ORG_CITY: BOSTON

ORG_NAME: BRIGHAM AND WOMEN'S HOSPITAL

PHR: Narrative HIV-1-infected cells persist lifelong despite highly efficient antiretroviral therapy, but may be vulnerable to specific host immune responses. Here, we will use novel single-cell next-generation sequencing approaches for profiling footprints of immune selection in three distinct human clinical trials testing specific immunological interventions.

PI_NAMEs: LICHTERFELD, MATHIAS  (contact)

PROGRAM_OFFICER_NAME: LAWRENCE, DIANE M

PROJECT_TERMS: Acceleration;Acute;acute infection;Address;Aftercare;Agonist;Anti-Retroviral Agents;antiretroviral therapy;Autologous;Automobile Driving;Biological;Biological Assay;CD4 Positive T Lymphocytes;Cells;Cellular Assay;Chromatin;chromosomal location;Chronic Disease;Clinical;clinical care;clinical phenotype;Clinical Trials;clinically significant;Communicable Diseases;Conduct Clinical Trials;curative treatments;Dimensions;Disease Management;DNA;Effector Cell;Evolution;Future;Genes;Genetic Transcription;Genome;Heterochromatin;Histone Deacetylase Inhibitor;HIV;HIV-1;Human;Immune;immune checkpoint;Immune response;Immune system;Immunity;immunological intervention;Immunologics;Immunomodulators;Individual;Infection;integration site;Interferons;Interruption;Intervention;Intervention Studies;Investigation;Junk DNA;Location;Mediating;memory CD4 T lymphocyte;Monitor;neutralizing antibody;novel;Participant;Pathway interactions;permissiveness;Persons;Pharmaceutical Preparations;pharmacologic;Phenotype;phenotypic biomarker;Predisposition;pressure;Process;Property;proteogenomics;Provirus Integration;Proviruses;Randomized Controlled Clinical Trials;randomized, controlled study;rational design;Repression;Research;Research Priority;Resistance;Resolution;response;Sampling;Satellite DNA;Series;single cell sequencing;single cell technology;Surface;T cell therapy;T-Lymphocyte;Techniques;Technology;Testing;Time;Vaccines;Viral;viral rebound;Viral reservoir;Virus Latency;Vorinostat;Work;zinc finger nuclease

PROJECT_TITLE: Immune selection of HIV-1 reservoir cells in human clinical trials

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IIDA-E (02)]


ADMINISTERING_IC: AI

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

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

ORG_CITY: Morrisville

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: INHALON BIOPHARMA, INC.

ORG_STATE: NC

PHR: Project Narrative There is no effective vaccine or treatment for human metapneumovirus (MPV), one of the leading causes of viral lower respiratory tract infections (LRTI) in children, the immunocompromised and the elderly. Inhalon is advancing an inhaled antibody-based therapy against MPV that can be dosed with at-home convenience. This SBIR would advance our MPV treatment through the key preclinical activities necessary to initiate clinical studies.

PI_NAMEs: HUTCHINS, JEFF T (contact)

PROGRAM_OFFICER_NAME: KIM, SONNIE

PROJECT_TERMS: 2019-nCoV;Accounting;Address;Age;Agreement;Animals;Anti-viral Agents;Antibody Therapy;Apical;Back;Blood;Bronchiolitis;Cell Line;Cells;Characteristics;Child;Chinese Hamster Ovary Cell;Clinic;clinical development;Clinical Research;Clinical Trials;Complex;Contracts;cost;cost effective treatment;Cotton Rats;Coupled;Critical Pathways;cross reactivity;crosslink;CXCL10 gene;CXCR3 gene;Cyclic GMP;Data;Daughter;design;Development;Diffuse;Diffusion;Dose;Drug Kinetics;effective therapy;Elderly;Engineering;Ensure;experience;Fc domain;first-in-human;Formulation;Hamsters;Home;Hospitalization;Human;Human Metapneumovirus;human monoclonal antibodies;human study;Immunocompromised Host;Infant;Infection;Inflammation Mediators;Inhalation;Inhalation Toxicology;Intervention;Lower Respiratory Tract Infection;Lower respiratory tract structure;Lung;manufacture;Metapneumovirus;Methods;Monoclonal Antibodies;Monoclonal Antibody Therapy;Morbidity - disease rate;mortality;Mucins;Mucous body substance;mucus clearance;Mus;Nebulizer;neutralizing monoclonal antibodies;Neutrophil Infiltration;Nose;pathogen;Patients;Pharmaceutical Preparations;pharmacologic;Phase;phase 1 study;Pilot Projects;Pneumonia;portability;Positioning Attribute;pre-clinical;preclinical study;prevent;Production;Proliferating;Prophylactic treatment;Proteins;Pulmonary Pathology;Rattus;Reporting;respiratory;Respiratory System;respiratory virus;Risk;Running;Safety;safety study;SARS-CoV-2 antibody;Serious Adverse Event;Side;side effect;Site;Small Business Innovation Research Grant;Specific qualifier value;sugar;Supportive care;Therapeutic;Tissues;Upper respiratory tract;vaccine access;Vaccines;vibration;Viral;Viral Load result;Viral Respiratory Tract Infection;Virion;Virus;Work

PROJECT_TITLE: IND-enabling development for IN-003, an inhaled mAb therapy against human metapneumovirus infection

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


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Adolescent Sexual Activity;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Infectious Diseases;Pediatric;Prevention;Sexually Transmitted Infections;Teenage Pregnancy

ORG_CITY: SCOTTS VALLEY

ORG_NAME: DFUSION, INC.

ORG_STATE: CA

PHR: PUBLIC HEALTH NARRATIVE Although 15-24 year olds are only 25% of the U.S. sexually active population, they account for over 50% of the 20 million new cases of STIs each year. While historically low, the U.S. teen pregnancy rate remains one of the highest in the developed world. The goal of this project is to support school and community-based educators working to reduce the ongoing problem of STIs and teen pregnancy in the United States, through the provision of effective virtual avatar-based training. Making Proud Choices! (MPC) is one of the most used, evidence-based HIV/STI/teen pregnancy risk-reduction programs. However, it is often not implemented with fidelity because schools and community educators commonly face cost and accessibility barriers with the MPC in-person training. In contrast, avatar-based trainings offer simulated classroom experiences that can provide sustainable, widespread access to training, dramatically improving sexual health outcomes for youth at reasonable cost. This project will develop and rigorously evaluate a full-scale avatar-based virtual training to prepare educators to lead MPC with youth, in support of the public health goal of reducing pregnancy and STI’s among adolescents.

PI_NAMEs: FIRPO-TRIPLETT, REGINA  (contact)

PROGRAM_OFFICER_NAME: POPKIN, RONNA

PROJECT_TERMS: 19 year old;Address;Adherence;Adolescent;Attitude;Behavior Therapy;Belief;Birth Rate;commercialization;Communities;community organizations;condoms;consistent condom use;cost;cost effective;Data;design;Development;Dropout;Educational Curriculum;Educational process of instructing;Elements;Ensure;Environment;ethnic disparity;evidence base;Evidence based program;experience;Exposure to;Face;Feedback;geographic disparity;Goals;health goals;High School Student;HIV;improved;Instruction;instructor;interest;Knowledge;Lead;Learning;Life;novel;online version;Outcome;pandemic disease;Participant;Persons;Phase;pilot test;Population;Pregnancy;Pregnancy in Adolescence;pregnancy prevention;Pregnancy Rate;Prevention;Prevention program;programs;prototype;Public Health;racial disparity;Randomized;Reaction;Reporting;Risk Reduction;Safe Sex;Safety;Sales;Schools;sex;Sexual Health;sexually active;Sexually Transmitted Diseases;simulation;skills;STI prevention;student participation;Students;Surveys;teen birth;Teenagers;Testing;Time;Training;Travel;treatment as usual;treatment group;trend;twelfth grade;unintended pregnancy;United States;usability;virtual;Writing;Youth

PROJECT_TITLE: Scaling Effective Behavioral Interventions with MPC Avatar-Based Virtual Training

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


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

ORG_CITY: LA JOLLA

ORG_NAME: AVERY DIGITAL DATA, INC.

PHR: The goal of this project is to greatly increase the industrial capability for making large pieces of DNA, to empower genetic engineers with much bigger DNA payloads to put into cells. Large pieces of DNA, containing many genes, could be used to program bacteria with entire production processes to make valuable drugs, or to program immune cells with much more capabilities to detect and kill cancer cells, or to create much larger payloads for mRNA vaccines, beyond one gene, to cover multiple viruses and strains. Therefore, by providing methods of making such large DNA economical and readily available to researchers, this project can have broad impact across all such areas of health where genetic engineering plays a direct or supporting role.

PI_NAMEs: DAS, SOMES KUMAR (contact)

PROGRAM_OFFICER_NAME: YEH, ALVIN TIEN-WEI

PROJECT_TITLE: Long DNA Assembly on Electronic Nanochannel Chip Devices

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


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

ORG_CITY: ATLANTA

ORG_NAME: BIOCIRCUIT TECHNOLOGIES, INC.

ORG_STATE: GA

PHR: Project Narrative Nerve Tape® is a sutureless nerve repair device with integrated microhooks for quick, easy application. These microhooks bind firmly and safely to outer connective tissues, while the device wraps to align nerve ends and protect the repair site for consistent, high-quality repair of nerve injuries. This project seeks to position Nerve Tape for widespread surgeon adoption by adding an important new size option and gathering new preclinical data in support of key marketing claims.

PI_NAMEs: CLEMENT, RYAN S (contact)

PROGRAM_OFFICER_NAME: CAPORELLO, EMILY LAURA

PROJECT_TERMS: Acceleration;Address;Adopted;Adoption;Area;Automobile Driving;axon regeneration;Back;Benchmarking;Binding;Biological;Cadaver;chronic pain;Clinical;Clinical Data;commercial launch;commercialization;Complex;Connective Tissue;cost;Data;design;Device Designs;Devices;Diameter;Digit structure;digital;digital treatment;experience;Face;Feedback;flexibility;Goals;Hand;Implant;implantation;improved;improved outcome;injury and repair;Interview;Joints;Knee;Legal patent;Location;manufacture;manufacturing process;Marketing;Measures;Microsurgery;Modeling;Motivation;Motor;Natural regeneration;Nerve;Nerve Endings;nerve injury;Nerve Regeneration;nerve repair;nitinol;Operative Surgical Procedures;Oryctolagus cuniculus;Outcome;Paralysed;Penetration;Perception;Performance;Phase;porcine model;Positioning Attribute;pre-clinical;Process;Production;Prognosis;Recovery;repaired;Resources;Risk;Safety;Secure;Sensory;Site;skills;Small Business Innovation Research Grant;Small Intestinal Submucosa;Speed;stem;Surgeon;Surgical sutures;Techniques;Technology;Testing;Thinness;Time;Tissues;uptake;usability;Validation;verification and validation;Work

PROJECT_TITLE: Line extension and expanded preclinical evidence for Nerve Tape, a sutureless nerve repair coaptation device

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


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

ORG_CITY: NEW HAVEN

ORG_NAME: ATLASXOMICS INC.

ORG_STATE: CT

PHR: In this Phase I SBIR study, AtlasXomics will develop a next-generation multi-omic spatial barcode deposition process and platform to expand tissue type compatibility, allowing more researchers to investigate more tissue types for epigenetic biomarkers of disease and to do so more efficiently. Epigenetics is critical in regulating gene expression in healthy and diseased tissue cells. Systematic epigenomic tissue analysis will allow researchers to bring to bear the power of spatial multi-modal omics to a broad range of research, including cancer and neurodegenerative diseases.

PI_NAMEs: MCCONNELL, TIMOTHY S (contact)

PROGRAM_OFFICER_NAME: MORRIS, STEPHANIE A

PROJECT_TERMS: aged;ATAC-seq;Automation;Bar Codes;Biological Assay;Brain;Cells;Chromatin;cost;Custom;Data Analyses;Deposition;design;Development;Devices;Disease;Environment;epigenetic marker;Epigenetic Process;epigenomics;fabrication;Failure;Feedback;field study;flexibility;Freezing;Gel;Gene Expression;genome-wide;high volume manufacturing;Human;human error;Hydrogels;improved;interest;Legal patent;Malignant neoplasm of brain;Malignant Neoplasms;Maps;meetings;Melanoma;Methods;Microfluidics;multimodality;multiple omics;Mus;Neurodegenerative Disorders;next generation;operation;Pain;Performance;Phase;Process;Production;Property;Protocols documentation;prototype;Quality Control;Research;Research Personnel;Resolution;Running;Scientist;sequencing platform;Small Business Innovation Research Grant;Specificity;Spottings;Structure;success;Systems Biology;Technology;Testing;Time;Tissue Expansion;Tissue Microarray;Tissues;tool;Training;Transcription Initiation Site;usability;user-friendly;Variant

PROJECT_TITLE: Development of a user-friendly next generation epigenomic chip adaptable to automation workflows

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


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Cancer;Clinical Research;Digestive Diseases;Esophageal Cancer;Prevention;Rare Diseases

ORG_CITY: Baltimore

ORG_NAME: CAPSULOMICS, LLC

ORG_STATE: MD

PHR: Project Narrative: Our team has a formidable history of invention, development, optimization, and validation of methylation-based PCR assays for the detection of esophageal cancer. We have merged two robust but simple methods for the safe, affordable, and accurate detection of ESCC using a non-invasive sponge device for sample collection and a streamlined epigenetic biomarker assay. Successful validation and early commercialization of our proposed assay with a 92% sensitivity and 87% specificity, will establish an inexpensive, noninvasive, and accurate method for widespread screening and early detection of ESCC to impact lives in the United States and in LMICs.

PI_NAMEs: LAUN, SARAH  (contact)

PROGRAM_OFFICER_NAME: ZHAO, MING

PROJECT_TERMS: accurate diagnosis;accurate diagnostics;Address;Adopted;Africa;Age;Algorithms;American;Area;Asia;Asian Americans;Biological Assay;Biological Markers;biomarker panel;Biostatistical Methods;Black American;Blinded;cancer prevention;capsule;Case/Control Studies;Cells;Cessation of life;Clinical;Clinical Research;Code;cohort;college;commercialization;cost;Cost Savings;Country;Current Procedural Terminology Codes;Data;Detection;detection assay;detection limit;Development;Devices;Diagnosis;Diagnostic;diagnostic strategy;Diagnostic tests;disease diagnosis;DNA;DNA Markers;DNA Methylation;Early Diagnosis;Eastern Africa;Endoscopy;epigenetic marker;Esophageal Squamous Cell Carcinoma;Esophagogastroduodenoscopy;Esophagus;Fatality rate;Feedback;forging;Funding;Future;Gastroenterology;Gender;Genes;Goals;Hispanic Americans;improved;Income;innovation;interest;invention;Laboratories;low and middle-income countries;Malignant neoplasm of esophagus;Malignant Neoplasms;Marketing;Medical;Methods;Methylation;minimally invasive;Modeling;Molecular;NIH Program Announcements;novel;Pathway interactions;Patients;Performance;Phase;phase 1 study;phase 2 study;population based;Populations at Risk;Porifera;Preparation;Price;Protocols documentation;Recommendation;Recording of previous events;Reproducibility;Research;Resource-limited setting;ROC Curve;sample collection;Sampling;screening;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Southern Africa;Specificity;Speed;success;Surveys;Survival Rate;TAC1 gene;Technology;Testing;Training;Uganda;United States;Universities;Validation

PROJECT_TITLE: An accurate, affordable, and transferable assay for minimally invasive detection of esophageal squamous cell carcinoma (ESCC) in Africa and the United States

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


NIH_SPENDING_CATS: Bioengineering;Nanotechnology

ORG_CITY: Raleigh

ORG_NAME: ADAMAS NANOTECHNOLOGIES, INC.

PHR: Narrative Single-molecule fluorescent live-cell imaging is a leading technology in fundamental and translational biology correlating individual protein function with biological outcomes. Ultrasmall fluorescent nanodiamond quantum sensors will be developed for advanced single-molecule studies by chemical stabilization of sensing centers within these particles through plasma-based modification enabling sensing of local electromagnetic fields, free radicals, temperature, pH, and conformational dynamics of proteins with nanoscale resolution.

PI_NAMEs: TORELLI, MARCO  (contact)

PROGRAM_OFFICER_NAME: BILLINGSLEA, EDDIE

PROJECT_TERMS: Address;Amination;Amines;Atmospheric Pressure;base;Biological;Biology;biomarker discovery;biomaterial compatibility;carboxylate;Cell Survival;Characteristics;Charge;Chemicals;Chemistry;Color;commercialization;Complex;Development;Diamond;Disease;drug discovery;electric field;Electromagnetic Fields;Electromagnetics;electron energy;Electron Spin Resonance Spectroscopy;Event;Free Radicals;Gases;improved;Individual;instrument;ionization;Ions;Ligands;live cell imaging;Magnetic Resonance;Measurement;Measures;Methods;Modality;Modification;Molecular;Molecular Biology;Molecular Conformation;Molecular Disease;molecular size;Monitor;nanodiamond;nanomaterials;nanoscale;Nitrogen;Noise;novel;optical emission;optical spectra;Optics;Outcome;particle;Performance;Phase;Physiologic pulse;Physiological;Plasma;Population;pressure;Production;Property;Protein Conformation;Protein Dynamics;protein function;prototype;quantum;quantum sensing;quantum sensor;Reaction;Reporter;Reporting;Resolution;screening;sensor;Shock;single molecule;spatiotemporal;Speed;Surface;Tail;Technology;Temperature;theories;Time;translational impact;Validation;Vendor;voltage;Width;zeta potential

PROJECT_TITLE: Advancing Nanodiamond Particles for Quantum Sensing


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Hearing Loss;Infectious Diseases;Natural Products;Neurosciences;Prevention

ORG_CITY: San Diego

ORG_NAME: TING THERAPEUTICS, INC.

PHR: PROJECT NARRATIVE The work in this proposal focuses on further preclinical development of TT003 to protect from aminoglycoside- induced hearing loss. If successful, this proposal will allow Ting Therapeutics to initiate conversations with pharmaceutical companies for the manufacturing and commercialization of TT003 and for IND-approval by the FDA for its use as a standard otoprotective component of aminoglycoside-based therapies.

PI_NAMEs: ZUO, JIAN  (contact)

PROGRAM_OFFICER_NAME: MILLER, ROGER

PROJECT_TERMS: Acetylcysteine;Acute;Adult;Aftercare;Aminoglycoside Antibiotics;Aminoglycosides;Animal Model;Animals;Anti-Bacterial Agents;Antioxidants;Attenuated;Audiology;Auditory;Auditory Brainstem Responses;authority;Bacteria;Bacterial Infections;Blood;Capsicum;Cavia;Cell Count;Chemosensitization;Clinical;Clinical Treatment;Clinical Trials;Cochlea;Collection;Colony-forming units;commercial application;commercialization;Contracts;Cystic Fibrosis;cystic fibrosis patients;Cytoprotection;Data;design;Detection;Dose;Drug Interactions;Drug Kinetics;drug testing;Drug usage;ebselen;efficacy study;Endotoxemia;Environment;excitotoxicity;experience;experimental study;Food and Drug Administration Drug Approval;Future;Glutamates;Glutathione Metabolism Pathway;Goals;good laboratory practice;Gram-Negative Bacterial Infections;guinea pig model;Hair Cells;hearing impairment;hearing preservation;Hearing Protection;High Pressure Liquid Chromatography;high throughput screening;Human;in vivo;Inflammation;inflammatory marker;International;Intranasal Administration;intraperitoneal;Investigational Drugs;Investments;Jaborandi Pepper;Kanamycin;Knowledge;Labyrinth;Legal patent;Lipopolysaccharides;manufacture;Mass Spectrum Analysis;Measures;Methodology;Modeling;Morphology;mouse model;Mus;Natural Compound;Natural Products;New Drug Approvals;No-Observed-Adverse-Effect Level;Observational Study;otoacoustic emission;otoprotectant;ototoxicity;Outcome;Patients;Perilymph;Pharmaceutical Preparations;Pharmacodynamics;pharmacokinetics and pharmacodynamics;pharmacologic;Pharmacologic Substance;Phase;phase 1 study;Physiological;Population;Pre-Clinical Model;preclinical development;preclinical study;preclinical trial;prevent;prevent hearing loss;Procedures;Proto-Oncogene Proteins c-akt;Pseudomonas aeruginosa;Pseudomonas aeruginosa infection;Quality of life;Regimen;research clinical testing;Research Contracts;Rights;septic patients;Small Business Innovation Research Grant;Sodium Chloride;STAT3 gene;Study models;technological innovation;Testing;Therapeutic;Therapeutic Index;Time;Toxic effect;Treaty;United States Food and Drug Administration;vitamin metabolism;webinar;Work;Zebrafish

PROJECT_TITLE: Therapeutics to prevent aminoglycoside-induced hearing loss

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


NIH_SPENDING_CATS: Clinical Research;Diabetes;Machine Learning and Artificial Intelligence;Maternal Health;Maternal Morbidity and Mortality;Microbiome;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Prevention;Women's Health Research

ORG_CITY: Brooklyn

ORG_NAME: BROOKLYN INNOSEQ INC.

ORG_STATE: NY

PHR: PROJECT NARRATIVE In this SBIR, Brooklyn InnoSeq will develop a novel microbiome screening test to predict Gestational Diabetes Mellitus (GDM) within the first trimester of pregnancy. This will empower clinicians or patients to implement timely interventions and management to improve maternal-fetal outcomes.

PI_NAMEs: FAN, NINI  (contact);SHIELDS, ANDREA DENISE;ZHOU, YANJIAO

PROGRAM_OFFICER_NAME: LONGO, MONICA

PROJECT_TERMS: adverse outcome;adverse pregnancy outcome;Affect;Algorithms;Bacteria;Bioinformatics;Biological Markers;biomarker validation;Birth;Businesses;Cesarean section;Characteristics;Clinical;Clinical Data;Clinical Research;Clinics and Hospitals;cohort;Cohort Studies;Collaborations;Collection;commercial application;Consumption;Data;Detection;Development;Diabetes Mellitus;Diagnosis;diagnosis standard;Diagnostic;diagnostic tool;disorder prevention;Early Diagnosis;early pregnancy;early screening;empowerment;Enrollment;Exclusion;Feces;fetal;First Pregnancy Trimester;Genes;Genomics;Gestational Diabetes;Glucose;Glucose Intolerance;glucose metabolism;Goals;gut microbiome;Health;Health Personnel;Health Professional;Home;Hospitals;Hour;improved;Incidence;innovation;Intervention;Laboratories;Legal patent;Machine Learning;machine learning algorithm;machine learning prediction;Marketing;maternal microbiome;Measures;Medical;medical complication;Metabolic;Metabolic Diseases;Metagenomics;Methodology;Methods;microbial;microbiome;Modeling;Mothers;Neonatal;Neonatal Hypoglycemia;Non-Insulin-Dependent Diabetes Mellitus;novel;OGTT;Oral;Outcome;Patients;Performance;Personal Satisfaction;Phase;Physicians;Play;Population;predictive modeling;Pregnancy;Pregnancy Complications;pregnancy disorder;pregnant;Pregnant Women;Premature Labor;Prevalence;prevent;Procedures;prospective;Publishing;Reporting;Risk;Risk Assessment;Risk Reduction;Role;sample collection;Sampling;screening;Second Pregnancy Trimester;Small Business Innovation Research Grant;Statistical Data Interpretation;statistics;Step Tests;stool sample;success;targeted biomarker;Technology;Testing;Therapeutic;Third Pregnancy Trimester;Time;tool;United States;user-friendly;Validation;Variant;Whole-Genome Shotgun Sequencing;Woman;Work

PROJECT_TITLE: Development and Validation of a Non-Invasive Microbiome-Based Diagnostic Tool for Early Detection of Gestational Diabetes Mellitus

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


NIH_SPENDING_CATS: Biotechnology;Gene Therapy;Genetics;Mucopolysaccharidoses (MPS);Neurosciences;Orphan Drug;Rare Diseases

ORG_CITY: Chapel Hill

ORG_NAME: NEUROGT, INC.

PHR: Project Summary Gene therapy products using adeno-associated-virus (AAV) vector have shown promise for treating monogenetic diseases in humans. This project targets the unmet need for mucopolysaccharidosis (MPS) IIIB, a devastating fatal disease in children and the challenge in scale-up rAAV manufacturing. The goal is to develop an effective gene therapy product targeting the root cause of the disease for the treatment of MPS IIIB in patients.

PI_NAMEs: MCCARTY, DOUGLAS M (contact)

PROJECT_TERMS: Address;adeno-associated viral vector;alpha-n-acetylglucosaminidase;autosome;Biodistribution;Bystander Effect;cell bank;Cells;Certification;Cessation of life;Child;clinical application;Codon Nucleotides;commercialization;Complementary DNA;Defect;Development;Disease;Engineering;Enzymes;Gene Delivery;gene therapy;gene therapy clinical trial;Gene Transduction Agent;gene-targeted therapy;Glycosaminoglycans;Goals;Heparitin Sulfate;Human;in vitro testing;in vivo;Injections;Lysosomal Storage Diseases;manufacture;manufacturing scale-up;Mendelian disorder;Mission;Mucopolysaccharidoses;Mus;neurogenetics;Neurologic;Neurologic Symptoms;neurotropic;Organ;Patients;Phase;phase 1 study;Phase I/II Clinical Trial;Positioning Attribute;pre-Investigational New Drug meeting;premature;Procedures;Production;Protocols documentation;Qualifying;Recombinant adeno-associated virus (rAAV);Reproducibility;Safety;Satellite Viruses;scale up;Small Business Innovation Research Grant;success;Suspensions;Testing;Therapeutic;Toxicology;Translations;vector;virtual;Work

PROJECT_TITLE: Development of gene therapy product for treating MPS IIIB

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


NIH_SPENDING_CATS: Autoimmune Disease;Biotechnology;Clinical Research;Clinical Trials and Supportive Activities;Eye Disease and Disorders of Vision;Gene Therapy;Gene Therapy Clinical Trials;Genetics;Immunotherapy;Lupus;Myasthenia Gravis;Neurosciences;Orphan Drug;Rare Diseases

ORG_CITY: Gaithersburg

ORG_NAME: CARTESIAN THERAPEUTICS, INC.

PHR: PROJECT NARRATIVE Cell therapy is a new technology that involves collecting a patient’s own immune cells, engineering them to fight a specific disease, then re-injecting the cells to the patient. In a recent clinical trial, we tested a new RNA-based approach for cell therapy that helped patients with the autoimmune disease myasthenia gravis. In this proposal we will manufacture additional cells to support clinical trials and analyze clinical samples; these are key steps to establish this exciting technology as a new option to safely and effectively treat patients with autoimmune disease.

PI_NAMEs: JEWELL, CHRISTOPHER M (contact)

PROGRAM_OFFICER_NAME: GILCHRIST, FLOY ANNETTE

PROJECT_TERMS: Address;Advanced Malignant Neoplasm;Adverse event;Antigens;Autoantibodies;Autoimmune;Autoimmune Diseases;Autoimmunity;Autologous;Automobile Driving;B-Lymphocytes;Biological Markers;Blood specimen;CAR T cell therapy;CD8-Positive T-Lymphocytes;Cell Maturation;Cell Proliferation;Cell secretion;Cell Separation;Cell Therapy;Cells;chemotherapy;chimeric antigen receptor;chimeric antigen receptor T cells;Cholinergic Receptors;Chronic;Chronic Inflammatory Demyelinating Polyneuropathy;Clinical;clinical effect;Clinical Trials;combat;commercialization;Complement;Complement Inactivators;cost;cytokine;cytokine release syndrome;Data;design;Disease;DNA;DNA biosynthesis;Dose;engineered T cells;Engineering;Enrollment;experience;Exposure to;fighting;Frequencies;Funding;Gene Transfer;Genome;Goals;IL27RA gene;Immune;immune modulating agents;Immune system;Immunosuppressive Agents;improved;Inflammation;Inflammatory;Infusion procedures;Inpatients;Lambert-Eaton Myasthenic Syndrome;Life;Longterm Follow-up;Lupus;Malignant Neoplasms;manufacture;Measures;Messenger RNA;Monitor;Monoclonal Antibodies;Muscle Weakness;Myasthenia Gravis;Myopathy;National Institute of Neurological Disorders and Stroke;neonatal Fc receptor;Nervous System;Neurologic;Neurology;Neuromuscular Junction;Neuromyelitis Optica;new technology;novel strategies;Outcome;Outpatients;participant enrollment;Pathogenicity;patient biomarkers;Patient Monitoring;Patients;Pharmaceutical Preparations;Phase;Phase II Clinical Trials;phase II trial;phase III trial;Phenotype;Placebo Control;Placebos;Plasma Cells;Positioning Attribute;preconditioning;Process;Proliferating;randomized placebo controlled trial;receptor expression;Receptor Signaling;Regulatory T-Lymphocyte;Relapse;response;RNA;Safety;Sampling;Serum;Small Business Innovation Research Grant;standard of care;symptom treatment;T cell clonality;T-cell receptor repertoire;T-Lymphocyte;Technology;Testing;Therapeutic;Tissues;Toxic effect;Transfection;Work

PROJECT_TITLE: Manufacturing RNA-based CAR T cells to combat autoantibody-associated autoimmune disorders (AAAD)

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

ORG_CITY: DURHAM

ORG_NAME: METABOLON, INC.

PHR: NARRATIVE The goal of this project is to identify metabolite biomarker signatures that can be used either alone or in conjunction with traditional risk factors to predict the progression of type 1 diabetes with greater accuracy than traditional risk factors alone. These biomarkers will improve our ability to evaluate a patient’s response to novel therapies that are designed to stop pre-clinical T1D from progressing to clinical disease. In success, this project represents a first step towards advancing treatment options for persons with T1D and thereby improving patient outcomes.

PI_NAMEs: KENNEDY, ADAM DAVID (contact)

PROGRAM_OFFICER_NAME: ARREAZA-RUBIN, GUILLERMO

PROJECT_TERMS: Advanced Development;Agreement;alternative treatment;Autoimmune Diseases;Beta Cell;Biochemical;Biological;Biological Markers;Biology;biomarker identification;biomarker performance;biomarker signature;Classification;Clinical;Collaborations;Collection;Colorado;Data;Development;diabetes mellitus therapy;Disease;Disease Progression;Environment;Genome;glucose metabolism;Goals;Health Status;High Pressure Liquid Chromatography;Immune response;improved;Individual;insight;Insulin;Insulin-Dependent Diabetes Mellitus;islet cell antibody;Islets of Langerhans;Laboratories;lifestyle factors;Measures;medical schools;Metabolic;Metabolism;metabolomics;Monitor;novel;novel therapeutics;Outcome;outcome prediction;patient response;Patient-Focused Outcomes;Patients;Performance;Persons;Phase;Phenotype;Positioning Attribute;pre-clinical;Predictive Factor;predictive marker;prevent;progression marker;random forest;Reporting;Risk Factors;Sampling;screening;Serum;small molecule;Statistical Data Interpretation;success;T-Lymphocyte;tandem mass spectrometry;Techniques;Testing;Therapeutic;therapy design;Time;tool;treatment response;Universities;Validation;Variant

PROJECT_TITLE: A metabolomics-based laboratory developed test to better predict and monitor progression of type 1 diabetes


NIH_SPENDING_CATS: Autoimmune Disease;Bioengineering;Clinical Research;Kidney Disease;Rare Diseases

ORG_CITY: BIRMINGHAM

ORG_NAME: RELIANT GLYCOSCIENCES LLC

ORG_STATE: AL

PHR: Narrative The proposed research focuses on developing a proprietary biomarker assay to assist in the development of needed therapies for the treatment of a chronic kidney disease, IgA nephropathy. IgA nephropathy is the most prevalent form of glomerulonephritis in the world. This assay will provide nephrologists and patients with IgAN a needed tool for diagnosing and monitoring the disease.

PI_NAMEs: PLACZEK, WILLIAM J.;RENFROW, MATTHEW B;SZUL, TOMASZ  (contact)

PROGRAM_OFFICER_NAME: GOSSETT, DANIEL ROBERT

PROJECT_TERMS: Acetylgalactosamine;Address;Affect;Age;Alabama;Ancillary Study;Antigen-Antibody Complex;Asian population;Autoantibodies;Autoantibody binding;Autoantigens;Autoimmune Diseases;Automobile Driving;Awareness;Binding;biobank;Biological Assay;Biological Markers;Caucasians;Characteristics;Chronic Kidney Failure;CLIA certified;Clinical;Clinical Trials;cohort;Collaborations;Commercial grade;commercialization;cost;Data;Deposition;Detection;detection assay;Development;Devices;Diagnosis;Disease;disease diagnostic;Drug Industry;Enzyme-Linked Immunosorbent Assay;Evaluation;experience;field study;Funding;Galactose;Gender;Glomerular Filtration Rate;Glomerulonephritis;Goals;IGA Glomerulonephritis;IgA1;IgG autoantibodies;Injury to Kidney;Kidney;Kidney Diseases;Kidney Failure;Laboratories;Lead;Lectin;Life;Measurement;Measures;Modeling;Monitor;New York;observational cohort study;Outcome;outcome prediction;Pathogenesis;Pathologic;Patients;Performance;Persons;Pharmacologic Substance;Phase;pilot lot production;Polysaccharides;pre-clinical;Preparation;Printing;Procedures;Process;Production;prognostication;Proteinuria;prototype;Publications;Publishing;Quality Control;Reagent;Recording of previous events;Renal glomerular disease;Reporting;Reproducibility;Research;Sampling;Sensitivity and Specificity;Serum;Shipping;Site;Source;specific biomarkers;Temperature;Testing;Time;tool;treatment response;United States National Institutes of Health;Universities;Validation;validation studies;Work

PROJECT_TITLE: GalNAc-specific measurement of Galactose-deficient IgA1 as a Biomarker for IgA nephropathy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (11)]


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Aging;Clinical Research;Clinical Trials and Supportive Activities;Eye Disease and Disorders of Vision;Machine Learning and Artificial Intelligence;Macular Degeneration;Neurodegenerative;Neurosciences;Prevention;Primary Health Care

ORG_CITY: Richmond Hill

ORG_NAME: IHEALTHSCREEN, INC.

PHR: PROJECT NARRATIVE Age-related macular degeneration (AMD) is the leading cause of blindness in developed countries. Early intervention and therapy can significantly reduce the progression of early to late AMD. Hence, the identification of patients with early AMD and referral to an ophthalmologist is critically needed to help prevent vision loss. To achieve this goal, we have developed iPredict-AMD, an automated screening and prediction system which will be prospectively validated in the clinical settings through this project.

PI_NAMEs: BHUIYAN, ALAUDDIN  (contact);SMITH, ROLAND THEODORE

PROGRAM_OFFICER_NAME: LEE, PAEK-GYU

PROJECT_TERMS: Affect;age related;Age related macular degeneration;American;Artificial Intelligence;Award;bevacizumab;Blindness;cardiovascular risk factor;checkup examination;Chronic Care;Clinic;Clinical;Clinical Trials;Code;Color;commercialization;Computer software;cost;Counseling;Current Procedural Terminology Codes;Data;Data Set;Developed Countries;diabetes management;diabetic patient;Diagnosis;disease diagnosis;Dryness;Early Diagnosis;Early identification;Early Intervention;Early treatment;Evaluation;Eye;Eye diseases;follow-up;Fundus photography;Generations;Goals;Guidelines;Human;Image;Implant;improved;Incentives;Incidence;Individual;Injections;Intervention;Lasers;Lawyers;Lead;Legal patent;Marketing;medical schools;meetings;Methods;Minerals;Modeling;Monitor;NAT2 gene;neovascularization;Nonexudative age-related macular degeneration;Ophthalmologist;Ophthalmology;Optical Coherence Tomography;Outcome Study;Patients;Performance;Pharmaceutical Preparations;Phase;phase 2 study;photobiomodulation;prediction algorithm;predictive modeling;predictive tools;prevent;Prevention;Prevention strategy;Primary Care;primary care setting;prognostic;progression risk;prospective;Protocols documentation;recruit;Reporting;Retinal Degeneration;Retinal Diseases;Risk;Risk Factors;Risk Reduction;Sales;screening;Small Business Innovation Research Grant;software as a medical device;software as a service;Specificity;success;Supplementation;System;Treatment Cost;United States National Institutes of Health;Validation;Vision;Visit;Visual Acuity;Vitamins

PROJECT_TITLE: A Model for Predicting 2-Year Risk of Incident Late Age-related Macular Degeneration


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Eye Disease and Disorders of Vision;Networking and Information Technology R&D (NITRD);Neurosciences

ORG_CITY: CHARLOTTESVILLE

ORG_NAME: RETIVUE

ORG_STATE: VA

PHR: Project Narrative 300,000 patients undergo retina (back of the eye) surgery each year in the US to restore lost vision, but poor outcomes can result if the cornea and lens (front of the eye), thru which surgeon sees the retina becomes cloudy. The RetiVue EntireEyeScope will solve this issue, with the surgeon inserting two microscopic cameras into the sclera (white part) of the eye, bypassing this cloudy front of the eye, allowing them to directly observe the back of the eye thru these cameras. Advanced software will transform video from these cameras into a real-time, VR, heads-up, 3-D stereo view of the retina, appearing to the surgeon as if they are looking directly through a clear front of the eye, and thus increasing the likelihood of their being able to fully restore vision.

PI_NAMEs: DEHOEG, ED  (contact)

PROJECT_TERMS: 3-Dimensional;Address;Adopted;Adoption;Algorithm Design;Algorithms;Anterior;Back;Birds;Blindness;Blood Vessels;Bypass;Cannulas;Complex;Computer software;convolutional neural network;Cornea;cost;Coupled;Crystalline Lens;Custom;Data Set;Depth Perception;design;Devices;Diameter;Disorientation;Disparity;Dissociation;Endophthalmitis;Endoscopes;Endoscopy;Excision;Eye;Eye Injuries;Family suidae;Fiber;Fiber Optics;Generations;Goals;Hand;Housing;Image;image processing;imaging capabilities;improved;instrument;lens;Light;Lighting;Manuals;Maps;Measurement;Methodology;Microscope;Microscopic;Modeling;monocular;Movement;Noise;novel strategies;Operative Surgical Procedures;Optics;Outcome;Output;Pathology;Patient-Focused Outcomes;Patients;Pattern;Perception;Positioning Attribute;prevent;Procedures;proliferative diabetic retinopathy;prototype;Recovery;repaired;Resolution;Retina;Retinal Detachment;Retinal Diseases;retinal imaging;Rotation;Sclera;sensor;Side;sight restoration;Signal Transduction;stem;Stimulus;Stream;success;Surgeon;surgery outcome;synthetic data;System;Technology;Time;Tissues;Titanium;Training;transmission process;ultra high resolution;usability;Variant;Vision;Vision Disparity;Visualization;Vitreous Hemorrhage

PROJECT_TITLE: RetiVue EntireEyeScope: A high resolution, top-down view, stereo, endoscopic viewing system for vitreoretinal surgery

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


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease Related Dementias (ADRD);Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Biomedical Imaging;Brain Disorders;Cerebrovascular;Dementia;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Vascular Contributions to Cognitive Impairment and Dementia (VCID)

ORG_CITY: Scarsdale

ORG_NAME: NEUROSCOPE INC.

PHR: Project Narrative The proposed research is relevant to public health because identifying pathological alterations to the perivascular space as part of brain clearance system is expected to aid in Alzheimer’s disease diagnosis and disease monitoring. Traditionally, assessment of brain clearance in clinic was limited to visual counting of perivascular spaces on MRI, which is time consuming and subjective. The aim of this proposal is to build the commercial IT ecosystem that enables transition of NeuroScope automated perivascular space mapping technology to clinic.

PI_NAMEs: CHOUPAN, JEIRAN  (contact)

PROGRAM_OFFICER_NAME: LUO, YUAN

PROJECT_TERMS: Adopted;Aducanumab;Adverse event;Affect;Alzheimer's Disease;Alzheimer's disease diagnosis;Alzheimer's disease pathology;Alzheimer's disease patient;Alzheimer's disease related dementia;American;Amyloid;analytical tool;Back;Blood Vessels;Boston;Brain;brain pathway;California;Cerebral Amyloid Angiopathy;Cerebral hemisphere hemorrhage;cerebral microbleeds;Characteristics;Clinic;Clinical;Clinical Assessment Tool;Clinical assessments;Clinical Data;clinical diagnosis;clinical diagnostics;Clinical Markers;Clinical Trials;clinically relevant;cloud based;Cloud Computing;cloud platform;Collaborations;commercialization;comorbidity;Computational Technique;Computer software;Consumption;Data;Data Set;Database Management Systems;Detection;Development;Devices;Diagnosis;Diagnostic;diagnostic criteria;diagnostic tool;Diffusion;Disease;drug development;Economic Burden;Ecosystem;Environment;experience;Functional disorder;Goals;Guidelines;Health;Health Insurance Portability and Accountability Act;Hospitals;Hour;Human;Image;imaging biomarker;imaging study;Imaging technology;Impaired cognition;in vivo;Industry;informatics infrastructure;Infrastructure;Ingestion;interest;Intervention;Label;Legal patent;Lesion;Letters;Magnetic Resonance Imaging;Manuals;Maps;Marketing;Measurement;Measures;Medical Device;Medical Imaging;Metabolic;misfolded protein;Monitor;Monoclonal Antibodies;Morphology;Nervous System Disorder;Neurofibrillary Tangles;Neurologist;Neurology;Pathologic;Pathway interactions;Patient Monitoring;Patients;Performance;Pharmacologic Substance;Phase;Play;Predisposition;Prevalence;prevent;Public Health;Quality Control;quantitative imaging;Radiology Specialty;Research;research clinical testing;Role;Scanning;Secure;Senile Plaques;Services;Severities;Siderosis;Small Business Technology Transfer Research;socioeconomics;software as a medical device;Specificity;Structure;System;tau Proteins;Techniques;Technology;Testing;Time;tool;tool development;treatment strategy;United States National Aeronautics and Space Administration;Universities;Validation;Vascular Dementia;Visual;Visualization;wasting;White Matter Hyperintensity;Work

PROJECT_TITLE: Development of perivascular space mapping toolset as a diagnostic aid for Alzheimer's disease


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Emerging Infectious Diseases;Genetics;Infectious Diseases;Nanotechnology

ORG_CITY: SILVER SPRING

ORG_NAME: AUTONOMOUS THERAPEUTICS, INC.

PHR: PROJECT NARRATIVE From SARS-CoV-2 to influenza, there is an urgent need to develop new antivirals that can maintain pan-variant efficacy as new viral variants evolve. For some viruses, the problem is even more acute: no approved antivirals exist at all. This effort aims to use synthetic biology to engineer RNA into sensors that can immediately quantify the efficacy of panels of drug candidates against every variant of a virus—to enable the rapid discovery of pan- variant antivirals for any RNA virus.

PI_NAMEs: NOTTON, TIMOTHY ;WEINBERGER, ARIEL  (contact)

PROJECT_TERMS: 2019-nCoV;Acceleration;Acute;Animal Model;Anti-viral Agents;anti-viral efficacy;antiviral drug development;Binding;Biological Assay;Cell Line;cell type;Cells;cost;Data;Democracy;DNA-Directed RNA Polymerase;drug candidate;Drug Delivery Systems;Drug Targeting;Ebola;Encephalitis Viruses;encryption;Engineering;Ensure;Equine Encephalomyelitis;Equipment;Evaluation;Family;Frequencies;Goals;Government;Hepatitis B;high throughput screening;Hour;Human Metapneumovirus;immunogenicity;in vivo;in vivo Model;Incidence;Infection;Influenza;Influenza A virus;Influenza B Virus;Legal patent;Libraries;lipid nanoparticle;member;Messenger RNA;Methodology;Methods;Modeling;Modification;multiplex assay;Mutate;Mutation;Nipah;Noise;novel;Nucleosides;Organoids;Output;parainfluenza virus;Peptide Hydrolases;Persons;pharmacokinetics and pharmacodynamics;Phase;Plaque Assay;Play;pre-clinical;Preclinical Testing;Proteins;prototype;Rapid screening;Reader;Reading;Replicon;Reporter;Reporting;Resistance;RNA;RNA Viruses;screening;Sensitivity and Specificity;sensor;Signal Transduction;single molecule;Specificity;synthetic biology;synthetic nucleic acid;Technology;Testing;Therapeutic;Tissues;Transfection;Translating;Treatment Protocols;Validation;validation studies;Variant;Viral;Viral Load result;Viral Proteins;virtual;Virus;Virus Diseases;Virus Replication

PROJECT_TITLE: Synthetic RNA sensors to enable high-throughput, quantitative screens for broad-spectrum antivirals


NIH_SPENDING_CATS: Biotechnology;Complementary and Integrative Health;Diabetes;Eye Disease and Disorders of Vision;Immunization;Neurosciences

ORG_CITY: Houston

ORG_NAME: EVERGLADES BIOPHARMA, LLC

ORG_STATE: TX

PHR: Project Narrative Diabetic retinopathy, a leading cause of vision loss in working adults, is currently treated with anti-angiogenic drugs, all of which target the same angiogenic factor with limited efficacy. An unmet clinical need is to develop anti-angiogenic therapies against independent targets for alternative or combination treatment to improve efficacy. This project will develop a novel therapy against such an independent target that is capable of synergistically improving efficacy through alternative or combination therapy to treat diabetic retinopathy.

PI_NAMEs: LI, WEI ;TIAN, HONG  (contact)

PROJECT_TERMS: Accounting;Adult;Affect;Age;aged;Alternative Therapies;alternative treatment;angiogenesis;Angiogenesis Inhibitors;Angiogenic Factor;animal facility;Animals;antiangiogenesis therapy;Basement membrane;Binding;Biological Assay;Blindness;Blood Vessels;Clinical;clinical translation;Clinical Trials;Combined Modality Therapy;Data;diabetic;Diabetic mouse;Diabetic Retinopathy;Disease;Dose;Drug Formulations;Drug Kinetics;drug testing;Endothelium;Extravasation;Fab Immunoglobulins;Fibrosis;follow-up;Formulation;good laboratory practice;humanized antibody;improved;inhibitor;Investigational Drugs;Investigational New Drug Application;Lucentis;macular edema;member;Methods;Molecular;Monoclonal Antibodies;Mus;neovascular;Neurons;neutralizing monoclonal antibodies;New Drug Approvals;novel;novel therapeutics;old mice;Oryctolagus cuniculus;Pathogenesis;Pathologic;Pathologic Neovascularization;Patients;Persons;Pharmaceutical Preparations;Pharmacological Treatment;Pharmacotherapy;Play;Practice Guidelines;pre-clinical;pre-Investigational New Drug meeting;preclinical study;prevent;proliferative diabetic retinopathy;ranibizumab;Receptor Signaling;Reporting;Resistance;response;Retina;retina blood vessel structure;Retinal Neovascularization;Role;Safety;secretogranin III;side effect;Signal Pathway;Stress;Therapeutic;Toxicology;Treatment Efficacy;treatment optimization;Treatment outcome;Vascular Diseases;Vascular Endothelial Growth Factors;Vision;Visual Acuity

PROJECT_TITLE: Developing a novel therapy for diabetic retinopathy


NIH_SPENDING_CATS: Biomedical Imaging;Clinical Research;Clinical Trials and Supportive Activities;Kidney Disease;Physical Injury - Accidents and Adverse Effects

ORG_NAME: SONAVEX, INC.

PHR: PROJECT NARRATIVE There are 4.3M patients on dialysis worldwide with End Stage Renal Disease that require access to their circulation (cannulation) to enable blood filtration via hemodialysis 3 times per week to survive. The preferred method of access, an arteriovenous (AV) fistula, is notoriously challenging for dialysis technicians to cannulate, and cannulation errors lead to serious complications such as hematoma, infection, and aneurysm formation including death from hemorrhage. We seek to commercialize a system that will allow dialysis technicians to easily cannulate AV fistulae without prior training and avoid the morbid and costly complications associated with current cannulation challenges.

PI_NAMEs: COOPER, RANDY ;KANG, XIN  (contact)

PROJECT_TERMS: 3D ultrasound;Adoption;Algorithms;American;Aneurysm;Appointment;Area;Arteriovenous fistula;arteriovenous graft;Authorization documentation;automated algorithm;blind;Blood;blood filtration;Blood Vessels;Cannulations;Caring;Catheters;Central Venous Access Catheter;Cessation of life;Circulation;Clinic;Clinical;clinical examination;Clinical Research;Clinical Trials;commercialization;Complex;cost;Data;Death Rate;Dependence;Detection;Diagnostic;Diagnostic tests;Dialysis patients;Dialysis procedure;Diameter;Education;End stage renal failure;experience;Failure;Feedback;first-in-human;Fistula;Fright;health related quality of life;Hematoma;Hemodialysis;Hemorrhage;high risk;Hospitalization;Human;iatrogenic injury;image guided;improved;improved outcome;Infection;Infiltration;Injury;Intervention;intervention cost;Kidney;Kidney Failure;Lead;Location;Marketing;Medicare/Medicaid;Methods;Modality;Morbidity - disease rate;mortality;Navigation System;Needles;Nephrology;Nurses;Operative Surgical Procedures;Outcome;Pain;Patient-Focused Outcomes;Patients;Phase;Physicians;Pilot Projects;Procedures;Quality of life;Reporting;Risk;routine practice;satisfaction;skills;Source;standard of care;System;Testing;three-dimensional visualization;Thrombosis;Time;Training;Translating;Trauma;ultrasound;Venous;verification and validation;Visit;Visual;Work

PROJECT_TITLE: Clinical Trial to Demonstrate Impact of an AI-enabled 3D Ultrasound-based Guidance System in Reducing Arteriovenous Fistula Cannulation Injury and Improving Patient Quality of Life


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Data Science;Dementia;Health Services;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Patient Safety;Prevention;Telehealth

ORG_CITY: Charlotte

ORG_NAME: AMISSA, INC.

PHR: Narrative This SBIR Phase II project will develop the first openly shared Alzheimer's Disease and dementia research platform comprising of longitudinal, real-world, wearable sensor measurements to enable the discovery of digital biomarkers and validation of low-cost, modifiable behavioral interventions. This project will benefit society by improving passive and unobtrusive remote health measurements, collecting and sharing rich digital health datasets, and identifying potential digital biomarkers that correlate to disease detection, progression, and prevention.

PI_NAMEs: CORKEY, JON ANDREW (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Academia;Academic support;Advocate;Affect;Aging;Agreement;Algorithms;Alzheimer's Disease;Alzheimer's disease related dementia;analytical tool;Apple;Apple watch;Area;Artificial Intelligence;Award;Behavior;Behavior Therapy;care costs;Caregivers;caregiving;Caring;cloud based;Cohort Studies;Collaborations;Collection;Computer software;computerized data processing;Computerized Medical Record;cost;cost of dementia;Country;Data;data access;Data Collection;Data Compression;data exchange;data interoperability;Data Science;Data Security;Data Set;Databases;Decentralization;Decision Making;Dementia;design;Detection;Devices;Diagnosis;digital;Digital biomarker;digital health;Disease;Disease Progression;Drug Prescriptions;Electronic Health Record;empowerment;Enrollment;Facilities and Administrative Costs;Fast Healthcare Interoperability Resources;Future;Galaxy;General Hospitals;Health;health data;Health system;Healthcare;Heart Atrium;Hospitals;improved;Individual;Industry;Industry Standard;Ingestion;innovation;interoperability;Intervention Studies;large datasets;Length of Stay;Licensing;Life;life span;lifestyle intervention;Massachusetts;Measurement;Measures;Medical;Medical Care Costs;medical schools;meetings;Metadata;Methods;Monitor;Onset of illness;Patient Care;Patient Data Privacy;Patient Self-Report;Patients;Performance;Persons;Pharmacologic Substance;Phase;Physical Exercise;Physiological;Population;population health;Prevention;Production;Productivity;Protocols documentation;prototype;Provider;remote patient monitoring;repository;Research;research and development;Research Personnel;Research Support;resilience;Schedule;Scientist;Secure;sedentary lifestyle;sensor;sleep behavior;Small Business Innovation Research Grant;smart watch;socialization behavior;Societies;Specific qualifier value;Speed;success;Symptoms;System;Techniques;telehealth;Testing;Time;transmission process;United States;United States National Institutes of Health;Universities;Validation;Visit;volunteer;Wages;wearable device;wearable sensor technology;web portal;wireless fidelity;World Health

PROJECT_TITLE: Empowering Advanced Alzheimers Disease and Dementia Research Through Remote Patient Monitoring and Cloud-Connected Wearable Devices

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


ORG_CITY: BOSTON

ORG_NAME: AXONIS THERAPEUTICS, INC.

ORG_STATE: MA

PHR: Project Narrative: One-third of mesial temporal lobe epilepsy have spontaneous recurrent seizures that are often resistant to commonly used antiepileptic drugs. Loss of excitation/inhibition balance in neuronal circuits is a pathological hallmark of epilepsy, and KCC2 hypofunction occurs in epilepsy patients. We are developing a novel orally administered drug targeting KCC2 that acts to rebalance the neuron activity within the brain, without sedative side effects, in order to treat seizures, address drug-resistance, and improve quality of life of epilepsy patients.

PI_NAMEs: HEGARTY, SHANE ;KADAM, SHILPA DATTATRAY (contact)

PROJECT_TERMS: acquired epilepsy;Acute;Address;Animals;anti-epileptic agents;arm;Binding;Biological Assay;Biological Availability;Biological Markers;biomarker development;Brain;Canis familiaris;Chemosensitization;Chlorides;Chronic;Clinic;Data;Development;Dose;Drug Modelings;Drug resistance;Drug Targeting;Electroencephalography;Electrophysiology (science);Epilepsy;epileptiform;Equilibrium;Event;excitatory neuron;experimental study;FDA approved;Frequencies;gamma-Aminobutyric Acid;Genetic;Goals;hippocampal sclerosis;Hippocampus;Histologic;improved;In Vitro;in vivo;Intractable Epilepsy;Investigation;kainate;Kainic Acid;Lead;lead candidate;Measures;medial temporal lobe;Mediating;Membrane;Modeling;Monitor;mossy fiber;mouse model;Mus;Mutation;neuronal circuitry;Neurons;neurotransmission;novel;novel therapeutics;Oral;Oral Administration;Pain;Pathologic;Pathology;Patients;Pharmaceutical Preparations;pharmacodynamic biomarker;pharmacokinetics and pharmacodynamics;pharmacologic;Phase;Phase I Clinical Trials;Pilot Projects;Potassium;Predisposition;Property;Proteins;Quality of life;Recurrence;Refractory;Regimen;Reporting;Resistance;response;Rodent;Rodent Model;sedative;Seizures;side effect;Signal Transduction;Small Business Innovation Research Grant;small molecule;spasticity;Spinal cord injury;Structure-Activity Relationship;Surface;symporter;synaptic inhibition;Temporal Lobe Epilepsy;Testing;Time;Toxicology;treatment group;trial planning;United States National Institutes of Health;Viral;voltage;Work

PROJECT_TITLE: Development of Oral KCC2 Potentiator AXN-027 as a Novel Anti-Epileptic Drug for Mesial Temporal Lobe Epilepsy

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


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Bioengineering;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Electronic Nicotine Delivery Systems;Lung;Lung Cancer;Prevention;Substance Misuse;Tobacco;Tobacco Smoke and Health

ORG_CITY: DARIEN

ORG_NAME: PREDICTABLY HUMAN, INC.

PHR: PROJECT NARRATIVE Smoking kills roughly 480,000 people in the US each year, causes 13 cancers, heart disease and lung disease, but unfortunately, FDA approved smoking medications have a very low success rate of only 16-24%. Predictably Human has developed “NoMore,” designed to be an FDA-approved prescription-only digitally- controlled aerosolized nicotine replacement therapy, with no harmful toxins, and with roughly two times the efficacy of existing treatments. Approval of this STTR application will help Predictably Human advance development the of NoMore from our current stage (prototype development) though IND approval and into initial human trials, at which point investor funding will be available to support comparative efficacy trials and submission of an NDA.

PI_NAMEs: DAVIS, JAMES M (contact)

PROGRAM_OFFICER_NAME: ANGELONE, LEONARDO MARIA

PROJECT_TERMS: abuse liability;Address;Advanced Development;aerosolized;Aerosols;Agreement;Animals;arm;Award;Biochemical;Bupropion;cancer type;Cell Culture Techniques;Chemistry;Cigarette;clinical efficacy;Clinical Trials;Communication;Companions;comparative efficacy;comparison control;Computer software;cytotoxicity test;Data;design;Development;Devices;digital;Drug Kinetics;efficacy trial;Electronic cigarette;Engineering;Exposure to;FDA approved;Feasibility Studies;Funding;Gas Chromatography;Goals;Heart Diseases;Human;Inhalation Toxicology;Institution;Laboratories;Liquid substance;Lung Diseases;Malignant Neoplasms;Mass Spectrum Analysis;Minor;Modification;Morbidity - disease rate;Mutagenicity Tests;Nicotine;Nicotine Dependence;nicotine replacement;nicotine vapor;Nicotine Withdrawal;open label;operation;Participant;Pathologic;Patients;Persons;Pharmaceutical Preparations;Phase;Placebo Control;Placebos;Positioning Attribute;pre-Investigational New Drug meeting;Preparation;programs;prototype;Research;Risk;Ritual compulsion;Safety;Sampling;Sensory;Serious Adverse Event;Small Business Technology Transfer Research;Smoker;Smoking;smoking abstinence;smoking cessation;Smoking Cessation Intervention;stability testing;success;Surveys;Testing;Time;Toxicology;Toxin;treatment trial;varenicline;Vascular Diseases;vibration;Visit

PROJECT_TITLE: Assessment of a Digitally Controlled Aerosolized Nicotine Replacement Therapy


NIH_SPENDING_CATS: Autoimmune Disease;Biotechnology;Digestive Diseases;Inflammatory Bowel Disease;Patient Safety

ORG_CITY: WASHINGTON

ORG_NAME: VITAKEY, INC.

ORG_STATE: DC

PHR: Project Narrative This proposal involves the optimization of a targeted intestinal release platform for precision delivery of large biologics including proteins. Targeted intestinal delivery system for biologics as a whole class, are anticipated to broadly improve safety profiles, improve patient compliance for oral dosage forms rather than infusions or injections, reduce pharmaceutical waste, and even offer treatment of chronic diseases at their source. Development of an effective orally- administered local delivery system for gastrointestinal biologics would yield an estimated $4 billion dollars per year in savings over cumulative drug costs, lowered incidences of serious adverse events/hospital stays, and reduced pharmaceutical waste.

PI_NAMEs: ANSELMO, AARON C (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Acids;Address;Adrenal Cortex Hormones;Affect;Anti-Inflammatory Agents;Antisense Oligonucleotides;Beclomethasone;Bile fluid;bile salts;Biological;Biological Products;Biological Response Modifier Therapy;biological systems;Bladder;Budesonide;Chronic Disease;Colon;Colonic inflammation;cost;Crohn's disease;cytokine;Data;Development;dextran sulfate sodium induced colitis;Dietary Proteins;Disease remission;Dosage Forms;Dose;Drug Costs;Encapsulated;Environment;Enzymes;Epithelium;Evaluation;expectation;Exposure to;Eye;Formulation;gastrointestinal;gastrointestinal system;Gastrointestinal tract structure;Generations;Glucocorticoids;Goals;Government;Hour;Human;improved;in vitro Model;Incidence;Industry;infection risk;Inflammation;Inflammatory Bowel Diseases;Infusion procedures;Injections;intestinal epithelium;Intestines;Investigation;Knee;Large Intestine;Length of Stay;Life;Light;Local Therapy;Lubrication;Malignant Neoplasms;Modeling;Mus;next generation;Oral;Oral Administration;Outcome;Pathology;Pathway interactions;Patient Compliance;Patients;Performance;pericardial sac;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Phenotype;Physiological;premature;prevent;Process;Production;Proteins;Rattus;Recombinants;response;Route;Safety;Savings;Serious Adverse Event;side effect;Site;Small Intestines;small molecule;Source;stem;Stomach;Stress;symptom treatment;synergism;System;systemic toxicity;targeted delivery;Technology;technology platform;Testing;therapeutic protein;TNF gene;Treatment Cost;Treatment Efficacy;Ulcerative Colitis;wasting

PROJECT_TITLE: Platform technology for targeted delivery of proteins to the intestines

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


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Dementia;Disability Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Rehabilitation;Telehealth

ORG_CITY: Louisville

ORG_NAME: B A MAZE, INC.

ORG_STATE: KY

PHR: PROJECT NARRATIVE Individuals living with cognitive impairment (CI) and/or Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) often struggle to maintain independence, and existing technologies that aim to support in-home living can be difficult for this population to use. At-Home Health Station (AHS) systems by B A Maze Inc. provide a technology platform that organizes health monitoring tools, enables prompted health information, and has secure data for streamlined patient-caregiver care and communication. The AHS will be developed via implementation feedback from individuals living with CI/ADRD, ensuring the design is appropriate to the specific needs of this population.

PI_NAMEs: MAZUR, ROBERT  (contact)

PROJECT_TERMS: Activities of Daily Living;acute care;Administrator;Adult;Affect;Age;Age of Onset;aged;aging population;aging process;Alzheimer's Disease;Alzheimer's disease related dementia;Awareness;Black race;care systems;Caregivers;Caring;Cognitive;cognitive ability;cognitive testing;commercial application;commercialization;Communication;Communication Tools;Computerized Medical Record;cost;COVID-19 pandemic;Data;Decision Making;Dementia;design;Development;Devices;Diagnosis;digital;disability;Disparity population;empowerment;end of life;Ensure;Evaluation;experience;Face;Feedback;Financial Hardship;Frontotemporal Dementia;Goals;Health;health care service;health organization;Health Promotion;Home;Home Care Services;Home visitation;human centered design;human old age (65+);Impaired cognition;improved;improved outcome;Incentives;Incidence;Independent Living;Individual;innovation;instrumental activity of daily living;Internet;Interview;Judgment;Learning;lifetime risk;Machine Learning;Measurement;Measures;Medicare;men;Methods;Monitor;multiple chronic conditions;older adult;Onset of illness;operation;Outcome;Participant;Patient Care;Patients;Persons;Phase;Play;Population;population health;Prevalence;Process;programs;Psychological Stress;Publishing;Quality of life;remote patient monitoring;Research;Secure;Security;smart device;social;Software Design;Software Engineering;Structure;System;Technology;technology platform;telecare;telehealth;Testing;Time;tool;United States National Aeronautics and Space Administration;Universities;usability;Vascular Dementia;Woman;Workload;young adult

PROJECT_TITLE: Connection, Independence, and Circular Support: Prompted Health Awareness Enabled by the At-Home Health Station


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Colorectal Cancer;Digestive Diseases;Pain Research;Patient Safety;Prevention

ORG_CITY: BROOKLYN

ORG_NAME: ERGAMI ENDOSCOPY, INC.

PHR: There are over 16 million colonoscopies each year in the US, however, looping during scope insertion causes significant challenges in colonoscopy including mucosal stretching and patient pain, endoscopy related injuries in endoscopists and nurses, and prolonged insertion time. We are developing a low cost robotic automated colonoscope insertion solution that reduces patient pain and the need for sedation; prevents endoscopy- related injuries in endoscopists and nurses; and enables faster insertion. Substantial productivity improvements, resulting from faster insertion time and improved recovery room efficiency due to sedation reduction, can help reduce backlog for this important cancer-screening procedure.

PI_NAMEs: DEO, HRISHIKESH  (contact)

PROGRAM_OFFICER_NAME: EVANS, GREGORY

PROJECT_TERMS: Administrator;Adoption;Age;Algorithms;Anatomy;Biomechanics;blind;Cancer Etiology;Cessation of life;clinically relevant;Colon;colon cancer treatment;Colon Carcinoma;Colonoscopes;Colonoscopy;commercial application;cost;Data;demographics;design;Devices;Diagnosis;Distal;Electromagnetics;Endoscopes;Endoscopy;Ensure;Family suidae;Feedback;Female;flexibility;Gastroenterologist;Growth;High Prevalence;improved;Injury;injury prevention;innovation;Insufflation;Intellectual Property;Legal patent;light weight;Location;Malignant Neoplasms;manufacture;Marketing;Methods;Modeling;mortality;Mucous Membrane;novel;Nurses;operation;Operative Surgical Procedures;Outcome;Outpatients;Pain;Patient risk;Patients;Phase;Physicians;Preparation;prevent;procedure cost;Procedures;product development;Productivity;Radial;Recovery;Recovery Room;Risk;Robotics;sample fixation;screening;Screening for cancer;Screening procedure;seal;Sedation procedure;Silicones;skills;Stretching;success;System;Testing;Time;Tissue Model;Tube;verification and validation;visual feedback;willingness;willingness to pay;Woman

PROJECT_TITLE: Automated rapid colonoscope insertion device to reduce physician injury and improve productivity


NIH_SPENDING_CATS: Assistive Technology;Behavioral and Social Science;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Kidney Disease

ORG_CITY: BEVERLY HILLS

ORG_NAME: WEARABLE ARTIFICIAL ORGANS, INC.

PHR: The Wearable Artificial Kidney WAK3 will provide dialysis treatment that is vastly superior to the currently available options, thereby reducing morbidity, mortality, medication consumption, and costs. This 2 lb. wearable dialysis machine, together with its stationary bedside unit, will provide continuous blood filtration like healthy, native kidneys, maintaining electrolyte and acid-base homeostasis and euvolemia. This will free ESKD patients from long dialysis sessions, to live more productive lives than ever before, working, going to school, and attending to ordinary life activities.

PI_NAMEs: GURA, VICTOR  (contact)

PROJECT_TERMS: Acids;Age;Animals;Area;Artificial Kidney;Artificial Organs;base;battery recharging;Biological;Blood;blood filtration;Blood specimen;Boston;Budgets;Businesses;California;Catheters;Charcoal;Clinic;Clinical;Clinical Research;Clinical Trials;Communication Methods;Consumption;cost;cost effective treatment;Data;Death Rate;Devices;Dialysis patients;Dialysis procedure;Electrocardiogram;Electrolytes;End stage renal failure;Enrollment;Ethnic Origin;Excision;experience;Experimental Designs;Failure;Family;Filtration;follow-up;Free Will;Hemodialysis;Home;Home visitation;Homeostasis;Hospitals;Hour;Human;improved;Individual;Informed Consent;innovation;Institutional Review Boards;Intervention;Intervention Studies;Journals;Kidney;Kidney Transplantation;Life;Marketing;Measurement;Medical;Medicare;Methods;miniaturize;Minority;Modeling;Monitor;Morbidity - disease rate;mortality;Nephrology;Nursing Staff;Outcome;Patient Preferences;Patients;Peer Review;Pharmaceutical Preparations;Phase;Phosphorus;Physical Examination;Physicians;posters;Procedures;Productivity;prospective;Protocols documentation;prototype;Publications;Pump;Quality of life;Questionnaires;Recording of previous events;recruit;Renal Replacement Therapy;Reporting;Research;Research Personnel;Rest;Safety;Salts;Schedule;Schools;Series;sex;side effect;Social Interaction;social media;Supervision;symposium;System;Telemetry;Testing;Toxin;Training;Universities;Urea;Uremia;Water;wearable device;Woman

PROJECT_TITLE: Dialyzing at home with a new model of the Wearable Artificial Kidney


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

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

ORG_CITY: SCITUATE

ORG_NAME: BIOMEMBRETICS, INC.

PHR: PROJECT NARRATIVE The goal of this STTR project is to develop and demonstrate a manufacturable technology for producing microfluidic oxygenators for commercial applications in the treatment of acute and chronic respiratory failure, one of the most significant health care challenges in the world. This project leverages three-dimensional branching channels that mimic the physiology of the natural vasculature, a technology that has been shown in research prototypes to have superior efficacy to conventional artificial lung devices. The development and implementation of the manufacturing technology, using high precision injection molding, will enable cost- effective and large-scale production to address this urgent medical need and rapidly growing market.

PI_NAMEs: ASTOR, TODD ;BORENSTEIN, JEFFREY T. (contact)

PROGRAM_OFFICER_NAME: SHENOY, SIDDHARTH KAUP

PROJECT_TERMS: 3-Dimensional;Acceleration;Acute;Acute Lung Injury;Acute Respiratory Distress Syndrome;Address;Adult;Alternative Therapies;Animal Model;Animals;artificial lung;Biochemical;Biomimetics;Blood;Blood flow;Carbon Dioxide;Childhood;Chronic;Chronic lung disease;Chronic Obstructive Pulmonary Disease;Clinical;clinical translation;combat injury;commercial application;commercialization;Communicable Diseases;Complex;Complication;Computer Models;cost;cost effective;COVID-19;Critical Illness;Data;Death Rate;design;Development;Devices;Drops;efficacy study;Extracorporeal Membrane Oxygenation;fabrication;Family suidae;Fiber;first-in-human;Future;Gases;Goals;Hand;Healthcare;Healthcare Systems;Heart Diseases;hemocompatibility;Hemorrhage;high volume manufacturing;Hour;Housing;Human Resources;In Vitro;Injections;injured;Injury;innovation;interest;Intubation;Laboratories;large scale production;Liquid substance;Lung;Lung Diseases;Lung infections;lung injury;Malignant Neoplasms;manufacturability;manufacturing process;manufacturing technology;Marketing;Mechanical ventilation;Mechanics;Medical;Membrane Oxygenators;Methods;microbial;Microcirculation;microfluidic technology;Microfluidics;Modeling;Molds;Morbidity - disease rate;mortality;new technology;Oxygen;Oxygenators;pandemic disease;patient population;Patients;Performance;Phase;Physiological;Physiology;Polymers;porcine model;pre-clinical;Preclinical Testing;pressure;Procedures;Process;programs;Property;prototype;Qualifying;Research;respiratory;Respiratory Disease;Respiratory Failure;response;Rest;Risk;Safety;safety study;scale up;Sedation procedure;Small Business Technology Transfer Research;Specific qualifier value;standard care;System;Technology;Testing;thrombotic;Thrombus;Translations;Trauma;Tube;United States;Validation

PROJECT_TITLE: Manufacturable Biomimetic Microfluidic Oxygenator for Safer, Simpler Treatment of Respiratory Failure

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


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Biotechnology;Contraception/Reproduction;Gene Therapy;Genetics;Mucopolysaccharidoses (MPS);Orphan Drug;Rare Diseases;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Non-Human;Transplantation

ORG_CITY: SAN FRANCISCO

ORG_NAME: MANDALMED, INC.

PHR: PROJECT NARRATIVE Approximately 1/250,000 people in the US are estimated to be afflicted with Morquio A or mucopolysaccharidosis type IVA (MPS IVA), a rare inherited disease that is caused by faulty genetic coding for the lysosomal enzyme N-acetylgalactosamine-6-sulfate sulfatase (GALNS) and is characterized by excessive accumulation of glycosaminoglycans (GAGs) in bodily tissues, which causes severe skeletal dysplasia, extremely stunted growth, and reduced life expectancy. The current treatments other than surgical intervention are enzyme replacement therapy (ERT) and hematopoietic stem cell transplantation (HSCT), both of which are not curative and have other significant drawbacks. This project is focused on development of a curative approach using an allogeneic human cell-based GT that is expected to be safe, relatively convenient, and much more effective than current treatments because of continuous delivery of high levels of GALNS to the body, especially to the bony and cartilaginous tissues.

PI_NAMEs: JOHN, CONSTANCE M;MOUNZIH, KHALID  (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Acetylgalactosamine;Address;Adult;adult stem cell;Adverse effects;Affect;age group;Allogenic;Animal Model;Animal Testing;Animals;Articular Range of Motion;Autologous;autosome;Blood;bone;Brain;cancer risk;Cartilage;cartilaginous;Caspase;cell bank;Cell Separation;Cells;cellular engineering;cellular transduction;Characteristics;chemotherapy;Child;Chondroitin Sulfate C;Circulation;Clinical;Clinical Data;Clinical Trials;Congenital musculoskeletal anomalies;curative treatments;Cytomegalovirus;design;Development;Developmental Bone Diseases;Disadvantaged;Disease;Dose;efficacy study;efficacy testing;Encapsulated;Engineering;Enhancers;enzyme deficiency;enzyme replacement therapy;Enzymes;experimental study;Eye;FDA approved;Future;Gangliosidosis GM1;Gene Modified;Gene Silencing;gene therapy;Gene Transduction Agent;Genetic;Genetic Code;genetic testing;genetically modified cells;Genome;Glycosaminoglycan Degradation Pathway;Glycosaminoglycans;Goals;Growth;Half-Life;Hematopoietic Stem Cell Transplantation;Hematopoietic stem cells;Hereditary Disease;Hip region structure;Hour;Human;Human Genetics;human stem cells;Hybrids;Immediate-Early Genes;Immune;Immunosuppression;Implant;improved;In Vitro;Individual;innovation;Intelligence;Intravenous infusion procedures;Investigational Drugs;Joint Laxity;Joints;Keratan Sulfate;L-Iduronidase;Lentivirus Vector;Life Expectancy;Lung;Lysosomal Storage Diseases;Mediating;Mesenchymal Stem Cells;Modification;mouse model;Mucopolysaccharidoses;Mucopolysaccharidosis I;Mus;Mutation;novel;novel therapeutics;Obstruction;odontoid process;Omentum;Operative Surgical Procedures;Organ;Orthopedic Surgery;Outcome;Pathology;patient population;Patient-Focused Outcomes;Patients;Peritoneal;Persons;Pharmaceutical Preparations;Phase;Phenotype;Physiological;Population;preclinical efficacy;Pregnant Uterus;Preparation;Prevalence;prevent;Price;Procedures;product development;promoter;Quality of life;Recombinants;Recommendation;reconstruction;Regimen;Safety;sertoli cell;skeletal;skeletal abnormality;skeletal dysplasia;skeletal tissue;spine bone structure;stem cell therapy;subcutaneous;suicide gene;Sulfatases;Sulfate;System;Testing;Testis;Therapeutic;therapeutic evaluation;Tissues;Toxicology;Trachea;Transgenes;Treatment Efficacy;Tumorigenicity;Variant;vector;Wheelchairs

PROJECT_TITLE: Cell-based Gene Therapy for MPS IVA


ORG_CITY: SAN DIEGO

ORG_NAME: MAXWELL BIOMEDICAL INC

PHR: NARRATIVE Current technologies and techniques are unable to reliably reduce AF event rates in a growing number of patients. The objective of this proposal is to validate the efficacy and initiate formal development of a novel multi- site pacing system that recognizes, and imperceptibly pace terminates AF.

PI_NAMEs: BEATTY, GRAYDON ERNEST (contact);COPPOLA, BENJAMIN ;WERNETH, RANDY

PROGRAM_OFFICER_NAME: BALIJEPALLI, RAVI C

PROJECT_TERMS: Ablation;Acute;Address;Adopted;Adult;Affect;Algorithms;Anesthesia procedures;Animal Model;Anti-Arrhythmia Agents;arm;Arrhythmia;Atrial Fibrillation;Cadaver;Cardiac;Cardiac ablation;Cardiac Output;cardiac pacing;Cardiac Surgery procedures;Cardiomyopathies;Cardiovascular system;Caring;Catheters;Cessation of life;Chronic;Cicatrix;Clinical;Clinical Research;common treatment;Complex;Computer Models;cost;Defibrillators;design;Development;Devices;Disease;dynamic system;Economic Burden;Economics;effective therapy;Effectiveness;efficacy evaluation;efficacy validation;Electric Countershock;Electrodes;Electronics;Epicardium;Epidemic;Event;Family suidae;Feedback;first-in-human;functional status;hazard;Healthcare Systems;Heart Atrium;Heart failure;heart rhythm;high risk;Hospitalization;human study;Impaired cognition;Implant;in vivo;Infection;Inferior;Lead;Left;Left atrial structure;Legal patent;Location;Methods;Morbidity - disease rate;mortality;National Heart, Lung, and Blood Institute;novel;Pain;Pain Threshold;Pathology;Pathway interactions;patient population;Patients;Pattern;Performance;Persons;Pharmaceutical Preparations;pharmacologic;phase 2 study;Physiologic pulse;Physiology;Play;porcine model;Positioning Attribute;Power Sources;pressure;Prevalence;Quality of life;Records;Refractory;Reporting;Reproducibility;response;Risk;Role;Running;Safety;safety assessment;Sedation procedure;Shock;Shoulder;Signal Transduction;simulation;Site;spatiotemporal;standard of care;stroke incidence;stroke risk;subcutaneous;success;Survival Rate;System;Systems Theory;Technology;technology/technique;Testing;timeline;Tissues;treatment strategy;trend;United States National Institutes of Health;Update;usability;voltage

PROJECT_TITLE: Spatial Resynchronization Therapy for AFib

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


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

ORG_CITY: MEMPHIS

ORG_NAME: TAVO BIOTHERAPEUTICS, INC

ORG_STATE: TN

PHR: Glaucoma is the leading cause of irreversible blindness in the world and is projected to affect ~6.3 million Americans by 2050, despite available treatments. At OculoTherapy, we will address the major limitations of current medications by advancing the development of a sustained-release, non-irritative formulation with a novel mechanism of action that coordinates multiple targets to normalize IOP. This treatment strategy will reduce the burden to glaucoma patients, increase compliance, and lead to better visual outcomes.

PI_NAMEs: JOHNSON, DIANNA AMMONS (contact)

PROJECT_TERMS: Address;Adult;Advanced Development;Affect;Agreement;American;Award;Blindness;Collaborations;Contracts;cost;Data;Development;Disease;Dosage Forms;Dose;drug development;Effectiveness;Engineering;Eyedrops;FDA approved;Feedback;first-in-human;Formulation;Future;Glaucoma;Good Manufacturing Process;Health Sciences;Home;Hyperemia;Incidence;Iris;Legal Blindness;Legal patent;legally blind;Link;manufacture;manufacturing organization;Marketing;modifiable risk;new therapeutic target;novel;novel therapeutics;Outcome;Pain;Pathway interactions;Patient Compliance;Patients;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Phase II Clinical Trials;Physiologic Intraocular Pressure;Pigmentation physiologic function;Play;pre-clinical;pre-Investigational New Drug meeting;preclinical development;pregabalin;Preparation;prevent;Production;Property;Protocols documentation;R24;Regulatory Pathway;Reporting;Research Contracts;Risk Factors;Role;Safety;Services;Side;side effect;Small Business Innovation Research Grant;standard of care;System;Tennessee;Therapeutic;Therapeutic Agents;Time;Topical application;Toxic effect;Toxicology;treatment strategy;trend;United States;United States National Institutes of Health;Universities;Visual;Visual Fields

PROJECT_TITLE: Late-stage Pre-clinical Development and GMP Production of a First-in-Class Extended Release IOP-lowering Formulation


NIH_SPENDING_CATS: Cancer;Cancer Genomics;Genetics;Human Genome;Immunotherapy;Lung;Lung Cancer;Precision Medicine

ORG_CITY: Phoenix

ORG_NAME: BINARY GENOMICS, INC.

ORG_STATE: AZ

PHR: PROJECT NARRATIVE: Some lung cancer patients have robust and durable tumor responses to immunotherapy, whereas others derive no benefit from such treatment. A blood test that monitors for changes in the amount of tumor DNA in the circulation could help to distinguish responders from non-responders, thereby improving clinical outcomes in such patients.

PI_NAMEs: BARRETT, MICHAEL T (contact);PATEL, ABHIJIT

PROGRAM_OFFICER_NAME: BOZZA, WILLIAM PATRICK

PROJECT_TERMS: Address;Biological Assay;Biological Markers;Blood;Blood Tests;Cancer Detection;cancer genome;cancer immunotherapy;Cancer Patient;cancer type;Carcinogenesis Mechanism;cell free DNA;checkpoint therapy;chemotherapy;Circulation;Clinical;clinical practice;clinical predictors;Clinical Sensitivity;Clinical Trials;commercial application;commercialization;Complex;Data;density;Detection;detection assay;detection limit;disorder control;DNA;DNA Probes;effective therapy;Epigenetic Process;exome sequencing;Fingerprint;Foundations;Gene Expression;Gene Silencing;Genome;Genomic Segment;Genomics;Hypermethylation;Immune;immune cell infiltrate;Immune checkpoint inhibitor;Immunotherapeutic agent;Immunotherapy;improved;ineffective therapies;Kinetics;Laboratories;liquid biopsy;Malignant neoplasm of lung;Malignant Neoplasms;Marketing;Measurement;Measures;Methods;Methylation;Monitor;mutant;Mutation;Non-Small-Cell Lung Carcinoma;Outcome;Paper;patient subsets;Patients;Pattern;Performance;Phase;Plasma;Prediction of Response to Therapy;Process;promoter;Protocols documentation;Publishing;radiological imaging;repository;Reproducibility;Research;research clinical testing;responders and non-responders;response;Sampling;Scanning;serial imaging;side effect;Signal Transduction;Somatic Mutation;Specific qualifier value;Specificity;success;Surveys;survival outcome;Technology;Testing;Therapeutic;Time;Treatment Efficacy;tumor;tumor DNA;Tumor Tissue;Universities;validation studies;virtual;Work

PROJECT_TITLE: Monitoring Immunotherapy Response via Gene Silencing Landscapes in Cell-Free DNA


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Eye Disease and Disorders of Vision

ORG_CITY: LANCASTER

ORG_NAME: LYNTHERA CORPORATION

ORG_STATE: PA

PHR: PROJECT NARRATIVE Among the estimated 165 million worldwide contact lens wearers, approximately one third of these suffer from allergies but face a challenge as the application of eye drops is generally incompatible with lens wearing. We propose to develop a next generation, 1-day drug delivery contact lens (DDCL) for olopatadine using boundary charge modifiers to extend and control drug release –the work will build on the Lynthera project team's previous accomplishments in the field – enabling the use of the most efficacious allergy drug and the most popular contact lens material (silicone hydrogel). A daily disposable DDCL with prescription and loaded with olopatadine can sustainably deliver high-precision dosage for at least 12 hours to relieve allergy symptoms.

PI_NAMEs: YANG, ARTHUR  (contact)

PROGRAM_OFFICER_NAME: GOVER, TONY DOUGLAS

PROJECT_TERMS: Address;Adherence;Affect;Agreement;Air Pollution;Allergens;Allergic Conjunctivitis;American;animal dander;Anions;Anti-Allergic Agents;Antihistamines;aqueous;Area;Award;Biological Availability;Blurred vision;bulbar conjunctiva;carbon emissions;Cations;Charge;Chemistry;Clinical;Clinical Research;clinical trial protocol;Clinical Trials;commercialization;conjunctiva;Contact Lenses;Corneal Opacity;Corneal Ulcer;Cyclic GMP;Data;density;design;Development;dosage;Drops;Drug Controls;Drug Delivery Systems;drug development;Drug Hypersensitivity;Drug Kinetics;Dryness;Electrostatics;environmental change;experience;Exposure to;Eye;Eyedrops;Face;Fatty Acids;Frustration;Grant;Histamine Agents;Hour;Hydrogels;Hydrophilic Contact Lenses;Hypersensitivity;Immune response;Implant;improved;In Vitro;in vivo;Inflammatory;Investigational Drugs;Investigational New Drug Application;Ionic Strengths;irritation;Label;Legal patent;lens;Licensing;Life;long chain fatty acid;manufacture;Manufactured Supplies;manufacturing process;Marketing;Modeling;Modification;Morphology;nano;Nature;New Zealand;next generation;ophthalmic drug;Optics;Oryctolagus cuniculus;Oxygen;Pamphlets;Patients;Pharmaceutical Preparations;Phase;Physiological;Pollen;Polymers;pre-clinical;pre-Investigational New Drug meeting;preclinical development;Preclinical Drug Development;Prevalence;Property;prototype;Publications;Quality Control;Recommendation;Recording of previous events;Redness;reduce symptoms;Research Personnel;Resolution;Role;Safety;Scheme;Seasons;side effect;Signs and Symptoms;Silicones;Source;Stimulus;Sting Injury;success;Surface;symptom management;Symptoms;Taiwan;Technology;technology platform;Time;Toxic effect;Toxicology;Translating;transmission process;United States National Institutes of Health;uptake;Water;Work

PROJECT_TITLE: Drug delivery platform for ocular allergy therapy


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Depression;Machine Learning and Artificial Intelligence;Mental Health;Microbiome;Networking and Information Technology R&D (NITRD);Nutrition;Pediatric

ORG_CITY: MINNEAPOLIS

ORG_NAME: SMART INFORMATION FLOW TECHNOLOGIES

ORG_STATE: MN

PHR: PROJECT NARRATIVE Teaching students about the microbiome and its relevance to their everyday lives can increase their interest in biomedical science and related careers while giving them the quantitative and computational problem-solving skills essential for success in such careers. Thus, Gut Grieff has the potential to increase the size and diversity of the biomedical science workforce to meet the increasingly prominent role the microbiome will have in biomedical science applications for healthcare. For those who do not choose to pursue biomedical careers, Gut Grieff will still increase people's microbiome science literacy so that they are informed and understand the role it plays in their and others' general health.

PI_NAMEs: AARON, ERIC ;WAUCK, HELEN  (contact)

PROGRAM_OFFICER_NAME: FAUPEL-BADGER, JESSICA

PROJECT_TERMS: Achievement;adaptive intervention;Adopted;Advocacy;Affect;Antibiotic Resistance;Antibiotics;Artificial Intelligence;Attention;Autoimmune Diseases;Bacteria;Biology;Biomedical Research;Cardiovascular Diseases;career;Career Choice;Caring;Collaborations;college;Computers;Control Groups;cost;design;Diet;dietary;digital;Disease;Disease Resistance;dysbiosis;Eating;Education;Educational process of instructing;Elements;empowerment;Environment;Environment Design;Evaluation Studies;experience;experimental study;Expert Systems;Exposure to;Feedback;follow-up;Food;Funding;Future;General Population;Genomics;Goals;Grief reaction;gut microbiome;Health;health application;Healthcare;high school;High School Student;Human;Human Microbiome;improved;Incidence;Individual;infancy;instructor;interest;Intervention;Interview;Judgment;K-12 student;Knowledge;Learning;learning outcome;Life;Link;literacy;Malignant Neoplasms;Measures;Mechanics;Metabolic;Microbe;microbiome;microbiome composition;microbiome research;microbiome therapeutics;Minor;Monitor;Musculoskeletal Diseases;Next Generation Science Standards;Online Systems;outreach;pedagogy;Performance;personalized learning;Persons;Phase;Play;Population;Problem Solving;programs;prototype;Public Health;recruit;Research;Research Project Grants;Rewards;Role;Running;Science;science education;skills;Small Business Innovation Research Grant;Structure;student participation;Students;success;Surveys;teacher;Testing;tool;Underrepresented Students;usability;Work

PROJECT_TITLE: Gut Grief! Developing an educational game to teach high schoolers about the gut microbiome

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MCST-M (56)]


ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

NIH_SPENDING_CATS: Cancer;Clinical Research;Genetics;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Neurosciences;Orphan Drug;Racial and Ethnic Minority Health Research;Rare Diseases;Social Determinants of Health

ORG_CITY: SAN ANTONIO

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER

PHR: Narrative - (Original from parent grant proposal) To address “PQ9: What methods can be developed to effectively study small or rare populations relevant to cancer research” we will develop organoids of rare neuroendocrine tumors pheochromocytomas and paragangliomas (PPGL). Currently there are no markers of clinical behavior and malignant PPGLs can only be recognized after metastases develop, for which there are few treatment options. PPGL organoids will enable investigation of tumor markers of outcome and drug screen to identify potential new therapies.

PI_NAMEs: DAHIA, PATRICIA LEAL (contact);SORAGNI, ALICE

PROGRAM_OFFICER_NAME: LI, JERRY

PROJECT_TERMS: Address;Admixture;African American;Alleles;anti-cancer research;Applications Grants;Asian;Award;Behavior;Biochemical;Biological;Biological Models;Biology;Cancer Center;cancer health disparity;Cancer Patient;cancer risk;Catchment Area;Clinical;clinical care;Clinical Research;Clinical Trials;clinically actionable;cohort;comparative;Data;design;Diagnosis;Disease;Disparity;Doctor of Philosophy;Drug Screening;economic indicator;effective therapy;ethnic diversity;ethnic minority;ethnic minority population;Ethnic Origin;Experimental Models;Future;Genetic;genetic selection;genomic profiles;Goals;Health;Hispanic;improved;in vivo;Individual;innovation;insight;Investigation;Latino;Low income;Malignant Paraganglionic Neoplasm;Malignant Pheochromocytoma;Metastatic Pheochromocytoma;Methods;minority patient;Modeling;Mutation;Native Americans;NCI-Designated Cancer Center;Neoplasm Metastasis;neuroendocrine cancer;Neuroendocrine Tumors;Not Hispanic or Latino;novel;novel therapeutics;Organoids;Outcome;Paraganglioma;parent grant;parent project;Patient Care;patient population;Patient Recruitments;Patients;Pediatric Oncologist;Pharmaceutical Preparations;Pheochromocytoma;Population;Population Sciences;predictive modeling;Prevalence;programs;Property;Protocols documentation;racial minority;rare cancer;recruit;Reporting;Research;response;Selection for Treatments;social health determinants;socioeconomic disadvantage;socioeconomics;South Texas;Standardization;Survival Rate;Toxic effect;treatment response;tumor;tumor behavior;Tumor Markers;Underrepresented Populations;Work

PROJECT_TITLE: Evaluating the impact of genetic ancestry on the biology and drug response profile of pheochromocytoma and paraganglioma-derived organoid models


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Radiation Oncology

ORG_CITY: MADISON

ORG_NAME: VOXIMETRY, INC.

ORG_STATE: WI

PHR: PROJECT NARRATIVE Although single photon emission tomography (SPECT) can potentially be used to tailor radiopharmaceutical therapy (RPT) prescriptions for each patient, conventional reconstruction methods lack the required quantitative accuracy and signal-to-noise (SNR) ratio to be clinically adopted for this purpose. Torch Recon, however, will fuse GPU-accelerated Monte Carlo simulation and artificial intelligence to improve accuracy and SNR, possibly reducing the amount of time to acquire a quantitatively accurate SPECT scan, making tailored RPT prescriptions clinically routine.

PI_NAMEs: GRUDZINSKI, JOSEPH  (contact)

PROGRAM_OFFICER_NAME: FRANCA-KOH, JONATHAN C

PROJECT_TERMS: absorption;Acceleration;Address;Adopted;Algorithms;Artificial Intelligence;Benchmarking;Biodistribution;Bone Marrow;cancer therapy;Characteristics;chemotherapy;Clinic;Clinical;clinical practice;Clinical Trials;clinically significant;commercialization;Computer software;Contracts;cost effective;Data;deep learning;deep learning algorithm;denoising;Deposition;digital;Dose;dosimetry;Effectiveness;Evaluation;experience;External Beam Radiation Therapy;Gamma Rays;Grant;Healthcare Systems;Image;Image Enhancement;image registration;improved;individual patient;individualized medicine;innovation;Institutional Review Boards;Intellectual Property;Isotopes;large datasets;Lead;Learning;Lymphoma;Metastatic Prostate Cancer;Methods;Modeling;Monte Carlo Method;Morphologic artifacts;Neuroendocrine Tumors;Noise;Normal tissue morphology;novel;Patient imaging;Patient-Focused Outcomes;Patients;Pattern;Performance;Pharmaceutical Preparations;pharmacokinetic model;Phase;Phase II Clinical Trials;Photons;Physiology;Play;Process;prospective;Radiation;Radiation Dose Unit;Radiopharmaceuticals;reconstruction;Reporting;Research;Resolution;Role;Safety;Scanning;Signal Transduction;single photon emission computed tomography;Small Business Innovation Research Grant;software systems;Spatial Distribution;statistics;Techniques;Testing;Time;Tissues;tomography;tool;Treatment outcome;treatment planning;treatment response;tumor;Tumor Tissue;usability;user-friendly;Validation;Vendor;Work

PROJECT_TITLE: Torch Recon: An Innovative Reconstruction Software for Increased Throughput and Improved Low-Count Quantitative SPECT Imaging


ORG_CITY: CAMBRIDGE

ORG_NAME: VELUM, INC.

PHR: PUBLIC HEALTH RELEVANCE STATEMENT Velum, Inc. has chemically copied and stabilized a gut hormone that naturally regulates blood glucose and body weight. Further optimization of this prototype hormone derivative will enable using it as a drug to enhance existing treatments for type 2 diabetes (T2D) and obesity. The compound can then either be used together with other medications, or it may be built into such medications so that only one combination drug is needed.

PI_NAMEs: BEINBORN, MARTIN ;KUMAR, KRISHNA  (contact)

PROGRAM_OFFICER_NAME: COOKE, BRAD

PROJECT_TERMS: Agonist;Animal Experiments;Animal Model;Animals;anorexic;Appetite Depressants;bariatric surgery;Blood;Blood Glucose;blood glucose regulation;Body Weight;Body Weight decreased;Brain;Cardiovascular Diseases;Cell Physiology;Cells;Chemicals;Circulation;Clinic;Clinical;clinical development;Companions;design;Development;Diabesity;Diabetes Mellitus;diabetes mellitus therapy;Diabetic mouse;diet-induced obesity;Dipeptidyl Peptidases;Dose;Drug Combinations;Drug Kinetics;Emergency Situation;Endocrine;Engineering;Enteroendocrine Cell;Enzymes;experience;experimental study;Future;Gastrointestinal Hormones;glucagon-like peptide 1;Glucose;Goals;Half-Life;Health;Health Care Costs;Hormonal;Hormone Receptor;Hormones;Hyperglycemia;improved;in vivo;Incidence;Injections;Insulin;Intestinal Secretions;Investigation;islet;Islet Cell;Lead;Link;Maintenance;Malignant Neoplasms;Measures;Mediating;Medical;Metabolic;Metabolic dysfunction;Metabolic syndrome;Metabolism;Minor;Modification;Morbidity - disease rate;mortality;mouse model;N-terminal;Nausea;neuropeptide Y;Neuropeptides;next generation;Non-Insulin-Dependent Diabetes Mellitus;novel;novel therapeutics;Obese Mice;Obesity;Obesity Epidemic;obesity treatment;Pathway interactions;peptide drug;peptide hormone;Peptide Hydrolases;Peptide YY;Peptides;Perioperative;Pharmaceutical Preparations;Pharmacotherapy;Phase;phase 1 study;phase 2 study;Physiological;Polypharmacy;preclinical evaluation;Prediabetes syndrome;Predisposition;preservation;prevent;Procedures;Production;Property;prototype;public health relevance;receptor;receptor function;Regulatory Pathway;Reporting;Risk;Risk Factors;safety assessment;Serum;Side;side effect;Stream;Streptozocin;success;synergism;Therapeutic;therapeutic development;Therapeutic Effect;therapeutic target;Time;translational pipeline;Treatment Efficacy;Twin Multiple Birth;United States

PROJECT_TITLE: A Robust Platform for Design and Development of Therapeutic Peptides for Metabolic Syndrome

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


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Brain Disorders;Caregiving Research;Clinical Research;Clinical Trials and Supportive Activities;Depression;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Palliative Care;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: Atlanta

ORG_NAME: KDH RESEARCH AND COMMUNICATION, INC.

PHR: Informal caregivers of older adults aging in place are at a substantial risk of negative emotional, mental, physical health implications, and increased mortality because of prolonged distress, intense physical demands, and sense of loss that affect caregivers’ physiological and psychological functioning. Among all caregivers, minorities are more likely to be long-time caregivers and are at higher risk for caregiver burden, stress, and burnout – and while more men in general, and Black and Latino men specifically, are full time caregivers for older adults, there are few resources to support this particularly at-risk group. We will finalize a culturally competent, online professional development course for community health workers to support male minority caregivers, then explore the impact of trained CHW outreach on caregiver knowledge, skills, and health, and wellbeing.

PI_NAMEs: COOPER, DEXTER L (contact)

PROGRAM_OFFICER_NAME: JOHNSON, JARRETT AINSWORTH

PROJECT_TERMS: 2 arm randomized control trial;Address;Affect;aging in place;Applications Grants;asynchronous communication;Benchmarking;bilingualism;Black race;burnout;Caregiver Burden;Caregiver support;Caregivers;caregiving;Caring;Characteristics;commercialization;Communication;Communities;community building;Community Health Aides;Competence;Contractor;course development;cultural competence;Data Set;Development;Distress;Effectiveness;Emotional;Emotional Stress;empowerment;Ensure;ethnic minority;Evaluation;evidence base;Evidence based program;experience;Face;Family;Family member;Film;Financial Hardship;Goals;Health;health disparity;Healthcare Systems;high risk;Home;human old age (65+);improved;informal caregiver;informal caregiving;Infrastructure;insight;Institutionalization;interest;Intervention;Knowledge;Latino;Letters;male;meetings;men;Mental Health;Methodology;Minority;Minority Men;Modeling;mortality;neglect;older adult;Older Population;optimism;Outcome;outreach;Personal Satisfaction;Persons;Phase;physical conditioning;Physiological;poor health outcome;Population;Populations at Risk;Positioning Attribute;Privatization;programs;prototype;Provider;Psyche structure;psychologic;Public Health;Publications;racial minority;Randomized, Controlled Trials;Reporting;Research;Resources;Risk;Role;satisfaction;Self Care;Self Efficacy;service organization;skills;Small Business Innovation Research Grant;Solid;Spanish/English;Stress;Technology;Terminology;Testing;Text;Time;Training;Training Programs;Trust;United States Dept. of Health and Human Services;usability;Writing

PROJECT_TITLE: Intervention to Help Orient Men to Excel (IN-HOME): A culturally appropriate CHW training program to reduce minority caregiver burden

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