investigational New Drug Application;Left Ventricular Ejection Fraction;Malignant - descriptor;Methods;Modeling;Monitor;Muscle Cells;Mutation;Myocardial;Myocardial Infarction;Nature;novel;Paint;Patients;Pattern;Perfusion;Pericardial body location;Persons;Phase;Pilot Projects;porcine model;Postoperative Period;Potassium Channel;pre-clinical;pre-clinical therapy;preclinical efficacy;preclinical safety;prevent;Procedures;Program Development;Proteins;prototype;Refractory;Reporting;Research;research clinical testing;response;Safety;safety study;Serious Adverse Event;Sinus;Small Business Innovation Research Grant;Small Business Technology Transfer Research;small hairpin RNA;sudden cardiac death;Sudden Death;Tachyarrhythmias;Techniques;Testing;therapy development;Time;Tissues;Toxic effect;transgene delivery;transgene expression;Transgenes;United States;Ventricular;Ventricular Arrhythmia;Ventricular Tachycardia

PROJECT_TITLE: Novel Gene Therapy, Techniques, and Devices to Prevent Ventricular Tachycardia

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IVBH-V (10)]


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Dietary Supplements;Kidney Disease;Nutrition;Orphan Drug;Rare Diseases

ORG_CITY: Newton

ORG_NAME: EXTEND BIOSCIENCES, INC.

PHR: PROJECT NARRATIVE Hypoparathyroidism is a classic hormone deficiency disorder that does not have a true replacement therapy. Untreated or inadequately treated hypoparathyroidism leads to severe calcium deficiency, which is life- threatening. Extend Biosciences is developing a long-acting hormone replacement therapy that the patient can self-administer at home.

PI_NAMEs: HALES, LAURA M (contact)

PROGRAM_OFFICER_NAME: LI, YAN

PROJECT_TERMS: Address;ADME Study;Adverse event;Arrhythmia;Biological Availability;Biological Sciences;Blood Chemical Analysis;Bone remodeling;bone turnover;calcification;Calcium;calcium supplementation;Chronic Disease;Clinical;Clinical Research;Clinical Trials;clinically significant;cohort;Continuous Infusion;conventional therapy;cost;Data;design;Deterioration;Development;Disease;Disease Management;disease model;Dose;Double-Blind Method;Drug Kinetics;efficacy study;Excipients;FDA approved;Feeling;Formulation;Freezing;Funding;Future;Grant;Half-Life;healthy volunteer;heart rhythm;Home;hormone deficiency;Hormone replacement therapy;Hormones;Human;hypercalciuria;Hypocalcemia;Hypoparathyroidism;improved;Infusion procedures;Injections;inorganic phosphate;Kidney Calculi;Kidney Failure;Left;Life;manufacture;Measures;Mediating;Medical;Metabolic;Methionine;Minerals;Monitor;Muscle Cramp;Needles;Nephrocalcinosis;oral supplementation;oxidation;parathyroid hormone (1-34);Paresthesia;patient subsets;Patients;Peptides;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;Phase;phase 1 study;Phase I Clinical Trials;Phase Ib Clinical Trial;Phase II Clinical Trials;phase II trial;Phosphorus;Physiological;pill;Placebo Control;Plasma;Play;Powder dose form;Preparation;Production;programs;PTH gene;Pump;Quality of life;Randomized;Rare Diseases;Rattus;Regimen;Renal function;Replacement Therapy;Research;Role;Safety;Schedule;Seizures;Self Administration;Serum;Serum Calcium Level;Small Business Innovation Research Grant;soft tissue;Spasm;Specific qualifier value;Subcutaneous Injections;Supplementation;System;Time;Toxicology;urinary;Urine;Vial device;Vitamin D;Vitamin D Analog;Vitamins;vocal cord;Writing

PROJECT_TITLE: Long-acting PTH for hypoparathyroidism

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

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

ORG_CITY: BUFFALO

ORG_NAME: POP BIOTECHNOLOGIES, INC

ORG_STATE: NY

PHR: The goal of this proposal is to continue the development of a novel, non-egg-based, influenza vaccine platform that allows for multiplexed antigen incorporation and produces robust, protective immune responses with less antigen content when compared to current vaccines. A liposome vaccine that display both recombinant influenza virus surface proteins (hemagglutinin and neuraminidase) from multiple viral strains will be comprehensively be interrogated in multiple animal challenge models to establish the efficacy of this approach.

PI_NAMEs: KUTSCHER, HILLIARD  (contact)

PROGRAM_OFFICER_NAME: GORDON, JENNIFER L

PROJECT_TERMS: Acute;Adjuvant;Agonist;Animals;Antibodies;Antigens;Baculovirus Expression System;Baculoviruses;Biomedical Research;Biotechnology;Cells;Cessation of life;chemical property;Chemistry;clinical candidate;clinical translation;Clinical Trials;Cobalt;Coupling;COVID-19 vaccine;Data;Data Set;design;Development;Dose;egg;Engineering;Ferrets;flu;Goals;head-to-head comparison;Hemagglutinin;Histidine;Human;Immune response;Immunization;immunogenic;immunogenicity;Immunologics;improved;Infection;Influenza;Influenza A Virus, H1N1 Subtype;Influenza A Virus, H3N2 Subtype;influenza infection;Influenza prevention;influenza virus strain;influenza virus vaccine;influenzavirus;Insecta;intercalation;Lipid A;Lipid Bilayers;Liposomes;manufacture;Membrane Proteins;Modeling;Modernization;Morbidity - disease rate;mortality;mosaic;Mus;nanoliposome;nanoparticle;Neuraminidase;next generation;nonhuman primate;novel;Oryctolagus cuniculus;particle;Phase;phase II trial;Phospholipids;physical property;Play;Population;Porphyrins;Positioning Attribute;pre-clinical;Preparation;Process;Production;prophylactic;protective efficacy;Proteins;Publishing;QS21;Recombinant Vaccines;Recombinants;Recommendation;Reporting;Research Institute;response;Role;Saponins;scale up;seasonal influenza;Seasons;Severities;Small Business Innovation Research Grant;stability testing;Surface;System;Technology;technology platform;Testing;Texas;TLR4 gene;Toxic effect;translational potential;Translations;Universities;Vaccination;Vaccine Adjuvant;vaccine candidate;vaccine formulation;vaccine platform;Vaccines;Viral;Viral Antigens;Virus

PROJECT_TITLE: Advanced testing of a hexavalent adjuvanted influenza vaccine platform for dose sparing, multiplexing, and rapid deployment

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


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Immunization;Immunotherapy;Orphan Drug;Pancreatic Cancer;Rare Diseases;Vaccine Related

ORG_CITY: BROOKLYN

ORG_NAME: LOKI THERAPEUTICS, INC

PHR: PROJECT NARRATIVE This project involves preparation and execution of a Fast-Track clinical trial with Listeria-tetanus toxoid (TT) and Gemcitabine (GEM) in patients with unresectable PDAC. This includes production of GMP Listeria-TT, tox and safety profiles in mice, IND and IRB approval, and testing of Listeria-TT+GEM in a Phase 1 clinical trial.

PI_NAMEs: BRADLEY, CHRIS  (contact);GRAVEKAMP, CLAUDIA ;KUANG, CHAOYUAN ;MCAULIFFE, JOHN

PROGRAM_OFFICER_NAME: BOZZA, WILLIAM PATRICK

PROJECT_TERMS: Abraxane;Adenocarcinoma;advanced pancreatic cancer;Age;Albert Einstein Cancer Center;Antigens;Attenuated;Bacteria;Blood;Cancer Etiology;CD4 Positive T Lymphocytes;chemotherapy;Childhood;China;Clinic;Clinical;Clinical Trials;Collaborations;college;Data;design;Diagnosis;Disease;Dose;Enzymes;Europe;Fluorouracil;Funding;gemcitabine;Goals;Grant;Granzyme;Immune response;immunogenic;Immunologics;immunosuppressed;Immunotherapeutic agent;improved;improved outcome;in vivo;innovation;insight;Institution;Institutional Review Boards;intraperitoneal;irinotecan;Japan;KPC model;Legal patent;Leucovorin;Licensing;Life;Listeria;Listeria monocytogenes;Malignant Neoplasms;manufacture;Maximum Tolerated Dose;Medical center;Medical Oncologist;Medicine;Memory;mortality;mouse model;Mus;neoantigens;Neoplasm Metastasis;neoplastic cell;New Jersey;Normal tissue morphology;oxaliplatin;pancreatic cancer patients;Pancreatic duct;Paper;Pathology;Patient Recruitments;Patients;perforin;Persons;Phase;Phase I Clinical Trials;Predisposition;Preparation;Process;Production;Protocols documentation;Recommendation;Regimen;Research;research clinical testing;Research Institute;response;Review Committee;Safety;safety and feasibility;safety study;safety testing;side effect;Silver;Small Business Technology Transfer Research;standard of care;T cell response;T memory cell;Testing;Tetanus;Tetanus Toxoid;Therapeutic;Toxic effect;Toxicology;Transgenic Organisms;Treatment Protocols;tumor;tumor microenvironment;Unresectable;Vaccinated

PROJECT_TITLE: Clinical testing of Listeria-TT and Gemcitabine in a Phase I clinical trial with PDAC patients

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


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Biotechnology;Genetics

ORG_CITY: NEW YORK

ORG_NAME: CHIMERNA THERAPEUTICS INC.

PHR: PROJECT NARRATIVE RNA vaccines and therapeutics have gained a lot of attention following the success of the mRNA-based COVID-19 vaccines and many new companies are entering the field. The sudden need for vast quantities of RNAs to be manufactured is hampered by significant supply chain issues and a lack of expertise. This proposal will result in a new method for manufacturing circular mRNAs using well-established yeast expression systems that aims to reduce the delays and costs associated with manufacturing and simplify purification for downstream applications.

PI_NAMEs: PICKERING, BRIAN FREDERICK (contact)

PROGRAM_OFFICER_NAME: HAPPEL, CHRISTINE MARIE

PROJECT_TERMS: Acceleration;Affinity;aptamer;Attention;Bacteria;Benchmarking;Binding;Biotechnology;Cell Physiology;Cells;chemical synthesis;Chromatography;circular RNA;cofactor;cost;cost effective;COVID-19 vaccine;Development;Dextrans;Diagnostic;Endotoxins;Engineering;Enzymes;Escherichia coli;Gel;Genetic Transcription;Goals;Guide RNA;Half-Life;In Vitro;Inflammatory Response;Internal Ribosome Entry Site;Lipids;Mammalian Cell;manufacture;manufacturing technology;Measures;Medical;Messenger RNA;Methods;Modification;novel;Organism;Output;Porifera;Production;promoter;protein expression;Proteins;Reaction;Research;research and development;Research Personnel;RNA;RNA chemical synthesis;RNA Processing;RNA vaccine;sephadex;Specificity;success;supply chain;System;Technology;technology platform;Testing;Therapeutic;therapeutic RNA;Time;Tornadoes;Transcript;Transfection;Untranslated RNA;Yeasts

PROJECT_TITLE: Development of circRNA manufacturing platform in yeast

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


ADMINISTERING_IC: DE

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Cancer;Cancer Genomics;Dental, Oral, and Craniofacial Disease;Genetics;Human Genome;Radiation Oncology

ORG_CITY: SAN DIEGO

ORG_NAME: SINOPIA BIOSCIENCES, INC.

ORG_STATE: CA

PHR: Project Narrative Inflammation of the mouth and esophagus, called oral mucositis, is a common and severe side- effect of chemo- and radiation therapy used in cancer treatment that has significant implications on outcomes and health care costs. Sinopia Biosciences has identified a target that shows efficacy in reducing both the duration and severity of oral mucositis in an established model. This proposal will develop a novel compound for that target for oral mucositis.

PI_NAMEs: LLOYD, COLTON JOSEPH (contact)

PROGRAM_OFFICER_NAME: LOPEZ, ORLANDO

PROJECT_TERMS: Acute;Affect;Animals;Appearance;Binding;Biological Availability;Biological Markers;Biological Sciences;BRD2 gene;Bromodomain;Bromodomains and extra-terminal domain inhibitor;Cancer Prognosis;cancer therapy;candidate identification;Cell Line;Cells;chemoradiation;chemotherapy;Clinic;Clinical;clinical candidate;Clinical Research;common treatment;computational platform;conditioning;cost;Data;design;Development;Dose;Esophagus;Evaluation;FDA approved;fractionated radiation;Functional disorder;gastrointestinal;Gene Expression;Gene Expression Profile;Genetic Transcription;Government;Hamsters;Head and Neck Cancer;head and neck cancer patient;Health Care Costs;Healthcare Systems;Hematologic Neoplasms;immunomodulatory therapies;In Vitro;in vivo;incremental cost;Infection;Inflammation;inhibitor;interest;intravenous administration;keratinocyte growth factor;Lesion;Malignant Neoplasms;Modeling;Mucositis;Mucous Membrane;Mus;novel;Oncology;Oral;Oral Administration;Oral cavity;oral mucositis;Oral mucous membrane structure;Oral Ulcer;Outcome;Pain;Patient-Focused Outcomes;Patients;Persons;Pharmaceutical Preparations;Phase;phase 1 study;Physicians;pre-clinical assessment;Pre-Clinical Model;preclinical study;Preclinical Testing;prevent;profiles in patients;programs;Property;Protein Family;Proteins;Radiation;Radiation therapy;Regimen;Safety;Severities;side effect;single-cell RNA sequencing;small molecule;Solid Neoplasm;Stem cell transplant;success;Supportive care;synergism;Testing;Therapeutic;Therapeutic Effect;Time;Toxic effect;Toxicology;transcriptome sequencing;Treatment Efficacy;tumor growth;Tumor Promotion;Ulcer;Validation;validation studies;Weight Gain;Work

PROJECT_TITLE: Preclinical assessment of a novel compound for treating radiation-induced oral mucositis

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


ORG_CITY: PRINCETON

ORG_NAME: INAEDIS, INC

PHR: Narrative Breaches in the logistically challenging cold chain infrastructure required for vaccine transport and delivery are overwhelmingly common, leading to wasted, ineffective, or even dangerous vaccines. Current freeze- and spray-drying technologies used to create cold chain-free pharmaceutical formulations are inefficient, energy intensive, and subject biological molecules to harmful drying and temperature stresses. This project will support the continued development of Rapid Room Temperature Aerosol Dehydration (RTAD), a scalable system for continuous dehydration of liquid pharmaceutical and biopharmaceutical formulations at short time scales and non-destructive temperatures, providing efficient and effective thermal stabilization of biological drugs.

PI_NAMEs: MEZHERICHER, MAKSIM  (contact)

PROGRAM_OFFICER_NAME: RAJAGOPAL, MEENA UMA

PROJECT_TERMS: Acute;Adverse event;adverse outcome;Aerosols;Affect;analog;Bacteriophages;Biological;Biological Products;Cessation of life;Cold Chains;Consumption;cost;crystallinity;Dangerousness;Dehydration;Development;diagnostic tool;Diameter;Disease;Disease Outbreaks;Drug Industry;Dryness;energy efficiency;Event;Exhibits;Exposure to;fine particles;Formulation;Freeze Drying;Freezing;Glass;Hour;Immunization;improved;indexing;Infrastructure;innovation;Laboratories;Life;lipid nanoparticle;liquid formulation;Liquid substance;manufacture;Measles;medication safety;Medicine;meter;Methods;Monoclonal Antibodies;Morphology;Nebulizer;Neurologic;particle;Particle Size;Particulate;Patients;Performance;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Play;Population;Positioning Attribute;Powder dose form;Process;process improvement;Production;Property;protein aggregation;Proteins;Provider;Ramp;rapid technique;reconstitution;Reporting;Research;Residual state;respiratory;Retrospective Studies;Risk;risk mitigation;Sampling;scale up;Shoulder;small molecule;Stress;Structure;study characteristics;success;supply chain;Survival Rate;Syncope;System;Techniques;Technology;technology platform;Temperature;Time;Transition Temperature;Ultrafine;Ultrasonics;United States Dept. of Health and Human Services;vaccine access;vaccine failure;Vaccines;Virus;Waste Products;wasting;World Health Organization

PROJECT_TITLE: Rapid Dehydration and Stabilization of Biopharmaceutical Formulations at Room Temperature

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


NIH_SPENDING_CATS: Bioengineering;Cardiovascular;Climate-Related Exposures and Conditions;Heart Disease

ORG_NAME: GENERAL ENGINEERING AND RESEARCH, LLC

PHR: Project Narrative The project addresses the need for a lightweight and efficient personal cooling garment to protect at-risk patients from extreme heat waves caused by climate change. We will develop an automated, high-throughput process to manufacture flexible thermoelectric devices and integrate them into a cooling garment. The demonstrated feasibility of scalable manufacturing and benchtop measurements of the cooling performance of the garment prototype will pave the way for further development of the technology towards commercialization.

PI_NAMEs: IHNFELDT, ROBIN  (contact)

PROGRAM_OFFICER_NAME: THAKAR, RAHUL GAUTAM

PROJECT_TERMS: Address;Adopted;Air;Air Conditioning;Blood;Blood Circulation;Capital;Cardiovascular system;Cause of Death;Cessation of life;Chills;climate change;Collaborations;commercialization;Consumption;cost;design;Development;Devices;Disease;Drops;Elderly;Electronics;Equipment;Europe;Event;Exercise;experimental study;extreme heat;fabrication;flexibility;Global Warming;Heart Diseases;Heat Stress;Heat Stress Disorders;Heat Waves;Hematological Disease;high risk;Hospitalization;Hospitals;Hot Spot;Human;human subject;Hypertension;Ice;Industry;Informal Social Control;Innovation Corps;Intellectual Property;Interview;invention;Investments;Laboratories;Legal patent;Licensing;light weight;Lung;Lung Diseases;Manikins;manufacture;Manufacturer;manufacturing process;Marketing;Measurement;Metabolic;miniaturize;Obesity;Outcome;Patients;Performance;Persons;Phase;Play;Populations at Risk;portability;Power Sources;printed circuit board;Process;Production;professor;programs;prototype;Public Health;Risk;scale up;sensor;Small Business Technology Transfer Research;solid state;Surface;Surveys;System;Technology;technology development;Temperature;Testing;Water;wearable device;Work

PROJECT_TITLE: Personal Cooling Garments to Protect at-Risk Patients from Extreme Heat Waves

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


ED_INST_TYPE: OVERALL MEDICAL

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

ORG_CITY: CLEVELAND

ORG_DEPT: NEUROLOGY

ORG_NAME: CLEVELAND CLINIC LERNER COM-CWRU

ORG_STATE: OH

PHR: PROJECT NARRATIVE: Retinal degeneration is a biological phenomenon that drives the pathology of eye disorders such as age-related macular degeneration, retinitis pigmentosa, and glaucoma. Mitochondrial dysfunction is a major contributor to these degenerative diseases that remains to be more thoroughly investigated. By analyzing specific mechanisms that lead to mitochondrial dysfunction in the retina and retinal pigment epithelium, I hope to better understand disease onset and reveal novel therapeutic targets to improve patient care.

PI_NAMEs: STURGIS, JOHNATHON BRIAN (contact)

PROGRAM_OFFICER_NAME: AGARWAL, NEERAJ

PROJECT_TERMS: Address;age related;Age related macular degeneration;age-related disease;Aging;Alleles;Alzheimer's Disease;Animal Model;Ataxia;Biochemical;Biological;Biological Phenomena;Biology;brain tissue;Cell Culture Techniques;Cell Line;Cell model;cell type;Cells;Chronic progressive external ophthalmoplegia;Clinical;Clone Cells;Defect;Degenerative Disorder;Development;Diabetic Retinopathy;Disease;DNA Damage;DNA Repair Pathway;Electroretinography;Environmental Risk Factor;Enzymes;Etiology;Exhibits;Exonuclease;Eye;Eye diseases;Future;Genetic;Glaucoma;Goals;Health;Histologic;Human;human tissue;Imaging Techniques;Immunofluorescence Immunologic;Impairment;improved;Investigation;knock-down;Knowledge;Label;Measurement;Metabolic;metabolic abnormality assessment;metabolic profile;Methods;Mitochondria;Mitochondrial DNA;mitochondrial DNA mutation;mitochondrial dysfunction;Modeling;mouse model;Mus;Mutate;Mutation;Neurodegenerative Disorders;Neuropathy;new therapeutic target;novel;Onset of illness;Optical Coherence Tomography;Oxidative Phosphorylation;Oxidative Stress;Parkinson Disease;Pathology;Patient Care;Phenotype;Photoreceptors;Physiological;Polymerase;postmitotic;Pre-Clinical Model;Predisposition;Protein Deficiency;Proteins;Reactive Oxygen Species;repaired;Respiratory Chain;Retina;Retinal Degeneration;Retinal Diseases;Retinitis Pigmentosa;Role;Sampling;small hairpin RNA;Structure of retinal pigment epithelium;Syndrome;Testing;Therapeutic Intervention;therapeutic target;Tissue Donors;Tissues;tool;transcriptome sequencing;Validation;Vision

PROJECT_TITLE: Characterizing the role of mitochondrial DNA mutations on retinal degeneration.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F05-D (21)]


ORG_CITY: COLLEGE STATION

ORG_NAME: BONDWELL TECHNOLOGIES LP

ORG_STATE: TX

PHR: Therapeutic antibodies have had a profound impact on the treatment of many diseases, but are extremely expensive to produce. Novel materials developed by Bondwell Technologies have the potential to dramatically increase binding capacity in a low-cost, single-use product. The proposed studies will expand efficiency of the membrane filters validated in Phase I and II studies. Membrane efficiency and industrial optimization will allow testing by our established Industry partners.

PI_NAMEs: HOWELL, DAVID W. (contact)

PROGRAM_OFFICER_NAME: SAKALIAN, MICHAEL

PROJECT_TERMS: Adoption;Antibodies;Antibody Therapy;Autoimmune Diseases;Benchmarking;Binding;Biocompatible Materials;cancer type;capsule;Cell Culture Techniques;Chimeric Proteins;Chromatography;clinical efficacy;Collaborations;commercialization;cost;crosslink;Custom;Data;density;design;Development;Disease;Electrospinning;experience;Fiber;Fractionation;Generations;Goals;Housing;Hydration status;improved;Industrialization;Industry;industry partner;International;Interview;large scale production;Lead;Learning;Licensing;Ligands;Literature;manufacture;manufacturing facility;manufacturing run;Marketing;Membrane;Methods;Monoclonal Antibodies;monoclonal antibody production;monomer;new technology;novel;novel therapeutics;operation;Pain;particle;Performance;Phase;Plant Resins;Polymers;polypeptide;preference;prevent;Process;Production;Property;Proteins;prototype;Publications;Publishing;ran GTP-Binding Protein;Recipe;Recovery;Research;residence;Risk;Sales;scale up;Solid;Source;success;symposium;Tandem Repeat Sequences;Techniques;Technology;technology validation;Tertiary Protein Structure;Testing;Texas;Therapeutic;Therapeutic antibodies;Therapeutic Monoclonal Antibodies;Universities;Work

PROJECT_TITLE: A high-efficiency, low-cost, single-use purification technology for therapeutic antibody manufacturing

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


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Coronaviruses;Coronaviruses Disparities and At-Risk Populations;Coronaviruses Therapeutics and Interventions;Emerging Infectious Diseases;Immunization;Immunotherapy;Infectious Diseases;Lung;Prevention;Vaccine Related

ORG_CITY: Morrisville

ORG_NAME: INHALON BIOPHARMA, INC.

PHR: Project Narrative Despite the availability of vaccines, outpatient treatments for COVID-19 that can reduce risk of hospitalization, have low risk of drug-drug interactions, and retain activity against any variant of SARS-CoV-2 are sorely needed to mitigate the ongoing economic and public health impacts of COVID-19. In this project, we are seeking to advance an inhaled immunotherapy for COVID-19 based on an antibody-like molecule that can neutralize all ACE2-binding pathogen, including every variant of SARS-CoV-2, trap the virus in airway mucus and facilitate rapid clearance of the virus from the airways. The proposed project would bring this new treatment through all activities required prior to initiation of Phase 1 clinical studies.

PI_NAMEs: HUTCHINS, JEFF T (contact)

PROGRAM_OFFICER_NAME: BASU, DIPANWITA

PROJECT_TERMS: 2019-nCoV;ACE2;Achievement;Affinity;airway epithelium;Ambulatory Care;Animals;Antibodies;antibody mimetics;Antibody Therapy;Apical;Back;Binding;Biological;Biological Assay;Biological Products;breakthrough infection;Bronchiolitis;Cells;Characteristics;Chiroptera;Clinic;Clinical Research;Coronavirus;cost effective treatment;COVID-19;COVID-19 impact;COVID-19 treatment;Critical Pathways;cross reactivity;Cyclic GMP;Data;Daughter;design;Development;Dose;Drug Interactions;Drug Kinetics;Economics;efficacy evaluation;efficacy testing;Enzyme-Linked Immunosorbent Assay;Escape Mutant;experience;Fc domain;FDA Emergency Use Authorization;flexibility;Formulation;Future;Hamsters;Histopathology;Home;Hospitalization;Human;Immune;Immunocompromised Host;Immunotherapy;improved;In Vitro;in vivo;Individual;Infection;Inhalation;Intercept;Intravenous infusion procedures;lamb model;Link;Liquid substance;Lower respiratory tract structure;Medicine;Mesocricetus auratus;Methods;Middle East Respiratory Syndrome;Modeling;Monoclonal Antibodies;Monoclonal Antibody Therapy;monomer;Mucins;Mucociliary Clearance;Mucous body substance;mucus clearance;Nebulizer;necrotic tissue;neutralizing monoclonal antibodies;Neutrophil Infiltration;Nose;Oral;pathogen;Paxlovid;Pharmaceutical Preparations;Pharmacotherapy;Phase;phase 1 study;Pilot Projects;Predisposition;pressure;prevent;Prevention;protein purification;Proteins;Public Health;Qualifying;Rattus;Reporting;research clinical testing;resilience;Resistance;Respiratory Syncytial Virus Infections;Respiratory Tract Infections;respiratory virus;Risk;Risk Reduction;Running;Safety;safety study;SARS-CoV-2 antibody;SARS-CoV-2 infection;SARS-CoV-2 variant;seasonal coronavirus;Self Administration;Serum;Severe Acute Respiratory Syndrome;Side;side effect;Small Business Innovation Research Grant;sugar;Testing;Therapeutic Monoclonal Antibodies;Time;Tissues;Training;transmission process;Upper respiratory tract;vaccine access;vaccine distribution;vaccine efficacy;vaccine hesitancy;Variant;variants of concern;Vero Cells;Viral;Viral Load result;Virion;Virus;Virus-like particle;Work

PROJECT_TITLE: SBIR: IND-enabling development of IN-007, an inhaled muco-trapping immunotherapy for COVID19 and other ACE2-targeted infections

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


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Contraception/Reproduction;Estrogen;Neurosciences;Nutrition;Obesity

ORG_CITY: HOUSTON

ORG_DEPT: PEDIATRICS

ORG_NAME: BAYLOR COLLEGE OF MEDICINE

PHR: PROJECT NARRATIVE Dysfunctional sexual behavior, characterized by disturbances in sexual desire, preference, arousal, and orgasm, is a common, burdensome, and costly health condition. Nutrition has a bidirectional role in the regulation of sexual behavior. This proposal will focus on the neurobiological mechanisms underlying the interaction between nutrition and sexual behavior.

PI_NAMEs: WANG, MENGJIE  (contact)

PROGRAM_OFFICER_NAME: RAVINDRANATH, NEELAKANTA

PROJECT_TERMS: Affect;arm;Arousal;Behavior;Body Weight;Body Weight decreased;Boxing;Brain region;career;cost;Coupling;Cre lox recombination system;Data;Dependovirus;deprivation;Development;Diet;Disease;Eating;Ejaculation;energy balance;epidemiology study;ESR1 gene;Estrogens;Exhibits;experimental study;Fasting;Female;female fertility;Fertility;Genetic;Goals;Health Care Costs;High Fat Diet;high risk;Hour;Human;Hypothalamic structure;Impairment;improved;Individual;Injections;insight;Institution;interest;Leptin;leptin receptor;Literature;Lordosis;male;Medial;Mediating;men;Mentors;Metabolic;Metabolism;midbrain central gray substance;Modeling;Molecular;Monitor;mouse genetics;Mus;neural circuit;neurobiological mechanism;Neurobiology;neuromechanism;Neurons;Neurosciences;novel therapeutic intervention;nutrition;Nutritional;Nutritional status;Obesity;optogenetics;Orgasm;Overweight;Physiological Processes;Pilot Projects;Population;Postdoctoral Fellow;preference;Preoptic Areas;Prevalence;psychologic;pup;Regimen;Regulation;Reporting;Reproduction;reproductive;Reproductive Biology;reproductive hormone;reproductive tract;Research;restoration;Role;Scientist;segregation;sex;Sex Behavior;Sex Functioning;sexual dimorphism;Sexual Dysfunction;Signal Transduction;skills;Structure of nucleus infundibularis hypothalami;Supplementation;Testing;Thinness;tool;training opportunity;Uncertainty;Underweight;Wild Type Mouse;Woman

PROJECT_TITLE: Nutrition Regulates Sexual Function

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F06-L (20)]


ORG_CITY: LA JOLLA

ORG_NAME: TEGA THERAPEUTICS, INC.

PHR: Project Narrative TEGA has developed an alternative source of heparin, an essential drug in modern medicine. Currently, heparin supplies are at risk because they rely on vast pig populations in China that can be decimated by disease. Our heparin is produced in recombinant cells in a completely controlled process that eliminates the risk of disease in animal populations. Through additional bioengineering we propose to produce heparin with reduced risks of known side effects. We will also develop a novel manufacturing process to increase production efficiency and reduce costs.

PI_NAMEs: GLASS, CHARLES ALEXANDER (contact)

PROGRAM_OFFICER_NAME: WARREN, RONALD Q

PROJECT_TERMS: Abattoirs;Affinity;African;animal tissue;Animals;Antibody Formation;Anticoagulants;Area;Asia;Asian;Attention;Automobile Driving;Binding Sites;Biological;Biomedical Engineering;bioprocess;Bioreactors;Biotechnology;Cardiopulmonary Bypass;Cardiovascular Surgical Procedures;Cell Count;Cell Culture Techniques;cell growth;Cell Line;cell type;Cells;cellular engineering;Cessation of life;Characteristics;China;Chinese;Chondroitin Sulfates;Classical Swine Fever;Clinic;Collaborations;commercialization;Complex;Congresses;cost;Culture Media;design;Development;Disaccharides;Disease;Disease Outbreaks;disorder risk;Dose;Ear Diseases;Economic Competition;Engineering;Enzymes;Essential Drugs;experience;Family suidae;Feasibility Studies;Formulation;Fractionation;Frequencies;Genetic Engineering;genetic manipulation;Goals;Growth;Growth Factor;Hemorrhage;Heparin;heparin-induced thrombocytopenia;Hospitals;improved;Intestinal Mucosa;Intestines;Language;Life;Mammalian Cell;manufacture;manufacturing process;Marketing;Mast Cell Neoplasm;Modern Medicine;Molecular Weight;Monitor;Motivation;Mus;novel;Operative Surgical Procedures;pandemic disease;Pathway interactions;Patients;Persons;PF4 Gene;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Polysaccharides;Population;Porcine Reproductive and Respiratory Syndrome;prevent;Prevention;Price;Procedures;Process;Production;Property;Prophylactic treatment;Protamines;Recombinant Proteins;Recombinants;Recycling;Regulation;Risk;Risk Reduction;scale up;Serum;side effect;Source;stem;Sulfate;supply chain;Suspension Culture;Technology;Testing;Thrombin;Thrombosis;Tissues;Translating;United States;Virus;Waste Products;Work

PROJECT_TITLE: Testing Novel Advancements to Recombinant Heparin Production


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Brain Disorders;Cannabidiol Research;Cannabinoid Research;Chronic Pain;Drug Abuse (NIDA only);Headaches;Migraine;Natural Products;Neurosciences;Pain Research;Substance Misuse;Therapeutic Cannabinoid Research

ORG_NAME: SCHEDULE 1 THERAPEUTICS, INC.

PHR: Narrative This SBIR focuses on developing an optimized combination CBD and THC fixed-dose therapeutic for FDA approval to treat migraine with and without aura, the second most debilitating disease worldwide. This new product will offer an optimally safe and effective cannabinoid combination to treat migraine under FDA oversight, within U.S. federal and international healthcare systems, and enabling careful physician led disease management as an alternative to self-medication with unregulated cannabis.

PI_NAMEs: PAPPAS, GEORGE  (contact)

PROGRAM_OFFICER_NAME: KARUPPAGOUNDER, SARAVANAN SHANMUGAM

PROJECT_TERMS: Acute;Adverse effects;Appropriateness Review;Auras;Behavioral;behavioral response;Biological Assay;Calcitonin Gene-Related Peptide;Cannabidiol;cannabinoid treatment;Cannabinoids;Cannabis;Central Nervous System Diseases;Clinical;Clinical Protocols;Clinical Research;commercial application;Complex;Contractor;Cyclic GMP;Data;debilitating pain;design;Development;Devices;Diagnosis;disability;Disease;Disease Management;Disodium Salt Nitroprusside;dosage;Dosage Forms;Dose;drug clearance;Drug Design;drug development;Drug Kinetics;Drug Packaging;epidemiology study;experience;Failure;FDA approved;Feedback;first-in-human;Formulation;Goals;Half-Life;Health;Healthcare Systems;Human;ineffective therapies;International;Investigational Drugs;Investigational New Drug Application;Iowa;lead candidate;Legal;manufacture;metabolic profile;Migraine;migraine treatment;Modeling;Mus;novel;novel therapeutics;Opioid;Pain;Pain Disorder;Patients;Pharmaceutical Preparations;Phase;Phase I Clinical Trials;phase I trial;Photophobia;Physicians;Plasma;pre-clinical;Pre-Clinical Model;pre-clinical research;pre-Investigational New Drug meeting;Prevalence;Price;Property;prototype;Readiness;Research;Research Support;Risk;Safety;Sales;Schedule;Self Medication;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Solubility;spontaneous pain;standard of care;Sublingual drug administration;success;Sunflower Oil;Symptoms;Testing;Tetrahydrocannabinol;Therapeutic;Toxicology;triptans;Universities

PROJECT_TITLE: Optimization of Cannabinoids for Development as FDA-Approved Migraine Therapeutics

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


NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Dental, Oral, and Craniofacial Disease;Dissemination and Implementation Research;Infectious Diseases;Pediatric;Prevention

ORG_CITY: Springfield

ORG_NAME: OREGON RES BEHAVIORAL INTERVENTION STRAT

PHR: Project Narrative This application features the construction and RCT-based evaluation of a professional development program and tool, BeReady2Smile_ProD, which will promote oral health behavioral parenting strategies among parents by providing a scalable and sustainable approach for distal training of Parenting Educators using both Home- based and Group-based delivery methodologies. Parenting Educators learn to lead parents through BeReady2Smile, a multimedia coordinated oral health prevention intervention program, to promote dental health targeted at parents of young children attending parenting education classes and families receiving group and home visiting services through Head Start and other early childhood agencies.

PI_NAMEs: FEIL, EDWARD GUSTAV;SMITH, DAVID RANDOLPH (contact)

PROGRAM_OFFICER_NAME: ELWOOD, WILLIAM N

PROJECT_TERMS: 2 year old;5 year old;Academy;Address;Adherence;Adolescent;Adopted;Advocate;American;arm;Attitude;Behavior;Behavioral;behavioral health;Behavioral Research;Benchmarking;Businesses;California;Certification;Child;Child Health;Child Rearing;Childhood;Collaborations;commercialization;Communities;Competence;cost effectiveness;Dental;Dental Care;Dental caries;Dental Hygiene;Dentists;Development;Dissemination and Implementation;Distal;early childhood;Education;Evaluation;experience;Family;Feedback;Foundations;Goals;Head Start Program;Health;Health education;Home;Home visitation;implementation fidelity;implementation outcomes;indexing;Infant;innovation;Intervention;intervention program;Knowledge;Lead;Learning;life span;Manuals;Marketing;Methodology;Methods;motivational enhancement therapy;Mouth Diseases;Multimedia;Oral health;Oregon;Outcome;Parenting Education;parenting intervention;Parents;Participant;Pediatric Dentistry;Pediatrics;Phase;pilot test;Prevention strategy;Preventive;preventive intervention;Privatization;Problem behavior;Process;Program Development;Program Sustainability;programs;Protocols documentation;prototype;psychologic;Public Health;Randomized;Recommendation;recruit;Regimen;Research;Research Institute;Resources;Risk;satisfaction;Services;skills;Small Business Innovation Research Grant;Spanish/English;Special Supplemental Nutrition Program for Women, Infants, and Children;Technology;Testing;Time;Toddler;tool;tool development;Toothbrushing;Toothpaste;Training;Training Programs;treatment as usual;United States;universal prevention;usability;Video Recording;Water fluoridation;web app;Work

PROJECT_TITLE: Multi-Media Professional Development for Parenting Educators to Deliver Oral Hygiene Education for Parents of Young Children

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


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

ORG_CITY: MADISON

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF WISCONSIN-MADISON

ORG_STATE: WI

PHR: PROJECT NARRATIVE Breast cancer lethality is primarily caused by metastasis. However, the genetic and epigenetic mechanisms contributing to metastasis remains unclear. This project aims to dissect network of molecular pathways and to identify epigenetic drivers of metastasis, which will provide a molecular basis for designing precision therapies to improve the survival of triple negative breast cancer patients.

PI_NAMEs: XU, WEI  (contact)

PROGRAM_OFFICER_NAME: AULT, GRACE S

PROJECT_TERMS: 4T1;Affect;anti-PD-1;anti-PD1 antibodies;Arginine;Biological Assay;Biological Availability;Breast Cancer Cell;Breast Cancer cell line;breast cancer metastasis;Breast Cancer Patient;Breast Cancer Treatment;Cancer Patient;CD8-Positive T-Lymphocytes;Cell Line;cell motility;Cells;Cellular Indexing of Transcriptomes and Epitopes by Sequencing;Cessation of life;Clinical;coactivator-associated arginine methyltransferase 1;Dependence;design;Development;Disease;Drug Combinations;Duct (organ) structure;Enhancers;Epigenetic Process;Estrogen Receptors;Event;Family member;Funding;Genetic;Genetic Engineering;Genetic Transcription;Growth;Harvest;Histone H3;histone methylation;Human;Immune checkpoint inhibitor;Immunocompetent;Immunotherapy;improved;In Vitro;in vivo;Infiltration;inhibitor;Invaded;Knock-out;Ligation;Link;loss of function;Malignant Breast Neoplasm;Malignant Neoplasms;MAP Kinase Gene;MAPK8 gene;Mediating;Metastatic breast cancer;Metastatic Neoplasm to the Lung;Methylation;migration;Mitogen-Activated Protein Kinases;Modeling;Molecular;mouse model;Mus;mutant;Mutate;Mutation;Neoplasm Circulating Cells;Neoplasm Metastasis;novel therapeutics;Oncogenes;Oncogenic;Oral;Organoids;overexpression;Pathway interactions;patient derived xenograft model;Pharmaceutical Preparations;pharmacologic;Phosphoproteins;Phosphotransferases;PIK3CG gene;Pre-Clinical Model;Precision therapeutics;Primary Neoplasm;Prognosis;programmed cell death ligand 1;Proliferating;Protein-Arginine N-Methyltransferase;Proteins;Proteomics;Recombinants;Regimen;Resistance;Signal Pathway;Signal Transduction;Site;SMARCA4 gene;stress activated protein kinase;Structure of parenchyma of lung;synergism;T cell infiltration;T cell response;Testing;therapeutic target;tool;transcriptome;treatment response;triple-negative invasive breast carcinoma;tumor;tumor growth;Tumor Immunity;Tumor Promotion;Tumor Tissue;Tumor-infiltrating immune cells

PROJECT_TITLE: Protein arginine methylation in breast cancer

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCTC-S (01)]


NIH_SPENDING_CATS: Bioengineering;Data Science;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_CITY: Brookings

ORG_NAME: RTUTOR, LLC

ORG_STATE: SD

PHR: Project Narrative  Many scientists face challenges in interpreting large data sets that are routinely gathered in modern biomedical research labs. We propose to develop a tool that leverages recent breakthroughs in artificial intelligence (AI) to assist researchers in conducting preliminary analyses in plain English. Our tool holds great potential to accelerate discoveries in biomedical research.

PI_NAMEs: BURKHALTER, DANIEL  (contact)

PROGRAM_OFFICER_NAME: YU, GUOQIN

PROJECT_TERMS: Acceleration;Adopted;Artificial Intelligence;Bioinformatics;Biomedical Research;biomedical scientist;Businesses;care outcomes;ChatGPT;Clinical;Clinical Trials;Code;Collaborations;Communities;computer code;Consumption;Data;Data Analyses;Data Set;data visualization;Development;Disadvantaged;Environment;Evaluation;experience;Face;Funding;Generations;Goals;graphical user interface;Home;Human;improved;Industrialization;Industry;insight;Institution;Instruction;intelligent personal assistant;Knowledge;Language;large datasets;large language model;Laws;Learning;Letters;Licensing;Marketing;Mathematics;Medical;Methods;Modeling;Modernization;multiple datasets;natural language;Nonprofit Organizations;outreach;Performance;Persons;Polishes;Problem Solving;Process;Productivity;programs;prompt engineering;prototype;Pythons;Reporting;Research Personnel;Resources;Schools;Scientist;Source Code;South Dakota;Statistical Computing;Statistical Methods;statistics;Structure;Students;System;task analysis;technological innovation;Testing;Text;Time;tool;Training;transcriptome sequencing;Translating;usability;Visit;Visualization;web site

PROJECT_TITLE: Democratizing statistical computing through AI

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Infectious Diseases

ORG_CITY: San Francisco

ORG_NAME: FLUID DISCOVERY INC

PHR: NARRATIVE This project will develop a point-of-care (POC) test for accurate HIV viral load monitoring, addressing a major unmet need in large-scale clinical trials of HIV cure strategies and general point-of-care quantitative diagnostics. By leveraging digital LAMP technology and an interdisciplinary team of experts, this grant will create a groundbreaking diagnostic platform to accelerate progress towards an HIV cure.

PI_NAMEs: PRINCE, ROBIN  (contact)

PROGRAM_OFFICER_NAME: JANCI, ELIZABETH WONDERLICH

PROJECT_TERMS: Abate;Acceleration;Acquired Immunodeficiency Syndrome;Address;Adherence;Affect;antiretroviral therapy;Binding;Biological Assay;Blood;Cellular Phone;Certification;CLIA certified;Clinical;Clinical Trials;Collaborations;commercialization;cost;cost effective;COVID-19 monitoring;Data Analyses;Detection;Development;Devices;Diagnostic;Diagnostic Equipment;diagnostic platform;digital;Disease;Engineering;Epidemic;Exhibits;experience;Fingers;Force of Gravity;Foundations;Genome;Goals;Grant;Head;Health;Health Care Costs;Healthcare;HIV;Human;Human immunodeficiency virus test;Image;improved;Incubated;Individual;Infrastructure;instrument;Investments;isothermal amplification;Laboratories;Light;Liquid substance;Measures;Mediating;Microfluidics;milliliter;Mission;Monitor;novel therapeutic intervention;novel therapeutics;Optics;pathogen;Persons;Pharmaceutical Preparations;Phase;Play;point of care;point of care testing;point-of-care diagnostics;Process;professor;prototype;Public Health;Research;research clinical testing;Research Institute;Research Personnel;Resolution;Resources;Role;sample collection;Sampling;Scientific Advances and Accomplishments;side effect;Specimen;Technology;technology development;Testing;tool;Training;United States;Validation;Variant;Viral;Viral load measurement;Viral Load result;viral rebound;virology;Virus;Work

PROJECT_TITLE: Point-of-care viral load monitoring to support large-scale clinical testing of new HIV cure strategies

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-F (14)]


ORG_CITY: LOS ANGELES

ORG_NAME: MOLECULAR INSTRUMENTS, INC.

PHR: Project Narrative Hybridization Chain Reaction: Automated Ultrasensitive Multiplex RNA and Protein Imaging We propose to engineer and commercialize molecular technologies that will enable automated, ultrasensitive, simultaneous imaging of multiple RNA and protein molecules within sample types critical to drug development, clinical pathology, and biological research. The resulting products will enable the development of new therapies, the clinical diagnosis of disease, and the study of human biology and disease.

PI_NAMEs: CHOI, HARRY MING TAK (contact)

PROGRAM_OFFICER_NAME: TAYLOR, VERONICA

PROJECT_TERMS: Anatomy;Antibodies;Biological;biological research;Chromogenic in situ Hybridization;clinical diagnosis;clinical diagnostics;Clinical Pathology;commercialization;cost;Development;Digestion;dimensional analysis;Discipline;Disease;disease diagnosis;drug development;empowerment;Engineering;Enzymes;experimental study;Fluorescence;Fluorescent in Situ Hybridization;genetic analysis;Genetic Transcription;Genome;Human Biology;human disease;Image;Immunofluorescence Immunologic;Immunohistochemistry;Immunooncology;In Situ;In Situ Hybridization;Label;Letters;Mediating;Methods;MicroRNAs;Molecular;Morphology;Nanotechnology;next generation;novel;novel therapeutics;Nucleic Acids;Organism;Pathologist;Penetration;Peptide Hydrolases;Pharmaceutical Preparations;protein expression;Proteins;Protocols documentation;Publishing;Rapid screening;Reaction;Reagent;research and development;Resolution;response;RNA;RNA analysis;RNA Splicing;Sampling;Scanning;Signal Transduction;single molecule;Slide;Stains;Stimulus;success;Technology;technology development;Tissues;Treatment Step


NIH_SPENDING_CATS: Bioengineering;Biotechnology

ORG_CITY: SEATTLE

ORG_NAME: MONOD BIO, INC.

ORG_STATE: WA

PHR: Project Narrative Due to the health dangers associated with endotoxin contamination, testing via Limulus Amebocyte Lysate (LAL) assays based on the blood extract of endangered horseshoe crabs is critical for pharmaceuticals, biological products, and medical devices. Here, to provide new endotoxin sensors with no requirement for horseshoe crab blood or any of its components, a novel bioluminescent endotoxin detection and quantification assay will be developed using alternative de novo protein endotoxin biosensors. By enabling the development of endotoxin sensing lucCage biosensors, this approach promises sustainable, inexpensive, and robust endotoxin bioassays of high impact in the biotechnology industry.

PI_NAMEs: QUIJANO RUBIO, ALFREDO  (contact)

PROGRAM_OFFICER_NAME: PITTENGER, STEVEN THEODORE

PROJECT_TERMS: Affinity;Algorithm Design;Binding;Biochemical;Biological;Biological Assay;Biological Markers;Biological Products;Biosensor;Biotechnology;Blood;Cell membrane;Cessation of life;Color;Complex Mixtures;cost;cost effective;COVID-19;design;Detection;detection assay;detection limit;Development;Devices;Directed Molecular Evolution;Disease Marker;Dryness;Endotoxins;Environmental Impact;Enzymes;Evolution;Fever;Formulation;Future;Harvest;Health;Heart Diseases;high throughput screening;Human;improved;In Vitro;Industry;Injectable;International;Laboratories;Limulus;Lipopolysaccharides;luminescence;Malignant Neoplasms;manufacture;Medical Device;medical implant;Medicine;Methods;Nature;novel;Organ failure;Organism;Outcome;Peptide Hydrolases;Phagocytes;Pharmacologic Substance;Phase;Predisposition;Property;Protein Engineering;Proteins;Publishing;Reading;Reagent;Recombinant Proteins;Resources;response;safety testing;Sampling;sensor;Septic Shock;Sustainable Development;Techniques;Technology;Temperature;Testing;Therapeutic;thermostability;timeline;Toxin;Variant;Xiphosura

PROJECT_TITLE: Novel Biosensor for Detection of Endotoxin


ADMINISTERING_IC: AG

ED_INST_TYPE: SCHOOLS OF PHARMACY

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);Biotechnology;Brain Disorders;Dementia;Neurodegenerative;Neurosciences

ORG_CITY: ORANGE

ORG_DEPT: PHARMACOLOGY

ORG_NAME: CHAPMAN UNIVERSITY

PHR: Project Narrative Erythropoietin (EPO) is a potential treatment for Alzheimer’s disease (AD), however does not cross the blood- brain barrier (BBB), and therefore requires large doses which result in adverse effects. EPO has been modified to enter the brain by binding to the BBB transferrin receptors, and using this approach, EPO can be ferried into the brain non-invasively without the need for high doses. Our recent work shows that this BBB-penetrating EPO is protective in mouse models of AD, and the goal of this proposal is to evaluate the efficacy, safety, and mechanisms of the BBB-penetrating EPO at escalating doses in mouse models of AD.

PI_NAMEs: SUMBRIA, RACHITA  (contact)

PROGRAM_OFFICER_NAME: CHAKROBORTY, SHREAYA

PROJECT_TERMS: 3xTg-AD mouse;Adverse effects;Adverse event;aged;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease model;Alzheimer's disease therapeutic;Amyloid beta-42;Amyloid beta-Protein;Amyloid beta-Protein Precursor;Amyloidosis;analog;Antibodies;Autophagocytosis;Behavioral;Binding;Biological Products;Blood - brain barrier anatomy;blood-brain barrier penetration;Brain;Brain Injuries;Cell Death;Cell Proliferation;Central Nervous System Diseases;cerebral microbleeds;Chimeric Proteins;Chronic;Circulation;Clinical;clinical translation;Clinical Trials;cognitive function;Complex;Data;Disease;Dose;Drug Delivery Systems;efficacy evaluation;Erythropoietin;Event;Funding;Gliosis;Goals;Hematology;Hematopoiesis;Hematopoietic;Histology;Homeostasis;Human;Immune response;Impaired cognition;indexing;insight;Investigation;Iron;Knock-in Mouse;Knowledge;macromolecule;Mediating;Metabolic;Molecular;Monitor;Monoclonal Antibodies;mouse model;Movement;Mus;Nerve Regeneration;neuroinflammation;neuron loss;Neurons;neuroprotection;novel;Outcome;overexpression;Pathogenesis;Pathogenicity;Pathologic;Pathology;Pathway interactions;Peripheral;Pharmacodynamics;Plasma;pre-clinical;preclinical development;prevent;Protein Overexpression;Proteomics;response;Reticulocytes;Safety;side effect;stem;Synaptophysin;tau Proteins;tau-1;Tauopathies;Techniques;TFRC gene;Therapeutic;Therapeutic Effect;Time;Tissues;transcytosis;Work

PROJECT_TITLE: Efficacy, safety, and mechanisms of brain penetrable erythropoietin in Alzheimer’s disease mouse models

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 NV-Q (02)]


ADMINISTERING_IC: AT

IC_NAME: NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH

NIH_SPENDING_CATS: Aging;Biotechnology;Complementary and Integrative Health;Dietary Supplements;Digestive Diseases;Microbiome;Neurodegenerative;Nutrition;Obesity

ORG_CITY: LUBBOCK

ORG_NAME: NEMALIFE INC.

PHR: Project Narrative The human gut microbiome is a complex community of microbes whose role in human health has only recently begun to be elucidated. Dysbiosis in the gut microbiome is associated with disorders that range from obesity to neurodegeneration to digestive diseases. Our Phase 1 application leverages multiple novel technologies to accelerate the discovery of therapeutically beneficial bacteria that can treat or prevent disease linked to dysbiosis.

PI_NAMEs: QURESHI, MOHAMMED ADNAN MOHAMMED HANIF (contact)

PROGRAM_OFFICER_NAME: KIM, HYE-SOOK

PROJECT_TERMS: Acceleration;Address;Affect;Alzheimer's Disease;Anaerobic Bacteria;Animals;Bacillus;Bacteria;Bifidobacterium;Bioinformatics;Biological;Biological Models;Biology;Caenorhabditis elegans;Catalogs;Collection;commercialization;Complex;computerized data processing;cost effective;Coupling;Culture Techniques;Data;Data Set;Databases;Development;Dietary Supplementation;dietary supplements;Digestive System Disorders;Disease;dysbiosis;Ecosystem;Feeds;fluorescence imaging;Food;Gastrointestinal tract structure;Genes;Gnotobiotic;gut dysbiosis;gut microbes;gut microbiome;Health;Health Benefit;healthy aging;high throughput screening;Human;human disease;Human Microbiome;improved;in vitro Model;in vivo;Individual;innovation;interest;Investigation;Lactobacillus;Leaky Gut;Link;Maintenance;Mammals;Marketing;Metabolic;metagenomic sequencing;Metagenomics;Microbe;microbial;microbial community;microbiome;microbiome research;Microfluidics;microorganism;Microscopic;model organism;Modeling;Mus;Nematoda;Nerve Degeneration;Nervous System Disorder;Neurodegenerative Disorders;new technology;novel;Obesity;Organism;Outcome;Pathology;Phase;Phenotype;Physiological;Physiology;Population;Positioning Attribute;prevent;Probiotics;Provider;Reagent;Research;research and development;Rodent Model;Role;Sampling;sarcopenia;screening;screening services;Services;Source;specific biomarkers;Supplementation;Technology;Testing;Therapeutic;Tissues;tool;transcriptomics;Translating

PROJECT_TITLE: Development of a high throughput in vivo screening platform for identifying novel pro-and postbiotic bacterial strains


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

ORG_NAME: ORPHAGEN PHARMACEUTICALS

PHR: PROJECT NARRATIVE Despite improvements in therapy over the last two decades, up to half of all inflammatory bowel disease (IBD) patients are unable to achieve long-term remission with available drugs. Orphagen proposes to develop a novel inhibitor of retinoic acid signaling that blocks the induction of two gut homing molecules on inflammatory T cells, preventing their accumulation in the intestine. Building on the promising preclinical efficacy and safety profile of potent and selective retinoid antagonists discovered at Orphagen, we aim to develop a first-in-class oral drug to alleviate suffering in IBD patients.

PI_NAMEs: THACHER, SCOTT MCNEAR (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Acute;Address;Adverse effects;All-Trans-Retinol;animal safety;antagonist;Anti-Inflammatory Agents;Antibodies;antigen-specific T cells;Antigens;appropriate dose;Biological Availability;Canis familiaris;CCR9 gene;cell motility;Chemicals;Chemistry;chemokine receptor;Citrobacter rodentium;Clinical;Clinical Trials;Colitis;Colon;Crohn's disease;Cyclic GMP;Data;Dendritic Cells;design;Development;Disease remission;Dose;drug development;Drug Kinetics;efficacy evaluation;efficacy study;Epithelium;experience;Future;Goals;Gut associated lymphoid tissue;Histology;Histopathology;Homing;Human;Immune;Immune system;immunoregulation;improved;In Vitro;in vitro Assay;in vivo;Inflammatory;Inflammatory Bowel Diseases;inhibitor;Integrins;Interleukin-12;interleukin-23;Intestinal Mucosa;Intestines;Investigation;Investigational New Drug Application;Lamina Propria;Lead;Ligands;manufacture;Maximum Tolerated Dose;Mediating;Metabolism;Methodology;Methods;migration;Modeling;Monoclonal Antibodies;monolayer;mouse model;murine colitis;Mus;new chemical entity;No-Observed-Adverse-Effect Level;novel;novel drug class;novel therapeutics;Oral;Organ;Pathology;Patients;Pharmaceutical Preparations;Pharmacology;Phase;Physiological;Plasma;Plasma Proteins;pre-clinical;preclinical development;preclinical efficacy;preclinical safety;prevent;Process;Qualifying;receptor;response;Retinoic Acid Receptor;retinoic acid receptor alpha;Retinoic Acid-Binding Proteins;Retinoids;Role;Safety;safety study;scale up;Severities;Signal Transduction;Small Business Innovation Research Grant;small molecule;synthetic enzyme;T-Cell Activation;T-Lymphocyte;Therapeutic;Tissues;Toxic effect;Toxicology;trafficking;transcription factor;Tretinoin;Ulcerative Colitis;United States Food and Drug Administration;Vitamin A

PROJECT_TITLE: A novel, pleiotropic oral drug class that inhibits gut migration of activated T cells

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


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;Brain Disorders;Clinical Research;Dementia;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Neurodegenerative;Neurosciences

ORG_CITY: ESCONDIDO

ORG_NAME: BETTER BRAINS, INC

PHR: PROJECT NARRATIVE Among the estimated 11 million care partners who provide care to persons with Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD), many are tasked with the management of dysphagia (swallowing difficulty) and they experience higher levels of emotional burden, isolation, depression, and hopelessness than their counterparts who do not manage dysphagia. In this Phase I project, we will employ two stages of user-centered design to determine the unique needs of AD/ADRD care partners who manage dysphagia and design an evidence-based intervention for dysphagia management with digital training content and behavioral nudges. Our goal is to commercialize the intervention to help care partners anticipate, avert, and respond to challenges faced with dysphagia management during the course of AD/ADRD and to enhance health and well-being.

PI_NAMEs: WERNER, NICOLE E;ZURAW, MATTHEW  (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Address;Alzheimer's Disease;Alzheimer's disease related dementia;American;Aspiration Pneumonia;Behavior;Behavioral;Behavioral Model;Brain;care outcomes;Caring;Centers for Disease Control and Prevention (U.S.);Clinical;Collaborations;commercialization;community organizations;Consensus;Critiques;Deglutition;Deglutition Disorders;Dementia;dementia care;design;digital;Education;Emergency department visit;Emotional;Ensure;Evidence based intervention;experience;Feeling hopeless;Funding Opportunities;Future;Goals;Habits;Health;Health Care Costs;improved;improved outcome;Indiana;Industry;Intervention;Investments;Knowledge;Length of Stay;Malnutrition;Medical Device;medical schools;Mental Depression;Methods;mortality;multidisciplinary;Needs Assessment;Nursing Homes;Outcome;Personal Satisfaction;Persons;Phase;Phase II Clinical Trials;Population;Prevalence;prevent;Process;prototype;Provider;Public Health Schools;Quality of life;Research;Research Personnel;Resources;response;Risk;skills;success;Testing;therapy development;Time;tool;Training;United States National Institutes of Health;Universities;user centered design;virtual;Wisconsin

PROJECT_TITLE: Dementia IDEAs: An Evidence-based Intervention for Dysphagia to supportthe Unique Needs of AD/ADRD Care Partners

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


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;Neurodegenerative;Neurosciences;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: MOUNTAIN VIEW

ORG_NAME: NEUCYTE, INC.

PHR: Narrative Alzheimer Disease is the most common age-related neurodegenerative disorder. Sporadic late-onset AD represents the majority of cases. The exponentially aging patient population means the healthcare burden will also increase exponentially. In this collaborative proposal, NeuCyte is partnering with UCSF to establish a reproducible, bioluminescence-based screening platform using mini-brain assembled organoids (assembloids) for sporadic late-onset Alzheimer Disease. These assembloids are more representative of the human brain because they can be coaxed into developing Alzheimer, which will allow pharma to test their compounds to identify new AD therapies to address this growing healthcare crisis.

PI_NAMEs: POON, WAYNE W (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: 3-Dimensional;AD transgenic mice;Address;age related neurodegeneration;Aging;Alzheimer disease screening;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease model;Alzheimer's disease patient;Alzheimer's disease related dementia;Alzheimer's disease therapeutic;Alzheimer's disease therapy;Amyloid;Animal Model;Animal Testing;apolipoprotein E-3;apolipoprotein E-4;Astrocytes;Biological Assay;Biological Models;Bioluminescence;Brain;Calcium;cell type;Cells;Cholesterol;Clinical Trials;commercialization;Communities;Cryopreservation;Development;differentiation protocol;Disease;disease model;DNA Sequence Alteration;drug discovery;Drug Screening;Engineering;Environment;Enzymes;excitatory neuron;Exhibits;Face;Failure;familial Alzheimer disease;Future;Generations;Genes;genome wide association study;Glutamates;Goals;Healthcare;healthcare burden;high throughput screening;high-throughput drug screening;Human;human induced pluripotent stem cells;Immunotherapy;improved;In Vitro;in vitro Assay;in vitro Model;in vivo;induced pluripotent stem cell;Induced pluripotent stem cell derived human neuron;induced pluripotent stem cell technology;Late Onset Alzheimer Disease;Lead;Libraries;Lipoproteins;Measures;Mediating;Microglia;microphysiology system;Modeling;mouse model;Mus;nanoluciferase;Nature;Nerve Degeneration;Neurofibrillary Tangles;Neuroimmune;neuroinflammation;neuron loss;Neurons;neuropathology;novel therapeutics;Organoids;patient population;Patients;Pharmaceutical Preparations;Phase;Phenotype;Population;pre-clinical;Production;Property;Reporter;Reproducibility;Rodent Model;screening;Screening procedure;Site;Societies;Somatic Cell;species difference;stem cell model;success;Synapses;tau mutation;tau Proteins;Testing;Therapeutic;Time;Translating

PROJECT_TITLE: NanoLuciferase-based AD/ADRD Microphysiological Systems Platform for High-throughput Screening

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


ED_INST_TYPE: UNIVERSITY-WIDE

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

ORG_NAME: UNIVERSITY OF WASHINGTON

PHR: Project Narrative Pathological tau causes neuronal dysfunction and neurodegeneration in tauopathies such as Alzheimer’s disease, frontotemporal lobar degeneration, and corticobasal degeneration. The proposed work investigates potential molecular mechanisms of proteostatic disruption underlying the neurotoxic effects of tau. Successful completion of this work will identify novel therapeutic targets for restoring tau proteostasis to treat tau accumulation and toxicity, with potential for future translational studies.

PI_NAMEs: HAN, MARINA  (contact)

PROGRAM_OFFICER_NAME: SARE, RACHEL

PROJECT_TERMS: Affect;age related neurodegeneration;Aging;Alzheimer's Disease;Apoptosis;ATF6 gene;Automobile Driving;Autophagocytosis;Biological Assay;C-terminal;Caenorhabditis elegans;Caspase;Clinical;Communities;connectome;corticobasal degeneration;Deposition;Disease;Elderly;Endoplasmic Reticulum;endoplasmic reticulum stress;Exhibits;Fred Hutchinson Cancer Research Center;Frontotemporal Lobar Degenerations;frontotemporal lobar dementia amyotrophic lateral sclerosis;Future;Genes;Genetic;genetic approach;Genetic Screening;hippocampal sclerosis;Hippocampus;Human;Human Pathology;Image;improved;Individual;insight;Institution;Investigation;Knock-out;Laboratories;life span;Mediating;misfolded protein;Modeling;Molecular;Molecular Neurobiology;Monitor;Movement;Nerve Degeneration;Neurites;Neurodegenerative Disorders;Neurofibrillary Tangles;Neurologic Deficit;Neurology;neuron loss;Neuronal Dysfunction;Neurons;neuropathology;Neurosciences;neurotoxic;neurotoxicity;new therapeutic target;Outcome;Pathologic;Pathology;Pathway interactions;Persons;Phenotype;Physicians;Process;protein aggregation;protein folding;protein TDP-43;Proteins;proteostasis;Research;Resources;response;reverse genetics;Role;Scientist;Senile Plaques;Severities;skills;sound;synergism;tau aggregation;tau Proteins;tau-1;Tauopathies;TDP-43 aggregation;Testing;Therapeutic;tool;Toxic effect;Training;transcription factor;transcriptomics;Transgenic Animals;Transgenic Organisms;translational approach;translational potential;translational study;Universities;Visualization;Washington;Work;XBP1 gene

PROJECT_TITLE: Investigating the role of the endoplasmic reticulum unfolded protein response in tauopathy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F03C-N (20)]


NIH_SPENDING_CATS: Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Hematology;Prevention

ORG_CITY: San Leandro

ORG_NAME: MERCATOR MEDSYSTEMS, INC.

PHR: RELEVANCE Americans experience between 200,000 and 700,000 new cases of deep vein thrombosis (DVT) each year, with estimates varying widely due to the likelihood of under-reporting. Thirty to fifty percent of all DVT patients develop the morbid post-thrombotic syndrome (PTS), which is a national health crisis. There is no effective treatment for DVT that is meant to avoid PTS, which limits the application of vein-clearing mechanical therapies that can provide immediate benefits. Development of therapies that specifically target the development of PTS are therefore critical in the overall treatment paradigm for DVT.

PI_NAMEs: SEWARD, KIRK  (contact)

PROGRAM_OFFICER_NAME: CHARETTE, MARC F

PROJECT_TERMS: Acute;Adoption;Affect;AFP gene;American;Anti-Inflammatory Agents;Anticoagulant therapy;Anticoagulants;Anticoagulation;Blinded;Blood flow;Blood Vessels;Catheters;Chronic;Cicatrix;Clinical;Clinical Data;Clinical Research;clinical research site;Clinical Trials;Collagen;cytokine;Data;Deep Vein Thrombosis;Deposition;design;Development;Dexamethasone;Disease;Distal;Dropout;effective therapy;Enrollment;Event;Excision;experience;Femur;Fibrosis;fighting;follow-up;Funding;Goals;Health;Hyperpigmentation;Impairment;improved;improved outcome;Incidence;Inflammation;Inflammatory;Infusion procedures;Injury;innovation;Left;Leg;Limb structure;Link;Location;Marketing;Measures;Mechanics;Mediating;Medical;Methods;mouse model;National Heart, Lung, and Blood Institute;non-compliance;novel;open label;Outcome;Participant;Patients;Pelvis;pharmacologic;Pharmacotherapy;Phase;phase II trial;Phase III Clinical Trials;phase III trial;Phosphate Buffer;pilot trial;Postphlebitic Syndrome;pre-clinical research;prevent;primary endpoint;Process;Protocols documentation;Quality of life;Randomized;randomized trial;Randomized, Controlled Trials;Reaction;Research;Resolution;response;response to injury;Safety;Saline;secondary endpoint;Signal Pathway;Signal Transduction;Site;skin ulcer;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Stents;Steroids;Subgroup;success;Swelling;Symptoms;technological innovation;Technology;Therapeutic;Therapeutic Intervention;therapy development;Thick;Thrombectomy;thrombolysis;Thrombosis;Thrombus;Tissues;Translating;United States National Institutes of Health;vascular inflammation;Veins;Venous;Venous Insufficiency;Venous Thrombosis

PROJECT_TITLE: Preventing Post-Thrombotic Syndrome after Deep Vein Thrombosis with Perivascular Anti-Inflammatory Agent Delivery

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IVBH-V (10)]


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Ovarian Cancer;Rare Diseases;Women's Health Research

ORG_CITY: CHATSWORTH

ORG_NAME: TRIFOIL IMAGING

PHR: Project Narrative Multi-Modality Optical Molecular Imaging System for Preclinical Cancer Models This application aims to upgrade our commercially available small animal whole-body fluorescent tomography system by using an intensified CCD camera as the detector. This will not only enhance the sensitivity and speed of the system but more importantly add 3D bioluminescence tomography capability, which is not available in any of the commercially available small animal imaging systems in the market.

PI_NAMEs: GULSEN, GULTEKIN ;MOY, AUSTIN  (contact)

PROGRAM_OFFICER_NAME: EVANS, GREGORY

PROJECT_TERMS: 3-Dimensional;absorption;Algorithms;Anatomy;animal imaging;Animals;antibody conjugate;Benchmarking;Bioluminescence;bioluminescence imaging;Cancer Model;Cells;charge coupled device camera;clinical translation;Collaborations;comparison group;Computer software;contrast enhanced;Contrast Media;cost;Data;Detection;detector;Development;Diameter;Disease;disease model;Event;Fluorescence;fluorescence imaging;Fluorescence Microscopy;Fluorescent Dyes;Future;Gene Expression;Gene Proteins;Genetic Engineering;Goals;Half-Life;Image;image reconstruction;imaging platform;imaging system;Imaging technology;Immunology;improved;in vivo;in vivo evaluation;in vivo imaging;in vivo imaging system;Industrialization;Infrastructure;innovation;Institution;instrument;instrumentation;Lasers;Life;light emission;Lighting;Location;Luc Gene;Luciferases;luciferin;Magnetic Resonance Imaging;Marketing;Measures;Modeling;Molecular;molecular imaging;Molecular Probes;Multimodal Imaging;multimodality;Mus;nanoparticle;Neurosciences;novel diagnostics;novel therapeutics;nuclear imaging;Nude Mice;Oncology;optical imaging;Optics;Ovarian;ovarian neoplasm;Performance;Perfusion;Phase;Photography;Play;pre-clinical;Proteins;Radiation therapy;radiotracer;reconstruction;Reporter;Reporter Genes;Reporting;Research;Role;Rotation;Signal Transduction;simulation;SKOV3 cells;Small Animal Imaging Systems;small molecule;Source;Speed;System;Technology;Time;Tissues;tomography;tool;Transfection;Transgenic Model;Transgenic Organisms;Translating;translational potential;treatment strategy;tumor;Validation;virology;Visualization;whole body imaging;X-Ray Computed Tomography;X-Ray Medical Imaging

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


ADMINISTERING_IC: LM

IC_NAME: NATIONAL LIBRARY OF MEDICINE

NIH_SPENDING_CATS: Clinical Research;Prevention

ORG_CITY: NOVI

ORG_NAME: NESTOTUS LLC

ORG_STATE: MI

PHR: PROJECT NARRATIVE Compared to health/care interventions that require in-person attendance, the advantages that digital health interventions (DHIs) offer – for advancing research and end-user perspectives (e.g., participants, clients) – are ten-fold. Yet, extensive resources are required to develop DHIs and there are currently no viable solutions for the long-term sustainability and maintenance of DHIs. The proposed 1-year SBIR Phase 1 project has a solution to these challenges by developing a functional software prototype of the HERO (Health/care Environment for Research and Organization programs) platform that will be secure, HIPAA compliant, intuitive to use, and state- of-the-art by including a suite of menu options with both a user and admin portal interfaces to create and/or host DHIs over time.

PI_NAMEs: MITCHELL, JASON W;UDUPI, SANTHOSH K (contact)

PROGRAM_OFFICER_NAME: BINGHAM, CLAYTON SCOTT

PROJECT_TERMS: Address;Adult;Age;American;Area;Attention;care outcomes;Caring;Client;Clinical;Collaborations;Communities;community organizations;Computer software;cost;Cost Savings;Couples;Data;Development;digital health;Dissemination and Implementation;driving force;Engineering;Ensure;Environment;Ethnic Origin;evidence base;experience;Feedback;flexibility;Funding;Gender;Geographic Locations;Grant;Health;health care settings;Health Insurance Portability and Accountability Act;Healthcare;HIV/STD;human centered design;human old age (65+);improved;Individual;innovation;Internet;Intervention;intervention program;Intervention Studies;Intuition;Lead;Leadership;Link;Maintenance;Mental Health;novel;Outcome;Participant;Pathway interactions;Persons;Phase;physical conditioning;pilot test;Population;programs;prototype;Public Health;Race;Recording of previous events;Research;Research Personnel;research study;Resources;Rural;Secure;Sexual Health;Side;Signal Transduction;Small Business Innovation Research Grant;social;Source;STI prevention;Surveys;Talents;Testing;Time;Travel;United States National Institutes of Health;Vulnerable Populations;web platform;web site;Work

PROJECT_TITLE: Development of H.E.R.O. (Health/care environment for research or organizations): A platform to develop, host, and maintain digital health interventions and programs

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