NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Cardiovascular;Clinical Research;Heart Disease;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Patient Safety

ORG_CITY: Carson

ORG_NAME: SAFEBEAT RX INC.

ORG_STATE: CA

PHR: PROJECT NARRATIVE Over 38 million people worldwide suffer from atrial fibrillation, but access to heart rhythm drugs is restricted by the required three-day hospitalization to start these oral medications due to rare but dangerous side effects. The objective of this SBIR is to expand the safety profile and clinical decision-making capacity of the SafeBeat product by using an ECG-enabled smartwatch to capture the effects of these drugs relative to circadian/ time-of-day effects, which no technology combines at present. The proposed research will advance technology created by SafeBeat Rx to atrial fibrillation patients without the access to heart rhythm drugs to start medications safely at home via automated mobile heart rhythm analysis.

PI_NAMEs: NAVARA, RACHITA  (contact);PATEL, KUNJ G.

PROGRAM_OFFICER_NAME: HSU, LI-YUEH

PROJECT_TERMS: Adopted;Adoption;Adverse effects;Affect;Agreement;Algorithms;American;Anti-Arrhythmia Agents;Arrhythmia;Atrial Fibrillation;Cardiac;Cardiovascular system;Caring;circadian;Client satisfaction;Clinical;clinical decision-making;Compensation;Computer software;Dangerousness;Data;Decision Making;decision-making capacity;Dedications;Devices;Disease;Diurnal Rhythm;dofetilide;dosage;Dose;Drug Modelings;Drug usage;Electric Countershock;Electrocardiogram;Future;Goals;Health Services Accessibility;Heart;heart rhythm;Home;Hospitalization;Hospitals;improved;Label;Lead;Licensing;Life;lifetime risk;Link;Machine Learning;machine learning algorithm;machine learning method;Marketing;Measurement;Measures;Medical;medication safety;meetings;Mission;Modeling;Monitor;Morbidity - disease rate;mortality;novel;Oral;Outcome;Outpatients;Palpitations;patient tolerability;Patients;Persons;Pharmaceutical Preparations;Phase;Physicians;Population;predictive modeling;Procedures;Recommendation;reduce symptoms;remote monitoring;remote patient monitoring;Research;response;Risk;Safety;side effect;signal processing;Signal Transduction;Small Business Innovation Research Grant;smart watch;Sotalol;stroke risk;System;Technology;Telemetry;Therapeutic Equivalency;Time;Titrations;Torsades de Pointes;Update;usability;Validation;Variant;Ventricular;Ventricular Tachycardia;Work

PROJECT_TITLE: A novel, smartwatch-enabled, automated mobile heart rhythm analysis technology to start antiarrhythmic medications safely at home


ADMINISTERING_IC: AG

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

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);Behavioral and Social Science;Brain Disorders;Caregiving Research;Clinical Research;Clinical Trials and Supportive Activities;Dementia;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Neurodegenerative;Neurosciences;Prevention;Social Determinants of Health

ORG_CITY: SAN LEANDRO

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: ONWARD HEALTH, INC

PHR: Public Health Relevance Lack of access to safe, reliable transportation causes 5.8 million Americans to miss their healthcare appointments each year (Wolfe et al, 2020). Traditional transportation solutions like curb-to-curb rideshare, taxis, and buses are often unreliable or unsafe for vulnerable populations including older adults with mobility impairments and those suffering from Alzheimer’ disease or Alzheimer’ disease related dementias (AD/ADRD), and age-related change in brain (Fraade-Blanar et al, 2021). Onward, a California based small business, has developed a technology enabled door-through-door rideshare service with a companion driver trained to support older adults and individuals with mild to moderate AD/ADRD.

PI_NAMEs: WACHTER PETTY, KIMBERLY  (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Address;Adherence;Age;age related changes;Algorithms;Alzheimer's Disease;Alzheimer's disease patient;Alzheimer's disease related dementia;Alzheimer's disease risk;American;Appointment;Area;Brain;Businesses;California;caregiver stress;Caregivers;caregiving;Caring;Certification;Clinical;Communication;Communities;Companions;competence factor;cultural competence;demographics;density;design;Diagnosis;Elder Abuse;elder neglect;Enrollment;falls;First Aid;Foundations;Geography;Goals;Health;health care service organization;Health Insurance Portability and Accountability Act;Healthcare;Home;Hour;Impaired cognition;improved;Individual;Infection Control;Intervention;Language;Market Research;medical appointment;mild cognitive impairment;Mobility decline;Modeling;National Institute on Aging;older adult;older patient;Older Population;Outcome;Participant;Patient Outcomes Assessments;Patients;Persons;Phase;preference;Prevention;primary outcome;public health relevance;Quality of life;Randomized, Controlled Trials;Research;San Francisco;satisfaction;Schedule;secondary outcome;Sedation procedure;Services;Small Business Innovation Research Grant;social determinants;social health determinants;Special needs;Technology;technology platform;Training;Transportation;transportation access;United States;Vulnerable Populations

PROJECT_TITLE: Onward Door-Through-Door Companion Rideshare Technology to Improve Care for Older Adults and Individuals with Alzheimer's Disease and Related Dementias (AD/ADRD)

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


ADMINISTERING_IC: VA

FUNDING_MECHANISM: OTHERS

IC_NAME: Veterans Affairs

ORG_CITY: NASHVILLE

ORG_NAME: VETERANS HEALTH ADMINISTRATION

ORG_STATE: TN

PHR: Our Veterans have become susceptible to infections with Mycobacterium tuberculosis—the agent of a chronic infectious disease called tuberculosis (TB). TB causes high morbidity and mortality. The global burden of TB continues to increase with the emergence of multidrug-resistant and extremely drug resistant M tuberculosis strains, and the lack of an effective vaccine that protects adults from mycobacterial infection and TB disease. The current application seeks support to develop an effective and durable vaccine that can protect our Veterans. As M tuberculosis is transmitted through aerosols and infects the lung mucosa, the challenge is to install immune effector cells at the site of infection. Our research group has developed ways to install pathogen-specific immune effectors in the lungs, which is the major route of mycobacterial infection. Using the new insights, we will develop and test a durable vaccine against TB in a preclinical animal model. This work will lead to the design of novel vaccine strategies against TB and enhance the quality of care of our Veterans’ health.

PI_NAMEs: JOYCE, SEBASTIAN  (contact)

PROJECT_TERMS: 2019-nCoV;Acute;Address;Adjuvant;Adult;Aerosols;Animal Model;Antibodies;Antigen Presentation;Antigen Presentation Pathway;Antigens;Aspergillus fumigatus;Award;Bacteria;base;Bioinformatics;Biological Assay;career;CD8-Positive T-Lymphocytes;CD8B1 gene;Cell Physiology;Cells;Cellular biology;Chemicals;Chronic;co-infection;Communicable Diseases;Contracts;Cytosol;Cytotoxic T-Lymphocytes;Dendritic Cells;density;design;Development;Disease;Drug resistant Mycobacteria Tuberculosis;Effector Cell;Epitopes;experience;Francisella tularensis;fungus;General Population;Goals;Health;Healthcare;Hepatitis B;Hepatitis C;high risk;HIV;HLA Antigens;Homelessness;Human;humanized mouse;Immune;Immune system;Immunity;Immunobiology;immunogenic;Immunologic Surveillance;improved;Incidence;Individual;Infection;Influenza A virus;Innate Immune System;insight;Investigation;Killer Cells;Life;Lung;Macrophage;member;Memory;Molecular;Molecular Profiling;Monitor;Monkeypox virus;Morbidity - disease rate;mortality;mouse model;Mouse Pox Virus;Mucous Membrane;Multi-Drug Resistance;Mycobacterium Infections;Mycobacterium tuberculosis;Mycobacterium tuberculosis antigens;nano;nanoparticle;National Institute of Allergy and Infectious Disease;next generation;novel;novel vaccines;Outcome;pathogen;Peptides;Phase;Phenotype;Population;Poxviridae;pre-clinical;preclinical study;Predisposition;prevent;programs;Proteomics;Public Health;Quality of Care;Quality of life;Research;Research Support;respiratory;Respiratory Mucosa;response;Route;Scientist;Scourge;Site;Smallpox;success;T-Lymphocyte;T-Lymphocyte Epitopes;Testing;Tissues;Transgenic Organisms;transmission process;treatment adherence;Tuberculosis;Tuberculosis Vaccines;Tularemia;United States National Institutes of Health;Vaccinated;Vaccination;vaccine delivery;Vaccine Design;vaccine development;vaccine platform;vaccine strategy;Vaccines;Vaccinia virus;Veterans;Virus;Virus Diseases;Work

PROJECT_TITLE: BLRD Research Career Scientist Award Application

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 RCSR-N (01)]


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

ORG_CITY: DEDHAM

ORG_NAME: CHROMATAN CORPORATION

ORG_STATE: MA

PHR: PROJECT NARRATIVE The overall goal of the proposed Direct to Phase II SBIR project is to commercialize Continuous Countercurrent Tangential Chromatography (CCTC) for recombinant AAV purification. This novel platform will enable column-free, continuous, and single-use purification of rAAVs. Successful commercialization of the CCTC system in this field will lead to at least a 50% reduction in downstream production costs, increased recoveries (by 40%) and improved product quality for these life saving therapies that provide effective treatments and cures for such conditions as cancer, hemophilia and many others.

PI_NAMEs: SHINKAZH, OLEG  (contact)

PROGRAM_OFFICER_NAME: SAKALIAN, MICHAEL

PROJECT_TERMS: adeno-associated viral vector;Affinity;Anions;Binding;Biological Products;Capsid;Cardiovascular system;Cells;cGMP production;Chromatography;Clinical;Collaborations;Column Chromatography;commercialization;Communicable Diseases;cost;Cyclic GMP;Data;design;Development;Disease;DNA;Drug Evaluation;Economic Models;effective therapy;Environment;Evaluation;Excision;Experimental Designs;flexibility;gene therapy;Generations;Goals;Grant;Growth;Hematology;Hemophilia A;improved;Industry;innovation;Life;Malignant Neoplasms;manufacture;Marketing;Measures;meetings;Metabolic;Modality;Modeling;Monoclonal Antibodies;Muscle;Neurologic;new technology;next generation;novel;operation;particle;Particle Size;Performance;Phase;Plant Resins;Play;Polishes;pressure;Process;process optimization;Production;Productivity;Proteins;Quality of life;Recombinant adeno-associated virus (rAAV);Recovery;Research;Resolution;Role;Running;Savings;scale up;Serotyping;Small Business Innovation Research Grant;System;Technology;Time;Training;United States National Institutes of Health;Work

PROJECT_TITLE: Resubmission - Development and scale-up of Continuous Countercurrent Tangential Chromatography (CCTC) for next generation AAV vector manufacturing (Direct to Phase II)

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


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

ORG_CITY: VAN NUYS

ORG_NAME: TRACE-ABILITY, INC.

PHR: Scaling up the Tracer-QC kit production will support expanding availability of Positron Emission Tomography (PET) imaging to broad Alzheimer’s disease (AD) population. Proposed work enables the broad US AD population to benefit from early disease detection by AD PET providing a window of opportunity to implement AD treatments or slow down disease progression, leading to improved quality of life for AD patients and their families. This work will further enable most effective clinical trials focused on treatment solutions for AD.

PI_NAMEs: ELIZAROV, ARKADIJ  (contact)

PROGRAM_OFFICER_NAME: LUO, YUAN

PROJECT_TERMS: Achievement;Address;Adoption;Alzheimer disease detection;Alzheimer's Disease;Alzheimer's disease patient;Alzheimer's disease therapy;Certification;Clinical;Clinical Trials;Complex;Contrast Media;Country;design;Development;Disease Progression;Ensure;Event;Family;Guidelines;improved;industrial production;Industrialization;Industry;innovation;Interruption;Legal patent;Life;manufacture;Manufacturer;manufacturing scale-up;Measurement;Measures;Methods;National Institute on Alcohol Abuse and Alcoholism;novel strategies;operation;Optics;Outcome;Patients;Performance;Phase;Population;Positron-Emission Tomography;Procedures;Process;Production;Quality Control;Quality of life;Radioactive;Research;Sampling;scale up;Site;skills;Standardization;Stream;System;Technology;Temperature;Testing;Therapeutic;Therapy trial;Tracer;Translating;Travel;Treatment Cost;Work

PROJECT_TITLE: Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers.

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


FUNDING_MECHANISM: NON-SBIR/STTR RPGS

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Depression;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Mental Health;Mental Illness;Prevention;Rehabilitation;Social Determinants of Health

ORG_CITY: BOSTON

ORG_NAME: FENWAY COMMUNITY HEALTH CENTER

PHR: PROJECT NARRATIVE To address the significant public health burden of depression and loneliness among older gay and bisexual men living with HIV (OGBMLH), evidence-informed intervention strategies that are systematically adapted based on stakeholder feedback are needed. Informed by systematically collected OGBMLH and other stakeholder feedback, the proposed Bridge to Belonging (B2B) intervention will leverage three evidence-based interventions (the cognitive behavioral therapy-based friendship enrichment program, motivational interviewing, and peer- mentoring) to reduce depression and loneliness by increasing engagement in community-building elder services. Should the B2B intervention be feasible and acceptable, we will pursue a fully powered multi-site hybrid type 1 R01 trial to concurrently assess the efficacy and the scalability of this needed intervention.

PI_NAMEs: BATCHELDER, ABIGAIL WINSTON (contact);CAHILL, SEAN

PROGRAM_OFFICER_NAME: GERALD, MELISSA S

PROJECT_TERMS: acceptability and feasibility;Activities of Daily Living;Address;Adherence;Advocate;Age;Ally;Anti-Retroviral Agents;Bereavement;Bisexual;Caring;Child;cisgender;Cognitive;Cognitive Therapy;Communication;Communities;community building;community engagement;Competence;Data;depressive symptoms;Discrimination;efficacy evaluation;Elderly;Enrollment;Epidemic;Ethnic Origin;Event;evidence base;Evidence based intervention;Exhibits;experience;Family;Feedback;Focus Groups;Fostering;Friendships;Fright;Gays;Government;Health;health service use;Heterosexuals;HIV;HIV Seronegativity;Hybrids;implementation intervention;improved;Individual;innovation;instrumental activity of daily living;Intervention;intervention refinement;Investigation;Lesbian Gay Bisexual Transgender Queer;Loneliness;Manuals;Marriage;men;Mental Depression;Mentorship;Modeling;Morbidity - disease rate;mortality;motivational enhancement therapy;novel;older adult;Patient Self-Report;peer;peer coaching;people of color;Persons;physical conditioning;Policies;Population;primary outcome;programs;Public Health;Quality of life;Race;reduce symptoms;Research;resilience;response;Series;service providers;service utilization;Services;Sexuality;Site;social;Social isolation;social stigma;Social support;Social Work;Source;Support Groups;Time;Training;trend;Viral Load result

PROJECT_TITLE: Bridge to Belonging (B2B): Peer led intervention to reduce loneliness and depression among older gay and bisexual men

STUDY_SECTION: HIBI

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Infectious Diseases;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Pediatric;Rare Diseases;Vector-Borne Diseases

ORG_CITY: Framingham

ORG_NAME: KEPHERA DIAGNOSTICS, LLC

PHR: Project Narrative This project addresses the critical need for a test for congenital Chagas disease which has emerged as a major manifestation of this neglected tropical disease borh within the U.S. and internationally. Congenital Chagas disease accounts for a significant percentage of cases and most importantly, can be effectively cured with existing drugs once diagnosed, but no such test has been validated and made commercially available. In Phase I, we propose to develop a congenital Chagas disease test based on native and/or synthetic antigens. In Phase II we will refine this assay into a manufactured product, carry out a validation study to support a 510(k) submission to FDA, and prepare for scale up and commercial launch of the assay.

PI_NAMEs: LEVIN, ANDREW E. (contact)

PROGRAM_OFFICER_NAME: JOY, DEIRDRE A

PROJECT_TERMS: Acute;Address;Adult;Algorithms;Antigens;Archives;assay development;Automation;Biological Assay;Birth;Blood;Cellular Phone;Chagas Disease;Chronic;Classification;classification algorithm;Clinical;commercial launch;commercialization;Computer software;congenital infection;Cost Savings;Country;cross reactivity;Data;Data Set;Databases;Detection;Development;Diagnosis;Diagnostic;diagnostic assay;Diagnostic tests;Enzyme-Linked Immunosorbent Assay;Epitopes;Excretory function;Face;Fetus;follow-up;Generations;Genome;global health;Hour;Human;Human Resources;Image;Immunoglobulin G;Immunoglobulin M;Individual;Infant;Infection;International;Interruption;Laboratories;laboratory equipment;Location;machine learning algorithm;manufacture;Methods;Microscopy;migration;Modeling;Mothers;neglected tropical diseases;Neonatal Screening;neonate;Output;Parasitemia;Parasites;Parasitic Diseases;Parasitic infection;Pattern;Peptides;Performance;Pharmaceutical Preparations;Phase;Plasma;Pregnancy;Process;prototype;Public Health;public health priorities;Pythons;Recombinants;Reproducibility;research study;Risk;Running;Sampling;scale up;Sensitivity and Specificity;Serum;Signal Transduction;smartphone application;Specificity;Standardization;success;supervised learning;Synthetic Antigens;synthetic peptide;Technology;Test Result;Testing;Training;training data;transmission process;Trypanosoma cruzi;Umbilical Cord Blood;Validation;validation studies;Venous;Western Blotting

PROJECT_TITLE: Diagnostic assay for congenital Chagas disease

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 DCAI-X (14)]


ORG_CITY: SAN ANTONIO

ORG_NAME: SOUTH TEXAS VETERANS HEALTH CARE SYSTEM

ORG_STATE: TX

PHR: Lymphoma is a cancer type that originates from lymphocytes, cells present in the bloodstream and specialized organs such as the spleen, bone marrow and lymph nodes. Lymphoma is more frequently diagnosed in veterans than in the civilian population. This higher incidence is thought to be related to toxic environmental exposures in the battlefield. The Aguiar research group studies the mechanism for lymphoma development and progression, with special emphasis on the basis for the disease’s heterogeneity, that is, why patients with similar tumor burden receiving similar treatment may have very differently outcomes, and either survive or die of their disease. Importantly, the research in the Aguiar lab is geared towards clinical translation, meaning that the discoveries from the laboratory are as expeditiously as possible brough to the “bedside”, in a manner that treatment can be rationally modified, and the cure rate improved.

PI_NAMEs: AGUIAR, RICARDO C (contact)

PROJECT_TERMS: Adult;alpha ketoglutarate;American Society of Hematology;anti-cancer;Antigen Presentation;Area;Award;B lymphoid malignancy;B-Cell Antigen Receptor;B-Cell Lymphomas;B-Lymphocytes;Biology;Blood;Blood Circulation;Bone Marrow;Cancer Biology;cancer cell;cancer type;career;Cells;Chemicals;chemotherapy;Chromosomal translocation;Chronic Myeloid Leukemia;Clinic;Clinical;clinical application;clinical heterogeneity;clinical translation;Clinical Trials;cohort;Collection;Credentialing;Cyclic AMP;Dana-Farber Cancer Institute;demethylation;design;Development;Diagnosis;differential expression;Disease;disease heterogeneity;DNA;DNA Methylation;Doctor of Philosophy;Enrollment;Environmental Exposure;Enzymes;Epigenetic Process;epigenome;Faculty;falls;Feedback;Fibroblast Growth Factor Receptors;Foundations;Funding;Gene Expression;Gene Expression Profiling;Genes;genome-wide;Health;Healthcare Systems;Hematologic Neoplasms;Histones;Hospitals;Hypermethylation;Immune checkpoint inhibitor;improved;In Vitro;in vivo;Incidence;inhibitor;Investigation;Investments;Isocitrate Dehydrogenase;Knowledge;Laboratories;large cell Diffuse non-Hodgkin's lymphoma;leukemia;Link;London;loss of function mutation;lymph nodes;Lymphocyte;Lymphoma;Lymphoma cell;Lymphomagenesis;Malignant Neoplasms;Maps;Mature B-Lymphocyte;Mediator;medical schools;Medicine;meetings;Mentors;Mentorship;Metabolism;MicroRNAs;Military Personnel;Mitochondria;mitochondrial metabolism;Molecular;Mutation;MYC gene;Myeloproliferative disease;Names;Nature;NF-kappa B;notch protein;novel;Oncogenes;Oncogenic;Organ;Outcome;overexpression;Paper;PARP9 gene;Pathogenesis;Pathway interactions;Patients;PDE4B;Phase;Phase I Clinical Trials;phase II trial;Philadelphia Chromosome;phosphodiesterase IV;Population;post-doctoral training;Postdoctoral Fellow;pre-clinical;Privatization;Productivity;programs;Property;Publications;Publishing;Randomized;randomized trial;recruit;Reporting;Research;Research Activity;rituximab;RNA;RNA methylation;Role;Safety;Scientist;Signal Transduction;Site;Somatic Mutation;South Texas;Spleen;Supplementation;Syndrome;System;Testing;Texas;therapeutic target;Time;tositumomab;transcription factor;Transferase;Translating;Tumor Burden;Tumor Immunity;tumor microenvironment;Universities;Veterans;Work


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Aging;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Urologic Diseases;Women's Health Research

ORG_CITY: CLEVELAND

ORG_NAME: COLLAMEDIX INC.

ORG_STATE: OH

PHR: PROJECT NARRATIVE CollaMedix has developed a pure-collagen sling, CollaSling, for treating stress urinary incontinence in women as an alternative to current polypropylene mesh slings. The CollaSling will be resorbed in the body over time. In this project, we will complete the development of the CollaSling and conduct a 20-participant Phase I pilot clinical trial at three medical centers.

PI_NAMEs: SHANKAR, SUBBA  (contact)

PROGRAM_OFFICER_NAME: TINGEN, CANDACE M

PROJECT_TERMS: Adverse event;Age;Aging;Agreement;Animals;arm;biomaterial compatibility;Capital;Cattle;Cells;Chronic;chronic pain;Cicatrix;Clinic;Clinical;clinical investigation;Clinical Research;clinical research site;Clinical Trials;Collagen;Collagen Type I;comparative efficacy;Consent Forms;Cyclic GMP;Data;Data Analyses;data management;data submission;Deposition;design;Development;Devices;document outlines;efficacy clinical trial;Ensure;fabrication;Family;first-in-human;follow-up;Fostering;Fund Raising;Growth;high risk;Hospitals;Implant;in vivo;Industrialization;Inflammation;Legal patent;Length;Life;Ligaments;manufacture;Manufacturer;Marketing;Measures;Medical;Medical center;Medical Device;meetings;method development;New Zealand;Operative Surgical Procedures;Organism;Participant;Pathway interactions;Patient Outcomes Assessments;Patients;pelvic organ prolapse;Phase;Pilot Projects;pilot trial;Polypropylenes;Prevalence;Process;Production;protocol development;Publications;Randomized;Randomized, Controlled Trials;Recommendation;reconstitution;Risk;Safety;Sales;scaffold;scale up;Shapes;Sheep;side effect;stability testing;standard of care;Sterilization;Stress Urinary Incontinence;Structure;Surgical incisions;Techniques;Technology;Testing;Textiles;Time;Tissues;University Hospitals;Validation;validation studies;verification and validation;volunteer;Weight-Bearing state;Woman;Work

PROJECT_TITLE: Collagen-based tissue guidance biofabric for treatment of stress urinary incontinence in women

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


NIH_SPENDING_CATS: Bioengineering;Infectious Diseases;Machine Learning and Artificial Intelligence

ORG_CITY: NEWARK

ORG_NAME: MSTM, LLC

ORG_STATE: DE

PHR: Project Narrative The critical need for early and direct detection (in situ, in vivo) of a rapidly spreading and previously unknown infectious agent was made clear by viral (SARS-CoV-2) and drug pandemics (oxycodone, fentanyl) as well as notorious diseases (cancers, Alzheimer’s), fungal and bacterial infections with nearly instantaneous and accurate results saving or improving many lives. Current results are too slow, inaccurate, insensitive, expensive, or simply not applicable to safely and directly detect a wide range of infectious agents and diseases on demand and nearly instantaneously, thus providing significant commercial opportunities for mass spectrometry (MS) instrumentation capable of doing this directly from 3- dimensional surfaces, and, when necessary, with spatial resolution achieved by incorporation of a laser. MSTM is developing an MS-based surface reader product to meet this challenge by 2027 with the potential to significantly lower cost through simpler, information rich, robust, and user-friendly technology in combination with artificial intelligence programs.

PI_NAMEs: TRIMPIN, SARAH  (contact)

PROGRAM_OFFICER_NAME: BARNES, CHARLES ASHLEY

PROJECT_TERMS: 2019-nCoV;3-Dimensional;Ablation;Achievement;Address;Alzheimer's Disease;American;Analytical Chemistry;Area;Artificial Intelligence;Atmospheric Pressure;Automobile Driving;Award;Bacterial Infections;Biochemistry;Biohazardous Substance;Biological;Biopsy;biothreat;Cancer Detection;Carbon Dioxide;Cessation of life;Chemicals;Chemistry;commercialization;Communicable Diseases;Communities;Computer Assisted;computer pattern recognition;cost;COVID-19 pandemic;Data;Detection;Development;Devices;Direct Costs;Disease;Doctor of Philosophy;Emergency Care;Employee;Equipment;experience;Faculty;Family;FDA approved;Fentanyl;Fingerprint;flexibility;Flushing;fungus;Future;Gases;Goals;Grant;Hazardous Substances;Health;Health Hazards;health management;Healthcare;Healthcare Systems;Human;improved;In Situ;in vivo;Individual;Industrialization;Industry;Infection;Infectious Agent;instrument;instrumentation;Intervention;invention;ion source;ionization;ionization technique;Ions;Lasers;Legal patent;Letters;Licensing;Link;Lipids;Liquid substance;machine learning algorithm;Maintenance;Malignant Neoplasms;Manufacturer;mass analyzer;mass spectrometer;Mass Spectrum Analysis;Measures;Medal;Medical emergency;member;Meniscus structure of joint;Methods;Molecular;Mycoses;new product development;new technology;next generation;Normal tissue morphology;Operative Surgical Procedures;Overdose;Oxycodone;pandemic disease;particle;pathogen;Patients;Performance;Persons;Pharmaceutical Preparations;Phase;portability;Positioning Attribute;professor;programs;Proteins;prototype;Reader;remote grading;Renaissance;Research;Research Personnel;Resolution;Robotics;Safety;Saints;Sales;Sampling;scale up;Semiconductors;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Societies;Solid;success;Surface;Technology;Testing;Time;Tissues;Tube;underserved area;United States National Institutes of Health;Universities;user-friendly;Vacuum;Viral;Virus;Volatilization;Water;Work

PROJECT_TITLE: Developing Technology to Remotely Measure Molecular Composition


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

ORG_CITY: WORCESTER

ORG_NAME: CODOMAX INC.

PHR: NARRATIVE Achieving robust protein expression is a pain point for customers in the biomanufacturing industry, as candidate proteins may be abandoned at the development phase due to low expression levels which limit commercial viability. Codomax has developed the Epi-MAX platform, a cell and codon engineering platform for enhanced protein synthesis. Here we propose to use our Epi-MAX technology to assess tRNA-centric changes in translation that occur during high protein expression and to re-engineer CHO cells for optimized translation of mRNA for target antibodies of interest.

PI_NAMEs: BEGLEY, THOMAS J;BYRNE, SHANE  (contact)

PROGRAM_OFFICER_NAME: RUDNICKI, DOBRILA DODA

PROJECT_TERMS: Antibodies;Antibody Formation;Antibody titer measurement;Automobile Driving;biological adaptation to stress;Biomanufacturing;Bispecific Antibodies;Cells;Chinese Hamster;Chinese Hamster Ovary Cell;Clustered Regularly Interspaced Short Palindromic Repeats;Codon Nucleotides;commercialization;Computer software;Coupled;CREB1 gene;CRISPR/Cas technology;Cytomegalovirus;Data;Development;Engineering;Enhancement Technology;Escherichia coli;expression vector;Foundations;Gene Expression;Generations;Genes;Genetic Transcription;Genome;Heat shock proteins;Human;Industry;innovation;interest;Light;Link;Liver;manufacturing process;Mass Spectrum Analysis;Messenger RNA;Metabolic;Modeling;Modification;mRNA Expression;mRNA Translation;Mus;Organ;Organism;Ovary;overexpression;Pain;Pattern;Phase;Pichia;Pilot Projects;Plasmids;Production;Productivity;programs;promoter;Protein Biosynthesis;protein expression;protein folding;Proteins;Proteome;Rattus;Reagent;Recombinant Proteins;response;Ribosomes;Sampling;Small Business Technology Transfer Research;Stress;System;Technology;Testing;Therapeutic antibodies;Time;transcription factor;transcriptome sequencing;Transfer RNA;Translating;translation factor;Translations

PROJECT_TITLE: Optimizing Antibody Production in CHO Cells Using Epi-MAX Technology to Increase Heavy and Light Chain Expression

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Autoimmune Disease;Diabetes;Wound Healing and Care

ORG_CITY: COLLEGE STATION

ORG_NAME: LYNNTECH, INC.

PHR: PROJECT NARRATIVE The potential long-term impact of this SBIR effort could be an effective new paradigm in the treatment of diabetic foot ulcers. Our envisioned cutaneous gel delivering the therapeutic small molecule that functions through an intriguing mechanism of action has the potential to not only close the DFU in a faster timeframe compared to current clinical methods, but also overcome the risks associated with existing approaches, reduce mortality and lower cost of treatment.

PI_NAMEs: SHARMA, ANJAL C (contact)

PROGRAM_OFFICER_NAME: LI, YAN

PROJECT_TERMS: Address;Amputation;Animal Model;Binding;Biological Assay;biomaterial compatibility;cancer cell;Carbopol;Cell Line;Cell Survival;Cells;Chronic;Clinical;Clinical Management;Clinical Treatment;Clinical Trials;Coculture Techniques;Code;Collaborations;Colon Carcinoma;commercialization;Complications of Diabetes Mellitus;Consultations;cost;Cost Savings;Cuprozinc Superoxide Dismutase;Cutaneous;cytokine;Data;Death Rate;Deposition;Dermal;Development;diabetes management;Diabetes Mellitus;diabetic;Diabetic Foot Ulcer;diabetic patient;diabetic wound healing;Dimerization;effective therapy;EGF gene;Epidemic;Epidermal Growth Factor Receptor;Epithelial Cells;Epithelium;Extracellular Domain;Fibroblasts;Financial Hardship;Formulation;Gel;Generations;Granulation Tissue;healing;Health Sciences;Healthcare Systems;Human;Immunoprecipitation;Impaired healing;improved;In Vitro;in vivo;individual patient;innovation;interest;Intervention;keratinization;keratinocyte;Kinetics;Libraries;Lower Extremity;MAP Kinase Gene;MAPK3 gene;Measures;medical schools;Metabolic Diseases;Methods;Modality;mortality;mouse model;National Cancer Institute;novel strategies;Outcome;Patients;pharmacokinetics and pharmacodynamics;Phase;PI3K/AKT;Process;Reactive Oxygen Species;receptor;Receptor Activation;Receptor Protein-Tyrosine Kinases;Receptor Signaling;Risk;Safety;screening;Signal Transduction;skin wound;Small Business Innovation Research Grant;small molecule;small molecule therapeutics;Solid;src-Family Kinases;Texas;Therapeutic;Time;Toxic effect;Treatment Cost;Universities;Western Blotting;wound;wound healing;Wound models

PROJECT_TITLE: Cutaneous Gel Delivering an Intriguing MOA Therapeutic to Treat DFU

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


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Data Science;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Machine Learning and Artificial Intelligence;Mental Health;Networking and Information Technology R&D (NITRD);Racial and Ethnic Minority Health Research;Social Determinants of Health;Telehealth

ORG_CITY: BELLEVUE

ORG_NAME: EMPATHY ROCKS INC

ORG_STATE: WA

PHR: Narrative The COVID-19 pandemic demonstrated the potential for Digital Mental Health (DMH) to meet the growing mental health crisis in the U.S., including the ability to reach historically underserved groups such as racial/ethnic minorities (REM). DMH use increased 7x between 2015 to 2021, however, much of this growth has been fast paced with little to no attention to cultural factors that are key to improved health outcomes. The goal of this SBIR Phase I project is to develop applications of artificial intelligence (AI) and natural language processing (NLP) for mental health equity by providing AI augmented real-time feedback, analysis and coaching on cultural attunement during mental health treatment—defined most commonly as provider behaviors that demonstrate awareness and responsiveness to the intersections of societal context, culture, and power, and that have been found to be a key ingredient in retaining REM in treatment. Copyright © BBC Entrepreneurial Training & Consulting Facilities_Other_Resources_Example_NIH_v00.doc

PI_NAMEs: LORD, SARAH PEREGRINE (contact)

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: acceptability and feasibility;Address;Adult;American;application programming interface;Artificial Intelligence;Artificial Intelligence enhanced;artificial intelligence model;Attention;Automobile Driving;Awareness;Behavior;Behavioral;behavioral health;Biological Sciences;Black American;Caring;Client;Clinical;Clinical Skills;clinically significant;commercial application;Communication;communication behavior;Copyright;COVID-19 pandemic;Data;data pipeline;demographics;Detection;Development;digital mental health;Distress;Dropout;Drops;Elements;Empathy;ethnic minority;ethnic minority population;Evaluation;experience;Failure;Feedback;Focus Groups;Fright;generative artificial intelligence;Genetic Transcription;Goals;Growth;Health;health application;health assessment;health disparity;health equity;Health Personnel;health service use;Health Services;Health Services Research;Healthcare;high risk;Hispanic Americans;Human;human model;improved;innovative technologies;Intervention;Label;Legal patent;Life;Lived experience;Marketing;Mental disability;Mental disorders;Mental Health;Mental Health Services;Metadata;minority patient;model development;Modeling;Monitor;Natural Language Processing;Outcome;Output;Patients;Phase;Positioning Attribute;premature;Provider;provider behavior;Race;racial bias;racial minority;randomized, clinical trials;Randomized, Controlled Trials;Reporting;Research Personnel;Resources;Risk;Secure;Series;Shapes;skills;Small Business Innovation Research Grant;success;System;technological innovation;Technology;telehealth;Therapeutic;Time;tool;Training;Transcript;Treatment outcome;trend;Underserved Population;United States National Institutes of Health;Work

PROJECT_TITLE: Empathy for Everyone: Generative AI that Improves Patient-Provider Cultural Attunement in Real Time

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Complementary and Integrative Health;Depression;Health Services;Mental Health;Neurosciences;Precision Medicine;Sleep Research

ORG_CITY: CHANTILLY

ORG_NAME: ARCASCOPE, INC

ORG_STATE: VA

PHR: PROJECT NARRATIVE Shift workers experience significant disruption to their internal clocks, which has marked effects on their health and quality of life. Lighting interventions hold promise for improving mood, fatigue, and performance in night shift workers. In this project, we will conduct a study to better understand how our shift work solution can improve real-world outcomes for healthcare shift workers.

PI_NAMEs: WALCH, OLIVIA  (contact)

PROGRAM_OFFICER_NAME: DIXIT, SHILPY

PROJECT_TERMS: Adult;Affect;Android;Apple watch;Award;Behavior Therapy;Biological;Biological Clocks;Businesses;Cardiovascular system;care outcomes;Cholesterol;circadian;Circadian desynchrony;Circadian Dysregulation;circadian pacemaker;Circadian Rhythms;Clinical;clinical application;cohort;Collaborations;Collection;commercialization;comparative effectiveness;Consumption;Control Groups;cost;Data;design;Effectiveness;Emergency response;Employee Engagement;Equity;Essential worker;evidence base;Exercise;experience;Exposure to;Fatigue;Feedback;Future;global health;Goals;Grant;group intervention;Health;Healthcare;Hormones;Hour;improved;Individual;Infrastructure;Intervention;Interview;Knowledge;Left;Light;Lighting;Long-Term Effects;Malignant Neoplasms;Marketing;mathematical model;Mathematics;Medicine;Melatonin;Mental Depression;Mental disorders;Metabolic;Methods;mobile application;Moods;Obesity;operation;Outcome;Performance;personalized intervention;Persons;Phase;Phototherapy;Physiological;poor health outcome;Population;precision medicine;Production;Productivity;Public Health;Qualitative Methods;Quality of life;Recommendation;Research;Resources;Risk;Route;Safety;satisfaction;Schedule;Series;shift work;Sleep;Sleep Deprivation;sleep health;Small Business Technology Transfer Research;smartphone application;social;Societies;standard measure;Structure;Techniques;Testing;Time;Translations;Triglycerides;Update;Waiting Lists;wearable device;Work

PROJECT_TITLE: Real-world translation of a dynamic and personalized intervention for shift workers


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

ORG_CITY: Canton

ORG_NAME: HARVARD PILGRIM HEALTH CARE, INC.

PHR: PROJECT NARRATIVE Preexposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition, but its population-level impact has been limited by barriers to access. Over-the-counter availability of PrEP could address several of those barriers, including challenges with attending frequent clinical visits, completing quarterly laboratory testing, and disclosing sexual or substance use behaviors to clinicians. This research will evaluate the acceptability, feasibility, and potential impact of over-the-counter PrEP, including the extent to which priority populations would be interested in using it, stakeholders’ perspectives on implementation, and long-term effects on health benefits and risks.

PI_NAMEs: KRAKOWER, DOUGLAS SCOTT;MARCUS, JULIA L. (contact)

PROGRAM_OFFICER_NAME: STIRRATT, MICHAEL JAMES

PROJECT_TERMS: acceptability and feasibility;Address;Adolescent and Young Adult;Advocate;Attitude;Behavior;Benefits and Risks;black men;black men who have sex with men;Black race;Caregivers;Categories;cis-female;cis-male;Clinic;Clinical;cohort;Communities;cost;Data;demographics;Disclosure;Discrimination;Disparity;Drug resistance;Epidemic;ethnic disparity;ethnic minority population;Ethnic Origin;Event;experience;Face;Fees;Focus Groups;Fright;Funding;Grant;Health Benefit;health care settings;Hepatitis B;HIV;HIV drug resistance;HIV Infections;Home;Human immunodeficiency virus test;implementation barriers;implementation strategy;Incidence;Insurance;interest;Judgment;Kidney;Laboratories;Logistics;Long-Term Effects;Manufacturer;Marketing;mathematical model;Medical;men;Methods;Monitor;Oral Contraceptives;Outcome;Parents;Persons;Pharmaceutical Preparations;Pharmacy facility;pill;Population;pre-exposure prophylaxis;prevent;programs;Provider;Public Health;Race;racial disparity;racial minority population;Relapse;Research;Risk;rural area;San Francisco;Schedule;self testing;Services;sex;Sexual Health;Sexuality;Sexually Transmitted Diseases;social stigma;stakeholder perspectives;substance use;Surveys;systemic barrier;Testing;transgender women;Treatment Failure;United States National Institutes of Health;Visit;willingness

PROJECT_TITLE: Over-the-Counter PrEP: Acceptability, Feasibility, and Potential Impact of Access without a Prescription (OFFSCRIPT)

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


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Eye Disease and Disorders of Vision;Neurosciences;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn

ORG_CITY: CHAPEL HILL

ORG_NAME: THEIA IMAGING LLC

ORG_STATE: NC

PHR: NARRATIVE  Handheld OCT can be used to screen for and diagnose eye disease in infants, young children and many patients in intensive care or with certain disabilities, who are unable to cooperate for conventional tabletop imaging and are unable to communicate about loss or disturbance of vision, making it difficult to diagnosis vision- threatening diseases before irrevocable vision loss occurs. While the field of view of most non-contact handheld systems is useful for macular imaging, it is insufficient for imaging of the peripheral retina where many pediatric retinal diseases occur. To provide better access to OCT imaging for this underserved patient population, Theia Imaging is pursuing commercialization of a modular, high-speed, portable, user-friendly, hand-held OCT system that supports traditional non-contact OCT and widefield contact OCT.

PI_NAMEs: DHALLA, AL-HAFEEZ ZAHIR;VIEHLAND, CHRISTIAN  (contact)

PROGRAM_OFFICER_NAME: LEE, PAEK-GYU

PROJECT_TERMS: Adoption;Adult;Affect;biomaterial compatibility;Blindness;care costs;Child;Childhood;Clinical;commercialization;Communication;Computer software;cost;design;Development;Devices;Diabetic Retinopathy;Diagnosis;diagnosis standard;diagnostic value;disability;Disease;Exclusion;Eye diseases;Feedback;flexibility;Future;Head;Health Services Accessibility;Image;imager;Improve Access;improved;Infant;insight;Intensive Care;lens;light weight;macula;Macular degeneration;Marketing;Medical Device;Methods;Modification;Mydriasis;Newborn Infant;novel;Optical Coherence Tomography;Outcome;Pathology;patient population;Patients;Peripheral;Phase;Point-of-Care Systems;Population;portability;Positioning Attribute;Premature Infant;Pupil;Rest;Retina;retina blood vessel structure;Retinal Diseases;Retinopathy of Prematurity;Risk;sample fixation;Scanning;Small Business Innovation Research Grant;Speed;standard of care;Structure;Support System;System;Systemic disease;Testing;Training;Translations;United States National Institutes of Health;Update;usability;user-friendly;Vision;Visualization;volunteer;Weight

PROJECT_TITLE: A Widefield, Handheld OCT system for Patients who are Unable to Cooperate

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


ADMINISTERING_IC: OD

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Dental, Oral, and Craniofacial Disease;Digestive Diseases;Gene Therapy;Genetics;Hematology;Immunotherapy;Pancreatic Cancer;Rare Diseases

ORG_CITY: PHILADELPHIA

ORG_DEPT: PATHOLOGY

ORG_NAME: UNIVERSITY OF PENNSYLVANIA

ORG_STATE: PA

PHR: Project narrative  Chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment of blood cancer, but it has yet to demonstrate efficacy in solid tumors, and our understanding of barriers is limited. I have developed an integrated spatial multi-omic analytical pipeline that I will apply to a comprehensive biobank from five CAR T- cell clinical trials to define the tumor microenvironment with greater precision than previously possible. My preliminary data suggest that CAR T-cell therapy fundamentally reorganizes the solid tumor microenvironment, and my proposed work will reveal mechanisms of resistance and response to guide the development of next- generation CAR T-cell therapies.

PI_NAMEs: RECH, ANDREW JOHN (contact)

PROGRAM_OFFICER_NAME: MILLER, BECKY

PROJECT_TERMS: Androgen Receptor;Antigen Targeting;Area;Back;biobank;Bioinformatics;Biological;Biological Models;Biology;blood treatment;Board Certification;cancer infiltrating T cells;CAR T cell therapy;career;career development;Cell Physiology;Cell secretion;Cells;Cellular biology;Characteristics;chimeric antigen receptor;chimeric antigen receptor T cells;Clinical;Clinical Trials;cytokine;cytotoxic;Data;design;Detection;Development;Development Plans;Disease;engineered T cells;Engineering;Environment;Epithelial Cells;Evolution;experience;Faculty;Financial Support;Foundations;Functional disorder;Future;Hematologic Neoplasms;Hematopoietic Neoplasms;Human;Human Resources;IL18 gene;Immune;Immune Evasion;Immunity;immunoengineering;improved;Infiltration;Inflammatory;Infusion procedures;Institution;Interferon Type I;Interferon Type II;Intervention;Investigation;Laboratories;laboratory experience;Link;Malignant neoplasm of pancreas;Malignant neoplasm of prostate;Medicine;Mentors;Mentorship;Mesenchymal;mouse model;multidisciplinary;multiple omics;Myelogenous;Myeloid Cells;Myeloid-derived suppressor cells;Myeloproliferative disease;neoplastic cell;next generation;Non-Hodgkin's Lymphoma;pancreatic ductal adenocarcinoma model;paracrine;Pathologist;Pathology;Pathway interactions;Patients;Pennsylvania;Phase I Clinical Trials;Postdoctoral Fellow;predicting response;predictive signature;professor;programs;Proteins;Publications;Research;Resistance;resistance mechanism;Resources;response;RNA analysis;Sampling;Scientist;Solid Neoplasm;spatial integration;Specimen;Students;success;T-Lymphocyte;Technology;Testing;Therapeutic;therapy resistant;Tissues;Toxic effect;Training;Transcript;transcriptome;Transforming Growth Factor beta;Treatment Efficacy;tumor;Tumor Antigens;tumor heterogeneity;tumor immunology;tumor microenvironment;Tumor Promotion;Universities;Up-Regulation;Work

PROJECT_TITLE: Response and resistance to chimeric antigen receptor T cell therapy in human solid tumors using spatial multi-omics

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Gene Therapy;Genetics;Immunotherapy;Nanotechnology;Organ Transplantation;Orphan Drug;Rare Diseases;Transplantation

ORG_CITY: Princeton

ORG_NAME: OPTIMEOS LIFE SCIENCES, INC.

ORG_STATE: NJ

PHR: Antigen-specific regulatory T cells, which suppress immune responses and maintain homeostasis, are potential cell therapies for autoimmune diseases and transplant rejection that do not produce global immune suppression. In this Phase I SBIR, Optimeos proposes to develop targeted nanoparticles for the in situ transformation of CD4+ T cells into antigen-specific regulatory T cells. This non-viral therapy will provide an off- the-shelf treatment for transplant rejection that reduces the risks of generalized immunosuppression and avoids the high costs of patient-specific ex vivo cell manufacturing.

PI_NAMEs: MARKWALTER, CHESTER EDWARD (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: Address;Adoptive Cell Transfers;Affect;Allogenic;American;Antibodies;Antigens;Autoimmune;Autoimmune Diseases;CAR T cell therapy;Caring;CD3 Antigens;CD4 Positive T Lymphocytes;Cell Physiology;Cell Therapy;Cells;chimeric antigen receptor;chimeric antigen receptor T cells;Clinic;Clinical;Complex;cost;cyanine dye 5;cytokine;design;Development;Disease;Dose;effector T cell;Encapsulated;Ensure;Exhibits;experimental study;Face;Formulation;FOXP3 gene;Generations;Genetic;Graft Rejection;graft vs host disease;Health Care Costs;HLA Antigens;HLA-A2 Antigen;Homeostasis;Human;humanized mouse;Hybrids;Immune;Immune response;Immune Tolerance;Immunologics;immunoregulation;Immunosuppression;improved;In Situ;In Vitro;in vivo;Incidence;Inflammation;Inflammatory;Instruction;Kidney Transplantation;Label;Lead;Ligands;lipid nanoparticle;Lipids;Liver;Lymphatic;Malignant Neoplasms;manufacture;manufacturing cost;Marketing;Mediating;Medical;Messenger RNA;Modeling;Monitor;mRNA delivery;Mus;nanocarrier;nanoparticle;nucleic acid delivery;Oncology;Patients;Performance;Peripheral;Peripheral Blood Mononuclear Cell;pharmacologic;Phase;phase 2 study;Phenotype;Play;Polymers;Population;Positioning Attribute;pre-clinical;preclinical efficacy;preclinical study;Process;Production;Property;Regimen;Regulatory T-Lymphocyte;Risk;Role;Safety;screening;Severities;Skin Transplantation;Small Business Innovation Research Grant;Specificity;Structure;surface coating;T cell response;T cell therapy;T-Lymphocyte;T-Lymphocyte Subsets;targeted delivery;Technology;Toxic effect;Transfection;Translations;transplant model;Transplant Recipients;Transplantation;transplantation therapy;Treatment Cost;Vaccines;Validation;Virus Integration;Work

PROJECT_TITLE: Targeted delivery of nucleic acid formulations for in vivo CAR-Treg generation


NIH_SPENDING_CATS: Brain Disorders;Cardiovascular;Heart Disease;Heart Disease - Coronary Heart Disease;Neurosciences

ORG_CITY: Fort Wayne

ORG_NAME: VIVACELLE BIO, INC.

ORG_STATE: IN

PHR: PROJECT NARRATIVE Cardiac arrest (CA) is a life-threatening condition that can lead to loss of pulse, cessation of breathing, and unconsciousness. In the US alone, over 805,000 people are affected annually by CA, with the average survival rate being as low as 10.4%. CA is usually caused by reduced blood flow and ineffective cardiac output, which can result in post-cardiac arrest brain injury if not treated promptly. To improve clinical outcomes and survival rates. , it's crucial to restore effective blood flow as soon as possible while minimizing the risk of reperfusion injury. Vivacelle Bio Inc. has developed a proprietary formulation called VBI-1, which is composed of micelles and liposomes. It acts as a colloidal volume expander, absorbs excessive nitric oxide and free radicals, and carries and releases oxygen. This formulation is specifically designed to address cardiac ischemia reperfusion injury. Our goal is to expand the use of intra-arterial infusion of VBI-1 for the management of cardiac arrest.

PI_NAMEs: SIMPKINS, CUTHBERT ORMOND (contact);WACKER, MICHAEL

PROGRAM_OFFICER_NAME: TINSLEY, EMILY

PROJECT_TERMS: absorption;Acute;Address;Adverse effects;Affect;Animals;Anti-Arrhythmia Agents;aqueous;Behavioral;Biodistribution;Biological Availability;biomaterial compatibility;Blood;Blood flow;Blood gas;Blood Pressure;blood pressure elevation;Brain;Brain Injuries;Breathing;Cardiac Output;Cardiotonic Agents;cerebral artery;Cerebral perfusion pressure;Cessation of life;China;Clinical;cognitive ability;Coronary artery;Country;Coupled;Data;design;Development;Diameter;Dose;efficacy evaluation;Electrolytes;Encapsulated;Ensure;Epinephrine;Event;experience;femoral artery;Formulation;Free Radicals;Goals;Grant;Heart Arrest;Heart Massage;Hematology;Hemorrhage;Hemorrhagic Shock;Histidine;Hong Kong;Hour;improved;in vivo;Induced Heart Arrest;Infusion procedures;Injury;International;Intervention;Intra-Arterial Infusions;Intravenous infusion procedures;Lead;Lecithin;Legal patent;Life;Liposomes;Liquid substance;Long term disability;Methods;Micelles;Mission;Modeling;monolayer;mortality;Myocardial Ischemia;nanoparticle;National Heart, Lung, and Blood Institute;neuroprotection;New Zealand;Nitric Oxide;novel;Organ;Outcome;Outpatients;Oxygen;Patients;Perfusion;Persons;Pharmaceutical Preparations;Phase;Phase II Clinical Trials;Physiologic pulse;pre-clinical;pressure;Rattus;Recovery;Reperfusion Injury;Respiration;restoration;Resuscitation;risk minimization;Risk Reduction;Safety;Sinus;Small Business Technology Transfer Research;South Africa;Soybean Oil;Survival Rate;Testing;Thermodynamics;Tissues;Treatment Protocols;Unconscious State;Validation;Vasoconstrictor Agents;Ventricular Fibrillation;Visceral;Vision

PROJECT_TITLE: Development of VBI-1 as a novel treatment protocol for outpatient cardiac arrest

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


NIH_SPENDING_CATS: Aging;Bioengineering;Nanotechnology

ORG_CITY: MOUNTAIN VIEW

ORG_NAME: KINETIC RIVER CORPORATION

PHR: PROJECT NARRATIVE The focus of this proposal is to develop a high sensitivity flow cytometry-based extracellular vesicle (EV) analyzer. The EV analyzer would provide significant advantages over current EV analyzers, including the high throughput of flow cytometry and the ability to simultaneously analyze, on a particle-by-particle basis, a proxy of size via light scattering and the presence of specific molecular markers via sensitive fluorescence analysis.

PI_NAMEs: VACCA, GIACOMO  (contact)

PROGRAM_OFFICER_NAME: BILLINGSLEA, EDDIE

PROJECT_TERMS: Address;Algorithmic Analysis;Algorithms;Alzheimer's Disease;anti aging;Ascites;Biological;Biological Assay;Biological Markers;Blood;Calibration;cardiac repair;Cell secretion;Cells;Central Nervous System;Cerebrospinal Fluid;clinical translation;Collaborations;commercialization;Complement;Correlation Studies;Data;Data Set;design;Detection;detector;Diagnostic;Disease;Error Sources;Event;Exhibits;experience;extracellular vesicles;Fingerprint;Flow Cytometry;Fluorescence;Future;gerotherapeutic;improved;Individual;instrument;interest;Investigation;Kinetics;Lasers;light scattering;Lipid Binding;Liquid substance;Manufacturer;Marketing;Methods;minimally invasive;Molecular;Molecular Analysis;molecular marker;Molecular Profiling;Multiparametric Analysis;nanoparticle;Nature;Noise;Nucleic Acids;Optics;Parents;Parkinson Disease;particle;Particle Size;Performance;Phase;Physiological;Preparation;prevent;Property;Proteins;Proxy;repair function;repaired;Research;Research Personnel;Resolution;Signal Transduction;Skin repair;Sorting;Source;stem cell function;stem cells;System;Technical Expertise;Techniques;Testing;Therapeutic;tool;Urine;usability;Validation;Vesicle;Work;wound healing

PROJECT_TITLE: An Ultrasensitive Flow Cytometry System for Multiparametric Analysis of Therapeutic Anti-Aging Extracellular Vesicles


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Dietary Supplements;Microbiome;Nutrition;Orphan Drug;Rare Diseases

ORG_CITY: LOS ANGELES

ORG_NAME: PETRI BIO LLC

PHR: Project Narrative  Classical Homocystinuria (HCU) is a rare metabolic condition caused by mutations in the cystathionine- -synthase (CBS) gene. A major barrier to current treatment is adherence to a methionine restricted diet. Petri Bio, Inc. has developed a novel strategy for producing enzyme therapeutics expressed in bacterial vectors compatible with the gut microbiome. This approach allows excess metabolites (such as methionine in HCU) to be reduced in the gut prior to systemic uptake and thus mimic the effect of a low methionine diet without strictly adhering to one. Here we will advance Petri’s proprietary bacterial therapeutic for HCU treatment by scaling up manufacturing, testing safety and efficacy, and preparing for human studies.

PI_NAMEs: SCHINAMAN, JOSEPH MOELLER (contact)

PROGRAM_OFFICER_NAME: SURPRIS, MARIPIERRE PAYEN

PROJECT_TERMS: Adherence;Amino Acids;Antibiotic susceptibility;attenuation;bacterial vector;Betaine;Biological Models;Biological Products;Biological Response Modifier Therapy;biomaterial compatibility;Catalysis;Classification;Clinical;Clinical Research;clinical translation;Clinical Trials;Cognitive deficits;Cystathionine;cytokine;Data;design;Detection;Development;Diarrhea;Diet;Dietary intake;dietary restriction;Dietary Supplementation;Doctor of Philosophy;Dose;Drug Kinetics;Effectiveness;efficacy study;efficacy testing;Engineering;Engraftment;Ensure;enzyme therapy;Enzymes;Excretory function;expression vector;eye center;Fermentation;Formulation;gene therapy;Genes;Genetic Models;genomic data;Goals;gut microbiome;Homocysteine;Homocystinuria;Human;in silico;In Vitro;in vitro testing;in vivo;Inflammatory;Investigational Drugs;Lead;lens;Long-Term Effects;manufacturing organization;manufacturing scale-up;Measures;meetings;Metabolic;Metabolic Diseases;Metabolic Pathway;Methionine;Methods;Microbe;microbial;microbial genomics;Modeling;mouse model;Mutation;Nausea;novel;novel strategies;Odors;Patients;Performance;Phase;phase 1 study;Plasma;pre-Investigational New Drug meeting;Preclinical Testing;Prevalence;Process;Production;programs;research clinical testing;Research Contracts;Rodent;Safety;safety testing;scale up;Schedule;side effect;small molecule therapeutics;standard of care;Standardization;stroke incidence;Testing;Therapeutic;therapeutic enzyme;therapeutic protein;thrombotic;Tissues;Toxicology;Transgenic Organisms;treatment strategy;uptake;vector;Vitamin B6;Work

PROJECT_TITLE: Live microbial therapeutics: an enhanced treatment paradigm for classical homocystinuria

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


NIH_SPENDING_CATS: Autism;Brain Disorders;Genetics;Intellectual and Developmental Disabilities (IDD);Machine Learning and Artificial Intelligence;Mental Health;Neurosciences;Pediatric;Stem Cell Research;Stem Cell Research - Embryonic - Human;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: New York

ORG_NAME: RUMI SCIENTIFIC, INC.

ORG_STATE: NY

PHR: Project Narrative There is currently no treatment for most Autism Spectrum Disorders (ASDs). Due to their life-long burden, an effective therapy for ASDs would have a profoundly positive impact on the lives of patients and caregivers. We therefore expect our discoveries to have a significant impact on society.

PI_NAMEs: ETOC, FRED  (contact)

PROGRAM_OFFICER_NAME: ANDERSON, PAIGE MARIE

PROJECT_TERMS: 3-Dimensional;Affect;Animal Model;Appearance;Artificial Intelligence;autism spectrum disorder;Behavior;Benchmarking;Biological Assay;Calcium;Caregivers;cell bank;Cell Line;Cells;Central Nervous System Diseases;Chemicals;Collaborations;Communication;Complex;convolutional neural network;Coupled;Data;data repository;deep learning;Defect;density;Development;differentiation protocol;Disease;disease phenotype;Dreams;drug development;drug discovery;effective therapy;Evaluation;experimental study;Failure;Foundations;FOXG1B gene;FOXP1 gene;Gene Mutation;Genes;Genotype;high throughput screening;Human;human pluripotent stem cell;Huntington Disease;Image;improved;In Vitro;innovation;Investments;large-scale imaging data;Lead;Libraries;Measures;Mediating;Methods;Modeling;morphological criteria;Morphology;mouse model;mutant;Mutation;nerve stem cell;Nervous System Disorder;neural;neural network;Neurodevelopmental Disorder;Neurological observations;Neurons;novel therapeutics;Nuclear Pore Complex;Organoids;Pathogenicity;Pathologic;patient derived induced pluripotent stem cells;Patients;Pattern;Pharmaceutical Preparations;Phase;Phenotype;Physiological;Process;Prosencephalon;Protocols documentation;reconstitution;Reporter;Reproducibility;Research;screening;self organization;Series;small molecule;small molecule therapeutics;Societies;Specific qualifier value;Stains;Standardization;statistics;Synapses;Techniques;Technology;Testing;Therapeutic;therapeutic candidate;Time;timeline;Tissues;tool;Validation

PROJECT_TITLE: An Integrated Drug Discovery Platform for Neurodevelopmental Disorders Using Standardized Self-Organizing Human Cerebroids

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


ED_INST_TYPE: SCHOOLS OF DENTISTRY/ORAL HYGN

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

NIH_SPENDING_CATS: Biotechnology;HIV/AIDS;Immunization;Infectious Diseases;Prevention;Vaccine Related;Vaccine Related - AIDS

ORG_DEPT: DENTISTRY

PHR: PROJECT NARRATIVE There are over 37 million people currently living with HIV and an additional 1.8 million are newly infected each year, yet despite decades of research we still do not have an efficacious vaccine. A major goal of vaccine design is the elicitation of broadly neutralizing antibodies, which target highly conserved epitopes on the HIV Envelope glycoprotein and confer protection against infection. This proposal seeks to understand the evolution and maturation of broadly neutralizing antibody lineages in innovative mouse and macaque models, which may ultimately inform the design of novel immunogens and vaccination regimens to elicit such lineages in humans.

PI_NAMEs: SKELLY, ASHWIN NICHOLAS (contact)

PROGRAM_OFFICER_NAME: CHAKRABARTI, BIMAL KUMAR

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Affinity;Animals;Antibodies;Antibody Response;Antigens;Automobile Driving;B cell repertoire;B-Lymphocytes;Binding;Bioinformatics;Biological Assay;Cells;Chronic;Clinical;clinically relevant;Communication;defined contribution;design;Development;doctoral student;Engineering;Environment;Enzyme-Linked Immunosorbent Assay;Epitopes;Evolution;Exposure to;Flow Cytometry;Foundations;Frequencies;Genes;genome sequencing;Glycoproteins;glycosylation;Goals;HIV;HIV envelope protein;HIV Infections;HIV-1;Human;Immunity;Immunization;Immunize;Immunoglobulins;Immunology;Individual;Infection;innovation;Knock-in Mouse;longitudinal analysis;Macaca;Macaca mulatta;Mentorship;Microbiology;Modeling;Monoclonal Antibodies;mouse model;Mus;Mutate;neutralizing antibody;next generation sequencing;novel;Oral;pandemic disease;Passive Immunization;pathogen;Pathway interactions;Patients;Pennsylvania;Persons;Physicians;Polysaccharides;pressure;Process;programs;Proteins;Protocols documentation;rational design;Regimen;Research;Research Personnel;Resources;response;Scheme;Scientist;Series;Serum;simian human immunodeficiency virus;skills;Solid;success;Testing;The Wistar Institute;Training;Translating;Universities;Vaccination;vaccination strategy;Vaccine Design;vaccine development;vaccine trial;Vaccines;Viral;viral entry inhibitor;Virus;Virus Diseases;virus envelope;Wild Type Mouse;Work;Writing

PROJECT_TITLE: Harnessing SHIVs and Sequential Immunization to Elicit V3 Glycan-Targeted bNAbs against HIV-1

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F17A-F (20)]


ORG_NAME: VA GREATER LOS ANGELES HEALTHCARE SYSTEM

PHR: Schizophrenia (SCZ) is a serious mental health disorder and is the most expensive per-patient condition within the VA, accounting for up to 20% of its healthcare budget. Pharmacological treatments help ameliorate acute symptoms of psychosis, including delusions and hallucinations; however, these treatments are resistant to impairments in everyday functioning, including impairments that contribute to social disability. Significant components of social disability are reduced objective connections with others (i.e., social disconnection) and the subjective experience of social disconnection (i.e., loneliness). The proposed study aims to leverage diverse methodologies to elucidate the nature and underlying mechanisms of social disconnection and loneliness. The knowledge gained from this project will inform novel interventions that target the specific components of social disability at multiple levels of analysis in Veterans with SCZ.

PI_NAMEs: ABPLANALP, SAMUEL JOSEPH (contact)

PROJECT_TERMS: Accounting;acute symptom;Affect;Amygdaloid structure;Area;Award;Behavior;Brain region;Budgets;California;career;Cellular Phone;Characteristics;Chronic;clinical center;cognitive task;Community Integration;comparison control;computerized data processing;Data;Data Analyses;Data Scientist;Delusions;density;digital phenotyping;Disabilities experience;Doctor of Philosophy;Ecological momentary assessment;Education;effective therapy;Environment;Evidence based treatment;experience;Face;Family member;Feeling;Friends;Functional impairment;Functional Magnetic Resonance Imaging;Fusiform gyrus;Goals;Hallucinations;Healthcare;Healthcare Systems;Homelessness;Human;Impairment;improved;indexing;Infrastructure;innovation;Intervention;Interview;K-Series Research Career Programs;Knowledge;Life;Literature;Loneliness;Los Angeles;Measures;Medial;member;Memory;Mental disorders;Mentors;Methodology;Methods;Modeling;mortality;Nature;neural;neuroimaging;neurophysiology;novel;Outcome;Pathway Analysis;Patient Self-Report;Patients;Pattern;Performance;Pharmacological Treatment;Positioning Attribute;Prefrontal Cortex;prevent;Process;programs;Psyche structure;Psychoses;Research;Research Personnel;Resistance;response;Schizophrenia;severe mental illness;social;social cognition;social contact;Social disability;Social Functioning;social influence;social metrics;Social Network;social neuroscience;Social Processes;sociodemographics;Specificity;Structure;suicidal behavior;Time;Training;treatment center;Universities;Veterans

PROJECT_TITLE: A Multimethod Approach of Social Disconnection in Schizophrenia: Leveraging Digital Phenotyping, Social Network Analyses, and Neuroimaging

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 MHBC-F (01)]


FUNDING_MECHANISM: OTHER RESEARCH-RELATED

NIH_SPENDING_CATS: Clinical Research;Dissemination and Implementation Research;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Infectious Diseases;Pediatric;Prevention

ORG_CITY: DURHAM

ORG_DEPT: SURGERY

ORG_NAME: DUKE UNIVERSITY

PHR: Project Narrative. Currents efforts are ramping up to control local HIV epidemics in Africa by providing effective treatment and prevention strategies for people living with HIV-1 infection. The 2024 INTEREST Conference will focus on the scientific training and capacity building of young African health care providers and basic science investigators to achieve the UNAIDS 95-95-95 target for 2030 by implementing and evaluating evidence- based: 1) early HIV-1 diagnosis in population at risk of infection, 2) effective and cost-effective antiretroviral treatment to achieve virus suppression, and 3) tailored prevention strategies. Moreover, the three-day INTEREST conference, which profiles state-of-the-art science, will support the career development of young African clinicians and scientists by: 1) fostering local and international scientific exchange; 2) providing opportunities to present their results; 3) facilitating their close interaction with scientific peers and invited international experts to explore career choices and opportunities for scientific collaboration; and 4) attending events dedicated to scientific writing of abstracts and grant proposal.

PI_NAMEs: FERRARI, GUIDO  (contact);TORPEY, KWASI

PROGRAM_OFFICER_NAME: GUTIERREZ, MARTIN

PROJECT_TERMS: Acceleration;Achievement;Acquired Immunodeficiency Syndrome;Adherence;Adolescent;Adult;Africa;Africa South of the Sahara;African;AIDS prevention;antiretroviral therapy;Applications Grants;Automobile Driving;Award;Awareness;Basic Science;behavioral and social science;career;Career Choice;career development;Caring;CD4 Lymphocyte Count;Cessation of life;Child;Clinical Research;Collaborations;Communities;comorbidity;cost;cost effective;Country;COVID-19 pandemic;Data;Dedications;demographics;Development;Diagnosis;disparity reduction;Education;effective therapy;Elderly;Ensure;Epidemic;Event;evidence base;experience;fighting;follow-up;Fostering;Funding;Future;Ghana;global health;Goals;Health;Health Personnel;Health Policy;Health Services Accessibility;health training;Healthcare;HIV;HIV diagnosis;HIV Infections;HIV Seropositivity;HIV-1;Human immunodeficiency virus test;Human Resources;implementation barriers;implementation science;improved;Individual;Infection;infection risk;International;Investments;Knowledge;Knowledge acquisition;Leadership;Measures;meetings;mortality;Motivation;Newly Diagnosed;novel;Outcome;pandemic disease;Pathogenesis;peer;Persons;Physicians;Populations at Risk;prevent;Prevention;Prevention Research;Prevention strategy;Public Health;Public Health Schools;Ramp;Recording of previous events;Reporting;Research;Research Personnel;Resource-limited setting;Resources;response;scale up;Science;Scientist;Serology;statistics;stem;symposium;Training;transmission process;Travel;Treatment Protocols;Treatment Step;treatment strategy;Uganda;Universities;Viral;Viral Drug Resistance;Viral load measurement;Viral Load result;viral transmission;Virus;Vocational Guidance;Work;Writing;Youth

PROJECT_TITLE: The 18th INTEREST Conference

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


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;Complementary and Integrative Health;Data Science;Dementia;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Machine Learning and Artificial Intelligence;Mental Health;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Palliative Care;Racial and Ethnic Minority Health Research;Rehabilitation

ORG_CITY: SAN JOSE

ORG_NAME: BEAVER HEALTH, INC.

PHR: Project Narrative As the number of people living with dementia is expected to double to 13.8 million by 2060, the strain on dementia family caregivers will be further intensified, especially for minoritized caregivers who are affected disproportionately and face cultural barriers in accessing support. This project aims to develop a personalized and culturally responsive mindfulness virtual coaching platform tailored to the needs of dementia caregivers. Successful completion will support the development of a novel mindfulness intervention delivery for AD/ADRD caregivers that addresses a significant market gap to increase health equity by offering a personalized, culturally relevant, and accessible support system to this underserved population.

PI_NAMEs: WANG, EMILY S. (contact)

PROGRAM_OFFICER_NAME: HARRELL, ERIN

PROJECT_TERMS: Accent;Address;Adherence;Adoption;Affect;Age;Alzheimer's Disease;Alzheimer's disease related dementia;American;Anxiety;Appearance;Artificial Intelligence;Asian;Behavior;Black race;Caregiver support;Caregivers;caregiving;Caring;Clinical;Code;Collaborations;commercialization;Computers;cost;cultural values;Dementia;Dementia caregivers;design;Development;Devices;Eating;efficacy study;Elderly;Emotional;ethnic diversity;Ethnic Origin;Exercise;experience;Face;Family Caregiver;Food;Gender;Goals;Health;health equity;Hearing;Home;Hour;Image;improved;Individual;interest;intervention delivery;Interview;Latinx;Life;Marketing;Mental Depression;Methods;mindfulness;mindfulness based cognitive therapy;mindfulness intervention;Minority;Modeling;Modification;Natural Language Processing;Natural Language Processing pipeline;new technology;Noise;novel;Oral cavity;Pacific Islander;Participant;personalized intervention;Persons;Phase;Positioning Attribute;preference;Privacy;Protocols documentation;prototype;Race;racial diversity;Reaction Time;recruit;Reporting;Risk;social stigma;sound;Speech;speech recognition;Stress;stress reduction;Support System;System;Telephone;Testing;Text;Time;Underserved Population;usability;virtual coach;Voice;web interface;Work;Writing

PROJECT_TITLE: A Personalized and Culturally Responsive Mindfulness Virtual Coach to Support Dementia Caregivers

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


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;HIV/AIDS;Immunization;Infectious Diseases;Malaria;Malaria Vaccine;Orphan Drug;Prevention;Rare Diseases;Tuberculosis;Tuberculosis Vaccine;Vaccine Related;Vector-Borne Diseases

PHR: Project Narrative. HIV prevention remains critical to turn the tide against new infections. The ability to develop locally relevant protective prevention strategies against HIV-1 will be a milestone for the African continent. Similarly, continuous efforts are required to develop strategies to also prevent TB and malaria, two major co-morbidities of HIV-1. The success of these endeavors will depend on the scientific literacy of young African scientists who will be involved with overseeing clinical trials and conducting research locally. The next series of Infectious Diseases in Africa: Training Symposium for the next generation of African scientists (IDA) aims to create knowledge and scientific literacy in Africa by enhancing the acumen of basic and clinical immunology research being performed by young African scientists. We propose a set of three symposia to address this need according to these two Aims: 1) To provide cutting-edge knowledge in the fields of HIV passive immunization and vaccine development and implementation for malaria and TB prevention; 2) To provide events that can enhance career development of the next generation of African scientists, including grant writing, poster and oral presentation skills, networking, and community engagement.

PI_NAMEs: ANDERSEN-NISSEN, ERICA ;FERRARI, GUIDO  (contact);GRAY, CLIVE MAURICE

PROJECT_TERMS: Academy;Accounting;Acquired Immunodeficiency Syndrome;Active Immunization;Address;Africa;Africa South of the Sahara;African;age group;AIDS prevention;Anti-Retroviral Agents;antiretroviral therapy;Basic Science;career development;Cause of Death;Child;Clinical;Clinical Immunology;clinical practice;Clinical Trials;co-infection;Communicable Diseases;community engagement;comorbidity;cost;Country;COVID-19 pandemic;Data Analyses;design;Development;Disease;Economics;Education;Educational process of instructing;efficacy clinical trial;Epidemic;epidemiologic data;Equilibrium;Event;Exercise;experience;Exposure to;Face;Faculty;Foundations;Funding;Future;Gender;Goals;Grant;Guidelines;high risk;HIV;HIV Infections;HIV-1;HIV-1 vaccine;HIV/AIDS;human capital;Iatrogenesis;Immunity;Infection;Infusion procedures;innovation;Knowledge;knowledgebase;Laboratories;Leadership;Malaria;Mentors;Mentorship;Minority;Monitoring Clinical Trials;Multi-Drug Resistance;neutralizing antibody;New York;next generation;novel vaccines;Oral;Outcome;Participant;Passive Immunization;pathogen;Persons;Pharmaceutical Preparations;posters;pre-exposure prophylaxis;prevent;Prevention;Prevention strategy;Prevention trial;Process;Professional Competence;Regimen;Reporting;Research;Research Personnel;Research Priority;Research Project Grants;Research Support;Research Training;resistant strain;role model;Science;scientific literacy;Scientist;Series;Sex Orientation;skills;South Africa;Students;success;symposium;tool;Training;Tuberculosis;United States National Institutes of Health;Universities;vaccination strategy;vaccine development;vaccine efficacy;vaccine strategy;Vaccines;Writing

PROJECT_TITLE: Infectious Diseases in Africa (IDA) Training Symposium for Next Gen Scientists


NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Bioengineering;Brain Disorders;Dementia;Mental Health;Networking and Information Technology R&D (NITRD);Neurodegenerative;Neurosciences;Patient Safety;Prevention

ORG_CITY: Boston

ORG_NAME: PASCALL SYSTEMS, INCORPORATED

PHR: PASCALL Systems, Inc aims to develop an integrated brain state monitor to provide personalized anesthesia decision support to prevent postoperative delirium (POD) in elderly and patients at risk for Alzheimer’s disease or related dementias. This next generation monitor integrates in real-time with the Electronic Medical Records, infusion pumps and anesthesia machine to provide three decision support features: 1) accurate age- compensated brain state tracking, 2) anesthetic dose guidance, and 3) POD risk prediction. The system can reduce half of the baseline incidence of POD (from 25% to 12.5%) and generate significant saving to the health care system which currently incurs $44,000 per POD patient per year.

PI_NAMEs: ARNEY, DAVID ;LE MAU, TUAN  (contact)

PROGRAM_OFFICER_NAME: BAKOS, ALEXIS DIANE

PROJECT_TERMS: Address;Age;Alzheimer's Disease;Alzheimer's disease related dementia;Alzheimer's disease risk;Anesthesia procedures;Anesthetics;Attention;Brain;Caring;Client satisfaction;Clinical;clinical decision support;Clinical Decision Support Systems;Clinical Pathways;Clinical Research;Clinical Trials;Communication;Compensation;Computer software;Computerized Medical Record;cyber security;Data;data acquisition;Data Set;Decision Support Systems;Delirium;Dementia;design;Devices;Dose;Drug Kinetics;Early Intervention;Elderly;Electroencephalography;Ensure;Functional impairment;General Anesthesia;Healthcare Systems;high risk;Hospital Information Systems;Hospitals;Hour;Impaired cognition;improved;Incidence;indexing;Infusion procedures;Infusion Pumps;Inhalation;innovation;interoperability;Intervention;Length of Stay;Life;Maintenance;Marketing;Medical Device;Medical History;Monitor;Neurosciences;next generation;novel;older adult;older patient;Operative Surgical Procedures;Outcome;Patients;Performance;personalized decision;Pharmaceutical Preparations;Pharmacodynamics;Phase;postoperative delirium;Postoperative Period;prevent;Prevention;Preventive;programmed cell death protein 1;programs;Protocols documentation;prototype;Pump;Recommendation;Risk;risk prediction;Risk Reduction;Running;Safety;sevoflurane;System;Tablets;Testing;Time;tool;trial planning;Unconscious State;United States;usability;verification and validation;wireless sensor;Work

PROJECT_TITLE: Developing an Integrated Brain State Monitor for Personalized Anesthesia Decision Support: Preventing Postoperative Delirium in Elderly and Patients At Risk for Alzheimer's or Related Dementias

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


NIH_SPENDING_CATS: Biotechnology;Cancer;Immunization

ORG_CITY: CAMBRIDGE

ORG_NAME: PEARL BIO, INC.

PHR: PROJECT NARRATIVE Antibody Drug Conjugates (ADCs) effectively target and kill diseased cells, yet suffer from low efficacy and toxicity, low tissue/tumor penetration, low cell internalization, heterogenous Drug Antibody Ratios (DARs) and off-target drug effects whereas nanobodies exhibit enhanced tumor penetration and access to unique epitopes, yet are limited therapeutically by short half-lives with unfavorable “peak-and-valley” pharmacokinetic profiles. To address these challenges, Pearl Bio has developed a proprietary technology platform to enable precise, multi-site incorporation of 2+ distinct synthetic amino acids to design tunable, multi-functionalized next-generation biologics. In this project, we will generate multi-functionalized nanobodies to precisely tune therapeutic properties: (i) lipidation for half-life tunability, (ii) tunable fluorescence-tagging for tumor detection and (iii) tunable Drug Antibody Ratio (DAR) for CTP conjugation with predictable homogenous products for enhanced tumor cytotoxicity.

PI_NAMEs: CHATTOPADHYAY, SOUVIK  (contact)

PROGRAM_OFFICER_NAME: KODURI, SAILAJA

PROJECT_TERMS: Acute;Address;Affinity;Albumins;Amino Acids;Animals;Antibodies;Antibody Binding Sites;Antibody-drug conjugates;Automobile Driving;Binding;Biological Assay;Biological Markers;Biological Products;Biology;Cell Culture Techniques;cell killing;Cells;Chemicals;Chemistry;Clinic;Clinical;clinical efficacy;Clinical Trials;Code;Collection;Cysteine;cytotoxic;cytotoxicity;design;design verification;Detection;Development;Disease;Dose;Dose Limiting;Doxorubicin Hydrochloride Liposome;Drug Design;drug efficacy;Drug Kinetics;Drug Targeting;Engineering;Epidermal Growth Factor Receptor;Epitopes;Exhibits;Failure;FDA approved;Fluorescence;fluorophore;Generations;Genomics;Goals;Half-Life;Heterogeneity;Hour;Immune system;immunogenic;immunogenicity;Impairment;improved;In Vitro;in vivo;Infusion procedures;innovation;Interleukin-10;Label;Legal patent;Licensing;Life Extension;Lipids;Lysine;Measures;mouse model;nanobodies;nanoengineering;nanosized;Neoplasm Metastasis;neoplastic cell;next generation;novel;novel strategies;novel therapeutics;Organism;Patients;Pegaspargase;Penetration;Performance;Pharmaceutical Preparations;Phase;Polyethylene Glycols;preservation;Primary Neoplasm;Production;Property;Proteins;Reaction;receptor internalization;response;Role;Safety;Serum;Serum Albumin;Shapes;Side;Site;Specificity;success;synthetic biology;System;targeted cancer therapy;Techniques;Technology;technology platform;Therapeutic;therapeutic development;Tissues;Toxic effect;Translations;Treatment Efficacy;tumor;Variant;Work

PROJECT_TITLE: Development of Programmable Nanobodies for Multi-functionalized Biologics


NIH_SPENDING_CATS: Bioengineering;Nanotechnology

ORG_CITY: VAIL

ORG_NAME: SCINTILLATION NANOTECHNOLOGIES, INC.

ORG_STATE: AZ

PHR: Project Narrative – Public Health Relevance: This research project will lead to development of a new category of radioisotope-responsive sensors that can be used for chemically selective detection of radioisotope labeled compounds in advanced bio/chemical and biological assays. The capabilities afforded by this research will play a pivotal role in disease-relevant signal transduction research, drug discovery, clinical evaluation and many other key applications.

PI_NAMEs: JANCZAK, COLLEEN  (contact)

PROJECT_TERMS: amphiphilicity;analytical method;aqueous;Area;Behavior;Beta Particle;Binding;Biochemical;Biological;Biological Assay;biological systems;Biomedical Research;Categories;Cells;Chemicals;cost;Detection;detection method;Development;Disease;Dopamine;dopamine D3 receptor;Drug Compounding;drug discovery;Drug Screening;Dyes;Environment;Exhibits;G-Protein-Coupled Receptors;Government;human disease;Hybrids;improved;Industrialization;innovation;Innovation Corps;Interview;Investigation;Knowledge acquisition;Label;Laboratory Research;Legal patent;Licensing;Lipids;Liquid substance;maleic acid;Maleic Anhydride;Mass Spectrum Analysis;Measurement;Measures;Membrane;Membrane Lipids;Membrane Proteins;Methodology;Methods;Modification;Molecular;Molecular Analysis;nanodisk;nanomaterials;nanoparticle;Nanotechnology;particle;Pathway interactions;Pharmaceutical Preparations;pharmacologic;Pharmacologic Substance;Phase;Physiological;Play;Polymers;Positioning Attribute;Preparation;Prevalence;Process;programs;Property;Proteins;Provider;public health relevance;Raclopride;Radioisotopes;Radiometry;receptor;receptor function;Research;research clinical testing;Research Personnel;Research Project Grants;Role;Sampling;Scintillation Counting;sensor;Series;Signal Transduction;Small Business Innovation Research Grant;small molecule;Specificity;Structure;Styrenes;Surface;surfactant;System;Technology;temporal measurement;Testing;Time;tool;Tracer;uptake;Validation;Vesicle;Water;Work

PROJECT_TITLE: Nanoparticle Radioassay for Proteins in Native Membranes

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


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

ORG_CITY: ROCKVILLE

ORG_NAME: SANARIA, INC.

ORG_STATE: MD

PHR: Project Narrative: We propose continued development, FDA regulatory submission, and additional manufacturing of aseptic, purified, vialed cryopreserved Plasmodium vivax sporozoites (PvSPZ) that meet regulatory standards, The product will be used initially to infect human subjects in controlled human malaria infections(CHMI) to assess its safety and infectivity. It will then serve as a tool to test the efficacy of anti-Pv drugs and vaccines and, given together with malaria chemoprophylactic drugs, become a potent PvSPZ- based vaccine. This product is called Sanaria® PvSPZ Challenge, and similar to PfSPZ Challenge will provide the larger malaria community with a safe quality-controlled reagent that exhibits minimal lot-to-lot variability in potency and is logistically more feasible to administer barring any geographical limitations, compared to traditional CHMI using mosquito bites.

PI_NAMEs: CHAKRAVARTY, SUMANA  (contact);HOFFMAN, STEPHEN LEV

PROGRAM_OFFICER_NAME: MO, ANNIE X  Y

PROJECT_TERMS: acquired immunity;Acute;Affect;African;Anopheles Genus;Anti-malarials;Antigens;asexual;Attenuated;Biological Assay;Bite;Blood;cell bank;Chemistry;Chemoprophylaxis;Clinical;clinical lot;Clinical Research;Clinical Trials;Communities;Complex;cost;Country;Cryopreservation;Culicidae;Cyclic GMP;Development;Diagnostic;drug efficacy;efficacy evaluation;efficacy testing;Erythrocytes;Exhibits;Falciparum Malaria;Feedback;feeding;Foundations;Funding;Future;geographic barrier;germ free condition;Glucosephosphate Dehydrogenase Deficiency;Goals;Good Manufacturing Process;Grant;Harvest;Hemolytic Anemia;Human;human subject;Human Volunteers;Immunity;Immunization;In Vitro;in vivo;Income;Infection;Injections;Intervention;Investigational New Drug Application;Life;Liver;Logistics;Malaria;malaria infection;Malaria Vaccines;manufacture;manufacturing run;Methods;Modeling;Monkeys;Morbidity - disease rate;Mus;Natural Immunity;Parasites;Patients;Persons;Pharmaceutical Preparations;Phase;phase 1 study;Plasmodium falciparum;Plasmodium vivax;Prevalence;Primaquine;Process;Production;programs;prophylactic;protective efficacy;Protocols documentation;Quality Control;Readiness;Reagent;Recommendation;Recurrence;Relapse;Research;Research Personnel;Safety;safety assessment;safety study;Saimiri;Small Business Innovation Research Grant;Sporozoites;standard care;Testing;tool;Vaccinated;Vaccination;vaccine trial;Vaccines;vector transmission;Vial device;Vivax Malaria;volunteer

PROJECT_TITLE: Manufacture of aseptic, purified, cryopreserved Plasmodium vivax sporozoites

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


ED_INST_TYPE: UNIVERSITY-WIDE

FUNDING_MECHANISM: RESEARCH CENTERS

ORG_CITY: SAN JUAN

ORG_NAME: UNIVERSITY OF PUERTO RICO MED SCIENCES

ORG_STATE: PR

PHR: NARRATIVE: The primary goal of this application is to sustain the Specific Pathogen Free (SPF) program at the Caribbean Primate Research Center (CPRC). Animals' characterization, both for the virology profile and MHC typing, is performed by state-of-the-art methodologies. The program supports several investigators conducting cutting- edge research on HIV and AIDS-related research projects in various areas, including pathobiology, characterization of the immune response, con-infections, and comorbidities, development of new HIV/AIDS vaccines and therapeutic approaches, including microbicides, among others.

PI_NAMEs: BURGOS-RODRIGUEZ, ARMANDO GIL;MARTINEZ, MELWEEN I.;SARIOL, CARLOS A (contact)

PROGRAM_OFFICER_NAME: SUI, YONGJUN

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Algorithms;Animals;Area;biodefense;Biological;Biological Models;Biological Warfare;Biomedical Research;Breeding;Budgets;Caribbean region;Caring;Characteristics;co-infection;cohort;Collaborations;Communicable Diseases;Communities;comorbidity;comparative;COVID-19 pandemic;COVID-19 vaccine;Development;Disease;driving force;Education;Ensure;Etiology;Funding;gene therapy;Genetic;genetic analysis;Genetic Variation;Genomics;Geographic Locations;germ free condition;Goals;Guidelines;Heterozygote;HIV vaccine;HIV/AIDS;Human;human disease;Immune response;improved;Income;India;Infection;Institution;Intervention;Island;Journals;Macaca mulatta;Maintenance;Major Histocompatibility Complex;Marketing;Medical;Medicine;Methodology;Methods;microbicide;Modeling;Monkeys;Nature;nonhuman primate;offspring;operation;peer;Population;Population Genetics;pressure;Primates;programs;Publications;Puerto Rico;Research;research and development;Research Personnel;Research Project Grants;Resources;Retroviridae;Safety;SARS-CoV-2 pathogenesis;Science;Secure;Simian Retroviruses;SIV;Stratification;Testing;Therapeutic;therapeutic development;Time;Training;United States National Institutes of Health;United States Public Health Service;Universities;vaccine development;vaccine formulation;Vaccine Therapy;Viral;virology;Virus;virus testing;Work

PROJECT_TITLE: MAINTENANCE OF THE CLOSED CPRC SPF COLONY

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 EMS-H (55)]


NIH_SPENDING_CATS: HIV/AIDS

PHR: NARRATIVE: This Core describes the solid Animal Care and Use Program in place at CPRC in support of the SPF colony. The Center complies with all federal and local regulations related to the care and use of laboratory animals and is fully-accredited by AAALAC. The SPF colony will be maintained in compliance with the regulatory bodies.

PI_NAMEs: MARTINEZ, MELWEEN I. (contact)

PROJECT_TERMS: Accreditation;Acquired Immunodeficiency Syndrome;Age;Alleles;animal care;Animal Testing;Animals;Biomedical Research;Breeding;Budgets;Caribbean region;Caring;Characteristics;Communities;cost;Ensure;Female;Funding;Funding Mechanisms;Genetic;Health;IACUC;Inbreeding;Income;Institution;Laboratory Animals;Macaca mulatta;Maintenance;male;Medical;Monitor;Monkeys;offspring;Primates;programs;Puerto Rico;Recovery;Regulation;Research;Research Personnel;Research Project Grants;Resources;Sales;Science;Services;Site Visit;SIV;Solid;Testing;United States Department of Agriculture;United States National Institutes of Health;Universities;Virus;virus testing;Visit;Work

PROJECT_TITLE: Husbandry and Management


NIH_SPENDING_CATS: HIV/AIDS;Infectious Diseases

PHR: NARRATIVE: The primary purpose of the virology testing arm of CPRC-SPF breeding program is to assure that its Indian- origin rhesus macaque colony, supporting NIH-sponsored research specially on HIV/AIDS, is free of Simian immunodeficiency virus (SIV), Type D Simian retrovirus (SRV-D), Simian T-lymphotropic virus (STLV-1) and Herpes B virus. Testing is conducted by using the state of the art methodologies.

PI_NAMEs: SARIOL, CARLOS A (contact)

PROJECT_TERMS: Adolescent;Algorithms;Animals;arm;Biochemistry;Biological Assay;Biological Models;Biomedical Research;Breeding;Caribbean region;Collaborations;Communities;Data;Diagnostic;diagnostic algorithm;Disease;driving force;Funding;Genetic;Geographic Locations;germ free condition;HIV;HIV/AIDS;Human;Human Resources;Individual;Institution;International;Island;Macaca;Macaca mulatta;Maintenance;Medical;Methodology;Modeling;Modification;Monkeys;nonhuman primate;Occupational Health;Peer Group;Physiology;Primates;programs;Protocols documentation;Research;research and development;Resources;Risk;Science;Simian Retroviruses;SIV;Source;STLV-3;Testing;therapeutic development;United States National Institutes of Health;virology;Virus;virus testing

PROJECT_TITLE: Viral Testing


NIH_SPENDING_CATS: Antimicrobial Resistance;Biotechnology;Infectious Diseases;Orphan Drug;Rare Diseases;Vector-Borne Diseases

ORG_CITY: NAPERVILLE

ORG_NAME: ACHEMINALL CORPORATION

ORG_STATE: IL

PHR: NARRATIVE The proposed studies focus on schistosomiasis, a significant, unmet medical need in 78 endemic countries, with more than 200 million people infected, 20 million with significant morbidity, and more than 200,000 deaths annually. Current schistosomiasis control strategies rely almost exclusively on chemotherapy; there is only one available drug and it is inevitable that drug-resistant parasites will evolve. The proposed research will exploit differences in redox defenses between schistosome worms and humans to discover and optimize small molecule orally bioavailable inhibitors to selectively disrupt worm redox for new treatments for schistosomiasis.

PI_NAMEs: PETUKHOV, PAVEL  (contact)

PROJECT_TERMS: Adolescent;Adsorption;Adult;Animal Model;Antioxidants;Binding;Biochemical;Biochemistry;Biological Assay;Biological Availability;Cessation of life;Chemicals;chemotherapy;Chronic disability;Chronic Disease;Clinical;comparative efficacy;Computer Assisted;Computer-Aided Design;Country;Cryoelectron Microscopy;design;Development;Disease;Drug Design;drug discovery;Drug Kinetics;drug metabolism;Drug resistance;Drug Targeting;efficacy evaluation;enzyme activity;Enzymes;Evolution;Excretory function;Feasibility Studies;follow-up;Follow-Up Studies;Future;glutaredoxin;Glutathione Reductase;Goals;high throughput screening;Human;improved;in silico;In Vitro;in vivo;Infection;inhibitor;intraperitoneal;Lead;Lethal Dose 50;Libraries;Ligands;Mammalian Cell;Mediator;Medical;meetings;member;Metabolism;Molecular;Molecular Target;Molecular Weight;Morbidity - disease rate;Mus;neglect;new therapeutic target;novel;novel therapeutic intervention;novel therapeutics;Oral;Oral Administration;Oxidation-Reduction;Parasite resistance;Parasites;Persons;Pharmaceutical Chemistry;Pharmaceutical Preparations;phase 2 study;Plasma;Praziquantel;Praziquantel resistance;preclinical study;Property;Protein Family;Proteins;Publishing;Recombinant Proteins;Research;Research Design;RNA Interference;Roentgen Rays;Safety;scaffold;Schistosoma;Schistosoma mansoni;Schistosome Parasite;Schistosomiasis;Schistosomicides;screening;Selenocysteine;small molecule;Solubility;standard of care;structural biology;Structure;Therapeutic;thioredoxin reductase;Toxic effect;TXN gene;Vertebrates

PROJECT_TITLE: Discovery and development of novel schistosomicidal agents


NIH_SPENDING_CATS: Genetics;HIV/AIDS;Infectious Diseases

PHR: NARRATIVE: We have designed genetic management strategies for the CPRC SPF and conventional colonies since 2015 in order to efficiently monitor the genetic diversity of SPF animals. As a result, we have constructed multigenerational pedigrees for the CPRC SPF program. We will use this relational database to aid researchers in selecting appropriate animals for their specific needs, maintaining genetic diversity in the colony, and enhancing the production of new SPF animals during the proposed project.

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Age;Alleles;Animal Experimentation;Animal Genetics;animal resource;Animals;Autoimmune Diseases;Biomedical Research;Breeding;cohort;Communicable Diseases;Communities;Data;Data Analyses;Databases;Decision Making;deep sequencing;design;Ensure;Exhibits;Founder Effect;Genetic;genetic analysis;Genetic Databases;Genetic Drift;Genetic Heterogeneity;genetic pedigree;Genetic Variation;Genome;Goals;Haplotypes;Health;HIV/AIDS;Inbreeding;Individual;life history;Longevity;Macaca mulatta;Maintenance;Methods;MHC Class I Genes;Mission;Modeling;Monitor;nonhuman primate;Phenotype;Population Genetics;preservation;Primates;Procedures;Production;Productivity;programs;relational database;reproductive;Research;Research Design;Research Personnel;Research Subjects;response;Science;Time

PROJECT_TITLE: MHC Genetic Typing


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Neurosciences;Patient Safety

ORG_CITY: Bedford

ORG_NAME: VIVONICS, INC.

PHR: Project Narrative  Ménière's disease (MD) is a debilitating ailment characterized by episodic attacks of vertigo, which greatly decrease patients' quality of life and increase their risk of injury from everyday activities. The etiology of the disease, however, is still unknown, making a comprehensive treatment difficult. We are developing an easy-to- use, portable system that utilizes non-invasive galvanic (electrical) vestibular stimulation to suppress vertigo, allowing MD patients to abort an attack and thereby improve their quality of life.

PI_NAMEs: HIRSCHMAN, GORDON B (contact);MCCASLIN, DEVIN LOCHLAN

PROGRAM_OFFICER_NAME: MILLER, ROGER

PROJECT_TERMS: Activities of Daily Living;Acute;Affect;analog;Binaural;caloric stimulation;Caloric Tests;Characteristics;Clinical;Clinical Data;Clinical Protocols;cohort;commercialization;Computer software;Dangerousness;data acquisition;design;Development;Devices;Disease;Documentation;Effectiveness;Electric Stimulation;Electrodes;Environment;Etiology;experience;fall injury;Frequencies;General Population;Health;Human;human subject;improved;Individual;Injury;Institutional Review Boards;Labyrinthitis;Left;Long-Term Effects;Marketing;Measures;Medical;Meniere's Disease;Mental Health;Methods;Michigan;Modeling;Motion;Motion Perception;neural;new technology;Operative Surgical Procedures;outreach;Pathologic Nystagmus;patient population;Patients;Perception;Persons;Phase;physical conditioning;portability;Quality of life;Randomized;Recovery;recruit;Reflex action;Reporting;Research;research clinical testing;response;Rest;Risk;Rotation;Safety;Semicircular canal structure;Severities;simulation;Skin;Specific qualifier value;success;Suggestion;Surveys;Symptoms;System;Technology;Temperature;Testing;Time;United States;Universities;usability;Vertigo;Vestibular Diseases;Vestibular dysfunction;Vestibular function;Vestibular Neuronitis;vestibular system;Vestibule;virtual;Visual;Water;wearable device

PROJECT_TITLE: Galvanic Vestibular Stimulation to mitigate episodic Vertigo