NIH_SPENDING_CATS: Cancer;Hematology;Orphan Drug;Physical Injury - Accidents and Adverse Effects;Radiation Oncology;Rare Diseases;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Nonembryonic - Human;Transplantation

ORG_NAME: OSSIUM HEALTH, INC.

PHR: NARRATIVE New and effective medical countermeasures are needed to protect victims of accidental radiation exposure or nuclear attack. These victims are highly susceptible to infections and uncontrolled bleeding due to injury to the blood forming components of bone marrow. Ossium Health is developing a readily deployable bank of cells that can form all blood components as a supportive therapy for victims of mass casualty radiation exposure events as well as conventional uses for blood cancer patients.

PI_NAMEs: JOHNSTONE, BRIAN H. (contact);SAHA, SUBHRAJIT

PROGRAM_OFFICER_NAME: RIOS, CARMEN I

PROJECT_TERMS: Accidents;Age;Allogenic;Anemia;animal rule;Area;Benchmarking;biodosimetry;Blood;Blood Platelets;bone;Bone Marrow;Bone Marrow Purging;Businesses;Cancer Patient;Caring;CD34 gene;cell bank;Cell surface;Cells;Clinical;clinical lot;Colony-Forming Units Assay;commercialization;Consult;cost;Cryopreservation;cytokine;Development;Devices;Dose;Dose Rate;Engraftment;Erythrocytes;Event;Exposure to;FDA approved;Flow Cytometry;Goals;Good Manufacturing Process;graft vs host disease;Health;Hematopoietic;Hematopoietic Neoplasms;Hematopoietic Stem Cell Transplantation;Hematopoietic stem cells;Hematopoietic System;Hemorrhage;high risk;HLA Antigens;Human;Immunocompetent;Immunocompromised Host;improved;In Vitro;in vivo;Individual;Infection;Infection prevention;infection risk;Injury;Intake;Intervention;Ionizing radiation;Leukopenia;Living Donors;Major Histocompatibility Complex;manufacture;manufacturing cost;Marketing;Marrow;mass casualty;Measurable;Medical;medical countermeasure;metropolitan;Modeling;mouse model;Mus;Myelogenous;Myeloid Progenitor Cells;Neutropenia;neutrophil;New York City;novel;Nuclear;Nuclear Warfare;optimal treatments;Organ Donor;Pancytopenia;Patients;Pharmaceutical Preparations;Phase;phase 2 study;pre-clinical;Predisposition;Procedures;Process;Production;progenitor;programs;Qualifying;Radiation;Radiation Accidents;radiation effect;Radiation exposure;Radiation Injuries;radiation mitigation;Radiation Protection;Radiation therapy;Radiation Toxicity;Recombinant Cytokines;Recombinants;reconstitution;Regimen;Registries;Regulation;Research;Safety;scale up;Sorting;Source;Specific qualifier value;Stem Cell Assay;stem cell population;stem cells;Sterility;success;Supportive care;System;Technology;Testing;Therapeutic;Thrombocytopenia;Tissue Donors;Transplantation;treatment optimization;Treatment Protocols;verification and validation;Washington

PROJECT_TITLE: Developing a bank of purified myeloid progenitor cells as a bridging therapy for transient pancytopenia resulting from radiation injury

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CTH-E (11)]


ADMINISTERING_IC: ES

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Genetics;Hematology;Prevention

ORG_CITY: ROCHESTER

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: LITRON LABORATORIES, LTD.

ORG_STATE: NY

PHR: Project Narrative Evaluating pharmaceuticals and various industrial chemicals for their capacity to cause DNA damage is a crucial step in protecting human health due to their potential to cause cancer and contribute to other diseases. As regulatory agencies shift away from the use of animals in risk assessment, toxicological risk assessment is in need of a reliable non-animal model to evaluate chemicals for DNA damaging potential. We will develop, optimize, and validate a comprehensive hen’s egg model for assessing chemicals for DNA damage potential, while fulfilling upcoming regulatory guidelines.

PI_NAMEs: BEMIS, JEFFREY C;BRIGGS, ERICA  (contact);DERTINGER, STEPHEN D

PROGRAM_OFFICER_NAME: SHAUGHNESSY, DANIEL

PROJECT_TERMS: Aneugens;Animal Model;animal safety;Animals;Antibodies;Apoptotic;Biological Assay;Biological Markers;Blood;Blood Cells;Body System;Brain;brain electrical activity;Cancer Etiology;carcinogenesis;Cell Nucleus;cell type;Cells;Characteristics;Chemicals;Chickens;Chromosome abnormality;clastogen;Comet Assay;Consumption;cytotoxic;cytotoxicity;Detection;Development;Disease;DNA Damage;Dose;egg;Embryo;Environment;Erythroblasts;Erythrocytes;Erythropoiesis;Evaluation;experimental study;Flow Cytometry;genotoxicity;Government Agencies;Guidelines;Hazard Identification;Health;Hematopoietic;Hepatic;Hepatocyte;Human;Image;Image Analysis;imager;In Vitro;in vitro Assay;in vivo;in vivo Model;Incidence;indexing;Individual;Industrialization;Industry;innovation;insight;Label;Left;Liver;Malignant Neoplasms;Manuals;Measures;Metabolic;Metabolic Activation;Metabolism;micronucleus;Micronucleus Tests;Microscopic;Microscopy;Modeling;Mutagenicity Tests;mutation assay;Nuclear;Organ;pain perception;Pharmacologic Substance;Phase;Physiological;Procedures;Protocols documentation;Reproducibility;Research;Research Design;response;Risk;Risk Assessment;Rodent;safety assessment;sample fixation;Slide;Stains;Structure;System;Technical Expertise;Testing;testing services;Time;tissue processing;Tissues;Toxic effect;Toxicogenetics;Toxicology;TP53 gene;treatment duration;Treatment Protocols;uptake;Validation;Whole Blood

PROJECT_TITLE: Development of a Comprehensive Hen's Egg Model for Genotoxicity Testing

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


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Autoimmune Disease;Biotechnology;Lung;Pulmonary Fibrosis;Scleroderma;Wound Healing and Care

ORG_CITY: CHARLESTON

ORG_NAME: FIBROBIOLOGICS, LLC

ORG_STATE: SC

PHR: Project Narrative In this Phase I STTR, FibroBiologics, LLC will determine antifibrotic activity of a novel antifibrotic peptide M10 in primary skin fibroblasts isolated from scleroderma patients and prove its feasibility in two different animal models of dermal fibrosis: bleomycin-induced and FSP-driven TβR1CA mouse models of dermal fibrosis. The impact of the proposed work on public health will be significant, as it will contribute to the development of an effective strategy for the treatment of systemic sclerosis. Moreover, the M10-based therapeutics developed in our study might be effective in other pathological conditions and diseases characterized by excessive scarring and fibrosis.

PI_NAMEs: BOGATKEVICH, GALINA S (contact);SILVER, RICHARD M.

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Affect;Amino Acids;Animal Model;Anti-Inflammatory Agents;Architecture;Autoimmune Diseases;autoimmune rheumatologic disease;Biological;Biological Models;Biological Response Modifier Therapy;Biotechnology;Bleomycin;Blood Coagulation Disorders;Blood Vessels;C-terminal;Cell Aging;Cell Culture Techniques;Cell Physiology;Cessation of life;Characteristics;chemical synthesis;Chronic;Cicatrix;Clinical Trials;Collaborations;Collagen;Connective Tissue Diseases;cytokine;Data;Death Rate;Deposition;Dermal;Dermis;Development;Disease;Dose;Down-Regulation;drug candidate;effective therapy;efficacy evaluation;efficacy validation;Evaluation;Event;Exhibits;Extracellular Matrix;Extracellular Matrix Degradation;Extracellular Matrix Proteins;FDA approved;Fibroblasts;fibrogenesis;Fibrosis;Formulation;Functional disorder;General Population;Goals;good laboratory practice;high risk;Histopathology;Human;Immunologics;Impairment;In Vitro;Inflammation;Inflammatory;interest;Interstitial Lung Diseases;Lead;Legal patent;Marketing;Measures;MET gene;Modeling;mortality risk;mouse model;Mus;nintedanib;novel;novel strategies;novel therapeutics;Organ;Pathologic;patient retention;Patients;peptide drug;Peptides;Persons;Pharmaceutical Preparations;pharmacologic;Pharmacologic Substance;Phase;Phase I Clinical Trials;Phenotype;Physiology;Play;Pre-Clinical Model;preclinical evaluation;primary endpoint;Process;Production;Property;Proteins;Public Health;Pulmonary Fibrosis;pulmonary function;Quantitative Evaluations;receptor;Receptor Protein-Tyrosine Kinases;Rheumatism;Role;Scleroderma;screening;secondary endpoint;senescence;Skin;skin fibrosis;skin organogenesis;Skin Tissue;Small Business Technology Transfer Research;Specificity;Subcutaneous Tissue;success;Systemic Scleroderma;TGF-beta type I receptor;Therapeutic;Therapeutic Agents;Thick;Tissues;tocilizumab;Toxic effect;treatment strategy;United States;Visceral;Work

PROJECT_TITLE: Development of a Novel Therapeutic Agent for Skin Fibrosis

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


ADMINISTERING_IC: MH

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Adolescent Sexual Activity;Behavioral and Social Science;Clinical Research;Dissemination and Implementation Research;HIV/AIDS;Health Services;Infectious Diseases;Pediatric;Prevention;Women's Health Research

ORG_CITY: BALTIMORE

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: UNIVERSITY OF MARYLAND BALTIMORE

ORG_STATE: MD

PHR: PROJECT NARRATIVE The proposed work seeks to study the first-ever implementation of long-acting injectable cabotegravir (CAB- LA) as part of a community-based service delivery model among AGYW in Zambia.

PI_NAMEs: CLAASSEN, CASSIDY W.;LAVOIE, MARIE-CLAUDE CAROLINE (contact)

PROGRAM_OFFICER_NAME: KAMATH, SUSANNAH M A

PROJECT_TERMS: Acceleration;Acquired Immunodeficiency Syndrome;Address;Adoption;Affect;Africa;African;AIDS prevention;Baltimore;Cause of Death;Characteristics;Clinical;clinical care;Clinical Trials;cohort;Communities;community based service;Consolidated Framework for Implementation Research;Country;Data;Diagnosis;Early identification;Educational process of instructing;Effectiveness;Electronic Health Record;Emergency Situation;empowerment;Enrollment;Epidemic;Epidemiology;Equity;experience;Female Adolescents;Focus Groups;Future;Guidelines;Health;Health Personnel;Health system;HIV;HIV Infections;implementation barriers;implementation determinants;implementation evaluation;implementation framework;implementation outcomes;implementation science;implementation strategy;Incidence;Inequity;Infection;Infrastructure;Injectable;Institution;Interview;Knowledge;Lead;Maintenance;male;Maryland;Mentors;Methods;Modality;Oral;Outcome;Participant;peer coaching;Phase;Population;pre-exposure prophylaxis;preference;prevent;Principal Investigator;programs;Qualitative Methods;Reach, Effectiveness, Adoption, Implementation, and Maintenance;Research;Research Personnel;resilience;response;Risk;Risk Reduction;scale up;Schedule;Service delivery model;Services;Site;social;Structure;Time;Trust;United States;United States National Institutes of Health;Universities;uptake;Work;young woman;Youth;Zambia

PROJECT_TITLE: Scaling Comprehensively Access to Long-acting for an Effective Use of PrEP (SCALE-UP)

STUDY_SECTION: PPAH

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


ADMINISTERING_IC: EB

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

ORG_NAME: ONCOBLAZE LLC

PHR: PROJECT NARRATIVE – RELEVANCE TO PUBLIC HEALTH The goal of the proposed project is the development of a method to deliver a large dose of chemotherapy to the surgical cavity following resection of a tumor. The purpose of this delivery is to kill remnant cancer cells that often remain after surgical tumor removal. If successful, the proposed method will reduce local tumor recurrences following surgery.

PI_NAMEs: HAEMMERICH, DIETER  (contact)

PROGRAM_OFFICER_NAME: ASHMONT, KARI RICH

PROJECT_TERMS: Address;Anatomy;Anthracycline;Blood;Blood Circulation;cancer cell;cancer type;Cells;chemotherapy;Clinical;design;Development;Devices;Dose;Doxorubicin;Drug Delivery Systems;Drug Monitoring;economic impact;Encapsulated;Excision;Exposure to;Feedback;fluorescence imaging;Fluorescent Dyes;Goals;health goals;Heating;High Dose Chemotherapy;Hour;Human;Hyperthermia;Idarubicin;Image;Infiltration;innovation;Lasers;Light;Liposomes;Localized Malignant Neoplasm;Location;Methods;Modeling;Monitor;Mus;nanoparticle;new technology;novel therapeutic intervention;Operative Surgical Procedures;particle;Patients;Penetration;Pharmaceutical Preparations;Physicians;pre-clinical;pre-clinical therapy;prevent;Public Health;real-time images;Recurrence;Recurrent tumor;Regional Anatomy;Research;Research Personnel;Residual Cancers;Residual state;Sarcoma;Scanning;Soft tissue sarcoma;Stream;Surface;Surgical margins;System;Technology;Temperature;Testing;Therapeutic;Time;Tissues;Treatment Cost;tumor;uptake;Visualization;Xenograft Model

PROJECT_TITLE: Laser-guided drug delivery to prevent tumor recurrences


ADMINISTERING_IC: HD

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

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

ORG_CITY: TRENTON

ORG_NAME: ADVANCED TACTILE IMAGING, INC.

ORG_STATE: NJ

PHR: Project Narrative The project addresses the critical challenge of identifying women at risk for spontaneous preterm birth, a leading cause of infant mortality and health complications globally. It focuses on improving diagnostic accuracy through cervical elastography, employing a specialized probe in a clinical study involving 750 pregnant women, to develop a portable, user-friendly Cervix Monitor device. This research aims to gather data for FDA submissions and create a tool for accurately measuring cervical changes and assessing risk of spontaneous preterm birth, addressing the limitations of current methods.

PI_NAMEs: EGOROV, VLADIMIR  (contact)

PROGRAM_OFFICER_NAME: LONGO, MONICA

PROJECT_TERMS: 5 year old;Address;Area;biomaterial compatibility;Breast;Cause of Death;Cervical;Cervical Ripening;Cervix Uteri;Child;Clinic;Clinical;clinical development;clinical practice;Clinical Research;Complex;Computer software;cost;cost effective;Country;Data;design;design verification;Detection;Development;Devices;Diagnostic;diagnostic accuracy;digital;Discipline of obstetrics;Elasticity;elastography;Electromagnetics;Failure;Female;Goals;Grant;High Risk Woman;Imaging Device;imaging system;improved;Infant Health;infant morbidity/mortality;Infant Mortality;Legal patent;Length;Measurement;Measures;Mechanics;Methods;Modulus;Monitor;monitoring device;Muscle;novel;novel marker;Pelvic floor structure;Performance;Phase;portability;predictive marker;Pregnancy;Pregnant Women;premature;Premature Birth;Production;Prostate;Reporting;Reproducibility;Research;Risk Assessment;Risk Factors;ROC Curve;Safety;Second Pregnancy Trimester;Secure;sensor;Software Design;software development;Specificity;Stress;System;Tactile;Techniques;Technology;Testing;Time;timeline;tool;Ultrasonic Transducer;ultrasound;United States National Institutes of Health;Update;user-friendly;Validation;validation studies;Visual

PROJECT_TITLE: Cervix monitor for risk assessment of spontaneous preterm delivery

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 EMS-S (90)]


ADMINISTERING_IC: AI

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

FUNDING_MECHANISM: TRAINING, INSTITUTIONAL

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Dissemination and Implementation Research;HIV/AIDS

ORG_CITY: NEW YORK

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

PHR: PROJECT NARRATIVE Despite recent advances in prevention and treatment, the scale of the HIV epidemic remains large. The Global HIV Implementation Science Research Training Program aims to increase the number of independent investigators with the knowledge and skills needed to rigorously test interventions to improve the uptake, implementation, and translation of recent scientific findings into standard of care (the know-do gap), as well as to evaluate the impact of bringing such interventions to scale. With stellar faculty, a unique training environment, and unparalleled research opportunities in domestic and international field settings, we are well-poised to continue this novel effort and nurture new investigators trained in multidimensional, interdisciplinary approaches to advance scientific knowledge and evaluate the impact of interventions which address this public health challenge.

PI_NAMEs: HOWARD, ANDREA ALLOCCO (contact)

PROGRAM_OFFICER_NAME: REFSLAND, ERIC WILLIAM

PROJECT_TITLE: Global HIV Implementation Science Research Training Grant

STUDY_SECTION: AIDS

STUDY_SECTION_NAME: Acquired Immunodeficiency Syndrome Research Study Section[AIDS]


ADMINISTERING_IC: NR

ED_INST_TYPE: OTHER SPECIALIZED SCHOOLS

IC_NAME: NATIONAL INSTITUTE OF NURSING RESEARCH

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Prevention;Racial and Ethnic Minority Health Research;Telehealth;Women's Health Research

ORG_CITY: DURHAM

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PHR: We propose an effectiveness-implementation type I hybrid study to test an intervention, Using PrEP, Doing it for Ourselves (UPDOs) Protective Styles, and its effectiveness to improve PrEP uptake among Black cisgender women using a cluster-randomized control trial and examining implementation determinants of UPDOs as a real-world intervention that can be scaled across the Southern US. Project activities will be delivered by an interdisciplinary team – advised by an external advisory panel and established community advisory council, and implemented across six counties in North Carolina, a southern region where HIV incidence is high— Cumberland, Durham, Forsyth, Guilford, Mecklenburg, and Wake counties. At the conclusion of the funded project, we will have rigorously evaluated the intervention ready for scale-up across the US south that has potential to significantly advance EHE goals, specifically for Black cisgender women, an invisible population in HIV prevention.

PI_NAMEs: RANDOLPH, SCHENITA D. (contact)

PROGRAM_OFFICER_NAME: WILLIS, LEIGH ANDREW

PROJECT_TERMS: acceptability and feasibility;Address;Affect;AIDS prevention;Awareness;Beauty;Black race;black women;Caring;cis-female;Cluster randomized trial;Code;cohort;Collaborations;Communities;community engagement;comparison control;Complex;Consolidated Framework for Implementation Research;Continuing Education;Control Groups;cost;cost effective intervention;County;Data Collection;Decision Making;design;Development;distrust;Drama;Effectiveness;effectiveness testing;effectiveness/implementation design;eHealth;Eligibility Determination;Enrollment;Female;follow-up;Foundations;Funding;Future;Gatekeeping;Gender;Geography;Goals;group intervention;Health;Health Services;Health Services Accessibility;HIV;HIV disparities;Home;Hour;Human immunodeficiency virus test;Humor;hybrid type 1 study;Hybrids;implementation context;implementation determinants;implementation evaluation;implementation framework;implementation outcomes;implementation strategy;implementation/effectiveness;improved;Incidence;Individual;Inequality;Injectable;interest;Internet;Intervention;Intervention Trial;Interview;Knowledge;Lived experience;Maintenance;Measures;men who have sex with men;Methods;Motivation;Newly Diagnosed;North Carolina;Online Systems;Oral;Participant;Perception;Pharmaceutical Preparations;Play;Population;pre-exposure prophylaxis;prevent;Privacy;Process;Provider;Randomized;Randomized, Controlled Trials;recruit;Reporting;Research;Role;Sampling;scale up;Secure;Series;Sexual Health;social stigma;Speed;Structure;Surveys;telehealth;Testing;theories;Training;treatment as usual;Trust;United States;uptake;Use Effectiveness;virtual;web site;Woman;Women's Health;Work

PROJECT_TITLE: Cluster Randomized controlled trial of Using PrEP, Doing it for Ourselves [UPDOs] Protective Styles: A salon-based intervention to improve PrEP uptake among Black cis-gender women."


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

ORG_CITY: NASHVILLE

ORG_NAME: VANDERBILT UNIVERSITY MEDICAL CENTER

ORG_STATE: TN

PHR: NARRATIVE People with HIV (PWHIV), young children, and pregnant persons are the populations at highest risk for tuberculosis (TB) and TB-related morbidity and mortality, so provision of safe, effective TB preventive treatment (TPT) is of high importance in these groups. In ASTERoiD, a Phase 3 randomized clinical trial, the Tuberculosis Trials Consortium (TBTC) is assessing an ultra-short (6 week) course of a single drug, rifapentine, aka “6wP,” for TPT in a large, diverse, international population of people at risk for TB. We propose to add clinical pharmacology (measurement of drug concentrations) to ASTERoiD so that we can confirm the right dosing of TB and HIV medicines for key priority populations (PWHIV, pregnant persons, and young children)(which will facilitate their safe inclusion in the trial), verify that PK targets are being met (and understand who is at risk for high or low drug concentrations), and evaluate relationships between drug concentrations and key treatment outcomes (like safety and tolerability).

PI_NAMEs: DOOLEY, KELLY E. (contact)

PROGRAM_OFFICER_NAME: MAHON III, ROBERT N

PROJECT_TERMS: 11 year old;Adult;adverse drug reaction;Age;Animal Model;antiretroviral therapy;appropriate dose;Area;arm;Cause of Death;Centers for Disease Control and Prevention (U.S.);Child;Clinical;Clinical Pharmacology;cohort;Data;data modeling;Data Pooling;design;Development;Disease;Dose;Drug Exposure;Drug Interactions;Drug Kinetics;Effectiveness;Enrollment;Ensure;Exclusion;Exposure to;Funding;Future;Geography;Healthcare;high risk;high risk population;HIV;HIV/TB;Individual;Infection;inter-individual variation;interest;International;isoniazid;Measurement;medication safety;Medicine;Minor Planets;Modeling;Morbidity - disease rate;mortality;Mus;NAT2 gene;Outcome;Parents;Participant;patient population;Patient-Focused Outcomes;Patients;Persons;Pharmaceutical Preparations;Pharmacogenetics;pharmacokinetic model;pharmacometrics;Phase;phase III trial;Population;Populations at Risk;pregnant;Pregnant Women;prevent;Prevention;Preventive therapy;Preventive treatment;Pulmonary Tuberculosis;Randomized;randomized, clinical trials;Recommendation;Regimen;Rifampin;Rifamycins;rifapentine;Risk;Risk Factors;Safety;Sampling;Source;standard of care;Study models;Target Populations;Testing;Time;translational model;Treatment outcome;Tuberculosis;tuberculosis drugs;tuberculosis treatment

PROJECT_TITLE: Short-course rifapentine for TB prevention for all: clinical  pharmacology matters

STUDY_SECTION: HCAC

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


ADMINISTERING_IC: DE

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Cancer;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Lung;Lung Cancer;Orphan Drug;Rare Diseases

ORG_CITY: SAN ANTONIO

ORG_NAME: KERACEUTICALS, INC.

ORG_STATE: TX

PHR: Narrative OSCC is the 6th most common cancer worldwide and is associated with high morbidity and a substantial economic burden. There is a severe lack of effective therapeutics, resulting in poor patient outcomes. Keraceuticals’ novel 1,3 thioureas offer a much-needed treatment option for OSCC, presenting a novel, potent, and selective treatment that may effectively address early and late-stage cancers and reduce patient medical costs.

PI_NAMEs: GONZALES, CARA B (contact)

PROGRAM_OFFICER_NAME: LOPEZ, ORLANDO

PROJECT_TERMS: Accounting;Address;Adverse effects;anti-cancer;Antineoplastic Agents;Antioxidants;Apoptosis;Biological Assay;Biological Availability;Blood;Calcium;cancer cell;cancer diagnosis;cancer type;Caring;Cell Line;Cell Proliferation;Cetuximab;Chemical Exposure;Cisplatin;Clinical;Clinical Trials;comparative efficacy;Complex;Cysteine;cytotoxicity;Development;Disease;Dose;Drug Kinetics;Drug or chemical Tissue Distribution;Economic Burden;efficacious treatment;efficacy evaluation;efficacy study;Electrophysiology (science);Endometrial Carcinoma;endoplasmic reticulum stress;Epidermal Growth Factor Receptor;Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor;Epithelium;Exhibits;Formulation;Future;Gefitinib;Genus Hippocampus;Goals;gulf coast;Half-Life;Head and Neck Squamous Cell Carcinoma;Histopathology;Homeostasis;improved;In Vitro;in vivo;inhibitor;innovation;intraperitoneal;Intraperitoneal Injections;Intravenous;intravenous administration;Invaded;Lead;Legal patent;liver function;Malignant Breast Neoplasm;malignant mouth neoplasm;Malignant neoplasm of brain;Malignant neoplasm of lung;Malignant neoplasm of prostate;Malignant Neoplasms;manufacture;Mediating;Medical Care Costs;Mesenchymal;meter;migration;Mitochondria;mitochondrial membrane;Modeling;Morbidity - disease rate;mouse model;mouth squamous cell carcinoma;Mus;neoplastic cell;Nodal;Non-Small-Cell Lung Carcinoma;novel;novel drug class;novel therapeutics;Oral;Oral Administration;Oxidative Phosphorylation;Patient-Focused Outcomes;Patients;Pharmaceutical Preparations;Phase;Phase I Clinical Trials;Plasma;Preparation;Quality of life;Reactive Oxygen Species;Receptor Signaling;Recurrence;Renal function;research and development;response;Small Business Technology Transfer Research;Survival Rate;targeted treatment;Therapeutic;therapeutically effective;Thiourea;Tongue Neoplasms;Toxic effect;Toxicology;Translating;tumor;tumor growth;Tumor Volume;United States;Xenograft Model

PROJECT_TITLE: 1,3-Thioureas as First In Class Mitochondrial Inhibitors to Treat Oral Cancer

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CTH-T (10)]


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Cancer;Childhood Leukemia;Gene Therapy;Genetics;Hematology;Immunotherapy;Lymphatic Research;Lymphoma;Orphan Drug;Pediatric;Pediatric Cancer;Rare Diseases

ORG_CITY: HOUSTON

ORG_NAME: MARCH BIOSCIENCES INC

PHR: Narrative Patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoma (TCL) currently face limited therapeutic options and a poor prognosis, with a 3-year survival rate under 20%. This proposal aims to improve alternative treatments through development of a dual antigen (CD5/CD7) targeting CAR T-cell therapy derived from haploidentical healthy donors to prevent antigen escape and improve anti-tumor response. Safety and applicability will also be improved by integrating an inducible suicide switch. Together with an accelerated, closed-circuit cGMP manufacturing process to facilitate rapid treatment for patients with aggressive disease, this approach is anticipated to substantially improve survival rates and quality of life for T-ALL/TCL patients, representing a significant advancement in in therapeutic options for these challenging malignancies.

PI_NAMEs: HEIN, SARAH MARIE (contact);MAMONKIN, MAKSIM

PROGRAM_OFFICER_NAME: DJEMIL, SARRA

PROJECT_TERMS: Acceleration;Acute T Cell Leukemia;acute T-cell lymphoblastic leukemia cell;Address;Allogenic;alternative treatment;Animals;Antigens;antileukemic activity;Antitumor Response;Autologous;B-Lymphocytes;Biological Assay;Biological Sciences;cancer cell;CAR T cell therapy;CASP9 gene;CD7 gene;Cell Line;Cell Therapy;Cells;chemotherapy;chimeric antigen receptor;chimeric antigen receptor T cells;Clinical;clinical translation;Coculture Techniques;college;cost;cytopenia;cytotoxicity;design;Development;Devices;Disease;Eligibility Determination;Engineering;Ensure;Face;fitness;flasks;functional status;Generations;Good Manufacturing Process;graft vs host disease;Hematologic Neoplasms;human model;immunogenic;Immunosuppression;improved;In Vitro;in vitro activity;in vivo;in vivo Model;Induction of Apoptosis;Infusion procedures;Laboratories;lead candidate;Licensing;Malignant - descriptor;Malignant Neoplasms;manufacture;manufacturing process;Medicine;Methods;Mus;next generation;novel therapeutics;Parents;patient derived xenograft model;patient population;Patients;Pharmaceutical Preparations;Phase;phase 1 study;Phase I Clinical Trials;Phase I/II Trial;Phenotype;Pre-Clinical Model;prevent;Process;Production;Prognosis;Progressive Disease;Proliferating;Quality of life;Recurrent disease;Refractory;Refractory Disease;Relapse;research clinical testing;Research Personnel;Resistance;response;Risk;risk minimization;Safety;Siblings;Small Business Innovation Research Grant;Suicide;Surface;Survival Rate;synergism;System;T-Cell Lymphoma;T-Lymphocyte;Technology;Testing;Therapeutic;therapy development;timeline;Translation Initiation;Treatment outcome;tumor;vector;Viral;Work;Xenograft Model;Xenograft procedure

PROJECT_TITLE: Dual-targeting allogeneic CAR T-cells for universal therapy of T-cell malignancies

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


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Aging;Bioengineering;Biotechnology

ORG_CITY: TUKWILA

ORG_NAME: ORA BIOMEDICAL, INC.

ORG_STATE: WA

PHR: PROJECT NARRATIVE C. elegans is one of the most widely used animal model systems yet many studies fail to be reproducible due in large part to poor data recording and variations in methodological and environmental variables. To improve rigor and reproducibility, we are building a novel laboratory tool (EleGantry) that will increase collection and reporting of critical data and eliminate several key sources of human error that lead to increased variability. This Phase I proposal will consist of developing the physical platform that will record images of animal populations and environmental data under normal laboratory conditions, the software suite to analyze and report data as well as remove several sources of human error, and a large benchmark dataset consisting of a natural products screen.

PI_NAMEs: LEE, MITCHELL BRENDON (contact)

PROGRAM_OFFICER_NAME: ZOU, SIGE

PROJECT_TERMS: Affect;Age;age related chronic disease;age-related disease;Aging;aging mechanism;Agreement;animal imaging;Animal Model;Animals;Automation;Benchmarking;Biological Aging;Biological Models;Biomedical Research;Biotechnology;Caenorhabditis elegans;Cell model;Cells;central database;Chronic disability;Clinical;Collection;commercial application;Computer software;Custom;Data;data acquisition;Data Analyses;Data Collection;Data Discovery;data dissemination;Data Reporting;Data Set;Development;Disease;disease model;drug discovery;Drug Interactions;Drug Screening;drug testing;drug use screening;economic cost;Effectiveness;Elderly;Ensure;Environmental Monitoring;Excision;experimental study;fighting;gerotherapeutic;Goals;Growth;Health;healthspan;healthy aging;Heart;high throughput screening;high-throughput drug screening;Human;human error;Humidity;Image;improved;in vivo;Individual;Infrastructure;Intervention;Invertebrates;Laboratories;Licensing;life span;Light;Link;Longevity;Machine Learning;Marketing;Meta-Analysis;Metadata;Methodology;Modeling;mouse model;mutant;Natural Products;neuronal circuitry;novel;operation;Outcome;Periodicals;Pharmaceutical Preparations;Phase;Phenotype;Population;pre-clinical;Preclinical Drug Development;primary endpoint;Procedures;prototype;Publications;Quality Control;Reagent;Reporting;Reproducibility;Research;Research Personnel;Resolution;Robotics;Role;screening;Small Business Innovation Research Grant;small molecule;Source;Survival Analysis;System;Tablets;Temperature;Testing;Therapeutic;Therapeutic Uses;Time;tool;Training;Translating;user friendly software;Validation;Variant

PROJECT_TITLE: EleGantry: a software and hardware infrastructure to improve rigor and reproducibility within invertebrate research

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


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Bioengineering;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Racial and Ethnic Minority Health Research;Rural Health;Social Determinants of Health

ORG_CITY: OXNARD

ORG_NAME: SUMA SOLUTIONS

ORG_STATE: CA

PHR: Narrative Certified Nurse Assistants (CNA) provide impactful care to the same vulnerable communities they often represent, but have the least amount of systemic support to ensure they stay licensed, compliant, and in the field. Therefore, Suma is developing a holistic compliance system for CNAs that allow all stakeholders to uplift, support, and retain the workforce. By supporting our direct care workers from minority and low-socioeconomic status communities, Suma will ensure that NIH-designated health disparity populations have access to a diverse, direct care workforce that will improve minority health and reduce health disparities in the United States and its territories.

PI_NAMEs: WHARTON, DENICE  (contact)

PROGRAM_OFFICER_NAME: BAKOS, ALEXIS DIANE

PROJECT_TERMS: Acute;Address;Admission activity;Adoption;Anxiety;Businesses;California;Caring;Certification;Code;Color;commercialization;Communities;Complex;Computer software;Continuity of Patient Care;County;cultural competence;Data;design;Development;digital;Disparity;Dropout;Ecosystem;empowerment;Ensure;Environment;Equity;ethnic minority;Feedback;Free Will;Funding;Growth;Health;Health care facility;health disparity populations;Health Personnel;Health Services Accessibility;Healthcare;Hour;Immigrant;improve minority health;improved;Indigenous;Industry;Infrastructure;innovation;Intervention;Investments;Language;Legal;Licensing;life span;Long-Term Care;Longevity;Longitudinal Studies;Low income;low socioeconomic status;Maps;Marketing;Measures;Minority;Modeling;Modernization;Monitor;Nurses;Nursing Homes;Occupations;older adult;Participant;Patient Care;Patients;people of color;Performance;Phase;Process;prototype;Provider;Qualifying;Quality of Care;Quality of life;Reduce health disparities;Reporting;Resources;response;Running;Rural;satisfaction;Services;Side;skills;Small Business Innovation Research Grant;software as a service;software development;Speed;stem;Stress;Stress Tests;Structure;Support System;System;technological innovation;Testing;United States;United States National Institutes of Health;usability;vulnerable community;Vulnerable Populations;Work;Workload

PROJECT_TITLE: Revolutionizing Healthcare Workforce Management: A Comprehensive Solution for Licensing Disparities and Workforce Retention in Certified Nurse Assistants (CNAs)

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


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology

ORG_CITY: EVERETT

ORG_NAME: GMJ TECHNOLOGIES, INC.

PHR: PROJECT NARRATIVE  This Small Business Innovation Research Fast Track project will produce a novel capillary electrophoresis with native mass spectrometry technique for direct identification of post-translational modifications underpinning charge variants in protein therapeutics. Charge variants are product variants with a net charge different from that of the intended product. They are recognized by regulatory agencies as critical quality attributes because of their potential impact on the safety and efficacy of the product. The outcome of this SBIR is an innovative approach to characterizing charge variants with a condition similar to the physiological condition, which will contribute to development and manufacturing of novel biologics and protein-based medicines.

PI_NAMEs: DADA, OLUWATOSIN  (contact)

PROGRAM_OFFICER_NAME: BARNES, CHARLES ASHLEY

PROJECT_TERMS: Academia;Acrylamides;Address;analytical tool;Antibody-drug conjugates;Biological Process;Biological Products;biopharmaceutical industry;Blood capillaries;Buffers;Capillary Electrophoresis;Cell Culture Techniques;Charge;Chemistry;Chimeric Proteins;commercialization;Complement component C4a;Complex Analysis;copolymer;Cost Savings;Detection;Deterioration;Development;Electrophoresis;engineering design;Evaluation;Evolution;experimental study;Fee-for-Service Plans;Feedback;Formulation;gene therapy;Guidelines;Head;Human;Hydrophobic Interactions;Hydrophobicity;Image;Immune;improved;Individual;Industry;Injections;innovation;interest;International;Ion-Exchange Chromatography Procedure;ionization;Ions;Isoelectric Focusing;Isoelectric Point;lipidomics;manufacture;Marketing;Mass Spectrum Analysis;Medicine;Molecular Conformation;Monitor;Monoclonal Antibodies;nano;next generation;novel;Nucleic Acids;Optics;Outcome;Parents;Performance;pH gradient;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Physiological;Polyethylene Glycols;Post-Translational Protein Processing;preservation;Process;Production;Protein Analysis;protein complex;Proteins;Proteomics;prototype;Quality Control;Recommendation;Recovery;Reproducibility;Research;Research Personnel;Resolution;Safety;Sampling;Science;Services;Small Business Innovation Research Grant;Surface;System;Techniques;Technology;Tertiary Protein Structure;Therapeutic;therapeutic protein;Therapeutic Research;United States Food and Drug Administration;Validation;Variant;Volatilization

PROJECT_TITLE: High-Resolution Native Capillary Zone Electrophoresis with Inline UV and Native Mass Spectrometry for Characterizing Charge Variants in Biologics

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


ADMINISTERING_IC: LM

IC_NAME: NATIONAL LIBRARY OF MEDICINE

NIH_SPENDING_CATS: Bioengineering;Clinical Research;Data Science;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Social Determinants of Health

ORG_CITY: ANN ARBOR

ORG_NAME: BIOMEDWARE

ORG_STATE: MI

PHR: 8. Project Narrative A key component in any investigation of association and/or cause-effect relationships between the environment and health outcomes is the availability of accurate and precise models of exposure. Because the cost of collecting field data is often prohibitive, it is critical to incorporate any source of secondary information available to supplement sparse datasets. Secondary data can take many forms (e.g., continuous or categorical measurement scale), and display different levels of reliability: hard vs soft data (e.g., interval-type data, probability distributions). This SBIR project is developing the first commercial software to offer tools for merging these different data layers using geostatistical AI models, while accounting for their spatial patterns, compositional nature (case of categorical attributes) and local uncertainty.

PI_NAMEs: GOOVAERTS, PIERRE E (contact)

PROGRAM_OFFICER_NAME: FARRELL, CATHERINE MARY

PROJECT_TERMS: Address;Air Pollution;American;Artificial Intelligence;artificial intelligence model;Birth;Censuses;Code;Colorectal Cancer;Communities;Computer software;cost;COVID-19;Data;Data Analyses;Data Set;Decision Making;design;Detection;Development;empowerment;Environment;Environmental Epidemiology;Environmental Health;Evaluation;forest;geochemistry;gradient boosting;Hazardous Substances;Health;Health Sciences;Incidence;Infrastructure;innovation;insight;Investigation;Isometric Exercise;Lead levels;Location;Machine Learning;machine learning algorithm;machine learning prediction;Marketing;Marriage;Measurement;Measures;Methodology;Methods;Minority Groups;Modeling;Municipalities;Nature;neoplasm registry;Noise;novel;novel strategies;Outcome;Paper;Pattern;Peer Review;Performance;Phase;predictive modeling;Probability;Protocols documentation;prototype;Publications;racial disparity;Recommendation;remote sensing;Research;research and development;Risk Assessment;Science;Services;Small Business Innovation Research Grant;software development;Soil;sound;Source;support vector machine;Technology;Test Result;Testing;tool;Uncertainty;United States;United States National Institutes of Health;usability;Validation;Visualization software;working group

PROJECT_TITLE: Geostatistical Software for Non-Parametric Geostatistical Modeling of Uncertainty


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

ORG_CITY: San Diego

ORG_NAME: EPIGENOME TECHNOLOGIES, INC.

PHR: Project Narrative We proposed to optimize Droplet Paired-Tag multi-ome kits for histone/TF profiling by incorporating reference materials, spectra, and quality management practices into our manufacturing process. We further proposed to extensively validate these kits by profiling four histone marks in three regions of AD and normal post-mortem brains (hippocampus, white matter, and cerebellum) and on sorted cell populations from these regions, generating multi-regional epigenetic maps of AD and normal brain. By providing both initial data and the kits necessary to expand the resource, we hope to catalyze the study of cellular AD epigenetics.

PI_NAMEs: HARTL, CHRISTOPHER  (contact)

PROGRAM_OFFICER_NAME: GRAY, ERIN EMILY

PROJECT_TERMS: 3-Dimensional;Acceleration;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease pathology;Alzheimer's disease related dementia;Alzheimer's disease risk;American;Amyloid;Antibodies;Atlases;Autopsy;biobank;Biological Assay;Blood Cells;Brain;Brain region;brain tissue;Buffers;Calibration;Cell Nucleus;Cell Separation;cell type;Cells;Cerebellum;Chromatin;Chromosome Mapping;Clinical Trials;Code;Complex;Data;Disease;Disease susceptibility;DNA Methylation;DNA-Binding Proteins;Elements;Encyclopedia of DNA Elements;Environmental Risk Factor;Epigenetic Process;epigenome;epigenomics;Etiology;Freezing;Gene Expression;Gene Expression Profile;Generations;Genes;Genetic;Genetic Transcription;genome browser;genome wide association study;Goals;Hippocampus;histone modification;Histones;Human;Human Genome;Impaired cognition;improved;Incubated;interest;Knowledge;Late Onset Alzheimer Disease;Life;Link;manufacturing process;manufacturing quality;Maps;markov model;Measurement;Molecular;monocyte;multiple omics;Nervous System Disorder;next generation;non-genetic;novel;Nuclear;Parietal Lobe;Pathogenesis;Patients;Pattern;peripheral blood;Persons;Pharmaceutical Preparations;Phase;Population;Post-Translational Protein Processing;Practice Management;Process;Production;programs;Protocols documentation;prototype;Publishing;quality assurance;Reagent;Reference Standards;Regulatory Element;Research;resilience;Resolution;Resources;response;Risk Factors;risk variant;Sampling;Shipping;Sorting;Stains;Standardization;System;Technology;Temperature;Testing;Time;Tissue Banks;Tissues;Titrations;tool;Transcriptional Regulation;transcriptome;Translating;treatment strategy;Untranslated RNA;Validation;Variant;Visualization;white matter;Whole Blood;Work

PROJECT_TITLE: Single-cell Epigenome Analysis of the Alzheimer's Disease Brain

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Diabetes;Wound Healing and Care

ORG_CITY: AURORA

ORG_NAME: GELSANA THERAPEUTICS, INC.

ORG_STATE: CO

PHR: Narrative There is an unmet need for innovative approaches for improving wound healing in patients with diabetes. In this project, GelSana will demonstrate feasibility for controlled release of PDGF from a novel zwitterionic hydrogel to accelerate diabetic wound healing. Success with these goals would support further work to complete IND enabling studies, where commercialization would significantly reduce morbidity associated with diabetic ulcerations.

PI_NAMEs: ROCKER, ADAM  (contact)

PROGRAM_OFFICER_NAME: LI, YAN

PROJECT_TERMS: Acceleration;Address;Adsorption;Advanced Development;Affect;Amputation;Anti-Bacterial Agents;Bacterial Infections;Bandage;Becaplermin;Biological;Biological Products;Bolus Infusion;cell type;cerium oxide nanoparticle;Charge;Chronic;Clinical;Collagen;Colorado;commercialization;comparison control;controlled release;cost;design;Diabetes Mellitus;diabetic;Diabetic Foot Ulcer;Diabetic mouse;diabetic ulcer;diabetic wound healing;Ensure;Environment;Extracellular Matrix;Family suidae;FDA approved;Fibroblasts;first-in-human;Foreign Bodies;Formulation;Frequencies;Gel;Goals;healing;Hospitalization;Hydrogels;Impaired wound healing;improved;In Vitro;Infection;Inflammation;Inflammatory;inflammatory marker;Inflammatory Response;innovation;Lead;lead candidate;Leg Ulcer;Licensing;limb amputation;Lower Extremity;Macrophage;Mechanics;Mediating;MicroRNAs;Morbidity - disease rate;mouse model;Mus;Nature;novel;open wound;Outcome;Outcome Assessment;Pain;Patients;PDGFA gene;Peptide Hydrolases;Persons;Pharmaceutical Preparations;Phase;Phenotype;Platelet-Derived Growth Factor;Polymers;porcine model;prevent;primary outcome;professor;Proliferating;Property;Proteins;Quality of life;Recombinants;Recovery;release factor;response;Saline;Schools;standard of care;Sterile coverings;Streptozocin;success;Technology;Therapeutic;Time;Tissues;Vascularization;Vertebral column;Work;wound;wound bed;wound closure;wound healing;wound treatment

PROJECT_TITLE: Advancing Diabetic Foot Ulcer Treatment with Provasliex, a Controlled PDGF Release Hydrogel for Promoting Vascularization and Managing Overactive Inflammation


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Biotechnology;Burden of Illness;Comparative Effectiveness Research;Digestive Diseases;Emerging Infectious Diseases;Infectious Diseases;Microbiome

ORG_CITY: BLACKSBURG

ORG_NAME: BIOTHERAPEUTICS, INC.

ORG_STATE: VA

PHR: Public Health Relevance Clostridioides difficile infection (CDI) is an opportunistic infection of the gastrointestinal tract (GI) that afflicts almost half a million people every year only in the U.S, with about 29,000 deaths within 30 days from the initial diagnosis. The socioeconomic burden of CDI in the US is estimated to be at least $6 billion. This SBIR Phase I application will advance the development of a safe and effective oral, once-daily, first-in-class immunoregulatory, antimicrobial-free precision immunology therapeutic with a novel mechanism of action for the treatment of CDI, through comparative studies with current standard of care and recently approved CDI therapies.

PI_NAMEs: HONTECILLAS, RAQUEL  (contact)

PROGRAM_OFFICER_NAME: RANALLO, RYAN

PROJECT_TERMS: 16S ribosomal RNA sequencing;Acceleration;Acute;Address;Advanced Development;Affect;Antibiotic Therapy;Antibiotics;Antibodies;antimicrobial;Binding;Biological Response Modifier Therapy;Biotechnology;Body Weight decreased;Cells;Cessation of life;Clinical;clinical development;Clostridiaceae;Clostridium difficile;Colitis;Colon;commercial application;comparative efficacy;Comparative Study;Computer Models;cost;Development;Diagnosis;Disease;Dose;Economic Burden;efficacy study;enteric infection;Epithelial Cells;Family;FDA approved;fecal transplantation;Flow Cytometry;gastrointestinal infection;Gastrointestinal tract structure;Gene Expression Profile;Gene Expression Profiling;Goals;Growth;gut microbiome;Hamsters;head-to-head comparison;Immune;Immunology;Immunophenotyping;immunoregulation;indexing;Infection;Infiltration;Inflammatory Bowel Diseases;lanthionine;Lesion;Ligase;Marketing;Metabolic;metabolomics;microbial;microbiome;microbiome composition;mitochondrial metabolism;Modeling;Monoclonal Antibodies;mouse model;novel;novel therapeutics;Opportunistic Infections;Oral;Oral Administration;Outcome;Pathogenicity;Pathology;Pathway interactions;Patients;Persons;Pharmaceutical Preparations;Phase;Play;porcine model;preclinical efficacy;Preclinical Testing;preservation;Process;public health relevance;Rectal Administration;Recurrence;recurrent infection;Regulatory T-Lymphocyte;Relapse;Reporting;research clinical testing;resistant strain;response;Role;Safety;Severity of illness;Small Business Innovation Research Grant;small molecule therapeutics;socioeconomics;standard of care;T cell response;Technology;Therapeutic;Toxin;Treatment Efficacy;United States;Vancomycin;Volatile Fatty Acids

PROJECT_TITLE: Comparative Efficacy of Therapeutics for Clostridioides difficile Infection

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


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Biotechnology

ORG_NAME: GATEWAY BIO, INC.

PHR: Project Narrative Polyethylene glycol or PEG is often attached to drug compounds to improve their stability and half-life in circulation. This moiety has been shown to induce the appearance of anti-PEG antibodies in patients, however, leading to reduced tolerability and efficacy of PEGylated drugs. Gateway Bio has developed a PEG alternative, poly(oligoethylene methyl methacrylate) or POEGMA, which has the same drug improvement capabilities without the induction of high antibody levels. Here, we will develop a POEGMA-modified version of a PEGylated drug, pegloticase, to validate the moiety’s capabilities in a drug with known efficacy but with tolerability concerns linked to its PEG modification.

PI_NAMEs: CHILKOTI, ASHUTOSH ;HUCKNALL, ANGUS  (contact)

PROGRAM_OFFICER_NAME: VEPA, SURYANARAYANA

PROJECT_TERMS: Aftercare;Allergic Reaction;Animals;Antibodies;Appearance;Architecture;Biological Assay;Biological Products;Biological Response Modifier Therapy;biomaterial compatibility;Chemistry;Chronic;Circulation;Clinical;Clinical Research;commercialization;Comparative Study;Contractor;Cosmetics;Data;Development;Drug Compounding;drug efficacy;Drug Kinetics;Effectiveness;enzyme activity;Enzymes;ethylene glycol;Exhibits;FDA approved;Fermentation;Formulation;Fright;Future;gel electrophoresis;Glycols;Goals;Gout;Grant;Half-Life;High Pressure Liquid Chromatography;Hour;Hydration status;Immune response;immunogenicity;Immunoglobulin G;Immunoglobulin M;improved;in vitro activity;in vivo;Individual;Laboratories;Licensing;light scattering;Link;manufacture;Manufacturer;manufacturing scale-up;Marketing;Mass Spectrum Analysis;Methods;Methylmethacrylate;Modification;mouse model;Mus;Names;novel;Pathway interactions;Patients;Pharmaceutical Preparations;pharmacologic;Phase;Polyethylene Glycols;Polymers;pre-Investigational New Drug meeting;Production;programs;Property;Radial;Refractory;response;Safety;safety testing;scale up;Serum;Small Business Innovation Research Grant;Structure;success;Technology;Testing;Therapeutic;Time;Toxic effect;Toxicity Tests;Toxicology;Universities;Urate Oxidase;Uric Acid;Validation;Vertebral column

PROJECT_TITLE: Scale-up and Toxicity Studies of POEGMA-Uricase

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


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

ORG_CITY: MONROVIA

ORG_NAME: IMMUNOVA THERAPEUTICS, LLC

PHR: PROJECT NARRATIVE Breast cancer is a leading cause of cancer-related deaths of women in the United States and worldwide. This SBIR-II application is to develop a novel T cell receptor-engineered CD4 T cell immunotherapy by targeting cancer-testis antigen KK-LC-1. To further improve the therapeutic potential, three key technologies have been incorporated into CD4 TCR-STEM T cell product by promoting stem-like memory T cells and resisting to immune suppression. The goal of this project is to develop GMP grade master cell bank and viral supernatants and determine the biodistribution and toxicity of CD4 TCR-STEM T cell product (IMT-422). The positive outcome of our proposed investigational new drug (IND)-enabling studies will accelerate the development of therapeutic CD4 TCR-STEM T cell immunotherapy, and shift the paradigm by paving the way for the development of novel immunotherapies to eradicate breast cancer (particularly triple-negative breast cancer).

PI_NAMEs: WANG, YICHENG  (contact)

PROGRAM_OFFICER_NAME: FRANCA-KOH, JONATHAN C

PROJECT_TERMS: Acceleration;Address;antigen-specific T cells;Antigens;Biodistribution;Cancer Etiology;cancer immunotherapy;cancer subtypes;cancer/testis antigen;CD4 Positive T Lymphocytes;cell bank;Cells;checkpoint therapy;Chemistry;chemotherapy;Clinical;Contract Services;cross reactivity;cytokine;Cytolysis;Data;Development;Drug Kinetics;engineered T cells;Engineering;Epidermal Growth Factor Receptor;Epitopes;Estrogen Receptors;exhaustion;Future;Goals;Growth;HLA-DR13;Human;Immune;immune checkpoint blockade;Immunoglobulin Constant Region;Immunosuppression;Immunotherapy;improved;Indiana;Infiltration;innovation;Institutional Review Boards;Investigational Drugs;knock-down;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant Neoplasms;manufacture;Mediating;Medical;Memory;Metastatic breast cancer;Mission;mouse model;Mus;Names;Nature;neoplastic cell;Normal tissue morphology;novel;novel strategies;novel therapeutics;Outcome;particle;Patients;pembrolizumab;Pharmaceutical Preparations;pharmacologic;Phase;phase 2 study;Phase I Clinical Trials;Phosphotransferases;Population;Positioning Attribute;Process;product development;Production;Progesterone Receptors;programmed cell death ligand 1;programmed cell death protein 1;Protocols documentation;Receptor Signaling;Reporting;Research Personnel;Resistance;Resistance development;response;Safety;scale up;Signal Transduction;Site;Small Business Innovation Research Grant;small hairpin RNA;Solid;Specificity;stem;success;T memory cell;T-Cell Receptor;T-Lymphocyte;Technology;Testing;Testis;Therapeutic;therapeutic development;Toxic effect;triple-negative invasive breast carcinoma;tumor;Tumor Antigens;tumor heterogeneity;Tumor Immunity;tumor microenvironment;United States;Universities;Variant;Viral;Women's mortality;Work;ZAP-70 Gene

PROJECT_TITLE: Development of CD4 TCR-engineered T cell immunotherapy in triple-negative breast cancer

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Autoimmune Disease;Lung;Orphan Drug;Pulmonary Fibrosis;Rare Diseases;Scleroderma

ORG_NAME: ADIUTRIX THERAPEUTICS

PHR: Narrative Fibrotic diseases affect multiple organ systems and cause about 30% of all deaths worldwide; however, no effective therapies exist. Adiutrix will develop a platform to identify a range of compounds targeting a key step in the fibrosis pathway. New therapies and significantly improved patient outcomes are expected from this project.

PI_NAMEs: LENNOX, RONALD  (contact);SILVER, RANDI BETH

PROGRAM_OFFICER_NAME: GOMEZ, CHRISTIAN RENE

PROJECT_TERMS: Actins;Active Sites;Address;Affect;analog;Animal Model;antifibrotic treatment;Binding;Binding Sites;Biological Assay;Bleomycin;Body System;Cessation of life;Chemicals;Chronic Kidney Failure;Clinical;Collagen;Complex;cost;Crohn's disease;design;Development;Disease;Disease Progression;drug efficacy;Drug Targeting;effective therapy;enzyme substrate;Enzymes;Europe;Exclusion;exosome;Extracellular Matrix;FDA approved;Fibroblasts;Fibrosis;Genes;Genetic Transcription;Human;Hydroxyproline;Hypoxia Inducible Factor;idiopathic pulmonary fibrosis;Immune System Diseases;improved;in silico;In Vitro;in vivo evaluation;indium-bleomycin;Inflammatory Response;inhibitor;interest;Intestinal Fibrosis;Intestines;kidney fibrosis;Lead;Ligand Binding Domain;Lung;Lung Transplantation;mast cell;Measures;Mediating;Medical Care Costs;medical schools;Modeling;Modification;mouse model;Mus;Nebulizer;nintedanib;novel;novel therapeutics;Oral;Organ;Pathologic;Pathway interactions;Patient Compliance;Patient-Focused Outcomes;Patients;Peptides;Pharmaceutical Preparations;Phase;Pirfenidone;prevent;Procollagen-Proline Dioxygenase;Production;Pulmonary Fibrosis;pulmonary function;response;Safety;Scleroderma;screening;Series;side effect;Signal Pathway;Silver;Skin;skin fibrosis;Smooth Muscle;stem;Structure of parenchyma of lung;Surgical wound;System;technology platform;Testing;Therapeutic;therapeutic target;therapeutically effective;Tissues;Transforming Growth Factor beta;Up-Regulation;vascular injury;wound healing

PROJECT_TITLE: Platform technology to identify and develop first-in-class anti-fibrotic therapeutics through inhibition of collagen CP4H

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


NIH_SPENDING_CATS: Autoimmune Disease;Bioengineering;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Colorectal Cancer;Digestive Diseases;Inflammatory Bowel Disease;Patient Safety;Rare Diseases

ORG_CITY: BELMONT

ORG_NAME: SAVAGE MEDICAL

PHR: PROJECT NARRATIVE The successful development of the proposed medical device will have a dramatic impact on surgical outcomes and quality of life of patients who undergo rectal cancer resection surgery by eliminating the high morbidity, mortality, and psychological burden of a protective stoma. This translates into a health care cost savings of around $65,000 per patient treated. Development of the proposed technology also has the ability to be a platform technology that can be used to treat many other diseases that benefit from temporary fecal diversion such as diverticulitis, inflammatory bowel disease (Crohn’s and Ulcerative Colitis), Ischemic Bowel Disease, and perianal/perineal wounds with a total market impact of $7.8 Billion.

PI_NAMEs: FONG, KENTON DODYAN (contact)

PROGRAM_OFFICER_NAME: REGMI, SAROJ GOPAL

PROJECT_TERMS: Acute;Address;Adverse event;Animal Model;Animals;Anus;biomaterial compatibility;Cancer Patient;cancer surgery;cancer therapy;Capital;Caring;Chronic;Clinical;Clinical Data;Clinical Protocols;Clinical Research Associate;Clinical Trials;cohort;Colon;Colon Carcinoma;Colorectal;Colorectal Cancer;Complication;Cost Savings;Country;Crohn's disease;Data;Data Set;design;design verification;Development;Device Designs;Devices;Diagnosis;Disease;Diverticulitis;Diverticulosis;Effectiveness;efficacy trial;Enrollment;Excision;experience;Failure;Feces;Funding;Future;Good Clinical Practice;healing;Health Care Costs;Health Expenditures;Healthcare Systems;Hospitals;Human;human study;improved;Individual;individual patient;Infection;Inflammatory Bowel Diseases;Injury;innovation;Institutional Review Boards;International;Intestinal Diseases;intestine surgery;Intestines;Intracolonic;Ischemic Bowel Disease;Life;Literature;Malignant Neoplasms;Marketing;Medical;Medical Device;meetings;migration;minimally invasive;Modeling;Modification;Monitor;Morbidity - disease rate;mortality;new technology;Operative Surgical Procedures;Ostomy;Patient Care;patient population;patient tolerability;Patients;Personal Satisfaction;prevent;Privatization;Procedures;Process;programs;Protocols documentation;psychologic;Quality of life;Randomized;Randomized, Controlled Trials;Rectal Cancer;Rectum;Reporting;Research Personnel;Retrieval;Risk Reduction;Safety;safety and feasibility;Sepsis;Series;Site;Specialist;Sterility;Stomas;success;Supervision;Surgeon;surgery outcome;Surveys;symposium;System;Technology;technology platform;technology validation;Testing;Translating;Ulcerative Colitis;United States National Institutes of Health;usability;wound

PROJECT_TITLE: Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Rectal Cancer Patients

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


NIH_SPENDING_CATS: Biotechnology;Brain Cancer;Brain Disorders;Cancer;Immunotherapy;Neurosciences;Orphan Drug;Pediatric;Radiation Oncology;Rare Diseases;Stem Cell Research;Stem Cell Research - Nonembryonic - Human

ORG_CITY: GURNEE

ORG_NAME: CREATIVE BIOTHERAPEUTICS, LLC

ORG_STATE: IL

PHR: PROJECT NARRATIVE Current therapies attempting to regress and cure brain tumors and brain metastases have failed due to drug and immune resistance from glioma stem cells which our research shows are highly associated with extracellular GRP78. Our overall goal for this NIH SBIR Phase I proposal is to further our proof-of-concept experiments with our patented anti-cancer GRP78 inhibitors establishing a lead candidate as an effective therapy for patients with pediatric and adult brain tumors and brain metastasis. A therapeutic alternative that is non-toxic and is effective at targeting this extracellular GRP78 in recurrent brain tumors and brain metastasis resulting in a significant increase in overall survival would prove to be paradigm altering.

PI_NAMEs: DAVIDSON, DONALD  (contact)

PROJECT_TERMS: 15 year old;Adult;Age;aggressive therapy;American Cancer Society;anti-cancer;Antineoplastic Agents;Binding;Biological Response Modifier Therapy;blood-brain tumor barrier;Brain;Brain Neoplasms;Breast;cancer recurrence;cancer stem cell;cancer therapy;Cell Physiology;Cell surface;Cessation of life;CFC1 gene;chemotherapy;Chicago;Child;Childhood;Clinical Research;Clinical Trials;Colon;Combined Modality Therapy;Cranial Irradiation;Creativeness;Death Rate;design;Disease;Documentation;Dose;drug candidate;drug development;drug discovery;Drug Industry;Drug resistance;effective therapy;efficacy evaluation;Essential Drugs;Event;Excision;experience;experimental study;extracellular;Extracellular Domain;family support;fighting;Foundations;Glioblastoma;Glioma;glucose-regulated proteins;Goals;GRP78 gene;Human;humanized mouse;Immune;immune resistance;Immunosuppression;Immunotherapy;In complete remission;In Vitro;in vivo;in vivo evaluation;Incidence;Induction of Apoptosis;inhibitor;Lead;lead candidate;Legal patent;Letters;Lung;Malignant Breast Neoplasm;Malignant neoplasm of brain;Malignant Neoplasms;Melanoma;Metastatic malignant neoplasm to brain;Modeling;molecular targeted therapies;Mothers;mouse model;Multiple Myeloma;Mus;N-terminal;Neoplasm Metastasis;neoplastic cell;Neurosphere;Neurosurgeon;Normal Cell;novel;novel therapeutics;Nude Mice;oncofetal antigen;Oncologist;Operative Surgical Procedures;Ovarian;Pain;Parents;Pathologic;Pathway interactions;Patients;Pediatric Hospitals;Pharmaceutical Preparations;Phase;Primary Brain Neoplasms;programmed cell death ligand 1;Prostate;Proteins;Protocols documentation;Provider;Radiation therapy;Radiosurgery;Recurrence;refractory cancer;Research;ROR1 gene;side effect;Small Business Innovation Research Grant;Son;Stable Disease;stem cells;Surface;Testing;Therapeutic;Toxic effect;tumor;tumor growth;tumor microenvironment;tumorigenic;United States National Institutes of Health;Work

PROJECT_TITLE: Developing a Novel Biologic Therapy to Eradicate Brain Cancer and Brain Metastasis


ADMINISTERING_IC: AT

IC_NAME: NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Complementary and Integrative Health;Mental Health;Networking and Information Technology R&D (NITRD);Patient Safety;Prevention

ORG_CITY: LEXINGTON

ORG_NAME: RALPHVR INC.

ORG_STATE: KY

PHR: Project Narrative This project will contribute to knowledge on delivery of mind and body interventions (MBIs) and specifically to the delivery of MBIs through digital technology including virtual and mixed reality. Furthermore, application of this knowledge will provide a treatment for delirium in the intensive care unit (ICU) which will contribute to enhanced health and decreased mortality both during and after admission to an ICU, as well as improve quality of life during an ICU stay.

PI_NAMEs: HOAGLAND, RICHARD  (contact)

PROGRAM_OFFICER_NAME: HORGUSLUOGLU, EMRIN U

PROJECT_TERMS: Address;Adherence;Admission activity;Adopted;Affect;Agitation;Algorithmic Software;American;Area;Behavior;brain dysfunction;Characteristics;Clinical;clinical efficacy;clinical practice;Cognitive;Complementary and alternative medicine;Complementary Medicine;Computer software;cost;COVID-19 patient;Data;Data Collection;Data Security;Death Rate;Delirium;design;Development;Devices;digital technology;disorder prevention;Economics;effective intervention;Effectiveness;efficacy evaluation;Emotional;Ensure;Esthetics;experience;Failure;Feasibility Studies;feasibility testing;Feedback;Financial cost;Focus Groups;Foundations;Goals;Health;Health Care Costs;health definition;Health Promotion;Healthcare Systems;high risk;Hospitalization;Hospitals;Hour;Impaired cognition;improved;innovation;innovative technologies;insight;Intensive Care Units;Intervention;intervention delivery;Interview;Kentucky;Knowledge;Length of Stay;Marketing;Mechanical ventilation;Mechanics;Mind-Body Intervention;mind/body;Mindfulness Training;mixed reality;Modality;Monitor;mortality;multi-component intervention;multisensory;Music;National Center for Complementary and Integrative Health;Nonpharmacologic Therapy;Nursing Staff;Outcome;patient oriented;Patient Preferences;Patients;Phase;Pilot Projects;prevent;programs;prototype;Quality of life;Randomized, Controlled Trials;Readiness;Recommendation;Reporting;Research Priority;resilience;Resources;restoration;Risk;Running;safety and feasibility;Severities;Sleep;Small Business Innovation Research Grant;social;Socialization;software systems;statistics;Structure;success;System;Technology;technology intervention;Testing;therapeutically effective;Time;tool;Translating;treatment strategy;Universities;usability;virtual;virtual delivery;virtual reality;virtual reality intervention;Voice

PROJECT_TITLE: Virtual PARTNER (Provide, Activate, Restore, Track, iNspire, Educate, Rehabilitate): Multi-component virtual reality application to target a reduction in delirium in the intensive care unit.

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);Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Dementia;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Prevention

ORG_CITY: Boston

ORG_NAME: EYENEXO LLC

ORG_STATE: MA

PHR: Narrative To support earlier and more accurate diagnosis of Alzheimer’s Disease, this application proposes to develop an automated system to assess early AD non-invasively, by testing innate defensive behavior in rodents. This objective addresses the PAS-22-196 “Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias”. A predictive biomarker for AD will support an earlier and accurate diagnosis of the disease to ensure appropriate care and advance clinical research.

PI_NAMEs: CHEN, DONG FENG ;LUO, GANG ;TOMASI, MATTEO  (contact)

PROGRAM_OFFICER_NAME: LUO, YUAN

PROJECT_TERMS: Acceleration;accurate diagnosis;Address;Affect;Age;age related neurodegeneration;aging process;Algorithms;Alzheimer disease detection;Alzheimer's Disease;Alzheimer's disease diagnosis;Alzheimer's disease diagnostic;Alzheimer's disease model;Alzheimer's disease pathology;Alzheimer's disease related dementia;Alzheimer's disease test;Alzheimer’s disease biomarker;Amyloid beta-Protein;Animal Behavior;Animal Model;Appearance;Area;Automation;Behavior;behavior change;behavior test;Behavioral Assay;Bilateral;Biological Markers;Brain;Brain region;Caring;clinical development;Clinical Research;clinically relevant;Cognitive;Comparative Study;Computer Vision Systems;Cost Savings;Decision Making;Dementia;Deposition;detection platform;Development;diagnostic platform;Disease;disease diagnosis;Disease Progression;Drug Targeting;early detection biomarkers;Early Diagnosis;Ensure;Evaluation;Evolution;field study;Freezing;functional decline;Grant;Health;Hippocampus;Human;imaging study;insight;Laboratories;Marketing;Memory;Methods;Midbrain structure;Monitor;morris water maze;mouse model;Mus;neurodegenerative dementia;Neurodegenerative Disorders;Neurons;neurophysiology;non-invasive system;normal aging;novel;novel therapeutic intervention;older adult;Pathogenesis;Pathologic Processes;Patients;Play;Positioning Attribute;pre-clinical;predictive marker;Prevalence;Research;response;Retina;Rodent;Role;sensorimotor system;Small Business Innovation Research Grant;Specificity;Standardization;Stimulus;Structure;superior colliculus Corpora quadrigemina;System;tau-1;Testing;Therapeutic;Time;Traction;Translational Research;Validation;Visual;visual stimulus

PROJECT_TITLE: Computer vision powered automation of rodent arena for assessment of early Alzheimer's disease.


NIH_SPENDING_CATS: Biotechnology;Brain Cancer;Brain Disorders;Cancer;Childhood Leukemia;Gene Therapy;Genetics;Hematology;Immunotherapy;Neurosciences;Orphan Drug;Pediatric;Pediatric Cancer;Rare Diseases

ORG_CITY: SHAKER HEIGHTS

ORG_NAME: KURE. AI, INC.

ORG_STATE: OH

PHR: This project is highly relevant to public health as its main objective is to lead to the development of a novel therapy for patients with relapsed/refractory cancer. It is hoped that this therapy will be more efficacious, cheaper and decrease the time to treatment for patients.

PI_NAMEs: SOLER, DAVID  (contact);WALD, DAVID

PROGRAM_OFFICER_NAME: BOZZA, WILLIAM PATRICK

PROJECT_TERMS: Acute Myelocytic Leukemia;Antibody Therapy;Antigen Targeting;Antigens;B lymphoid malignancy;B-Lymphocytes;Binding;Brain;Breast;cancer cell;Cancer Model;cancer subtypes;cancer type;CAR T cell therapy;CD19 gene;Cell surface;cell type;Cells;Chemistry;chemotherapy;chimeric antigen receptor T cells;Clinic;Clinical;Clinical Trials;Cytoplasm;Data;density;design;Development;Disease remission;efficacy evaluation;efficacy study;Flow Cytometry;Glioblastoma;Hematologic Neoplasms;Hematology;Hematopoietic;Hematopoietic Neoplasms;Heterogeneity;high standard;Human;human cancer mouse model;human model;Immunohistochemistry;improved;improved outcome;In complete remission;In Vitro;in vitro Model;in vivo;Ligand Binding;Lung;Malignant neoplasm of brain;Malignant neoplasm of pancreas;Malignant Neoplasms;malignant stomach neoplasm;manufacture;manufacturing process;Melanoma;Membrane Proteins;Metabolic;microbial;Modeling;mouse model;Mucous Membrane;Multiple Myeloma;Mus;Myeloid Cells;neoplastic cell;Non-Hodgkin's Lymphoma;Normal Cell;novel;novel therapeutic intervention;novel therapeutics;Organ;Outcome;Pancreas;Pathology;Patient-Focused Outcomes;Patients;Peripheral Blood Mononuclear Cell;Plasma Cells;Primary Brain Neoplasms;Primary Neoplasm;Proliferating;Prostate;Proteins;Public Health;Refractory;refractory cancer;Refractory Disease;Relapse;Reporting;response;Riboflavin;Safety;safety assessment;Sampling;Serum;Solid Neoplasm;standard of care;Structure;success;Surface;T-Lymphocyte;Testing;Therapeutic;therapeutic target;Time;Tissues;Toxic effect;treatment duration;tumor;Tumor Cell Line;Undifferentiated;Work

PROJECT_TITLE: Development of a novel pan-cancer CAR-T product against AML and Glioblastoma


ORG_CITY: Lynnfield

ORG_NAME: ORTHOLEVO, INC.

PHR: PROJECT NARRATIVE  Current surgical and non-surgical treatment options for patients suffering from shoulder stiffness (contrac- ture, or arthrofibrosis) are limited in scope and effectiveness, with a significant number of patients never regaining full joint function. Ortholevo has developed a unique treatment for shoulder contracture. This first of its kind therapy delivers the protein, relaxin-2, using a sustained release polymeric microparticle formulation to restore the range of motion and reduce shoulder contracture.

PI_NAMEs: COOPER, BENJAMIN GOLDMAN (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Abbreviations;Achievement;Acute;Address;Adrenal Cortex Hormones;Anesthesia procedures;Ankle;Articular Range of Motion;Biodistribution;Biomechanics;Capital Financing;Childbirth;Clinical;clinical investigation;Clinical Research;Clinical Trials;Collagen;commercialization;Contracts;Contracture;Data;Development;diabetic;Disease;Dosage Forms;Drug Delivery Systems;Effectiveness;efficacy validation;Elbow;Encapsulated;Engineering;Evaluation;experience;Experimental Designs;Exposure to;Female;Fibroblasts;Fibrosis;Formulation;Freezing;Frequencies;General Population;Goals;Histologic;Hormones;Human;Immobilization;improved;In Vitro;in vivo;Incidence;Individual;individualized medicine;Inflammation;Injectable;Injections;joint function;Joints;Knee;Laboratories;Ligaments;male;manufacture;Manufactured form;Manufacturer;Marketing;Medicine;meetings;Metalloproteases;Microspheres;Modeling;Motion;Motivation;Musculoskeletal;Nerve;Non-Steroidal Anti-Inflammatory Agents;Operative Surgical Procedures;Orthopedics;Pain;particle;Patients;Pelvis;peptide drug;peptide hormone;Peptides;Pharmaceutical Preparations;Phase;Physical therapy;Polymers;pre-Investigational New Drug meeting;Privatization;Procedures;Process;product development;Production;Proteins;Rattus;reduce symptoms;Relaxin;residence;restoration;Risk;Safety;Science;Shoulder;Site;Small Business Innovation Research Grant;Specific qualifier value;stability testing;standard of care;Sterilization;substance use;Symptoms;System;Technology;Testing;Therapeutic;therapeutic protein;Time;Tissues;Toxicology;Translations;Trauma;United States;Work;Writing

PROJECT_TITLE: Late Stage Development of Sustained-release Relaxin for Treating Joint Contracture

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


ORG_CITY: SAN DIEGO

ORG_NAME: NARWHAL BIO, INC.

PHR: PROJECT NARRATIVE Cell-cell interactions drive biological processes in metazoans and consequently play a key role in many of today’s challenging diseases. Enabling methods for on-the-fly identification and downstream isolation of live cells engaging in clinically relevant cell-cell interactions would allow a deeper understanding of underlying biology and consequently lead to the discovery of additional druggable targets. We propose an instrument, software, and consumable platform for imaging, identifying, tagging, and isolating live cells engaging in clinically relevant cell- cell interactions at scale.

PI_NAMEs: AZIMI, BEHRAD ;BEIERLE, JOHN M (contact);HU, KENNETH HSUEH-HENG

PROGRAM_OFFICER_NAME: TAYLOR, VERONICA

PROJECT_TERMS: Adoption;Antibodies;Antigen Presentation;Antigen-Presenting Cells;antigen-specific T cells;Autoimmune Diseases;Autoimmunity;Behavior;Biological;Biological Assay;Biological Models;Biological Process;Biology;Bone Marrow;cancer cell;Carbon Dioxide;CD8-Positive T-Lymphocytes;Cell Communication;Cell Survival;Cells;Cellular Assay;cellular engineering;Clinical;clinically relevant;Clustered Regularly Interspaced Short Palindromic Repeats;Coculture Techniques;Communication;Computer software;Coupling;cytotoxic;Dendritic Cells;Developmental Biology;Developmental Process;Discrimination;Disease;drug discovery;druggable target;Elements;ERBB2 gene;Event;Exhibits;experimental group;Flow Cytometry;Fluorescence;Fluorescence Microscopy;Frequencies;Genome engineering;Genotype;Hand;Hour;Image Cytometry;imaging platform;Immunology;In Situ;instrument;Intervention;Jurkat Cells;Lead;Lipopolysaccharides;Malignant Neoplasms;Methods;Microglia;Modeling;Molecular;Monitor;Monodon;Motility;multiple omics;Myeloid Cells;Nerve Degeneration;Nervous System Disorder;Neurology;Neurons;Outcome;Pathology;Pathway interactions;Peptides;Pharmacologic Substance;Phase;Phenotype;photoactivation;Play;Population;Process;programmed cell death ligand 1;programmed cell death protein 1;Proliferating;prototype;Reagent;Research Personnel;Sampling;screening;Signal Transduction;SKOV3 cells;Specialist;Stains;Stratification;Surface;System;T-Cell Activation;T-Lymphocyte;targeted treatment;technology validation;Testing;Therapeutic;Therapeutic Intervention;Time;Tissue Sample;tool;Validation

PROJECT_TITLE: A Universal Tool for Unravelling the Requirements for Clinically Relevant Cell-Cell Interactions via In Situ Phenotyping and Tagging of Live Cells

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


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;Biotechnology;Brain Disorders;Dementia;Neurodegenerative;Neurosciences;Prevention

ORG_CITY: EVANSTON

ORG_NAME: ENCUE INC.

PHR: PROJECT NARRATIVE Pharmacological treatment to slow or stop the progression or prevent Alzheimer’s Disease (AD) represents an unmet medical need. ENCUE, LLC aims to discover and develop novel therapeutic agents that can restore synaptic health. The success of our drug development program will provide a novel pharmacological treatment at the earliest stages of AD-induced dementia.

PI_NAMEs: LOFFLER, ALICIA  (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: Achievement;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease pathology;Alzheimer's disease patient;AMPA Receptors;Amyloid beta-42;Amyloid beta-Protein;Amyloid deposition;Animal Model;Animals;antagonist;Antibodies;autocrine;Autopsy;Behavioral;Binding;Biological;Biological Assay;Biological Markers;Blood;Brain;Calcium;Cell Surface Receptors;Cells;Chemistry;Clinical;Cognitive deficits;Collection;Complex;Data;Dementia;Dendritic Spines;Development;Disease;Disease Progression;Dose;drug development;drug discovery;Drug Kinetics;Early treatment;efficacy evaluation;Electroencephalography;Enzyme-Linked Immunosorbent Assay;Event;excitotoxicity;extracellular;FDA approved;fluoro jade;Frequencies;Functional disorder;functional plasticity;Genetic Transcription;Glutamates;Goals;Growth Factor;Health;Hippocampus;Hour;IGF1R gene;IGF2R gene;Immunohistochemistry;Impaired cognition;In Situ Nick-End Labeling;Induced Neurons;Injections;Intravenous Bolus;Isoxazoles;Knock-in Mouse;Lead;Learning;link protein;Literature;Long-Term Potentiation;manufacture;Maximum Tolerated Dose;Measurement;Measures;Mediating;Medical;MEKs;Memantine;Memory;Meta-Analysis;Modeling;Morphology;mouse model;Mus;N-Methyl-D-Aspartate Receptors;N-Methylaspartate;nanomolar;Nature;Neuronal Plasticity;Neurons;neurotoxicity;novel;novel therapeutics;object recognition;Pathologic;Pathology;Pharmaceutical Preparations;Pharmacological Treatment;Phase;phase 1 study;preclinical evaluation;prevent;Program Development;programs;Property;receptor;Recombinant Insulin-Like Growth Factor;Regimen;Research;response;Sampling;Senile Plaques;side effect;Signal Transduction;Small Business Innovation Research Grant;small molecule;Stains;success;Symptoms;Synapses;Synaptic plasticity;Synaptosomes;tau Proteins;tau-1;Tauopathies;Testing;Therapeutic;Therapeutic Agents;Therapeutic Intervention;Time;Toxic effect;Toxicology;Translations

PROJECT_TITLE: Development of Novel Small molecule modulators of synaptic plasticity for the treatment of AD-induced cognitive decline

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


NIH_SPENDING_CATS: Assistive Technology;Autoimmune Disease;Bioengineering;Diabetes;Eye Disease and Disorders of Vision;Prevention

ORG_CITY: LOUISVILLE

ORG_NAME: AMIDEBIO, LLC

PHR: NARRATIVE Diabetes is rapidly becoming a global health crisis. In both Type I and Type II diabetics glycemic control is paramount as the inability to maintain glycemic control results in a number of secondary complications including neuropathy, nephropathy and retinopathy, that often lead to amputations, dialysis and blindness. Frequent hypoglycemic incidences lead to impaired awareness of hypoglycemia (IAH) that occurs in more than 25% of Type I diabetics and 10% of Type II diabetics. The proposed studies will bring 3 lead candidates (suitable for preventing severe hypoglycemia in patients suffering from IAH), through manufacturing, safety and efficacy studies in order to finalize the selection of a drug candidate to bring forward to an Investigational New Drug (IND) application in preparation for the first clinical trial for safely addressing IAH.

PI_NAMEs: FLUDZINSKI, PAWEL  (contact)

PROGRAM_OFFICER_NAME: ARREAZA-RUBIN, GUILLERMO

PROJECT_TERMS: Accident and Emergency department;Address;Adult;Adverse effects;Affect;Agonist;Amputation;analog;Artificial Pancreas;Awareness;Biological;Blindness;Blood Glucose;cardiovascular risk factor;Cessation of life;Clinical Treatment;Clinical Trials;commercialization;Complication;Complications of Diabetes Mellitus;Data;Dedications;design;Diabetes Mellitus;diabetic;Dialysis procedure;dosage;Dose;drug candidate;drug development;efficacy study;Emergency Situation;Ensure;Equipment;experience;Exposure to;Feedback;Fermentation;Formulation;global health;Glucagon;Glucose;glycemic control;habituation;healthy volunteer;Hormones;Hospitalization;Human;Hypoglycemia;immunogenicity;Impairment;improved;In Vitro;in vitro Model;in vivo;in vivo evaluation;Incidence;Insulin;Insulin Infusion Systems;Insulin Receptor;Insulin Resistance;Insulin-Dependent Diabetes Mellitus;Investigational New Drug Application;Kidney Diseases;large scale production;Lead;lead candidate;lead series;Legal patent;Link;manufacture;manufacturing process;Metabolic Diseases;Methodology;Methods;milligram;Miniature Swine;Molecular;Monitor;Moon;Neuropathy;Non-Insulin-Dependent Diabetes Mellitus;novel;Patients;peptide drug;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;Phase;phase 2 study;Physiological;Plasma;preclinical study;Preparation;prevent;Process;Production;Protocols documentation;Pump;Quantitative Structure-Activity Relationship;Rattus;Recombinants;Refrigeration;Retinal Diseases;Risk;Safety;safety study;Self Administration;Series;Structure;System;Technology;Testing;Toxicology;Trees;Type 2 diabetic;type I and type II diabetes;type I diabetic;validation studies;vigilance;Visit;Work

PROJECT_TITLE: Dual Agonist Insulins for Treating Diabetics with Impaired Awareness ofHypoglycemia (IAH)

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


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

ORG_CITY: DURHAM

ORG_NAME: EYDIS BIO, INC.

PHR: PROJECT NARRATIVE Alzheimer's disease is a neurodegenerative disorder characterized by the accumulation of abnormal protein aggregates in the brain, leading to cognitive decline. Emerging research suggests that targeting transforming growth factor β-activated protein kinase 1 (TAK1) may offer a novel therapeutic approach, as TAK1 plays a crucial role in neuroinflammation and cell survival, potentially mitigating the progression of Alzheimer's disease by modulating these pathways.

PI_NAMEs: SCARNEO, SCOTT  (contact)

PROJECT_TERMS: ABCB1 gene;Address;Aducanumab;advanced disease;aged;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease patient;Alzheimer's disease therapy;Amyloid beta-Protein;analog;antagonist;APP-PS1;Applications Grants;Biological Assay;Biological Availability;Blood - brain barrier anatomy;Brain;brain tissue;Cell Survival;Central Nervous System;Cerebrospinal Fluid;Cessation of life;Cholinesterase Inhibitors;clinical development;Collaborations;Combined Modality Therapy;cytokine;Data;Dementia;dentate gyrus;Development;Diagnosis;Disease;Disease Pathway;Disease Progression;Dorsal;Drug Kinetics;Drug Targeting;effective therapy;efficacy evaluation;Female;Funding;Future;Genetic;global health;Grant;Health care facility;Hippocampus;Histologic;Home;Human;Immunomodulators;Impaired cognition;improved;In Vitro;in vivo;in vivo evaluation;Inflammatory;inhibitor;innovation;Knock-out;Lead;lead candidate;Legal patent;Libraries;male;Mediator;Memantine;Modeling;mouse model;Mus;N-Methylaspartate;Neurodegenerative Disorders;neuroinflammation;neuron loss;Neurons;new therapeutic target;North Carolina;novel;novel therapeutic intervention;novel therapeutics;older patient;Oral;Outcome;Pathogenesis;Pathway interactions;Patients;Penetrance;Performance;Persons;Pharmacologic Substance;Phase;Phosphorylation;Phosphotransferases;Play;pre-clinical;preclinical development;prevent;Program Development;protein aggregation;Protein Kinase;Public Domains;Research;Role;safety study;Sampling;scaffold;Series;Serum;Signal Transduction;Small Business Innovation Research Grant;Small Business Technology Transfer Research;small molecule;small molecule inhibitor;Structure-Activity Relationship;success;targeted treatment;tau Proteins;Tauopathies;Testing;Therapeutic;Tissue Sample;Tissues;Transforming Growth Factor beta;transforming growth factor beta3;Transforming Growth Factors;United States;United States National Institutes of Health;Universities;Validation;Work

PROJECT_TITLE: Development of orally bioavailable and blood-brain barrier penetrant, small molecule TAK1 inhibitors as a novel treatment for Alzheimer's Disease


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Depression;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Mental Health;Mental Illness;Networking and Information Technology R&D (NITRD);Pediatric;Racial and Ethnic Minority Health Research;Rehabilitation;Social Determinants of Health;Telehealth

ORG_CITY: GRAND PRAIRIE

ORG_NAME: THE SWEET I AM, PLLC

PHR: NARRATIVE The Sweet I am, PLLC d/b/a Anticipate Joy is addressing the mental health crisis among college students and the systemic inequalities in mental healthcare that disproportionately impact black college students by creating a promising solution for group teletherapy, which is equivalent to individual teletherapy in terms of treatment outcomes. The goal of the current SBIR is to test TheraGroup, the first large scale virtual group platform for evidenced-based mental health therapy. The TheraGroup application addresses the market surge in the demand for care and the shortage of mental health professionals as it represents an economically viable treatment alternative to individual teletherapy.

PI_NAMEs: TETTERTON, PHD, VERONICA  (contact)

PROGRAM_OFFICER_NAME: PATEL, ANURADHA DIPAK

PROJECT_TERMS: access disparities;Address;African American student;alternative treatment;Anxiety;anxiety reduction;Black American;Black Populations;Black race;Caring;Case Study;caucasian American;Client;Cognitive Therapy;cohort;college;commercial application;Communication;Communication Tools;compare effectiveness;Coping Skills;Counseling;Creativeness;Data;depressive symptoms;Development;Devices;Disparity;Education;Electronic Mail;Employee;Equipment and supply inventories;equity, diversity, and inclusion;evidence base;experience;Feasibility Studies;Feedback;General Population;Generalized Anxiety Disorder;Goals;Group Therapy;Health;Health Insurance Portability and Accountability Act;Health Professional;Health Technology;help-seeking behavior;higher education;Historically Black Colleges and Universities;improved;Individual;Inequality;innovation;insight;Institution;Intervention;Licensing;Longitudinal Studies;Marketing;Measures;Mental Depression;Mental disorders;Mental Health;Mental Health Services;mobile application;Modality;Online Systems;Operating System;Outcome;Outcome Measure;pandemic disease;Participant;Patient Monitoring;Patients;peer;Performance;Phase;poor health outcome;Population;Provider;psychological distress;Public Health;Questionnaires;Race;racial disparity;Randomized;Randomized, Controlled Trials;remediation;Reporting;repository;Research;Resources;Risk;Running;Secure;Security;Services;skills training;Small Business Innovation Research Grant;social stigma;solidarity;standard of care;Stress;Students;study population;Substance abuse problem;Suicide;Surveys;System;Technology;telehealth;Telephone;Teletherapy;Testing;Text;Text Messaging;Therapeutic;Time;tool;Treatment outcome;treatment services;Trust;university student;Videoconferencing;virtual;virtual group;web site

PROJECT_TITLE: Guided group telehealth to deliver evidence-based therapeutic care to Black college students

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


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

ORG_CITY: Rockville

ORG_NAME: RISE THERAPEUTICS, LLC

PHR: Project Narrative Over 3 million adults in the U.S. suffer from inflammatory bowel disease (IBD). This project aims to advance a novel oral immune therapy, R-3750, which delivers SlpA to the intestinal tract to reestablish gut immune homeostasis. As demonstrated preclinical and clinically, SlpA reduces gut inflammation, reestablishes gut mucosal barrier function, induces positive maintenance of the gastrointestinal microbiome, and eliminates symptoms of colitis. Based upon these properties, commercialization of R-3750 could provide an important IBD treatment with a novel mechanism of action that is oral-based, safer than current drug options, and lower cost.

PI_NAMEs: FANGER, GARY  (contact);JANARDHANAN, SATHYANARAYANA

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Adult;analytical method;Animal Model;Anti-Inflammatory Agents;Bacteria;Binding;Biological;Biological Assay;Biological Markers;bioprocess;C-Type Lectins;capsule;Cell Adhesion Molecules;Cell Line;Cell Physiology;Cells;chronic inflammatory disease;Climacteric;Clinical;clinical development;Clinical Distribution;Clinical Protocols;clinical research site;Clinical Trials;Colitis;commensal bacteria;commercialization;Consent Forms;Containment;cost;Crohn's disease;cytokine;Data;Dendritic Cell Pathway;Dendritic Cells;Development;Diagnosis;Digestive System Disorders;Disease;Documentation;Dose;Drug Compounding;Drug Delivery Systems;drug development;Engineering;Enteral;Equipment;Evolution;Excipients;Excretory function;Fermentation;Formulation;Freeze Drying;Future;gastrointestinal;Genetic Engineering;Goals;Growth;gut homeostasis;gut inflammation;gut microbiome;Gut Mucosa;Homeostasis;Homologous Gene;Human Microbiome;Immune;Immunity;Immunotherapy;improved;Inflammation;Inflammatory;Inflammatory Bowel Diseases;Infrastructure;innovation;intestinal barrier;intestinal epithelium;Intestines;Investments;Label;lactic acid bacteria;Lactococcus;Lactococcus lactis;Life;Ligands;lipoteichoic acid;Maintenance;manufacture;manufacturing capabilities;manufacturing facility;manufacturing process;manufacturing run;Mediating;Medical;Medicine;Membrane;Methods;microbiome;microbiota;Modeling;Mucous Membrane;Mus;normal microbiota;novel;novel therapeutics;operation;Oral;Oral Administration;oral immunotherapy;Outcome;Pathway interactions;Patients;Pattern recognition receptor;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Phase I Clinical Trials;Phase II Clinical Trials;Play;Powder dose form;pre-clinical;Preparation;prevent;Probiotics;Process;process evaluation;product development;Production;Property;Proteins;Qualifying;receptor;Recombinants;Records;Refractory;Reporting;Research;research clinical testing;Role;Running;scale up;side effect;Signal Transduction;Signaling Protein;Small Business Innovation Research Grant;Solubility;Source;success;Surface;Symptoms;synthetic biology;System;Testing;Therapeutic;Ulcerative Colitis;vaccine delivery

PROJECT_TITLE: A Novel Synthetically Engineered Oral Immunotherapy for Treating Ulcerative Colitis


ADMINISTERING_IC: NS

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Machine Learning and Artificial Intelligence;Neurosciences

ORG_DEPT: NEUROSCIENCES

ORG_NAME: DUKE UNIVERSITY

PHR: Project Narrative Learning complex skills is aided by imitation of a skilled tutor. It is unknown how neural variability generates specific behavioral variability in pursuit of learning goals. This proposal develops and uses cutting-edge computational tools and optical imaging of neural activity to assess how neural variability directs variability in produced actions during complex skill learning.

PI_NAMEs: MARTINEZ, MILES  (contact)

PROGRAM_OFFICER_NAME: MATTHEWS, MARGUERITE

PROJECT_TITLE: Neural and behavioral mechanisms of song learning in zebra finches


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

ORG_CITY: SEATTLE

ORG_DEPT: OTOLARYNGOLOGY

ORG_NAME: UNIVERSITY OF WASHINGTON

PHR: Project Narrative  Vestibular hair cells are essential for our sense of balance, equilibrium, and general well- being. Degeneration of hair cells is thought to be a primary cause of vestibular dysfunction in aging patients and in patients exposed to ototoxic drugs. This project seeks to provide important new information about the molecular signatures and functions of vestibular hair cells in mice that will contribute toward developing new therapies to restore balance function to human patients.

PI_NAMEs: CIANI, AMANDA NICHOLE (contact)

PROGRAM_OFFICER_NAME: SCHURMAN, JACLYN REBECCA

PROJECT_TERMS: Ablation;Adult;afferent nerve;Age;Aging;Animal Behavior;Animals;balance testing;Behavior;behavior test;Bioinformatics;Brain Stem;cell injury;cell regeneration;cell type;Cells;Cellular biology;Cerebellum;Classification;Data;Development;Dissection;epithelial repair;Epithelium;equilibration disorder;Equilibrium;experience;Exposure to;Eye Movements;follow-up;functional restoration;Future;Gene Expression;Genes;Genetic Transcription;Goals;hair cell regeneration;Hair Cells;Head;Head Movements;Human;improved;In Situ Hybridization;insight;interest;Knowledge;Label;Location;Mammals;Measurement;Measures;Mentors;Messenger RNA;Molecular;Molecular Biology;molecular marker;Molecular Profiling;Morphology;Motion;Motor;Mus;Natural regeneration;Nerve;nerve supply;normal aging;notch protein;novel;novel marker;novel therapeutics;Organ;ototoxicity;ototoxin;Patients;Peripheral;Personal Satisfaction;Pharmaceutical Preparations;Physiological;Physiology;Population;Property;protein expression;Proteins;Publications;Quality of life;Research;Research Personnel;Research Training;response;Rotarod Performance Test;Sensory;Sensory Receptors;single nucleus RNA-sequencing;single-cell RNA sequencing;Space Perception;Stimulus;Supporting Cell;Tamoxifen;Technology;Test Result;Testing;therapy development;tool;transcriptomics;Type I Hair Cell;Type II Hair Cell;Universities;Utricle structure;Vestibular dysfunction;Vestibular epithelia;Vestibular function;Vestibular Hair Cells;Vestibular Nerve;vestibular system;vestibulo-ocular reflex;Work

PROJECT_TITLE: Molecular and functional characterization of type I and II vestibular hair cells in adult mice


NIH_SPENDING_CATS: Antimicrobial Resistance;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: SANTA BARBARA

ORG_NAME: XIRETSA INC.

PHR: PROJECT NARRATIVE Antimicrobial resistance (AMR), which caused 1.27M deaths and 47.6M years of life lost in 2019, is an existential threat requiring immediate, innovative action. The CDC and WHO have recognized Klebsiella pneumoniae, a gram-negative bacterium that causes severe infection and often presents extensive resistance to antibiotics, as an urgent threat for which new antibiotics are direly needed. In this project, we will demonstrate that our new class of membrane-modifying antimicrobials, called Anti-infective Conjugated Electrolytes (ACEs), represent a promising platform from which viable leads can be developed into highly differentiated antibiotics to combat serious AMR threats including K. pneumoniae.

PI_NAMEs: MORELAND, ALEX SAJOVIC (contact);ZURAWSKI, DANIEL VINCENT

PROGRAM_OFFICER_NAME: XU, ZUOYU

PROJECT_TERMS: Acceleration;Anti-Infective Agents;anti-microbial peptide;Antibiotic Resistance;Antibiotics;antimicrobial;Antimicrobial Resistance;arms race;Bacteria;bacterial resistance;bactericide;Benchmarking;Biological;Biological Assay;California;Cell Membrane Permeability;Cessation of life;Chemical Structure;Chemicals;Chemistry;Chest;Collaborations;combat;Combating Antibiotic Resistant Bacteria;Competence;cytotoxicity;Derivation procedure;design;Development;Disease;Drug Kinetics;drug resistance development;Electrolytes;Elements;Enteral;Escherichia coli;flexibility;Foundations;Functional disorder;Future;Genes;global health;Goals;Gram-Negative Bacteria;Growth;Health;Hemolysis;Horizontal Gene Transfer;Human;Immune system;improved;In Vitro;in vitro activity;in vivo;Infection;innovation;insight;intercalation;Investigation;Kinetics;Klebsiella pneumoniae;Knowledge;Lead;lead optimization;Life;Local Anti-Infective Agents;Lower Respiratory Tract Infection;Lung;Lung infections;manufacture;Membrane;Membrane Proteins;microbial;Microbial Biofilms;Modeling;Modern Medicine;mortality;mouse model;Multi-Drug Resistance;Multiple Bacterial Drug Resistance;Mus;Mutate;novel;pathogen;Penetration;Performance;Persons;Pharmaceutical Chemistry;Pharmaceutical Preparations;Phase;Polymyxins;programs;Property;Research;Resistance;Resistance development;respiratory;Respiratory Tract Infections;Safety;safety testing;scaffold;small molecule;Structure;Structure-Activity Relationship;Syndrome;synergism;Testing;Therapeutic;Time;Toxic effect;United States National Institutes of Health;Universities;Validation;years of life lost

PROJECT_TITLE: New Antimicrobials that Act Via Membrane Remodeling for Critical Gram-Negative Pathogens


NIH_SPENDING_CATS: Cancer;Cancer Genomics;Clinical Research;Genetics;Human Genome;Lung;Lung Cancer;Rare Diseases

ORG_CITY: BOULDER

ORG_NAME: ORBIT GENOMICS, INC.

PHR: DEVELOPMENT OF A LUNG-CANCER SUBTYPING DIAGNOSTIC Narrative (3 sentences) Knowledge of a patient’s lung cancer subtype impacts treatment decisions and outcomes, and thus is critical information for the clinician. Orbit Genomics uses information in a person’s genome to determine the progression of cancer cell types without the need for a biopsy. Lung cancer subtype markers will be found and added to Orbit Genomics’ existing lung cancer diagnostic test which will save lives, improve patient outcomes while reducing patient suffering and save billions of dollars.

PI_NAMEs: GARNER, HAROLD R (contact)

PROGRAM_OFFICER_NAME: ZANE, LINDA KARINE

PROJECT_TERMS: Adenocarcinoma;Algorithms;Alleles;Allelotyping;analysis pipeline;arm;Benign;Biopsy;Biopsy Specimen;Blood;Blood specimen;Blood Tests;Cancer Patient;cancer subtypes;cell type;Cells;Classification;Clinical;clinical diagnosis;clinical research site;Clinical Trials;cohort;comparative;Computer software;Custom;Data;Detection;Development;Diagnosis;Diagnostic;diagnostic accuracy;Diagnostic tests;diagnostic value;DNA;effective therapy;exome;experimental study;Frequencies;Genome;Genomics;Genotype;Goals;Image;improved;Individual;Knowledge;Laboratories;Large Cell Carcinoma;Large Cell Lung Carcinoma;Lung Carcinoma;Lung nodule;Machine Learning;Malignant - descriptor;Malignant neoplasm of brain;Malignant neoplasm of lung;Malignant Neoplasms;Maps;Marketing;Measures;medical schools;Microsatellite Repeats;Minor;Modeling;mortality;Non-Small-Cell Lung Carcinoma;novel;Oncologist;Outcome;Pathologic;Pathology;Patient-Focused Outcomes;Patients;Performance;Persons;Phase;Predictive Value;prevent;procedure cost;Production;Prospective Studies;prototype;Publications;Reporting;Research Project Grants;Sampling;Selection for Treatments;Small Business Innovation Research Grant;small cell lung carcinoma;Specificity;Squamous Cell;Squamous cell carcinoma;Technology;Testing;Training;treatment response;tumor progression;Validation;Weight

PROJECT_TITLE: Development of a lung cancer subtyping diagnostic