PHR: Project Narrative The parathyroid hormone (PTH)-related protein (PTHrP) is a key paracrine and autocrine regulator of bone formation and remodeling, tooth eruption, mammary gland development, placental calcium ion transport, and the main cause of hypercalcemia and osteolysis in patients with malignancy. The proposed research will investigate a novel component, heparin/heparan sulfate, in PTHrP signaling via its PTH type 1 receptor (PTHR). The findings will advance our fundamental understanding of the key cellular and molecular mechanisms underlying PTHrP signaling that are essential for the development of new therapies targeting PTHrP associated diseases.

PI_NAMEs: SAVRANSKY, SOFYA  (contact)

PROGRAM_OFFICER_NAME: CASTLE, ARTHUR

PROJECT_TERMS: Affect;autocrine;Basic Amino Acids;Binding;Binding Proteins;Binding Sites;Biological;Biological Assay;biophysical techniques;Bone remodeling;Calcium;Calcium ion;Calorimetry;Cell membrane;Cell surface;Cells;Chondrocytes;Coupling;Cyclic AMP;Data;Dependence;Development;Disease;Embryo;Endocrine;Endosomes;Event;experimental study;Extracellular Matrix;fluorescence imaging;Fluorescence Resonance Energy Transfer;G Protein-Coupled Receptor Signaling;G-Protein-Coupled Receptors;Glycosaminoglycans;Goals;GTP-Binding Proteins;Heparin;Heparin Binding;Heparin Lyase;Heparitin Sulfate;Homeostasis;Hormones;Human;Hypercalcemia;imaging approach;imaging modality;Impairment;inorganic phosphate;insight;Ion Transport;Ions;Kidney;Kinetics;Ligands;Location;Malignant Neoplasms;mammary gland development;Mediating;Molecular;Molecular Conformation;Motion;Mutate;N-terminal;new therapeutic target;novel;optical imaging;Osteoblasts;Osteogenesis;Osteolysis;paracrine;parathyroid hormone-related protein;Patients;Pharmacology;Pilot Projects;Placenta;Production;Property;Proteins;PTH gene;receptor;receptor binding;Receptor Signaling;Recombinants;Recycling;Research;residence;response;Role;Second Messenger Systems;Signal Transduction;Signaling Molecule;Signaling Protein;single molecule;stoichiometry;Surface Plasmon Resonance;Testing;Time;Titrations;Tooth eruption;trafficking;transmission process;Variant;Work

PROJECT_TITLE: The role of cell surface glycosaminoglycans (GAGs) in PTHrP bias signaling

STUDY_SECTION_NAME: Special Emphasis Panel[ZDK1 GRB-2 (O1)]


ADMINISTERING_IC: DA

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

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

ORG_CITY: PHILADELPHIA

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: EPIVARIO, LLC

ORG_STATE: PA

PHR: Developing a novel epigenetic regulator as a treatment for opioid use disorder Project Narrative Opioid use disorder (OUD) has been declared a public health emergency almost 5 years ago; and despite the availability of FDA-approved medications, relapse and overdose death rates continue to increase. A major challenge for existing treatments is drug- and cue-related memories that remain, which have been linked to craving-induced relapse. EpiVario has identified ACSS2 as a novel epigenetic regulatory mechanism in drug-related memory and developed proprietary ACSS2 inhibitors with efficacy in different substance use disorders, including OUD, and the funds from this SBIR Phase I will help develop next-generation ACSS2 inhibitors as novel pharmacotherapy for the treatment of OUD through epigenetic regulation of memory re-consolidation.

PI_NAMEs: KIM, THOMAS  (contact)

PROGRAM_OFFICER_NAME: SABIRZHANOV, BORIS YEVGENYEVICH

PROJECT_TERMS: abuse liability;Acetate-CoA Ligase;Acetyl Coenzyme A;addiction;Address;ADME Study;Alcohols;American;Animal Model;Applications Grants;Association Learning;Automobile Driving;Behavior;Behavior Therapy;Behavioral;Binding;Biological;Biological Assay;blood-brain barrier crossing;Brain region;Cessation of life;Characteristics;Cocaine;cofactor;Communities;craving;Cues;Data;Death Rate;Defect;Development;Disease;Drug abuse;Drug Prescriptions;Drug Targeting;druggable target;Economic Burden;Effectiveness;efficacy testing;Enzymes;Epigenetic Process;epigenetic regulation;Exhibits;experimental study;FDA approved;Fentanyl;Funding;Gene Expression;Generations;Genes;Genetic;Genetic Transcription;Half-Life;Healthcare Systems;Heroin;Hippocampus;Histone Acetylation;histone modification;Immediate-Early Genes;improved;In Vitro;in vitro Assay;Individual;Induced Neurons;inhibitor;innovation;Intravenous;knock-down;Lead;Learning;Link;long term memory;Medical;Memory;memory consolidation;memory process;memory recall;Metabolic;Modeling;Neuronal Plasticity;next generation;Nicotine;novel;novel strategies;Opiate Addiction;Opioid;opioid epidemic;opioid injection;Opioid Receptor;opioid use;opioid use disorder;overdose death;Oxycodone;oxycodone self-administration;Pharmaceutical Preparations;Pharmacodynamics;pharmacologic;Pharmacologic Substance;Pharmacotherapy;Phase;Play;pre-clinical;prescription opioid misuse;Prevalence;Process;Property;public health emergency;Rattus;Relapse;relapse risk;Research;response;Rodent;Rodent Model;Role;Safety;Self Administration;Short-Term Memory;side effect;Small Business Innovation Research Grant;small molecule inhibitor;Stress;Substance abuse problem;substance misuse;Substance Use Disorder;Testing;Therapeutic;Time;United States

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


ADMINISTERING_IC: DK

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Nutrition;Obesity;Prevention

ORG_CITY: PROVIDENCE

ORG_NAME: MIRIAM HOSPITAL

ORG_STATE: RI

PHR: PROJECT NARRATIVE This project aims to optimize adherence to dietary self-monitoring, a major determinant of outcomes produced by behavioral obesity treatment, which is recommended as a first-line intervention for cardiovascular disease. We propose to conduct a micro-randomized trial to empirically optimize use of gold standard full dietary self- monitoring and four burden-reducing self-monitoring alternatives over 24 weeks of treatment. The project will produce broadly-applicable self-monitoring recommendations and a highly personalized self-monitoring selection algorithm to improve self-monitoring adherence and weight loss throughout behavioral obesity treatment.

PI_NAMEs: GOLDSTEIN, STEPHANIE PAIGE;THOMAS, JOHN GRAHAM (contact)

PROGRAM_OFFICER_NAME: HALES, CRAIG MAURICE

PROJECT_TERMS: Address;Adherence;Adult;Age;Algorithms;automated algorithm;Behavior;Behavior monitoring;behavior prediction;Behavior Therapy;Behavioral;Behavioral Medicine;Body mass index;Body Weight;Body Weight decreased;Cardiovascular Diseases;Categories;Clinical;Consensus;Consumption;Data;Diet;Diet Monitoring;dietary;Eating Behavior;efficacy evaluation;Energy Intake;experience;falls;Food;Frequencies;Future;Health Benefit;improved;Individual;Individual Differences;individualized medicine;Intervention;Learning;Machine Learning;Methods;Monitor;Morbidity - disease rate;mortality;Obesity;obesity treatment;Outcome;Overweight;Participant;Patients;Performance;Persons;Prediction of Response to Therapy;programs;Psychological reinforcement;Public Health;Race;Randomized;randomized trial;Recommendation;Research;Research Support;Resources;Risk;Role;Sampling;Self Efficacy;sensor;sex;smart scale;smart watch;social health determinants;Technology;Testing;Theoretical model;theories;Time;Treatment outcome;Weight;Work

PROJECT_TITLE: Microrandomized Trial to Optimize Use of Burden-reducing Self-monitoring Approaches in Behavioral Obesity Treatment

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CCHI-X (02)]


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

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

ORG_CITY: Ithaca

ORG_NAME: TET MEDICAL

ORG_STATE: NY

PHR: Narrative TETmedical’s innovative technology and easy to use diagnostic system has the ability to improve the health of Americans who are at risk of liver disease or drug-induced liver injury (DILI) through AST and ALT monitoring. The groundbreaking impact of the TET platform would dramatically alter the monitoring of patients in clinical trials for new drugs; on medications known to induce DILI like antibiotics, central nervous system (CNS) agents, cancer chemotherapeutics, and immunomodulatory agents; those with chronic disease conditions that affect the liver; and those exposed to potential toxins in the workplace.

PI_NAMEs: COHEN, ROY  (contact);FISCHELL, DAVID

PROGRAM_OFFICER_NAME: CROUCHER, LEAH TOLOSA

PROJECT_TERMS: Affect;Alanine Transaminase;Allopurinol;American;Antibiotics;Aspartate Transaminase;Award;Biochemical Reaction;Biological Assay;Biomimetics;Biosensor;Blood;Blood specimen;burn pit;Calibration;Central Nervous System Agents;Chemistry;chemotherapeutic agent;Chronic Disease;Clinic;Clinical;clinical trial participant;Clinical Trials;Collection;cost;Coupled;Coupling;design;Detection;detection assay;Development;Devices;Diagnosis;diagnostic platform;diagnostic technologies;Diagnostic tests;Dimensions;Disease;drug induced liver injury;drug metabolism;Drug Monitoring;Elderly;Electronics;Environment;Enzyme Stability;Enzymes;Evaluation;Exposure to;Freeze Drying;Frequencies;Funding;Future;Geography;Gold;Health;Hemolysis;hepatocellular injury;Home;home test;Human;Immobilized Enzymes;immune modulating agents;improved;innovation;innovative technologies;Laboratories;Liver;Liver diseases;liver function;liver injury;Location;luminescence;Malignant Neoplasms;Manufacturer;Measurement;Measures;medication safety;Methods;Methotrexate;Military Personnel;Monitor;nanoparticle;Normal Range;novel;novel therapeutics;Nucleic Acids;Output;Paper;Patient Monitoring;Patients;Pesticides;Pharmaceutical Preparations;Phase;Plasma;point of care;Point of Care Technology;point of care testing;prevent;Process;Proteins;prototype;rapid test;Reaction;Reader;real time monitoring;response;Risk;Safety;sample collection;Sampling;Serum;Site;Source;Speed;System;Technology;technology platform;technology validation;Testing;Time;Toxin;Travel;United States National Institutes of Health;validation studies;Visit;Work;Workplace

PROJECT_TITLE: Tethered Enzyme Technology for PoC and At-home Real-time Monitoring of Liver Function

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Biotechnology;Immunization;Infectious Diseases;Lymphatic Research;Orphan Drug;Prevention;Rare Diseases;Vaccine Related;Vector-Borne Diseases

ORG_CITY: SEATTLE

ORG_NAME: PAI LIFE SCIENCES, INC.

ORG_STATE: WA

PHR: PROJECT NARRATIVE This project aims to bring the first human helminth vaccine for lymphatic filariasis, a gruesome disfiguring disease that affects 120 million people in 52 countries, up to the clinical trial stage. The vaccine - once available - will benefit 856 million people who are at-risk of acquiring the disease impacting global health.

PI_NAMEs: CARTER, DARRICK ALBERT (contact);KALYANASUNDARAM, RAMASWAMY

PROGRAM_OFFICER_NAME: MO, ANNIE X  Y

PROJECT_TERMS: Adjuvant;Adult;Affect;Agonist;aluminum sulfate;Animal Model;Animal Testing;Antigens;Bacteria;Biological;Biological Assay;Biological Sciences;Brugia malayi;cell bank;Chemistry;chemotherapy;Chronic;Clinical;clinical development;Clinical Research;Clinical Trials;Contracts;Country;Coupled;Culicidae;Cyclic GMP;design;Development;disability-adjusted life years;Disease;disease classification;disease transmission;drug testing;Effectiveness;Endemic Diseases;Engineering;Experimental Animal Model;Filaria bancrofti;Filarial Elephantiases;first-in-human;Formulation;functional mimics;Future;Gerbils;global health;Grant;Helminths;Human;Immunity;Incidence;Individual;Infection;Infection Control;Infectious Agent;Interruption;Jird;Larva;Licensing;Lymphatic;Lymphatic System;Lymphedema;Macaca mulatta;manufacture;Modeling;Morbidity - disease rate;mortality;Mus;neglected tropical diseases;non-compliance;nonhuman primate;novel;Oryctolagus cuniculus;Pamphlets;Parasites;Pathology;Patients;Persons;Pharmaceutical Preparations;Pharmacotherapy;Phase;phase 2 study;physically handicapped;Populations at Risk;pre-clinical;Predisposition;prevent;Preventative vaccination;Preventive vaccine;programs;prophylactic;Prophylactic treatment;Proteins;Protocols documentation;Protozoa;Public Health;Recombinant Fusion Proteins;Reporting;Research;Research Personnel;Resolution;Resources;Risk;Rodent;Rodent Model;Running;Safety;Small Business Innovation Research Grant;Sterility;Technology;Testing;Therapeutic;TLR4 gene;Toxicology;transmission process;United States National Institutes of Health;vaccine candidate;vaccine efficacy;vaccine immunogenicity;Vaccines;Virus;World Health;World Health Organization;Writing

PROJECT_TITLE: A Vaccine for Lymphatic Filariasis, LFGuard™

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


ADMINISTERING_IC: HL

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

ORG_CITY: PITTSBURGH

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF PITTSBURGH AT PITTSBURGH

PHR: Project Narrative Right heart failure (RHF) is the leading cause of death among patients diagnosed with pulmonary arterial hypertension (PAH). Consequently, RHF is caused by increased lung arterial resistance and, hence, thickening and blockage of pulmonary arteries. Despite approved therapies to treat PAH, RHF contributes to greater than 50% of patient deaths in this disease. This project aims to open a new field of inquiry of PAH by identifying a novel pathway in arterial cell proliferation in PAH. By extension, new druggable inhibitors are expected to target mediators in this pathway with the goal of mitigating PAH.

PI_NAMEs: GOOSSEN, CHRISTIAN J (contact)

PROGRAM_OFFICER_NAME: SUTLIFF, ROY L

PROJECT_TERMS: Actins;Animal Model;antagonist;Apoptosis;Apoptotic;arterial lesion;Award;Binding;Bioinformatics;bioinformatics tool;career;Cause of Death;CDK2 gene;CDK4 gene;Cell Cycle;Cell Cycle Progression;cell injury;Cell Nucleus;Cell Physiology;Cell Proliferation;Cell Separation;Cells;Cessation of life;Confocal Microscopy;Coronary artery;Cyclin D1;Cyclin-Dependent Kinase Inhibitor;cyclin-dependent kinase inhibitor 1B;Cyclin-Dependent Kinases;Cyclins;Cysteine;Cytosol;Development;Diagnosis;Disease;Disinhibition;Doctor of Philosophy;Endothelial Cells;Endothelium;Enzymes;Equilibrium;Etiology;Exposure to;Family;Financial Support;Fostering;Genetic;Goals;Heart;hemodynamics;Human;Hypertrophy;Hypoxemia;Hypoxia;hypoxia-induced pulmonary hypertension;immunocytochemistry;In Vitro;in vivo;indexing;inhibitor;interest;KDR gene;Laboratories;Lesion;Literature;Lung;lung microvascular endothelial cells;Malignant Neoplasms;Mass Spectrum Analysis;Measurement;Mediating;Mediator;member;Mentorship;migration;Modeling;Mus;NADPH Oxidase 1;neoplastic;normoxia;novel;Oranges;oxidation;Oxidation-Reduction;Pathway interactions;Patients;PECAM1 gene;permissiveness;Phenotype;Phosphorylation;Phosphotransferases;Physiological;Predisposition;programs;Proliferating;Protein Isoforms;pulmonary arterial hypertension;pulmonary artery endothelial cell;Pulmonary artery structure;Pulmonary Pathology;Pulmonary Vascular Resistance;Rattus;Reactive Oxygen Species;Reporting;Research;Resistance;response;Retinoblastoma;Retinoblastoma Protein;right ventricular failure;Rodent;Role;Science;Scientist;senescence;Signal Transduction;skills;Small Interfering RNA;Smooth Muscle;Smooth Muscle Myocytes;Stains;stem;Survival Rate;Testing;Time;Tissues;Training;tumorigenesis;Vascular remodeling;Western Blotting;Wild Type Mouse;Work

PROJECT_TITLE: Endothelial NOX1-Mediated AMPKa1 Propagates Hypoxia-Induced Pulmonary Hypertension via the CIP/KIP family of CDK inhibitors

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F10A-K (20)]


ADMINISTERING_IC: AR

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Congenital Structural Anomalies;Pediatric;Rare Diseases;Wound Healing and Care

ORG_CITY: CAMBRIDGE

ORG_DEPT: CHEMISTRY

ORG_NAME: HARVARD UNIVERSITY

ORG_STATE: MA

PHR: Project Narrative Cell attachment to the basement membrane by integrins is critical to maintain structural integrity of the skin, and disrupting dermoepidermal junctions can lead to epidermolysis bullosa (EB), a fragile skin blistering disease. This research aims to determine how an integrin binding protein, CD151, affects the function of integrin α3β1, both of which are necessary for appropriate epithelial binding to the basement membrane and silencing mutations of either cause EB. A molecular structure of the complex and defining the signaling response of this signaling complex will provide understanding for epidermal adhesion and could be exploited therapeutically to strengthen epidermis attachment in EB and potentially other diseases of the skin.

PI_NAMEs: LITZAU, LAUREN ANNE (contact)

PROGRAM_OFFICER_NAME: VINCENT, ISAAH S

PROJECT_TERMS: adhesion receptor;Adhesions;Adhesives;Adopted;Affect;Affinity;Area;ascorbate;Basement membrane;Binding;Binding Proteins;Biological;Biological Process;Biology;Biotinylation;Bulla;Cell Adhesion;Cell-Matrix Junction;Cells;Cellularity;clinical phenotype;Complex;Cryoelectron Microscopy;Cytoskeleton;Defect;Dependence;Dermis;Development;Disease;disease phenotype;Dissociation;Engineering;Epidermis;Epidermolysis Bullosa;Epithelial Cells;Epithelium;Event;Extracellular Matrix;Focal Adhesions;Foundations;Hemidesmosomes;Homeostasis;Human;Hydrogen Peroxide;Impairment;in vivo;Integrin alpha3beta1;Integrin Binding;Integrins;Kidney;Knock-in;Label;Laminin;Ligands;Link;loss of function mutation;Lung;Mass Spectrum Analysis;Membrane;migration;Molecular;Molecular Conformation;Molecular Structure;Mutation;particle;Peroxidases;Phosphotransferases;Protein Family;Proteins;Radial;receptor;Regulation;Research;response;Role;Signal Transduction;Skin;skin disorder;Structure;Tertiary Protein Structure;Therapeutic;Time;trafficking;Transmembrane Domain;Work

PROJECT_TITLE: The tetraspanin CD151 and integrin α3β1 signaling complex in basement membrane adhesion

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


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Bioengineering;Osteoporosis;Physical Injury - Accidents and Adverse Effects;Women's Health Research

ORG_CITY: SANTA BARBARA

ORG_NAME: ACTIVE LIFE SCIENTIFIC, INC.

ORG_STATE: CA

PHR: Narrative Patients who suffer a fracture but have non-osteoporotic BMD present a unique challenge to physicians since they have no way of identifying these patients before a fracture occurs. OsteoProbe was developed to identify patients at risk of bone fragility through a Phase II SBIR grant, private investment, research, and development. Phase II results demonstrate that OsteoProbe is a strong predictor of skeletal fragility in women. This study will expand on the Phase II work to include males, establish OsteoProbe as a better clinical predictor of bone strength at the hip, wrist, and spine compared to DXA; transition OsteoProbe into an optimized configuration for manufacturing and support in the commercial environment; and provide for a new FDA clearance of OsteoProbe as a clinically useful device aimed at addressing the bone quality diagnostic gap in the general population.

PI_NAMEs: BURKS, PETER  (contact);TANG, SIMON YUE-CHEONG

PROGRAM_OFFICER_NAME: JOSEPH, LYNDON

PROJECT_TERMS: Address;Adopted;age related;aging population;Area;bone;Bone Density;bone fragility;bone health;bone quality;bone strength;Bone Tissue;Budgets;Cadaver;Clinic;Clinical;clinical decision-making;clinical predictors;clinically relevant;clinically significant;Code;commercialization;Communication;cost;Data;Data Analyses;Death Rate;Decision Making;demographics;design;Development;Devices;Diagnosis;Diagnostic;Diagnostic Equipment;Dual-Energy X-Ray Absorptiometry;Environment;Face;Female;Femur;Fracture;fracture risk;fragility fracture;Funding;Future;General Population;Grant;handheld mobile device;Health Care Costs;Healthcare;high risk;Hip region structure;Human;improved;in vivo;indexing;Individual;Intention;Investments;Label;male;manufacturability;manufacture;Marketing;Measurement;Measures;Mechanics;Medical;Medical Device;men;mobile computing;Modernization;Morbidity - disease rate;mortality;new technology;novel;Osteopenia;Osteoporosis;Pathway interactions;Patients;Phase;phase 2 study;Physicians;Population;Privatization;Procedures;Process;Production;Productivity;Public Health;Publishing;Race;racial diversity;Radial;Regulation;Research;Risk;Secure;sex;Site;skeletal;Small Business Innovation Research Grant;Statistical Data Interpretation;Techniques;Testing;tibia;Time;Tissues;tool;usability;Vertebral column;Woman;Women's study;Work;Wrist

PROJECT_TITLE: Measuring Whole and Tissue Level Bone Strength in men

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 MSOS-M (11)]


ORG_CITY: LANCASTER

ORG_NAME: CERULEAN SCIENTIFIC INC.

PHR: PROJECT NARRATIVE After peripheral artery disease (PAD) progresses to critical limb ischemia (CLI), many patients require a peripheral vascular graft (PVG) to increase blood blow to the affected limbs; however, PVG have failure rates of 20–50% within the first year of surgery, and >60% after 5 years. Unfortunately, no available single solution addresses the three main causes of PVG failure to improve long-term patient outcomes. FreeFlow developed a coating technology to reduce the failure rate of PVG by ameliorating these causes of failure; in this proposal, we will further validate our technology in PVG and complete our path to marketability, with the long-term goal of improving the outcomes of patients with PAD and CLI.

PI_NAMEs: MCFARLAND, TODD  (contact);MYERS, DANIEL DURANT;OBI, ANDREA TARA

PROGRAM_OFFICER_NAME: AGRAWAL, NITIN

PROJECT_TERMS: Acute;Address;Adhesions;Adsorption;Affect;Albumins;American;Amputation;Anticoagulation;Area;Arteries;Bacteria;Binding Proteins;Biological;biomaterial compatibility;Blood;Blood flow;Blood Proteins;Blood Vessel Prosthesis;Blood Vessels;Buffers;Bypass;canine model;Cardiovascular system;Cavia;Cell Death Induction;Cell-Matrix Junction;Cessation of life;Characteristics;Coagulation Process;commercialization;critical limb Ischemia;cytotoxicity;Data;design;Development;Devices;Effectiveness;efficacy study;Evaluation;experimental study;Failure;FDA approved;Fibrinogen;Fluorocarbons;fungus;genotoxicity;Goals;good laboratory practice;graft dysfunction;graft failure;hemocompatibility;Heparin;Histologic;hospital readmission;Hospitalization;Hour;Hyperplasia;Image;implantation;improved;improved outcome;In Vitro;in vivo;Infection;invention;Isolated limb perfusion;Legal patent;Limb structure;Liquid substance;manufacture;Marketing;Measures;Medical Device;medical implant;Microbial Biofilms;Modification;Operative Surgical Procedures;Outcome;pathogen;Patient Care;Patient-Focused Outcomes;Patients;Peripheral;Peripheral arterial disease;Phase;Physiological;Plasma;Polytetrafluoroethylene;prevent;Prevention;Procedures;Process;Proteins;Recording of previous events;Saline;Sampling;Sheep;standard of care;Stenosis;Structure;success;Surface;Surgeon;systemic toxicity;Technology;technology development;Testing;Thinness;Thrombin;thrombogenesis;Thrombosis;Thrombus;Ulcer;Vascular Graft;Veins;Weight;Whole Blood;wound

PROJECT_TITLE: Slippery, Omniphobic Coating to Prevent Thrombosis and Biofilm Formation on Peripheral Vascular Grafts

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


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Climate-Related Exposures and Conditions;Clinical Research;Prevention;Social Determinants of Health

ORG_CITY: WASHINGTON

ORG_NAME: AMELIA TECHNOLOGIES, LLC

ORG_STATE: DC

PHR: Identifier: 1410957 EcoWell- A planet in a plate. NARRATIVE Climate change represents the greatest challenge humanity has faced. The climate issue will require decision making at the population level that will define the trajectory of mankind. However, lack of science literacy has already become a roadblock to mitigation approaches. Climate change education is imperative to combat the growing misinformation surrounding the issue. Yet, environmental science education suffers from a lack of innovative technologies that allow students to do active interrogative analysis of the subject matter. We have developed a complete active learning approach to climate change consisting of novel hardware, supported by a suite of educational kits focused on climate change backed by formal assessment. Using the revolutionary, EcoWell™- A planet in a plate, fully integrated system will allow students to directly compare the impact of small changes in climate parameters on biological endpoints and facilitate the teaching of vital data interpretation skills.

PI_NAMEs: ELL, BRIAN ;SNOWFLACK, DANIELLE ;SYKORA, PETER  (contact)

PROGRAM_OFFICER_NAME: SHAUGHNESSY, DANIEL

PROJECT_TERMS: Active Learning;Address;Affect;Algae;Bacteria;Biocompatible Materials;Biodiversity;Biological;Biological Assay;Biological Models;Biological Process;Carbon Dioxide;Chemicals;Climate;climate change;climate data;combat;Communication;cost;Data;Data Analyses;Decision Making;Dedications;design;Development;Devices;Education;Educational Assessment;Educational Curriculum;Educational Models;Educational process of instructing;educational resource development;effectiveness evaluation;Effectiveness of Interventions;Environment;Environmental Science;Evaluation;evidence base;experience;experimental study;Frustration;Generations;Global Warming;Greenhouse Effect;Growth;harmful algal blooms;Human;Humanities;Incubators;Infrastructure;innovation;innovative technologies;Instruction;instrument;Intuition;Knowledge;Laboratories;Learning;Light;literacy;Marketing;Measures;Methods;Microclimate;Misinformation;Modeling;Multimedia;Nature;Nematoda;novel;novel strategies;Planets;plant growth/development;Plants;Policy Maker;Pollution;Population;Population Dynamics;Prevalence;Protocols documentation;prototype;Resources;Science;science education;Scientist;skills;social;Sterilization;Students;success;System;Systems Integration;teacher;Technology;Temperature;Testing;Time;touchscreen;Ultraviolet Rays;United States National Institutes of Health;Vaccination;water treatment

PROJECT_TITLE: EcoWell- A planet in a plate.

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


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Drug Abuse (NIDA only);Harm Reduction for Substance Misuse;Health Services;Opioid Misuse and Addiction;Opioids;Physical Injury - Accidents and Adverse Effects;Prescription Drug Misuse;Prevention;Primary Health Care;Substance Misuse;Substance Misuse Prevention

ORG_CITY: NORTHBROOK

ORG_NAME: OPREMS LLC

ORG_STATE: IL

PHR: Narrative The opioid crisis is a public health and economic crisis that is eroding the quality of life in the United States. ONE (Opioid and Naloxone Education) is our innovative approach to screening and educating patients who receive prescribed opioid medications at participating community pharmacies. This proposal intends to integrate the tools and process developed by the ONE Program into a digital platform to improve the ability to consistently deliver screening for opioid risk and provide education and interventions as part of an FDA opioid REMS program.

PI_NAMEs: FERRARESE, NICK  (contact)

PROGRAM_OFFICER_NAME: ANGELONE, LEONARDO MARIA

PROJECT_TERMS: Abnormal coordination;Address;Artificial Intelligence;Assessment tool;Behavior;Behavioral;Belief;Cessation of life;Characteristics;Clinical;Clinical Practice Guideline;Community Participation;Community Pharmacy;Computer software;Computers;Data;data de-identification;digital;digital platform;Drug user;Economics;Education;Effectiveness;Electronics;Elements;Eligibility Determination;Evaluation;evidence base;Feedback;Frequencies;Health;Health Personnel;high risk;Illicit Drugs;illicit opioid;improved;Individual;Infrastructure;innovation;Intervention;Location;Measures;Modeling;Naloxone;naloxone dispensing;North Dakota;Opiate Addiction;Opioid;Opioid Analgesics;opioid epidemic;opioid misuse;opioid mortality;opioid overdose;opioid therapy;opioid use;Outcome;Overdose;overdose death;overdose prevention;Overdose reduction;Pain;Paper;Patient Education;patient response;Patients;Persons;Pharmaceutical Preparations;Pharmacy facility;Phase;Pilot Projects;prescription opioid;Prescription opioid overdose;Prevention strategy;preventive intervention;primary care setting;Primary Prevention;Process;programs;Provider;Public Health;Quality of life;Recommendation;Research;Research Personnel;response;Risk;Risk Assessment;Risk Factors;Safety;screening;Screening procedure;screening program;Site;Small Business Technology Transfer Research;Statistical Data Interpretation;substance abuse prevention;Surveys;synthetic opioid;Tablets;Testing;Time;tool;Uncertainty;United States;United States Dept. of Health and Human Services;United States Food and Drug Administration;United States National Center for Health Statistics;United States National Institutes of Health;Universities

PROJECT_TITLE: Feasibility of Electronic Screening to Identify Risk of Opioid Misuse and Overdose


NIH_SPENDING_CATS: Biotechnology;Prevention

ORG_CITY: Morrisville

ORG_NAME: MUCOMMUNE, LLC

ORG_STATE: NC

PHR: Narrative: Recent clinical reports suggest patients can develop anti-PEG antibody (APA) responses to some PEGylated drugs, which in turn compromise their efficacy and safety. Here, we are developing MM-010 as a safe, cost- effective and readily translatable method to intervene against induction of APA and APA-mediated negative outcomes for PEGylated drugs. If successful, our work will provide a low-cost, generalizable strategy for overcoming PEG-sensitivity for many PEGylated medicines.

PI_NAMEs: KUSHIRO, KEIICHIRO  (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: Acceleration;Allergic Reaction;allergic response;American;Anaphylaxis;Animal Model;Animals;Antibodies;Antibody Response;Antibody titer measurement;assay development;B-Cell Antigen Receptor;B-Lymphocytes;Binding;Biological;Biological Assay;Buffers;Case Study;Circulation;Clinic;Clinical;clinical development;clinical lot;Clinical Pathways;Clinical Research;clinical translation;Clinical Trials;cost;cost effective;COVID-19;Data;design;Development;Dose;drug clearance;Drug Kinetics;effective intervention;Emergency Situation;Ensure;Enzyme-Linked Immunosorbent Assay;Epinephrine;Evaluation;experience;Family suidae;Feedback;first-in-human;Formulation;Foundations;Future;Goals;Government;Haptens;High Pressure Liquid Chromatography;Human;Hypersensitivity;Immunocompetent;Immunologics;Immunosuppression;Individual;Infusion procedures;Injections;Intervention;Licensing;Lipids;Liposomes;lot production;Marketing;Measures;Mediating;Medicine;Methods;Modeling;Molecular;Mus;nanomedicine;No-Observed-Adverse-Effect Level;Outcome;Pathway interactions;Patients;Pegaspargase;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Phase I Clinical Trials;Pilot Projects;Plasma;Polyethylene Glycols;Polymers;porcine model;pre-clinical;prevent;Production;Proteins;Publishing;Qualifying;Rattus;Reaction;Recovery;Reporting;Research;Research Design;response;Resuscitation;Risk;risk mitigation;RNA vaccine;Runaway;Safety;Sampling;Small Business Innovation Research Grant;Specimen;Sprague-Dawley Rats;Standard Model;Surface;Technology;therapeutic nanoparticles;Time;Toxic effect;Toxicokinetics;Toxicology;Urine;Work

PROJECT_TITLE: IND-enabling development of MM010, a PEG-specific intervention that blocks allergic response and restores repeated dosing for select PEGylated medicines impacted by anti-PEG antibody


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Infectious Diseases;Orphan Drug;Rare Diseases

ORG_CITY: BOULDER

ORG_NAME: BOLDER BIOTECHNOLOGY, INC.

ORG_STATE: CO

PHR: Narrative. The U.S. government is urgently seeking therapies to protect against and improve survival from Burkholderia pseudomallei (Bpm) and other intracellular bacteria because of their high lethality, inherent antibiotic resistance, ease of dissemination and potential use as bioterrorism weapons. We will evaluate a novel, engineered protein with enhanced bioavailability and pharmacological properties for its ability to stimulate host innate immunity to protect against lethal Bpm infection. These studies will lead to a broad- spectrum treatment effective against Bpm and many other emerging bacterial, viral, and fungal diseases of great importance to public health and national security.

PI_NAMEs: COX, GEORGE NORBERT (contact)

PROGRAM_OFFICER_NAME: MUKHOPADHYAY, SUMAN

PROJECT_TERMS: Acute;analog;Animals;Antibiotic Resistance;Antibiotics;Antibodies;antimicrobial;arm;Aspergillus;Bacteria;bacterial resistance;Biological Availability;Biological Models;Biological Products;Bioterrorism;bioweapon;Burkholderia Infections;Burkholderia mallei;Burkholderia pseudomallei;Category B pathogen;Cells;chemokine;Chronic;Classification;combat;comparative efficacy;Contracts;COVID-19 pandemic;cytokine;Data;Death Rate;Development;Disease;Disease Outbreaks;DNA Sequence Alteration;Dose;Drug Kinetics;Drug resistance;Ebola;Ebola virus;effective therapy;efficacy evaluation;Emergency Situation;Emerging Communicable Diseases;first responder;fungus;Government;Grant;Half-Life;Health;Health Personnel;high risk;Homologous Gene;Hour;Human;Immune system;Immunity;improved;In Vitro;in vivo;Infection;Innate Immune System;Interferon Type II;Intramuscular;Intramuscular Injections;intraperitoneal;Intraperitoneal Injections;Macrophage;man;manufacture;mass casualty;Medicine;Melioidosis;Methods;Microbe;Modeling;Morbidity - disease rate;mortality;Mus;Mutate;Mutation;National Institute of Allergy and Infectious Disease;National Security;Natural Immunity;Neopterin;nonhuman primate;novel;novel therapeutics;pathogen;Pathogenicity;Pathway interactions;Patients;Pharmaceutical Preparations;pharmacologic;phase 2 study;Plasma;prevent;Property;Protein Engineering;Proteins;Protozoa;Public Health;Resistance;Resistance development;Risk;Safety;Site;subcutaneous;Subcutaneous Injections;Technology;Testing;Therapeutic;Therapeutic antibodies;Toxoplasma;Tularemia;unvaccinated;Vaccines;Viral;Virus;Virus Diseases;weapons

PROJECT_TITLE: Improving survival from Burkholderia pseudomallei and other pathogenic intracellular bacteria

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


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Bioengineering;Biomedical Imaging

ORG_CITY: DURHAM

ORG_NAME: RAMONA OPTICS, INC.

PHR: Current microscopes cannot form 3D images with cellular-scale resolution over an area larger than a few square centimeters, which limits the throughput and accuracy of model organism screening methods in neuroscience, toxicology and pharmacology. Ramona Optics aims to create a new micro-camera array microscope platform (MCAM-3D) for parallelized 3D imaging of unconstrained model organisms over an entire well plate area (8x12 cm) at cellular-level detail, allowing scientists for the first time to acquire 3D behavior and morphological data at high throughput. In this project, Ramona Optics Inc. will integrate 3D and a lateral perspective imaging modalities into a single instrument and will produce associated software for automated organism analysis to improve the rigor, efficiency, and translatability of high-content screening experiments.

PI_NAMEs: HARFOUCHE, MARK  (contact)

PROGRAM_OFFICER_NAME: CONTRERAS, MIGUEL A

PROJECT_TERMS: 3-Dimensional;Acceleration;Adopted;Affect;Agar;Agriculture;Anesthesia procedures;Area;automated analysis;Behavior;Behavioral;behavioral phenotyping;Biological Assay;biomedical imaging;Brain;Collaborations;Computer software;Custom;Data;design;Detection;Development;developmental disease;Developmental Process;Devices;Dictionary;Discipline;Disease;Disease Progression;Drosophila genus;Drosophila melanogaster;drug discovery;Drug Screening;Ensure;Experimental Models;experimental study;Eye;feeding;Feeding behaviors;Fluids and Secretions;fundamental research;Genetic;gigabyte;graphical user interface;Height;high resolution imaging;Human body;Image;Image Analysis;image processing;image registration;imaging modality;Imaging technology;improved;in vivo;insight;instrument;interest;Investigation;Laboratory Organism;large-scale imaging data;Larva;Lateral;lens;Libraries;Light;limb movement;Machine Learning;Manuals;Maps;Marketing;Measurement;Measures;meter;Methods;Microscope;Microscopic;Microscopy;model organism;Morphology;Movement;Names;Neurosciences;novel;open source;optical imaging;Optics;Organism;parallelization;Peristalsis;Pharmacology;Pharmacology and Toxicology;Positioning Attribute;prevent;Published Comment;Research;Resolution;sample collection;Science;Scientist;screening;Sedation procedure;Side;software development;Sparrows;Specimen;Speed;Statistical Data Interpretation;stereoscopic;Tail;Technology;Three-Dimensional Image;Three-Dimensional Imaging;Time;tool;Toxicology;Training;Universities;Variant;Zebrafish

PROJECT_TITLE: High-content behavioral phenotyping of model organisms in three dimensions with a gigapixel microscope

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


ADMINISTERING_IC: CA

ED_INST_TYPE: SCHOOLS OF DENTISTRY/ORAL HYGN

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Cancer Genomics;Gene Therapy;Genetics;Human Genome;Immunotherapy

ORG_DEPT: DENTISTRY

ORG_NAME: UNIVERSITY OF PENNSYLVANIA

PHR: PROJECT NARRATIVE With chronic stimulation by tumor antigen, chimeric antigen receptor (CAR) T cells enter a state of exhaustion that severely limits their otherwise potent anti-cancer capacity. Epigenetic reprogramming is strongly implicated in CAR T cell exhaustion, and the specific genes regulated by key epigenetic players represent potential actionable targets for modulation in CAR T cells to confer resistance against exhaustion. This proposal aims to create a novel system for inducible global epigenetic gene activation (seTET) as well as introduce the first split-engineered epigenome editors (seEE) for controllable activation of specific genes, and to apply seTET and seEE in a CAR T cell “stress test” to identify relevant gene inhibition targets for overcoming CAR T cell exhaustion, which will guide efforts to improve the efficacy of this immunotherapy.

PI_NAMEs: ERLITZKI, NOA  (contact)

PROGRAM_OFFICER_NAME: PURI, ANU

PROJECT_TERMS: adeno-associated viral vector;Affect;anti-cancer;Antigens;Biochemistry;Biological Assay;Biology;cancer therapy;Candidate Disease Gene;CAR T cell therapy;career;career development;CCI-779;Cellular immunotherapy;chimeric antigen receptor;chimeric antigen receptor T cells;Chronic;Clinical;Clustered Regularly Interspaced Short Palindromic Repeats;Collaborations;Communication;CpG Islands;CRISPR interference;Cues;Cytosine;delivery vehicle;demethylation;design;Development;differential expression;Digestive System Disorders;DNA;DNA Methylation;DNA Modification Process;doctoral student;Engineering;Enzymes;Epigenetic Process;epigenetic regulation;epigenetic silencing;epigenome;epigenome editing;exhaustion;Family;Foundations;Functional disorder;Funding Opportunities;Gastrointestinal Diseases;Gene Activation;Gene Expression Regulation;gene repression;Gene Silencing;Gene Targeting;Genes;genome editing;genome editor;genomic locus;Goals;Hematologic Neoplasms;Immersion;Immunotherapy;improved;Individual;insight;interest;Knock-out;knockout gene;Knowledge;Link;Literature;Lymphocyte;Malignant Neoplasms;Mediating;Mediator;Medical;medical schools;medical specialties;Methylation;Modeling;Mutation;N-terminal;Nature;novel;Oncogenic;overexpression;oxidation;Pathway interactions;Phenotype;Physicians;Physiological;Predisposition;prognostication;programs;promoter;Property;Proteins;receptor;Recovery;Reporting;Research;Research Priority;Resistance;response;Safety;Scientist;screening;Sirolimus;Site;small molecule;Stress Tests;Students;success;Surface;System;Technology;therapeutic target;tool;Training;Training Programs;translational potential;Treatment Efficacy;tumor;Tumor Antigens

PROJECT_TITLE: Deciphering and modulating CAR T cell persistence with controllable epigenome editors

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F08-L (20)]


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Depression;Health Services;Major Depressive Disorder;Maternal Health;Maternal Morbidity and Mortality;Mental Health;Mental Illness;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Serious Mental Illness;Women's Health Research

ORG_CITY: SCARSDALE

ORG_NAME: VOICELOVE LLC

PHR: Postpartum depression (PPD) is a devastating complication of childbirth that can be exacerbated in mothers with infants admitted to the neonatal intensive care unit (NICU). Lack of infant and social connectedness increases PPD risk; however, NICU units are understaffed and ill-equipped to address parental mental health. VoiceLove LLC is developing a novel HIPAA-compliant mobile application that enables expanded family engagement by circumventing barriers to communication by allowing an electronic venue for direct parent- family-provider interaction.

PI_NAMEs: OSMUNDSON, SARAH SCHEIDERICH (contact)

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: Address;Admission activity;adverse outcome;Anxiety;burnout;Caring;Child;Child Development;Childbirth;Clinical;Clinical Research;Cognitive;Communication;comparison intervention;Complication;cost;Cost Savings;Data;depressive symptoms;design;Development;direct patient care;Discipline of Nursing;effectiveness evaluation;efficacy evaluation;Electronics;Emotional;empowerment;Event;experience;Family;Family member;Feedback;Feeling;Fostering;Friends;Future;Goals;Health Insurance Portability and Accountability Act;Health Personnel;healthcare burden;high risk behavior;Hospitalization;Hospitals;Impairment;improved;Infant;Infant Care;Infant Health;innovation;Intervention;loved ones;Major Depressive Disorder;Measures;Medical;Medical Care Team;meetings;Mental Depression;Mental disorders;Mental Health;mobile application;Mothers;Neonatal Intensive Care Units;neonate;new technology;New York;novel;Nurses;Parents;Patients;Perception;Personal Satisfaction;Persons;Phase;Pilot Projects;Population;Positioning Attribute;Post-Traumatic Stress Disorders;Postpartum Depression;Postpartum Period;Premature Infant;Presbyterian Church;Prevalence;primary outcome;programs;prototype;Provider;provider communication;psychosocial development;Quality of life;Randomized, Controlled Trials;Reporting;Resource Development;Risk;Risk Factors;satisfaction;secondary outcome;Self Efficacy;Self-Injurious Behavior;Series;Severities;Small Business Technology Transfer Research;social;Social support;Source;Stress;Substance abuse problem;success;Support System;Surveys;System;Technology;Telephone;Time;tool;treatment as usual;trial comparing;usability;verbal;Visit;Voice;Work;working group

PROJECT_TITLE: VoiceLove: NICU Utilization of Remote voice Technology to improve mateRnal Experience (NURTURE)

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


ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

NIH_SPENDING_CATS: Aging;Basic Behavioral and Social Science;Behavioral and Social Science;Chronic Pain;Clinical Research;Neurosciences;Pain Research;Physical Activity;Prevention

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

PHR: Project Narrative Chronic musculoskeletal pain in older age is common and often leads to lower physical activity in this population; however, some older adults with pain are physically active. This proposal investigates the neural and behavioral measures of motivation that may protect against the detrimental effects of pain on physical activity. The results of this study may help identify modifiable protective factors and inform future targets to promote pain resiliency in older adults.

PI_NAMEs: WITONSKY, KAILYN FAYE  (contact)

PROGRAM_OFFICER_NAME: FRANKOWSKI, DAVID WITT

PROJECT_TERMS: Abbreviations;Accounting;Address;Adult;advanced analytics;Age;Aging;Analgesics;analytical method;Animals;Automobile Driving;behavior measurement;Behavioral;biracial;Black race;Body Composition;brain health;Characteristics;Chronic Care;chronic musculoskeletal pain;chronic pain;Clinical;clinical epidemiology;Clinical Trials;cohort;Communication;Communities;comorbidity;Competence;Corpus striatum structure;cost;Cross-Sectional Studies;Data;Dementia;design;disability risk;Epidemiologic Methods;Epidemiologist;Epidemiology;epidemiology study;evidence base;Exercise;experience;Foundations;Funding;Future;Goals;Health;human old age (65+);improved;innovation;insight;Investigation;Learning;Location;Longitudinal cohort;Longitudinal Studies;Measurement;Measures;Mediating;Mental Depression;Mentorship;Modeling;Motivation;muscle strength;neural;neural correlate;Neurobiology;Neuroepidemiology;neuroimaging;novel;older adult;Pain;Pain Measurement;pain reduction;Participant;Patient Self-Report;Perception;Persons;Physical activity;Physical Performance;Physicians;Polypharmacy;Population;Process;protective factors;Quality of life;Race;randomized trial;Research;Research Design;Research Methodology;Research Project Grants;resilience;Rest;Role;Severities;sex;Site;skills;Social Network;Social support;Techniques;Training;Walking;Woman;Work;young adult

PROJECT_TITLE: High physical activity in older adults with pain: behavioral and neural drivers of pain resilience

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F18-E (20)]


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Orphan Drug;Prevention;Rare Diseases;Vaccine Related

ORG_CITY: ROCKVILLE

ORG_NAME: ABVACC, INC.

ORG_STATE: MD

PHR: There has been a rise in filovirus outbreaks caused by Marburg virus, a relative of Ebola virus most specifically in July 2022 and March 2023. These filovirus outbreaks threaten human life, the world economy, and the healthcare system, therefore the need for a highly effective and safe vaccine against Marburg Virus Disease (MVD) is paramount. In this proposal, we seek to develop a vaccine against MVD comprised of a Marburg glycoprotein component in combination with a safe and novel adjuvant that has shown excellent safety in millions of people during COVID-19 pandemic. The vaccine induces broadly neutralizing antibodies against multiple strains of MARV and showed 100% protection against lethal challenge in small animals. Therefore, we aim to further develop this subunit vaccine as a highly efficacious and safe candidate for protection against a large Marburg outbreak.

PI_NAMEs: KAILASAN, SHWETA  (contact)

PROGRAM_OFFICER_NAME: DUPUY, LESLEY CONRAD

PROJECT_TERMS: Adjuvant;Advanced Development;Affinity;Africa;African;Agonist;Aman;Angola;Animals;Antibodies;Antibody titer measurement;Antigen-Antibody Complex;Antigens;Binding;Biochemical;Biological Assay;Case Fatality Rates;Cavia;Cells;Cessation of life;clinical development;COVID-19 pandemic;Cyclic GMP;design;Development;Disease;Disease Outbreaks;Distant;Dose;Ebola;Ebola Hemorrhagic Fever;Ebola virus;efficacy study;Engineering;Enzyme-Linked Immunosorbent Assay;Epitopes;Equatorial Guinea;Exclusion;Exhibits;experience;Fatality rate;Filoviridae Infections;Filovirus;Flow Cytometry;Ghana;Glycoproteins;Grant;guinea pig model;Healthcare Systems;hemorrhagic fever virus;Human;Immune response;Immunity;Immunization;Immunize;immunogenic;immunogenicity;Immunology;In Vitro;in vivo;Inbred BALB C Mice;Infection;Innate Immune Response;Knowledge;Life;Macaca fascicularis;Marburg Virus Disease;Marburgvirus;Medical;Medicine;Modeling;Monoclonal Antibodies;Mus;neutralizing antibody;new outbreak;nonhuman primate;novel;pathogen;Persons;Phase;Phylogenetic Analysis;Play;Point Mutation;pre-clinical;product development;Production;Property;protein purification;Proteins;Quality Control;rational design;Recombinants;Regimen;Reporting;Research;Rodent;Role;Safety;Small Business Innovation Research Grant;sobriety;stable cell line;Streptavidin;Structural Biologist;Structure;Subunit Vaccines;success;T cell response;T-Cell Activation;Tanzania;Testing;Texas;Therapeutic;Time;TLR7 gene;TLR8 gene;Universities;Vaccine Adjuvant;vaccine candidate;Vaccine Design;vaccine development;Vaccines;viral outbreak;Viremia;Virus

PROJECT_TITLE: Development of a Marburgvirus subunit vaccineadjuvanted with a novel TLR7/TLR8 agonist


NIH_SPENDING_CATS: Asthma;Biotechnology;Lung

ORG_CITY: BLACKSBURG

ORG_NAME: BIOTHERAPEUTICS, INC.

ORG_STATE: VA

PHR: Public Health Relevance Asthma is a chronic, widespread allergic disease with total expenses exceeding $80 billion annually in the U.S. Current therapies for asthma are modestly successful but leave significant subpopulations of patients without adequate response. This SBIR I application will develop a novel, oral, immunoregulatory small-molecule therapeutic for asthma with a novel mechanisms of action.

PI_NAMEs: BASSAGANYA-RIERA, JOSEP  (contact)

PROGRAM_OFFICER_NAME: LIU, QIAN

PROJECT_TERMS: Acceleration;Airway Resistance;Allergic Disease;Animal Model;Anti-Inflammatory Agents;Asthma;asthma model;asthmatic patient;Autoimmune;Autoimmune Diseases;Benchmarking;Benign;Binding;Biological Assay;Biological Response Modifier Therapy;Biotechnology;bronchial epithelium;Canis familiaris;CD4 Positive T Lymphocytes;Cells;chemokine;Chronic;Clinical Trials;Coculture Techniques;commercial application;Computer Models;cytokine;Development;Disease;Dose;efficacy evaluation;Epithelial Cells;Evaluation;Extrinsic asthma;Flow Cytometry;Genus Hippocampus;Goals;Goblet Cells;guinea pig model;Histopathology;Human;Hyperplasia;Hypersensitivity;IL17 gene;IL8 gene;Immune;Immunology;immunoregulation;improved;Inflammation;Inflammatory;inhibitor;innovation;Interleukin-2;Interleukin-6;lanthionine;Legal patent;Ligands;Ligase;Lung;Macrolides;Marketing;Medical;Metabolic;metabolic profile;Methods;Methotrexate;Modeling;mouse model;Mus;neutrophil;Neutrophil Infiltration;novel;novel therapeutic intervention;novel therapeutics;Oral;Outcome;Ovalbumin;Pathway interactions;patient subsets;Peripheral Blood Mononuclear Cell;Pharmaceutical Preparations;Phase;Phase I Clinical Trials;Positioning Attribute;Pre-Clinical Model;Program Development;Proliferating;public health relevance;Pyroglyphidae;Rattus;receptor;Regulatory T-Lymphocyte;Reporting;response;Risk;Route;Safety;side effect;Signal Transduction;Small Business Innovation Research Grant;small molecule therapeutics;Stat5 protein;steroid dependence;success;synergism;Target Populations;Therapeutic;TNF gene;Toxic effect;Treatment Efficacy

PROJECT_TITLE: Development of Novel Immunoregulatory Therapeutics for Asthma

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


PHR: RELEVANCE TO PUBLIC HEALTH This project aims to demonstrate that CLA acts as a biological relay through the formation of protective and anti- inflammatory NO2-CLA during cardiac IR injury. Successful completion may lead to nutritional interventions to limit damage and preserve cardiac function during IR.

PI_NAMEs: COLUSSI, NICOLE  (contact)

PROGRAM_OFFICER_NAME: CHEON, YEWON

PROJECT_TERMS: Amino Acids;Anti-Inflammatory Agents;Autoimmune;Biochemical;Biological;biological systems;Blood flow;Cardiac;Cardiac Myocytes;Cell Culture Techniques;Cell membrane;Cells;Chemicals;Chemistry;Clinical Research;Complex;Conjugated Linoleic Acids;Coronary artery;Coupled;Crowding;Cysteine;Cytoprotection;Dietary Intervention;Esterification;Evaluation;Event;Fatty Acids;Free Radicals;Generations;Heart;Heart Arrest;heart function;heart preservation;Immunofluorescence Immunologic;in vivo;Infarction;Inflammation;Inflammatory;Injury;innovation;insight;Interruption;Intravenous;Ischemia;Label;Ligation;Lipid Bilayers;Lipid Peroxidation;Lipids;Liquid Chromatography;Mass Spectrum Analysis;Measurement;Mediating;Membrane;Membrane Lipids;Metabolic;Mitochondria;Modeling;Mus;Myocardial;Myocardial Ischemia;Myocardial Reperfusion Injury;Myocardium;NF-kappa B;nitrated conjugated linoleic acid;nitration;Nitric Oxide;Nitric Oxide Synthase;Nitrites;nitroalkene;Nitrogen Dioxide;novel;Oral;Outcome;oxidative damage;Oxidative Stress;Oxygen;Patients;Phospholipase;Phospholipids;Physiological;Plasma;Post-Translational Protein Processing;pre-clinical;Pre-Clinical Model;preclinical study;preference;Production;protective effect;Proteins;Proteomics;Public Health;Reaction;Reactive Oxygen Species;Reperfusion Injury;Reporting;Resolution;response;restoration;Role;Scheme;Signal Pathway;Signal Transduction;Signaling Molecule;small molecule;Source;Sulfhydryl Compounds;Superoxides;systemic inflammatory response;tandem mass spectrometry;Testing;Therapeutic;Tissues;Triglycerides;Unsaturated Fatty Acids;Vascular blood supply;Virus Diseases;Work

PROJECT_TITLE: Bridging the gap of endogenous nitro-conjugated linoleic acid formation and signaling


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

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

ORG_CITY: SAN DIEGO

ORG_NAME: ABTERRA BIOSCIENCES, INC.

PHR: Therapeutic antibody drugs are discovered using a small number of approaches that do not sample the full antibody population in an individual. Deep sequencing of the antibody repertoire can help improve and find new therapeutic candidates with the aid of novel algorithms and deep learning models.

PI_NAMEs: CASTELLANA, NATALIE  (contact)

PROGRAM_OFFICER_NAME: YU, GUOQIN

PROJECT_TERMS: Acceleration;algorithm development;Algorithms;analysis pipeline;Animal Model;Antibodies;Antibody Repertoire;Antibody Response;Antigens;assay development;Autoimmune Diseases;B-Lymphocytes;Bacteriophages;Biological Assay;Biological Sciences;Bone Marrow;candidate selection;Cells;Client;Computer software;COVID-19 pandemic;Data;Data Set;Decision Making;deep learning;deep learning model;deep sequencing;Development;Disease;drug discovery;Evaluation;Evolution;Family;Foundations;Genetic;Genomics;graphical user interface;High-Throughput Nucleotide Sequencing;Human;human subject;Hybridomas;Immune;Immune response;Immune system;improved;In Vitro;in vivo;Individual;Informatics;insight;large scale data;Llama;Machine Learning;Mainstreaming;Methods;Mining;Modeling;Mus;Mutation;Mutation Analysis;natural antibodies;next generation;next generation sequencing;novel;novel therapeutics;Oryctolagus cuniculus;Pattern;Peripheral Blood Mononuclear Cell;Persons;Phage Display;Pharmaceutical Preparations;Phase;Play;Population;Process;Property;Proteomics;Protocols documentation;Reagent;Research;response;Risk;risk mitigation;Role;Sampling;Serum;Services;Signal Transduction;software development;Source;Speed;Spleen;success;Survivors;Techniques;Technology;Therapeutic antibodies;therapeutic candidate;Time;tool;Traction;Training;transcriptomics;tumor;Vaccinated;vaccine response;Viral;Yeasts

PROJECT_TITLE: REPTOR: accelerating antibody discovery and improving hits with machine learning

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


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

ORG_CITY: HOUSTON

ORG_DEPT: NEUROSCIENCES

ORG_NAME: BAYLOR COLLEGE OF MEDICINE

ORG_STATE: TX

PHR: PROJECT NARRATIVE A subset of individuals exhibits resilience to Alzheimer’s disease, as indicated by significant Alzheimer’s disease neuropathology on autopsy despite intact cognition. Underlying pathways that engage this resilience remain largely unknown, making it difficult to develop targeted therapies that harness these naturally-occurring pathways. My goal is to investigate genetic mechanisms of natural resilience, so that we can design strategies that leverage these underlying mechanisms to therapeutically confer resilience to Alzheimer’s disease progression.

PI_NAMEs: ST. ROMAIN, COREY  (contact)

PROGRAM_OFFICER_NAME: WAGSTER, MOLLY V

PROJECT_TERMS: Abeta synthesis;Age;Age Months;Alzheimer's Disease;Alzheimer's disease patient;Alzheimer's disease risk;Amyloid beta-Protein;antagonist;Anticonvulsants;Atosiban;Autopsy;Behavior;Biochemical;Cell Physiology;Cells;Chronic;Cognition;cohort;Data;Data Set;dementia risk;dentate gyrus;design;Development;differential expression;Disease;Disease Progression;Electroencephalography;Epilepsy;epileptiform;Exhibits;experience;Frequencies;Generalized seizures;Genes;Genetic;Goals;Hippocampus;Human;Human Amyloid Precursor Protein;Hypothalamic structure;Immunohistochemistry;Impaired cognition;Impairment;improved;Incidence;Individual;Infusion procedures;insight;J20 mouse;Mediating;Mediator;Memory;Memory impairment;Memory Loss;Modeling;Monitor;mouse model;Mus;muscle enhancer factor-2A;mutant;Neuromodulator;Neurons;neuropathology;neuroprotection;new therapeutic target;non-demented;novel therapeutic intervention;older adult;overexpression;Oxytocin;Oxytocin Receptor;paraventricular nucleus;Pathway interactions;Pilot Projects;Predisposition;Production;promote resilience;Proxy;Publishing;receptor expression;Recording of previous events;resilience;response;Risk Factors;Role;Sampling;Seizures;Senile Plaques;Signal Transduction;Social Behavior;Social Interaction;Social isolation;spatial memory;System;targeted treatment;tau aggregation;Testing;Therapeutic;Time;transcription factor;transcriptome sequencing;Transgenic Mice

PROJECT_TITLE: Genetic resiliency to disease progression in Alzheimer's disease

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


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

ORG_CITY: FREMONT

ORG_NAME: SANSIMEON, INC

PHR: The ability to sequence 10 million - 100 million single cells per experiment will enable researchers to develop the next generation of cell therapies to treat cancer with greater efficacy at reduced cost. Existing methods for single cell sequencing do not support throughput beyond 1 million cells per experiment, and alternative approaches to scale single cell sequencing are unsuitable for translational research due to trade-offs in performance and ease-of-use. Sansimeon’s approach uniquely scales single cell sequencing with throughput >100M cells, and our streamlined workflow to sequence cells directly from crude & complex samples (such as whole blood or bone marrow aspirates), with a single-step automated workflow, makes the platform ideally suited for high- throughput translational research applications.

PI_NAMEs: SPUHLER, PHILIPP STEFAN (contact)

PROGRAM_OFFICER_NAME: FUFA, TEMESGEN D

PROJECT_TERMS: Acceleration;adaptive immune response;Address;Adoption;Adult;authority;B-Cell Antigen Receptor;B-Lymphocytes;Bar Codes;Barbering;Biological Sciences;Blood specimen;Bone Marrow Aspiration;Buffers;CAR T cell therapy;Cell Separation;Cell Survival;Cell Therapy;Cells;cellular engineering;Centrifugation;Chromium;Clinical Research;Clonal Expansion;Clustered Regularly Interspaced Short Palindromic Repeats;commercialization;Complex;Computer software;Consumption;cost;CRISPR screen;design;Development;Device Designs;Disease;DNA sequencing;Doctor of Philosophy;droplet sequencing;Drops;Encapsulated;Engineering;experience;experimental study;expiration;fabrication;Generations;Genes;Genetic Transcription;genome-wide;Genomics;Human;Immune;Immune response;Immunotherapy;improved;Leukocytes;Malignant Neoplasms;manufacture;Maps;Marketing;Methods;Microfluidic Microchips;Microfluidics;next generation;novel therapeutics;operation;Patients;Performance;Peripheral;personalized cancer therapy;Persons;Pharmaceutical Preparations;Phenotype;preclinical study;Price;Process;product development;Research;Research Personnel;response;Running;Sampling;scale up;sequencing platform;single cell analysis;single cell sequencing;Small Business Innovation Research Grant;success;Suspensions;System;T-Lymphocyte;Technology;Time;tool;transcriptome;Translational Research;translational scientist;Tumor Debulking;Whole Blood;Work

PROJECT_TITLE: A Uniquely Scalable Approach to Single Cell Sequencing for the Development of Next Generation Cell Therapies

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


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Autoimmune Disease;Bioengineering;Biotechnology;Brain Disorders;Multiple Sclerosis;Neurodegenerative;Neurosciences

ORG_CITY: TOPSFIELD

ORG_NAME: ARTIFICIAL AXON LABS INC.

PHR: Project Narrative Artificial Axon Labs Inc. is developing a transformational drug screening platform to discover currently non- existing remyelinating therapies for incurable myelin diseases, with the focus on multiple sclerosis (MS). Although the disease modifying therapies for MS available today can prevent the formation of new inflammatory lesions, they do not stop the progression of neurodegeneration and disability in patients, because they fail to stimulate regeneration of myelin, a process called remyelination. To discover urgently needed remyelinating drugs, we developed entirely novel platform, where we use state-of-the art 3D printed artificial axons, very similar to real biological axons, to directly visualize and quantify myelination in response to compounds in the conditions similar to that in the MS brain. Our Artificial Axons platform provides entirely novel and powerful drug discovery tool, which can deliver remyelination drug candidates with a high therapeutic potential in MS patients.

PI_NAMEs: JAGIELSKA, ANNA  (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: 3-Dimensional;3D Print;Acceleration;Address;Affect;Alzheimer's Disease;Architecture;Axon;Biological;Biological Assay;Biomimetics;Brain;cell type;Cells;Central Nervous System;Cessation of life;Characteristics;Clinic;Clinical;Coculture Techniques;commercialization;Complex;Cone;Data;Demyelinations;Development;disability;Disease;Dose;drug candidate;drug discovery;Drug Screening;drug testing;efficacy testing;Elements;Engineering;Environment;experimental study;Fiber;flexibility;Geometry;Glass;Goals;Grant;In Vitro;Inflammatory;inhibitor;innovation;insight;Interferon Type II;Legal patent;Lesion;leukodystrophy;Libraries;Measures;Mechanics;Membrane;Methods;Modeling;Multiple Sclerosis;Multiple Sclerosis Lesions;multiple sclerosis patient;multiple sclerosis treatment;Myelin;myelination;Natural regeneration;Nerve Degeneration;Nerve Tissue;Nervous System Disorder;Neurodegenerative Disorders;Neurons;novel;novel strategies;oligodendrocyte myelination;Oligodendroglia;Optic Neuritis;Outcome;Parkinson Disease;Patients;performance tests;permissiveness;Pharmaceutical Preparations;Phase;Phenotype;Preparation;prevent;Process;Property;remyelination;repaired;Reproducibility;response;screening;Screening procedure;Small Business Innovation Research Grant;Structure;success;Technology;technology platform;Therapeutic;Tissues;tool;two-dimensional;United States National Institutes of Health;virtual model;Visualization

PROJECT_TITLE: In vitro myelination assay modeling the environment of MS lesions for predictive discovery of remyelinating therapies.

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


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Coronaviruses;Coronaviruses Diagnostics and Prognostics;Emerging Infectious Diseases;Infectious Diseases;Influenza;Pneumonia and Influenza

ORG_CITY: MENLO PARK

ORG_NAME: NUMENTUS TECHNOLOGIES INC.

PHR: PROJECT NARRATIVE Conventional PCR is one of the most widely used methods for molecular diagnostics and testing today. A faster, less expensive, and versatile PCR technology would find applications in a wide range of biomedical areas currently using conventional PCR (e.g., infectious disease, cancer, neuroscience, and basic research). Moreover, easy portability could enable point-of-contact/POC PCR analyses in resource-poor communities and for emergency and disaster response.

PI_NAMEs: FARIS, GREGORY W (contact)

PROGRAM_OFFICER_NAME: BASU, DIPANWITA

PROJECT_TERMS: 2019-nCoV;acronyms;anti-cancer research;Area;Base Sequence;Basic Science;Benchmarking;Biological Assay;biosafety level 3 facility;Calibration;Communicable Diseases;Complementary DNA;Computer software;cost;COVID-19 assay;COVID-19 monitoring;COVID-19 pandemic;Custom;Data;design;Detection;Development;Disasters;DNA;DNA amplification;DNA Binding;ds-DNA;Dyes;Emergency Situation;experience;fabrication;Fluorescence;gamma irradiation;Healthcare;Heating;Hour;Human;Hybrids;improved;Infection;Influenza A virus;Influenza B Virus;instrument;instrumentation;International;melting;Methods;Modeling;Molecular Diagnostic Techniques;molecular diagnostics;Monitor;Motor;multiplex assay;Neurosciences Research;Nucleic Acids;Optics;Performance;Phase;Polymerase;Polymerase Chain Reaction;portability;printed circuit board;prototype;Reaction;Resolution;Resource-limited setting;respiratory virus;response;Reverse Transcription;RNA;RNA amplification;RNA Sequences;Sample Size;Sampling;Single Nucleotide Polymorphism;Single-Stranded DNA;Speed;synthetic construct;synthetic nucleic acid;System;Technology;Temperature;Testing;Time;Validation;Virus;Work

PROJECT_TITLE: Rapid, versatile PCR


ORG_CITY: BOSTON

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: HARVARD MEDICAL SCHOOL

PHR: Project Narrative Type 1 Diabetes (T1D) is an autoimmune disease in which T cells destroy pancreatic β-cells. Each T cell targets specific antigens via recognition through its T cell antigen receptor (TCR), which must survive thymic selection before it can migrate to the pancreas or other peripheral tissues. With paired TCR and transcriptomic data at single-cell resolution, this project investigates the hypothesis that human leukocyte antigen (HLA) alleles confer risk for T1D via the thymic selection of β-cell-specific TCRs that are predisposed for inflammatory T cell states.

PI_NAMEs: LAGATTUTA, KAITLYN ANNE (contact)

PROGRAM_OFFICER_NAME: GONDRE-LEWIS, TIMOTHY A

PROJECT_TERMS: Accounting;Affect;Age;Algorithms;Alleles;Antigen Receptors;antigen-specific T cells;Antigenic Variation;Antigens;attributable risk;Autoantigens;autoencoder;Autoimmune Diseases;Autoimmunity;autoreactive T cell;Beta Cell;Bioinformatics;bioinformatics tool;case control;Cells;Charge;Clinical;cohort;Computing Methodologies;Data;Data Set;design;dimension reduction;Disease;effector T cell;Electrostatics;engineered beta cell;Environment;Familiarity;Foundations;functional genomics;G6PC2 gene;Generations;Genes;Genetic;Genetic study;Genetic Transcription;genomic data;Genotype;Heritability;HLA Antigens;Human Genetics;Hydrophobicity;Immune response;Immunologics;Immunology;Individual;Inflammation;Inflammatory;insight;Insulin-Dependent Diabetes Mellitus;Intervention;islet;Learning;Libraries;Manuscripts;Mediating;Memory;Mentorship;method development;Methods;migration;Monitor;Mucous Membrane;novel;Oral;Organoids;Pancreas;Pathogenicity;Pattern;Peripheral;Persons;Phenotype;Physicians;Positioning Attribute;preproinsulin;Publishing;Receptor Gene;Regulatory T-Lymphocyte;Research;Resolution;Resources;Risk;risk variant;Scientist;Serum;skills;Specificity;Statistical Models;Structure of beta Cell of islet;T cell differentiation;T cell therapy;T-Cell Antigen Receptor Specificity;T-Cell Receptor;T-Lymphocyte;T-Lymphocyte Subsets;Testing;therapeutic target;Thymus Gland;Tissues;Training;training data;transcriptome;transcriptomics;translational impact;V(D)J Recombination;Work;Writing;Yeasts

PROJECT_TITLE: HLA risk alleles cause Type 1 Diabetes by modifying the selection of T cell receptors that recognize pancreatic beta cell antigens

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F07B-G (20)]


NIH_SPENDING_CATS: Biotechnology;Chronic Pain;Neurodegenerative;Neurosciences;Pain Research;Peripheral Neuropathy

ORG_CITY: NEW HAVEN

ORG_DEPT: NEUROLOGY

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: Project Narrative Chronic pain is the leading cause of disability worldwide and current treatments are ineffective and addictive. UbiquiNaV is an engineered bifunctional protein that enables targeted degradation of an ion channel implicated in human pain conditions – this study aims to evaluate the ability of UbiquiNaV to reduce the excitability of pain- sensing neurons and to reveal the mechanism of this reduction. This study may lead to compounds that enable targeted degradation of peripheral ion channels as novel analgesic agents for non-addictive pain therapy.

PI_NAMEs: TYAGI, SIDHARTH  (contact)

PROGRAM_OFFICER_NAME: MOHAPATRA, DURGA PRASANNA

PROJECT_TERMS: Absence of pain sensation;Action Potentials;Adverse effects;Afferent Neurons;alternative treatment;Analgesics;Animal Model;Axon;Binding;Biological Assay;Catalytic Domain;Cell surface;chronic pain;Clathrin;Clinic;Closure by clamp;Coupled;Data;density;Development;Dimerization;disability;Disease;Electrophysiology (science);Endocytosis;Engineering;gain of function mutation;Genetic;global health;Goals;Health Care Costs;Human;ineffective therapies;innovation;Ion Channel;Knockout Mice;Label;Laboratories;Link;live cell imaging;loss of function;Mediating;Membrane Proteins;Mentors;Myosin ATPase;Names;Neurology;neuronal cell body;neuronal excitability;Neurons;Neurosciences;Nociceptors;novel;novel therapeutics;overexpression;Pain;Pain management;pain model;pain sensation;pain sensitivity;painful neuropathy;Peripheral;Phase;Physicians;Physiological;Protein Engineering;Protein Isoforms;Proteins;Rattus;Reagent;Regulation;Research;Scientist;Sensory;side effect;Sirolimus;small molecule;Sodium;Sodium Channel;Specificity;Spike Potential;Spinal Ganglia;Stimulus;Surface;System;Tail;Testing;Therapeutic;Therapeutic Agents;Time;trafficking;treatment strategy;ubiquitin ligase;Ubiquitination;United States;Validation;Video Microscopy;voltage;voltage clamp;Western Blotting;Work

PROJECT_TITLE: Targeted degradation of NaV1.8 as a therapeutic strategy for pain

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F03B-L (20)]


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease Related Dementias (ADRD);Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Amyotrophic Lateral Sclerosis (ALS);Biotechnology;Brain Disorders;Dementia;Frontotemporal Dementia (FTD);Genetics;Neurodegenerative;Neurosciences;Orphan Drug;Rare Diseases

ORG_CITY: Brooklyn

ORG_NAME: LUCERNA, INC.

PHR: PUBLIC HEALTH RELEVANCE STATEMENT To overcome the “undruggable” protein problem, researchers have turn to drugging mRNAs that translate into these undruggable proteins or non-coding RNAs that regulate the biogenesis of these proteins. Avenues of controlling RNA degradation include induced proximity degradation or splicing modulated nonsense-mediated decay. Early-stage RNA degradation drug discovery has been hindered by current high-throughput screening assay technologies designed for protein targets. Therefore, this project will develop a cell- based assay platform that monitors selected RNA turnover more accurately to accelerate the discovery of small molecule drugs that modulate RNA stability.

PI_NAMEs: O'HANLON, RYAN  (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: Acceleration;Affect;analytical method;Antisense Oligonucleotide Therapy;Antisense Oligonucleotides;arm;Binding;Biogenesis;Biological Assay;Biology;c9FTD/ALS;C9ORF72;Cells;Code;Communities;Coupled;Cystic Fibrosis;Cytosol;Data;Defect;Degradation Pathway;design;Disease;disease phenotype;dravet syndrome;drug discovery;Drug Modulation;Drug Targeting;drug use screening;Duchenne muscular dystrophy;Event;experimental study;Foundations;frontotemporal lobar dementia amyotrophic lateral sclerosis;gain of function;Genes;Genetic;Goals;high throughput screening;Housekeeping;Human;Human Genome;Immune response;Ligands;Luciferases;Measures;Messenger RNA;Modeling;Monitor;mRNA Export;Neurodegenerative Disorders;Noise;Nonsense-Mediated Decay;novel therapeutics;Nuclear Export;Nuclear RNA;Pancreatic ribonuclease;Pathology;Pathway interactions;Performance;Pharmaceutical Preparations;Phase;phase 2 study;Phenotype;Play;premature;prevent;protein degradation;Protein Engineering;Protein Truncation;Proteins;Proteome;public health relevance;Publishing;Quality Control;Recording of previous events;Reporter;Reporting;Research Personnel;response;Ribonucleases;RNA;RNA Binding;RNA Degradation;RNA Processing;RNA Splicing;RNA Stability;screening;Signal Transduction;Signaling Protein;Site;Small Business Innovation Research Grant;small molecule;small molecule inhibitor;small molecule therapeutics;Spinal Muscular Atrophy;tau aggregation;Tauopathies;Technology;Terminator Codon;Therapeutic;therapeutic target;Time;Tissues;Transcript;Translating;Translations;Untranslated RNA

PROJECT_TITLE: Cell-based RNA degradation assay for C9ALS/FTD drug discovery


NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Immunization;Infectious Diseases;Orthopoxviruses;Prevention;Rare Diseases;Social Determinants of Health;Vaccine Related

ORG_CITY: BALTIMORE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

PHR: PROJECT NARRATIVE The US Monkeypox (MPOX) Epidemic is a public health emergency of international concern which has disproportionately affected gay and other men who have sex with men (MSM) in the United States (US). Testing and pre-exposure prophylaxis for MPOX prevention (e.g., vaccination) promise to be efficacious opportunities to abate the epidemic, but little data exists in the US to describe disparities and barriers to uptake, such as stigma. Using a large cross sectional annual study of approximately 10,000 MSM in the US, the American Men’s Internet Survey, we aim to 1) Evaluate determinants and disparities of MPOX vaccination amongst MSM, 2) Characterize differences in MPOX testing uptake amongst MSM experiencing MPOX-like symptoms, and 3) Develop MPOX-specific stigma measures to evaluate the impacts of MPOX-related stigma amongst MSM.

PI_NAMEs: CARPINO, THOMAS  (contact)

PROGRAM_OFFICER_NAME: CHUANG, ELEANORE JENNIFER

PROJECT_TERMS: Abate;access disparities;Access to Information;Address;Adult;Affect;Age;aged;American;Anxiety;Awareness;Behavior;Behavioral;Biological;Biological Factors;Bisexual;Central Africa;Cessation of life;Chills;cis-male;Clinical;Collaborations;Communicable Diseases;Communication;Communities;community-level factor;Constitutional Symptom;Country;COVID-19;Data;Data Sources;Disparity;Dose;Drug usage;Epidemic;Epidemiologic Factors;Epidemiology;Ethnic Origin;Exanthema;experience;Factor Analysis;Fever;Future;Gays;Goals;Health;health care availability;health care service;health disparity;Health Services;Healthcare;HIV;HIV/AIDS;Human;Immunocompromised Host;Incidence;Individual;individual variation;Infection;Infectious Disease Epidemiology;innovation;International;Internet;Knowledge;Lesion;Literature;Logistic Regressions;marginalization;Measures;member;men;men who have sex with men;Mental Depression;Mentorship;Methodology;Methods;Modeling;Monkeypox;Monkeypox virus;mortality;multilevel analysis;new outbreak;Orthopoxvirus;Outcome;Pain;Perception;Persons;Policies;Population;Positioning Attribute;pre-exposure prophylaxis;Prevention;Property;psychologic;Psychological Factors;Psychometrics;Public Health;public health emergency;Race;racial disparity;Recurrence;Reporting;reproductive;Research;response;Risk;Risk Factors;Sexual Health;social;social stigma;sociodemographics;Stigmatization;Structural Racism;study population;Subgroup;Surveys;Symptoms;Target Populations;Techniques;Testing;testing services;testing uptake;Training;transmission process;treatment services;trend;United States;Universities;uptake;Vaccination;vaccine acceptance;vaccine access;Vaccines;Virus;Work;Zoonoses

PROJECT_TITLE: Epidemiological factors related to human monkeypox virus (MPOX) in men who have sex with men (MSM) in the United States


ADMINISTERING_IC: EB

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Bioengineering;Patient Safety;Wound Healing and Care

ORG_CITY: Middletown

ORG_NAME: REVMEDICA, INC.

PHR: PROJECT NARRATIVE Malfunctioning of surgical stapling device leading to surgical complications and in few cases to death, is a major cause of concern for their use. RevMedica’s surgical stapling device Cybernetic performs real-time tactile clamping with tissue sensing technology, uses a force sensor and radio frequency identification (RFID) tags to determine optimal stapling parameters. It will decrease the degree of subjective decisions made while suturing and thus will enhance surgeon’s performance

PI_NAMEs: WENCHELL, THOMAS GEORGE (contact)

PROGRAM_OFFICER_NAME: ASHMONT, KARI RICH

PROJECT_TERMS: Acute;Adverse effects;Adverse event;Algorithms;Animal Testing;Animals;Appearance;Articulation;Biomedical Engineering;cancer recurrence;cancer risk;Cesarean section;Cessation of life;Chest;Chronic;Clinical;Closure by clamp;Collaborations;commercialization;cost;Cybernetics;Data;Day Surgery;Decision Making;Defect;design;Development;Devices;efficacy testing;Electronics;Elements;Engineering;Ensure;Equipment;ergonomics;experience;Extravasation;Family suidae;Feasibility Studies;Feedback;Fistula;force sensor;Gastrectomy;gastrointestinal;Gastrointestinal tract structure;Health;Health care facility;Healthcare Systems;Hemorrhage;Hemostatic function;Hospitals;Hybrids;improved;in vivo;Industrialization;Infection;Injury;innovation;Intellectual Property;Laparoscopic Surgical Procedures;Legal patent;manufacture;Manufacturer;Mechanics;Medical Device;Methods;Modernization;Movement;Operative Surgical Procedures;Organ;Patients;Performance;performance tests;Phase;phase 2 study;preclinical study;Preparation;pressure;Procedures;product development;Protocols documentation;prototype;radio frequency;Reporting;Research;Risk;Safety;safety testing;Savings;sensor;sensor technology;Sepsis;Site;Small Business Innovation Research Grant;Specimen;Sterility;Structure of parenchyma of lung;Surgeon;Surgical complication;surgical risk;Surgical Staplers;Surgical Staples;Surgical sutures;Surgical wound;System;Tactile;Technology;Testing;Thick;Time;Tissues;tool;Trauma;usability;Uterus;Validation;Variant;wasting;Work;wound closure

PROJECT_TITLE: Hybrid surgical stapler with tissue sensing technology

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


ORG_CITY: ANAHEIM

ORG_NAME: LEBRUN LABS, LLC

PHR: Narrative A Product and chemical testing for the potential to corrode the skin is conducted to ensure correct safety labeling so that individuals can take adequate precautions to avoid injury. This project will develop a new kind of nonanimal, high-throughput, field test to identify dermal corrosives that will improve the capabilities of manufacturers, first responders, and regulators to warn the public about chemicals and products that could potentially damage the skin. Successful development and validation of the new method proposed here will enable early, accurate, on-site warning and thereby reduce the chance of toxic chemical injury as well as potentially open a door to a new way of nonanimal toxicology testing that may be used for other classes of toxins and target tissues in the future.

PI_NAMEs: LEBRUN, STEWART  (contact)

PROGRAM_OFFICER_NAME: RAVICHANDRAN, LINGAMANAIDU V

PROJECT_TERMS: Address;Animals;blind;Cells;Chemical Injury;chemical release;Chemicals;Chemistry;Classification;Corrosion;Corrosives;Data;data submission;Databases;Dermal;Dermis;Destinations;Development;Diagnostic Reagent Kits;Ensure;enzyme activity;Enzymes;Epidermis;Evaluation;Exposure to;field study;first responder;Freeze Drying;Future;Generations;Glycerol;Goals;Hazardous Substances;Human;Hypersensitivity skin testing;improved;Incubated;Individual;Injury;innovation;Keratin;Label;Laboratories;Laws;Legal patent;Life;manufacture;Manufacturer;manufacturing test;Materials Testing;Measurable;Measures;Medical;Methods;Molecular Conformation;molecular marker;Molecular Structure;novel strategies;Oryctolagus cuniculus;Outcome;Performance;Phase;Poison;portability;predictive modeling;Procedures;Production;protein biomarkers;Proteins;Public Health;Reader;Reagent;Research;Safety;Site;Skin;skin damage;Skin injury;stability testing;Temperature;Testing;Time;timeline;Tissues;Toxicity Tests;Toxicology;Toxin;Tube;Validation;validation studies;Work

PROJECT_TITLE: An In Chemico Test to Identify Dermal Corrosives


ORG_CITY: Wilmington

ORG_NAME: CELLERGY PHARMA

ORG_STATE: DE

PHR: Project Narrative The incidence of allergic diseases including allergic asthma and food allergy are increasing around the world. There are no cures for the treatment of these diseases. The proposal aims to develop preclinical in vivo functionality data for our chimeric antigen receptor engineered T cells, living cells that may provide long-term efficacy for the treatment of severe allergic diseases.

PI_NAMEs: MA, ZHENGYU  (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: Academia;Adrenal Cortex Hormones;Adult;Adverse event;Affinity;Allergens;Allergic;Allergic Disease;allergic response;Allergy to peanuts;American;Antibodies;associated symptom;Asthma;Autoimmune Diseases;Autologous;B-Lymphocytes;Basophils;Binding;bioluminescence imaging;Bone Marrow;cancer cell;CAR T cell therapy;CD19 gene;Cell Culture System;cell killing;Cell Lineage;Cell Survival;Cells;Cellular Membrane;Child;chimeric antigen receptor;chimeric antigen receptor T cells;Chronic;clinical application;cost;cost effective;CRISPR/Cas technology;crosslink;Cultured Cells;Data;design;Development;Disease;Dose;Drops;Drug Industry;Drug Targeting;efficacy testing;engineered T cells;Engraftment;enzyme linked immunospot assay;Enzyme-Linked Immunosorbent Assay;experimental study;extracellular;Extracellular Domain;Extrinsic asthma;FDA approved;Firefly Luciferases;food avoidance;Food Hypersensitivity;Future;genetically modified cells;Goals;Hematologic Neoplasms;Home;Hospital Administration;Human;humanized mouse;Hypersensitivity;IgE;IL4 gene;Immune response;Immunocompetent;Immunocompromised Host;improved;In Vitro;in vivo;Incidence;Inflammatory;Infusion procedures;Injections;innovation;Interferon Type II;Interleukin-12;Knock-out;Malignant - descriptor;manufacture;manufacturing cost;mast cell;Mediator;Membrane;Modeling;Monitor;Monoclonal Antibodies;mouse model;Multiple Myeloma;Mus;novel strategies;omalizumab;oral immunotherapy;Patients;Peripheral Blood Mononuclear Cell;Phase;phase 1 study;phase 2 study;Physiological;Plasma Cells;Population;potency testing;pre-clinical;Production;Quality of life;receptor;Recombinants;reduce symptoms;Refractory;Research;Safety;Serum;side effect;Source;Specificity;Spleen;success;symptom management;Symptoms;T-Cell Development;T-Lymphocyte;Tail;Testing;Time;Toxic effect;Treatment Efficacy;United States;Urticaria;Veins;Xenograft Model

PROJECT_TITLE: Chimeric antigen receptor (CAR) T cell therapy for severe allergic diseases.

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cardiovascular;Heart Disease;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: FARMINGTON

ORG_NAME: POTENTIOMETRIC PROBES, LLC

PHR: PROJECT SUMMARY/ABSTRACT POTENTIOMETRIC PROBES Potentiometric Probes is developing fluorescent dyes that convert electrical signals of heart cells and tissue into optical signals that can be recorded with cameras. These probes allow researchers to screen drugs rapidly for cardiotoxicity, as well as to study how electrical signals are generated and propagate in the heart, providing insights into mechanisms of genetic diseases and links to cardiac arrhythmias and failure.

PI_NAMEs: ACKER, COREY  (contact)

PROGRAM_OFFICER_NAME: SHI, YANG

PROJECT_TERMS: absorption;Action Potentials;Arrhythmia;Benzopyrans;Biological Assay;Biological Models;Blood Transfusion;Calcium;Cardiac;Cardiac Myocytes;Cardiotoxicity;Cell Culture Techniques;Cell membrane;Cells;chromophore;Clinical;clinical application;Communities;Complement;Coupling;Dangerousness;Drug Screening;Dyes;Electrodes;Electrophysiology (science);Eligibility Determination;experimental study;Family suidae;flexibility;Fluorescence;Fluorescent Dyes;Fluorine;follow-up;Fostering;Frequencies;Future;Genetic Predisposition to Disease;Goals;Heart;heart cell;Heart failure;Heart Research;high resolution imaging;high throughput screening;Human;human induced pluripotent stem cells;human stem cell-derived;Image;in vivo;Individual;induced pluripotent stem cell;industry partner;insight;invention;Ion Channel;Left;Legal patent;Letters;Light;light intensity;Link;Maps;Marketing;Measurement;Measures;Morphologic artifacts;Motion;multi-electrode arrays;multiplexed imaging;near infrared dye;Noise;novel therapeutics;optical sensor;Optics;optogenetics;Patients;Performance;personalized medicine;Pharmacology;Phase;phase 2 study;Physiological;Physiology;preservation;Property;Protocols documentation;ratiometric;Records;redshift;Research;research and development;Research Personnel;Resolution;Rhodopsin;Safety;screening;sensor;Signal Transduction;Skin;Small Business Innovation Research Grant;Source;spatiotemporal;Speed;Stains;Suspensions;System;Techniques;Technology;Testing;Tissues;tool;Toxicity Tests;Validation;validation studies;voltage;voltage sensitive dye;Work

PROJECT_TITLE: A Palette of Near-Infrared Voltage Sensors for Cardiac Research and Safety Pharmacology


NIH_SPENDING_CATS: Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Sexually Transmitted Infections;Women's Health Research

ORG_CITY: REDMOND

ORG_NAME: METABOLITEDX CORP

PHR: PROJECT NARRATIVE Bacterial vaginosis (BV) is the most common reason for women in the US to seek medical care for vaginal symptoms resulting in up to 10 million healthcare provider visits annually, however there are few commercially available point-of-care diagnostic options for BV. Detection of small molecule metabolites is one promising diagnostic approach for BV that can eventually be deployed for rapid diagnosis at the point of care. This STTR Phase I proposal seeks to validate promising metabolite biomarkers of BV by assessing their diagnostic performance in a diverse population of women with high prevalence of vaginal symptoms to ensure that representative candidate metabolites are selected for future product development.

PI_NAMEs: SRINIVASAN, SUJATHA  (contact)

PROGRAM_OFFICER_NAME: GLOCK, JONATHAN A

PROJECT_TERMS: adverse outcome;Affect;Age;Agreement;Anaerobic Bacteria;Area;assay development;assigned female at birth;Bacteria;Bacterial Vaginosis;Biological Assay;biological heterogeneity;Biological Markers;biomarker validation;candidate marker;candidate validation;Caring;Certification;Characteristics;Clinic;Clinical;co-infection;Communities;Complex;cost;Cost Effectiveness Analysis;Detection;Development;Diagnosis;Diagnostic;diagnostic accuracy;diagnostic assay;Diagnostic Equipment;diagnostic platform;diagnostic strategy;Diagnostic tests;Economics;Elements;Enzymes;Ethnic Origin;Evaluation;FDA approved;follow-up;Future;Health Personnel;Heterogeneity;High Prevalence;high risk;Individual;innovation;Invaded;Lactobacillus;Legal patent;Licensing;liquid chromatography mass spectrometry;machine learning model;Measures;Medical;metabolomics;Methods;Microscopy;Mission;Molecular;Molecular Diagnostic Testing;Neuraminidase;North America;Nucleic Acid Amplification Tests;Office Visits;Outcome;Pelvic Examination;Pelvic Inflammatory Disease;Performance;Phase;point of care;point of care testing;point-of-care diagnostics;Population;Population Heterogeneity;Premature Birth;Privacy;product development;Productivity;Race;racial difference;rapid diagnosis;Rapid diagnostics;reproductive;Research;Risk;routine Bacterial stain;Sampling;Sexual Health;Sexually Transmitted Diseases;skills;Small Business Technology Transfer Research;small molecule;Socioeconomic Status;socioeconomics;Specificity;Spectrometry;Symptoms;Technology;Testing;Time;Training;Translating;Vagina;Vaginal Discharge;vaginal fluid;vaginal infection;Vaginitis;Visit;Woman;Women's Group;Women's prevalence

PROJECT_TITLE: Development of Small Molecule Biomarker-Based Diagnostics for Bacterial Vaginosis

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


NIH_SPENDING_CATS: Autoimmune Disease;Digestive Diseases;Genetics;Inflammatory Bowel Disease;Microbiome

ORG_CITY: NEW YORK

ORG_NAME: WEILL MEDICAL COLL OF CORNELL UNIV

PHR: PROJECT NARRATIVE Inflammatory bowel disease (IBD) is a chronic immune-mediated disease that impacts over 3 million Americans, represents a major socio-economic health challenge, and currently has limited preventative, therapeutic or curative treatment strategies. Basic, translational, and clinical studies defined that the pathogenesis of IBD is mediated by a loss of immunologic tolerance to beneficial microbes colonizing the intestine termed microbiota. The focus of this proposal is to delineate a novel pathway that is essential to orchestrate immune tolerance to gut microbiota and restrain intestinal inflammation, as well as explore the pre- clinical therapeutic potential of our findings.

PI_NAMEs: SONNENBERG, GREGORY F (contact)

PROGRAM_OFFICER_NAME: HUDSPETH, KELLY

PROJECT_TERMS: Address;American;Antigen Presentation;Antigen-Presenting Cells;Antigens;beneficial microorganism;CD4 Positive T Lymphocytes;cell type;Chronic;chronic inflammatory disease;Cleavage Under Targets and Release Using Nuclease;Clinical Research;Communicable Diseases;curative treatments;cytokine;Data;Disease;DNA;draining lymph node;Endowment;Funding;Gastrointestinal tract structure;Genes;Genetic;Genetic Transcription;genetic variant;germ free condition;gut health;gut inflammation;gut microbiota;Health;health economics;Histocompatibility Antigens Class II;Homing;host microbiota;Human;Immune;Immune system;Immune Tolerance;immunoregulation;imprint;Individual;Inflammation;Inflammatory;Inflammatory Bowel Diseases;Interferons;Intestines;Investigation;Knowledge;Link;lymph nodes;Lymphoid Cell;Mediating;Metabolic Diseases;Microbe;microbial;microbiota;migration;Molecular;mouse model;Mus;Nature;novel;novel therapeutics;Pathogenesis;Pathway interactions;pre-clinical;pre-clinical therapy;preservation;prevent;Process;programs;Property;Publishing;Regulation;Regulatory T-Lymphocyte;Research;restraint;Role;Seminal;sensor;Signal Transduction;socioeconomics;Specimen;Symbiosis;T cell differentiation;T cell response;T-Cell Activation;T-Cell Receptor;T-Lymphocyte;Testing;Therapeutic;therapeutic evaluation;Transcription Repressor;Translating;translational study;treatment strategy

PROJECT_TITLE: Immune regulation of intestinal health and disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-W (03)]


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

ORG_CITY: COLUMBUS

ORG_NAME: MOLECULAR TECHNOLOGIES LABORATORIES LLC

ORG_STATE: OH

PHR: Project Narrative Alzheimer’s disease is a major burden for older adults and the healthcare system in the United States. Thus, effective treatments for Alzheimer’s disease are desperately needed but remain elusive. Evaluating new therapies is an important step in bringing us closer to preventing or curing Alzheimer’s disease.

PI_NAMEs: BRODY, RICHARD S (contact);HUFFMAN, DEREK MAJOR;KOPCHICK, JOHN JOSEPH;MILMAN, SOFIYA

PROJECT_TERMS: Achievement;Acromegaly;Acute;Affinity;Age;aged;Aging;Alzheimer disease prevention;Alzheimer's Disease;Alzheimer's disease model;Alzheimer's disease related dementia;Alzheimer's disease risk;Alzheimer's disease therapeutic;Amino Acids;Animal Model;antagonist;Attenuated;attenuation;Autophagocytosis;base;Binding;biobank;blood-brain barrier crossing;Centenarian;Central Nervous System;cerebral amyloidosis;Chronic;Chronology;Clinic;Clinical;Clinical Trials;Cognition;cognitive enhancement;cohort;Communities;Cross Circulation;Data;Dementia;design;Development;Disease;Dose;Drug Kinetics;effective therapy;Effectiveness;efficacy study;Exhibits;experience;FDA approved;Female;Formulation;Foundations;Frequencies;Genetic;Genetic Carriers;genetic variant;Growth Hormone Receptor;hazard;Healthcare Systems;Human;hyperphosphorylated tau;Impaired cognition;in vivo;Individual;Injections;innovation;insulin sensitivity;Insulin-Like Growth Factor I;learning ability;life span;Link;Longevity;male;manufacturing scale-up;Memory;Metabolic Clearance Rate;Metabolic dysfunction;Methods;model organism;Modeling;mouse model;neuroinflammation;new therapeutic target;novel;novel therapeutics;old mice;older adult;Oxidative Stress;Pathogenesis;Pathway interactions;Patients;pegvisomant;Peripheral;Persons;Pharmacodynamics;pharmacokinetics and pharmacodynamics;pharmacologic;Phase;phase 2 study;Phase Transition;Plasma;pleiotropism;Population;preservation;prevent;Prevention;Production;Property;Proteins;receptor;receptor binding;Regimen;Research;resilience;response;Risk;Rodent;Rodent Model;Safety;Senile Plaques;Serum;sex;Signal Transduction;Site;Somatotropin;stem;subcutaneous;Tauopathies;Testing;therapeutic development;therapeutic target;Time;Translating;Treatment Efficacy;United States;Vascular Diseases;Wild Type Mouse

PROJECT_TITLE: Development of a Growth Hormone Receptor antagonist for the delay or prevention of ADRD

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Cancer Genomics;Clinical Research;Gene Therapy;Genetics;Human Genome;Immunotherapy;Networking and Information Technology R&D (NITRD)

ORG_CITY: San Carlos

ORG_NAME: CELLDOM, INC.

PHR: NARRATIVE “Living medicines” like chimeric antigen receptor (CAR)-T cell immunotherapies have led to miraculous cures in aggressive leukemias and lymphomas in children and adults. Since each drug lot serves only one patient, manufacturing and QC testing must be performed individually on every patient sample; however current potency testing platforms are unable to reliably predict clinical outcomes. To solve the need for a more comprehensive CAR-T potency assay, Celldom is developing a platform that combines image-based phenotyping with molecular profiling at the massive scales necessary to measure the ability of CAR-T effector cells to kill their targets, proliferate, and produce molecules necessary to mount a defense against antigen-expressing tumor cells.

PI_NAMEs: YELLEN, BENJAMIN BIRON (contact)

PROGRAM_OFFICER_NAME: LOU, XING-JIAN

PROJECT_TERMS: Adult;analysis pipeline;Antigen-Presenting Cells;Antigens;assay development;Biological;Biological Assay;Biological Markers;Biological Products;CAR T cell therapy;CD19 Antigens;CD8B1 gene;cell killing;Cell surface;Cell Therapy;cell type;Cells;Cellular Assay;Centrifugation;chemotherapy;Child;chimeric antigen receptor;chimeric antigen receptor T cells;Classification;Clinical;Clinical Data;Clinical Trials;clinically relevant;Clonality;Coculture Techniques;commercialization;Computer software;Computer Vision Systems;cytokine;Cytolysis;cytotoxic;Cytotoxic T-Lymphocytes;cytotoxicity;Data;data analysis pipeline;Detection;detection limit;Development;DNA;Dyes;effector T cell;Engineering;Event;experimental study;fluorescence imaging;Foundations;Funding;Gene Expression;Genes;Genetic Transcription;Genome;Genomics;Goals;Growth;Image;Image Analysis;imager;Immune response;Immunology procedure;Immunotherapy;improved;in vivo;Individual;Infusion procedures;innovation;instrument;Interferon Type II;Interleukin-2;Kinetics;leukemia/lymphoma;light transmission;Liquid substance;Malignant Neoplasms;manufacture;manufacturing quality;Marketing;Measurement;Measures;Medicine;Membrane;Methods;Modeling;Molecular;Molecular Profiling;Monitor;neoplastic cell;Outcome;Patients;Pharmaceutical Preparations;Phase;Phenotype;Population;potency testing;predict clinical outcome;Proliferating;Property;Reagent;real-time images;Research;response;RNA;Sampling;Selection Criteria;sensor;Small Business Innovation Research Grant;small molecule;software development;Solid;Speed;standard of care;success;Surface;T-Lymphocyte;Testing;Therapeutic;Time;TNF gene;tool;transcriptome;transcriptome sequencing;transcriptomics;Transfusion;tumor;virtual;whole genome

PROJECT_TITLE: High throughput CAR-T potency assay based on functional and transcriptional measurements on single cell co-cultures