ORG_CITY: GAINESVILLE

ORG_DEPT: GENETICS

ORG_NAME: UNIVERSITY OF FLORIDA

PHR: Narrative This application aims to identify and determine the mode of action of host pioneer factors that could modulate HIV production from infected cells. Understanding how these host proteins regulate HIV will allow one to leverage host regulators as therapeutic or diagnostic targets, or tools for current HIV cure approaches.

PI_NAMEs: MEDIOUNI JABLONSKI, SONIA  (contact)

PROGRAM_OFFICER_NAME: LAWRENCE, DIANE M

PROJECT_TERMS: Acceleration;Acute;age acceleration;antiretroviral therapy;Binding;Biological Markers;Blood;CD4 Positive T Lymphocytes;Cell Line;Cell model;Cell Separation;Cells;Characteristics;ChIP-seq;Chromatin;chromatin remodeling;Cytolysis Induction;cytotoxicity;Data;Dependence;detection limit;Development;Diagnostic;disease phenotype;Disease remission;DNA;Down-Regulation;Drug resistance;Ensure;Environment;Epigenetic Process;Estrogens;Family;Family Study;Flow Cytometry;follow-up;Gene Silencing;Genes;Genetic Transcription;Goals;Heterochromatin;HIV;HIV Infections;Homeodomain Proteins;Human;Immune;improved;In Vitro;in vitro Assay;in vivo Model;inhibitor;Integration Host Factors;Interruption;knock-down;Laboratories;latent infection;Libraries;Life;Literature;male;Maps;Measures;Mediating;member;memory CD4 T lymphocyte;Modeling;National Institute of Allergy and Infectious Disease;novel;Nucleosomes;Persons;Physical condensation;Play;Population;Production;Productivity;promoter;Property;Proteins;Proviruses;reactivation from latency;recruit;Refractory;Regulation;Reporter;Reporting;Repression;Reproducibility;Research Proposals;Resistance development;RNA Polymerase II;Role;Shock;side effect;small hairpin RNA;Stigmatization;T-Cell Proliferation;T-Lymphocyte;tat Protein;Therapeutic;Time;tool;Toxic effect;transcription factor;Transcriptional Activation;Transcriptional Regulation;transcriptome sequencing;United States National Institutes of Health;vector;Viral;Viral Load result;Viral Proteins;viral rebound;viral RNA;Virus;women's treatment

PROJECT_TITLE: Delving into a Unique Transcription Factor Family to Regulate HIV Transcription


ADMINISTERING_IC: GM

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Biotechnology

ORG_CITY: MALVERN

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: LIFESENSORS, INC.

ORG_STATE: PA

PHR: Ubiquitin proteasome system plays an important role in cell physiology. Hijacking ubiquitin ligases to degrade target proteins has emerged a novel approach to develop unique drugs. Two main drug modalities in targeted protein degradation (TPD) field are PROTACs (PROteolysis TArgeting Chimeras) and MGs (Molecular Glues). Molecular glues have significant advantage over PROTACs as they adhere more closely to conventional small molecule drugs. The proposed approach is based upon LifeSensors TUBE technology to rationally discover novel molecular glue drugs.

PI_NAMEs: KADIMISETTY, KARTEEK  (contact)

PROGRAM_OFFICER_NAME: SALVADOR MORALES, CAROLINA

PROJECT_TERMS: analog;Antibodies;Autophagocytosis;Binding;Biological Assay;blood-brain barrier penetration;CDK4 gene;Cell Physiology;Cells;Central Nervous System Diseases;Chemicals;clinical development;Complex;course development;design;Development;Disease;Dose;drug discovery;Embryo;Enzymes;Event;Fibroblasts;Fluorescence Resonance Energy Transfer;G-substrate;Glues;Health;immune modulating agents;In Vitro;inhibitor;Libraries;Ligands;Ligase;Link;LRRK2 gene;Luciferases;luminescence;Lysine;Marketing;Measurement;Mediating;Medicine;Modality;Molecular;Molecular Target;Monitor;Morphologic artifacts;multicatalytic endopeptidase complex;Mus;Nature;Nerve Degeneration;novel;novel strategies;Parkinson Disease;Peptides;Pharmaceutical Preparations;Phase;Phenotype;Play;Polyubiquitination;Process;Protac;protein degradation;protein transport;Proteins;Proteolysis;Proteome;rational design;receptor function;recruit;Regulation;Role;screening;Signal Transduction;small molecule;small molecule inhibitor;small molecule libraries;Speed;Structure;success;System;Technology;technology development;technology platform;Thalidomide;Therapeutic;Therapeutic Intervention;tool;Ubiquitin;ubiquitin ligase;ubiquitin-protein ligase;Ubiquitination;Zinc Fingers

PROJECT_TITLE: Molecular glue degraders for LRRK2

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


ADMINISTERING_IC: AI

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: HIV/AIDS;Immunization;Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_CITY: DURHAM

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PHR: Project Narrative We will study how HIV-1 viral proteins are sensed by B cells expressing B cell antigen receptors (BCRs) of HIV- 1 broadly neutralizing antibodies and initiate signaling events for their activation. Using high-resolution assays and B cells from animal models expressing BCRs of HIV unmutated precursors, we will define the key properties of BCR-antigen interactions and B cell membrane events that promote co-stimulation and optimal B cell activation and lead to the development of anti-HIV protective antibodies. Our proposed work will guide and facilitate the development of anti-viral vaccines.

PI_NAMEs: ALAM, S. MUNIR  (contact);RETH, MICHAEL ;VERKOCZY, LAURENT KARL

PROGRAM_OFFICER_NAME: SINGH, ANJALI

PROJECT_TERMS: Affinity;Amino Acid Motifs;Animal Model;Antibodies;Antibody Specificity;antigen binding;Antigen Receptors;Antigens;antiviral drug development;Automobile Driving;B cell repertoire;B-Cell Activation;B-Cell Antigen Receptor;B-Lymphocytes;BACH2 gene;Back;Binding;Binding Sites;Biochemical;Biological Assay;biophysical properties;Biophysics;CD70 antigen;Cell Compartmentation;Cell Line;Cell membrane;Cell surface;Compensation;Complex;Coupling;design;Development;Epitopes;Event;FCGR2B gene;Floor;Frequencies;Germ Lines;Goals;Grant;HIV;HIV Antigens;HIV envelope protein;HIV Receptors;HIV-1;HIV-1 vaccine;Human;Immunization;Immunoglobulin G;Immunoglobulin M;Immunologics;in vivo;Kinetics;Knock-in Mouse;Ligands;Light;Measurement;Memory;Memory B-Lymphocyte;Modeling;Molecular;Molecular Conformation;mouse model;Mutation;neutralizing antibody;Physiological;Plasma Cells;Play;Polysaccharides;Preclinical Testing;programs;Property;receptor;Receptor Activation;recruit;Regulation;Resolution;response;Role;Signal Transduction;Specificity;Structure of germinal center of lymph node;Testing;TNFRSF5 gene;Vaccinated;vaccine development;Viral Proteins;Viral Vaccines;Work

PROJECT_TITLE: Antigen recognition and activation of HIV-specific B cell antigen receptors

STUDY_SECTION: HIVD

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


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Cancer;Immunotherapy

ORG_CITY: New York City

ORG_NAME: SYNTHIS THERAPEUTICS, INC.

ORG_STATE: NY

PHR: Synthis NCI Ph II Project Narrative TGF- is a clinically validated cancer pathway, but systemic TGF- therapies are toxic with limited efficacy for cancer patients. At Synthis, we have developed a first in class, cell-targeted TGF- therapy that safely restores immune mediated tumor clearance and improves patient response rates, across the majority of solid tumors.

PI_NAMEs: THOMAS-KARYAT, DORI A (contact)

PROGRAM_OFFICER_NAME: DJEMIL, SARRA

PROJECT_TERMS: Advanced Malignant Neoplasm;Adverse event;angiogenesis;Animals;antagonist;anti-PD-1;Antibodies;Antibody-drug conjugates;Automobile Driving;Benchmarking;biomarker identification;Biotechnology;Bladder;Blood;bone;Cancer cell line;Cancer Patient;cancer therapy;Cardiac;Cardiotoxicity;CD8-Positive T-Lymphocytes;Cells;checkpoint therapy;Clinical;clinical candidate;clinical development;Clinical Trials;Colorectal;cytokine;Data;Development;Dose;Drug Kinetics;Drug toxicity;efficacy testing;Engraftment;expectation;FDA approved;first-in-human;FOXP3 gene;Freedom;Funding;Goals;Grant;Head and Neck Cancer;Health;Heart;Homeostasis;Human;humanized mouse;Immune;immune activation;immune cell infiltrate;Immune checkpoint inhibitor;immune function;Immune response;Immune system;immune-related adverse events;Immunologic Memory;Immunosuppression;improved;In Vitro;in vivo;Indolent;Industry Standard;Inflammatory;inhibitor;interest;Legal patent;Link;Lung;Lymphocyte;Malignant Neoplasms;Mediating;Melanoma;Modeling;Mus;Neoplasm Metastasis;novel;novel therapeutics;Pathway interactions;patient prognosis;patient response;Patients;pembrolizumab;Peripheral Blood Mononuclear Cell;Pharmaceutical Preparations;Phase;Phosphorylation;pre-clinical;preclinical study;Prostate;Publishing;Rattus;reconstitution;refractory cancer;Regulatory T-Lymphocyte;Resistance;Rodent;Role;Safety;safety assessment;safety testing;Schedule;Series;Serum;Signal Transduction;Small Business Innovation Research Grant;Solid Neoplasm;Sprague-Dawley Rats;Standard Model;Systemic Therapy;T-Cell Activation;T-Lymphocyte;Therapeutic;Tissues;Toxic effect;tumor;tumor growth;tumor microenvironment;Tumor Promotion;Tumor stage;virtual;Western Blotting;ZAP-70 Gene

PROJECT_TITLE: In vivo efficacy, safety and PK/PD analysis of SYN101, a first in class, immune cell targeted TGFb therapy for cancer patients

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


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Depression;Dissemination and Implementation Research;Health Services;Mental Health;Primary Health Care

ORG_CITY: CAMBRIDGE

ORG_NAME: DIMAGI, INC.

ORG_STATE: MA

PHR: PROJECT NARRATIVE There is an urgent demand for mental health services in the US, particularly in communities facing an increasing incidence of depression and/or those with limited access to mental health specialists and resources. The goal of this Phase II SBIR project is to enhance and evaluate the efficacy of a scalable digital solution designed to augment the work of non-specialist providers (NSPs), such as community health workers, trained to deliver brief psychosocial interventions to individuals experiencing symptoms of depression. The proposed innovation will be expressly designed to promote quality assurance and NSP skill development while also serving as a critical support system for NSPs themselves, with the goal of ultimately scaling quality mental health care delivery and improving mental health outcomes.

PI_NAMEs: HO, Y. XIAN  (contact);LESH, NEAL

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: Address;Adoption;Anxiety;Area;Behavioral;behavioral health;Caring;commercialization;Communities;Community Health Aides;Competence;Computer software;cost;Cost Analysis;Country;Data;data visualization;depressive symptoms;design;Development;digital;digital platform;digital solutions;Economics;effective intervention;effectiveness measure;efficacy evaluation;Ethnic Population;Evaluation;Evaluation Studies;evidence base;experience;Feedback;gaps in access;Goals;Health;health care delivery;health equity;Health Personnel;Health system;Human Resources;implementation cost;implementation framework;improved;Incidence;India;Individual;innovation;insight;interest;interoperability;Intervention;Licensing;Measurement;member;Mental Depression;Mental Health;mental health counseling;Mental Health Services;Methods;Modeling;novel;Nurses;Outcome;Paper;Participant;Patients;peer;Peer Review;peer support;Performance;Persons;Phase;Positioning Attribute;Predictive Analytics;Preparation;primary outcome;Professional counselor;programs;prototype;Provider;Psychiatrist;psychologic;Psychologist;psychosocial;Qualifying;quality assurance;Quality of Care;racial population;Recommendation;Recovery;recruit;Reporting;Resources;satisfaction;secondary outcome;Secure;Self Efficacy;Services;skill acquisition;Small Business Innovation Research Grant;Specialist;Standardization;success;Supervision;Support System;Surveys;System;Systems Analysis;teacher;Testing;Texas;therapy duration;Time;tool;Training;usability;Work

PROJECT_TITLE: A novel digital platform for measurement-based peer supervision of non-specialist providers conducting brief psychological interventions

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


NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Cost Effectiveness Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Natural Products;Prevention;Social Determinants of Health;Substance Misuse;Tobacco;Tobacco Smoke and Health

ORG_CITY: CHICAGO

ORG_DEPT: PSYCHIATRY

ORG_NAME: UNIVERSITY OF CHICAGO

ORG_STATE: IL

PHR: Project Narrative. People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, we aim to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.

PI_NAMEs: HIMELHOCH, SETH S (contact);KAHLER, CHRISTOPHER W.;KOECH, EMILY ;SHUTER, JONATHAN

PROGRAM_OFFICER_NAME: PARASCANDOLA, MARK

PROJECT_TERMS: Abstinence;acceptability and feasibility;Acute;Address;Administrative Supplement;Africa;Africa South of the Sahara;African;Agonist;Alcohol consumption;alcohol measurement;alcohol misuse;alcohol use disorder;alcoholism therapy;Alcohols;Amplifiers;Animal Model;antiretroviral therapy;Award;Awareness;Back;Behavior;Behavior Therapy;Behavioral;Belief;Biochemical;Blood;brief advice;Bupropion;Canada;Cancer Control;cancer prevention;Carbon Monoxide;Cessation of life;Cigarette;Consensus;Cost Analysis;cost effective;cost effectiveness;cost estimate;Counseling;Country;craving;cytisine;Data;design;Diagnosis;Disease;Disparity;drinking;Dryness;Eastern Europe;effectiveness trial;Epidemic;Esophagus;evidence base;Exhalation;Exhibits;experience;Farm;Free Will;General Population;Health;health disparity;Heart Diseases;Heavy Drinking;HIV;HIV Infections;HIV/AIDS;Home;Human;Incidence;Income;incremental cost;Individual;interest;International;Intervention;intervention effect;Intervention Studies;Intervention Trial;Kenya;Knowledge;Letters;low and middle-income countries;Malignant neoplasm of esophagus;Malignant Neoplasms;Marketing;Measures;Mediating;Mediator;men;Modeling;National Formulary;neoplasm resource;Nicotinic Receptors;optimal treatments;Outcome;Outcome Study;Participant;Patient Self-Report;Pattern;Persons;Pharmacotherapy;phosphatidylethanol;pilot test;Placebo Control;placebo controlled trial;Placebos;Population;Prevalence;Preventable cancer cause;primary outcome;programs;Publishing;randomized controlled design;randomized placebo controlled trial;randomized trial;Randomized, Controlled Trials;Research;Resource-limited setting;response;Risk;Russia;Science;secondary outcome;Self Efficacy;Smoke;Smoking;smoking cessation;social cognitive theory;Spottings;standard care;Stress;Substance Use Disorder;success;synergism;theories;Time;Tobacco;tobacco advertising;Tobacco smoke;Tobacco smoking behavior;Tobacco use;Tobacco Use Cessation;Tobacco Use Disorder;tobacco user;Treatment Efficacy;treatment optimization;treatment research;treatment strategy;treatment trial;trial comparing;varenicline;virtual;Woman;Work

PROJECT_TITLE: Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol use among PWH in Nairobi, Kenya

STUDY_SECTION: HIBI

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


ADMINISTERING_IC: AA

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Basic Behavioral and Social Science;Behavioral and Social Science;Bioengineering;Clinical Research;Machine Learning and Artificial Intelligence;Mental Health;Networking and Information Technology R&D (NITRD);Pediatric;Prevention;Social Determinants of Health;Substance Misuse;Substance Misuse Prevention;Underage Drinking

ORG_CITY: GREENSBORO

ORG_NAME: PREVENTION STRATEGIES, LLC

PHR: NARRATIVE  Alcohol use and misuse typically begin to develop during adolescence. This project addresses deterring the onset of use through a gamified prevention strategy that addresses key modifiable psychosocial mediators. The resulting product has the potential to be widely disseminated.

PI_NAMEs: HANSEN, WILLIAM B. (contact)

PROGRAM_OFFICER_NAME: RUFFIN, BEVERLY

PROJECT_TERMS: 15 year old;Address;Adolescence;Adolescent;Adolescent Development;Age;age group;alcohol behavior;Alcohol consumption;alcohol involvement;alcohol misuse;alcohol prevention;alcohol risk;Alcohols;Algorithms;anti social;antisocial behavior;aspirate;Attitude;Automated Abstracting;Behavior;Behavioral;Belief;Categories;Choice Behavior;Code;Cognitive;Collaborations;Creativeness;Data;design;deter alcohol use;Development;developmental psychology;digital;Drug Prevention Program;Drug usage;Education;Educational process of instructing;Elements;Etiology;experience;experimental study;Exposure to;Failure;Feedback;Filament;fitness;formative assessment;Friends;Friendships;Future;game development;Genetic Transcription;Goals;graphical user interface;high risk;Individual;Interview;Knowledge;Learning;Libraries;Life;Life Style;Machine Learning;machine learning algorithm;markov model;Mechanics;Mediator;Methods;Modeling;natural language;normative education;Outcome;Participant;peer;Peer Group;Perception;Persons;Pharmaceutical Preparations;Phase;phase I trial;Play;preference;Prevention strategy;Procedures;Process;programs;protective factors;prototype;Psychological Theory;psychosocial;Psychosocial Factor;Randomized;recruit;Research;Research Support;Resources;response;Rewards;Risk;Risk Behaviors;Risk Factors;Risk Reduction;skill acquisition;skills;Small Business Innovation Research Grant;social;social influence;Social Interaction;social norm;Social Psychology;social skills;Social skills development;sound;success;Talents;Technology;Testing;Text;theories;therapy design;Time;tool;Training;training data;undergraduate student;Universities;virtual;virtual world;Youth

PROJECT_TITLE: A Gamified Approach to Adolescent Alcohol Prevention that Strengthens Social Skills and Personal Values


FUNDING_MECHANISM: RESEARCH CENTERS

NIH_SPENDING_CATS: Building Research Capacity at Institutions with Limited NIH Funding

ORG_CITY: Newark

ORG_NAME: UNIVERSITY OF DELAWARE

ORG_STATE: DE

PI_NAMEs: PARRENO, JUSTIN  (contact)

PROGRAM_OFFICER_NAME: KRASNOVA, IRINA N

PROJECT_TITLE: Cytoskeletal Mechanisms that Regulate Chondrocyte Architecture and Phenotype


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

ORG_CITY: Raleigh

ORG_NAME: ADAMAS NANOTECHNOLOGIES, INC.

PHR: Narrative Direct quantification of reactive oxygen species (ROS) in whole blood is expected to have significant impact on diagnosis and treatment of a large number of diseases accompanied by an oxidative stress. Currently there is a gap in analytical tools to characterize these important analytes in physiologically relevant conditions. To address this need, we seek to develop a quantum sensor to measure ROS in whole blood with minimal processing through a full end-user solution.

PI_NAMEs: TORELLI, MARCO  (contact)

PROGRAM_OFFICER_NAME: SENTHIL, GEETHA

PROJECT_TERMS: Acetates;Address;adduct;Agonist;analytical tool;autooxidation;Basic Science;Benchmarking;Biological;Biological Assay;biomarker discovery;biomedical facility;Biomedical Research;Blood specimen;Cell Separation;Cells;chemical synthesis;Chemistry;clinical diagnostics;Clinical Research;commercialization;Communicable Diseases;density;design;design and construction;Detection;detection limit;Development;Devices;Diagnosis;Diamond;Disease;drug discovery;Electron Spin Resonance Spectroscopy;Electronics;Enzymes;Family;Flow Cytometry;Fluorescence;Free Radicals;Generations;Goals;Health;Homeostasis;Hour;Human;improved;Incubated;Inflammatory;instrument;instrumentation;Kinetics;leucyl-phenylalanine;Ligands;Liquid substance;Magnetism;Maintenance;Measurement;Measures;Medical center;Methodology;Modality;Modeling;Modification;Monitor;Myristates;NADPH Oxidase;nanodiamond;nanoscale;neutrophil;new technology;Nitrogen;Optics;Outcome;Output;Oxidative Stress;Pathogenesis;Performance;Phase;Physiological;Play;preservation;Process;Property;Protocols documentation;prototype;quantum optics;quantum sensing;quantum sensor;Reaction;Reactive Oxygen Species;Reading;Reagent;Relaxation;Reproducibility;Research Personnel;Resolution;response;Role;Sampling;Scheme;sensor;sensor technology;signal processing;Silicon Dioxide;Small Business Innovation Research Grant;Speed;Spin Trapping;Staphylococcus aureus;Superoxides;Surface;Technology;temporal measurement;Testing;Time;tool;Validation;Whole Blood;Xanthine Oxidase

PROJECT_TITLE: Nanodiamond Quantum Sensors for Free Radical Detection

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Nanotechnology;Urologic Diseases;Women's Health Research

ORG_CITY: HOPKINTON

ORG_NAME: NOVAGYN LLC

ORG_STATE: NH

PHR: NARRATIVE Stress urinary incontinence is prevalent in more than ¼ of adult women and the current surgical solutions, primarily synthetic midurethral slings, can cause tissue erosion and other complications. Our goal is to provide an electrospun silk fibroin and polyhydroxybutyrate alternative to synthetic polypropylene mesh that dissolves over time and replaces the support provided by the sling with healthy scar tissue formation. Achieving this goal will limit the complications and necessary revision surgeries seen due to polypropylene mesh.

PI_NAMEs: THOMSON, REBECCA  (contact)

PROGRAM_OFFICER_NAME: GOSSETT, DANIEL ROBERT

PROJECT_TERMS: Adult women;Animal Model;Autologous;Biocompatible Materials;biomaterial compatibility;Biomimetics;Biopolymers;Bladder;Blood Vessels;Cell Adhesion;cell growth;Cell-Matrix Junction;Cicatrix;Collaborations;Collagen;combat;copolymer;Coughing;Deposition;Devices;Electrospinning;Exercise;experience;Extracellular Matrix;Extracellular Matrix Proteins;Extravasation;fabrication;Failure;Fiber;Fibroblasts;Fibroins;Friction;Future;Generations;Goals;Growth;healing;Hemorrhage;improved;In Vitro;in vivo;Incontinence;Infection;Infiltration;innovation;Intervention;irritation;Jogging;manufacture;mechanical properties;Mechanics;Medical Device;Microbiology;Modulus;nanofiber;Operative Surgical Procedures;patient oriented;Patients;Pelvic Floor Disorders;Pelvic floor structure;pelvic organ prolapse;Pessaries;Phase;Physical Exercise;Physical therapy;Polymers;Polypropylenes;pressure;prevent;Procedures;Proliferating;Property;Protocols documentation;prototype;Quality of life;Reconstructive Surgical Procedures;Reporting;Research;Resort;scaffold;Second Look Surgery;side effect;Silk;Small Business Technology Transfer Research;Sneezing;sound;standard of care;Stress;Stress Urinary Incontinence;success;Surgical Mesh;Technology;Tendon structure;Testing;Time;Tissue Engineering;Tissues;translational applications;Urethra;Urination;Urine;Vagina;Weight;Woman;Women's Health;Work;wound

PROJECT_TITLE: Natural Electrospun Scaffolds as an Alternative to Synthetic Mesh for Stress Urinary Incontinence

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


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Clinical Research;Eye Disease and Disorders of Vision;Health Services;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurosciences;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Primary Health Care;Rare Diseases

ORG_CITY: LAKE OSWEGO

ORG_NAME: SILOAM VISION, INC.

ORG_STATE: OR

PHR: Re#nopathy of prematurity (ROP) is a leading cause of childhood blindness, which is most o=en preventable when accurate and #mely ROP diagnosis can be provided. Digital fundus imaging can add value to ROP care by making telemedicine feasible, providing photo-documenta#on that can be used to assess disease progression over #me, and facilita#ng ar#ﬁcial intelligence (AI) applica#ons. In this applica#on, Siloam Vision will bring to market two next-genera#on laser-based ultra-wideﬁeld re#nal imaging systems, a two dimensional scanning laser ophthalmoscope and a three dimensional handheld op#cal coherence tomography system, which may reduce access barriers to digital imaging, telemedicine, and AI integra#on.

PI_NAMEs: JIAN, YIFAN ;JONAS, KARYN  (contact)

PROGRAM_OFFICER_NAME: LEE, PAEK-GYU

PROJECT_TERMS: 3-Dimensional;accurate diagnosis;adaptive optics scanning laser ophthalmoscopy;Address;Adult;Angiography;Artificial Intelligence;artificial intelligence algorithm;Biological Markers;Blindness;Caring;Child;Child health care;Childhood;Clinical;clinical diagnosis;Clinical Research;Clinical Trials;commercialization;commercialization readiness;Computer software;Consumption;Contact Lenses;cost;Custom;Data Set;design;Devices;Diagnosis;diagnostic accuracy;digital;digital imaging;Disease;Disease Progression;Electronics;Engineering;Eye;FDA approved;Feasibility Studies;fundus imaging;generative adversarial network;Goals;Health;health assessment;Healthcare Systems;high resolution imaging;Image;imaging system;improved;innovation;Intelligence;Lasers;Light;Lighting;Marketing;Mechanics;Methods;Neonatal;neonate;Newborn Infant;novel;novel strategies;ocular imaging;ophthalmic examination;Ophthalmoscopes;Ophthalmoscopy;Optical Coherence Tomography;Optics;Pathology;pediatric patients;Performance;Persons;Phase;Physiological;point of care;portability;premature;Premature Infant;Price;Primary Care;Production;prototype;Radiology Specialty;Recording of previous events;Resolution;Retina;Retinal Diseases;retinal imaging;Retinopathy of Prematurity;Scanning;screening;skills;Speed;Staging;Stress;Structure;superresolution imaging;System;Techniques;Technology;Telemedicine;Three-Dimensional Imaging;Time;tomography;two-dimensional;ultra high resolution;Uncertainty;United States;Vision;Visualization;Weight;Work

PROJECT_TITLE: Ultrawide field non-mydriatic portable pediatric retinal imaging

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


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Digestive Diseases;Nutrition;Pregnancy;Women's Health Research

ORG_CITY: CALIFON

ORG_NAME: INTEGURX THERAPEUTICS LLC

ORG_STATE: NJ

PHR: Pregnancy-induced nausea and vomi�ng (PINV) aﬀects up to 85% of pregnant women (2-3 million/year), typically for 10-15 weeks or longer; symptoms, which can be severe, o�en occur unpredictably. While most pregnant women can tolerate their symptoms with dietary modiﬁca�ons or the approved pyridoxine + doxylamine combina�on, a sizable minority (10-20%) require more eﬀec�ve medica�on. The annual US economic impact of PINV – therapeu�c interven�ons, lost workdays and even hospitaliza�ons if pa�ents are inadequately treated -- is considerable and may exceed $1 Billion. Ondansetron has proven to be highly eﬀec�ve and remains a drug of choice amongst many Obstetricians, but oral administra�on mul�ple �mes daily can be challenging during intense periods of nausea. InteguRx seeks to cimcumvent the need for oral medica�on in PINV by developing a transdermal ondansetron patch for which it hopes to seek regulatory approval.

PI_NAMEs: SHANGOLD, GARY  (contact)

PROGRAM_OFFICER_NAME: REN, ZHAOXIA

PROJECT_TERMS: absorption;Acceleration;Achievement;Address;Adhesions;Adhesives;Affect;Ambulatory Care;analytical method;antagonist;Biological Assay;Biological Availability;Cadaver;carcinogenesis;Cavia;Cell model;Circulation;Clinical;Clinical Research;cost effective;Deglutition;Dermal;design;Development;Diet Modification;dietary;Diffusion;Dimensions;Disabling;Dosage Forms;Dose;Drug Delivery Systems;Drug Kinetics;Economic Burden;economic impact;Enhancement Technology;Ensure;FDA approved;fetal;Film;follow-up;Formulation;good laboratory practice;Grant;healthy volunteer;Hospitalization;Human;In Vitro;in vivo;Investigational New Drug Application;irritation;Label;manufacture;maternal morbidity;Measures;Methods;Miniature Swine;Minority;Nausea;Nausea and Vomiting;neurodevelopment;novel;off-label use;Ondansetron;Oral;Oral Administration;Oral Ingestion;Oryctolagus cuniculus;Outcome;Parenteral Nutrition;Patients;Penetration;Performance;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Physical Chemistry;Postoperative Nausea and Vomiting;pre-clinical;Pre-Clinical Model;pre-Investigational New Drug meeting;preclinical study;Pregnancy;Pregnant Women;Process;Product Approvals;product development;programs;Property;Protocols documentation;prototype;Publishing;Qualifying;Route;Safety;safety study;scale up;Second Pregnancy Trimester;Serum;Skin;Small Business Innovation Research Grant;Specific qualifier value;Symptoms;System;targeted delivery;Technology;Therapeutic;Toxic effect;Transdermal substance administration;Vitamin B6;Vomiting;Woman;Work

PROJECT_TITLE: Development of an Ondansetron Transdermal Patch for Pregnancy-Induced Nausea and Vomiting

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


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

ORG_CITY: HOLLISTON

ORG_NAME: ACPHARIS, INC.

PHR: The use of PROteolysis TArgeting Chimeras (PROTACs) has become an important technology for modulating a protein of interest (POI) by degradation, but computational tools for analysis and design need substantial further development. Here we address some of the important problems, namely the modeling, stability, and degradation efficiency of POI-PROTAC-E3 ligase ternary complexes.

PI_NAMEs: BEGLOV, DMITRI  (contact)

PROGRAM_OFFICER_NAME: NGUYEN, HAN

PROJECT_TERMS: Address;Algorithms;Binding;Biological Availability;Cell Line;Cell Membrane Permeability;Chemical Structure;Complex;computer program;Computer software;computerized tools;cost;Data;design;Development;Dissociation;Docking;Environment;essays;experience;flexibility;Fourier Transform;Goals;improved;interest;Licensing;Ligand Binding;Ligands;Link;Literature;machine learning method;Measures;Methods;Modeling;Molecular Conformation;molecular dynamics;Monte Carlo Method;Neighborhoods;programs;Property;Protac;protein degradation;protein protein interaction;Proteins;Protocols documentation;Publications;recruit;Sampling;Site;software development;Solubility;Speed;statistical and machine learning;Structural Models;Structure;Sum;Technology;Testing;ubiquitin-protein ligase;Ubiquitination;Width

PROJECT_TITLE: Algorithm and software for predicting the structure and degrading efficiency of PROTACs

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


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Brain Disorders;Clinical Research;Complementary and Integrative Health;Drug Abuse (NIDA only);Health Services;Mental Health;Networking and Information Technology R&D (NITRD);Prevention;Social Determinants of Health;Substance Misuse;Substance Misuse Prevention;Telehealth

ORG_CITY: BEVERLY

ORG_NAME: SEE YOURSELF HEALTH, LLC

PHR: PROJECT NARRATIVE The Chiron Project: Using Virtual Reality to Prevent Substance Use Disorder in Healthcare Workers Facing Burnout At See Yourself Health (SYH), we aim to tackle the pervasive problem of workplace stress and burnout in healthcare settings putting health professionals at risk for hazardous alcohol and substance use. We propose to develop an immersive virtual workspace to offer health professionals easy access and engagement in high-fidelity, collaborative burnout prevention programming to master essential skills in self-compassion, resilience and self-management, with access to confidential peer support, and timely evidence-based care for those coping with hazardous health behaviors without the risk of burnout-related stigma.

PI_NAMEs: DRASCHER, MAXWELL LEE (contact);MITCHELL, SUZANNE

PROGRAM_OFFICER_NAME: ANGELONE, LEONARDO MARIA

PROJECT_TERMS: active duty;Address;Affect;Agreement;Alcohol abuse;Alcohol consumption;alcohol use disorder;blood glucose regulation;burnout;Caring;Chronic;Client satisfaction;Clinical Trials;Cognitive Therapy;Collaborations;Communities;Community Health;comparative effectiveness;Compassion;coping;cost;Cost Savings;Depersonalization;depressive symptoms;deter alcohol use;diabetes distress;Diabetes Mellitus;Education;Educational Curriculum;Emotional;emotional symptom;Employee Assistance Program (Health Care);Epidemic;evaluation/testing;evidence base;Exercise;exhaustion;experience;Fatigue;feasibility testing;Feeling;Goals;Growth;handheld mobile device;Hazardous Substances;Health;Health behavior;health care settings;Health Personnel;health plan;Health Professional;Health Promotion;Health system;health training;Healthcare;help-seeking behavior;Hybrids;Impairment;improved;Individual;Industry;Insurance Carriers;Intervention;Learning;Life;Maintenance;Marketing;Mental Depression;Methods;mindfulness;mindfulness-based stress reduction;mobile application;Nurses;Occupations;online course;online version;Patient Care;patient safety;peer;Peer Group;peer learning;peer support;Persons;Phase;Physicians;prevent;Prevention;Professional Burnout;Professional Organizations;programs;prototype;psychologic;Recommendation;Reporting;Research;resilience;Risk;Risk Reduction;Safety;Secondary to;Self Direction;Self Management;self-compassion;Services;simulation;skills;Social isolation;social stigma;Stress;stress management;Substance abuse problem;substance use;Substance Use Disorder;substance use prevention;Surgeon;Symptoms;Technology;telehealth;Testing;Therapeutic;tool;Training;Training Programs;Training Support;Trauma;usability;virtual;virtual healthcare;virtual reality;Work;Workplace

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


ADMINISTERING_IC: OD

FUNDING_MECHANISM: CONSTRUCTION GRANTS

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: HIV/AIDS

ORG_CITY: ATLANTA

ORG_NAME: EMORY UNIVERSITY

ORG_STATE: GA

PI_NAMEs: COHEN, JOYCE KIMBERLY (contact)

PROGRAM_OFFICER_NAME: AGGARWAL, MONIKA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Animal Housing;Animals;Area;Breeding;Clinical;Genetic;Housing;Macaca mulatta;nonhuman primate;Primates;programs;Research;Research Personnel;Running;SIV

PROJECT_TITLE: Expanded SPF breeding colony housing at the Emory National Primate Research Center

STUDY_SECTION: STOD

STUDY_SECTION_NAME: Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities[STOD]


NIH_SPENDING_CATS: Adolescent Sexual Activity;Clinical Research;Contraception/Reproduction;Pediatric;Prevention;Teenage Pregnancy;Women's Health Research

ORG_CITY: COLUMBIA

ORG_DEPT: OBSTETRICS & GYNECOLOGY

ORG_NAME: UNIVERSITY OF MISSOURI-COLUMBIA

ORG_STATE: MO

PHR: PROJECT NARRATIVE The proposed research is relevant to public health because it intends to identify a new and improved method of contraceptives for women. Ineffectiveness of current over-the-counter (OTC) contraceptives is one of the major contributors to the high unintended pregnancy rate in the United States. This project aims to provide a proof-of- concept outcome for a novel on-demand contraceptive that keeps semen in a gel-like state in the vagina and blocking of sperm transport in the female reproductive tract.

PI_NAMEs: MATZUK, MARTIN M.;SLAYDEN, OV D;WINUTHAYANON, WIPAWEE  (contact)

PROGRAM_OFFICER_NAME: LINDSEY, CHRISTOPHER CHARLES

PROJECT_TERMS: 3-Dimensional;Address;Adolescent;analog;Antibodies;Azoles;Back;Binding;candidate validation;Cell Survival;Cells;Cervical;cervicovaginal;Cessation of life;Chemistry;chymotrypsin;condoms;Contraceptive Agents;Contraceptive Availability;contraceptive efficacy;Contraceptive methods;DNA;Dose;Ejaculation;Elastases;Embryo;enzyme activity;Epithelial Cells;experimental study;Failure;Female;Female Contraceptive Agents;female reproductive tract;Fertility;Fertilization;Film;Fluorides;Gel;Genes;Goals;Health;healthcare burden;hormonal contraception;Human;Hyperviscosity;implantation;improved;In Vitro;in vitro Assay;in vivo;Infertility;inhibitor;innovation;Kinetics;Lead;Libraries;Liquid substance;Macaca mulatta;Male Infertility;Medical;men;Methods;Molecular;Mucous body substance;Mus;nanomolar;natural Blastocyst Implantation;nonhuman primate;novel;novel strategies;novel therapeutics;Outcome;Peptide Hydrolases;Permeability;Pharmacodynamics;pharmacologic;Pilot Projects;Porifera;Pregnancy;Pregnancy in Adolescence;pregnancy prevention;Pregnancy Rate;prevent;Process;Prostate;Prostate-Specific Antigen;protein function;Proteins;prototype;Public Health;Reporting;reproductive tract;Research;Research Personnel;Resources;reversible contraceptive;Risk;screening;Seminal fluid;Seminal Plasma;Series;Serine Protease;Serine Proteinase Inhibitors;Site;small molecule;small molecule inhibitor;small molecule libraries;Specificity;sperm cell;sperm function;Sperm Motility;Sperm Transport;Spermatocidal Agents;statistics;System;Technology;Teenagers;Testing;three dimensional cell culture;Thrombin;Tight Junctions;Time;Tissues;Titrations;Toxic effect;translational approach;unintended pregnancy;United States;Unwanted pregnancy;Uterus;Vagina;Viscosity;Withdrawal;Woman;women's prevention;Work

PROJECT_TITLE: Disruption of semen liquefaction using specific KLK3 inhibitors as a new contraceptive

STUDY_SECTION: CMIR

STUDY_SECTION_NAME: Cellular, Molecular and Integrative Reproduction Study Section[CMIR]


NIH_SPENDING_CATS: Behavioral and Social Science;Biodefense and Related Countermeasures;Clinical Research;Clinical Trials and Supportive Activities;Cost Effectiveness Research;Dissemination and Implementation Research;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Lung;Mental Health;Pediatric;Pediatric - AIDS;Prevention;Rare Diseases;Tuberculosis

ORG_CITY: SEATTLE

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: NARRATIVE HIV and tuberculosis (TB) are two infections that often occur among members of the same household and cause a high number of deaths globally. This study tests an implementation strategy to include HIV testing and medications to prevent HIV infection as part of public health outreach to household members of people with TB in Uganda. We hypothesize that this approach could reduce HIV infections by leveraging existing TB public health programs to also deliver medications to prevent HIV.

PI_NAMEs: ROSS, JENNIFER M (contact)

PROGRAM_OFFICER_NAME: STIRRATT, MICHAEL JAMES

PROJECT_TERMS: acceptability and feasibility;Adolescent;Adult;Affect;Africa South of the Sahara;AIDS prevention;antiretroviral therapy;Biological Assay;care delivery;Caring;Cause of Death;Cessation of life;Clinic;Communities;Complement;cost;cost effective;cost effectiveness;Cost Effectiveness Analysis;cost estimate;Counseling;Couples;Data;economic impact;Effectiveness;Eligibility Determination;Enrollment;Epidemic;Evaluation;Exposure to;Future;General Population;Guidelines;Health;High Prevalence;HIV;HIV Infections;HIV Seronegativity;HIV/TB;Home;Household;Human immunodeficiency virus test;implementation evaluation;implementation framework;implementation outcomes;implementation strategy;implementation trial;Incidence;Infection;innovation;Intervention;intervention participants;Interview;Investigation;Link;marginalized community;mathematical model;member;microcosting;Modeling;Morbidity - disease rate;mortality;Motion;multidisciplinary;Outcome;outreach;Participant;person centered;Persons;Pharmaceutical Preparations;pre-exposure prophylaxis;pregnant;Prevalence;prevent;Prevention;primary outcome;Process;programs;Protocols documentation;Public Health;Pulmonary Tuberculosis;Qualitative Methods;Randomized;randomized trial;Reach, Effectiveness, Adoption, Implementation, and Maintenance;Recommendation;Research Personnel;scale up;screening;self testing;Services;standard of care;Tenofovir;Testing;Time;trial design;Tuberculosis;Uganda;uptake;Urine;Work

PROJECT_TITLE: TB PrEP - Integrating HIV prevention with TB household contact evaluation

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 SCIL-A (03)]


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Basic Behavioral and Social Science;Behavioral and Social Science;Biotechnology;Brain Disorders;Dementia;Neurodegenerative;Neurosciences;Physical Activity;Prevention

ORG_CITY: SAN DIEGO

ORG_NAME: CEIBA BIO INC.

ORG_STATE: CA

PHR: PROJECT NARRATIVE Our research team recently identified Glycosylphosphatidylinositol-Specific Phospholipase D1 (Gpld1) as a liver-derived exercise factor in blood plasma that mediates the neurogenic and cognitive benefits of exercise in aged mice. In this project, we propose to generate proof of concept data that demonstrate recombinant GPLD1 protein as a potential therapeutic blood- based exercise mimetic to treat Alzheimer’s disease-related dementias by conferring cognitive benefits in aged mice and Alzheimer’s models.

PI_NAMEs: DING, ZHAOQING  (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: Adherence;Adult;aged;Aging;Alkaline Phosphatase;Alternative Therapies;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease pathology;Alzheimer's disease patient;Alzheimer's disease related dementia;Alzheimer's disease risk;Amyloid beta-Protein;Benchmarking;Biological Assay;biophysical properties;Blood;Blood - brain barrier anatomy;Blood Vessels;Brain;Brain-Derived Neurotrophic Factor;Ceiba;Cell Physiology;Central Nervous System;Chimeric Proteins;Cognitive;cognitive benefits;cognitive function;commercialization;Data;Disease;Doctor of Philosophy;Dose;Elderly;Enzymes;Exercise;frailty;Funding;Generations;Glycosylphosphatidylinositols;Guidelines;Health;Human;Impaired cognition;improved;In Vitro;in vivo;Incubators;Infrastructure;Investigational New Drug Application;Lead;lead optimization;Learning;Liver;Measures;Mediating;Medical;Memory;mimetics;Modification;Molecular Target;mouse model;Mus;neurobehavioral;Neurodegenerative Disorders;neuropathology;Neurosciences;novel;old mice;older adult;overexpression;Pathology;Patients;Perception;Peripheral;pharmacokinetics and pharmacodynamics;Phase;phospholipase D1;Physical activity;Physical Exercise;Plasma;Plasminogen;Property;Proteins;Recombinant Proteins;Recombinants;Recommendation;Rejuvenation;Research;Resources;Safety;Science;Synaptic plasticity;Technology;Testing;Therapeutic;Therapeutic Agents;therapeutic candidate;therapeutic development;Therapeutic Intervention;therapeutic target;Translating;Validation;Vitronectin;Wild Type Mouse;Work

PROJECT_TITLE: Developing blood-based exercise mimetic as a treatment for Alzheimer's disease and related dementias

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


NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Clinical Research;Conditions Affecting the Embryonic and Fetal Periods;Lung;Pediatric;Pregnancy;Urologic Diseases

ORG_CITY: WOODSIDE

ORG_NAME: VORTEX MEDICAL INC.

PHR: PROJECT NARRATIVE Vesicoamniotic shunts (VAS) are used to bypass the bladder obstruction in fetuses with lower urinary tract obstruction (LUTO), but their high dislodgement rate (up to 80%) leads to the need for repeated invasive procedures during pregnancy. Vortex Medical is developing a novel shunt that incorporates enhanced anchors to reduce dislodgement, materials to improve ultrasound visualization for accurate deployment, and a unique ability to be resheathed and removed (e.g., after birth). The Vortex shunt will reduce the risks associated with using VAS, improve treatment efficacy and reliability, and reduce neonatal morbidity and mortality, which will significantly decrease healthcare expenditures associated with LUTO and dramatically improve quality-of-life for patients.

PI_NAMEs: JOHNSON, ERIC  (contact)

PROJECT_TERMS: Acute;Address;Amniotic Fluid;Animals;Benefits and Risks;Birth;Bladder;Bladder neck obstruction;Bypass;Chest;Chronic;Clinical;Clinical Trials;Clinical Trials Design;Collaborations;Congenital Abnormality;Contracts;Coupling;Custom;Data;design;design,build,test;Devices;Drainage procedure;Edema;effective therapy;Ensure;Environment;Failure;Family;Fatigue;fetal;Fetal Growth;Fetal Movement;Fetal Sheep;Fetus;fetus surgery;first-in-human;flexibility;Foundations;Goals;Health Expenditures;Healthcare;Hemostatic function;Human;Implant;improved;in utero;in vivo;in vivo evaluation;Incidence;Injury to Kidney;innovation;Joints;Kidney;Location;Lower urinary tract;Lung;lung development;lung injury;lung lesion;malformation;manufacturability;manufacture;Manufacturer;Marketing;Medical;meetings;metallicity;Methods;migration;Molds;Morbidity - disease rate;mortality;mortality risk;neonatal morbidity;Neonatal Mortality;novel;Nylons;operation;Outcome;Patients;Performance;Phase;Physicians;Pilot Projects;Pleural effusion disorder;Polyurethanes;Preclinical Testing;Pregnancy;prenatal;prenatal therapy;Procedures;prototype;Pulmonary Hypertension;pulmonary hypoplasia;Quality of life;Regulatory Pathway;renal damage;Reporting;Risk;Safety;sample fixation;Savings;Second Pregnancy Trimester;Shunt Device;Silicones;Small Business Innovation Research Grant;Specific qualifier value;Surgeon;Survivors;System;Testing;Third Pregnancy Trimester;Treatment Efficacy;Tube;ultrasound;Urethra;urinary;Urinary tract;urinary tract obstruction;Urine;usability;Uterus;verification and validation;Visualization

PROJECT_TITLE: Developing a novel vesico-amniotic shunt to treat fetal lower urinary tract obstruction

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


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;Burden of Illness;Clinical Research;Dementia;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Neurodegenerative;Neurosciences;Prevention;Rehabilitation

ORG_CITY: MINNEAPOLIS

ORG_NAME: INNOVATIVE DESIGN LABS, INC.

ORG_STATE: MN

PHR: Project Narrative Measures of cognitive decline can help to inform family members, caregivers, and health-care providers about the functional status and needs of independent-living older individuals. Alterations in measures of gait speed, cadence, and variability in particular have been shown to precede dementia onset, predict diagnosis, and even differentiate between neurologic diseases. While expensive laboratory grade systems such as motion capture can capture precise gait parameters exist, a tool that could conveniently, consistently, and cost-effectively measure these important biomarkers would make their clinical use at scale practical and more accessible.

PI_NAMEs: CONDON, JOHN PAUL (contact)

PROGRAM_OFFICER_NAME: LUO, YUAN

PROJECT_TERMS: 3-Dimensional;Academy;Adult;Affect;Aging;aging demography;Algorithms;Alzheimer's Disease;Alzheimer's disease related dementia;Alzheimer's disease risk;American;Area;Bathing;Biological;Biological Markers;biomarker development;Blood Tests;Caregivers;Cerebrospinal Fluid;Characteristics;Charge;Clinical;cognitive change;Collaborations;Collection;Communities;community setting;Conduct Clinical Trials;cost;cost effective;cost effective measures;daily functioning;Data;Data Set;Dementia;demographics;design;Detection;Development;Devices;Diagnosis;Direct Costs;Disease;Disease Progression;disorder risk;Equilibrium;fall risk;Family member;Feedback;Focus Groups;foot;Functional disorder;functional status;Gait;Gait abnormality;Gait speed;General Population;Health;Health Personnel;Height;Impaired cognition;improved;Independent Living;Individual;innovation;Laboratories;Length;Life;Longitudinal trends;Manuals;Marketing;Measurement;Measures;Medicine;Memory;Monitor;Motion;Nervous System Disorder;Neurosciences Research;older adult;Older Population;Parameter Estimation;Patients;Performance;Phase;Population;Populations at Risk;pressure;Process;Production;Property;prototype;remote administration;Reporting;Research;Research Personnel;Rural Community;Sampling;screening;sensor;Services;Shoes;software systems;statistics;Supervision;Symptoms;System;Telephone;Testing;Time;tool;underserved community;United States National Institutes of Health;Visual;Walking;wearable device;wireless fidelity

PROJECT_TITLE: A Gait and Path Tortuosity System for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD)


ADMINISTERING_IC: LM

IC_NAME: NATIONAL LIBRARY OF MEDICINE

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

ORG_CITY: SAINT PAUL

ORG_NAME: NESTED KNOWLEDGE, INC

PHR: PROJECT NARRATIVE Systematic Literature Reviews are central to decision-making throughout the healthcare ecosystem, including reimbursement, regulatory approval, society guidelines, and physician decision-making. However, these reviews are highly work-intensive, limiting the ability to synthesize evidence to compare therapies. Nested Knowledge provides an Artificial Intelligence-assisted workflow that enables rapid, updatable, interactive reviews, including automated extraction of data from text. We propose to create and test a novel Large Language Model to extract data from tables and inform automated comparative analysis of therapies.

PI_NAMEs: KALLMES, KEVIN  (contact)

PROGRAM_OFFICER_NAME: BINGHAM, CLAYTON SCOTT

PROJECT_TERMS: Acceleration;Adopted;Adoption;Agreement;analytical tool;Artificial Intelligence;Automation;Clinical;clinical infrastructure;Clinical Research;Clinical Sciences;commercialization;Communities;comparative;Computer software;cost;Data;Data Analyses;Data Element;Data Set;Decision Making;diagnostic accuracy;Economics;Ecosystem;Electronics;Ensure;frontier;Goals;Grant;Guidelines;health economics;Health Personnel;Health Technology;Healthcare;Human;improved;Informatics;insight;Institution;interactive visualization;interest;Intervention;Knowledge;large language model;Location;Manuals;Manuscripts;Maps;Marketing;Meta-Analysis;Methods;Modeling;novel;Performance;Phase;Physicians;Positioning Attribute;Process;Provider;Publishing;Quality Control;Records;Research;Research Personnel;Review Literature;Safety;Scientist;screening;sharing platform;Small Business Innovation Research Grant;Societies;Source;Standardization;statistics;Structure;System;systematic review;Technology;Technology Assessment;Testing;Text;Time;tool;United States National Institutes of Health;Update;Validation;Visual;Work;working group

PROJECT_TITLE: Automating Tabular Data Extraction to Accelerate Evidence Synthesis and Systematic Literature Review

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


NIH_SPENDING_CATS: Biotechnology;Chronic Liver Disease and Cirrhosis;Digestive Diseases;Hepatitis;Liver Disease

ORG_CITY: BROOKLYN

ORG_NAME: XYLYX BIO, INC.

PHR: NARRATIVE In this SBIR Fast Track project, Xylyx proposes to develop and commercialize a liver fibrosis cell-based assay platform that helps scientists develop effective drugs for treating liver fibrosis, a devastating disease process that leads to progressive liver dysfunction, cirrhosis, and liver failure. Predictive models for testing liver fibrosis drug candidates are lacking, leaving a significant unmet need and market gap for a physiologically-relevant assay platform. The commercial product from this project will be an assay platform that accelerates drug development for liver fibrosis, and empowers high-impact discoveries that will improve treatment options and outcomes for millions of patients with fibrotic liver diseases.

PI_NAMEs: O'NEILL, JOHN DAVID (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: 3-Dimensional;Acceleration;Address;Affect;Animal Model;Biochemical;Biological Assay;Biomanufacturing;Biopsy;Breast;Cause of Death;Cell Separation;Cells;Cessation of life;chronic liver disease;Cirrhosis;Clinical;Coculture Techniques;Coenzyme A;commercialization;Communication;cost;Data;Data Set;Decision Making;Dependence;Deposition;Development;Disease;disease model;Documentation;drug candidate;drug development;Drug Screening;drug testing;empowerment;Engineering;Extracellular Matrix;Fibrosis;Gene Expression;Gene Expression Profiling;Genes;Goals;Hepatic Fibrogenesis;Hepatic Stellate Cell;Hepatitis C;Hepatocyte;Histologic;Histopathology;Human;human disease;Human Engineering;human model;human tissue;improved;In Vitro;in vitro Assay;in vitro Model;in vivo;Industry;International;Interview;Knowledge;Kupffer Cells;Legal patent;Lesion;Liver;Liver diseases;Liver Dysfunction;Liver Failure;Liver Fibrosis;Malignant neoplasm of liver;manufacture;manufacturing process;Manuscripts;Marketing;matrigel;Mechanics;metabolomics;Methods;Modeling;Molecular;Morphology;mortality;multiple omics;nintedanib;non-alcoholic fatty liver disease;nonalcoholic steatohepatitis;Organoids;Outcome;Pathologic;Patients;Performance;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Pharmacotherapy;Phase;Phenotype;Physiological;Pirfenidone;Play;Population;pre-clinical;predictive modeling;Primary carcinoma of the liver cells;Process;product development;Progressive Disease;Proliferating;Property;Protein Secretion;Proteins;Proteomics;Protocols documentation;Publications;Publishing;Pulmonary Fibrosis;quality assurance;Quality Control;Reporting;Reproducibility;response;Risk;Risk Reduction;Rodent;Role;scale up;Scientist;Services;Slice;Small Business Innovation Research Grant;Specific qualifier value;spheroids;Stains;standard of care;Standardization;stellate cell;stem;success;supply chain;technological innovation;Technology;Testing;testing services;Text;Tissues;transcriptome sequencing;validation studies;verification and validation;Viral hepatitis;Work

PROJECT_TITLE: Liver fibrosis cell-based assay platform: integrating patient-derived fibrotic liver ECM with primary stellate cells, Kupffer cells, and hepatocytes to accelerate anti-fibrotic drug development

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


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Biotechnology;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Dementia;Immunization;Neurodegenerative;Neurosciences

ORG_CITY: LA JOLLA

ORG_NAME: CENNA BIOSCIENCES, INC.

PHR: Narrative Alzheimer’s disease (AD) is a devastating degenerative neurological disorder that affects one- tenth of the population over the age of 65. Cenna’s novel peptide drug mP8 reduces the toxic species Aß in vitro and in transgenic mouse brains and is being developed as a new, first-in-class disease-modifying drug for the treatment of AD. IND-enabling GLP studies have been completed and the proposed studies will complete the regulatory requirements and submission of an IND to the FDA and carry out Phase 1 clinical trials.

PI_NAMEs: DEWJI, NAZNEEN N (contact)

PROGRAM_OFFICER_NAME: WILLIAMS, BENFEARD LEECHELLE

PROJECT_TERMS: Abeta synthesis;Aducanumab;Affect;Alzheimer's Disease;Alzheimer's disease model;Amino Acids;Amyloid beta-Protein;beta secretase;Biological Markers;Brain;Brain hemorrhage;Cell Physiology;Clinic;Clinical;clinical development;Clinical Drug Development;Clinical Research;Clinical Trials;Cognitive;cognitive performance;cohort;cost;Cyclic GMP;Disadvantaged;Disease;Dose;Double-Blind Method;drug candidate;Drug Kinetics;Enzymes;Failure;FDA approved;first-in-human;Formulation;healthy volunteer;human old age (65+);improved;In Vitro;inhibitor;Injection product;Length;manufacture;Manufactured Materials;Medical;Methods;Monkeys;Monoclonal Antibodies;Neurodegenerative Disorders;neurotoxic;new technology;novel;novel therapeutic intervention;novel therapeutics;open label;Pathologic;Patients;peptide drug;Persons;Pharmaceutical Preparations;Pharmacology Study;Pharmacotherapy;Phase;Phase I Clinical Trials;Placebo Control;Placebos;Plasma;Population;pre-Investigational New Drug meeting;Preparation;prodromal Alzheimer's disease;product development;programs;prototype;Qualifying;Randomized;Rattus;Safety;secretase;Small Business Innovation Research Grant;stability testing;subcutaneous;Subcutaneous Injections;Swelling;tau Proteins;tau-1;Technology;Testing;Therapeutic;Therapeutic Monoclonal Antibodies;Toxicology;Transgenic Mice

PROJECT_TITLE: EARLY CLINICAL DEVELOPMENT OF MODIFIED P8 FOR THE TREATMENT OF ALZHEIMER'S DISEASE


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Emergency Care;Hematology

ORG_CITY: Lexington

ORG_NAME: NEW HEALTH SCIENCES, INC.

PHR: While whole blood is already being used both in on-site pre-hospital care, during transport and in emergency rooms to reduce preventable deaths from hemorrhaging, it has only recently been recognized as the first-choice transfusion material for saving victims of severe bleeding and resulting shock. However, modern blood banking has primarily focused on blood components (red blood cells, platelets and plasma), resulting in a lack of development and innovation when it comes to whole blood processing and storage. The proposed storage platform intends to modernize whole blood storage by providing increased efficacy of oxygen delivery and hemostatic function, as well as eliminating unused whole blood waste, often caused by its shorter shelf-life when compared to red cells, by recovering red cells for further storage and transfusion.

PI_NAMEs: STOLLA, MORITZ ;YOSHIDA, TATSURO  (contact)

PROGRAM_OFFICER_NAME: AGRAWAL, NITIN

PROJECT_TERMS: Accident and Emergency department;Address;Adoption;Air;Ambulances;Animal Model;Anticoagulants;Authorization documentation;Binding;Biological Assay;Biological Products;Blood;Blood Banks;Blood Component Removal;Blood Gas Analysis;Blood Platelets;Blood Transfusion;Blood Volume;Cessation of life;Coagulation Process;commercialization;Control Groups;cost;crystalloid;cytochrome c oxidase;Data;Development;effective therapy;Environment;Equipment and supply inventories;Erythrocytes;Evaluation;experience;feasibility testing;Flow Cytometry;Fresh Frozen Plasmas;Goals;Grant;Hemoglobin;Hemorrhage;Hemorrhagic Shock;Hemostatic Agents;Hemostatic function;high throughput screening;Hospitals;Hypoxia;Impairment;In Vitro;in vivo;Individual;Infusion procedures;innovation;Lesion;Life;Logistics;Marketing;Measures;Metabolic;Metabolism;metabolomics;Methods;Military Personnel;Mitochondria;Modeling;Modernization;mortality;mouse model;Mus;novel;Organ;Outcome;Oxidative Phosphorylation;Oxygen;Persons;Phase;phase 1 study;Plasma;platelet function;Pre-hospitalization care;prevent;preventable death;Publications;Rattus;Recovery of Function;Refrigeration;Rejuvenation;remote location;Research;Resuscitation;Role;Running;Saline;Schedule;screening;Shock;Site;Small Business Innovation Research Grant;Study models;System;Tail;Technology;Temperature;Testing;Therapeutic Equivalency;Time;Transfusion;Transgenic Mice;Trauma;trauma centers;wasting;Whole Blood

PROJECT_TITLE: Hypoxically stored whole blood--evaluation of platelet activities under hypoxic storage conditions

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 IVBH-V (11)]


ADMINISTERING_IC: MD

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

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

ORG_CITY: BALTIMORE

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

ORG_STATE: MD

PHR: This K01 Mentored Research Scientist Development Award seeks to investigate the intersections of U.S. housing and HIV policies, while refining and measuring the implementation of an unconditional direct cash transfer intervention to address homelessness and promote HIV service engagement among lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ) youth. The proposed training plan will build on PI Rao’s experience in implementation research and in working directly with community partners and provide her with the necessary skills and experience to execute the aims, including 1) methods to describe and analyze health policies, 2) qualitative and mixed-methods approaches, and 3) content expertise in guaranteed income and unconditional cash transfers in the United States. Over the five years of the award and through a combination of mentor-specific and Scientific Advisory Committee Meetings, coursework and other didactic training, experiential learning, research group meetings, and national and international scientific meetings, as well as the execution of the proposed aims, PI Rao will be well-positioned to submit a hybrid implementation- effectiveness R01 and pursue an independent research career.

PI_NAMEs: RAO, AMRITA  (contact)

PROGRAM_OFFICER_NAME: JOHNSON, JARRETT AINSWORTH

PROJECT_TERMS: Active Learning;Address;Advisory Committees;Advocacy;AIDS prevention;Attitude;Award;Baltimore;behavior change;Belief;career;Cities;Communities;community partners;Consolidated Framework for Implementation Research;Data;design;Discrimination;Drops;Economics;effectiveness trial;effectiveness/implementation hybrid;Enrollment;Environment;Epidemiologist;Evaluation;Evolution;experience;Face;federal policy;Focus Groups;Funding;Gender;Goals;Government Agencies;Group Meetings;Guidelines;health care service;health disparity;Health Policy;HIV;Home;Homeless Youth;Homelessness;Housing;housing instability;Hybrids;implementation barriers;implementation context;implementation facilitation;implementation framework;implementation intervention;implementation measures;implementation outcomes;implementation research;implementation science;implementation strategy;improved;Incentives;Income;indexing;Individual;Infrastructure;injection drug use;innovation;insight;International;Intervention;Interview;Knowledge;land use;Laws;Lesbian Gay Bisexual Transgender Queer Questioning;Link;Lived experience;Maintenance;Maps;marginalization;Measures;meetings;Mentored Research Scientist Development Award;Mentors;Methods;Municipalities;National Institute on Minority Health and Health Disparities;Outcome;Ownership;Partnership Practice;peer;Persons;physical abuse;Policies;Policy Analysis;Population;Positioning Attribute;Proctor framework;programs;Prostitution;Provider;Reach, Effectiveness, Adoption, Implementation, and Maintenance;Research;Resources;Risk;Risk Factors;safety net;scale up;service engagement;service uptake;service utilization;Services;Sex Orientation;Sexual abuse;Shelter facility;Site;skills;social;social stigma;Source;stakeholder perspectives;Strategic Planning;Stratification;Structure;supported housing;Surveys;syndemic;System;Training;Training Programs;transmission process;United States;Vulnerable Populations;willingness;Work;young adult;Youth

PROJECT_TITLE: Policy and implementation context of an unconditional cash transfer program to address homelessness and improve HIV service uptake among marginalized youth in the United States

STUDY_SECTION_NAME: Special Emphasis Panel[ZMD1 DRI (M2)]


NIH_SPENDING_CATS: Biotechnology;Cancer;Dental, Oral, and Craniofacial Disease;Genetics;Immunotherapy;Orphan Drug;Precision Medicine;Radiation Oncology;Rare Diseases

ORG_CITY: Gaithersburg

ORG_NAME: MIRECULE, INC.

PHR: Project Narrative HNSCC is the 6th most common form of cancer. Greater than half of patients present with late stage III or IV disease, with an average 5-year survival rate of ~40%. In this Phase II SBIR study we will develop MC-30, an antibody RNA conjugate consisting of mimic of miR-30-5p coupled to anti-EGFR antibody cetuximab. MC-30 has the ability to down regulate key oncogenic pathway targets in HNSCC and overcome therapeutic resistance. Our novel ARC will offer an effective treatment of patients with unresectable, advanced HNSSC, and eventually for multiple multi-drug resistant cancers for which there are currently no treatment options and survival is measured in months.

PI_NAMEs: SALEH, ANTHONY D (contact)

PROGRAM_OFFICER_NAME: ZANE, LINDA KARINE

PROJECT_TERMS: Address;Adhesions;analytical method;anti-cancer;anti-PD1 antibodies;anti-PD1 therapy;Antibodies;Antibody Therapy;Binding;Biopolymers;cancer cell;Cetuximab;Chemicals;chemoradiation;Cisplatin;Clinical;clinical development;clinical risk;Compensation;Complex;Coupled;Data;Detection;detection method;Development;Diagnosis;Dimensions;Disease;Disease Progression;Dose;effective therapy;efficacy evaluation;efficacy study;EGFR inhibition;Enzyme-Linked Immunosorbent Assay;Epidermal Growth Factor Receptor;Excipients;Extracellular Matrix;Growth Factor Receptors;Head and Neck Squamous Cell Carcinoma;high risk;IGF1R gene;in vivo;innovation;Investments;Malignant Neoplasms;manufacture;Maximum Tolerated Dose;Measures;Messenger RNA;Metastatic/Recurrent;method development;Methods;MicroRNAs;migration;mouse model;multidrug resistant cancer;Mus;new therapeutic target;Newly Diagnosed;Nodal;novel;Oligonucleotides;Oncogenic;Outcome;overexpression;Parents;Pathway interactions;patient derived xenograft model;patient subsets;Patients;Pharmaceutical Preparations;Phase;phase 1 study;phase I trial;Population;Positioning Attribute;pre-clinical;pre-Investigational New Drug meeting;preclinical efficacy;Preparation;prevent;Privatization;Process;Prognosis;Progression-Free Survivals;Proliferating;Reaction;receptor internalization;Regimen;Replacement Therapy;Repression;resistance mechanism;restoration;RNA;Safety;safety study;scale up;Signal Transduction;Small Business Innovation Research Grant;standard of care;Survival Analysis;Survival Rate;targeted agent;targeted treatment;Testing;Therapeutic;therapeutic target;therapy resistant;Toxic effect;Toxicology;treatment response;tumor growth;Tumor Suppressor Proteins;Tumor Tissue;Unresectable;Up-Regulation;Validation;Work

PROJECT_TITLE: Development of an antibody-oligonucleotide conjugate for treatment of Head and Neck Squamous Cell Carcinoma

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


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Bioengineering;Neurodegenerative;Neurosciences;Peripheral Neuropathy;Physical Injury - Accidents and Adverse Effects;Regenerative Medicine;Rehabilitation;Transplantation

ORG_CITY: PITTSBURGH

ORG_NAME: RENERVA, LLC

PHR: Narrative - More than 500,000 surgical procedures are performed annually in the United States to address nerve injuries at a cost of more than $1.1B. Despite advances in microsurgical techniques and the inherent ability of the peripheral nervous system to regenerate, fewer than 50% of patients report satisfactory functional recovery, likely due to slow nerve growth (~1mm/day) and difficulty in growth across sites of injury (inflammation, scarring, and axon misdirection). The current project will test and optimize the formulation of peripheral nerve matrix, a tissue-based hydrogel derived from porcine nerve that can be delivered into the lumen of a nerve conduit, for use in critical nerve gap defects and exceed the performance of the gold-standard nerve autograft.

PI_NAMEs: SOLETTI, LORENZO  (contact)

PROGRAM_OFFICER_NAME: CAPORELLO, EMILY LAURA

PROJECT_TERMS: Acceleration;Achievement;Action Potentials;Address;Affect;Allografting;American;Animal Model;Autologous Transplantation;Axon;Biocompatible Materials;biomaterial compatibility;Cattle;Cells;Chondroitin Sulfates;chronic pain;Cicatrix;Clinical;clinical translation;clinically relevant;Collagen Type I;commercialization;Complex;cost;Data;Defect;Development;Economic Burden;efficacy testing;Electrophysiology (science);Engineering;Environment;Evaluation;Event;Failure;Family suidae;Filler;Formulation;functional improvement;functional outcomes;Future;Gel;Goals;Growth;Growth Factor;Histologic;Hydrogels;immunogenicity;improved;In Vitro;in vivo;Inflammation;Injury;injury and repair;Length;Life;Macrophage;Maintenance;Marketing;mechanical properties;Mechanics;Microsurgery;Modeling;Modulus;Motor;motor impairment;Natural regeneration;Nerve;nerve autograft;Nerve Crush;nerve damage;nerve gap;nerve injury;Nerve Regeneration;nerve repair;Nerve Tissue;neuromuscular function;Operative Surgical Procedures;Outcome;Patients;Performance;Peripheral nerve injury;Peripheral Nerves;Peripheral Nervous System;Phase;Phenotype;pre-clinical;preclinical efficacy;preclinical safety;prevent;Procedures;Process;Property;Proteins;psychosocial;Qualifying;Quality of life;Rattus;Recovery;Recovery of Function;recruit;regenerative;release factor;repaired;Reporting;Residual state;restoration;Risk;Rodent;safety testing;Schwann Cells;Sensory;Sensory impairment;Series;Silicones;Site;System;Techniques;Technology;Temperature;Testing;Time;Tissues;Translating;translational approach;Tube;United States;Work

PROJECT_TITLE: Restoration of Neuromuscular Function Following Critical Nerve Gap Injuries

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


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Health Services;Prevention;Social Determinants of Health

PHR: Project Narrative The need for healthcare workers is increasing due to the aging population, expansion of insurance coverage, and healthcare innovations. While the introduction of STEM educational products has been working to increase the number of students pursuing careers in science, technology, engineering, and math, the health science area has been underserved. A product that engages students in activities rooted in scientific inquiry released to health science may increase interest and the belief they can successfully pursue healthcare-related careers.

PROGRAM_OFFICER_NAME: FAUPEL-BADGER, JESSICA

PROJECT_TERMS: 3D Print;Affect;after-school program;aging population;Anatomy;Area;Belief;Biology;Biosensor;career;Career Choice;Collaborations;commercialization;Communication;Computer software;Consult;cost;cost effective;curriculum development;Data;Data Analyses;design;Development;Education;Educational Curriculum;Educational process of instructing;Electrical Engineering;Exercise;experience;experimental study;Feedback;Friends;Grant;Growth;guided inquiry;Health;health knowledge;Health Personnel;Health Promotion;Health Sciences;Healthcare;Healthcare promotion;Heart Rate;implementation science;Industry;information technology workforce;innovation;instrumentation;Insurance Coverage;interest;Learning;Measurement;Mechanics;meetings;Methods;Minnesota;Modernization;Mollies;Next Generation Science Standards;Occupations;Pathway interactions;Phase;Physical Education;Physiology;Population;Principal Investigator;Process;Production;professor;programs;Recovery;Research;Resources;Robotics;Science;science education;Science, Technology, Engineering and Mathematics;Science, Technology, Engineering and Mathematics Education;Scientific Inquiry;sensor;sensor technology;Series;Small Business Innovation Research Grant;sobriety;STEM career;STEM program;student participation;Students;System;teacher;Teacher Professional Development;Techniques;Technology;technology development;Testing;Time;United States;Universities;virtual reality;workforce needs;Workplace;Yeasts

PROJECT_TITLE: Biomedical Sensing, Measurement, and Instrumentation with hands-on activities to promote healthcare-related careers

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


ED_INST_TYPE: PRIMATE CENTERS

NIH_SPENDING_CATS: Aging;Estrogen;HIV/AIDS;Infectious Diseases;Menopause;Osteoporosis;Stem Cell Research;Stem Cell Research - Nonembryonic - Non-Human;Women's Health Research

ORG_CITY: PORTLAND

ORG_DEPT: OTHER HEALTH PROFESSIONS

ORG_NAME: OREGON HEALTH & SCIENCE UNIVERSITY

PHR: PROJECT NARRATIVE Due to the effectiveness of antiretroviral therapy (ART), there is an increase in women living with HIV (WLWH) who are aging and will undergo menopause. We intend to measure the impact of i) simian immunodeficiency virus (SIV) infection ii) ART-suppression iii) menopause and iv) presence or absence of hormone replacement therapy (HRT), on bone architecture and quality in a unique nonhuman primate model. These studies will focus on compound bone loss, bone health and fracture risk in our model of postmenopausal WLWH-with and without HRT and our results could inform future care options to protect these women from compounded risk of bone fractures and osteoporosis.

PI_NAMEs: SAUTER, KRISTIN AD (contact)

PROGRAM_OFFICER_NAME: RADKE, JOSHUA BRYAN

PROJECT_TERMS: acute infection;Address;Adipocytes;Affect;Age;Aging;aging population;AIDS population;antiretroviral therapy;Architecture;Attenuated;Bar Codes;Biochemical Markers;bone;bone cell;Bone Density;bone health;bone loss;Bone Marrow;bone mass;bone quality;Bone remodeling;Bone Resorption;burden of illness;Caring;Cartilage;CD4 Positive T Lymphocytes;cell type;Cells;Characteristics;Chronic;Clinical Research;Combined Modality Therapy;Data;Development;Disease;Drug Interactions;Effectiveness;Estradiol;Estrogen deficiency;Estrogen Replacement Therapy;Estrogen Replacements;Estrogen Therapy;Estrogens;Female;Flow Cytometry;Fracture;fracture risk;Funding;Future;Histologic;HIV;HIV-1;HIV/AIDS;Hormone replacement therapy;Hormone use;Hormones;Implant;improved;Infection;Life Expectancy;longitudinal analysis;Macaca mulatta;Measures;Menopausal Symptom;Menopause;Mesenchymal Stem Cells;microCT;Modeling;nonhuman primate;novel;Osteoblasts;Osteoporosis;Osteoporosis prevention;osteoprogenitor cell;Ovariectomy;Pathology;Persons;Pharmaceutical Preparations;Phenotype;Pluripotent Stem Cells;Postmenopause;progenitor;receptor;Regimen;Research Project Grants;response;Risk;Roentgen Rays;Sex Differences;Silastic;SIV;skeletal;skeletal stem cell;Sorting;stem;stem cells;stromal progenitor;United States National Institutes of Health;Viral Load result;Viral reservoir;Viremia;Virus Diseases;Woman

PROJECT_TITLE: Impact of estrogen replacement therapy on bone health in an aging population of women living with HIV

STUDY_SECTION: AIDS

STUDY_SECTION_NAME: Acquired Immunodeficiency Syndrome Research Study Section[AIDS]


NIH_SPENDING_CATS: Biotechnology;Cancer;Lung;Orphan Drug;Prevention;Pulmonary Fibrosis;Rare Diseases

ORG_NAME: NOVOMEDIX, INC.

PHR: Project Narrative The ultimate goal of this program is to develop and commercialize a novel oral small molecule therapy that improves outcomes for those with idiopathic pulmonary fibrosis or other types of progressive pulmonary fibrosis by preventing disease progression and potentially reversing lung damage.

PI_NAMEs: SIME, PATRICIA JANET;SWINDLEHURST, CATHY A (contact);THATCHER, THOMAS HENRY

PROGRAM_OFFICER_NAME: VUGA, LOUIS J

PROJECT_TERMS: adenylate kinase;Agonist;Agreement;airway epithelium;American;Animal Model;Animal Testing;Animals;aorta constriction;Back;Bleomycin;Cancer Model;Cardiomyopathies;cardioprotection;Cell Culture Techniques;Cellular Assay;Collagen;commercialization;Connective Tissue;Deposition;Development;Disease;Disease Progression;Doxorubicin;drug candidate;drug development;Epithelial Cells;Extracellular Matrix;Extrinsic allergic alveolitis;FDA approved;Fibroblasts;Fibronectins;Fibrosis;fibrotic interstitial lung disease;Future;Gel;Goals;Heart failure;Histology;idiopathic pulmonary fibrosis;improved outcome;In Vitro;in vivo;Inflammation;Inspiratory Capacity;interest;Interleukin-11;Ionizing radiation;Lead;lead candidate;Liver Fibrosis;Lung;lung histology;lung injury;lung repair;Malignant Neoplasms;manufacturing scale-up;Messenger RNA;Modeling;mortality;mouse model;Mus;Myofibroblast;nintedanib;novel;Oral;Patients;Periodicity;Persons;Pharmaceutical Preparations;Phase;Phenotype;Physiological;Pirfenidone;Play;prevent;Prevention;Production;programs;Proliferating;Proteins;Pulmonary Fibrosis;pulmonary function;Research;Resistance;Role;Sarcoidosis;scale up;Series;side effect;Silicosis;Small Business Innovation Research Grant;small molecule;Standard Model;Stretching;Survival Rate;three-dimensional modeling;Tissues;Transforming Growth Factor beta;translational model;Western Blotting

PROJECT_TITLE: Novel oral small molecules for progressive pulmonary fibrosis

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


ORG_CITY: Baltimore

ORG_NAME: SCANOGEN, INC.

PHR: Project Narrative We propose the development of a fully automated molecular platform for the diagnosis of bloodstream infections directly from whole blood without the need for blood culture. Here, we will develop and validate the first assay that will run on the platform. The assay will identify a panel of the most relevant yeasts and broadly detect every Candida species with a turn-around-time of 1.2 hours. The new assay responds to the urgent need for rapid identification of yeast pathogens in patients suspected of sepsis.

PI_NAMEs: CELEDON, ALFREDO ANDRES (contact)

PROGRAM_OFFICER_NAME: RITCHIE, ALEC

PROJECT_TERMS: Adoption;Affect;anti-fungal agents;assay development;Biological Assay;Blood;Blood specimen;Body Fluids;Candida;Clinical;Clinical Research;Clinical Sensitivity;Collaborations;Complex;Computer software;cost;cost effective;Death Rate;design;Detection;detection limit;detection method;detection platform;Development;Diagnosis;diagnosis standard;Diagnostic;Electronics;Engineering;experience;Feedback;Goals;Hospitals;Hour;improved;improved outcome;Infection;instrument;Length of Stay;Life;Logistics;Manuals;manufacturability;manufacture;Marketing;Mechanics;microorganism;Molecular;novel;pathogen;Patient-Focused Outcomes;Patients;Performance;Phase;Physicians;Pilot Projects;Preparation;Probability;Process;Production;Property;Protocols documentation;Recommendation;Refrigeration;Reproducibility;research clinical testing;Risk;Running;Sampling;scale up;Scanning;Scientist;screening;Sepsis;single molecule;Specificity;System;Technology;Testing;Time;touchscreen;United States;United States Food and Drug Administration;Universities;Update;usability;Whole Blood;yeast infection;Yeasts

PROJECT_TITLE: Bloodstream infection detection directly on whole blood

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-B (13)]


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cystic Fibrosis;Genetics;Human Genome;Lung;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Rare Diseases

ORG_CITY: CAMBRIDGE

ORG_NAME: XGENOMES CORP.

PHR: PROJECT NARRATIVE The sequence of our genomes underlies our health, but the cost and performance of current sequencing technologies are preventing genomics from realizing its full potential in healthcare. XGenomes’ novel and highly differentiated technology will revolutionize sequencing workflows and performance. This will help overcome current barriers that prevent sequencing becoming a routine part of our healthcare management.

PI_NAMEs: MIR, KALIM ULLAH (contact)

PROGRAM_OFFICER_NAME: MORRIS, STEPHANIE A

PROJECT_TERMS: Address;Algorithms;base;Binding;bioinformatics pipeline;Biological Assay;Blinking;Buffers;Cells;Chemicals;Chemistry;Clinical;clinical practice;clinically relevant;Computer software;cost;Cost Savings;Cystic Fibrosis Transmembrane Conductance Regulator;Data;Delta F508 mutation;density;Detection;Development;Distant;DNA;DNA sequencing;Elements;Event;Exons;experience;fluorescence imaging;fluorophore;Frequencies;Funding;Future;Genes;Genome;Genomics;Glass;Goals;Health;health management;Healthcare;Human;Image;image processing;Immobilization;Individual;Informatics;innovation;instrument;Kinetics;Knowledge;Letters;liquid biopsy;machine learning algorithm;Malignant Neoplasms;Maps;Measures;Methylation;Microscopy;Modification;Molecular;Monitor;nanopore;next generation sequencing;novel;novel strategies;Nucleic Acids;Nucleotides;Oligonucleotide Probes;Oligonucleotides;Performance;Phase;Positioning Attribute;Preparation;prevent;Privatization;Property;Protocols documentation;prototype;Reading;Reagent;Recurrence;Regulator Genes;Reproducibility;Research;RNA;Running;Sampling;scale up;sequencing platform;single cell sequencing;single molecule;Single Nucleotide Polymorphism;Site;Specificity;statistical and machine learning;superresolution imaging;synthetic construct;targeted sequencing;Technology;Temperature;Testing;Time;ultra high resolution;Variant;whole genome;Work

PROJECT_TITLE: Super-resolution single-molecule sequencing by observing the dynamic hybridization of a repertoire of oligonucleotides to DNA targets


NIH_SPENDING_CATS: Assistive Technology;Bioengineering

ORG_CITY: Miami

ORG_NAME: CITY LABS, INC.

ORG_STATE: FL

PHR: PROJECT NARRATIVE City Labs is making a tritium betavoltaic battery for leadless cardiac pacemakers (LCP); the battery can be as small as 0.1 cc, while providing a consistent ≥3.8 microwatts for 20 years. A biocompatible polyimide-based package will provide outgassing capabilities adequate for reaching diminutive volume and sufficient power requirements while minimizing the risk of package rupture. Development of a diminutive, helium-diffusing polyimide package will facilitate the potential use of LCPs for dual and multi-chamber pacing driven by a dramatic reduction in battery size.

PI_NAMEs: CABAUY, PETER  (contact)

PROGRAM_OFFICER_NAME: LIU, SONGTAO

PROJECT_TITLE: Leadless Pacemaker Betavoltaic Power Source

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


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Brain Disorders;Dementia;Neurodegenerative;Neurosciences;Prevention;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: ATLANTA

ORG_NAME: LENA BIOSCIENCES, INC.

PHR: This project will lay out foundation for cost-effective screening solutions that incorporate human genetic diversity in chemical hazard assessment. The “virtual human population” screen will assess the variability in inter-human thresholds, and identify susceptible individuals that respond adversely to lower doses of toxic chemicals or through different dose-dependent mechanisms than the rest of the population.

PI_NAMEs: VUKASINOVIC, JELENA  (contact)

PROGRAM_OFFICER_NAME: SHAUGHNESSY, DANIEL

PROJECT_TERMS: 3-Dimensional;Acetaminophen;Acetylcholinesterase;Acetylcholinesterase Inhibitors;Ache;Adverse effects;Adverse event;Affect;age effect;age group;Agreement;Agrochemicals;Air;Alzheimer's Disease;Alzheimer's disease risk;assay development;Astrocytes;Biochemical;Biological Assay;Biological Sciences;Biology;biopharmaceutical industry;Body Weight;Brain;Cell Death;Cell Differentiation process;Cell Respiration;Cells;Cellular Stress;Chemicals;cholinergic neuron;Coculture Techniques;Complex;consumer product;Consumption;Cooperative Research and Development Agreement;cost;cost effective;Data;Dose;drug induced liver injury;drug metabolism;drug withdrawal;Electron Transport;Elements;Enzymes;Ethnic Origin;Exposure to;Food;Foundations;gamma-Aminobutyric Acid;Gender;Genetic;Genetic Variation;Genome;Glutamates;Goals;Hazard Assessment;Health;Hemoglobin;Hepatocyte;Human;Human Genetics;human induced pluripotent stem cells;In Vitro;Individual;induced pluripotent stem cell;Industrial Product;Late Onset Alzheimer Disease;Legal patent;Liver;Macrophage;Marketing;Measures;Microglia;microphysiology system;Mitochondria;Modeling;multidisciplinary;National Institute of Environmental Health Sciences;Natural Immunity;Neurodegenerative Disorders;Neurons;Organ;Overdose;Oxidative Stress;Oxygen;Oxygen Consumption;Perfusion;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Pharmacology;Physiological;Poison;Population;postmitotic;Predisposition;Publications;Regenerative capacity;Reporting;Research;resilience;response;Rest;Risk;Risk Assessment;scaffold;screening;sex;Small Business Innovation Research Grant;Soil;System;Technology;technology development;technology platform;Testing;three dimensional cell culture;Tissue Engineering;Toxic effect;toxicant;Toxicity Tests;Toxicology;troglitazone;Uncertainty;Vendor;virtual human;Water;Withdrawal;Xenobiotic Metabolism

PROJECT_TITLE: An integrated MPS platform with "virtual humans" for chemical toxicity testing


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

ORG_CITY: DEL MAR

ORG_NAME: VIROGENICS, INC.

PHR: Narrative Currently there are no drugs that can prevent, slow or stop the progression of Alzheimer's disease. Our goal is to advance a novel compound that is both neuroprotective and able to harness advantageous aspects of the brain's immune system to prevent the loss of brain function in Alzheimer's disease and age-related cognitive decline. We have completed a Phase 1 clinical trial and now propose to conduct studies that will allow a longer term Phase 2 clinical trial.

PI_NAMEs: MAHER, PAMELA ANNE;RASCHKE, WILLIAM C (contact)

PROJECT_TERMS: Address;Adult;Adverse effects;Affect;Age-associated memory impairment;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease patient;Animals;Behavioral;Brain;Canis familiaris;capsule;Characteristics;Clinical;Clinical Trials;Cognition;Data;design;Development;Disease;disease model;Dose;drug candidate;drug development;Drug Interactions;Elderly;Elements;Evaluation;executive function;first-in-human;flexibility;Funding;Future;Genetic;Goals;Human;human subject;Immune system;Impaired cognition;improved;Length;Long-Term Effects;Manuals;Memory;Memory impairment;mouse model;neuroprotection;novel;novel strategies;novel therapeutic intervention;Oral;Parents;Patients;Pharmaceutical Preparations;pharmacologic;Phase;Phase I Clinical Trials;phase I trial;Phase II Clinical Trials;phase II trial;Play;Population;Preparation;prevent;Process;Quality of life;Rattus;Request for Applications;Role;Scientist;Senile Plaques;Series;Small Business Innovation Research Grant;small molecule;tablet formulation;Tablets;Testing;Therapeutic;therapeutic candidate;Time;Toxicology

PROJECT_TITLE: Paving the Way to Phase 2 Trials of CMS121 for Alzheimer's Disease


ORG_CITY: OMAHA

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF NEBRASKA MEDICAL CENTER

ORG_STATE: NE

PHR: Narrative With the introduction of combinational antiretroviral therapy (cART), the average age of people living with HIV (PLWH) increased considerably, and at present in the United States, more than half of the PLWH are aged 50 years or older. The interplay between HIV and aging involves complex immunological changes expected to influence the viral reservoirs. Therefore, this proposal is designed to understand the impact of aging-associated changes in DNA methylation profile and immune cell functions in HIV reservoirs using an SIV-infected cART- treated non-human primate model.

PI_NAMEs: ACHARYA, ARPAN  (contact)

PROGRAM_OFFICER_NAME: MIROCHNITCHENKO, OLEG

PROJECT_TERMS: 5 year old;acute infection;Address;Adult;Age;age related;age related changes;age-related disease;aged;Aging;aging population;aging process;aging related;animal old age;Antigen-Antibody Complex;Antigens;antiretroviral therapy;Autopsy;Birth;Blood - brain barrier anatomy;Blood Vessels;Brain;brain cell;CD4 Positive T Lymphocytes;Cell Physiology;cell type;Cells;chemokine;Chronic;Chronology;Clonal Expansion;cohort;Custom;cytokine;design;Disease;DNA Methylation;epigenetic aging;Epigenetic Process;epigenome;Genetic;Goals;HIV;Human;human data;Immune;Immune system;Immunophenotyping;Infant;Inflammation;Inflammatory;inflammatory milieu;insight;integration site;Interruption;Intervention;ITGAM gene;latent HIV reservoir;Letters;Life;lymph nodes;Lymphoid Tissue;Macaca;Macaca mulatta;Macrophage;Measures;Memory;memory CD4 T lymphocyte;Methylation;methylation pattern;Microglia;Modeling;monocyte;Mononuclear;neonate;nonhuman primate;Older Population;Peripheral Blood Mononuclear Cell;Persons;Phagocytes;Plasma;Population;Proliferating;Proviruses;Rectum;Reporting;Research;Sampling;SIV;Source;Study models;systemic inflammatory response;T memory cell;T-Lymphocyte;T-Lymphocyte Subsets;Therapeutic;Time;Tissues;United States;Viral;viral rebound;Viral reservoir;Virus Activation;Virus Integration

PROJECT_TITLE: SIV reservoirs dynamics during aging

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


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

ORG_CITY: SOLON

ORG_NAME: ZWICOAT MATERIALS INNOVATIONS, LLC

ORG_STATE: IA

PHR: Project Narrative: ZCMI is pioneering the application of zwitterionic thin-film coatings to existing medical implants—e.g., cochlear implants and endotracheal tubes—to greatly reduce scarring and infection rates that are common complications in these devices. Our company’s patented one-step process produces a mechanically-robust, ultra-low-fouling coating that permanently bonds to biomaterials. This SBIR project targets the development of scalable coating methods, rigorous testing under practical operating conditions, and comprehensive industry consultations in order to set the stage for a transformative commercial impact on the medical implant industry.

PI_NAMEs: HANSEN, KAMERON REX (contact)

PROGRAM_OFFICER_NAME: MILLER, ROGER

PROJECT_TERMS: 3T3 Cells;Address;Adhesions;Biocompatible Materials;Biological;biomaterial compatibility;capsule;Catheters;Cell Adhesion;Chronic;Cicatrix;Cochlea;Cochlear Implants;commercialization;Communication impairment;Complex;Confocal Microscopy;Consultations;covalent bond;Data;deep brain stimulator;Development;Devices;Dysarthria;Effectiveness;elastomeric;Elastomers;electric impedance;Electrodes;Encapsulated;endotracheal;Engineering;Equipment Malfunction;fabrication;Fibrosis;Film;Foreign Bodies;Friction;Geometry;Health Care Costs;Hearing;hearing impairment;Hospitals;Immunofluorescence Microscopy;Impairment;Implant;implantable device;implantation;Implanted Electrodes;improved;In Vitro;Industry;industry partner;Infection;infection rate;infection risk;Inflammation;Inflammatory;innovation;Intensive Care;Interview;Intubation;Iridium;Laryngeal Granuloma;Lead;Legal patent;Light;Longevity;Malignant Neoplasms;manufacture;Manufacturer;manufacturing process;Marketing;Mechanics;Medical;Medical Device;medical implant;meter;Methods;Microbial Biofilms;Mission;Modification;Modulus;Molds;Motivation;National Institute on Deafness and Other Communication Disorders;Nerve Tissue;neural;Nosocomial Infections;novel;Operating Rooms;Operative Surgical Procedures;Pacemakers;patient safety;Patient-Focused Outcomes;Patients;Performance;Persons;Phase;Physicians;Plastics;Platinum;polydimethylsiloxane;Polymers;Positioning Attribute;Procedures;Process;Property;Proteins;Protocols documentation;prototype;Provider;Public Health;Quality of life;Reaction;Research;Resistance;respiratory;response;Risk;Safety;Sensory;Serum Proteins;Silastic;Silicones;Small Business Innovation Research Grant;Specialist;Spinal Cord;Stenosis;Stents;Sterilization;success;Surface;Surgeon;Surveys;Techniques;Technology;Technology Transfer;Testing;Thick;Thinness;Tissues;tracheomalacia;Tracheotomy procedure;Tube;urinary;Work

PROJECT_TITLE: Durable Zwitterionic Coatings: Dramatic Reduction of Implant-Induced Inflammation and Fibrosis


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Acute Respiratory Distress Syndrome;Biodefense and Related Countermeasures;Biotechnology;Lung;Orphan Drug;Physical Injury - Accidents and Adverse Effects;Pulmonary Fibrosis;Rare Diseases

ORG_CITY: KINGS PARK

ORG_NAME: CMTX BIOTECH, INC.

PHR: PUBLIC HEALTH STATEMENT / PROJECT NARRATIVE Vesicating chemicals have been identified by the U.S. Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) as highly toxic chemicals of concern to public health security due to the devastating health effects of exposure. Vesicating agents can cause moderate to debilitating injuries and pain to the eye, skin, and mucous membranes. Sulfur mustard is a human-made chemical warfare agent that causes blistering of the skin and mucous membranes on contact. Depending on the dose, route, and duration of exposure, toxic symptoms can range in varying degrees of ocular and dermal burns, blister formation, bronchospasm, dyspnea, pulmonary edema, bronchitis, and immune- and bone marrow suppression. Unfortunately, no known antidote exists for sulfur mustard exposure. There remains a critical need for safe and effective medical countermeasures for the treatment of acute and chronic lung injuries caused by the inhalation of SM. This proposed project is directly relevant to the public health, since it is to develop a promising drug candidate for the treatment of this critical unmet medical need.

PI_NAMEs: VERESS, LIVIA AGNES (contact)

PROGRAM_OFFICER_NAME: YEUNG, DAVID

PROJECT_TERMS: Acne;Acute Lung Injury;Acute Respiratory Distress Syndrome;aerosolized;Agreement;AIDS with Kaposi's sarcoma;Animal Model;Antibiotics;Antidotes;Biological;Biological Markers;Biological Products;Biotechnology;Bone Marrow Suppression;Bronchial Spasm;Bronchiolitis Obliterans;Bronchitis;Bronchopulmonary Dysplasia;Bulla;Burn injury;Caring;CASP1 gene;Chemical Warfare;Chemical Warfare Agents;Chemicals;Chronic Lung Injury;Clinical;Clinical Treatment;Clinical Trials;commercial application;commercialization;cytokine;Dermal;Disease;Disparate;Disseminated Malignant Neoplasm;Dose;Doxycycline;drug candidate;drug development;drug production;Dyspnea;effective therapy;Eligibility Determination;emergency service responder;Endotoxins;Epithelium;expedited review;Exposure to;Eye;Family suidae;Fibrosis;forging;Formulation;Functional disorder;Future;Gelatinase A;Gelatinase B;Glioma;Goals;Good Manufacturing Process;guinea pig model;Hamsters;Health;hemodynamics;Histologic;Histology;Histopathology;Hospitals;Hour;Human;Immune;improved;Industrial Accidents;Inflammasome;Inflammation;Inflammatory;inflammatory marker;Inflammatory Response;Ingestion;Inhalation;Injury;Interleukin-6;International;Intravenous;Investigational Drugs;Knowledge;Lead;Lesion;lewisite;Licensing;lung injury;manufacturing scale-up;Marketing;Matrix Metalloproteinases;Mechanical ventilation;Mechlorethamine;Medical;medical countermeasure;Modeling;Mucous Membrane;Mus;Mustard;Mustard Gas;novel;novel therapeutics;Nuclear;Oral;Oral Administration;Pain;Pathogenesis;Pathologic;Patients;Peer Review;Periodontitis;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Poison;pre-Investigational New Drug meeting;Prevention;Public Health;Publications;Pulmonary Edema;Pulmonary Fibrosis;Radiology Specialty;Rattus;Recurrence;Refractory;Rosacea;Route;Safety;SARS-CoV-2 infection;Secure;Security;Sepsis;Sheep;Skin;Small Business Technology Transfer Research;small molecule;smoke inhalation;Symptoms;systemic inflammatory response;Terrorism;Tetracyclines;Therapeutic;TNF gene;Training;United States Dept. of Health and Human Services;Vesicants;voucher;Work

PROJECT_TITLE: A Novel, Host-Directed Therapeutic for the Treatment of Sulfur Mustard Induced Lung Injury


ORG_CITY: CORAL GABLES

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE

PHR: In this grant, we propose to identify several uninvestigated mechanisms through which aging deteriorates HIV-induced immune dysfunction, and we will identify possible senescent and metabolic candidates to target in order to prevent the negative effects of aging and HIV on the immune system. From a clinical perspective, this proposal may provide data that will open new avenues and help us to progress towards an overall better immune system in individuals with increased age and in those with HIV.

PI_NAMEs: FRASCA, DANIELA  (contact);PALLIKKUTH, SURESH

PROGRAM_OFFICER_NAME: TILAHUN, MULUALEM ENYEW

PROJECT_TERMS: acylcarnitine;Age;age effect;Aging;anaerobic glycolysis;analog;antiretroviral therapy;B-Lymphocyte Subsets;B-Lymphocytes;Bioenergetics;Biolectric Impedance;Blood;Body Composition;Body fat;CD8B1 gene;Cell Aging;Cell Physiology;cell type;Cells;Cellular Metabolic Process;Chronic;Clinical;cohort;Cohort Studies;comorbidity;Cytosol;Dasatinib;Data;Defect;Deterioration;Dose;Elderly;Environment;experimental study;fatty acid metabolism;Fatty Acids;fecal microbiome;Flow Cytometry;Functional impairment;Gender;Gene Expression Profile;Genus Hippocampus;Glucose;glucose uptake;Grant;Hip region structure;HIV;HIV Infections;Immune;immune activation;immune function;Immune response;Immune system;Immune System Diseases;Immunity;immunological status;immunoregulation;improved;In Vitro;Incubated;Individual;Infection;Inflammaging;Inflammation;Inflammatory;inflammatory marker;inhibitor;insulin sensitivity;Intervention;Lead;Lipids;Mass Spectrum Analysis;Measures;Metabolic;Metabolic Pathway;metabolic profile;Metabolism;metabolomics;microbial;microbiome analysis;Mitochondria;monocyte;Mus;Nutrient;obese person;Obesity;Oxidative Phosphorylation;Participant;Pathway interactions;Persons;Phenotype;Play;prevent;Protocols documentation;Pyruvate;Quercetin;Regulation;Reporting;Role;Sampling;senescence;senolytics;Serum;single-cell RNA sequencing;sociodemographics;Solid;Stains;stool sample;systemic inflammatory response;T-Lymphocyte;Testing;Thigh structure;Thinness;Tissues;uptake;Vaccines;Viral;Virus;Weight

PROJECT_TITLE: Metabolic deficits and immune dysfunction in aging people living with HIV