ORG_CITY: LEXINGTON

ORG_NAME: W-Z BIOTECH, LLC

PHR: We are proposing to develop a single port, pulsatile ventricular assist device (sppVAD) for total left ventricle (LV) support that employs a minimally invasive single cannulation technique for implantation and features a compact size/easy ambulation for patient discharge/at-home mechanical circulatory support. Our enabling technologies that form the sppVAD system are a valved single lumen cannula (VSLC), a valveless single port diaphragm displacement pump (spDDP), and a compact/portable console. Our sppVAD system is a novel invention that fills a large unmet clinical need for a minimally invasive, ambulatory, at-home temporary total LV support to improve patient outcomes.

PI_NAMEs: TOPAZ, STEPHEN R (contact)

PROGRAM_OFFICER_NAME: FENTON, KATHLEEN NELLE

PROJECT_TERMS: Aorta;Apical;Area;ascending aorta;biomaterial compatibility;Biotechnology;Blood;Cannulas;Cannulations;Cardiac;Cardiogenic Shock;Cattle;Circulation;Clinical;commercialization;Dedications;design;Development;Devices;Drainage procedure;Engineering;Ensure;experience;Extracorporeal Membrane Oxygenation;fabrication;Failure;flexibility;Friends;Geometry;Goals;Heart;Heart Injuries;Heart Transplantation;hemocompatibility;Hemolysis;Home;Housing;hypoperfusion;implantation;improved;improved outcome;In Vitro;in vivo;Infusion procedures;innovation;invention;Kentucky;Laboratory Animal Production and Facilities;Left ventricular structure;Life;Low Cardiac Output;Lung;Marketing;mechanical circulatory support;minimally invasive;mortality;multidisciplinary;Multiple Organ Failure;myocardial injury;novel;Organ;Outcome;Patient Discharge;Patient-Focused Outcomes;Patients;Performance;Perfusion;Phase;polycarbonate;Polyurethanes;portability;Preclinical Testing;prevent;Pulsatile Flow;Pump;purge;Recovery;research and development;Resistance;Respiratory Diaphragm;restoration;Safety;Scientist;Self-Help Devices;Sheep;Small Business Innovation Research Grant;Stress;Support System;Surgeon;System;Techniques;Technology;Testing;Thoracic Surgical Procedures;Universities;usability;ventricular assist device;Withdrawal

PROJECT_TITLE: Development of a Minimally Invasive Single Cannulation, Compact Single Port Pulsatile Ventricular Assist Device (sppVAD) for Total LV Support

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


ADMINISTERING_IC: CA

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: LEBANON

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: DOSEOPTICS, LLC

ORG_STATE: NH

PHR: Narrative Surgery can be made more specific through the use of fluorescent markers, which enhance contrast during tumor resection in certain types of cancer. Pressure-Enhanced Sensing Surgery (PRESS) allows dynamic imaging of tissue function using a commonly available human-use contrast agent to stimulate immediate fluorescence when there is hypoxia present. This project will advance an optical imaging system that enables real-time imaging of hypoxia in surgery, allowing the surgeon to remove tissue based upon its dysfunctional neovasculature and chronic or transient hypoxia.

PI_NAMEs: PETUSSEAU, ARTHUR F;WARE, WILLIAM  (contact)

PROGRAM_OFFICER_NAME: ZHAO, MING

PROJECT_TERMS: Aminolevulinic Acid;Animals;Blood flow;Blood Pressure;cancer surgery;cancer type;Cells;Chronic;Clinical;Clinical Trials;contrast enhanced;Contrast Media;Custom;design;digital imaging;Doctor of Philosophy;Dose;Effectiveness;Environment;Excision;experience;Feedback;Fluorescence;fluorescence imaging;Goals;Head;Health;Heme;Human;Hypoxia;Image;image guided;Image-Guided Surgery;imaging system;in vivo;in vivo evaluation;Industry;Kinetics;Knowledge;Laboratories;Lasers;Length;Light;Malignant - descriptor;Malignant Neoplasms;Maps;Medical;Methods;millisecond;Modality;mouse model;neovasculature;neurosurgery;Noise;Normal tissue morphology;Operative Surgical Procedures;optical imaging;Optics;Oxygen;Palpation;pancreas xenograft;pancreatic neoplasm;Phase;phase 1 testing;Photobleaching;Physiologic pulse;pressure;Prodrugs;programs;protoporphyrin IX;prototype;real-time images;recruit;response;Roentgen Rays;Signal Transduction;Skin Carcinoma;Small Business Innovation Research Grant;Solid;Surgeon;Surgical margins;Surgical Oncology;System;Techniques;Technology;Testing;Time;Tissue imaging;tissue mapping;tissue phantom;Tissues;tool;Tracer;Training;Translations;tumor;Tumor Biology;tumor growth;Tumor Markers;Tumor Tissue;Validation;Vascular Patency;Visualization;Work;Xenograft Model;Xenograft procedure

PROJECT_TITLE: Pressure-Enhanced Sensing Surgery (PRESS) as a tool for surgical guidance.

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


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

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

ORG_CITY: PHILADELPHIA

ORG_NAME: AXONOVA MEDICAL, LLC

ORG_STATE: PA

PHR: PROJECT NARRATIVE Peripheral nerve injury (PNI), especially those that are long defects or proximal injuries requiring long regenerative distances often result in poor functional recovery, leading to a drastic decrease in quality of life. Current clinical practices take nearby healthy nerve and attach it to injured nerve or it’s innervated muscle in order to protect loss of function. To address this need, we have developed a potentially transformational approach to maintain the distal structures and the pro-regenerative environment using implantable micro-tissue engineered nerve grafts (µTENGs) that act as tissue engineered neuromuscular interfaces so that effective reinnervation can occur, even in cases where repair of the damaged nerve is delayed, thus leading to increased functional recovery.

PI_NAMEs: KATIYAR, KRITIKA  (contact)

PROGRAM_OFFICER_NAME: CAPORELLO, EMILY LAURA

PROJECT_TERMS: Acceleration;Address;Afferent Neurons;Animal Model;Animals;Architecture;Atrophic;attenuation;Autologous Transplantation;Award;Axon;axon regeneration;axonal degeneration;Biological Products;Cell Survival;Chitosan;Chronic;Classification;Clinic;Clinical;clinical implementation;clinical practice;Clinical Trials;clinically relevant;Defect;Denervation;density;design;Development;Diameter;Dimensions;Distal;Dose;efficacy evaluation;efficacy study;Electrophysiology (science);Environment;Family suidae;Functional Regeneration;Funding;Good Manufacturing Process;Health;Human;Hydrogels;Implant;implantation;in vivo;Injectable;injured;Injury;injury and repair;Laboratories;Licensing;Limb structure;loss of function;Maintenance;manufacture;manufacturing process;Medical;meter;Methods;minimally invasive;Morphology;Motor;Motor Neurons;Multiple Trauma;Muscle;Muscular Atrophy;Natural regeneration;Nerve;nerve damage;nerve gap;nerve injury;nerve repair;nerve supply;Nervous System;neural network;neuromuscular;Neuromuscular Junction;Neurons;nonhuman primate;Operative Surgical Procedures;Outcome;pathogen;Pathway interactions;Patients;Peripheral nerve injury;peroneal nerve;Phase;phase 1 study;Population;porcine model;pre-clinical;pre-Investigational New Drug meeting;preclinical efficacy;preclinical safety;Process;Proxy;Quality Control;Quality of life;Race;Rattus;reconstruction;Recovery;Recovery of Function;regenerative;reinnervation;repair model;repaired;Rodent;Safety;safety study;Schwann Cells;Secure;Sensory;Sepharose;Site;Small Business Innovation Research Grant;standard of care;Structure;success;Testing;Time;Tissue Engineering;Tissues;Transplantation

PROJECT_TITLE: Development of Tissue Engineered Neuromuscular Interfaces from GalSafe Neurons

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


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

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

ORG_CITY: Centennial

ORG_NAME: DREAM FACE TECHNOLOGIES, LLC

ORG_STATE: CO

PHR: NARRATIVE This Commercialization Readiness Pilot (CRP) project aims to enhance the capabilities of our socially assistive robot, Ryan® CompanionBot, in preparation for fundraising and full-scale commercialization. Given the documented shortage of caregivers and the escalating healthcare demands, particularly for seniors with Alzheimer's disease (AD) and AD-related dementia (ADRD), the current market landscape underscores the urgent demand for innovative solutions, including impactful and interactive social robots. Ryan® is an intelligent, expressive, and conversational humanoid social robot that has been meticulously crafted and rigorously tested to enhance the quality of life for older adults with AD/ADRD, optimize caregiver support, deliver substantial economic benefits to the healthcare industry, and provide essential aid to families caring for seniors with AD/ADRD as well as seniors dealing with social isolation.

PI_NAMEs: MAHOOR, MOHAMMAD  (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Address;Administrator;Adopted;Affect;aging population;Alzheimer's Disease;Alzheimer's disease related dementia;American;Artificial Intelligence;Assisted Living Facilities;Award;Awareness;Brain;Canada;Caregiver support;Caregivers;caregiving;Caring;Clinical Trials;Collaborations;commercialization;commercialization readiness;common symptom;commune;Communication difficulty;Computer software;Computers;cost;cost effective;cost of dementia;Coupled;COVID-19 mortality;COVID-19 pandemic;Dementia;design;Development;Diagnosis;Dreams;Economics;Elements;Equipment and supply inventories;Europe;Face;Facial Expression Recognition;Family;Family member;Feedback;field study;Friends;Funding;Future;Goals;Grant;Growth;Health care facility;Health Insurance Portability and Accountability Act;Healthcare;Healthcare Industry;Hobbies;Hour;human old age (65+);Impaired cognition;Individual;innovation;Intellectual Property;interest;International;Interview;invention;large scale production;Lawyers;Learning;Legal;Legal patent;manufacture;Marketing;Memory Loss;Mental Depression;Moods;novel;older adult;operation;pandemic disease;Personal Satisfaction;Phase;Pilot Projects;Policies;Population;Preparation;Privacy;programs;Psyche structure;Quality of life;Regulation;repetitive behavior;Resources;response;Robot;Sales;Secure;Short-Term Memory;Site;Small Business Innovation Research Grant;social assistive robot;Social Interaction;Social isolation;success;Surveys;Technology;Testing;tool;United States National Institutes of Health;wearable device;Work;Workload

PROJECT_TITLE: Ryan® CompanionBot for Assisting Older Adults with Early-Stage Alzheimer's Disease and Dementia

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


NIH_SPENDING_CATS: Biotechnology;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Gene Therapy;Gene Therapy Clinical Trials;Genetics;Hematology;Immunotherapy;Lymphatic Research;Lymphoma;Orphan Drug;Rare Diseases

ORG_CITY: HOUSTON

ORG_NAME: MARKER THERAPEUTICS, INC.

ORG_STATE: TX

PHR: Narrative This application will advance a novel therapy, whereby white blood cells are trained in the laboratory to recognize and kill cancer cells. These killer cells have the capacity to recognize multiple surface markers expressed by the tumor cells but not healthy cells. To date, more than 180 patients have been treated in clinical studies with this therapy with no serious side effects. This project will advance this innovative cellular therapy to treat patients with Non-Hodgkin’s Lymphoma (NHL), a malignant cancer of the lymph system, who relapsed following third line treatment and are left with minimal treatment options.

PI_NAMEs: VERA, JUAN FERNANDO (contact)

PROGRAM_OFFICER_NAME: LOU, XING-JIAN

PROJECT_TERMS: Address;Antigen Targeting;Antigen-Presenting Cells;antigen-specific T cells;Antigens;Antitumor Response;Area;arm;Autologous;Biologic Characteristic;Biological Products;Blood Component Removal;cancer cell;Cancer Patient;CAR T cell therapy;CD19 gene;CD8B1 gene;Cell Therapy;Cells;Cellular immunotherapy;Cessation of life;Characteristics;chimeric antigen receptor T cells;Clinic;Clinical;Clinical Data;clinical efficacy;Clinical Protocols;Clinical Research;clinical research site;Clinical Trials;comparative efficacy;Cryopreservation;CTAG1 gene;Cyclic GMP;cytokine;cytokine release syndrome;Data;Disease remission;Dose;efficacy outcomes;Enrollment;Epitopes;Failure;Future;Genetic Engineering;Goals;Grant;Hematologic Neoplasms;Immune system;Immunologic Monitoring;Immunotherapy;improved;In complete remission;in vivo;Infusion procedures;innovation;Killer Cells;Laboratories;Left;Leukocytes;Licensing;Lymphatic System;Lymphoma;Malignant - descriptor;Malignant Neoplasms;manufacture;manufacturing process;Medical;neoplastic cell;neurotoxicity;Non-Hodgkin's Lymphoma;non-Hodgkin's lymphoma patients;novel;novel therapeutics;Outcome;Outpatients;overexpression;participant enrollment;Patient Dropouts;Patient Recruitments;Patient-Focused Outcomes;Patients;Pharmaceutical Preparations;Phase;phase 1 study;phase I trial;Phenotype;predict clinical outcome;Predisposition;preferentially expressed antigen in melanoma;primary endpoint;Proliferating;Relapse;relapse patients;research clinical testing;response;Safety;safety assessment;safety outcomes;screening;secondary endpoint;side effect;Site;Specificity;Surface;survivin;T cell differentiation;T cell therapy;T memory cell;T-Cell Activation;T-Lymphocyte;TCR Activation;Technology;Testing;Tissues;Training;tumor;Tumor Antigens;Tumor Escape;WT1 gene

PROJECT_TITLE: A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered to Patients with Relapsed Non-Hodgkin Lymphoma

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


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

ORG_CITY: Providence

ORG_NAME: BOLDEN THERAPEUTICS, INC.

ORG_STATE: RI

PHR: PROJECT NARRATIVE There is a tremendous need for new approaches for treating neurological diseases, especially Alzheimer’s disease. The experiments proposed herein will test lead drug candidates in highly relevant AD human cellular models and pursue three key development milestones for our development: assessing our candidate’s capacity to achieve RNA splicing, alter protein expression, and modulate signaling and function. If successful, these experiments will significantly de-risk our drug development program and enable rapid preclinical development of our novel approach to treat or prevent Alzheimer’s disease.

PI_NAMEs: VALAT, ANNE  (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: Adult;age related;aged;Aging;Agrin;Alternative Splicing;Alzheimer disease prevention;Alzheimer's Disease;Alzheimer's disease pathology;Alzheimer's disease patient;Alzheimer's disease therapy;Animal Model;Antisense Oligonucleotide Therapy;Antisense Oligonucleotides;apolipoprotein E-4;astrocyte progenitor;Astrocytes;Binding Proteins;Biological;Biological Markers;biomarker identification;Bone Morphogenetic Proteins;Cell Culture Techniques;Cell Line;Cell model;cell type;Cells;Cerebrospinal Fluid;Chemistry;clinical development;clinical implementation;Cognition;cognitive function;Confidential Information;Data;Dementia;Deposition;Development;Disease;Dose;drug candidate;drug development;efficacy study;efficacy testing;Engineering;Environment;Exhibits;exon skipping;experimental study;Exposure to;Funding;Gene Expression;Goals;Hippocampus;Human;Human Cell Line;human disease;Immunohistochemistry;improved;In Vitro;in vivo;induced pluripotent stem cell;interest;Investigational New Drug Application;Knock-in Mouse;Lead;lead candidate;Learning;Medicine;Memory;mild cognitive impairment;minimally invasive;Motor Neurons;mouse model;Mus;nerve stem cell;Nervous System Disorder;Neurodegenerative Disorders;neurogenesis;Neurologic;Neuromuscular Junction;neuron loss;Neurons;newborn neuron;novel;novel strategies;Pathway interactions;patient stratification;Patients;Phase;Physiological;potential biomarker;pre-clinical;preclinical development;prevent;Program Development;protein expression;Proteins;receptor;Reporting;response;restraint;Risk;RNA Splicing;Role;Route;Shapes;Signal Transduction;Signaling Protein;SMN2 gene;Spinal Muscular Atrophy;targeted biomarker;Testing;Therapeutic;therapeutic target;therapeutically effective;Transcript;transcriptome sequencing;transcriptomic profiling;transcriptomics;treatment response;Validation;Work

PROJECT_TITLE: Preclinical characterization of splice-modifying antisense oligonucleotides targeting neurogenesis in human AD neural cells

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


ADMINISTERING_IC: EB

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Dental, Oral, and Craniofacial Disease;Infectious Diseases;Patient Safety

ORG_CITY: BROOKLYN

ORG_NAME: PHARYNVAC SURGICAL TECHNOLOGY INC.

ORG_STATE: NY

PHR: Project Narrative Current sinonasal surgery exposes staff to pathogens and toxins, causes avoidable patient nausea, and suffers from obstructed endoscopic visualization. Here we describe the further development of a novel oral/nasopharyngeal balloon aspiration catheter to solve these existing problems in the sinonasal surgical space.

PI_NAMEs: ILORETA, ALFRED-MARC  (contact);RAPOPORT, BENJAMIN ISAAC

PROGRAM_OFFICER_NAME: ASHMONT, KARI RICH

PROJECT_TERMS: 3D Print;Abbreviations;Accidents;Address;Adverse event;aerosolized;Anesthesia procedures;Animal Model;Animals;aspirate;Biocompatible Materials;Biological;Blood;Body Fluids;Cadaver;Catheters;clinic ready;Clinical Protocols;Clinical Research;Clinical Trials;clinically relevant;Contusions;COVID-19 pandemic;Data;design;Development;Device Designs;Device Safety;Devices;Documentation;Dust;Eligibility Determination;Endoscopy;Event;Excision;Exposure to;first-in-human;Fluoroscopy;Future;Good Manufacturing Process;Hemorrhage;high risk;histological specimens;Hour;Human;improved;Ingestion;Institutional Review Boards;Interruption;Intratracheal Intubation;iterative design;Lead;Location;Lung;manufacture;manufacturing process;Marketing;Measures;meetings;migration;Modeling;Mucous Membrane;Nasal cavity;Nasopharynx;Nausea;neurosurgery;Nose;novel;Operating Rooms;operation;Operative Surgical Procedures;Oral;Oral cavity;Oropharyngeal;Outpatients;particle;Particulate;Particulate Matter;pathogen;Patients;Periodicals;personal protective equipment;Pharyngeal structure;Phase;Postoperative Period;prevent;Procedures;Protocols documentation;Resolution;respiratory pathogen;Safety;safety and feasibility;sample fixation;Secure;Sheep;sheep model;Site;Smoke;Specific qualifier value;Stomach;Study models;Suction;Surgeon;Techniques;Technology;Testing;Time;Tissues;tool;Toxin;Ultrafine;Upper respiratory tract;Vacuum;verification and validation;Viral;Visualization;Work

PROJECT_TITLE: Development of a novel kit for reduction of aerosolized particles during endonasal surgeries: the PharynVac Device

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


ADMINISTERING_IC: HD

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

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

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;HIV/AIDS;Infectious Diseases;Microbiome;Prevention;Sexually Transmitted Infections;Topical Microbicides;Women's Health Research

ORG_CITY: SEATTLE

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: NARRATIVE Globally, more than half of all people living with HIV are women and girls, and understanding how sexual behaviors influence HIV susceptibility is critical for reducing HIV acquisition in women. Vaginal washing is a common behavioral practice that has consistently been associated with increased HIV susceptibility by an unknown mechanism. The purpose of this proposal is to evaluate the mechanism underlying the link between vaginal washing and HIV acquisition risk by measuring cervicovaginal inflammation, epithelial integrity, and concentrations of protective Lactobacillus species in a well-characterized cohort of women who engage in sex work in Mombasa, Kenya.

PI_NAMEs: SABO, MICHELLE CATHERINE (contact)

PROGRAM_OFFICER_NAME: RUSSO, DENISE

PROJECT_TERMS: Abstinence;Address;Africa South of the Sahara;Antigen-Presenting Cells;arm;Atopobium vaginae;Bacteria;Bacterial Vaginosis;behavior influence;Behavioral;Behavioral Model;Biological;Biopsy Specimen;CD4 Positive T Lymphocytes;cell type;Cells;Cervical;cervical biopsy;cervicovaginal;cohort;Cohort Studies;Colposcopy;comparison control;Complement;Computer software;cytokine;Data;Detection;Epithelium;Evaluation;Fertility;Flow Cytometry;girls;High Prevalence;high risk;HIV;HIV risk;Image Analysis;Immune;Immune system;Immunoassay;Immunofluorescence Immunologic;improved;Individual;Inflammation;Inflammation Mediators;Inflammatory;insight;interest;Interleukin-1;Intervention;Kenya;Lactobacillus;Lesion;Link;Liquid substance;Measurement;Measures;Mediating;Messenger RNA;Meta-Analysis;microbial;Mucins;Mucous Membrane;Observational Study;Outcome;Participant;Pathway interactions;Pelvic Inflammatory Disease;Persons;Polymerase Chain Reaction;Population;Predisposition;programs;Proteins;Public Health;Randomized;randomized trial;Randomized, Controlled Trials;recruit;Reporting;Reproductive Health;Risk;sex;Sex Behavior;Sexually Transmitted Diseases;Signal Pathway;Stains;Testing;Theoretical model;Tight Junctions;Tissues;transcriptome sequencing;Vagina;vaginal lactobacilli;vaginal microbiota;Woman;Women's cohort;Women's study;Women's trial;Work

PROJECT_TITLE: The impact of vaginal washing on cervical inflammation: a randomized controlled trial of women from sub-Saharan Africa at high risk for HIV acquisition.

STUDY_SECTION: HIVD

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Immunization;Infectious Diseases;Malaria;Malaria Vaccine;Nanotechnology;Orphan Drug;Prevention;Rare Diseases;Vaccine Related;Vector-Borne Diseases

ORG_CITY: NEW HAVEN

ORG_NAME: L2 DIAGNOSTICS, LLC

ORG_STATE: CT

PHR: NARRATIVE The continued devastating consequences of malaria underscore the urgent need for novel preventive strategies against the disease. The proposed project will deliver an antimalaria mRNA vaccine using dissolvable microneedle patches (MNPs), addressing the issues of cold- chain storage and hypodermic needle delivery, which are hugely limiting factors in vaccination, particularly for populations residing in endemic, resource-poor countries.

PI_NAMEs: ANTHONY, KAREN G. (contact)

PROGRAM_OFFICER_NAME: MO, ANNIE X  Y

PROJECT_TERMS: Address;Animals;Anopheles gambiae;Anti-malarials;Biology;Bite;Characteristics;circumsporozoite;circumsporozoite protein;Clinical;Clinical Research;Clinical Trials;Cold Chains;Collaborations;Communicable Diseases;Country;Culicidae;Development;Disease;Dose;Erythrocytes;fighting;Formulation;Future;Goals;Grant;Hepatic;Human;hypodermic needle;Immune;Immunity;Immunization;Immunize;immunogenicity;immunoreaction;improved;in vivo;Individual;Infection;Injections;Intramuscular;Intramuscular Injections;Laboratories;Life;Liver;Malaria;Malaria Vaccines;Marketing;Measures;Messenger RNA;Methods;mouse model;mRNA delivery;mRNA lipid nano particle vaccine;Mus;Needles;nonhuman primate;novel;novel vaccines;Outcome;Pain;Parasites;Phase;Plasmodium;Plasmodium falciparum;Population;pre-clinical;Preparation;prevent;Prevention strategy;Printing;Proteins;receptor binding;Research;Research Institute;Resistance development;Resources;response;RNA vaccine;Saliva;Salivary Proteins;SARS-CoV-2 spike protein;Severity of illness;Small Business Technology Transfer Research;Sporozoites;Sterility;Suspensions;Temperature;thermostability;Time;transmission process;United States National Institutes of Health;Vaccinated;Vaccination;vaccine candidate;vaccine development;vaccine efficacy;vaccine formulation;Vaccines;vector;vector mosquito;wasting

PROJECT_TITLE: Delivery of a candidate AgTRIOVx malaria vaccine by thermostable microneedle patches

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Aging;Biotechnology;Clinical Research;Lung;Orphan Drug;Pulmonary Fibrosis;Rare Diseases

ORG_CITY: TUCSON

ORG_NAME: FIBRONOX, L.L.C.

ORG_STATE: AZ

PHR: PROJECT NARRATIVE: Fibrotic disorders represent a major health problem in the U.S, with a rising incidence (particularly among the elderly); Idiopathic pulmonary fibrosis (IPF) is among the most relentless and fatal fibrotic diseases. Although there is no cure for IPF, two FDA-approved treatments have been shown to slow but do not stop the decline in lung function, and only have a modest survival benefit. The overall goal of the proposed studies is to further validate optimized Nox4 inhibitor candidates, which demonstrate efficacy for reversing age-dependent established fibrosis – strategies that can reverse established fibrosis may represent the holy grail for therapeutic strategies to more effectively treat IPF and other fibrotic diseases.

PI_NAMEs: HECKER, LOUISE ;PATTI, JOSEPH  (contact)

PROGRAM_OFFICER_NAME: GOMEZ, CHRISTIAN RENE

PROJECT_TERMS: Address;Adverse effects;Affect;Age;age related;Aging;Bioinformatics;Biological Assay;Biotechnology;Bleomycin;Blood Vessels;Cells;Cicatrix;clinical development;Clinical Trials;clinically relevant;Collaborations;Development;Diagnosis;Disease;Dose;drug candidate;Drug Exposure;Drug Kinetics;drug metabolism;Drug Targeting;Elderly;Enzymes;Evaluation;FDA approved;Fibrosis;functional decline;Gases;Goals;Health;Heart;Human;idiopathic pulmonary fibrosis;improved;In Vitro;in vivo;Incidence;Inhalation;Inhalation Therapy;inhibitor;inhibitor therapy;innovation;Kidney;Lead;Legal patent;Licensing;Liver;Lung;lung injury;Maximum Tolerated Dose;Mediating;Mediator;Modeling;Mutagenesis;Myofibroblast;nintedanib;novel;Oral;Oral Administration;Organ;Outcome;Oxidants;Pathologic;Pathway interactions;Patients;Pharmaceutical Preparations;Phase;Phenotype;Pirfenidone;Population;preclinical development;Pulmonary Fibrosis;pulmonary function;Quality of life;Resolution;Respiratory Failure;Respiratory Therapy;Rights;Risk;Rodent;screening;Series;Side;side effect;single-cell RNA sequencing;Skeletal Muscle;Skin;Slice;Small Business Innovation Research Grant;Specificity;standard of care;Therapeutic;therapeutic development;Therapeutic Index;therapeutic target;Tissues;Universities;Up-Regulation

PROJECT_TITLE: Advanced Pre-clinical development of Nox4 inhibitors for Pulmonary Fibrosis

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


ORG_NAME: QSCINT IMAGING SOLUTIONS, LLC

PHR: Project Narrative: Targeted alpha therapy is a promising approach to precise targeting and elimination of smaller cancers which has already found success in FDA-approved treatments for bone metastases from prostate cancer. This project develops a technology for imaging the distribution of alpha and beta emitters and then assigning labels to the various primary and decay isotopes of the emitter, resulting in a form of spectroscopy. The technology developed by this project will result in a powerful tool for radiopharmaceutical researchers to characterize the distribution and fate of various radioactive isotopes for their candidate targeted alpha therapy molecules at various stages of study as notably this ability is currently not available.

PI_NAMEs: MOORE, JARED WILLIAM (contact)

PROJECT_TERMS: Affinity;Algorithm Design;Algorithms;Alpha Particles;Area;Autoradiography;Beta Particle;Binding;Biodistribution;cancer cell;Cancer Relapse;cancer therapy;Cell Death;cell killing;Cells;Characteristics;Charge;Chelating Agents;Data;Daughter;Dedications;design;Development;Devices;Diameter;digital;DNA Double Strand Break;Dose;Dose Limiting;dosimetry;Equilibrium;experimental study;FDA approved;Goals;Grant;Image;imaging approach;imaging detector;Imaging Device;imaging system;Imaging technology;improved;innovation;ionization;Ionizing radiation;Isotope Therapy;Isotopes;Label;Ligands;Malignant Neoplasms;Marketing;Measurement;Measures;Medical;Metastatic Neoplasm to the Bone;Methodology;Methods;Micrometastasis;Normal tissue morphology;novel;Organ;Paper Chromatography;Parents;particle detector;Phase;Phase I Clinical Trials;Procedures;product development;prostate cancer metastasis;prototype;quality assurance;quantum;Radiation;Radio;radiochemical;Radioisotopes;Radionuclide therapy;Radiopharmaceuticals;Radium-224;Research;Research Personnel;Research Support;Residual Neoplasm;Resolution;response;safety assessment;Science;Spatial Distribution;spectroscopic imaging;Spectrum Analysis;success;System;targeted treatment;Techniques;Technology;Therapeutic;Therapeutic Effect;Therapeutic Studies;Thin Layer Chromatography;Time;Tissues;tool;Toxic effect;tumor;tumor progression;uptake;Wait Time;Work

PROJECT_TITLE: Novel Isotopic Spectroscopy Imaging Tools for Advancing Targeted Alpha Cancer Therapies

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


NIH_SPENDING_CATS: Aging;Clinical Research;Lung;Orphan Drug;Pulmonary Fibrosis;Rare Diseases

PHR: PROJECT NARRATIVE: Fibrotic disorders represent a major health problem in the U.S, with a rising incidence (particularly among the elderly); Idiopathic pulmonary fibrosis (IPF) is among the most relentless and fatal fibrotic diseases. Although there is no cure for IPF, two FDA-approved treatments have been shown to slow but do not stop the decline in lung function, and only have a modest survival benefit. The overall goal of the proposed studies is to safety and efficacy of Nrf2 activators, which demonstrate efficacy for reversing age-dependent established fibrosis – strategies that can reverse established fibrosis may represent the holy grail for therapeutic strategies to more effectively treat IPF and other fibrotic diseases.

PI_NAMEs: HECKER, LOUISE  (contact)

PROJECT_TERMS: Affect;Age;age related;Aging;Antioxidants;Biotechnology;Cicatrix;clinical translation;Clinical Trials;clinically relevant;Collaborations;commercialization;Data;Development;Diagnosis;Disease;Disease Progression;Dose;drug development;Drug Kinetics;Effector Cell;efficacy evaluation;Elderly;Evaluation;Exhibits;experience;FDA approved;fibrogenesis;Fibrosis;Fumarates;Goals;Health;Human;idiopathic pulmonary fibrosis;improved;in vivo;Incidence;Inhalation;Inhalation Therapy;Injury;lead candidate;Legal patent;Lung;Maximum Tolerated Dose;Mediating;Modeling;mouse model;Multiple Sclerosis;Mus;Myofibroblast;No-Observed-Adverse-Effect Level;novel;novel therapeutic intervention;nuclear factor-erythroid 2;old mice;Oral;Oxidation-Reduction;Oxidative Stress;Pathogenesis;Pathologic;Patients;Pharmaceutical Preparations;Pharmacology and Toxicology;Phase;Phase III Clinical Trials;Population;preclinical development;preclinical efficacy;preclinical safety;Process;Pulmonary Fibrosis;pulmonary function;pulmonary function decline;Respiratory Failure;response;Rodent;Rodent Model;Safety;Side;Site;Slice;Small Business Technology Transfer Research;System;Therapeutic;therapeutic development;Therapeutic Index;therapeutic target;Tissues;Universities

PROJECT_TITLE: Repurposing of FDA-approved Nrf2 Activators as a Novel Inhaled Therapy for Pulmonary Fibrosis


ADMINISTERING_IC: GM

ED_INST_TYPE: ORGANIZED RESEARCH UNITS

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

ORG_CITY: BOISE

ORG_NAME: BOISE STATE UNIVERSITY

ORG_STATE: ID

PHR: Project Narrative Overall The Center of Biomedical Research Excellence in Matrix Biology will have a lasting and significant impact on the success of investigators as they establish their independently funded biomedical research programs. It will strengthen the research environment that was established during previous phases and sustain the change from a primarily undergraduate university to a doctoral research institution with biomedical research infrastructure. Phase 3 will solidify the impact of matrix biology investigation by biomedical researchers addressing challenges to disease diagnosis, prevention and treatment through shared core facilities and mentored career development strategies.

PI_NAMEs: OXFORD, JULIA THOM (contact)

PROGRAM_OFFICER_NAME: FRINCU, CRINA

PROJECT_TERMS: Address;animal care;Area;Award;base;Biocompatible Materials;Bioinformatics;Biology;Biomedical Engineering;Biomedical Research;Biometry;breast cancer metastasis;Businesses;Cardiovascular Diseases;cardiovascular health;career;career development;Cell Nucleus;Centers of Research Excellence;Chemistry;cohort;Communities;computer science;Core Facility;Dedications;design;Development;Discipline;Disease;disease diagnosis;Disease Progression;Educational process of instructing;Educational workshop;Electrical Engineering;Environment;Extracellular Matrix;Extramural Activities;Funding;Goals;Grant;Growth;healing;Health;Histology;Idaho;Image;improved;Individual;Industry;Institution;instrumentation;Interdisciplinary Study;Investigation;Journals;Knowledge;Laboratories;Leadership;Ligaments;Liver Fibrosis;Manuscripts;materials science;Mechanics;mechanotransduction;meetings;Mentors;metabolomics;Microscopy;Mission;multidisciplinary;Natural regeneration;Nature;neuroinflammation;novel;operation;Peer Review;Phase;Physics;Pilot Projects;Positioning Attribute;Prevention;Principal Investigator;Program Development;programs;Proteomics;Publishing;recruit;repaired;Research;Research Infrastructure;Research Personnel;Research Project Grants;Research Support;Role;Skin Cancer;success;sustainable resource;Technology;Therapeutic;therapeutic development;Tissue Engineering;tissue regeneration;tissue repair;Tissues;training opportunity;Translating;undergraduate student;Universities;vaccine development;Writing

PROJECT_TITLE: Center of Biomedical Research Excellence in Matrix Biology Phase 3

STUDY_SECTION_NAME: Special Emphasis Panel[ZGM1 RCB-4 (C3)]


NIH_SPENDING_CATS: Building Research Capacity at Institutions with Limited NIH Funding

PROJECT_TERMS: Address;Administrative Personnel;Advisory Committees;Animal Experimentation;Annual Reports;base;Biology;Biomedical Research;Businesses;career development;Caring;Cells;Centers of Research Excellence;cohort;Collaborations;college;Communities;Core Facility;Cost Analysis;Development;Disease;Educational process of instructing;Educational workshop;Evaluation;expectation;Extracellular Matrix;Extramural Activities;Faculty;faculty support;Fostering;Funding;Future;Goals;Grant;Growth;Health;Health Sciences;Housing;implementation facilitation;improved;Individual;Infrastructure;infrastructure development;instrumentation;Interdisciplinary Study;Knowledge;Marketing;Measures;meetings;member;Mentors;Mentorship;multidisciplinary;operation;Patient Care;Periodicals;Phase;phase 3 testing;Pilot Projects;Policies;Positioning Attribute;Process;Program Development;Program Sustainability;programs;Readiness;Records;recruit;Reporting;Research;research and development;research facility;Research Infrastructure;Research Personnel;Research Project Grants;Research Support;Science;Series;Strategic Planning;Talents;Teacher Professional Development;Technology;tenure track;theories;Time;Training Programs;Translating;undergraduate student;Universities;Work;Workload;Writing

PROJECT_TITLE: Administrative Core


PI_NAMEs: PU, XINZHU  (contact)

PROJECT_TERMS: Address;Adopted;Area;base;Binding;Biology;Biomedical Research;Businesses;Cells;Centers of Research Excellence;college;Communities;Computer software;Core Facility;Cost Sharing;Dedications;design;Development;Educational workshop;Engineering;Ensure;Environment;Equipment;Experimental Designs;experimental study;Extracellular Matrix;Extramural Activities;Fee-for-Service Plans;Fees;Fostering;Funding;Future;Generations;Goals;graduate student;Grant;Growth;Health Sciences;Histology;Human Resources;Idaho;Image;Industry;industry partner;Infrastructure;Institution;instrumentation;Interdisciplinary Study;Investigation;Investments;Laboratories;Maintenance;Mass Spectrum Analysis;Microscopy;Molecular Analysis;multidisciplinary;operation;Osteopathic Medicine;Phase;Practice Management;Preparation;Productivity;programs;Publications;Research;Research Infrastructure;Research Personnel;Research Support;Research Technics;Research Training;Resources;response;Schedule;Service delivery model;Services;skills;Structure;Students;Study models;System;Technical Expertise;Techniques;Tissues;Training;Training and Education;training opportunity;Training Support;undergraduate student;United States National Institutes of Health;Universities

PROJECT_TITLE: Biomolecular Research Core


PI_NAMEs: LUNDGREN, MATT  (contact)

PROJECT_TERMS: Administrative Supplement;animal care;Animal Experimentation;Animal Housing;Animal Model;Award;base;Biological Models;Biology;Biomedical Research;Businesses;Caring;Centers of Research Excellence;Collaborations;college;Communities;Computer software;Continuing Education;Core Facility;cost;Dedications;Development;Engineering;Ensure;Environment;Equipment;experience;Experimental Designs;experimental study;Faculty;faculty research;faculty support;Fee-for-Service Plans;Fees;Fostering;Foundations;Funding;Gene Modified;Goals;graduate student;Grant;Health Sciences;Housing;human disease;human model;Human Resources;Immunodeficient Mouse;Individual;innovation;Institution;Interdisciplinary Study;Investments;Laboratories;Location;Maintenance;member;model development;Modeling;Monitor;multidisciplinary;Mus;operation;payment;Phase;preservation;Procedures;Production;programs;Rattus;recruit;Research;Research Infrastructure;Research Personnel;Research Training;Resources;responsible research conduct;Rodent;Schedule;Service delivery model;Services;standard care;Stream;Structure;Students;System;Technical Expertise;Techniques;Training;Training and Education;training opportunity;Universities;Veterinarians;Work;Zebrafish

PROJECT_TITLE: Biomedical Research Vivarium


NIH_SPENDING_CATS: Aging;Bioengineering;Breast Cancer;Cancer;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Racial and Ethnic Minority Health Research;Social Determinants of Health;Women's Health Research

ORG_CITY: PORTLAND

ORG_NAME: KELIOMICS, INC.

ORG_STATE: OR

PHR: PROJECT NARRATIVE In this SBIR, Keliomics plans to develop breakthrough, ex vivo tumors for breast cancer therapeutic development. These tumors are specifically designed to develop new therapeutics that can resolve known racial disparities in breast cancer survival.

PI_NAMEs: LAU, FRANK  (contact)

PROGRAM_OFFICER_NAME: ZANE, LINDA KARINE

PROJECT_TERMS: Accounting;Address;Adipocytes;Adjuvant Chemotherapy;advanced breast cancer;Benchmarking;Biological;Biometry;Black race;black women;Breast;Breast Cancer Model;breast cancer survival;Breast Cancer therapy;cancer subtypes;Cell Line;Cells;chemotherapy;Clinical;Clinical Data;Clinical Trials;Combination Drug Therapy;commercial application;commercialization;cost;design;Development;Disparity;Duct (organ) structure;Economics;Engineering;Environment;erbB-2 Receptor;ERBB2 gene;Extracellular Matrix;Failure;Goals;high risk;hormone receptor-negative;Human;Immune;improved;In complete remission;International;Investigational Drugs;Investments;Legal patent;Malignant Breast Neoplasm;Malignant Neoplasms;Mammary Gland Parenchyma;Mammary Neoplasms;Marketing;Medical;Modeling;Nature;Neoadjuvant Therapy;novel therapeutics;Obesity;Outcome;Pathologic;Pathologist;patient derived xenograft model;patient response;Patients;Pharmaceutical Preparations;Pharmacotherapy;Phase;phase 1 study;Positioning Attribute;pre-clinical;Pre-Clinical Model;Production;Publishing;Race;racial disparity;Receptor Protein-Tyrosine Kinases;response;Small Business Innovation Research Grant;social;spheroids;standard of care;Stromal Cells;survival disparity;Technology;Therapeutic;therapeutic development;Therapeutic Uses;Tissue Donations;Tissues;treatment duration;treatment response;tumor;Tumor Biology;Tumor stage;White Women

PROJECT_TITLE: Engineering ex vivo breast tumors in human breast tissue to address racial disparities in HR-/ERBB2+ breast cancer


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

ORG_CITY: San Carlos

ORG_NAME: ALTAY THERAPEUTICS, INC.

ORG_STATE: CA

PHR: Narrative Interstitial lung disease in scleroderma (SSc ILD) is a life-threatening disease associated with excessive inflammation and scarring of the lung. If left untreated, SSC ILD patients will require oxygen therapy, lung transplantation and sadly ultimately succumb to their disease. Therefore, finding a safe treatment is in great clinical need. Here, we identified a cellular protein that play’s a major role in SSc ILD and developed a series of drugs with low toxicity, potentially providing a safe treatment option for patients suffering from SSc ILD.

PI_NAMEs: OZES, ALI RAYET (contact)

PROGRAM_OFFICER_NAME: VUGA, LOUIS J

PROJECT_TERMS: American;Architecture;attenuation;Autoimmune Diseases;Binding;Binding Sites;Biopsy;Bleomycin;California;Cells;Clinical;Collaborations;Collagen;commercialization;cytotoxic;cytotoxicity;Data;Deposition;Development;Disease;DNA;DNA Binding;DNA Binding Domain;drug development;Drug Kinetics;efficacy study;Endothelium;Enzyme-Linked Immunosorbent Assay;Extracellular Matrix;FDA approved;Fibroblasts;Fibronectins;Fibrosis;fibrotic lung;Follow-Up Studies;Functional disorder;Gene Expression;Gene Expression Profile;Genes;Genetic Risk;Genetic Transcription;genome wide association study;Grant;Hydroxyproline;in silico;In Vitro;in vivo;Inflammation;inhibitor;Interleukin-6;interstitial;Interstitial Lung Diseases;knock-down;Lead;Left;Life;Lung;lung basal segment;Lung Diseases;Lung Transplantation;Measures;Methods;Microvascular Dysfunction;Modeling;mortality;mouse model;Mus;Myofibroblast;nanomolar;next generation;nintedanib;Normal tissue morphology;novel;novel strategies;novel therapeutic intervention;Outcome;Oxygen Therapy Care;Pathway interactions;Patients;Persons;Pharmaceutical Preparations;pharmacologic;Pharmacology Study;Phase;Play;prognostic;Property;prophylactic;protein protein interaction;Proteins;Publishing;Pulmonary Fibrosis;Quantitative Reverse Transcriptase PCR;Reporting;Research Personnel;Research Support;response;risk variant;RNA;Role;Route;Sampling;San Francisco;Scleroderma;screening;Series;Skin;skin fibrosis;Slice;Small Business Innovation Research Grant;small molecule;Stains;STAT1 gene;STAT3 gene;Stretching;Structure of parenchyma of lung;Systemic Scleroderma;Systemic Therapy;Testing;Therapeutic;therapeutic target;Tissues;tocilizumab;Toxic effect;transcription factor;Transforming Growth Factor beta;translational impact;treatment response;Universities;Validation

PROJECT_TITLE: The development of a STAT3 inhibitor for lung scleroderma


NIH_SPENDING_CATS: Aging;Bioengineering;Biomedical Imaging;Cancer;Data Science;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Prevention;Prostate Cancer;Urologic Diseases

ORG_NAME: ALPENGLOW BIOSCIENCES, INC.

PHR: NARRATIVE The diagnosis of prostate cancer relies on centuries-old pathology technology, which has flaws that lead to poor prediction of metastatic risk in biopsy specimens. This project aims to develop innovative methods for prostate cancer pathology in two ways: 1) to accelerate and automate the preparation of prostate biopsies for 3D imaging, and 2) to develop machine learning algorithms and deploy them in a study to demonstrate the clinical value of the technology. The objectives of this proposal are consistent with the goals of the NCI IMAT SBIR program, which aims to support the early-stage development and validation of highly innovative technologies relevant to cancer diagnosis in the context of commercial use.

PI_NAMEs: REDER, NICHOLAS  (contact)

PROJECT_TERMS: 3-Dimensional;Acceleration;Accreditation;Address;Adoption;Advanced Development;androgen independent prostate cancer;Antibodies;Archives;Artificial Intelligence;artificial intelligence algorithm;Automation;Award;base;Biological Sciences;Biology;Biopsy;Biopsy Specimen;Cancer Detection;cancer diagnosis;Cancer Etiology;Cancer Patient;cancer risk;Carcinoma;Cells;Cessation of life;Characteristics;Clinical;Clinical Data;Color Perception;commercialization;computerized tools;curative treatments;Data Set;Development;Diagnosis;Diagnostic;Diagnostic Procedure;Disease;Dyes;Early identification;Effectiveness;efficacy validation;Future;Glass;Goals;Grant;head-to-head comparison;Hematoxylin and Eosin Staining Method;high risk;Hour;Human;Image;image reconstruction;Imaging Device;Immune;improved;Indolent;innovation;innovative technologies;International;Laboratories;Localized Disease;Machine Learning;machine learning algorithm;machine learning model;machine learning prediction algorithm;Malignant neoplasm of prostate;Malignant Neoplasms;men;Methods;Modeling;Molecular Computations;molecular diagnostics;Morbidity - disease rate;mortality;Nature;Neoplasm Metastasis;Nerve;Nomograms;novel therapeutics;Pathologist;Pathology;patient subsets;Patient-Focused Outcomes;Patients;Pharmaceutical Preparations;Phase;Pilot Projects;Positioning Attribute;predictive modeling;Preparation;Prevalence;Process;programs;Prostate;prostate biopsy;Prostate carcinoma;Protocols documentation;Publications;Risk;Sampling;Slide;Small Business Innovation Research Grant;Speed;Stains;Standardization;statistics;Structure;success;Techniques;Technology;Technology Assessment;Three-Dimensional Imaging;Time;tissue preparation;Tissues;tool;Training;Validation

PROJECT_TITLE: 3D Spatial Biology of Prostate Cancer Biopsies For Earlier Identification of High Risk Patients


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Autism;Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Disability Research;Dissemination and Implementation Research;Intellectual and Developmental Disabilities (IDD);Machine Learning and Artificial Intelligence;Mental Health;Pediatric;Telehealth

ORG_CITY: Millbrae

ORG_NAME: CARE.COACH CORPORATION

PHR: NARRATIVE This research and development with the care.coach avatar and conversational agent will deliver an effective, meaningful, and ready-to-be-commercialized digital health intervention that adapts to the needs, preferences and goals of autistic young adults to support and benefit their health, functioning, and quality of life. The prod- uct and platform have the potential to improve the health and wellbeing of millions of Americans, including those with autism.

PI_NAMEs: KERSSENS, CHANTAL M (contact)

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: adaptive intervention;Adherence;adolescent with autism spectrum disorder;Adoption;Adult;adult with autism spectrum disorder;Age;American;Artificial Intelligence;artificial intelligence algorithm;autism spectrum disorder;autistic;Awareness;behavioral health;care coordination;care costs;Caring;chatbot;Chronic Disease;Clinic Visits;Clinical;Clinical Protocols;Clinical Trials;Collaborations;college;commercialization;Communities;community partners;Companions;comparison intervention;Competence;Complex;Computer software;Consultations;cost effective;design;Developmental Disabilities;digital;digital health;digital intervention;efficacy testing;Emergency Situation;emerging adult;Empathy;Enrollment;Ensure;Environment;evidence base;Family;feasibility trial;Friends;Goals;Health;Home;Human;implementation protocol;improved;Individual;individuals with autism spectrum disorder;innovation;Intellectual functioning disability;Intention;Intervention;Interview;Life;life span;Manuals;Measures;meetings;Mental Health;Methods;Modeling;Monitor;Occupations;older adult;Outcome;Outcome Measure;Paper;Participant;peer;Personal Satisfaction;personalized medicine;Persons;Phase;pilot test;preference;Process;programs;Protocols documentation;Quality of life;Randomized;Randomized, Controlled Trials;remote control;Reporting;Research;research and development;Research Design;Safety;Sampling;Secondary Schools;Self Direction;Self Efficacy;Self Management;Small Business Innovation Research Grant;Specific qualifier value;Standardization;Structure;Students;success;Support System;Technology;technology platform;Teenagers;Testing;Time;Training;Translating;treatment planning;Underemployment;Unemployment;usability;virtual;virtual health;Work;young adult;young adult with autism spectrum disorder

PROJECT_TITLE: Optimizing and testing the care.coach avatar as a personalized, engaging and adaptive virtual health assistant for maximizing functional and quality of life outcomes in autistic young adults

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


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Hematology;Networking and Information Technology R&D (NITRD);Patient Safety;Rare Diseases

ORG_CITY: NEW ORLEANS

ORG_NAME: LEVISONICS, INC.

ORG_STATE: LA

PHR: PROJECT NARRATIVE A million people suffering from congenital hemophilia receive lifelong procoagulant medication. Regular monitoring of the effects of these drugs is necessary to adjust the dosage and prevent adverse drug events, but reliable, safe, and convenient tools for frequent coagulation monitoring are currently unavailable. We aim to address this unmet need by developing an innovative point-of-care platform to perform comprehensive, global coagulation testing with a single drop of blood.

PI_NAMEs: KASIREDDY, NITHYA  (contact)

PROGRAM_OFFICER_NAME: WARREN, RONALD Q

PROJECT_TERMS: Acoustics;Activated Partial Thromboplastin Time measurement;Address;Adult;Adverse drug effect;Adverse drug event;Algorithms;Ambulatory Care Facilities;appropriate dose;Behavior;Biological Assay;Blood;Blood coagulation;Blood Coagulation Disorders;Blood Platelets;Blood specimen;Bypass;Characteristics;Childhood;Clinical;Coagulation Process;Collaborations;Complex;Computer software;computerized data processing;cost;Data;data acquisition;design;Development;Devices;dosage;Dose;Drops;Drug Interactions;Drug Monitoring;Effectiveness;Elasticity;Electronics;Equilibrium;Evaluation;expectation;experimental study;Factor VIII;Fibrin;Food Interactions;Goals;graphical user interface;healthy volunteer;Hemophilia A;Hemorrhage;Hemostatic Agents;improved;innovation;Kinetics;Laboratories;Life;Marketing;Measurement;Measures;Methods;mimetics;Modernization;Monitor;monitoring device;Neonatal;operation;Outcome;Output;Pathway interactions;patient population;Patients;pediatric patients;Performance;Persons;Pharmaceutical Preparations;Phase;Plasma;Plasma Proteins;point of care;prevent;Process;profiles in patients;Property;prototype;Recombinants;Reference Values;Replacement Therapy;Reproducibility;research and development;response;risk prediction;Sampling;Shapes;side effect;Site;Small Business Innovation Research Grant;Spectrum Analysis;standard care;Techniques;Technology;Testing;Therapeutic;Time;tool;Training;Treatment Cost;Universities;Update;viscoelasticity;Viscosity;Visualization;Whole Blood

PROJECT_TITLE: Coagulation Monitoring in Hemophilia via Acoustic Tweezing Spectroscopy


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

ORG_CITY: Saint Louis

ORG_NAME: EQUATOR THERAPEUTICS, INC.

ORG_STATE: MO

PHR: Project Narrative This project will identify molecules that stimulate native pathways responsible for heat production in our body, with the goal of developing a drug to safely increase energy expenditure. This drug will reverse obesity, insulin resistance, type 2 diabetes and fatty liver disease, and will have potential to transform the treatment of metabolic disorders. 1

PI_NAMEs: VU, SIMON  (contact)

PROGRAM_OFFICER_NAME: COOKE, BRAD

PROJECT_TERMS: Address;Adenine Nucleotide Translocase;Adult;Agonist;analog;Binding Proteins;Binding Sites;Biological Availability;blood glucose regulation;Body Composition;Body Temperature;Body Weight decreased;Brown Fat;Chemicals;Chronic;Desire for food;Development;diet-induced obesity;Disease;disease model;Dose;drug discovery;Eating;effective therapy;efficacy evaluation;efficacy study;Elderly;Energy Intake;Energy Metabolism;experimental study;Fatty acid glycerol esters;fatty liver disease;Foundations;Generations;GLP-I receptor;Goals;High Prevalence;Human;In Vitro;in vivo;Indirect Calorimetry;Inner mitochondrial membrane;insight;Insulin Resistance;Lead;lead optimization;Liver;long chain fatty acid;Measurement;Measures;Mediating;Metabolic;Metabolic Diseases;metabolic rate;Metabolism;Methods;Mitochondria;mitochondrial uncoupling protein;Molecular;Nature;Non-Insulin-Dependent Diabetes Mellitus;Obese Mice;Obesity;obesity treatment;Oral;Oxygen;Patch-Clamp Techniques;Pathway interactions;Pharmaceutical Chemistry;Pharmaceutical Preparations;pharmacologic;Phase;Physiological Processes;Plasma Proteins;Play;Preparation;Proteins;Reaction;Reporting;Rodent;Rodent Model;Role;Running;Safety;screening;Series;Site;Skeletal Muscle;Small Business Innovation Research Grant;small molecule;Testing;Therapeutic;Thermogenesis;Tissues;Variant;Water consumption;Weight;Work

PROJECT_TITLE: New Generation of Mitochondrial Uncouplers for the Treatment of Metabolic DIsorders

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


FUNDING_MECHANISM: OTHER RESEARCH-RELATED

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Coronaviruses;Emerging Infectious Diseases;HIV/AIDS;Infectious Diseases;Prevention

ORG_CITY: SILVERTHORNE

ORG_NAME: KEYSTONE SYMPOSIA

PHR: PROJECT NARRATIVE The global COVID-19 pandemic has had a profound impact on how scientists view the interconnectivity of viral infections, especially how an underlying HIV condition may influence an individual’s disease progression after exposure. Despite decades of research and therapeutic breakthroughs, there is still no cure for HIV, and many living with HIV are particularly vulnerable to infections from emerging and (re)-emerging viruses. This Keystone Symposia conference aims to bring together a diverse group of world experts on HIV and other viruses, like SARS-CoV-2 and Influenza, to identify collective research priorities, establish new partnerships and advance knowledge in virology alongside vaccine and treatment approaches with an aim to accelerate robust prevention and cure of viral diseases.

PI_NAMEs: SHEPPARD, TERRY L. (contact)

PROGRAM_OFFICER_NAME: GUTIERREZ, MARTIN

PROJECT_TERMS: 2019-nCoV;Acceleration;Affect;Antibodies;career development;clinical practice;co-infection;Collaborations;Communicable Diseases;Communities;COVID-19 pandemic;Disease Outbreaks;Disease Progression;Educational workshop;Emerging infection;emerging virus;Environment;epidemic preparedness;Evolution;Fostering;future epidemic;future pandemic;Genes;Germany;Glean;Goals;HIV;improved;Individual;Infection;Influenza;insight;Knowledge;Learning;long-term sequelae;member;Mentors;Messenger RNA;Methodology;Molecular;Monkeypox;multidisciplinary;next generation sequencing;Outcome;pandemic disease;pandemic potential;pandemic preparedness;pathogen;Pathogenesis;Persons;posters;Prevention;programs;Readiness;Research;Research Personnel;Research Priority;response;Scientist;Structure;symposium;Technology;Therapeutic;Therapeutic Research;Time;transmission process;Update;Vaccines;Viral;Viral Hemorrhagic Fevers;virology;Virus;Virus Diseases;Work

PROJECT_TITLE: HIV and (Re)Emerging Viruses: Aligning Lessons Across Pandemics

STUDY_SECTION_NAME: Special Emphasis Panel[ZAI1 LK-D (J1)]


NIH_SPENDING_CATS: Hematology;Kidney Disease

ORG_CITY: MILWAUKEE

ORG_NAME: FUNCTION THERAPEUTICS, INC.

ORG_STATE: WI

PHR: Acute kidney injury (AKI) is the sudden and dangerous loss of kidney function in response to inflammatory events like major trauma, surgery, systemic infection, or the use of certain medications. There are presently no FDA-approved drugs specifically for the prevention of AKI. This project will develop and investigate a subset of parmodulins, a new class of antithrombotic and anti-inflammatory molecules, and test them in a mouse model of AKI.

PI_NAMEs: DOCKENDORFF, CHRISTOPHER  (contact)

PROGRAM_OFFICER_NAME: CONAGE-POUGH, JASON EDWARD

PROJECT_TERMS: Academia;activated Protein C;Acute Renal Failure with Renal Papillary Necrosis;Alabama;analog;anti-cancer;Anti-Infective Agents;Anti-Inflammatory Agents;Anticoagulants;Apoptosis;Bilateral;Biological Assay;cancer therapy;Cardiac;chemotherapy;Chronic Kidney Failure;Clinical;Coagulation Process;Collaborations;COVID-19 patient;Cytoprotection;cytotoxicity;Cytotoxin;Dangerousness;Data;design;Development;Diabetic Nephropathy;disease model;Doctor of Medicine;Doctor of Philosophy;Dose;drug discovery;Drug Kinetics;efficacy study;Endothelial Cells;Endothelium;Enzymes;Event;experience;FDA approved;Future;G-Protein-Coupled Receptors;Hospitalization;Hospitals;improved;In Vitro;in vitro Assay;in vivo;in vivo Model;Infection;Inflammatory;inhibitor;Injury;Injury to Kidney;Investigation;Ischemia;kidney cell;Kidney Diseases;Lead;lead series;Leadership;Liver Microsomes;Measures;meetings;member;Modeling;Morbidity - disease rate;mortality;mouse model;Mus;Myocardial Ischemia;nanomolar;novel;Operative Surgical Procedures;pandemic disease;PAR-1 Receptor;Pathologic;Pathway interactions;Patients;Peptide Hydrolases;Pharmaceutical Chemistry;Pharmaceutical Preparations;pharmacologic;Plasma;preclinical development;prevent;Prevention;Privatization;Probability;Process;programs;Property;protective effect;Protocols documentation;Renal function;renal ischemia;Reperfusion Injury;Reperfusion Therapy;Reporting;Research;response;Risk;Route;Safety;Series;Sickle Cell Anemia;Signal Transduction;small molecule;Solubility;Staurosporine;stroke therapy;Systemic infection;Testing;Therapeutic;Thrombin;Thrombin Receptor;thromboinflammation;Thrombosis;thrombotic;Trauma;Universities;Validation

PROJECT_TITLE: Inhibitors of Thromboinflammation for Acute Kidney Injury

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


ADMINISTERING_IC: AT

IC_NAME: NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH

NIH_SPENDING_CATS: Assistive Technology;Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;Lung;Mental Health;Pediatric;Prevention

ORG_CITY: West Lafayette

ORG_NAME: LIVOTION LLC

ORG_STATE: IN

PHR: Given the considerable prevalence, severity, and impact of stress among college students, the development of scalable stress-management programs that are cost-effective, time-efficient, and applicable to real-world academic settings is sorely needed. Here, we propose to further develop, evaluate, and refine scalable implementation materials and accurate measurement tools to support future real-world effectiveness studies of an affordable, technology-based breathing intervention. Results will solidify the feasibility, usability, and efficacy of a scalable intervention, the AIRpen, for potentially optimizing the delivery, practice, and fidelity of diaphragmatic breathing (DB) practices in real-world settings to improve students’ mental health.

PI_NAMEs: AGUIRRE, MILTON  (contact)

PROGRAM_OFFICER_NAME: HORGUSLUOGLU, EMRIN U

PROJECT_TERMS: acceptability and feasibility;addiction;Address;Adherence;Affect;Air Movements;Anxiety;Behavior;Behavioral;Biofeedback;Bite;Breathing;Breathing Exercises;Cellular Phone;Chest;Chronic stress;Clip;college;Conduct Clinical Trials;Coping Skills;cost effective;Counseling;COVID-19 pandemic;Data;design;Development;Devices;Diagnosis;Education;Educational Intervention;Effectiveness;effectiveness study;effectiveness trial;experience;Feedback;Frequencies;Funding;Future;global health;Good Manufacturing Process;Habits;Health Personnel;help-seeking behavior;improved;Industry;Inhalators;Institutional Review Boards;Internet;Intervention;Laboratories;Licensing;manufacture;Marketing;Measurement;Measures;Mechanics;Mental Depression;Mental disorders;Mental Health;Methods;mhealth interventions;Mind;mobile application;Monitor;Notification;Participant;Patient Self-Report;Persons;Phase;Physiological;Population;Positioning Attribute;Practice Management;Prevalence;prevent;program costs;Protocols documentation;prototype;Provider;Psychologist;Quasi-experiment;Relaxation Therapy;remediation;Reporting;research study;Resistance;respiratory;Respiratory Diaphragm;Respiratory Muscles;Risk Factors;Sampling;secondary outcome;Self Efficacy;sensor;Severities;Small Business Technology Transfer Research;Stigmatization;Stress;Stress and Coping;stress management;stress symptom;Students;Surveys;Symptoms;Techniques;Technology;technology intervention;Testing;Textiles;Time;tool;Training;Treatment Effectiveness;undergraduate student;Universities;university student;usability;verbal;web-based intervention;Writing

PROJECT_TITLE: A scalable intervention for stress management practices

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


ORG_CITY: Portland

ORG_NAME: PDX PHARMACEUTICALS, INC.

PHR: Project Narrative Lung cancer is by far the leading cause of cancer deaths in the US and worldwide; standard chemo and radiation therapy is not widely effective, and less than 20% of patients respond to immunotherapy. In the parent fast-track SBIR grant, we develop a next generation immunotherapy, based on nanoparticle co-delivery of a potent anti-cancer RNA, an immune checkpoint inhibitor, and an immune-stimulating agent, that will lead to antitumor immune response and curative outcomes in advanced lung cancer patients. This grant will enhance our commercialization readiness by supporting intellectual property protection of the technology in the US and abroad and initiating regulatory-compliant manufacturing of our drug loaded nanoparticles.

PI_NAMEs: NGAMCHERDTRAKUL, WORAPOL  (contact);YANTASEE, WASSANA

PROGRAM_OFFICER_NAME: FRANCA-KOH, JONATHAN C

PROJECT_TERMS: Achievement;Adoption;Animal Model;anti-cancer;anti-PD-L1 antibodies;anti-PD1 antibodies;anti-tumor immune response;Antibodies;antibody conjugate;Antigen Presentation;Antigens;Biodistribution;Biological Assay;cancer cell;Cancer Etiology;cancer immunotherapy;Cancer Patient;cancer survival;cancer therapy;CD8-Positive T-Lymphocytes;Cell Death;Cells;Cessation of life;chemotherapy;Clinic;Clinical;Clinical Trials;Collaborations;Combination immunotherapy;commercialization readiness;Communication;Country;crosslink;Data;Doctor of Philosophy;Dose;Drug Combinations;Drug Kinetics;Evaluation;flexibility;Formulation;Fund Raising;Funding;Future;Grant;Health;Heterogeneity;Home;humanized mouse;Immune;immune checkpoint blockade;Immune checkpoint inhibitor;Immune Evasion;immune stimulant;Immunologic Stimulation;Immunology;Immunosuppression;Immunotherapy;In Vitro;in vivo;Infiltration;Infusion procedures;inhibitor;Intellectual Property;International;Investments;Laboratories;Lawyers;Lead;Legal patent;Malignant neoplasm of lung;Malignant Neoplasms;manufacture;Methods;Minority;Mitotic;Modeling;Monitor;Mus;Nanoimmunotherapy;nanoparticle;nanoparticle delivery;Nanotechnology;nanotherapeutic;Nature;next generation;Non-Small-Cell Lung Carcinoma;nonhuman primate;novel;Oregon;Outcome;Parents;Particle Size;patient derived xenograft model;Patients;PD-1/PD-L1;Pharmaceutical Preparations;Pharmacologic Substance;Pharmacology;Pharmacotherapy;Phase;Phase I/II Clinical Trial;Phosphotransferases;PLK1 gene;Positioning Attribute;Preparation;Privatization;Process;programmed cell death ligand 1;programs;Publishing;Qualifying;Radiation therapy;Readiness;Regimen;Reporting;Resistance;response;RNA;Role;Safety;Saline;Science;Silicon Dioxide;Small Business Innovation Research Grant;Small Interfering RNA;Specificity;Standardization;STAT3 gene;success;Survival Rate;Systems Biology;T-Cell Activation;Technology;Testing;Therapeutic;Therapeutic Agents;Toxic effect;Toxicology;tumor;Tumor Antigens;Tumor Burden;tumor microenvironment;United States National Institutes of Health;Universities;uptake;Vial device

PROJECT_TITLE: Advancing the commercialization readiness of nanoparticle-based immunotherapy for cancer treatment


ORG_CITY: CAMBRIDGE

ORG_NAME: COALESENZ INC.

ORG_STATE: MA

PHR: NARRATIVE Acute bleeding, often caused by impaired blood coagulation, is a severe outcome that sadly occurs in over 40% of patients on mechanical circulatory support. The clinical management of hemostasis in these patients is often challenging due because bleeding and coagulation need to be precisely managed. By comprehensive coagulation and platelet profiling at the point-of-care, the iCoagLab device will enable rapid diagnosis of bleeding or thrombosis risk, ultimately improving patient outcome.

PI_NAMEs: NADKARNI, SEEMANTINI K (contact)

PROGRAM_OFFICER_NAME: GOLDBERG, ILANA GRACE

PROJECT_TERMS: Acute;Address;Adoption;ADP Receptors;Anticoagulants;Anticoagulation;Award;Biological Assay;Blood;Blood coagulation;Blood Coagulation Disorders;Blood Coagulation Factor;Blood Platelets;blood product;Blood specimen;Boston;Cardiac;Cardiac Surgery procedures;Cardiogenic Shock;Cause of Death;Clinical Management;Coagulation Process;companion diagnostics;Complex;Consumption;Coronary;cost;crosslink;design;Devices;diagnostic tool;Dose;Event;Fibrin;Fibrinogen;Fibrinolysis;Formulation;Freeze Drying;Functional disorder;Future;Goals;Hand;Heart failure;Hematocrit procedure;hemodynamics;Hemoglobin;Hemorrhage;Hemostatic function;Heparin;high risk;Impairment;improved;innovation;instrument;Intervention;invention;Laboratories;Laser Speckle Imaging;Lasers;Life;Life Experience;light scattering;Liquid substance;Lung;Manuals;Measurement;Measures;mechanical circulatory support;Mechanics;meter;Modulus;Monitor;mortality;Motion;novel;Organ failure;Outcome;particle;Patient-Focused Outcomes;Patients;Pattern;Phase;phase 2 study;platelet function;point of care;polymerization;Polymers;portability;prevent;Property;Prothrombin time assay;Pulmonary Embolism;Pump;rapid diagnosis;Reagent;Refrigeration;Research;Rheology;Risk;Sampling;shear stress;Small Business Technology Transfer Research;Source;Stroke;Technology;Testing;Therapeutic;Thrombosis;Time;time use;Tissues;tool;Variant;viscoelasticity;von Willebrand factor receptor;Weight;Work

PROJECT_TITLE: Multifunctional coagulation and platelet profiling during cardiaccirculatory support


NIH_SPENDING_CATS: Autoimmune Disease;Diabetes

ORG_CITY: BEVERLY HILLS

ORG_NAME: METANOIA BIO LLC

PHR: PROJECT NARRATIVE Type-2 diabetes (T2D), the most prevalent type of diabetes, is a chronic metabolic disease characterized by hyperglycemia. Few (if any) of the new-age therapies currently available on the market were designed with the underlying mechanism(s) of T2D in mind. Findings from this STTR will fill our existing gaps in knowledge relating to mechanistically how -cell fitness competition may be subjugated to induce functional cell regeneration and provide proof-of-concept that a PFKFB3 inhibitor can restore -cell function, allowing for future therapeutic strategies in T2D.

PI_NAMEs: GREEFF, OPPEL  (contact)

PROJECT_TERMS: 6-Phosphofructo-2-kinase;absorption;Adult;Affect;Age;age-related disease;aged;Antibodies;aqueous;Beta Cell;Biological Availability;blood glucose regulation;Cell Hypoxia;Cell model;Cell Nucleus;Cell Physiology;cell regeneration;Cell Survival;Cells;Chemicals;Chronic;Collaborations;Collection;comparative efficacy;comparison control;Computer software;design;Diabetes Mellitus;Diabetic mouse;Disadvantaged;Disease;Docking;Dose;Excision;fitness;Fructose;Fructose-2,6-bisphosphatase;Functional disorder;Functional Regeneration;Future;Glucose;glucose tolerance;glycemic control;High Fat Diet;Homing;Hyperglycemia;hypoxia inducible factor 1;improved;in vivo;inhibitor;inhibitor therapy;injured;Insulin;Insulin Resistance;insulin secretion;insulin sensitivity;islet;Knockout Mice;Knowledge;Lead;Ligands;Marketing;Metabolic;Metabolic Diseases;Metabolic stress;Metabolism;Metformin;Mind;Modeling;molecular dynamics;Monitor;non-diabetic;Non-Insulin-Dependent Diabetes Mellitus;novel;novel strategies;open source;Oral;Oral Administration;Pathologic;Pathology;Pathway interactions;Performance;Peripheral;Persons;Pharmaceutical Preparations;pharmacologic;Phase;Phenotype;Phosphotransferases;Physiological;Pre-Clinical Model;Prediabetes syndrome;Process;programs;Property;protein aggregation;Proteins;Role;Safety;scaffold;Signal Transduction;simulation;Small Business Technology Transfer Research;small molecule;Solubility;Specificity;Stress;Therapeutic;therapeutic candidate;Tissues;virtual;Work;Workload

PROJECT_TITLE: Targeting PFKFB3 kinase for activation of cell competition and elimination of dysfunctional beta-cells in type-2 diabetes


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

ORG_CITY: BRYAN

ORG_NAME: OLERA INC.

PHR: PROJECT NARRATIVE This project addresses one of the most significant issues with the U.S. elder care system: the prohibitively high senior care costs and barriers to accessing care. It does so through the development and evaluation of a novel AI-powered care planning technology designed to help caregivers of older adults in need of care, particularly those with AD/ADRD, find underutilized financial aid resources and personalized guidance to accessing and afford available support systems on the local, state, and federal levels. The project builds on a previous Fast-Track SBIR project developing a web-based caregiver support platform (The Olera Platform) that connects families to local financial, legal, and care resources by applying Large Language Models (LLMs), a novel class of AI, and generative AI techniques in an innovative approach to senior care planning.

PI_NAMEs: FALOHUN, TOKUNBO  (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Address;aging population;Alzheimer's disease related dementia;American;Artificial Intelligence;care costs;care systems;Caregiver support;Caregivers;caregiving;Caring;Categories;Characteristics;Clinical;community partners;Community Services;Complex;Data;Decision Making;dementia care;design;Development;disability;Ecosystem;Elderly;Eligibility Determination;Emerging Technologies;Engineering;Environment;Evaluation;experience;Family;Family Caregiver;Federal Aid;Feedback;Food;Generations;generative artificial intelligence;Health;Health Services Accessibility;Healthcare;Housing;Human;improved;Individual;Industrialization;innovation;intelligent agent;Interview;large language model;Learning;Legal;Licensing;Long-Term Care for Elderly;Machine Learning;Measures;Medical;mobile application;Modeling;Needs Assessment;novel;older adult;Online Systems;Outcome;Output;patient home care;Perception;Personal Satisfaction;personalized care;Phase;Positioning Attribute;programs;Psychological reinforcement;Qualifying;Resources;response;Retrieval;screening;Self Efficacy;service coordination;service organization;Services;Small Business Innovation Research Grant;Social Workers;Support System;Surveys;Techniques;Technology;Testing;tool;Training;Transportation;usability;Vision;Volunteer Group

PROJECT_TITLE: Olera CareNavigator - Increasing Affordability and Accessibility of Senior Care For Dementia Family Caregivers

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


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Patient Safety;Physical Activity;Physical Injury - Accidents and Adverse Effects;Physical Rehabilitation;Prevention;Rehabilitation

ORG_CITY: Beaverton

ORG_NAME: SENAPTEC INC.

PHR: Project Narrative Falls are a major cause of death and morbidity for older adults, and due to sensory and neuromuscular changes, our risk of falling increases as we age. Physical therapy and exercises can help us maintain and improve our balance and stability, but many older adults may not have ready access to therapy or may be unable or unwilling to adopt and sustain exercise programs that could help mitigate their risk of falling. Senaptec and their academic partners have found that their stroboscopic eyewear, “Strobes”, developed for and used by professional athletes across the world to enhance performance, can improve balance for older adults who use them during standing tasks of daily living at home for brief intervals and are now optimizing the Strobe design for this population and conducting a randomized control trial to test the efficacy of Strobe therapy for reducing fall risk in older adults.

PI_NAMEs: YOO, HERBERT  (contact)

PROGRAM_OFFICER_NAME: JOSEPH, LYNDON

PROJECT_TERMS: Accident and Emergency department;Activities of Daily Living;Adopted;Adult;Age;Aging;aging in place;aging population;Ankle;Athletic;balance testing;Balance training;battery life;Blinded;Caring;Cause of Death;Cessation of life;Chronic;Clinic;clinical efficacy;clinically relevant;Communities;Complex;cost;Dependence;design;Development;Devices;Dimensions;Documentation;efficacy evaluation;efficacy study;efficacy testing;Elderly;Electronics;Environment;Equilibrium;exercise program;fall injury;Fall prevention;fall risk;falls;fear of falling;Feeling;Frequencies;functional decline;Gait;Health;healthy volunteer;Home;Hospitalization;Hour;human subject;human very old age (85+);Impaired cognition;improved;Individual;Injury;Laboratories;lens;Light;light transmission;Lighting;liquid crystal;Manuals;manufacture;Marketing;Medical Device;meetings;meter;Metric System;millisecond;Modality;model design;Morbidity - disease rate;Motor;neuromuscular;neuromuscular training;Nursing Homes;older adult;Older Population;Participant;Patient Self-Report;Pattern;Performance;Peripheral;Phase;Physical Exercise;Physical therapy;Pilot Projects;Population;preference;Prevention program;Procedures;programs;prototype;Randomized, Controlled Trials;Regimen;Rehabilitation therapy;Reporting;Research Training;resistance exercise;Risk;Risk Factors;Risk Reduction;Schools;sensor;Sensory;Small Business Innovation Research Grant;Social isolation;Specific qualifier value;Statistical Data Interpretation;Study Subject;supply chain;System;Technology;Testing;Therapeutic;Time;tool;Training;Translating;Transportation;Universities;usability;Vision;Visual;visual stimulus;Work

PROJECT_TITLE: Development of an In-Home Sensory Training Therapy to Mitigate Falls Risk Among the Elderly


ADMINISTERING_IC: OD

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Bioengineering;Data Science;Dental, Oral, and Craniofacial Disease;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurosciences

ORG_DEPT: PHYSICS

ORG_NAME: HARVARD UNIVERSITY

PHR: Project Narrative To extract mechanistic insights into brain function and its disorders from large-scale neural recordings, modern systems neuroscience demands new theoretical approaches and data analysis tools. The proposed project aims to build rigorous foundations for data-driven recurrent neural network modeling. It will elucidate the fundamental domain of validity of this increasingly popular paradigm for making sense of high-dimensional neural data.

PI_NAMEs: ZAVATONE-VETH, JACOB ANDREAS (contact)

PROGRAM_OFFICER_NAME: MILLER, BECKY

PROJECT_TERMS: Admission activity;Affect;Appointment;Area;Award;Behavior;Benchmarking;biological systems;Biology;Brain;career;Communities;Community Developments;Computing Methodologies;computing resources;Data;Data Analyses;data pipeline;Data Science;Data Set;data-driven model;deep learning;Dimensions;Disease;Dryness;dynamic system;Electrophysiology (science);Environment;experience;Faculty;feeding;Fellowship;Foundations;Goals;graduate student;Grain;Habenula;high dimensionality;High Performance Computing;Home;HRK gene;Hypothalamic structure;Infrastructure;insight;Institution;interest;Laboratories;Lead;Learning;learning network;Machine Learning;mathematical methods;Mathematics;Measures;Memory;Mentors;Mentorship;Methods;Modeling;Modernization;multidimensional data;Mus;network architecture;neural;neural model;neural network architecture;Neural Network Simulation;Neurons;Neurosciences;Optics;Paper;Partner in relationship;Physics;Population;Printing;Procedures;programs;Publications;Publishing;Recurrence;recurrent neural network;Research;research and development;Research Assistant;Research Support;Rewards;Science;Scientist;Signal Transduction;Structure;synthetic data;System;Systems Theory;Testing;Theoretical model;theories;tool;Training;undergraduate student;Universities;Validation;Work

PROJECT_TITLE: Understanding data-driven models for neural dynamics

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 HSS-E (70)]


NIH_SPENDING_CATS: Aging;Back Pain;Bioengineering;Biomedical Imaging;Networking and Information Technology R&D (NITRD);Pain Research;Patient Safety

ORG_CITY: PALO ALTO

ORG_NAME: ILLUMINANT SURGICAL, INC.

PHR: PROJECT NARRATIVE PRISM is a novel camera-projector surgical navigation system that is robustly combatting the three main barriers to universal adoption of computer-assisted navigation: long and invasive set-up processes, unintuitive visualization, and high acquisition costs. Through its markless registration pipeline that obviates the need for the implantation of fiducial markers, dynamic projection mapping that displays patient anatomy and guidance information directly on the surface of the patient’s skin, and low-cost hardware, PRISM is the first to create and integrate each of these key features into a single product. With the growing global and domestic rates of spinal surgeries to treat cases of spinal degenerative disease and low back pain, PRISM can provide surgeons with much-needed guidance to improve patient outcomes, decrease complications, and reduce reoperations in an affordable, accessible manner.

PI_NAMEs: HU, JAMES  (contact)

PROGRAM_OFFICER_NAME: TSAP, LEONID V

PROJECT_TERMS: 3-Dimensional;Address;Admission activity;Adopted;Adoption;Age;Algorithms;Anatomy;Architecture;Articular Range of Motion;Biomechanics;Cadaver;Clinical;commercialization;Complication;Computer Assisted;Computer software;Computer Vision Systems;cost;Data;Dedications;Development;Devices;digital twin;Disease;Elements;Environment;experience;Fluoroscopy;Funding;Future;Generations;Grant;Hospital Costs;hospital readmission;Human;implantation;improved;Individual;Intuition;Lateral;Literature;Location;Low Back Pain;Maps;Measures;Mission;Modeling;models and simulation;Navigation System;novel;Observational Study;Operative Surgical Procedures;Pain;Pathway interactions;Patient-Focused Outcomes;Patients;Pattern;Perioperative complication;Phase;Pilot Projects;Positioning Attribute;Procedures;Process;Radiation exposure;radiological imaging;readmission rates;Repeat Surgery;Research;Rotation;Scanning;sensor;simulation;Skin;Small Business Innovation Research Grant;software development;Sorting;Specimen;Spinal;Spinal Degenerative Disorder;spine bone structure;Spine surgery;standard of care;Structure;subcutaneous;Surface;Surgeon;System;Techniques;Technology;Testing;Time;tool;Translations;United States National Institutes of Health;Validation;validation studies;Vertebral column;Visualization

PROJECT_TITLE: Software Development and Cadaveric Testing of Deformable Registration Pipeline in Novel Camera-Projector Surgical Navigation Device


ADMINISTERING_IC: DE

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Dental, Oral, and Craniofacial Disease;Rare Diseases

ORG_CITY: BEACHWOOD

ORG_NAME: MOLECULAR THERANOSTICS, LLC

ORG_STATE: OH

PHR: Narrative: Our targeted fluorescence dye binds to a cancer-specific protein found in head and neck cancer, allowing surgeons to detect tumors and visualize tumor boundaries with fluorescence imaging in real time to achieve precision surgical removal of tumors. The commercialization of such an imaging agent offers an innovative solution to improve primary and metastatic head and neck cancer resection for better surgical outcomes.

PI_NAMEs: HALL, RYAN CHRISTOPHER (contact)

PROGRAM_OFFICER_NAME: LOPEZ, ORLANDO

PROJECT_TERMS: Adjuvant Chemotherapy;Affect;Affinity;Aftercare;Amino Acids;Animal Model;Binding;Cancer Detection;cancer recurrence;cancer surgery;Cell surface;Chemical Structure;Chemotherapy and/or radiation;Clinical;clinical development;clinical translation;commercialization;Consensus;design;Detection;Development;diagnostic strategy;Diameter;Disease;Dyes;Effectiveness;Excision;Exhibits;experimental study;Extracellular Matrix;Fibronectins;Fluorescence;fluorescence imaging;fluorodeoxyglucose positron emission tomography;Goals;Head and Neck Cancer;head and neck cancer patient;Head and Neck Surgery;High Pressure Liquid Chromatography;Histologic;Hour;Human;Image;image guided;Image-Guided Surgery;imaging agent;imaging modality;imaging probe;Immunohistochemistry;improved;innovation;Intravenous;Investigation;Label;Licensing;Light;lymph nodes;Malignant Neoplasms;Measurement;Metastatic Neoplasm to Lymph Nodes;meter;Molecular;molecular imaging;molecular marker;Neck Dissection;Neoplasm Metastasis;neoplastic cell;Nodule;Normal tissue morphology;Oncoproteins;operation;Operative Surgical Procedures;Patients;Peptides;Phase;phase 1 study;Positive Lymph Node;pre-clinical;Primary Neoplasm;Procedures;Protein Isoforms;Proteins;prototype;Quality of life;Radiology Specialty;Recurrence;Reporting;Residual Neoplasm;Risk;Signal Transduction;Small Business Innovation Research Grant;Solid;Solid Neoplasm;Specificity;Specimen;Stains;Structure;Surgeon;surgery outcome;Surgical margins;targeted imaging;Testing;theranostics;Therapeutic;Time;Tissues;Topical application;tumor;Tumor Tissue;Universities;Visualization;water solubility;Xenograft procedure

PROJECT_TITLE: A peptide targeted fluorescence probe for precision surgery of head and neck cancer


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

ORG_CITY: SAN DIEGO

ORG_NAME: SINOPIA BIOSCIENCES, INC.

PHR: Project Narrative Machine learning and omics data technologies have the potential to accelerate and improve drug discovery. However, data types that are closest to the phenotype, such as metabolomics, have not been systematically utilized. This proposal focuses on developing methods and validating a metabolomics-based data-driven drug discovery platform.

PI_NAMEs: BLOEM, BERNARD  (contact)

PROGRAM_OFFICER_NAME: YU, GUOQIN

PROJECT_TERMS: Acceleration;Address;adverse drug reaction;Age;algorithm development;Algorithms;Area;Benchmarking;Biological;Biological Assay;Biological Sciences;Biotechnology;Cell Line;Cells;Chemical Structure;commercialization;Complex;Computing Methodologies;Custom;Data;Data Analyses;Data Set;data standards;Development;Disease;drug development;drug discovery;Drug Targeting;druggable target;Etiology;experimental study;Gene Expression;Gene Expression Profile;Generations;Genetic;genome annotation;Goals;Grant;Image;improved;In Vitro;Inflammation;insight;large datasets;Learning;Libraries;Link;Machine Learning;machine learning model;Maps;Measurement;Measures;Metabolic;metabolic profile;Metabolism;metabolomics;Methods;molecular phenotype;Molecular Profiling;Molecular Target;novel;Oncology;Parkinson Disease;Pathogenesis;Pharmaceutical Preparations;Phase;Phenotype;phenotypic data;Property;prospective;Proteins;Proteomics;Reproducibility;Sampling;screening;small molecule;small molecule libraries;software development;Standardization;success;Systems Biology;Technology;Testing;Therapeutic;therapeutic candidate;Training;transcriptome sequencing;transcriptomics;Validation

PROJECT_TITLE: Development and validation of data standards and computational methods for large scale metabolomics data analysis for data driven drug discovery


NIH_SPENDING_CATS: Autoimmune Disease;Bioengineering;Biotechnology;Diabetes;Nanotechnology;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Embryonic - Human;Transplantation

ORG_CITY: OAKLAND

ORG_NAME: MINUTIA, INC.

PHR: Project Narrative The success of beta cell replacement therapy for patients with type 1 diabetes (T1D) suffers from a paucity of donor islets, an inhospitable transplant environment that causes graft failure, and the absence of sensing technology capable of monitoring cell health, function, and duress. We address these challenges by generating surrogate islet organoids from stem cells and engineering them to resist inflammatory strense and immune rejection as well as to sense molecular biomarkers for cellular dysfunction. Our proposal describes novel strategies for an inflammatory stress resilient ß-cell replacement product that can be monitored non-invasively for cellular health with direct implications for long-term survival and function of sc-islet grafts, leading to insulin independence for patients with T1D.

PI_NAMEs: DIGOVICH, CATHERINE  (contact)

PROGRAM_OFFICER_NAME: ARREAZA-RUBIN, GUILLERMO

PROJECT_TERMS: Address;Allogenic;Anti-Inflammatory Agents;Antibodies;Antigens;Autoimmune;Autoimmune Process;Beta Cell;beta cell replacement;Blood;CD3 Antigens;cell injury;cell killing;Cell Line;Cell Physiology;cell replacement therapy;Cell Transplantation;Cells;Cessation of life;Chronic;Clinical;Clinical Trials;Code;Collaborations;Continuous Glucose Monitor;cytokine;Cytoprotection;cytotoxic;cytotoxicity;Data;Dependence;design;Detection;Development;Diabetes Mellitus;differentiation protocol;Disease;Donor person;Drug Kinetics;Encapsulated;Endocrine;Engineering;Engraftment;Environment;Enzymes;Epigenetic Process;Event;experience;Exposure to;Face;Formulation;Functional disorder;Genes;Genetic Engineering;Glucose;glucose metabolism;Goals;graft failure;graft function;Health;Human;human embryonic stem cell;human embryonic stem cell line;human stem cell-derived;Immune;Immune response;Immune system;Immune Targeting;Immunologic Cytotoxicity;Immunosuppression;Immunosuppressive Agents;Implant;improved;In Vitro;in vivo;Inflammation;Inflammatory;inflammatory milieu;Inflammatory Response;Infusion procedures;Insulin;Insulin-Dependent Diabetes Mellitus;Intramuscular;islet;Islet Cell;islet stem cells;Islets of Langerhans;Islets of Langerhans Transplantation;Knock-out;Laboratories;lead candidate;Life;Link;Measures;Mediating;Methods;MicroRNAs;Microvascular Dysfunction;Minority;Modification;molecular marker;Monitor;monitoring device;mouse model;Mus;nanosensors;non-invasive monitor;novel strategies;Operative Surgical Procedures;Organ Donor;Pancreas;Patients;Persons;Pluripotent Stem Cells;pre-clinical;Pre-Clinical Model;preclinical study;prevent;product development;promote resilience;Protocols documentation;Publishing;Raman Spectrum Analysis;Reporter;resilience;Resistance;response;restoration;return to use;Risk;risk/benefit ratio;sensor;sensor technology;Signal Transduction;Site;Source;stem cell function;stem cell organoids;stem cells;Stress;stress resilience;subcutaneous;success;Surface;Technology;Therapeutic;Therapeutic Intervention;tissue repair;Tissues;Transplant Recipients;Transplantation;Trauma

PROJECT_TITLE: Monitoring and increasing resilience of stem cell derived pancreatic islet cell grafts


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Brain Disorders;Chronic Pain;Drug Abuse (NIDA only);Neurosciences;Opioid Misuse and Addiction;Opioids;Pain Research;Patient Safety;Prescription Drug Misuse;Substance Misuse

ORG_CITY: Salt Lake City

ORG_NAME: REBEL MEDICINE INC

ORG_STATE: UT

PHR: Project Narrative In this proposal, Rebel Medicine will develop a novel extended-release local anesthetic technology that could reduce or eliminate the need for opioids after surgery. Opioids are associated with a variety of adverse events such as addiction, respiratory depression, cognitive impairment, nausea, constipation, and death which can considerably affect patient outcomes and cost after surgery. A safe and effective alternative to opioids for postoperative pain management can provide significant value to the customer, patient, and society alike by reducing opioid-related adverse events and the costs associated with them.

PI_NAMEs: DAVIS, BRETT  (contact)

PROGRAM_OFFICER_NAME: SABIRZHANOV, BORIS YEVGENYEVICH

PROJECT_TERMS: Abdomen;Absence of pain sensation;Acetaminophen;Acute;Acute pain management;addiction;Address;Advanced Development;Adverse effects;Adverse event;Affect;Analgesics;Anesthetics;Animals;Appendectomy;Arthroscopy;Bupivacaine;care costs;Catheters;Cessation of life;Clinical;clinical translation;Collagen;commercialization;Constipation;cost;Development;Disease;Doctor of Philosophy;Dose;Drug Delivery Systems;Drug Evaluation;Drug Kinetics;efficacy evaluation;Employee;Equipment;Family suidae;Formulation;Gel;Goals;Hernia;Hip region structure;Hour;Impaired cognition;Implant;In Vitro;in vivo;individual patient;Indwelling Catheter;infection risk;Infusion Pumps;Injectable;Injections;intense pain;Ion Exchange;ionic bond;Knee;knee replacement arthroplasty;Length of Stay;Lipids;lipophilicity;Liposomes;Local anesthesia;Local Anesthetics;Marketing;Mastectomy;materials science;medical specialties;Medical Technology;Medicine;Modification;Morphine;multidisciplinary;Narcotics;Nausea;next generation;non-opioid analgesic;Non-Steroidal Anti-Inflammatory Agents;novel;Oils;Operative Surgical Procedures;Opioid;opioid misuse;opioid use;Orthopedics;Oxycodone;Pain;Pain management;pain model;pain relief;patient population;Patient-Focused Outcomes;Patients;Perioperative;Persons;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Phase II Clinical Trials;Polymers;porcine model;Postoperative Pain;pre-clinical;prescription opioid;prescription opioid misuse;Procedures;Property;Rattus;Reaction;readmission rates;reconstruction;Recording of previous events;Recovery;repaired;research and development;Risk;Rotator Cuff;Safety;Salts;screening;Shoulder;Site;Small Business Innovation Research Grant;Societies;Sodium Chloride;Solubility;Standardization;Surgeon;Surgical Management;surgical pain;Syringes;System;Technology;technology development;Thoracotomy;Toxic effect;United States National Institutes of Health;Ventilatory Depression;Vision

PROJECT_TITLE: Extending duration of an injectable long-acting local anesthetic formulation using novel salts

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


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Gene Therapy;Genetics;Immunotherapy;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_CITY: Houston

ORG_NAME: CELLCHORUS INC.

PHR: NARRATIVE In recent years, therapies have been developed that use cells as living drugs. Progress is unfortunately limited, in part, by a lack of integrated methods to inform on the quality of cell therapies and identify features that can predict treatment success or life-threatening side effects. This project will develop user-friendly kits for our platform called TIMING providing end-users with new, fast, specific, and predictive results to accelerate translational research and development of more effective cell therapies to benefit patients.

PI_NAMEs: BERDEAUX, REBECCA L (contact);COOPER, LAURENCE J.N.

PROGRAM_OFFICER_NAME: BALAKRISHNAN, KRISHNA B

PROJECT_TERMS: Acceleration;Agreement;antitumor effect;Artificial Intelligence;artificial intelligence algorithm;Behavior;Benchmarking;Biological Assay;cancer type;CAR T cell therapy;CD3 Antigens;CD8B1 gene;cell behavior;Cell Communication;Cell Death;Cell Death Induction;cell motility;Cell surface;Cell Therapy;Cells;Cellular biology;Cellular immunotherapy;chimeric antigen receptor;chimeric antigen receptor T cells;Clinical;Clinical Trials;commercialization;Complex;Computer software;Contracts;cost;cytokine;cytotoxic;cytotoxicity;Data;Development;Diagnostic Reagent Kits;Disparate;Engraftment;Environment;exhaust;exhaustion;FDA approved;Formulation;Gene Modified;gene therapy;Hematologic Neoplasms;Image;Imaging Techniques;Immune;improved;Individual;Infusion procedures;innovative technologies;instrumentation;Kilogram;Kinetics;Laboratories;Letters;Life;Manuals;manufacture;Marketing;Measures;Metabolic;Metabolism;Methods;microscopic imaging;Microscopy;migration;Mitochondria;Modality;Molecular;molecular phenotype;Movement;multimodal data;multimodality;nano;neoplastic cell;Noise;Output;Paper;Patient Care;patient population;Patients;Performance;Pharmaceutical Preparations;Phase;Phenotype;Population;power analysis;preclinical development;Prediction of Response to Therapy;Process;Proliferating;Protocols documentation;prototype;Reagent;Reporting;Research;research and development;response;Reverse Transcriptase Polymerase Chain Reaction;Running;Sampling;side effect;Signal Transduction;single cell analysis;Small Business Innovation Research Grant;Stains;Standardization;success;Surface;synaptogenesis;System;T-Lymphocyte;Technology;Therapeutic;therapy development;Time;time use;tool;Training;Translational Research;user-friendly;Validation

PROJECT_TITLE: Integrated assays of single-cell dynamics and molecular phenotype for cell therapy manufacturing

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


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

ORG_CITY: HAYWARD

ORG_NAME: ONDAVIA, INC.

PHR: Project Narrative Clean water is necessary for a healthy society, yet we are faced with constant new concerns about pollution in our water sources—including ever-increasing threats from trace pollutants such as metals that are widely present in our water supplies. Carcinogenic compounds like hexavalent chromium are present in the tap water of 200 million Americans, yet our water managers, research scientists and government agencies do not have available the types of low-cost/high- performance analytical tools they need to adequately study and monitor water pollutants at relevant parts-per-billion levels. OndaVia’s goal for this SBIR Phase II project is to develop an in-line, semi-continuous hexavalent chromium analysis system that will provide a tool for scientists, engineers, and regulators across the water sector to monitor trace contamination automatically.

PI_NAMEs: PETERMAN, MARK C (contact)

PROGRAM_OFFICER_NAME: HENRY, HEATHER F

PROJECT_TERMS: Address;American;Ammonia;analytical method;analytical tool;Arsenic;Belief;Biological Response Modifier Therapy;Calibration;California;carcinogenicity;Chemicals;Chromates;Chromium;chromium hexavalent ion;commercialization;Complex;cost;Coupled;design;Detection;detection limit;detection method;detection platform;Development;Disclosure;drinking;drinking water;Electrodes;Engineering;Evaluation;experience;Failure;Feasibility Studies;Future;Goals;Government Agencies;ground water;Hour;improved;Industrialization;Industry;innovative technologies;instrument;Isotopes;Laboratories;Lead;Legal patent;Liquid substance;Marketing;Measurement;Measures;Metals;Methods;Monitor;new technology;Nitrates;non-compliance;Optical Methods;Optics;Outcome;Oxygen;Performance;Phase;pollutant;Pollution;Positioning Attribute;Process;prototype;Provider;Raman Spectrum Analysis;Reagent;Reference Standards;Regulation;Research;Research Institute;Sampling;Scanning;Scientist;single molecule;Site;Small Business Innovation Research Grant;Societies;Source;Spectrum Analysis;success;Surface;System;Systems Analysis;Technology;technology development;technology platform;Testing;Time;tool;United States;wasting;Water;Water Pollutants;water sampling;Water Supply;water testing;water treatment;Work

PROJECT_TITLE: Automated, in-line hexavalent chromium analyzer

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