NIH_SPENDING_CATS: Cancer;Clinical Research;Prevention

ORG_CITY: Tucson

ORG_NAME: PRECISION EPIGENOMICS, INC.

ORG_STATE: AZ

PHR: Projective Narrative Determining the etiology of pleural effusion is a common challenge in clinical practice. Diagnosis is typically delayed in malignant pleural effusion. The goal of this project is to establish a new molecular diagnostic approach using Sentinel-MPE test to diagnose malignant pleural effusion.

PI_NAMEs: NELSON, MARK ANTHONY (contact)

PROGRAM_OFFICER_NAME: LOU, XING-JIAN

PROJECT_TERMS: Address;Affect;Arizona;Benign;Bioinformatics;Biological Assay;Biopsy;Blinded;Body Fluids;cancer cell;Cancer Center;Cancer Detection;cancer diagnosis;Cancer Diagnostics;Cancer Patient;cancer type;Case/Control Studies;cell free DNA;Characteristics;CLIA certified;Clinical;clinical practice;clinical research site;Collaborations;Common Carcinoma;Cytology;Data;design;Detection;detection sensitivity;detection test;Development;Diagnosis;Diagnostic;diagnostic strategy;Diagnostic tests;diagnostic tool;diagnostic value;Differential Diagnosis;DNA;DNA Methylation;Early Diagnosis;effusion;epigenomics;Etiology;experience;experimental study;Goals;Histologic;improved;Incidence;Inflammation;Laboratories;Lead;liquid biopsy;Liquid substance;Malignant - descriptor;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant neoplasm of pancreas;Malignant Neoplasms;Malignant Pleural Effusion;Marketing;Mesothelial Cell;Methods;Methylation;methylation biomarker;minimally invasive;Molecular;Molecular Diagnostic Testing;molecular diagnostics;molecular marker;Morbidity - disease rate;Morphology;Multi-site clinical study;neoplastic;neoplastic cell;Newly Diagnosed;novel;novel diagnostics;Pathology;Patient Care;Patients;Performance;Pilot Projects;Plasma;Pleura;Pleural;Pleural Diseases;Pleural effusion disorder;Process;prospective;Qualifying;ROC Curve;Sampling;Secondary to;Sensitivity and Specificity;Sentinel;Series;Signal Transduction;Small Business Innovation Research Grant;Surface;Technology;Testing;tool;tumor;Tumor Burden;Tumor stage;Universities;validation studies;verification and validation

PROJECT_TITLE: Development of a Molecular Assay to Diagnose Malignant Pleural Effusions

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


ADMINISTERING_IC: HL

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

ORG_CITY: SAN DIEGO

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: 3DT HOLDINGS, LLC

ORG_STATE: CA

PHR: NARRATIVE His pacing has recently emerged as treatment for heart failure which is an epidemic healthcare issue in the US. The objective of this Phase I proposal is to develop specialized tools to simplify His pacing and improve outcome for heart failure patients.

PI_NAMEs: COMBS, WILLIAM  (contact);KASSAB, GHASSAN S

PROGRAM_OFFICER_NAME: LIU, SONGTAO

PROJECT_TERMS: Address;Anatomy;Angiotensin-Converting Enzyme Inhibitors;Apex of the Heart;Bundle-Branch Block;Cardiac;cardiac resynchronization therapy;Cardiovascular system;Catheters;Chronic;Clinic;Clinical;cohort;Compensation;Consumption;Coronary;Coronary sinus structure;design;Devices;Diagnosis;Distal;Diuretics;Electrodes;Endocardium;Ensure;Epidemic;Family suidae;Fluoroscopy;Freedom;Goals;Health Care Costs;Healthcare;Heart;Heart failure;heart function;hemodynamics;Image;Implant;improved;improved outcome;Lead;Left;left ventricular assist device;Length;Location;Maps;Mechanics;Monitor;Morphology;mortality;Myocardial tissue;new technology;novel;Outcome;Pacemakers;Patients;Pattern;Pharmaceutical Preparations;Phase;Physiological;porcine model;Positioning Attribute;preservation;Radiation;Reproducibility;response;Right atrial structure;Rotation;Safety;sample fixation;Signal Transduction;Small Business Innovation Research Grant;Structure of purkinje fibers;success;Suction;Surface;System;Technology;Time;Tissues;tool;Translating;Treatment Cost;Variant;Ventricular;Work

PROJECT_TITLE: Novel Stabilization Catheter for His Pacing Lead Implant

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


ORG_CITY: Cambridge

ORG_NAME: DNA MEDICINE INSTITUTE

ORG_STATE: MA

PHR: PROJECT NARRATIVE Millions of patients currently benefit from direct factor Xa inhibitors such as apixaban and rivaroxaban. These patients can require emergency management if they suffer from uncontrolled bleeds or strokes. There is an urgent need to rapidly measure drug levels and hemoglobin at the point-of-care so andexanet alfa or thrombolytics can be safely administered in the shortest time possible.

PI_NAMEs: CHAN, EUGENE YAN-HO (contact)

PROGRAM_OFFICER_NAME: WARREN, RONALD Q

PROJECT_TERMS: Accident and Emergency department;Acute;age acceleration;Ambulances;andexanet;Anticoagulants;Antithrombin III;Area;Atrial Fibrillation;Benchmarking;Bilirubin;Biological Assay;Biological Availability;blind;Blinded;Blood;Blood capillaries;Blood specimen;Clinical;cost effective;design;Detection;detection limit;Development;Devices;dosage;drug clearance;drug testing;Emergency Situation;Ensure;Event;Factor Xa;Fluorescence;Fluorogenic Substrate;Freeze Drying;Guidelines;Hematocrit procedure;Hemoglobin;Hemorrhage;Heparin;Hospitalization;improved;Individual;individualized medicine;inhibitor;innovation;Intervention;Ischemic Stroke;Laboratories;Life;Light;Linear Regressions;Low-Molecular-Weight Heparin;Measurement;Measures;Metabolic Clearance Rate;meter;Methods;Microfluidics;monitoring device;Names;Nature;normal aging;Operative Surgical Procedures;Oral;Output;Patients;Performance;Pharmaceutical Preparations;Phase;point of care;point of care testing;Positioning Attribute;Reaction;Reagent;reconstitution;Reporting;Resources;response;risk mitigation;sample collection;Sampling;Sensitivity and Specificity;Series;Site;software systems;Specific qualifier value;Specificity;Standardization;Stroke;success;System;Techniques;Testing;Therapeutic;Time;Titrations;Triglycerides;validation studies;Venous;Whole Blood;Work

PROJECT_TITLE: 5-Minute Point-of-Care Anti-Factor Xa Test for Emergent Patient Management

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


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

ORG_CITY: Dallas

ORG_NAME: MAX-IR LABS, LLC

ORG_STATE: TX

PHR: Project Narrative Per- and polyfluoroalkyl substances (PFAS) are contaminants of emerging concern due to their persistent and bioaccumulative nature and high toxicity to human health and the ecosystem. PFAS sensors are essential in remediation applications to accurately detect and monitor the presence of these persistent contaminants. The public health relevance of the proposed sensor technology is its potential for real-time water quality monitoring in order to limit human exposure and environmental contamination.

PI_NAMEs: ROODENKO, ECATHERINA  (contact)

PROGRAM_OFFICER_NAME: HENRY, HEATHER F

PROJECT_TERMS: acronyms;American;Arizona;Attention;Attenuated;Biocompatible Coated Materials;Carbon;Carboxylic Acids;Categories;Chemicals;Classification;Collaborations;commercialization;Computer Analysis;Computer software;Contracts;cost effective;Data;Data Collection;Discriminant Analysis;Ecosystem;Environmental Pollution;Evaluation;exposed human population;field study;Goals;Health;Human;In Situ;industrial production;Industrialization;infrared spectroscopy;Ion Exchange;Kinetics;Laboratories;Legal patent;Licensing;Location;Measurement;Measures;Membrane;Methods;Monitor;Natural regeneration;Nature;Noise;North Dakota;Optics;Performance;Phase;Poly-fluoroalkyl substances;Polymers;portability;Preparation;Principal Component Analysis;Procedures;Process;Production;programs;Property;prototype;public health relevance;Regenerative research;remediation;Research;Sales;Sampling;scale up;Schedule;screening;sensor;sensor technology;Signal Transduction;Site;Small Business Innovation Research Grant;smart technologies;Societies;Standardization;Sulfonic Acids;Superfund;Surface;Technology;Temperature;Testing;Time;Toxic effect;Training;treatment optimization;Universities;Validation;Water;water sampling;water testing;water treatment;waveguide

PROJECT_TITLE: PFAS sensor for remediation and industrial wastewater treatment optimization applications

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


ORG_CITY: MALVERN

ORG_NAME: SHIFA BIOMEDICAL CORPORATION

ORG_STATE: PA

PHR: Project Narrative Heart disease is the leading cause of death for both men and women in the US. A high cholesterol level is a well-known risk factor for heart disease. Our goal is to develop new cholesterol oral bioavailable lowering drugs that have an effect on all individuals with high cholesterol levels, including that segment of the population that do not respond to statin, are statin intolerant or have very high cholesterol levels.

PI_NAMEs: ELSHOURBAGY, NABIL A (contact)

PROGRAM_OFFICER_NAME: DANTHI, NARASIMHAN

PROJECT_TERMS: Acids;Adverse event;Animals;antagonist;Anticholesteremic Agents;Binding;Biological Assay;Biological Availability;Biophysics;Black race;Blood;Blood Pressure;Body System;Canis familiaris;Cardiovascular Diseases;Cardiovascular system;Cause of Death;Cells;Central Nervous System;Certification;Cessation of life;Cholesterol;Cholesterol Homeostasis;Chromosome abnormality;Clinic;Clinical Trials;Conscious;cost;Cost of Illness;Coupled;Cytochrome P450;Data;Degradation Pathway;Development;Documentation;Dose;drug development;Drug Kinetics;drug market;Electronics;Enzymes;Epidemic;Exhibits;Failure;Formulation;Funding;G-Protein-Coupled Receptors;Genetic;Goals;Half-Life;Heart Diseases;Heart Rate;Hepatic;High Fat Diet;Hour;Human;hypercholesterolemia;improved;In Vitro;in vivo;Individual;Injectable;Investigational Drugs;Investigational New Drug Application;Ion Channel;Label;LDL Cholesterol Lipoproteins;Lead;Liquid substance;Liver;Liver Microsomes;Low Density Lipoprotein Receptor;Low-Density Lipoproteins;manufacture;Marketing;Maximum Tolerated Dose;men;meter;method development;Molecular Chaperones;Monoclonal Antibodies;Mus;Mutation;nano;nanoformulation;nanomolar;nanoparticle;novel;Nuclear Receptors;Oral;Oral Administration;Patients;Peptide Hydrolases;Persons;Pharmaceutical Preparations;Pharmacodynamics;pharmacokinetics and pharmacodynamics;pharmacologic;Pharmacologic Substance;Pharmacology;Phase;Phase I Clinical Trials;Phosphotransferases;Plasma;Population;pre-Investigational New Drug meeting;Preparation;Process;process optimization;Property;Protein Isoforms;Protein Precursors;Recombinants;Recovery;respiratory;Risk;Risk Factors;Rodent Model;Safety;Scanning;Services;Small Business Innovation Research Grant;small molecule;Solid;Subtilisin Like Proprotein Convertases;Technology;Testing;therapeutic target;Toxic effect;Toxicokinetics;Toxicology;United States;uptake;Validation;Value of Life;virtual screening;Woman;Work

PROJECT_TITLE: Executing the IND-Enabling Studies for Oral PCSK9/LDLR antagonist


ORG_CITY: POTOMAC

ORG_NAME: MIRA MEDICAL, LLC

ORG_STATE: MD

PHR: Project Narrative We will develop a new extracorporeal membrane oxygenation (ECMO) pump designed to efficiently accommodate the low flow rates needed for pediatric and neonatal patients. This device could improve our ability to perform extracorporeal membrane oxygenation and improve pediatric critical care.

PI_NAMEs: CLEARY, KEVIN R. (contact)

PROGRAM_OFFICER_NAME: SOOD, BEENA G

PROJECT_TERMS: Adult;Animals;Aorta;Back;base;biomaterial compatibility;Biomedical Engineering;Blood;Blood Cells;Blood flow;blood pump;Blood Volume;Businesses;Carbon Dioxide;Cardiopulmonary;Cardiovascular system;Child;Childhood;Circulation;Clinical;Clinical Management;Clinical Trials;comparative;Computer Models;Consultations;Critical Care;Dedications;design;Development;Devices;Diameter;Doctor of Philosophy;Drops;Engineering;Erythrocytes;Excision;experience;Extracorporeal Membrane Oxygenation;Geometry;Goals;Heart;Hematologist;Hemoglobin concentration result;Hemolysis;Hospitals;improved;improved outcome;indexing;innovation;Intercept;Laboratory Research;Lead;Life;Liquid substance;Maryland;Measures;Medical;medical schools;Modeling;multidisciplinary;Neonatal Intensive Care Units;neonatal patient;neonate;Neonatology;operation;Output;Oxygen;Oxygenators;Patients;pediatric patients;Pediatric Surgical Procedures;Pediatrics;Performance;Plasma;Platelet Activation;Population;prevent;Principal Investigator;professor;Prognosis;programs;prototype;Pump;Quality of life;Respiratory Failure;Rupture;Safety;Self-Help Devices;shear stress;Small Business Technology Transfer Research;Specific qualifier value;standard of care;System;Testing;Thrombosis;Toddler;tool;Training;Tube;Universities;Venous;Washington;Water;Work

PROJECT_TITLE: Efficient low flow pump for pediatric extracorporeal membrane oxygenation


ADMINISTERING_IC: MD

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Behavioral and Social Science;Biodefense and Related Countermeasures;Clinical Research;Clinical Trials and Supportive Activities;Coronaviruses;Coronaviruses Disparities and At-Risk Populations;Emerging Infectious Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Racial and Ethnic Minority Health Research;Rural Health;Social Determinants of Health

ORG_CITY: WINSTON-SALEM

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: WAKE FOREST UNIVERSITY HEALTH SCIENCES

ORG_STATE: NC

PHR: As the total number of COVID-19 cases continue to skyrocket in the United States, glaring racial disparities in morbidity and mortality have emerged, with African Americans being disproportionately impacted. Public health campaigns and non-pharmaceutical interventions that are community-driven and developed in collaboration with community members, public health agencies, and researchers may offer a more acceptable and effective approach that could enable the US to drastically reduce COVID-19 transmission and address individual and socio-structural barriers that lead to worse COVID-19-related outcomes among African Americans. Our study goals are to leverage social innovation and multisectoral partnerships to promote COVID-19 testing and encourage the public to adopt health-promotive behaviors.

PI_NAMEs: RITCHWOOD, TIARNEY D (contact)

PROGRAM_OFFICER_NAME: MUJURU, PRISCAH

PROJECT_TERMS: 2019-nCoV;Address;Adopted;Adult;African American;African American population;American;Behavior;care coordination;Communities;community academic partnership;community collaboration;community led intervention;Contact Tracing;coronavirus disease;COVID-19;COVID-19 complications;COVID-19 morbidity;COVID-19 testing;crowdsourcing;digital;Disease;disparities in morbidity;empowerment;experimental study;Goals;Health;Health Campaign;Individual;Inequity;innovation;Intervention;Investigation;Link;Masks;meetings;member;mortality;North Carolina;novel coronavirus;Outcome;Persons;Play;programs;Protocols documentation;Public Health;racial disparity;Randomized;Research Personnel;Resources;response;Risk;Role;Rural;Rural Community;Safety;SARS-CoV-2 exposure;SARS-CoV-2 infection;SARS-CoV-2 transmission;Services;social;social structure;Structural Racism;Time;United States;Vulnerable Populations

PROJECT_TITLE: Community-Academic Partnerships to Address COVID-19 Inequities within African American Communities


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Bioengineering

ORG_CITY: BATON ROUGE

ORG_NAME: LASER BIOANALYTICS LLC

ORG_STATE: LA

PHR: Project Narrative Determining the structure of lipids in tissue is important to understanding biological systems and diagnosing and treating diseases. The goal of this project is to develop a new device for patterned photochemical modification of lipids in tissue to enhance structure determination by imaging mass spectrometry. The proposed system uses pulsed ultraviolet and visible laser beams to drive photochemical reactions in tissue that allow the structure and distribution of lipids in tissue sections to be determined.

PI_NAMEs: MURRAY, KERMIT KING (contact)

PROGRAM_OFFICER_NAME: SALVADOR MORALES, CAROLINA

PROJECT_TERMS: Ablation;Acetone;Alkanes;Benzophenones;Biochemical;biological systems;Cardiovascular Diseases;Cell membrane;Cellular Structures;Chemicals;Chemistry;Clinical;Clinical Research;cycloaddition;Deposition;Derivation procedure;Device or Instrument Development;Devices;Diagnosis;Diagnostic;Disease;experimental study;fundamental research;Goals;Image;improved;innovation;instrument;instrumentation;interest;ionization;Ions;Isomerism;Laboratory Research;Lasers;lipid structure;Lipids;Location;Louisiana;mass spectrometer;mass spectrometric imaging;Mass Spectrum Analysis;Metabolic Diseases;Methods;Microscope;Modification;nanosecond;new technology;Pattern;Phase;Photochemistry;Physiologic pulse;pi bond;Positioning Attribute;Procedures;Process;professor;Proteins;prototype;Reaction;Reagent;Research;Research Support;Resolution;Sampling;Scanning Probe Microscopes;Signal Transduction;Slide;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Source;Specific qualifier value;Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization;Structure;System;tandem mass spectrometry;Techniques;Technology;Tissues;tool;ultraviolet;Ultraviolet Rays;Universities;Unsaturated Fats;Visible Radiation;Work

PROJECT_TITLE: Photochemical Tissue Modification for MALDI Mass Spectrometry Imaging

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


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Chronic Pain;Clinical Research;Health Services;Mental Health;Mental Illness;Pain Research;Prevention;Serious Mental Illness;Substance Misuse;Telehealth

ORG_CITY: HANOVER

ORG_NAME: SQUARE2 SYSTEMS, INC.

ORG_STATE: NH

PHR: Project Narrative The proposed project will be the first to commercialize a unique transdiagnostic digital therapeutics development and hosting platform grounded in the science of behavior change for any population. This will replace the currently time- and cost-inefficient processes of developing digital therapeutics and rapidly accelerate the pace at which science-based digital therapeutics can transform healthcare.

PI_NAMEs: GRABINSKI, MICHAEL JOHN (contact)

PROGRAM_OFFICER_NAME: HAIM, ADAM J

PROJECT_TERMS: Acceleration;Accident and Emergency department;Achievement;Address;Adult;Alcohols;Anxiety;Attention deficit hyperactivity disorder;Behavior;behavior change;Behavior Therapy;Behavioral;behavioral health;Binge eating disorder;Budgets;Cannabis;Caring;Charge;chronic pain;chronic pain patient;Clinical;Clinical Research;commercialization;Communities;Computer software;cost;Development;diabetes management;Diagnostic;digital delivery;digital health;digital platform;digital treatment;Disease;Disease remission;Drops;Eating Disorders;Emergency department visit;Ethnic Origin;Evaluation;evidence base;Exercise;experience;functional improvement;Funding;Future;Health;Health behavior;Health behavior and outcomes;Health Care Costs;health equity;Health Personnel;Healthcare;improved;Inpatients;interest;Language;Learning;Medical;medication compliance;Mental Depression;Mental disorders;Mental Health;Mental Health Services;mental training;Modeling;Nature;Nicotine;Opioid;Pain management;Panic Disorder;patient oriented;Persons;Phase;polysubstance use;Population;Positioning Attribute;prevent;Prevention;Problem behavior;Process;prototype;Race;Research;Research Personnel;scale up;Schizophrenia;Science;Scientist;Sex Orientation;skills;Small Business Innovation Research Grant;Smoking;Stimulant;substance use;Substance Use Disorder;substance use treatment;Suicide;suicide rate;System;Target Populations;Testing;Therapeutic;therapeutic development;Time;tool;Transcend;United States National Institutes of Health;usability;Work

PROJECT_TITLE: Transforming mental health care via science-based, personalizable and scalable digital therapeutics

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Infectious Diseases;Microbiome;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Sexually Transmitted Infections;Women's Health Research

ORG_CITY: EMERYVILLE

ORG_NAME: TOPAZ BIOSCIENCES, INC.

PHR: NARRATIVE Bacterial vaginosis (BV) is the most common vaginal dysbiosis in women of reproductive age and is associated with a number of serious health complications including preterm delivery, low birth weight, miscarriage, sexually transmitted infections, and pelvic inflammatory disease. Standard antibiotic treatment suffers from high rates of relapse, the development of antibiotic resistant bacteria, and collateral damage to the beneficial bacteria in the vaginal microbiome. Topaz Biosciences is developing a class of high-specificity, cell wall- degrading enzymes that enable targeted killing of a bacteria that plays a critical role in the development of BV, Gardnerella vaginalis, while preserving the components of the healthy vaginal microbiome and providing an alternative to traditional antibiotics.

PI_NAMEs: LIU, OLIVER WEI (contact)

PROGRAM_OFFICER_NAME: CONNOLLY, KRISTIE LEE

PROJECT_TERMS: Age;anti-microbial drug;Antibiotic Therapy;Antibiotics;Atopobium vaginae;Bacteria;Bacterial Antibiotic Resistance;Bacterial Vaginosis;Bacteriophages;Benchmarking;Binding;Biological Assay;Biological Sciences;Cell Wall;Cells;Chimeric Proteins;Codon Nucleotides;Data Set;Databases;design;Development;domain walls;dysbiosis;endolysin;Engineering;Environment;Enzymes;Epitopes;Etiology;Gardnerella;Gardnerella vaginalis;Growth;Health;improved;insight;Lactobacillus;Libraries;Low Birth Weight Infant;Lytic;Measurement;Metagenomics;Microbial Biofilms;microbiome;novel;Organism;Pelvic Inflammatory Disease;Phase;Play;Premature Birth;preservation;Proliferating;Property;Prophages;protein B;Proteins;Relapse;Reproducibility;reproductive;Role;screening;Sexually Transmitted Diseases;Source;Specificity;Spontaneous abortion;Staphylococcus aureus;synthetic biology;Temperature;Testing;thermostability;Topaz;Vagina;vaginal microbiome;Woman

PROJECT_TITLE: Metagenomic discovery and optimization of novel endolysins targeting Gardnerella vaginalis to treat bacterial vaginosis

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


ADMINISTERING_IC: DP

IC_NAME: NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION

ORG_CITY: Del Mar

ORG_NAME: EMPOWERX, INC.

PHR: Project Narrative With 95% of unintended pregnancies in the United States attributed to incorrect, inconsistent, or non-use of contraception, improving access to reliable contraception is an important public health issue and pharmacists are well-positioned to improve access via pharmacist-prescribed contraception services. This application builds upon the findings from Phase I to create a user-informed, comprehensive Hormonal contraceptive Access via Pharmacist Prescribing Implementation (HAPPI) toolkit comprising of a software application and a web-based professional community of practice to support implementation of pharmacist-prescribed contraception services. Principles of co-design, user experience (UX) research and design, and a clinical trial will be used to ensure the end product is proven, useful, market-ready, and acceptable to end-users, and therefore set up for commercial success.

PI_NAMEs: MEREDITH, ASHLEY H;NEWLON, JENNY LEIGH;RAFIE, SALLY  (contact)

PROGRAM_OFFICER_NAME: BROWN, NATALIE

PROJECT_TITLE: Hormonal contraceptive Access via Pharmacist-Prescribing Implementation package (HAPPI)

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


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Behavioral and Social Science;Biotechnology;Brain Disorders;Drug Abuse (NIDA only);Neurosciences;Opioid Misuse and Addiction;Opioids;Prescription Drug Misuse;Substance Misuse

ORG_CITY: NEW YORK

ORG_NAME: JILLION THERAPEUTICS INC.

ORG_STATE: NY

PHR: Project narrative: Substance use disorders (SUDs) such as opioid use disorders (OUDs) result from the imbalance of signaling pathways affecting the reward system, and lead to long-lasting changes in the brain. This rewiring of the brain greatly affects G-protein coupled receptors (GPCRs), an important therapeutic class representing about a third of all FDA approved drugs. Remarkably, 85 of those receptors are understudied (also called orphan or oGPCRs), and several are highly and selectively expressed in brain regions that are important for SUDs, and selectively in important neuronal cell types. These oGPCRs represent fantastic opportunities to rebalance defective brain pathways. This Phase I SBIR proposal aims at demonstrating that our powerful DNA-encoded library (DEL) technology can be used very effectively to identify high-affinity drug- like molecules binding to one of those uncharacterized signaling receptors to modulate its activity. The goal is to correct long lasting brain signaling anomalies created by chronic opioid use and OUDs in general without targeting the problematic opioid receptor system, or any of the conventional ones including the dopaminergic system. Demonstrating the validity of this approach could serve as the blueprint for finding cures to other SUDs.

PI_NAMEs: FLAJOLET, MARC  (contact)

PROGRAM_OFFICER_NAME: NGUYEN, TAM L

PROJECT_TERMS: Address;Adult;Affect;Affinity;Agonist;American;antagonist;Anxiety;Basal Ganglia;Behavior;behavior test;Binding;Biochemical;Biological;Biological Assay;Brain;brain pathway;Brain region;Cell Line;Cell membrane;cell type;Cells;chemical synthesis;Chemicals;Chronic;Classification;Competence;Corpus striatum structure;cost effective;Coupled;CREB1 gene;Cyclic AMP;Data;Dedications;Dependence;Detergents;Digit structure;Disease;DNA;Dopamine;Dopamine Receptor;DRD2 gene;drug discovery;drug of abuse;Drug Receptors;Drug Screening;Drug usage;Drug Use Disorder;drug-like compound;Eligibility Determination;Ensure;Equilibrium;Escherichia coli;Ethanol;Exhibits;experience;Family;FDA approved;Floods;Foundations;Future;G Protein-Coupled Receptor Signaling;G-Protein-Coupled Receptors;Geometry;Goals;heuristics;high throughput screening;high-throughput drug screening;Imaging Device;Immobilization;improved;in vivo;innovation;Knockout Mice;Knowledge;Libraries;Licensing;Ligands;Link;Mammalian Cell;Mediating;Melatonin;Membrane;Mental Depression;Mental disorders;Methods;Molecular Weight;Morphine;Morphine Abuse;Morphine Dependence;mu opioid receptors;nanodisc technology;nanomolar;Neurons;neurotransmission;novel;novel therapeutics;Opioid;opioid overdose;Opioid Receptor;opioid use;opioid use disorder;Orphan;Outcome;overexpression;Pathway interactions;Pharmaceutical Chemistry;Pharmaceutical Preparations;Phase;Phosphorylation;Physiological;Population;preference;Prevalence;programs;Property;protein purification;Proteins;Protocols documentation;receptor;Receptor Signaling;Regulation;Reporting;Research;Rewards;Sampling;scaffold;screening;selective expression;Series;Signal Pathway;Signal Transduction;Small Business Innovation Research Grant;Solubility;Source;Sphingolipids;stable cell line;Statistical Data Interpretation;Substance Use Disorder;System;Techniques;Technology;Testing;Therapeutic;tool;Toxic effect;translational approach;Universities;Validation;Withdrawal

PROJECT_TITLE: The use of DNA-encoded library (DEL) technology for the identification of therapeutic molecules to treat opioid use disorders (OUDs)

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Biotechnology;Chronic Liver Disease and Cirrhosis;Digestive Diseases;Gene Therapy;Genetics;Liver Disease;Orphan Drug;Rare Diseases

ORG_CITY: HOUSTON

ORG_NAME: HYDROGENE THERAPEUTICS INC

PHR: PROJECT NARRATIVE There is currently no gene therapy delivery method that is suitable for translation into the clinic to safely treat Hereditary Tyrosinemia type 1 (HT1). HydroGene has developed a method of hydrodynamic injection through the biliary system to deliver non-viral DNA directly and efficiently into human livers. Given the routine nature and safety of the procedure, along with low costs associated with the production of naked DNA, this method is well suited for clinical translation toward scalable and affordable gene therapy of HT1 and many other genetic liver diseases.

PI_NAMEs: KUMBHARI, VIVEK  (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Acute;Affect;Ammonia;Animal Model;Animals;autosome;Benign;Biliary;biliary tract;Biochemical;Biodistribution;Blood;Blood Circulation;Cell Death;Cells;Cessation of life;Chronic;Cirrhosis;Clinic;Clinical;clinical application;clinical translation;Clinical Trials;clinically relevant;cost;cost effective;curative treatments;Data;daughter cell;Disease;DNA;DNA Transposons;Dose;Enzymes;experience;Family suidae;Fibrosis;Fumarylacetoacetase;Gene Delivery;Gene Expression;gene therapy;gene-targeted therapy;Genes;Genetic;Genome;Genomics;Goals;Growth;Hepatocyte;hepatocyte injury;Histology;Human;Hydrolase;Immune;immunotoxicity;In Vitro;in vivo;Inborn Errors of Metabolism;Inflammation;Inherited;Injections;Interruption;Left;Legal patent;Life;Liquid substance;Live Birth;Liver;Liver diseases;Liver Dysfunction;Liver Failure;Liver Fibrosis;liver injury;liver transplantation;manufacture;meetings;Membrane;Messenger RNA;Methods;Modeling;mouse model;mRNA delivery;Mus;Nature;Neurocognitive Deficit;Neurologic;non-viral gene delivery;non-viral gene therapy;Normal Range;Other Genetics;Patients;Pharmacological Treatment;Phase;Phenotype;plasmid DNA;Population;pressure;Primary carcinoma of the liver cells;procedure safety;Procedures;Production;promoter;Protein Isoforms;Protocols documentation;Rare Diseases;Regimen;renal damage;Residual state;Risk;RNA;Safety;succinylacetone;System;Tail;Toxic effect;Transgenes;Translating;Translations;Transposase;Treatment Efficacy;Treatment Protocols;tumor;Tyrosine;Tyrosine Metabolism Pathway;Tyrosinemias;vector;Veins;Weight

PROJECT_TITLE: Lifelong Correction of Hereditary Tyrosinemia Type 1 and Other Monogenic Liver Diseases using Liver-specific Hydrodynamic Gene Delivery through the Biliary System

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


NIH_SPENDING_CATS: Autism;Behavioral and Social Science;Brain Disorders;Clinical Research;Intellectual and Developmental Disabilities (IDD);Mental Health;Mental Illness;Pediatric;Serious Mental Illness;Suicide

ORG_CITY: CHICAGO

ORG_NAME: ADAPTIVE TESTING TECHNOLOGIES

ORG_STATE: IL

PHR: Project Narrative While psychiatric conditions and suicide risk occur at substantially elevated rates in children and adolescents with autism, there is a lack of validated tools to promote psychiatric evaluation in this population. The goal of this project is to develop an accurate, comprehensive, and efficient measure of mental health symptoms in autistic youth, the K-CATⓇ Autism Version, to improve the detection and subsequent treatment of co-occurring psychiatric difficulties.

PI_NAMEs: CERVANTES, PAIGE ELIZABETH;COHEN, YEHUDA  (contact)

PROGRAM_OFFICER_NAME: GRABB, MARGARET CHRISTINE

PROJECT_TERMS: 17 year old;acceptability and feasibility;Address;adolescent with autism spectrum disorder;adverse outcome;Algorithms;Anxiety;Area;Assessment tool;Attention;Attention deficit hyperactivity disorder;Autism Diagnosis;autism spectrum disorder;autistic children;Bipolar Disorder;blind;Caregivers;Caring;Child;Clinical assessments;clinical research site;Communities;Complex;computerized;Conduct Disorder;Data;Detection;Development;Diagnosis;Dimensions;Disease;Disparity;Educational Status;Electronics;Eligibility Determination;emotion regulation;Emotional disorder;Evaluation;evidence base;Exclusion;experience;Feedback;Feeling;Funding;General Population;Generalized Anxiety Disorder;Goals;health assessment;Hylobates Genus;impression;improved;individuals with autism spectrum disorder;informant;instrument;Intellectual functioning disability;Interview;Language;Letters;Licensing;Major Depressive Disorder;Manic;Measures;Mental Depression;Mental Health;Methods;Modification;Monitor;Moods;Online Systems;Oppositional Defiant Disorder;Outcome;Parents;Participant;Performance;Phase;Pilot Projects;Population;prevent;Property;Psychometrics;Questionnaires;recruit;Reporting;Research;Sampling;screening;Services;Severities;social communication;Structure;Substance Use Disorder;suicidal risk;Suicide;suicide rate;Surveys;Symptoms;Technology;Testing;Time;tool;Training;treatment response;Validation;Youth

PROJECT_TITLE: Modifying and validating the K-CAT mental health scales for children and adolescents on the autism spectrum


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Biotechnology;Cardiovascular;Duchenne/ Becker Muscular Dystrophy;Muscular Dystrophy;Orphan Drug;Pediatric;Rare Diseases

ORG_CITY: BOSTON

ORG_NAME: MYOFINITY BIOSCIENCES INC

PHR: PROJECT NARRATIVE Muscular dystrophies are severe genetic disorders involving progressive muscle wasting that leads to compromised muscle structure, decreased muscle function, loss of independence and eventual death. Becker muscular dystrophy (BMD) is a common lethal genetic disease that represents a truly unmet medical need, as there is currently no cure for any form of muscular dystrophy. Our commercialization effort proposed in this project will generate proof-of-principle data and other data to prepare a new protein therapeutic product for future clinical trials for the treatment of BMD in patients without other impactful treatment options for this lethal disease.

PI_NAMEs: WEISLEDER, NOAH  (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Acceleration;Amino Acid Motifs;Amino Acid Sequence;Becker Muscular Dystrophy;Binding;Binding Proteins;Biochemical;Biological Assay;Biotechnology;Cardiac Myocytes;Cardiovascular system;Cell Culture Techniques;Cells;Cessation of life;Chemistry;Chinese Hamster Ovary Cell;Clinical;clinical development;Clinical Treatment;Clinical Trials;cohort;Collaborations;commercialization;Compensation;Complementary therapies;Cultured Cells;Cytoskeletal Proteins;Data;Development;Disease;Doctor of Philosophy;Dose;Duchenne muscular dystrophy;dysferlinopathies;Dystrophin;efficacy testing;efficacy trial;Engineering;Escherichia coli;Future;Generations;Genes;Genetic Diseases;Goals;Heart Injuries;Human;immunogenicity;improved;improved outcome;Inbred BALB C Mice;interest;Investigational New Drug Application;Knockout Mice;Laboratories;Letters;Link;manufacture;Measurement;Medical;Membrane;metabolic abnormality assessment;Metabolism;Methods;Modeling;mouse model;Mus;Muscle;Muscle Cells;Muscle Development;Muscle function;muscle physiology;Muscular Atrophy;Muscular Dystrophies;muscular structure;Mutation;Myoblasts;Myocardium;Myopathy;novel;novel therapeutics;Ohio;overexpression;Pathology;Patient-Focused Outcomes;Patients;Pharmacologic Substance;Phase;Phenotype;Phosphatidylserines;preclinical efficacy;preclinical trial;Predisposition;Procedures;Production;professor;Property;protein function;Proteins;Protocols documentation;Randomized;Recombinants;Recording of previous events;repaired;Research;restoration;Rodent Model;scale up;Site;skeletal;Skeletal Muscle;Small Business Innovation Research Grant;Source;stability testing;success;technology platform;Therapeutic;Therapeutic Intervention;therapeutic protein;therapy development;Toxic effect;Toxicokinetics;TRIM Motif;ubiquitin-protein ligase;United States Food and Drug Administration;Universities;Work

PROJECT_TITLE: Membrane repair as a therapeutic intervention for treating Becker Muscular Dystrophy


NIH_SPENDING_CATS: Aging;Kidney Disease

ORG_CITY: CHARLESTON

ORG_NAME: FIBROTHERAPEUTICS, INC.

ORG_STATE: SC

PHR: Narrative Fibrosis (the stiffening of tissues due to collagen overproduction/deposition) and blood vessel leakage are major contributors to the pathological alterations in tissue structure and function that occur in many organs in which fibrotic diseases are occurring. We have been developing a novel peptide drug based on the caveolin-1 scaffolding domain peptide (CSD) and have identified an orally active Lead Compound that inhibits fibrosis and vascular leakage in multiple model systems. In this proposal, we will develop the Lead Compound as a treatment for chronic kidney disease by using two model systems to determine the dose dependence of its beneficial effects, its toxicity (if any) at high doses, and its beneficial effects when treatment is delayed until the disease is well-developed.

PI_NAMEs: HOFFMAN, STANLEY R (contact)

PROGRAM_OFFICER_NAME: CONAGE-POUGH, JASON EDWARD

PROJECT_TERMS: absorption;Active Sites;ADME Study;Adult;Affect;African American population;aged;aging related;Albuminuria;American;Amino Acids;Angiotensin II;Asian population;Biochemistry;Biological Markers;Biological Models;Bleomycin;Blood Pressure;Blood Vessels;Body System;Body Weight;Brain;caveolin 1;Cells;Characteristics;Chronic Kidney Failure;Collagen;coronary fibrosis;Creatinine;Dependence;Deposition;Detection;Diabetes Mellitus;Dialysis procedure;Disease;Dose;drug development;Drug usage;End stage renal failure;Enzymes;Essential Hypertension;Evaluation;Excretory function;Extravasation;Fibrosis;Future;Glomerular Filtration Rate;glomerulosclerosis;Heart;High Pressure Liquid Chromatography;High Prevalence;Hispanic Populations;improved;Infiltration;Inflammatory;Infusion procedures;Kidney;Kidney Diseases;Kidney Failure;kidney fibrosis;Kidney Transplantation;Lead;Length;Metabolism;Modeling;Morphology;mouse model;Mus;Names;novel;novel therapeutics;Obesity;old mice;Operative Surgical Procedures;Oral;Oral Administration;Organ;Pathologic;Pathway interactions;peptide drug;Peptide Fragments;Peptides;pharmacologic;Phase;Phosphotransferases;Play;Positioning Attribute;Production;Profibrotic signal;Property;Protein Tyrosine Kinase;Protocols documentation;Pulmonary Fibrosis;Regulation;Renal function;Role;scaffold;Series;skin fibrosis;Small Business Technology Transfer Research;Structure;success;Tertiary Protein Structure;Therapeutic;Therapeutic Index;therapeutic target;Tissues;Toxic effect;Toxicology;Ureteral obstruction;Water;Weight;Western Blotting

PROJECT_TITLE: Novel Therapeutic for Kidney Failure: A Modified, Water-Soluble Orally-Active Caveolin-1 Scaffolding Domain Peptide with Improved Characteristics for Drug Development

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


NIH_SPENDING_CATS: Biotechnology;Cancer;Congenital Structural Anomalies;Gene Therapy;Genetics;Hematology;Orphan Drug;Pediatric;Pediatric Cancer;Primary Immunodeficiencies;Rare Diseases;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Nonembryonic - Non-Human;Transplantation

ORG_CITY: FORT WORTH

ORG_NAME: KINETIQ THERAPEUTICS LLC

PHR: Public Health Relevance Fanconi anemia is a rare genetic disorder that primarily affects children and causes congenital deformities, damages the organs, and leads to potentially life-threatening bone marrow failure and cancers. Currently, no standard treatments are available and Fanconi patients rely on symptomatic management, blood transfusions, or bone marrow transplants to alleviate disease burden. To solve these challenges, Kinetiq is developing a novel therapy aimed to degrade the toxic substances linked to disease. Successful development of this treatment will greatly improve patient quality of life and well-being and potentially extend life expectancy.

PI_NAMEs: CAO, MINGJU  (contact)

PROGRAM_OFFICER_NAME: QASBA, PANKAJ

PROJECT_TERMS: Acceleration;Acetaldehyde;Address;Affect;aldehyde dehydrogenases;Aldehydes;Animal Model;Biodistribution;Biological Sciences;Blood;Blood Cell Count;Blood specimen;Blood Transfusion;Bone Marrow;Bone marrow failure;Bone Marrow Transplantation;burden of illness;Cardiorenal syndrome;Catabolism;cell injury;Child;Clinical;commercial application;common symptom;comparison intervention;Complex;conditioning;Congenital Abnormality;Defect;Development;Disabling;Disease;DNA Damage;DNA Repair;Dose;drug disposition;Drug Kinetics;Drug Metabolic Detoxication;Drug or chemical Tissue Distribution;Environment;enzyme activity;enzyme replacement therapy;Enzymes;Ethnic Population;Exhibits;Exposure to;Fanconi's Anemia;Fluorometry;Food;Formaldehyde;Future;gastroesophageal cancer;gene therapy;Genes;Genome Stability;genotoxicity;Half-Life;Heart;Hematologic Neoplasms;Hematopoiesis;Hematopoietic;Hematopoietic Cell Growth Factors;Hematopoietic Stem Cell Transplantation;Hereditary Disease;improved;in vivo;Industrialization;Ingestion;Inherited;Intervention;intravenous injection;Kidney;Legal patent;leukemia;Life;Life Expectancy;Link;Liver;Lung;malformation;Malignant Neoplasms;Marketing;Mass Spectrum Analysis;Metabolism;Microcephaly;Modality;Molecular;Morbidity - disease rate;mortality;mortality risk;Mutation;Myocardial Ischemia;novel;novel therapeutic intervention;novel therapeutics;Organ;Outcome;Oxidoreductase;Pancreas;Pancytopenia;Pathogenesis;Pathway interactions;Patients;Penetration;Personal Satisfaction;Persons;pharmacologic;Phase;Physiological;Plasma;Play;Poison;post intervention;Predisposition;Prevalence;Procedures;Property;public health relevance;Quality of life;racial population;rare genetic disorder;Recurrence;Regimen;repaired;Risk;Rodent;Role;Safety;Sampling;skeletal;Skin;Skin Abnormalities;Skin Pigmentation;Small Business Innovation Research Grant;Source;Sprague-Dawley Rats;standard care;standard of care;Steroids;Stimulant;Syndrome;Testing;Texas;Therapeutic;therapy development;Time;Tissues;Toxic effect;Transplantation;Weight;Work

PROJECT_TITLE: Evaluating a Novel Enzymatic Modality for the Treatment of Fanconi Anemia


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Orphan Drug;Pediatric;Rare Diseases;Stem Cell Research;Stem Cell Research - Nonembryonic - Non-Human

ORG_NAME: NOSTOPHARMA, LLC

PHR: Project Narrative Progressive osseous heteroplasia (POH), an extremely rare genetic disorder, with currently no effective treatment available, is characterized by abnormal and progressive development of bone in areas of the body where bone is not normally present (heterotopic ossification). Nostopharma is developing repurposed drug combinations as a promising approach to achieve a synergistic therapeutic effect, dose, and toxicity reduction of Hedgehog pathway (Hh) inhibitors for POH patients. The supplemental study will evaluate the broad range of small molecules that can be repurposed towards altering the aberrant mesenchymal progenitor cells differentiation into bone cells and drug combination efficacy in-vitro.

PI_NAMEs: JEREMIC, JELENA GVOZDENOVIC (contact)

PROGRAM_OFFICER_NAME: RAJAGOPAL, MEENA UMA

PROJECT_TERMS: Acute;Address;Adenylate Cyclase;Affect;Area;Arsenic Trioxide;Authorization documentation;bone;bone cell;Bone Development;Bone Diseases;Childhood;Chronic;Clinical;clinical development;Combined Modality Therapy;Connective and Soft Tissue;Connective Tissue;Dermal;Dose;Drug Combinations;Drug Exposure;drug repurposing;effective therapy;Encapsulated;Erinaceidae;Fascia;Formulation;Frequencies;G-Protein-Coupled Receptors;Genes;GNAS gene;Growth;GTP-Binding Protein alpha Subunits, Gs;Heterotopic Ossification;immunoregulation;In Vitro;infancy;inhibitor;joint stiffness;Joints;Lead;Ligaments;Limb structure;Mesenchymal Stem Cells;Mus;Muscle;Mutation;nanoparticle;novel;Osteoblasts;Osteogenesis;Pathway interactions;Patients;Physiologic Ossification;pre-clinical;Progressive osseous heteroplasia;rare genetic disorder;Role;screening;Seminal;side effect;Skeletal Muscle;small molecule;smoothened signaling pathway;soft tissue;stem cell differentiation;stem cell fate;stem cells;subcutaneous;Tendon structure;Testing;Therapeutic Effect;Time;Tissues;Toxic effect

PROJECT_TITLE: Small molecules combination therapy using polypharmacology approach as a novel treatment paradigm for rare bone disease


NIH_SPENDING_CATS: Antimicrobial Resistance;Assistive Technology;Biodefense and Related Countermeasures;Bioengineering;Cardiovascular;Emerging Infectious Diseases;Hematology;Infectious Diseases;Transplantation

ORG_CITY: ATHENS

ORG_NAME: NYTRICX INC.

ORG_STATE: GA

PHR: NARRATIVE Endograft infection, neointimal proliferation, and thrombosis are the three main clinical complications with prosthetic ePTFE stent grafts affecting patients following endovascular arterial repair. The main objective of this STTR proposal is two develop ePTFE endograft devices that integrate Nitric Oxide (NO)-releasing polymer technology to achieve long-term (> 30-d) release of NO at the device interface to reduce the incidence of infection, neointimal proliferation, and thrombosis all of which contribute to prosthetic graft failure.

PI_NAMEs: GARREN, MARK RICHARD STEPHEN;SHEBUSKI, RONALD J. (contact)

PROGRAM_OFFICER_NAME: LIU, SONGTAO

PROJECT_TERMS: Address;Adhesions;Affect;Animal Model;Anticoagulation;antimicrobial;Biological;biomaterial compatibility;Bioreactors;Blood;Blood Platelets;Blood Vessel Prosthesis;Cardiac;Cardiovascular system;Categories;Cell Adhesion;Cell Culture Techniques;cell growth;Cell Physiology;Cell Proliferation;Cell surface;Cells;Clinical;clinical application;clinically relevant;commercialization;Devices;Endothelium;Enterococcus faecalis;Equipment Malfunction;Escherichia coli;Evaluation;Event;Exhibits;Family suidae;FDA approved;Fibroblasts;Formulation;Future;graft failure;graft function;Growth;Guidelines;hemocompatibility;Hemolysis;Heparin;Human;Hydrophobicity;Immune system;improved;In Vitro;in vivo;Incidence;Infection;Infection prevention;Intervention;Klebsiella pneumoniae;Legal patent;Mammalian Cell;mechanical properties;Mechanics;Medical Device;Metals;methicillin resistant Staphylococcus aureus;Methods;microbial;Microbial Biofilms;migration;Modeling;N-acetylpenicillamine;Nitric Oxide;Nitric Oxide Donors;Outcome;pathogen;Patients;Performance;Platelet Activation;Polymers;Porosity;pre-clinical;Procedures;Proliferating;Prosthesis;Proteins;Pseudomonas aeruginosa;repaired;research clinical testing;Resistance;restenosis;Risk;Series;Silicone Elastomers;Small Business Technology Transfer Research;Smooth Muscle Myocytes;Staphylococcus epidermidis;Stents;success;Surface;surface coating;Surface Properties;Technology;Testing;Thrombosis;Vancomycin resistant enterococcus;Vancomycin-resistant S. aureus;Vascular Endothelial Cell;Whole Blood

PROJECT_TITLE: Enhanced Prosthetic Vascular Graft Function by Local Release of Nitric Oxide


NIH_SPENDING_CATS: Behavioral and Social Science;Chronic Pain;Clinical Research;Comparative Effectiveness Research;Health Services;Mental Health;Networking and Information Technology R&D (NITRD);Neurosciences;Opioids;Pain Research;Telehealth

ORG_CITY: TEMPE

ORG_NAME: GOALISTICS, LLC

PHR: NARRATIVE Development of a Psychologist/Nurse Practitioner-guided, evidence-based online pain self-management program delivered via Telehealth would significantly narrow the non-opioid treatment gap for people with chronic pain. To achieve this, we will develop training materials for Psychologists and Nurse Practitioners that align with the topics and goals of an existing evidence-based online pain management program. Additionally, we will establish a web-based Portal designed to host this training and the pain program, showcase profiles of our certified Psychologists and Nurse Practitioners, enable the pairing of our certified providers with adults with pain, and generate automated reports detailing program user engagement and completion of the pain program.

PI_NAMEs: RUEHLMAN, LINDA SUE (contact)

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: Achievement;addiction;Adult;Advocate;Alternative Therapies;alternative treatment;Amalgam;American;Analgesics;Anxiety;authority;Certification;Chronic;chronic pain;chronic pain management;Client;Clinical;comparative efficacy;coping;Coping Skills;Counseling;design;Development;Educational Curriculum;Effectiveness;Emotional;Evaluation;evidence base;Evidence based treatment;experience;Face;formative assessment;Goals;improved;Individual;innovation;Instruction;interest;Internet;Intervention;Knowledge;Learning;learning outcome;Licensing;Manuals;Marketing;Medical;Mental Depression;Mental Health;Methods;Modeling;non-cancer chronic pain;non-cancer pain;non-opioid analgesic;Nurse Practitioners;Occupational;Opioid;opioid therapy;opioid use;Outcome;Outcome Measure;Overdose;Pain;Pain management;pain self-management;Persons;Pharmaceutical Preparations;Phase;Physicians;Policies;prescription opioid;Process;programs;Property;prototype;Provider;psychoeducation;Psychologist;Recommendation;Reporting;Research;Risk;satisfaction;Self Direction;Self Efficacy;self-management program;Severities;side effect;skills;social;Standardization;Stress;success;telehealth;Testing;timeline;Training;Training Programs;Twin Multiple Birth;usability;virtual;web portal;willingness

PROJECT_TITLE: Training Psychologists and Nurse Practitioners in the Use of an Evidence-Based Online Pain Self-Management Program: Leveraging the Power of Expert Guidance and Telehealth

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


ORG_CITY: DAVIS

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF CALIFORNIA AT DAVIS

PHR: Aberrant excitatory neurotransmission underlies many neurological and psychiatric diseases including Alzheimer’s disease, epilepsy, depression and schizophrenia. AMPA receptors mediate the majority of fast excitatory neurotransmission. Permanent up-and down-regulation of their activity underlies learning and memory. However, over-activation of AMPA receptors can be damaging to the nervous system, producing seizures or neuronal death as induced by strokes. Proteins that regulate synaptic AMPA receptor targeting represent promising targets for drug developments. This potential remains largely unrealized despite a wealth of tantalizing preclinical data. We have identified a novel brain-specific postsynaptic membrane protein (SynDIG1) and a related protein (SynDIG4) that regulate synaptic AMPA receptor content and function. Defects in SynDIG1 and SynDIG4 might contribute to the etiology of certain brain diseases. Intriguingly, long-term potentiation, a cellular mechanism of learning and memory, is absent in acute hippocampal slices from mice with a targeted deletion of the SynDIG4 gene. Our work on the role of SynDIG4 in AMPA receptor function will provide insight into fundamental molecular mechanisms of synaptic transmission and into potential defects that underlie various brain diseases.

PI_NAMEs: DIAZ, ELVA D (contact);HELL, JOHANNES W

PROGRAM_OFFICER_NAME: DRISCOLL, JAMIE DANIELLE

PROJECT_TERMS: Acute;Address;Age;Alzheimer's Disease;AMPA Receptors;Biological Assay;Brain;Brain Diseases;Cell surface;Cells;Chemicals;Cognitive;cognitive skill;Color;Complex;Data;Defect;density;Dissociation;DLG4 gene;domain mapping;Down-Regulation;drug development;Drug Targeting;Electrophysiology (science);Epilepsy;Etiology;Exhibits;Family;Genes;Glycine;Hippocampus;Image;in vivo;insight;Integral Membrane Protein;interdisciplinary approach;Investigation;knock-down;Knock-out;Knockout Mice;Knowledge;Label;Learning;Long-Term Depression;Long-Term Potentiation;Maintenance;Mediating;Membrane Proteins;Memory;Mental Depression;Mental disorders;Methods;Microscopy;Modeling;Molecular;morris water maze;Mus;mutant;N-Methylaspartate;Nervous System;Nervous System Disorder;neural network;neuromechanism;neuron loss;Neurons;neurotransmission;novel;object recognition;Permeability;PHluorin;postsynaptic;Postsynaptic Membrane;pre-clinical;Proline;Proteins;Proteomics;receptor;receptor function;recruit;Regulation;Role;Schizophrenia;Seizures;Site;Slice;Stimulus;Stroke;Surface;Synapses;synaptic depression;Synaptic plasticity;Synaptic Receptors;Synaptic Transmission;Testing;Tetanus;ultra high resolution;Up-Regulation;Variant;Viral;Visualization;Wild Type Mouse;Work

PROJECT_TITLE: SynDIG1/Prrt1 regulation of extrasynaptic GluA1-containing AMPARs during plasticity

STUDY_SECTION: SYN

STUDY_SECTION_NAME: Synapses, Cytoskeleton and Trafficking Study Section[SYN]


FUNDING_MECHANISM: TRAINING, INDIVIDUAL

NIH_SPENDING_CATS: Brain Disorders;Genetics;Mental Health;Mental Illness;Neurosciences;Schizophrenia;Serious Mental Illness

ORG_CITY: PITTSBURGH

ORG_DEPT: PSYCHIATRY

ORG_NAME: UNIVERSITY OF PITTSBURGH AT PITTSBURGH

PHR: Project Narrative The ability to successfully perform key cognitive functions, such as working memory, are thought to rely on the ability of somatostatin interneurons in layer 2/superficial 3 of the dorsolateral prefrontal cortex to successfully filter out potential distracting stimuli. Thus, the reported alterations in these somatostatin neurons in schizophrenia might represent the neural substrate for impaired distractor filtering and deficits in working memory. In this proposal, we will investigate the nature and basis of somatostatin neuron alterations in schizophrenia, providing key insights into novel therapeutic strategies to improve the function of these neurons and working memory in the illness.

PI_NAMEs: DIENEL, SAMUEL JAMES (contact)

PROGRAM_OFFICER_NAME: SABBAGH, JONATHAN JACOB

PROJECT_TERMS: Address;Affect;Biological Models;cell type;Cells;clinical heterogeneity;Cognitive deficits;cognitive function;Data;Dendrites;density;Disease;Distal;Down-Regulation;Enzymes;Exhibits;Failure;Fluorescent in Situ Hybridization;functional disability;functional improvement;Future;gamma-Aminobutyric Acid;Gene Expression;gray matter;hippocampal pyramidal neuron;Impaired cognition;Impairment;improved;indexing;Individual;insight;Interneurons;inward rectifier potassium channel;Kir2.1 channel;Label;Lasers;Lateral;Measures;Mediating;Memory impairment;Messenger RNA;Modeling;mRNA Expression;Nature;neural;Neurons;Neuropeptides;novel;novel therapeutic intervention;novel therapeutics;overexpression;Performance;Prefrontal Cortex;Primates;Proxy;Pyramidal Cells;Reporting;Resistance;Sampling;Schizophrenia;Secondary to;Short-Term Memory;Signal Transduction;Somatostatin;SOX6 gene;Stimulus;Testing;Transcript;transcriptome sequencing;vesicular GABA transporter;Viral;white matter

PROJECT_TITLE: Somatostatin Interneurons in Prefrontal Cortical Microcircuits in Schizophrenia


ED_INST_TYPE: SCHOOL OF MEDICINE & DENTISTRY

ORG_CITY: ROCHESTER

ORG_DEPT: GENETICS

ORG_NAME: UNIVERSITY OF ROCHESTER

PHR: Caenorhabditis elegans has been a workhorse for gene discovery and pathway analysis, and is the only established system where high-throughput genetic analysis can be conducted in the context of a living multi-cellular organism. The goal of this research is to develop viral vector-based technologies to facilitate large scale genetic screens based on targeted gene overexpression, which would be of wide interest within the C. elegans community and fuel years of genetic discovery across a range of disciplines. Our goals are to achieve targeted gene activation in C. elegans using vesicular stomatitis virus to deliver a single guide RNA (CRISPRa), and to develop Orsay virus as a vector to exogenously deliver genes of interest into C. elegans.

PI_NAMEs: FERRAN, MAUREEN C;SAMUELSON, ANDREW VAUGHN (contact)

PROGRAM_OFFICER_NAME: YEH, ALVIN TIEN-WEI

PROJECT_TERMS: Acceleration;Aging;Animals;Area;Biological;Biological Models;Biological Phenomena;biological systems;Caenorhabditis elegans;cell type;Cells;Clustered Regularly Interspaced Short Palindromic Repeats;Communities;Complex;COVID-19 pandemic;CRISPR interference;CRISPR screen;CRISPR/Cas technology;Development;Discipline;Disease;Double-Stranded RNA;Escherichia coli;expression vector;feeding;flexibility;follow-up;Foundations;functional genomics;Gene Activation;gene delivery system;gene discovery;Gene Expression;Gene Targeting;Genes;Genetic;genetic analysis;genetic approach;Genetic Screening;Genomic approach;Goals;grasp;Guide RNA;Health;high throughput screening;Human;improved;Infection;Innate Immune Response;innovation;insight;interest;Intestines;Investigation;knock-down;large datasets;Large-Scale Sequencing;Libraries;Light;Low Density Lipoprotein Receptor;Mediating;Messenger RNA;Methods;model organism;Modernization;mutant;Natural Immunity;Nematoda;Open Reading Frames;Organism;overexpression;pathogen;Pathogenicity;Pathway Analysis;Phenotype;Population;Process;Production;promoter;Promoter Regions;Protein Isoforms;Reagent;receptor;recombinant viral vector;Recombinants;Regulation;Reporter Genes;Research;RNA;RNA delivery;RNA Interference;screening;success;System;Systems Biology;Technology;Testing;Tissues;tool;Transcription Coactivator;Transgenic Animals;Transgenic Organisms;uptake;usability;Variant;vector;Vesicular stomatitis Indiana virus;Viral;Viral Genome;Viral Vector;Virion;Virus;Virus Diseases;virus host interaction;Work

PROJECT_TITLE: Viral vector-mediated gene activation to facilitate large-scale genetic analysis in Caenorhabditis elegans.

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-BST-M(82)S]


NIH_SPENDING_CATS: Autoimmune Disease

ORG_NAME: AOHBIO CORPORATION

ORG_STATE: OH

PHR: PROJECT NARRATIVE Vitiligo, which is characterized by the patchy loss of skin pigmentation, affects over 2 million U.S. citizens and between 0.5% to 2% of the global population. Despite the large number of people adversely affected by this condition, therapeutic options for vitiligo are quite limited. Thus, this work seeks to develop a novel small molecule therapeutic for vitiligo.

PI_NAMEs: MCCALL, KELLY  (contact)

PROJECT_TERMS: Active Sites;Affect;Antibodies;Apoptosis;Attenuated;autoimmune pathogenesis;Autoimmune Process;beta catenin;Binding;Biological Assay;Cell Cycle;Cell Nucleus;Cell Survival;chemokine;cost;cost effective;Cream;CXCL10 gene;CXCL9 gene;CXCR3 gene;cytokine;Data;Development;Disease;Drug Kinetics;Epidermis;expectation;Family;FDA approved;Formulation;Foundations;Future;Glycogen (Starch) Synthase;Glycogen Synthase Kinase 3;Goals;Human;human model;human tissue;inhibitor;insight;Interferon Type II;Investigation;Janus kinase;keratinocyte;kinase inhibitor;Lead;Maintenance;melanocyte;Metabolic;Motivation;mouse model;Mus;Names;novel;novel therapeutics;Ohio;Patients;Persons;Pharmaceutical Preparations;Pharmacodynamics;Phase;phase 2 study;Phosphorylation;Population;Prevalence;prevent;Proliferating;Quality of life;Reagent;Research;response;Role;safety study;Sampling;Signal Transduction;Skin;Skin Pigmentation;Small Business Technology Transfer Research;small molecule therapeutics;Source;Testing;Therapeutic;Tube;Universities;Vitiligo;Well in self;Work

PROJECT_TITLE: Novel Small Molecule Therapeutic for Vitiligo

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


ADMINISTERING_IC: DE

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Congenital Structural Anomalies;Dental, Oral, and Craniofacial Disease;Genetics;Human Genome;Pediatric

ORG_NAME: MAYO CLINIC ROCHESTER

ORG_STATE: MN

PHR: NARRATIVE Cleft palate is one of the most common birth defects, requiring significant surgical, medical, and psychosocial intervention. Normal palate development is mediated by multiple signaling pathways and hundreds of genes, and their perturbation by genetic or environmental insult leads to cleft palate. This project will apply gene expression and predictive, multiscale network analyses to gain insight into palate development and the involvement of key process such as epithelial/mesenchymal interactions in mouse models of human clefting to ameliorate or prevent abnormal palatogenesis.

PI_NAMEs: JABS, ETHYLIN WANG (contact);VAN BAKEL, HARM

PROGRAM_OFFICER_NAME: SAIFUDEEN, ZUBAIDA

PROJECT_TERMS: Adhesions;advanced system;Affect;Age;Anterior;Binding;Biological;Biomechanics;cell type;Cells;Cleft Palate;Clinical;Complex;Computational Biology;Congenital Abnormality;craniofacial;CRISPR/Cas technology;Critical Pathways;Data;Data Set;Defect;Development;Developmental Biology;Diagnosis;differential expression;Disease;Embryo;Epithelium;Etiology;Event;FGFR2 gene;Fibroblast Growth Factor;gene discovery;Gene Expression;Gene Expression Profile;Gene Expression Profiling;Genes;Genetic;Genetic Transcription;Genotype;Goals;Growth;Human;human model;Immunohistochemistry;improved;in silico;In Situ Hybridization;in vivo;Individual;innovation;insight;Internet;Intervention;Intuition;Knock-in;Knockout Mice;Libraries;Link;Literature;Maps;Maxilla;Medial;Mediating;Medical;Mesenchymal;Mesenchyme;Methods;Modeling;Molecular;molecular scale;Morphogenesis;Morphology;mouse model;Movement;Multiomic Data;Mus;mutant;mutant mouse model;Mutant Strains Mice;Mutation;network models;novel;null mutation;Operative Surgical Procedures;oral cleft;Organ Culture Techniques;orofacial cleft;Outcome;palatal shelves;Palate;palatogenesis;Pathologic;Pathway Analysis;Pathway interactions;Pattern;Population;prevent;Prevention;Process;Property;psychosocial;Psychosocial Assessment and Care;Resolution;RNA;RNA Splicing;Role;Series;SHH gene;Signal Pathway;Signal Transduction;simulation;single cell sequencing;single-cell RNA sequencing;Structural Congenital Anomalies;Structure;System;Systems Biology;Technology;Tissue-Specific Gene Expression;Tissues;tool;transcription factor;transcriptome;transcriptome sequencing;transcriptomics;Validation;Wild Type Mouse;Work

PROJECT_TITLE: Transcriptome and Network Analysis of Cleft Palate

STUDY_SECTION: GHD

STUDY_SECTION_NAME: Genetics of Health and Disease Study Section[GHD]


NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Drug Abuse (NIDA only);Opioid Misuse and Addiction;Opioids;Substance Misuse

ORG_NAME: NIRSUM LABORATORIES, INC.

PHR: PROJECT NARRATIVE The ongoing epidemic of opioid abuse, overdoses, and deaths is unprecedented in severity. Current treatment options are limited and could be improved upon. The goal of this research is to accelerate a clinical stage a novel therapeutic agent that has a better profile than currently available therapies for the treatment of opioid use disorder into Phase 3 trials and FDA registration.

PI_NAMEs: SHAH, NIKEJ  (contact);SORENSON, MARK

PROGRAM_OFFICER_NAME: SOUSA, JASON CARLOS

PROJECT_TERMS: Abstinence;Acceleration;addiction;Affinity;Agonist;Amendment;analog;antagonist;Award;Binding;Buprenorphine;carcinogenicity;Cessation of life;Chemicals;Chemistry;Clinical;Clinical Data;Clinical Research;Clinical Trials;Complex;Confidential Information;Consumption;cost;craving;Cyclic GMP;Data;Development;Dose;Dropout;Drug Kinetics;Drug Metabolic Detoxication;Evaluation;Fentanyl;forgiveness;Formulation;Friction;Funding;Generations;Goals;Government;Grant;Helping to End Addiction Long-term;Human;improved;Injectable;Injection Site Reaction;Injections;Intramuscular;Intramuscular Injections;Kidney Diseases;Legal patent;Liver diseases;manufacture;Marketing;Medical;medication for opioid use disorder;meetings;Methadone;mu opioid receptors;Mus;nalmefene;Naltrexone;novel;novel therapeutics;open label;Opiate Addiction;Opioid;opioid abuse;Opioid agonist;Opioid Antagonist;opioid epidemic;opioid use disorder;opioid withdrawal;Overdose;overdose risk;Patient Discharge;Patients;Performance;Persons;Pharmaceutical Preparations;Pharmacodynamics;Phase;phase 3 study;phase III trial;Plasma;Population;Population Study;practice setting;Process;process improvement;Prodrugs;programs;Provider;Public Health;Qualifying;Rattus;reconstitution;Refrigeration;Relapse;relapse risk;Research;Risk;Risk Reduction;safety study;Schedule;Severities;social;social stigma;Special Population;synthetic opioid;Syringes;System;Temperature;Therapeutic;Therapeutic Agents;Time;Toxicology;treatment duration;United States;United States Food and Drug Administration;Update;uptake;Validation;Ventilatory Depression;Withdrawal;Work

PROJECT_TITLE: Select Late-Stage CMC, Non-clinical Studies, and Quality Programs to Accelerate NRS-033 Towards Pivotal Studies and Registration in Opioid Use Disorder

STUDY_SECTION: NIDA

STUDY_SECTION_NAME: Medication Development Research Study Section[NIDA-L]


ED_INST_TYPE: SCHOOLS OF DENTISTRY/ORAL HYGN

NIH_SPENDING_CATS: Prevention

ORG_DEPT: OTHER BASIC SCIENCES

ORG_NAME: NEW YORK UNIVERSITY

PHR: Mitochondrial permeability transition is stress-induced damage to the mitochondrial inner membrane that disrupts mitochondrial function and leads to cell death. Our proposal aims to investigate molecular mechanisms underlying permeability transition. This knowledge will help to understand one of the central pathological events that cause damage during the stroke and heart attack.

PI_NAMEs: PAVLOV, EVGENY  (contact)

PROGRAM_OFFICER_NAME: ANSONG, CHARLES KWAKU

PROJECT_TERMS: Animal Diseases;Biological Assay;Calcium;Cell Death;Cell Membrane Permeability;Cells;Cessation of life;Complex;Coupled;Disease;Drug Targeting;electrical potential;Electrophysiology (science);Energy-Generating Resources;Ensure;Eukaryotic Cell;Event;Functional disorder;Generations;Goals;Homeostasis;Inner mitochondrial membrane;Knowledge;Link;Measurement;Measures;Membrane Potentials;Methods;Mitochondria;mitochondrial membrane;Modeling;Molecular;Myocardial Infarction;Nerve Degeneration;oxidation;Oxidative Phosphorylation;patch clamp;Pathologic;Pathway interactions;Permeability;Phosphorylation;Potential Energy;prevent;Prevention;Process;programs;Regulation;Research;Respiratory Chain;Severities;Stress;Stroke;Therapeutic;therapeutic development;Tissues

PROJECT_TITLE: Molecular mechanisms of the mitochondrial permeability transition

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-CB-J(55)R]


ADMINISTERING_IC: CA

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: PHILADELPHIA

ORG_NAME: NRG ONCOLOGY FOUNDATION, INC.

PHR: NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-RTOG 1216 BIQSFP Project Title: Integral Determination of p16 Expression in Oropharyngeal Carcinoma as an Eligibility Criterion BIQSFP entire project duration: 2020 to 2025 • Total # screened/tested to date: 0; Total # planned for entire BIQSFP project: 135 (no invoices have  been received to date for screening activities) • # of patients expected to be screened/tested during the reporting period: 10 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: p16; # tests expected to be completed: 6 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes  If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention?  o Accrual for this study has been acceptable with 60 patients expected to be enrolled in  grant year 10. The need for confirmation of p16 status for the nasopharyngeal patients  has not occurred at the rate originally projected and therefore less funds have been  expended than originally projected. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN003 BIQSFP Project Title: pHH3 Mitotic Index as an Integrated Marker BIQSFP entire project duration: 2017 to 2025 • Total # screened/tested to date: 184; Total # planned for entire BIQSFP project: 222 • # of patients expected to be screened/tested during the reporting period: 24 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: pHH3; # tests expected to be completed: 24 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? No  (see below). • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention?  o The sample size for this trial was increased from 133 to 163 patients in a June 2022 protocol  amendment due to the higher number of patients than expected withdrawing consent for  treatment with RT on the trail. Based on current screening patterns it is expected that 222  patients will be needed to meet the new sample size for the intervention step. . December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN007 BIQSFP Project Title: O6-methylguanine DNA methyltransferase gene (MGMT) promoter methylation testing by MGMT-STP27 BIQSFP entire project duration: 2020 to 2025 • Total # screened/tested to date: 374; Total # planned for entire BIQSFP project: 750 • # of patients expected to be screened/tested during the reporting period: 0 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: MGMT-STP27; # tests expected to be completed: 0 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes  If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? The study was  permanently closed to accrual in June 2023 as the results of the Phase II futility analysis did  not meet the threshold to move the protocol to the Phase III portion. The trial closed with 374  patients screened and 159 of those patients enrolled on step 2 treatment intervention arms December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN009 BIQSFP Project Title: Real Time Integrated Neurocognitive Function Study Comparing Neurocognitive Function with the Clinical Trial Battery in Patients with High Brain Met Velocity Treated with SRS or SRS + HA-WBRT, NRG BN009 BIQSFP entire project duration: 2021 to 2026 • Total # screened/tested to date: 14; Total # planned for entire BIQSFP project: 350 • # of patients expected to be screened/tested during the reporting period: 10 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: Neurocognitive Tools; # tests expected to be completed: 10 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? No If  “no,” please explain.  o This study opened for patient enrollment in December of 2020 and accrual for the last three  years was significantly slower than the 10 patients per month which was expected. To  improve accrual the study team amended the trial in April 2023 and made the following changes:   The stereotactic radiosurgery (SRS) plus hippocampal-avoidant whole brain  radiotherapy (HA-WBRT) arm was modified to be HA-WBRT alone. The NRG-BN009  team and the NRG Brain Tumor Committee leadership felt that modifying this arm will  remove insurance barriers and significantly increase physician and patient  enthusiasm for the study, and thereby accrual without changing the. fundamental  scientific question being addressed, which is the comparison of a focal irradiation  approach (Salvage SRS alone) versus a HA-WBRT approach (extensive field  irradiation). The primary hypothesis that the latter strategy will improve freedom from  neurologic death will not be affected by this amendment.   In addition, the protocol was revised to allow patients to have undergone multiple  SRS treatments to different brain metastases as long as prior brain metastasis  velocity (BMV) has been less than 4 brain metastases/year. This change was made  because presentation with high BMV, and not number of prior SRS treatments, is  central to the primary hypothesis being tested.   Lastly, the protocol eligibility was changed to permit enrollment of patients with prior  small cell cancer, as prior small cell cancer was included in the multiple series that  demonstrated the importance of BMV. • Do you anticipate a need to extend the study period? Yes If “yes,” please explain.  o This study was originally projected to complete accrual and testing during 2026. If the  amendment detailed above is successful in improving accrual an extension to the BIQSFP  will be required. If the accrual does not improve the trial will be closed without meeting its  required sample size. The decision regarding study closure will be made during grant  year 11. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? Yes  o The budget has been modified to reflect the slow accrual to this study and the decreased  effort required for neurocognitive testing. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN011 BIQSFP Project Title: “O6-methylguanine DNA methyltransferase gene (MGMT) promoter methylation testing by MGMT-STP27 BIQSFP entire project duration: 2021 to 2025 • Total # screened/tested to date: 204; Total # planned for entire BIQSFP project: 1110 • # of patients expected to be screened/tested during the reporting period:150 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: MGMT; # tests expected to be completed: 150 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes  If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention?  o Accrual has been slower than expected for this study but it is still within the CTEP  required accrual guidelines. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-HN001 BIQSFP Project Title: Integral determination of pre- and post-treatment EBV DNA in EBV+ nasopharyngeal carcinoma for risk group stratification BIQSFP entire project duration: 2020 to 2024 • Total # screened/tested to date: 828; Total # planned for entire BIQSFP project: 828 (The study closed to  accrual in July 2023 and the last patient underwent testing in October 2023) • # of patients expected to be screened/tested during the reporting period: 18 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: Eligibility & Post RT EBV DNA; # tests expected to be completed: 18* • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes  If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? This study is  now closed to patient accrual and all EBV DNA testing is completed. Final invoicing and testing reconciliation is now in progress. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-HN006 BIQSFP Project Title: Determining Negative Predictive Value of FDG PET/CT for N0 Neck in T1-T2 Oral Cavity SCC Patient BIQSFP entire project duration: 2020 to 2025 • Total # screened/tested to date: 254; Total # planned for entire BIQSFP project: 560 • # of patients expected to be screened/tested during the reporting period: 100 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: FDG PET/CT; # tests expected to be completed: 100 • • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes  If “no,” please explain.  Do you anticipate a need to extend the study period? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? No December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-HN011 BIQSFP Project Title: Tumor-derived plasma EBV DNA-guided optimal maintenance immunotherapy for Epstein-Barr Virus-associated recurrent and/or metastatic nasopharyngeal carcinoma. BIQSFP entire project duration: 2023 to 2027 • Total # screened/tested to date: 0; Total # planned for entire BIQSFP project: 184 • # of patients expected to be screened/tested during the reporting period: 6 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: EBV DNA; # tests expected to be completed: 0 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes  If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? This study is  expected to open for accrual in January 2024. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report – Grant Year 10 Study Number: NRG-GU005 BIQSFP Project Title: Evaluating response to moderate hypofractionation vs. SBRT in NRG GU005 based on Decipher Genomic Classifier Integrated Biomarker BIQSFP entire project duration: 2022 to 2024 • Total # screened/tested to date: 30; Total # planned for entire BIQSFP project: 550 • # of patients expected to be screened/tested during the reporting period: 150 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: Decipher GC Score; # tests expected to be completed: 550 • • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded  assays/tests within projected turn-around time? No If “yes,” please explain. • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes  If “no,” please explain.  Do you anticipate a need to extend the study period? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? No A pilot run of 30 samples was sent from the NRG UCSF Biobank in December 2023 to Veracyte (Decipher). If they are processed successfully, future batches of 30 samples will be sent every two weeks for processing. All processing will be completed during year 11 of the grant. December 2023

PI_NAMEs: LE, QUYNH-THU XUAN;MANNEL, ROBERT S.;WOLMARK, NORMAN  (contact)

PROGRAM_OFFICER_NAME: MOONEY, MARGARET M

PROJECT_TERMS: Address;Affect;Aftercare;Amendment;arm;Attention;biobank;Biological Assay;Biological Markers;Brain;Brain Neoplasms;Budgets;Cancer Therapy Evaluation Program;Cessation of life;Clinical Trials;Consent;DNA;Eligibility Determination;Enrollment;fluorodeoxyglucose positron emission tomography;Freedom;Funding;Futility;Future;genomic signature;Grant;Guidelines;Hippocampus;Human Herpesvirus 4;Image;Immunotherapy;improved;Insurance;Intervention;irradiation;Leadership;Maintenance;malignant oropharynx neoplasm;meetings;Metastatic malignant neoplasm to brain;methylation testing;MGMT gene;mouth squamous cell carcinoma;Names;Nasopharynx;Nasopharynx Carcinoma;Neck;Neurocognitive;neurocognitive test;Neurologic;Oncology;operation;participant enrollment;patient biomarkers;patient screening;Patients;Pattern;PET/CT scan;Phase;Physicians;Plasma;Predictive Value;Process;programs;Progress Reports;promoter;Protocols documentation;Quality of life;Radiation therapy;Radiation Therapy Oncology Group;Radiosurgery;Recurrence;Reporting;response;Risk;Running;S-Phase Fraction;Sample Size;Sampling;Schedule;screening;Series;Small Cell Carcinoma;Stratification;Testing;Time;tool;treatment arm;Tumor-Derived

PROJECT_TITLE: NRG Oncology Network Group Operations Center


ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

PHR: Candidate HIV vaccines for therapy of people who were already infected have met with limited success in clinical trials. One possible explanation for poor results is the tendency of a therapeutic vaccine to further expand anti-HIV immune cells that are already exhausted by chronic infection, rather than eliciting new and more effective immune responses. We want to understand what features of the vaccine and host allow therapeutic vaccination to elicit a superior immune response that may control the HIV virus after daily antiretroviral therapy is stopped.

PI_NAMEs: HARTIGAN-O'CONNOR, DENNIS J. (contact);RUTISHAUSER, RACHEL LENA

PROGRAM_OFFICER_NAME: CRAWFORD, KEITH W

PROJECT_TERMS: Activities of Daily Living;Address;Affect;age group;Animals;Anti-Inflammatory Agents;Antigen Presentation;Antigens;antiretroviral therapy;Cells;Chronic;chronic infection;Clinical Trials;cytotoxic;Data;Dominant Negative Receptor;Dominant-Negative Mutation;Ensure;Evaluation;exhaust;Exhibits;experimental study;Exposure to;follow-up;Fostering;Funding;Generations;HIV;HIV vaccine;Human;IL10 gene;Immune;Immune response;Infant;Infection;information gathering;Interleukin-10;interleukin-10 receptor;Intervention;juvenile animal;Learning;Link;Literature;Macaca;mature animal;Mediating;Memory;Metabolic;Metabolism;multiple omics;Newborn Animals;Newborn Infant;nonhuman primate;Parents;Pathway interactions;Peptides;Persons;Phase;Program Research Project Grants;programs;Property;recruit;Regimen;Reporting;response;Sampling;Signal Transduction;SIV;SIV Vaccines;Specificity;stem;stemness;success;T cell response;T memory cell;T-Lymphocyte;Techniques;Testing;Therapeutic;therapeutic vaccine;transcription factor;transcriptomics;Vaccinated;Vaccination;vaccination strategy;Vaccine Antigen;vaccine delivery;Vaccine Therapy;vaccine trial;Vaccines;vector;vector vaccine;Viral;Viremia;Virus;Work

PROJECT_TITLE: Supplement to A Multi-omics Approach to Immune Responses in HIV Vaccination and Intervention


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

ORG_NAME: JILLION THERAPEUTICS INC.

PHR: Project narrative: A number of neurodegenerative diseases affecting the brain such as Alzheimer’s disease and sporadic frontotemporal dementia have in common the accumulation with age of structures called neurofibrillary tangles. These tangles are made of a protein tau that aggregates in some conditions. These small aggregates are toxic and might spread within the brain slowly incapacitating it fully. This Phase I SBIR proposal aims at demonstrating that the DNA-encoded library (DEL) technology can be used very effectively to identify and validate high-affinity drug- like molecules binding to tau (e.g., monomers, oligomers, aggregates), affecting its biology and reducing tau aggregation and/or seeding. Ultimately, the goal is to block disease progression throughout the brain and create a disease modifying therapy (DMT). This approach could potentially serve as the blueprint for any proteinopathies.

PI_NAMEs: FLAJOLET, MARC  (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: Affect;Affinity;Age;Alzheimer's Disease;Amyloid beta-Protein;Bar Codes;behavior test;Binding;Binding Sites;Biochemical;Biological;Biological Assay;Biology;Brain;Bypass;chemical synthesis;Complex;cost effective;Coupled;Dedications;Digit structure;Disease;Disease Progression;DNA;DNA analysis;Docking;drug discovery;Drug Screening;drug-like compound;Eligibility Determination;Ensure;Escherichia coli;experience;fast protein liquid chromatography;Fluorescence;Foundations;Frontotemporal Dementia;Funding;Future;Generations;Goals;heuristics;high throughput screening;high-throughput drug screening;Image;Immobilization;improved;in silico;In Vitro;in vivo evaluation;inhibitor;instrument;Libraries;light scattering;Mammalian Cell;meter;Methods;Modeling;Molecular Weight;monomer;nanomolar;Neurodegenerative Disorders;Neurofibrillary Tangles;Neuroglia;Neurons;novel;Outcome;Pathologic;Pathology;Peptides;Pharmaceutical Chemistry;pharmacophore;Phase;Phosphorylation;Physiological;Pick Disease of the Brain;Protein Biochemistry;Proteins;Research;screening;Series;Small Business Innovation Research Grant;Specificity;Statistical Data Interpretation;Structure;Structure-Activity Relationship;Surface Plasmon Resonance;System;tau aggregation;tau Proteins;Tauopathies;Technology;Testing;Time;Toxic effect;Tracer;Tube;Validation

PROJECT_TITLE: Targeting biologically relevant tau monomers and oligomers using a novel DEL drug discovery platform to treat Alzheimer’s disease and tauopathies

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


ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

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

ORG_CITY: SEATTLE

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: PROJECT NARRATIVE This study proposes to examine and test, via behavioral economic choice-based conjoint study design, optimal combinations of product attributes and features predictive of Filipinx trans women’s acceptability and preferences pre-exposure prophylaxis (PrEP), including preferences for co-use of gender-affirming hormone options. The results provide foundational data insights to address and improve engagement across PrEP options and co-use of gender-affirming hormones, and test via a future larger scale (R01) behavioral economic-structural strengthening intervention, the identified optimized PrEP program profile(s), for Filipinx trans women.

PI_NAMEs: OPERARIO, DON ;RESTAR, ARJEE JAVELLANA (contact);SISON, OLIVIA ;WICKERSHAM, JEFFREY ALLEN

PROGRAM_OFFICER_NAME: CUMMINS, JAMES E

PROJECT_TERMS: Address;Adherence;Adult;Age;AIDS prevention;Awareness;behavioral economics;care systems;Cicatrix;Continuity of Patient Care;cost;Data;Decision Making;design;Development;Discrimination;Dose;Economic Factors;Economics;Effectiveness;Epidemic;evidence base;Exercise;experimental study;Future;Gender;gender affirming care;gender affirming hormones;Goals;Health;health economics;HIV;Home;Hormone use;Hormones;implementation barriers;implementation outcomes;improved;Incentives;Incidence;Infection;informant;insight;Insurance;interest;International;Intervention;Interview;Knowledge;Location;low and middle-income countries;Measures;Modality;opportunity cost;outreach;Philippines;pill;pilot test;Policies;Policy Maker;Population;pre-exposure prophylaxis;preference;primary care provider;programs;Provider;Public Health;Publishing;Research;Research Design;Resource-limited setting;response;Rural;Sampling;Scientist;service delivery;side effect;social;social stigma;Specialist;success;Surveys;Testing;theories;therapy design;therapy development;timeline;tool;transgender;transgender women;Unemployment;United States National Institutes of Health;uptake;urban residence;Woman;Work

PROJECT_TITLE: Applying a Behavioral Economic Approach on PrEP and Hormone Options among Transgender Women

STUDY_SECTION: HIBI

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


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Physical Injury - Accidents and Adverse Effects;Prevention;Rehabilitation;Rural Health;Social Determinants of Health

ORG_CITY: MATTHEWS

ORG_NAME: FORESIGHTCARES INC.

PHR: Project Narrative This project presents AVA, a video-based mobile app for at-home fall risk assessment of older adults, only using a smartphone to enable a much higher access, low-cost solution with full privacy protection. AVA empowers caregivers to assess the gait, balance, and strength of their older adults independently without the direct supervision of healthcare professionals. The Phase I study focuses on validating AVA's AI-based assessment technology and its usability in diverse home and independent living settings which can lead to revolutionizing current fall risk assessment practices.

PI_NAMEs: TABKHI, HAMED  (contact)

PROGRAM_OFFICER_NAME: JOSEPH, LYNDON

PROJECT_TERMS: 3-Dimensional;Accelerometer;Address;Age;Aging;American;Architecture;assessment application;Assessment tool;balance testing;Benchmarking;Businesses;Calibration;Caregivers;Cellular Phone;Collaborations;Communities;community living;Computer software;Computer Vision Systems;Controlled Environment;cost;Custom;Data Reporting;Data Set;deep learning;demographics;design;Development;Devices;Diagnosis;Dropout;Economics;Emotional;emotional distress;empowerment;Ensure;Environment;Equilibrium;Exercise;experience;Face;fall risk;falls;Family member;Financial Hardship;Gait;Goals;Guidelines;Health;Health Professional;healthy aging;Home;Human;improved;Independent Living;Individual;innovation;insight;Intervention;large language model;loved ones;Maps;Measurement;Medical;member;mobile application;Mobile Health Application;Modeling;Monitor;Motion;North Carolina;older adult;operation;Outcome;Participant;Patient Self-Report;Persons;Pharmaceutical Preparations;Phase;phase 1 study;physical therapist;Physiological;Population;pre-trained model;Privacy;privacy protection;programs;promoter;prototype;Quality of life;Questionnaires;Relaxation;Research;Risk Assessment;Rural;rural area;rural underserved;screening;self supervised learning;Severities;Side;smart device;Social isolation;Software Engineering;Specialist;success;Supervision;System;Tablets;Techniques;Technology;Technology Assessment;Telephone;Testing;Time;tool;Training;underserved area;underserved community;United States Dept. of Health and Human Services;Universities;usability;Validation;Visit;Visual;wearable device

PROJECT_TITLE: AVA_ AI Video-Based Mobile Application for Reliable, Accessible, and Low-Cost Fall Risk Assessments of Older Adults

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


NIH_SPENDING_CATS: Physical Injury - Accidents and Adverse Effects;Regenerative Medicine;Transplantation;Wound Healing and Care

ORG_NAME: FESARIUSTHERAPEUTICS, INC.

PHR: NARRATIVE Current treatment approaches for full thickness skin loss due to large acute burns have significant limitations, including slow, inconsistent, and inadequate tissue formation, hence impaired wound healing. The commercialization of DermiSphereTM is expected to improve clinical practice in surgical fields where full thickness skin loss is common including, but not limited to, trauma, burns, and post-oncologic reconstructive surgery, by significantly decreasing the time required to achieve a healed wound, as well as increasing the thickness of the regenerated dermis in a scenario of full thickness skin loss.

PI_NAMEs: SAPIR LEKHOVITSER, YULIA  (contact)

PROGRAM_OFFICER_NAME: KODURI, SAILAJA

PROJECT_TERMS: Acute;Address;Anatomy;angiogenesis;animal efficacy;Animal Model;Autologous;Autologous Transplantation;Biopsy;Burn injury;burn wound;Care given by nurses;Cells;Cellular Infiltration;Clinical;clinical practice;Collagen;commercialization;Complication;cost;Cues;Data;Deposition;Dermal;Dermis;Development;Devices;Domestic Pig;efficacy study;Esthetics;Film;flexibility;Formulation;functional outcomes;Goals;healing;Hemorrhage;Hydrogels;Immobilization;Impaired wound healing;Implant;implantation;improved;in vivo;infection risk;Infiltration;Inflammatory;innovation;Interview;Invaded;Lateral;Marketing;Materials Testing;Natural regeneration;Operative Surgical Procedures;Outcome;Patients;Phase;Physiological;Pilot Projects;Polymers;porcine model;Procedures;Process;Property;prototype;re-epithelialization;Recommendation;Reconstructive Surgical Procedures;resilience;revascularization;scaffold;scale up;Secure;Silicones;Site;Skin;skin burn;Skin graft;skin regeneration;Small Business Innovation Research Grant;standard care;Surgical sutures;Therapeutic;Thick;Thinness;third degree burn;Time;Tissue Harvesting;Tissues;Trauma;Vascularization;Work;wound;wound bed;wound healing;Wound models

PROJECT_TITLE: An advanced dermal regeneration scaffold for skin loss due to burn wounds

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


ADMINISTERING_IC: VA

IC_NAME: Veterans Affairs

ORG_NAME: PHILADELPHIA VA MEDICAL CENTER

PHR: More than 200,000 Veterans are discharged from the hospital to skilled nursing facilities (SNFs) annually, but more than 1 in 4 is readmitted to the hospital from SNF and less than half have returned to the community by 100 days following hospital discharge. Although the intent of SNF care is to allow recuperation and rehabilitation, Veterans who do not successfully recover are commonly placed in institutional long-term care at significant cost to themselves and to the VA, which spends more than $7 billion annually on institutional care. Veterans receive care in SNFs inside and outside the VA with different rates of success in returning them to the community. This project seeks to identify “high-value” SNFs (those that deliver the best rates of returning Veterans to the community for the lowest costs) across VA and non-VA facilities and understand how much “matching” a Veteran with specific needs to specific SNFs improves value. We then use what we have learned to build models for how the VA could create the highest-value SNF network possible.

PI_NAMEs: BURKE, ROBERT EDWARD (contact)

PROJECT_TERMS: Acute;acute care;adverse event risk;adverse outcome;Affect;Age;Algorithms;Area;authority;Big Data;care costs;care episode;care providers;Caring;Characteristics;Communities;Community Healthcare;community living;Contracts;cost;Data;Data Set;Data Sources;Development;Emergency department visit;Engineering;Enrollment;Fee-for-Service Plans;Fees;Geriatrics;Health care facility;health economics;Healthcare;Home;hospital readmission;Hospitalization;Hospitals;human old age (65+);improved;improved outcome;Individual;innovation;insight;Institution;Leadership;Learning;Life;Long-Term Care;Machine Learning;machine learning method;Marketing;Medicaid;Medical;Medicare;Methodology;Methods;military veteran;model building;Modeling;mortality;novel;Nursing Homes;Nursing Staff;operation;Outcome;Patients;point of care;Policies;Population;Positioning Attribute;Process;Provider;Proxy;Publishing;Quality of Care;Queuing Theory;Recording of previous events;Rehabilitation therapy;Risk;Risk Adjustment;risk prediction;Role;Shapes;Site;Skilled Nursing Facilities;success;System;Techniques;tool;Variant;Veterans;Work

PROJECT_TITLE: Improving Post-Acute Care Value for Veterans

STUDY_SECTION_NAME: HSR-6 Aging, Recovery, and Workforce[HSR6]


ORG_NAME: JESSE BROWN VA MEDICAL CENTER

PHR: Suppressing neuroinflammation and promoting remyelination is an important area of research. Here, we will test a novel idea that cinnamon metabolite sodium benzoate binds to peroxisome proliferator-activated receptor β to stimulate anti-inflammation and promote remyelination, leading to neuroprotection in an animal model of traumatic brain injury. This study will enhance the possibility of attenuating neuroinflammation, stimulating remyelination and treating patients with traumatic brain injury with cinnamon and its metabolite sodium benzoate as primary or adjunct therapy. 1

PI_NAMEs: PAHAN, KALIPADA  (contact)

PROJECT_TERMS: Animal Model;Anti-Inflammatory Agents;Area;axon injury;Behavioral;Benzoates;Binding;Brain;Cause of Death;Child;Chronic;Cinnamon - dietary;comorbidity;Demyelinations;disability;Exhibits;Failure;FDA approved;Flavoring;Food Preservatives;glial activation;I Kappa B-Alpha;Inflammation;inhibitor;injury-related death;Ligand Binding Domain;Ligands;Link;Medicine;Microglia;Military Personnel;mouse model;Nature;neuroinflammation;neuroprotection;Nonketotic Hyperglycinemia;novel;oligodendrocyte progenitor;Oligodendroglia;Outcome;Patients;Peroxisome Proliferator-Activated Receptors;Persons;Pharmacotherapy;Recording of previous events;remyelination;Research;Risk;Sodium;Spices;Sri Lanka;stem cells;TBI Patients;Testing;Traumatic Brain Injury;Urea cycle disorders

PROJECT_TITLE: Cinnamon and traumatic brain injury