NIH_SPENDING_CATS: Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Heart Disease;Prevention

ORG_CITY: BOSTON

ORG_NAME: MASSACHUSETTS GENERAL HOSPITAL

PHR: People living with HIV (PWH) have increased risk of cardiovascular disease (CVD) that is caused in part by risk factors that differ from those in people without HIV. Risk prediction scores can estimate an individual’s risk of developing a CVD event, but established scores have been shown to be inaccurate in PWH. The goal of this proposal is to develop a new CVD risk prediction score for PWH, using data from a large global HIV prevention trial (Randomized Trial to Prevent Vascular Events in HIV, REPRIEVE) and incorporating biomarkers of inflammation, imaging, and genetic information to improve the accuracy of CVD risk prediction for the HIV population.

PI_NAMEs: TRIANT, VIRGINIA ATHENA (contact)

PROGRAM_OFFICER_NAME: COADY, SEAN

PROJECT_TERMS: adjudication;Aging;Algorithms;Angiography;Autoimmune Diseases;barrier to care;Biological Markers;Blood Vessels;Calibration;Cardiovascular Diseases;cardiovascular disorder prevention;cardiovascular disorder risk;cardiovascular risk factor;Cardiovascular system;Caring;Clinical;clinical care;clinical practice;clinical risk;cohort;comorbidity;Coronary Arteriosclerosis;coronary computed tomography angiography;coronary plaque;Coupled;Data;demographics;design;Discrimination;Disease;Disease Outcome;Disparity;Ethnic Origin;Event;Funding;General Population;Genetic;genetic information;genetic variant;Genotype;Geographic Locations;Goals;Guidelines;HIV;HIV prevention trial;Image;immune activation;immune imaging;Immunologic Markers;Immunologics;improved;indexing;Individual;Inequity;Inflammation;Inflammatory;interest;Knowledge;lifestyle factors;Modeling;multidisciplinary;novel;Participant;Performance;Persons;Phenotype;polygenic risk score;Population;Population Group;Positioning Attribute;prevent;Prevention strategy;Preventive care;prototype;Race;randomized trial;Research;Risk;Risk Factors;risk prediction;risk prediction model;sex;Vulnerable Populations;Work;X-Ray Computed Tomography

PROJECT_TITLE: Enhancing cardiovascular risk prediction in HIV using novel factors in the REPRIEVE trial

STUDY_SECTION: HCCS

STUDY_SECTION_NAME: HIV Comorbidities and Clinical Studies Study Section[HCCS]


ADMINISTERING_IC: DA

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Drug Abuse (NIDA only);Fentanyl Misuse and Addiction;Nanotechnology;Neurosciences;Opioid Misuse and Addiction;Opioids;Physical Injury - Accidents and Adverse Effects;Substance Misuse

ORG_CITY: SAN DIEGO

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: CIBOTS, INC.

ORG_STATE: CA

PHR: The number of opioid deaths has exploded in the last two years. This eruption of overdose deaths is being wrought by a deadly cocktail of fentanyl and xylazine. Xylazine, also known as “Tranq” or “zombie drug”, is a powerful veterinary sedative that is incredibly dangerous to people on its own. Xylazine extends the high or euphoria of opioids, affording greater profits for traffickers. No approved antidote for xylazine exists. Further, an agent reversing both opioid and xylazine overdose is an unmet clinical need. Our Solution: NarcoBondα2/µO - a “nanosponge” containing decoy receptors for fentanyl (mu opioid receptor) and xylazine (α2A-adrenergic receptor -α2A) safely corrals these drugs in the peripheral blood, sparing the patient from the high CNS concentrations that depress respiration and cause death. A beneficial outgrowth of this mechanism is a broad capability to mitigate against all opioids & all alpha2 agonists (e.g., Xylazine or its future illicit successors). Clinical development of NarcoBondα2/µO will deliver a much needed paradigm shifting treatment for drug overdose, saving lives.

PI_NAMEs: ESMAELI-AZAD, BABAK  (contact)

PROGRAM_OFFICER_NAME: SABIRZHANOV, BORIS YEVGENYEVICH

PROJECT_TERMS: Absence of pain sensation;Accounting;Acute;Adrenergic Receptor;Agonist;Analgesics;antagonist;Antidotes;Back;Binding;Biological Assay;Biomimetics;Brain;Cause of Death;Cell membrane;Cells;Central Nervous System;Cessation of life;Cholesterol;Choline;Circulation;Clinical;clinical development;Cyclic AMP;Dangerousness;Data;Derivation procedure;Development;Dose;drug of abuse;Drug Receptors;Environment;Euphoria;Explosion;Fentanyl;first responder;Future;Hospitals;Human;Illicit Drugs;In Vitro;innovation;Intravenous;Legal patent;Lethal Dose 50;Life;Link;liposomal formulation;Liposomes;Literature;Membrane Proteins;Methamphetamine;mu opioid receptors;Mus;Naloxone;nano;nanoparticle;Nanosphere;Opioid;opioid epidemic;opioid mortality;opioid overdose;Overdose;overdose death;Patients;Peripheral;peripheral blood;Persons;Pharmaceutical Preparations;pharmacologic;Phase;phase 2 study;Phospholipids;Plasma;Play;Porifera;Quality Control;radioligand;receptor;receptor binding;Resources;Respiration;respiratory;Respiratory physiology;response;Rodent;Route;screening;Sedation procedure;sedative;side effect;Small Business Innovation Research Grant;Specificity;Spinal Cord;stem;Surface;Time;Toxic effect;United States;Ventilatory Depression;Work;Xylazine

PROJECT_TITLE: Xylazine and opioid overdose mitigation therapy using decoy receptor biomimetic nanoparticles, NarcoBond platform

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

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

ORG_CITY: DURHAM

ORG_NAME: EYDIS BIO, INC.

ORG_STATE: NC

PHR: PROJECT NARRATIVE Development of an orally bioavailable inhibitor of the protein kinase TAK1 should have a major impact on systemic sclerosis-associated interstitial lung disease (SSc-ILD) treatment strategies by broadening the landscape of therapeutic options for these patients. Current standard of care for SSc-ILD is primarily symptom- based with limited efficacy, and no treatment has been shown to alter disease progression or reduce mortality, leading to an increased burden on the quality of life of patients and higher costs to the US healthcare system and economy at large. Providing the SSc-ILD market with a novel alternative to current treatment options (such as a TAK1 inhibitor) which is safer and more effective than current products, will significantly improve the quality of care for SSc patients in the US and across the globe.

PI_NAMEs: HAYSTEAD, TIMOTHY A;SCARNEO, SCOTT  (contact)

PROGRAM_OFFICER_NAME: VUGA, LOUIS J

PROJECT_TERMS: Animals;Aspergillus fumigatus;Attenuated;Autoimmune;Automobile Driving;Biological Availability;Bleomycin;Cardiovascular system;Cell Reprogramming;cell type;Cessation of life;Clinical Treatment;Complex;cost;cytokine;Cytokine Signaling;Data;Death Rate;Development;Disease;disease model;Disease Progression;Disproportionately impacts women;Dose;Elements;Epigenetic Process;FDA approved;Female;Fibroblasts;Fibrosis;Future;Gene Expression;Genetic Risk;genotoxicity;Healthcare Systems;Histologic;Human;immunomodulatory therapies;improved;In Vitro;in vivo;Infection;Inflammation;Inflammatory;inhibitor;innovation;Interleukin-6;Interstitial Lung Diseases;Intervention;Investigational Drugs;IRAK4 gene;Laboratories;Lead;Ligands;lung histology;lung pathogen;Macrophage;male;Mammalian Cell;Marketing;Measurement;Mediating;Mediator;Medical;Mesenchymal Stem Cells;Methotrexate;Micronucleus Tests;Modeling;mortality;mouse model;Mus;Myofibroblast;new therapeutic target;novel;Nuclear;Older Population;Opportunistic Infections;Oral;Organ;p38 Mitogen Activated Protein Kinase;pathogen;Pathogenesis;Pathogenicity;Pathway interactions;Patient Care;Patients;Pharmaceutical Chemistry;Pharmacodynamics;Pharmacology;Phase;Phase I Clinical Trials;Phosphotransferases;Play;pre-clinical;pre-Investigational New Drug meeting;preclinical study;Prevention;Process;Production;programs;protein activation;Protein Kinase;protein kinase inhibitor;PTK2 gene;Pulmonary Fibrosis;pulmonary function;Quality of Care;Quality of life;Rare Diseases;Recovery;response;Risk;Role;Safety;scaffold;Schedule;Serology;Severity of illness;Signal Pathway;Signal Transduction;skin fibrosis;small molecule inhibitor;Sprague-Dawley Rats;standard of care;Symptoms;System;Systemic Scleroderma;Systemic Therapy;targeted treatment;Therapeutic;therapeutic target;TLR4 gene;Toxicology;Transforming Growth Factor beta;treatment strategy;vascular injury;Work

PROJECT_TITLE: Novel compounds for the treatment of systemic sclerosis-associated interstitial lung disease

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


ADMINISTERING_IC: AA

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Brain Disorders;Breastfeeding, Lactation and Breast Milk;Clinical Research;Clinical Trials and Supportive Activities;Conditions Affecting the Embryonic and Fetal Periods;Dissemination and Implementation Research;Fetal Alcohol Spectrum Disorders (FASD);HIV/AIDS;Infectious Diseases;Intellectual and Developmental Disabilities (IDD);Maternal Health;Maternal Morbidity and Mortality;Pediatric;Pediatric - AIDS;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Prevention;Substance Misuse;Women's Health Research

ORG_CITY: LOS ANGELES

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: UNIVERSITY OF CALIFORNIA LOS ANGELES

PHR: PROJECT NARRATIVE  South Africa has the highest combined prevalence of alcohol use in pregnancy and HIV in the world; pregnant women without HIV require access to effective HIV prevention including oral pre-exposure prophylaxis (PrEP), and pregnant women living with HIV who use alcohol may access antiretroviral therapy (ART) late or disengage with ART prior to or during pregnancy, increasing the risk of vertical HIV transmission. There are no evidence-based, community-informed interventions available to minimize the range of negative health outcomes due to alcohol and HIV in pregnancy. Our innovative study seeks to: · Aim 1: Conduct a mixed methods assessment of alcohol use in pregnancy and facilitators of alcohol  reduction in pregnancy among multilevel stakeholders of pregnant women who use alcohol to identify  clinic and community level facilitators that could be used to reduce the use of alcohol during pregnancy; · Aim 2: Adapt and refine an evidence-based HIV prevention intervention, Mentor Mothers (MM+), to  include perinatal alcohol use and HIV care with potential beneficiaries (pregnant women who use  alcohol), healthcare providers and community leaders; · Aim 3: Evaluate the feasibility and acceptability of MM+ on reduction of alcohol use (primary outcome)  and PrEP use (in pregnant women without HIV) and ART adherence (in pregnant women living with  HIV) (secondary outcomes), as well as feasiblity (among providers), acceptabilty (among pregnant  women) and fidelity to the intervention, to inform future research and scaled interventions in South  Africa and throughout the region.

PI_NAMEs: ESSACK, ZAYNAB ;JOSEPH DAVEY, DVORA LEAH (contact)

PROGRAM_OFFICER_NAME: FREEMAN, ROBERT

PROJECT_TERMS: acceptability and feasibility;Acquired Immunodeficiency Syndrome;Address;Adherence;Africa;AIDS prevention;Alcohol consumption;alcohol consumption during pregnancy;alcohol research;Alcohols;antenatal;antenatal care;antiretroviral therapy;Area;Behavioral;Behavioral Research;beneficiary;brief intervention;California;care outcomes;Caring;Child;Childhood;Clinic;Collaborations;Collection;Communities;community based participatory approach;community based participatory research;community burden;community collaboration;community engaged intervention;community engagement;community partners;comorbidity;Counseling;Data;deviant peer;Disproportionately impacts women;drinking;Educational workshop;Epidemiology;Evaluation;evidence base;Evidence based intervention;experience;Family;Feedback;Fetal Alcohol Syndrome;Fetus;Focus Groups;Foundations;Goals;Harm Reduction;Health;health of the mother;Health Personnel;HIV;HIV risk;Human;implementation outcomes;improved;Incidence;innovation;Intervention;Interview;Lactation;Live Birth;Los Angeles;Maternal and Child Health;Measures;member;Mentors;Mentorship;Methods;Midwife;Modeling;Mothers;motivational enhancement therapy;National Institute on Alcohol Abuse and Alcoholism;novel;Nurses;Oral;Outcome;Participant;peer;peer coaching;Perception;Perinatal;Persons;phosphatidylethanol;Postpartum Period;pre-exposure prophylaxis;Pregnancy;pregnant;Pregnant Women;Prevalence;Prevention;preventive intervention;primary outcome;Prior Therapy;Process;Professional counselor;Provider;Randomized, Controlled Trials;reduced alcohol use;Research;Risk;Risk Factors;Science;secondary outcome;Social Behavior;sociodemographics;South Africa;Structure;success;Surveys;syndemic;Techniques;Tenofovir;Testing;therapy adherence;Training;transmission process;Universities;Urine;Vertical Transmission;women of color

PROJECT_TITLE: A community-based adaptation of a peer-led intervention to address alcohol use and HIV risk in pregnant women in South Africa (Mentor Moms+)

STUDY_SECTION: PPAH

STUDY_SECTION_NAME: Population and Public Health Approaches to HIV/AIDS Study Section[PPAH]


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Emerging Infectious Diseases;Infectious Diseases;Prevention

ORG_CITY: WESTPORT

ORG_NAME: LUNA BIOSCIENCE, INC.

ORG_STATE: CT

PHR: Narrative We aim to produce new rapid, point-of-care tests for the diagnosis of leptospirosis, an infectious disease affecting more than 1 million people around the world with death rates as high as 20%. There is no vaccine to prevent this disease, and early diagnosis leads to improved outcomes. Remarkably, no clinically actionable and accurate test is currently available to diagnose this disease, which affects civilians and military personnel in the United States as well as neglected populations in the developing world.

PI_NAMEs: CHAURASIA, REETIKA  (contact)

PROGRAM_OFFICER_NAME: RITCHIE, ALEC

PROJECT_TERMS: Acute;Address;Affect;Affinity;Animal Model;antigen detection;Antigens;antimicrobial;authority;Automobile Driving;biobank;Biological Assay;Biological Products;Biological Sciences;biophysical properties;Blood;Blood specimen;Body Fluids;burden of illness;Case Fatality Rates;Cholera;Chronic;climate change;Clinical;clinical care;Clinical Management;clinically actionable;clinically relevant;commercial application;Communicable Diseases;Connecticut;Country;Data;Death Rate;Detection;detection assay;detection test;Devices;Diagnosis;Diagnostic;Diagnostic tests;Disease;disease diagnosis;Disease Management;Early Diagnosis;Early identification;Enzyme-Linked Immunosorbent Assay;Epitopes;Event;Fever;Floods;Hamsters;Hand;health data;Hemorrhage;Human;Immunoconjugates;improved;improved outcome;In Vitro;Income;Inequality;Infection;innovation;Intellectual Property;interest;Kidney Failure;Laboratories;lateral flow assay;Legal patent;Leptospira;Leptospira interrogans;Leptospirosis;Licensure;Lipopolysaccharides;low and middle-income countries;Lung;manufacturing scale-up;Marketing;Mediating;Mediation;member;Military Personnel;Monoclonal Antibodies;neglect;novel;Occupations;Outcome;Pathogenesis;Pathogenicity;Patients;Performance;Persons;Phase;point of care;point of care testing;Policy Making;Population;Preparation;prevent;product development;Proteins;prototype;Public Health;public health intervention;rapid diagnosis;Recombinants;Refractory;research clinical testing;Risk;Sales;Sampling;Sanitation;Security;Sensitivity and Specificity;Serum;Shock;Small Business Technology Transfer Research;Solid;Specimen;Testing;therapeutic development;Therapeutic Intervention;Typhoid Fever;Undifferentiated;United States;Universities;urban setting;Urbanization;Urine;vaccine development;Vaccines;Virulence;Water;Weather;Whole Blood;Work;Zoonotic Bacterial Infection

PROJECT_TITLE: Leptospiral VM Protein Antigen Detection for Rapid Diagnosis of Leptospirosis

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


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Cancer;Cervical Cancer;Genetics;Immunization;Immunotherapy;Infectious Diseases;Orphan Drug;Prevention;Rare Diseases;Sexually Transmitted Infections;Vaccine Related;Women's Health Research

ORG_CITY: RICHMOND

ORG_NAME: AMPEDRNA BIOSCIENCES LLC

ORG_STATE: VA

PHR: Despite the success of prevention efforts, human papillomavirus (HPV) is responsible for a large proportion of global cancer cases, including head and neck and cervical cancers, with greater than 18,000 deaths annually in the US. Immunotherapy with immune checkpoint inhibitors is a highly promising approach for the treatment of the most devastating solid tumors, including HPV-related cancers, but only a fraction of patients actually respond to treatment and new techniques are needed to boost the efficacy of immunotherapy. Mini-circular RNA is a highly immunogenic therapeutic cancer vaccine platform that can elicit robust activation and expansion of long- lasting tumor-targeted T cells, and a superior mini-circular RNA cancer vaccine for HPV related cancers could significantly boost the efficacy of existing immunotherapies.

PI_NAMEs: PARRY, GORDON  (contact)

PROGRAM_OFFICER_NAME: LI, MELISSA WANLING

PROJECT_TERMS: Address;anti-PD-1;antibody inhibitor;antigen-specific T cells;Antitumor Response;antiviral immunity;Benchmarking;Binding;biobank;C57BL/6 Mouse;cancer cell;Cancer Etiology;cancer immunotherapy;cancer therapy;Cancer Vaccines;Cancerous;CD14 gene;CD44 gene;CD8-Positive T-Lymphocytes;Cells;Cessation of life;checkpoint inhibition;circular RNA;Clinical;clinical development;Clinical Trials;Coculture Techniques;Codon Nucleotides;Collecting Cell;Combination immunotherapy;cost;cost effective;Cryopreservation;cytokine;Data;Dendritic Cells;Development;Disease;Dose;Double-Stranded RNA;Early treatment;efficacy evaluation;efficacy study;Encapsulated;Epitopes;exhaust;genetically modified cells;Goals;Haplotypes;Head and Neck Cancer;high risk;HPV E7;Human;Human Papilloma Virus Vaccine;Human Papilloma Virus-Related Malignant Neoplasm;Human Papillomavirus;Human papillomavirus 16;human subject;Immune;Immune checkpoint inhibitor;Immune system;Immunocompetent;immunogenic;immunogenicity;Immunosuppression;Immunotherapy;improved;in silico;In Vitro;in vivo;Infection;innovation;Interferon Type II;Interleukin-2;Kinetics;Length;Lesion;Ligation;Malignant neoplasm of anus;Malignant neoplasm of cervix uteri;Malignant neoplasm of pancreas;Malignant Neoplasms;Melanoma;Messenger RNA;Modeling;Monitor;monocyte;Mus;neoplasm immunotherapy;neoplastic cell;novel therapeutic intervention;Oligonucleotides;Papillomavirus Transforming Protein E6;Patients;Peptides;Peripheral;Peripheral Blood Mononuclear Cell;Pilot Projects;premalignant;Prevalence;Preventative vaccination;Prevention;Process;protein activation;Protein Inhibition;protein kinase R;Proteins;Pseudouridine;receptor;Recurrence;response;Risk;RNA;RNA chemical synthesis;RNA vaccine;Safety;Sampling;screening;SELL gene;Solid Neoplasm;Stains;Structure;success;systemic toxicity;T cell response;T cell therapy;T memory cell;T-Cell Activation;T-Lymphocyte;Techniques;Therapeutic;therapeutic vaccine;therapeutically effective;Time;Toxicology;Transfection;Translations;Treatment Efficacy;treatment response;tumor;Tumor Expansion;tumor growth;vaccine platform;Vaccines;Viral Vector;Virus

PROJECT_TITLE: Highly stable mini-circRNA vaccine with maximally activated and long-lasting T cells for HPV-related cancer combination immunotherapy

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


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cardiovascular;Data Science;Heart Disease;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Transplantation

ORG_CITY: DUBLIN

ORG_NAME: DASISIMULATIONS LLC

ORG_STATE: OH

PHR: PROJECT NARRATIVE The current process physicians must undergo to obtain pre-procedural planning measurements before transcatheter aortic valve replacement (TAVR) is very time-consuming and subject to high variability between physicians and manual error. Additionally, the burden of taking these measurements is often given to industry representatives who only measure for the valve manufactured by the device company they represent. The software developed in this grant proposal uses artificial intelligence to automatically complete patient-specific measurements, eliminating manual error and device bias.

PI_NAMEs: DASI, LAKSHMI PRASAD (contact)

PROGRAM_OFFICER_NAME: EVANS, FRANK

PROJECT_TERMS: adverse outcome;Algorithms;Anatomy;aortic valve;aortic valve replacement;Applications Grants;Artificial Intelligence;artificial intelligence model;Artificial Intelligence platform;Bicuspid;Biological;Cardiac;Catheters;Clinic;Clinical;cloud based;commercialization;Complex;Complication;Computer software;Computer Vision Systems;Consumption;contrast enhanced computed tomography;convolutional neural network;Coronary;Coupling;Data Science;Data Set;Detection;Devices;Dimensions;Doctor of Philosophy;Engineering;experience;Feedback;Food Packaging;Future;Grant;Hand;Health Care Costs;Heart;Heart Valves;Hospitals;Hour;Human;Image;imager;Incidence;Industry;innovation;Intellectual Property;interest;Intervention;Knowledge;Lead;Learning;Legal patent;Licensing;Manuals;manufacture;Manufacturer;Marketing;Measurement;Measures;Medical center;Morphology;next generation;Occupations;Ohio;Patient-Focused Outcomes;Patients;Persons;Phase;Physicians;Physiology;Procedures;Process;radiologist;Recommendation;Reporting;Reproducibility;Sales;Sample Size;Sampling;Savings;sex;simulation;Small Business Innovation Research Grant;software as a medical device;software development;Specialist;Surgeon;Techniques;Technology;Testing;Time;tool;Training;Translating;United States;United States Food and Drug Administration;Universities;Validation;valve replacement;verification and validation;Work;X-Ray Computed Tomography

PROJECT_TITLE: Rapid, Automatic, AI Driven, Aortic Valve Measurement Software

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 ISB-S (13)]


ADMINISTERING_IC: AG

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Aging;Pain Research;Physical Injury - Accidents and Adverse Effects

ORG_CITY: New Rochelle

ORG_NAME: NEW YORK/R&D/CTR/TRANSLATIONAL MED/THER

ORG_STATE: NY

PHR: Project Narrative Tendinopathy is a common age-related chronic tendon disorder, characterized by pain and impaired performance, and currently has no cure or effective treatments. The proposed study will test the efficacy and safety of a novel class of exosomes in validated animal models of tendinopathy. The preclinical study is a critical step for the translation of this novel class of exosomes toward the clinical phase and ultimately an FDA-approved drug for tendinopathy.

PI_NAMEs: FUNG, DAVID T (contact)

PROGRAM_OFFICER_NAME: FOX, JENNIFER THERESA

PROJECT_TERMS: 3-Dimensional;achilles tendon;adipose derived stem cell;Adverse effects;age related;Allogenic;Animal Model;Attention;Autologous;Biological;Biological Products;bone marrow mesenchymal stem cell;Businesses;cell bank;Chronic;Clinical;Clinical Pathology;collagenase;commercialization;Cues;Data;Deterioration;Development;Disease;Dose;Drug Kinetics;effective therapy;efficacy evaluation;efficacy testing;Engineering;Equity;exosome;FDA approved;Fiber;Filtration;Future;Goals;Histologic;Histopathology;HMGB1 gene;Human;Hyaluronic Acid;Impairment;improved;Injections;interest;Investments;manufacturing process;Marketing;Measurement;mechanical properties;Modeling;nanoparticle;New York;Non-Steroidal Anti-Inflammatory Agents;novel;Oryctolagus cuniculus;Outcome;Pain;pain behavior;pain relief;Pathogenesis;Pathologic;Pathology;Performance;Pharmaceutical Preparations;Phase;phase 2 study;Placebos;polycaprolactone;pre-clinical;preclinical study;Process;Production;protein biomarkers;Rattus;research and development;Safety;scaffold;Schedule;Signaling Molecule;Silk;Site;Small Business Innovation Research Grant;stem cells;Steroids;success;Surface;Swelling;System;Techniques;Technology;Tendinopathy;tendon rupture;Tendon structure;Testing;Therapeutic;Therapeutic Effect;Tissues;Toxic effect;translational medicine;translational therapeutics;Translations

PROJECT_TITLE: Exosome drug for tendinopathy

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

ORG_CITY: EAST HANOVER

ORG_NAME: MYRACLE THERAPEUTICS INC

ORG_STATE: NJ

PHR: Project Narrative Global or adipocyte-specific deletion of the zinc-dependent enzyme, histone deacetylase 11 (HDAC11), in mice prevents weight gain and improves overall metabolic health (e.g., enhanced glucose tolerance and reduced liver steatosis) by promoting energy expenditure and ameliorating fat dysfunction, hallmarks of which are insulin resistance, inflammation and fibrosis. HDAC11 presents a novel, druggable target against which it is possible to develop selective inhibitors which could become safe and effective drugs for patients suffering from obesity and its metabolic adverse effects. This work is focused on discovering lead compounds and sets the stage for subsequent lead optimization and Investigational New Drug filing.

PI_NAMEs: BELL, DAWN  (contact)

PROGRAM_OFFICER_NAME: COOKE, BRAD

PROJECT_TERMS: Adipocytes;Adipose tissue;Adult;Adverse effects;aged;Agonist;ATP Synthesis Pathway;Biological Assay;Brown Fat;Cardiovascular Diseases;Cause of Death;Chemicals;Child;Chronic;Deacetylase;design;Desire for food;Development;Disease;druggable target;Electron Transport;Energy Metabolism;Enzymes;Fatty acid glycerol esters;Fatty Liver;feeding;Fibrosis;Functional disorder;Funding;GLP-I receptor;glucose tolerance;Goals;HDAC11 gene;Health;high throughput screening;Histone Deacetylase;Histone Deacetylase Inhibitor;Human;human disease;Hydroxamic Acids;improved;In Vitro;in vivo;Individual;Inflammation;inhibitor;innovation;Insulin;Insulin Resistance;interest;Investigation;Investigational Drugs;Investments;Knock-out;Knockout Mice;Lead;lead optimization;Licensing;Link;Lysine;Metabolic;Metabolic Diseases;mimetics;Molecular;Mus;Names;Non-Insulin-Dependent Diabetes Mellitus;novel;novel therapeutics;Obesity;Obesity associated disease;obesity treatment;Overweight;Pancreas;Patients;Pharmaceutical Chemistry;Pharmaceutical Preparations;Pharmacologic Substance;Pharmacotherapy;Phase;Phenotype;Prevalence;prevent;programs;Property;Series;Structure-Activity Relationship;targeted agent;Therapeutic;Thermogenesis;tool;uncoupling protein 1;United States;United States National Institutes of Health;Weight Gain;Work;Zinc

PROJECT_TITLE: Discovery and optimization of novel, selective HDAC11 inhibitors for the treatment of obesity and related diseases.

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


ED_INST_TYPE: SCHOOLS OF NURSING

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Cardiovascular;Clinical Research;Clinical Trials and Supportive Activities;Complementary and Integrative Health;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Heart Disease;Mental Health;Prevention;Social Determinants of Health;Women's Health Research

ORG_CITY: BIRMINGHAM

ORG_DEPT: OTHER HEALTH PROFESSIONS

ORG_NAME: UNIVERSITY OF ALABAMA AT BIRMINGHAM

ORG_STATE: AL

PHR: Project Narrative This project focuses on adapting and pilot testing an effective stress management intervention uniquely tailored to mitigate cardiovascular disease risk among women living with HIV (WLHIV) In the Southern United States (US). WLHIV in this region often experience an intersectionality of structural and social stressors (e.g., poverty, stigma, and discrimination) which negatively contributes to increased risk for cardiovascular disease through their impact on stress. By tailoring the intervention to meet the unique needs and challenges of this population, we aim to enhance the acceptability, relevance, and usefulness of the evidence-based intervention to reduce stress and improve cardiovascular disease outcomes among WLHIV in the South.

PI_NAMEs: WISE, JENNI M (contact)

PROGRAM_OFFICER_NAME: CAMPO, REBECCA A

PROJECT_TERMS: Address;Adherence;Anxiety;Award;behavior test;Behavior Therapy;Behavioral;biological adaptation to stress;Blood Pressure;blood pressure reduction;Cardiac rehabilitation;Cardiovascular Diseases;cardiovascular disorder risk;cardiovascular risk factor;care providers;Clinical;comorbidity;Consultations;Data;Death Rate;design;Development;Diabetes Mellitus;Discrimination;Disease;disease disparity;Disease Management;Disease Outcome;Educational Intervention;efficacy testing;efficacy validation;Energy Metabolism;Ensure;Environmental Impact;environmental stressor;evidence base;Evidence based intervention;experience;Exposure to;Faith;Feedback;Focus Groups;Gene Expression;General Hospitals;General Population;Goals;high risk;HIV;HIV Infections;Hydrocortisone;Hypertension;implementation intervention;implementation trial;improved;Individual;Inflammatory;insight;insulin secretion;intersectionality;Intervention;Interview;K-Series Research Career Programs;Knowledge;life span;Link;Massachusetts;Measurement;Mediating;Mental Depression;Mentors;Mentorship;Morbidity - disease rate;Obesity;Pathway interactions;perceived stress;Persons;Physiological;pilot test;Population;Poverty;preference;Prevalence;Prevention Guidelines;programs;promote resilience;Quality of life;randomized trial;Research;Research Personnel;resilience;response;Risk;Risk Factors;Risk Reduction;skills;social health determinants;social stigma;social stressor;Stress;stress management;stress reduction;stress related disorder;stress resilience;structural determinants;Sympathetic Nervous System;Symptoms;Testing;Training;Training Support;treatment as usual;United States;United States National Institutes of Health;uptake;Viral;Vulnerable Populations;Woman;women's morbidity;Women's mortality;women's outcomes;Women's prevalence;Work

PROJECT_TITLE: Adapting and Piloting a Stress Management Intervention to Reduce Cardiovascular Disease Risk among Women Living with HIV

STUDY_SECTION: MPOR

STUDY_SECTION_NAME: NHLBI Mentored Patient-Oriented Research Study Section[MPOR (JA)]


FUNDING_MECHANISM: TRAINING, INDIVIDUAL

NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Emerging Infectious Diseases;Genetics;Hematology;Human Genome;Infectious Diseases;Lymphatic Research;Lymphoma;Rare Diseases

ORG_CITY: CHICAGO

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

ORG_STATE: IL

PHR: PROJECT NARRATIVE Kaposi’s Sarcoma-Associated Herpesvirus (KSHV) is a primary cause of several AIDS-associated cancers. This research aims to determine the roles of KSHV-encoded microRNAs (miRNAs), which have largely remained unknown. Results will not only deepen our understanding of how KSHV causes cancer but also provide broader insights into cancer biology, offering potential avenues for improved therapeutic strategies across various malignancies.

PI_NAMEs: ORTEGA, JESUS ANGEL (contact)

PROGRAM_OFFICER_NAME: MOITRA, KAROBI

PROJECT_TERMS: AIDS related cancer;Apoptosis;Architecture;B lymphoid malignancy;B-Cell Lymphomas;Base Pairing;Binding;Bioinformatics;Biology;Cancer Biology;Cancer Etiology;Cell Cycle Progression;Cell Line;Cell Proliferation;Cell Survival;Clustered Regularly Interspaced Short Palindromic Repeats;Cullin Proteins;Custom;Data;Data Set;Dependence;design;Etiology;experimental study;Gene Expression;gene repression;Genes;Genome;genome editing;genome-wide;Goals;HIV/AIDS;Human;Human Herpesvirus 8;improved;Individual;inhibitor;innovation;insight;Institution;Laboratory Research;loss of function;Lymphoma;Lymphoma cell;Lymphomagenesis;Lytic;Malignant Neoplasms;Mentors;Messenger RNA;MicroRNAs;Molecular;Molecular Biology;Molecular Conformation;Neoplasms;novel;novel therapeutic intervention;Nucleotides;Oncogenic;Oral;Pathogenesis;Play;posttranscriptional;primary effusion lymphoma;Prognosis;Proliferating;Proteins;Publishing;recruit;Repression;Research;RNA-Induced Silencing Complex;Role;Running;skills;success;Therapeutic;transcriptome;transcriptome sequencing;tumorigenesis;ubiquitin-protein ligase;Untranslated RNA;Viral;Work;Writing

PROJECT_TITLE: Viral miRNA Essentiality in Primary Effusion Lymphoma

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


NIH_SPENDING_CATS: Biotechnology;Clinical Research;Gene Therapy;Genetics;HIV/AIDS;Immunotherapy;Infectious Diseases

ORG_CITY: SEATTLE

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: PROJECT NARRATIVE HIV remains a substantial public health burden, as antiretroviral therapy (ART) is capable of suppressing viral replication but not curing infected individuals. Therefore, transmission continues globally with treatment barriers that include limited healthcare access and toxicity from ART. To achieve viral suppression without the need for ART, this proposal will advance HIV-targeting CAR T cells with enhanced long-term persistence.

PI_NAMEs: BUI, JOHN K (contact)

PROGRAM_OFFICER_NAME: POON, BETTY

PROJECT_TERMS: Adherence;Adoptive Cell Transfers;Agonist;Allogenic;Antigens;antiretroviral therapy;Antitumor Response;Applications Grants;Attention;Binding;Biological Assay;CAR T cell therapy;career;cell killing;Cell Physiology;Cells;chimeric antigen receptor;chimeric antigen receptor T cells;Chronic;chronic infection;Collaborations;Communicable Diseases;Communication;Communities;cytokine;cytotoxicity;Data;design;Dimensions;Disease;Disease Progression;Disease remission;Drug Kinetics;efficacy evaluation;Engineering;exhaustion;experience;Fostering;functional improvement;Future;gene therapy;Goals;health care availability;Hematopoietic Stem Cell Transplantation;high risk;HIV;HIV Infections;Immune;Immune response;Immunophenotyping;Immunotherapy;In Vitro;in vivo;Individual;Infection;infectious disease treatment;insight;Institution;Interleukin-15;Interruption;Laboratories;Learning;Ligands;lymph nodes;Malignant Neoplasms;Measures;Membrane;Mentors;Modeling;next generation;nonhuman primate;novel;Outcome;Persons;Pharmaceutical Preparations;Physicians;Positioning Attribute;prevent;Principal Investigator;Proliferating;Public Health;Publications;Research;Safety;Scientific Inquiry;Scientist;Series;Signal Transduction;success;symposium;T cell response;T-Cell Activation;T-Cell Immunologic Specificity;T-Cell Proliferation;T-Lymphocyte;Technical Expertise;Testing;Toxic effect;trafficking;Training;Translating;transmission process;treatment response;treatment strategy;Viral;Viral Load result;viral rebound;Viremia;Virion;Virus;Virus Replication;Writing

PROJECT_TITLE: ENHANCEMENT OF CD4CAR T-CELL PERSISTENCE IN VIVO

STUDY_SECTION: AIDS

STUDY_SECTION_NAME: Acquired Immunodeficiency Syndrome Research Study Section[AIDS]


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

ORG_CITY: MIDWEST CITY

ORG_NAME: ALZARROK BIO LLC

ORG_STATE: OK

PHR: Project Narrative: Alzheimer’s disease (AD) is a progressive neurodegenerative disorder, leading to cognitive decline and irremediable progression to full dementia and death. Absence of safe and effective pharmacological treatment for AD remains a huge unmet clinical need. Our drug candidate is expected to inhibit safely and efficiently the underlying complex pathogenesis driving the progression of this disease, by virtue of its synergistic multitarget activity.

PI_NAMEs: KASUS-JACOBI, ANNE  (contact)

PROGRAM_OFFICER_NAME: MARTIN, ZANE

PROJECT_TERMS: abeta deposition;Adverse effects;Affinity;Agonist;Alzheimer's Disease;Alzheimer's disease brain;Alzheimer's disease model;Alzheimer's disease patient;APP-PS1;Automobile Driving;behavioral outcome;Binding;Biochemical;Biological;Blood;Brain;brain tissue;Bypass;Calgranulin B;Cathepsin G;Cells;Cerebral Ventricles;Cessation of life;Clinic;Clinical;Clinical Trials;Complex;Dementia;Development;Devices;Disease Progression;Dose;drug candidate;Drug Interactions;Drug Targeting;effective therapy;efficacy evaluation;efficacy study;FDA approved;Formulation;Generations;Genes;Genetic Transcription;Goals;Hippocampus;Human;Impaired cognition;In Vitro;in vivo;Induced Neurons;Intranasal Administration;Lead;Measures;Mediator;Methods;mouse model;Mus;Nerve Degeneration;Neurodegenerative Disorders;neuroinflammation;neuron loss;neurotoxicity;Nose;osmotic minipump;Outcome;overexpression;Pathogenesis;Pathway interactions;Patients;peptide drug;Peptides;Persons;Pharmaceutical Preparations;Pharmacological Treatment;Phase;Phenotype;preclinical efficacy;Proteins;receptor;receptor for advanced glycation endproducts;Regimen;risk minimization;Saline;Self Administration;Signal Pathway;Societies;Symptoms;Testing;Therapeutic;Time;TLR4 gene;Transgenic Mice;Up-Regulation;Wild Type Mouse

PROJECT_TITLE: Multi-target Peptide Drug for Alzheimer's Disease

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


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

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

ORG_CITY: San Francisco

ORG_NAME: SPIKEGADGETS, LLC

PHR: This project aims to develop and commercialize an integrated circuit that can amplify and digitize 512 concurrent neural signals from multi-channel electrode arrays. Furthermore, we aim to develop and commercialize electronics that control multiple EChips at once and log the data to an SD card, offering a way to scale channel counts to above 2000 without the need for cables between the animal and a computer.

PI_NAMEs: DENES, PETER ;KARLSSON, MATTIAS PETER (contact)

PROGRAM_OFFICER_NAME: DURKIN, JACLYN MARIE

PROJECT_TITLE: A commercialized platform for diversified large-scale chronic electrophysiology

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


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

ORG_CITY: AURORA

ORG_NAME: NEUREXIS THERAPEUTICS, INC.

ORG_STATE: CO

PHR: PROJECT NARRATIVE Global cerebral ischemia (GCI) occurs not only during drowning and suffocation, but also during cardiac arrest. This results in neuronal cell death, especially in brain areas important for learning and memory, which causes many GCI patients to experience long-lasting cognitive impairments. This proposal will work towards approval of first-in-human clinical trials of a compound (tatCN19o) that can protect neurons from cell death even when administered after GCI has already occurred.

PI_NAMEs: GOFORTH, ROBYN L (contact)

PROGRAM_OFFICER_NAME: GILCHRIST, FLOY ANNETTE

PROJECT_TERMS: Adverse effects;American;Anatomy;Animal Model;aqueous;Area;Asphyxia;Behavioral;Binding;Biochemical;Biological;blood-brain barrier penetration;Brain;calmodulin-dependent protein kinase II;Canis familiaris;Cardiac;Cardiopulmonary Resuscitation;Cardiovascular system;Cells;Cerebral Ischemia;Cessation of life;Characteristics;Clinical;Clinical Protocols;Clinical Research;Clinical Trials;clinically relevant;Colorado;commercialization;Data;Detection;detection method;Development;Dissociation;Dose;Drowning;Drug Kinetics;Endotoxins;experience;Family suidae;first-in-human;Formulation;Freeze Drying;Heart Arrest;Hospitalization;Human;Impaired cognition;Impairment;improved;In Vitro;in vivo;in vivo evaluation;inhibitor;Injectable;Intellectual Property;Ischemia;kinase inhibitor;Kinetics;Lead;Learning;Legal patent;Licensing;Liquid substance;Marketing;Measures;Memory;Methods;Mus;Mutant Strains Mice;natural hypothermia;neuron loss;neuroprotection;Neuroprotective Agents;Patients;Peptides;Pharmaceutical Preparations;pharmacokinetics and pharmacodynamics;Pharmacology Study;Phase;Phase I Clinical Trials;Phosphotransferases;Plasma;pre-clinical;pre-Investigational New Drug meeting;Preparation;Process;Qualifying;Rattus;Reporting;Research Design;Residual state;respiratory pharmacology;Retrograde amnesia;Rodent;Safety;safety assessment;safety study;Saline;Sampling;Signal Transduction;Small Business Innovation Research Grant;standard of care;Sterility;Synapses;Telemetry;Testing;Therapeutic;Toxic effect;Toxicology;Universities;Validation;Ventricular Fibrillation;Water;Work

PROJECT_TITLE: IND-enabling studies for a potent and efficient neuroprotective drug


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

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

ORG_CITY: BLOOMINGTON

ORG_NAME: MEGADALTON SOLUTIONS, INC

ORG_STATE: IN

PHR: Project Narrative Charge detection mass spectrometry (CD-MS) is a technique for accurate molecular weight determination of large species such as virus particles, gene therapy vectors, liposomes, and nanoparticles which can not be analyzed using conventional mass spectrometry. This proposal outlines a strategy for designing an array of CD-MS detectors optimized for high-throughput analysis of particles in the megadalton to gigadalton mass range with throughput and sensitivity that are both expected to be approximately 100-fold higher than ion-trap CD-MS. This instrument will be widely applicable in biopharmaceutical development, diagnostics exploration, and therapeutic target evaluation.

PI_NAMEs: DRAPER, BENJAMIN E (contact)

PROGRAM_OFFICER_NAME: TAYLOR, VERONICA

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Adenoviruses;Algorithms;Amplifiers;analog;analytical ultracentrifugation;Back;Biological;Biological Products;Calibration;Capsid;Cells;Charge;Chemistry;Code;code development;Computer Analysis;computerized data processing;Consumption;Coupled;Custom;Data;design;design and construction;Detection;detection limit;detector;Development;Devices;Diagnostic;Diameter;digital;Electronics;Electrostatics;Emerging Technologies;Evaluation;exosome;Flying body movement;Fourier Transform;Frequencies;Gene Transduction Agent;Genetic Materials;Heavy Ions;high throughput analysis;HIV;Hour;improved;In Vitro;Individual;instrument;integrated circuit;Investigation;Ions;lens;Lentivirus;Lentivirus Vector;Lipoproteins;Liposomes;mass spectrometer;Mass Spectrum Analysis;Measurement;Measures;meetings;Metals;Molecular Sieve Chromatography;Molecular Weight;nanoparticle;Noise;Optics;particle;Performance;Physiologic pulse;Plastics;programs;Proteins;Reproducibility;Research;Resolution;Retroviridae;Running;Sampling;Series;Services;Signal Transduction;simulation;software development;System;Techniques;Technology;therapeutic target;Time;transmission process;Virion;voltage;Writing

PROJECT_TITLE: Multi-detector Array CD-MS for Rapid Analysis of Very High Mass Analytes

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Cancer Genomics;Dental, Oral, and Craniofacial Disease;Genetic Testing;Genetics;Human Genome;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Precision Medicine;Prevention;Rare Diseases

ORG_CITY: WILMINGTON

ORG_NAME: NORD BIO INC

ORG_STATE: DE

PHR: Cancer is a major global health issue, and early detection and monitoring are crucial for improving patient outcomes, yet currently, diagnosis and genomic analysis for personalized treatment often require invasive procedures such as biopsies. As an alternative, the detection of circulating free DNA (cfDNA) in biological fluids like blood has shown promise as a non-invasive method for detecting cancer. In this proposal, we aim to develop a reliable assay to detect and monitor cancer non-invasively using cfDNA in saliva in head and neck squamous cell carcinoma (HNSCC) samples, develop the experimental and computational methodology for HNSCC saliva cancer genomic tests, and evaluate the feasibility, sensitivity, and cost-effectiveness of this approach.

PI_NAMEs: LESHCHINER, IGNATY  (contact);LIVITZ, DIMITRI

PROGRAM_OFFICER_NAME: FRANCA-KOH, JONATHAN C

PROJECT_TERMS: Aftercare;Algorithms;analysis pipeline;Apoptosis;assay development;Atlases;Biological;Biological Assay;Biological Markers;Biopsy;Blood;Blood Cells;Blood specimen;Body Fluids;cancer cell;Cancer Detection;cancer diagnosis;cancer genomics;cancer recurrence;Cause of Death;cell free DNA;Cells;Clinical;Computational Technique;Computer Models;Computing Methodologies;Consumption;cost;cost effectiveness;Data;design;Detection;detection method;Detection of Minimal Residual Disease;detection sensitivity;Development;Diagnosis;Disease;DNA;DNA analysis;DNA Methylation;DNA Sequence Alteration;DNA sequencing;driver mutation;Early Diagnosis;Early treatment;effective therapy;Epithelium;Event;genomic data;Genomics;global health;Head and Neck Squamous Cell Carcinoma;High Prevalence;Home;HPV-negative head and neck cancer;improved;interest;Larynx;Libraries;Liquid substance;machine learning method;machine learning model;Malignant - descriptor;Malignant Neoplasms;Methodology;Methods;Modality;Modeling;Monitor;Mucous Membrane;Mutation;Mutation Detection;Necrosis;Non-Invasive Cancer Detection;Nucleic Acids;Operative Surgical Procedures;Oral cavity;oral HPV-positive head and neck cancers;Outcome;Patient-Focused Outcomes;Patients;personalized medicine;Pharyngeal structure;Phase;Plasma;Positioning Attribute;Preparation;Prevalence;Procedures;prototype;rapid test;Recording of previous events;Recurrence;Residual Cancers;Residual Neoplasm;Residual state;Resistance;Risk;Saliva;saliva sample;Sampling;screening;Screening for cancer;Sensitivity and Specificity;Signal Transduction;Single Nucleotide Polymorphism;Solid Neoplasm;Source;synthetic construct;Techniques;Testing;Time;Training;treatment response;tumor;tumor DNA;Tumor Tissue;Tumor-Derived;Urine;Validation

PROJECT_TITLE: Non-invasive cancer detection and residual disease monitoring by cell-free nucleic acid from saliva


ED_INST_TYPE: BIOMED ENGR/COL ENGR/ENGR STA

NIH_SPENDING_CATS: Aging;Bioengineering;Cancer

ORG_CITY: HADLEY

ORG_DEPT: ENGINEERING (ALL TYPES)

ORG_NAME: UNIVERSITY OF MASSACHUSETTS AMHERST

ORG_STATE: MA

PHR: Project Narrative Pharmacologically delaying skeletal aging is the most effective strategy to prevent bone metastasis, but the limited long-term efficacy of existing drugs and increased lifespan of cancer survivors pose new challenges. An osteoid-inspired demineralized bone paper has demonstrated compelling biological relevance and significance in reproducing essential bone tissue complexity and multi-cellular processes while allowing for microscopy imaging. This proposal aims to develop demineralized bone paper-based human bone metabolic and senolytic assays that will facilitate the development of new anti-bone-aging drugs and effective treatment regimens.

PI_NAMEs: LEE, JUNGWOO  (contact)

PROGRAM_OFFICER_NAME: OSSANDON, MIGUEL

PROJECT_TERMS: Acceleration;Adoption;Affect;Aging;Biochemical;Biological;Biological Assay;Biomedical Engineering;bone;bone aging;bone loss;Bone Marrow;bone marrow mesenchymal stem cell;Bone Matrix;bone metabolism;Bone Metastases Prevention;Bone remodeling;Bone structure;Bone Tissue;Cancer Survivor;CD14 gene;Cell Aging;Cell Physiology;Cell secretion;Cells;Clinical;clinically relevant;Coculture Techniques;Collagen;commercialization;cortical bone;Dasatinib;Data Analyses;demineralization;Deposition;Development;drug discovery;Drug Modelings;Drug Modulation;Drug Screening;Drug Targeting;effective therapy;extend lifespan;extracellular;Goals;Human;improved;In Vitro;Inflammatory;Interphase Cell;Label;Link;Mechanical Stress;Mechanics;Metabolic;Metastatic Neoplasm to the Bone;meter;microscopic imaging;Microscopy;Minerals;Modeling;Monitor;monocyte;Mononuclear;Morbidity - disease rate;mortality;Multicellular Process;Mus;novel drug class;Osteoblasts;Osteoclasts;Osteoid;Osteoporosis;Paper;peripheral blood;Pharmaceutical Preparations;pharmacologic;Pharmacotherapy;Phenotype;Positioning Attribute;pre-clinical;Prediction of Response to Therapy;preservation;prevent;Prevention strategy;Quercetin;Research;response;Rest;Risk Factors;senescence;senescent cell;senolytics;Series;side effect;skeletal;Slice;Standardization;Stromal Cells;survivorship;Testing;Thinness;tissue culture;Tissue Model;Tissues;transmission process;Treatment outcome;Treatment Protocols;treatment strategy;vibration;Work;Zoledronate

PROJECT_TITLE: Develop and validate demineralized bone paper-based human bone metabolic and senolytic assays

STUDY_SECTION_NAME: Special Emphasis Panel[ZCA1 TCRB-D (M2)]


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Genetic Testing;Genetics;Human Genome;Precision Medicine;Prevention

ORG_CITY: Worcester

ORG_NAME: CANTATA BIO LLC

PHR: NARRATIVE Up to 25-50% of diagnosed cancers remain without an identifiable driver mutation due to limitations of current diagnostic technologies, reducing the applicability of targeted treatments. While current approaches based on next-generation sequencing technology can detect small mutations with >99% accuracy, detecting larger structural variants and alterations in overall DNA structure that contribute to tumorigenesis is more challenging. The goal of this SBIR is to optimize and validate a rapid, automatable proximity ligation-based assay for enhanced detection of structural alterations in multiple cancer types.

PI_NAMEs: MUNDING, ELIZABETH  (contact)

PROGRAM_OFFICER_NAME: MORRIS, STEPHANIE A

PROJECT_TERMS: Accounting;actionable mutation;Address;Adoption;Affect;Automation;Automobile Driving;Benchmarking;Biological Assay;Blood;Cancer Detection;cancer diagnosis;Cancer Diagnostics;cancer genomics;Cancer Patient;cancer type;causal variant;Cause of Death;Cessation of life;Clinical;clinical application;Clinical Oncology;clinically relevant;commercial application;commercial launch;commercialization;Complex;Copy Number Polymorphism;cost;Cytogenetics;Data;Data Analyses;Defect;Detection;detection sensitivity;Development;Diagnosis;Diagnostic;diagnostic technologies;Diagnostic tests;Disease;DNA;DNA Structure;driver mutation;drug discovery;Ensure;Epigenetic Process;epigenomics;Event;Formalin;Freezing;Generations;Genetic;Genetic Variation;Genome;genome sequencing;genomic profiling;Genomics;Goals;Hi-C;Hour;improved;Informatics;innovation;insertion/deletion mutation;Laboratories;Libraries;Ligation;Liquid substance;Malignant Neoplasms;Marketing;Methods;Molecular Cytogenetics;mortality;multiple omics;Mutation;next generation sequencing;novel;novel diagnostics;Nucleotides;Oncology;Outcome;Paraffin Embedding;Pathogenicity;Performance;Persons;Phase;phase 1 study;prevent;Prognosis;Protocols documentation;Readiness;Research;Resolution;restriction enzyme;Sampling;Shotgun Sequencing;Shotguns;Single Nucleotide Polymorphism;Small Business Innovation Research Grant;standard of care;targeted treatment;Techniques;Technology;Testing;three dimensional structure;Tissues;tool;Translational Research;tumorigenesis;user-friendly;Validation;Variant;variant detection;whole genome;Work

PROJECT_TITLE: Commercialization of a rapid, automated Hi-C platform for sensitive genomic profiling of multiple cancer sample types


ORG_CITY: SAN DIEGO

ORG_NAME: EPIGEN BIOSCIENCES, INC.

PHR: Narrative The objective is to discover and develop news drugs for the treatment of stroke, a leading cause of morbidity and mortality in the US.

PI_NAMEs: STOWE, ANN MARIE;UTESHEV, VICTOR V (contact)

PROJECT_TERMS: Acute;aged;Agonist;alpha-bungarotoxin receptor;Alteplase;Anti-Inflammatory Agents;Area;Biological Assay;Blood;Brain Injuries;Cannulas;Cause of Death;Cells;Choline;cholinergic;Clinical;clinical application;clinically relevant;Collection;comparative efficacy;cost;cytokine;Data;Development;Dimethyl Sulfoxide;disability;drug candidate;Drug Kinetics;Early Intervention;effective therapy;Encapsulated;endovascular thrombectomy;Ensure;epigen;Female;Formulation;Hour;Immune;improved;in vivo evaluation;Infarction;Inflammatory;Intravenous;intravenous administration;intravenous injection;Ischemia;Ischemic Penumbra;Ischemic Stroke;Kentucky;Lead;Longitudinal Studies;Magnetic Resonance Imaging;male;Mediating;Middle Cerebral Artery Occlusion;Modeling;Morbidity - disease rate;mortality;Mus;nano;nanoparticle;Nerve Degeneration;neurobehavioral;neuroinflammation;Neurologic Deficit;Neurons;news;Nicotinic Receptors;novel;novel therapeutic intervention;Particle Size;Pathway interactions;Patients;Perfusion;Peripheral;Pharmaceutical Preparations;Pharmacotherapy;Phase;Pilot Projects;Population;Positioning Attribute;positive allosteric modulator;post stroke;primary endpoint;primary outcome;Randomized;Rattus;receptor;Receptor Activation;Recovery;Rehabilitation therapy;Reperfusion Therapy;Reporting;Risk;Rodent;Rodent Model;Safety;secondary endpoint;Secure;Site;Small Business Innovation Research Grant;Small Business Technology Transfer Research;Solubility;Solvents;spatiotemporal;Stroke;stroke recovery;stroke therapy;Structure of jugular vein;Testing;Therapeutic;Tissues;Trauma patient;Treatment Efficacy;Unconscious State;United States;Universities;vasogenic edema;Water;Work;young adult

PROJECT_TITLE: Novel Product Formulation toModulate Alpha7 Nicotinic Receptors for Therapy in Stroke Recovery


NIH_SPENDING_CATS: Behavioral and Social Science;Biotechnology;Clinical Research;Clinical Trials and Supportive Activities;Congenital Structural Anomalies;Mucopolysaccharidoses (MPS);Neurodegenerative;Neurosciences;Orphan Drug;Pediatric;Precision Medicine;Prevention;Rare Diseases

ORG_CITY: BROOKLYN

ORG_NAME: PHOENIX NEST, INC.

PHR: PROJECT NARRATIVE Our project is focused on development of a new treatment for Sanfilippo Syndrome Type C, a fatal neurodegenerative disorder of childhood, which has enormous health and socioeconomic impact on many families and on the healthcare system. We will execute a clinical natural history study per the recommendation FDA/CBER in an effort to identify biomarkers and tools that can be used to measure therapeutic efficacy. We intend to develop and commercialize the first specific therapy for this indication.

PI_NAMEs: SINGAMSETTY, SRIKANTH  (contact)

PROGRAM_OFFICER_NAME: CAPORELLO, EMILY LAURA

PROJECT_TERMS: 15 year old;5 year old;Acetyl Coenzyme A;Acetyltransferase;Affect;Age;Age Years;Animals;Authorization documentation;Behavior assessment;Binding;Biochemical Markers;Biological;Biological Assay;biomarker identification;Blood;Body Fluids;Carbohydrates;Case Study;Cessation of life;Childhood;Cities;Clinic;Clinical;Clinical assessments;clinical biomarkers;clinical outcome measures;clinical predictors;Clinical Protocols;Clinical Research;Clinical Services;Clinical Trials;cognitive testing;commercialization;Communication;Communities;Consultations;Contract Services;Data;Data Analyses;Data Collection;Defect;Dementia;Deposition;design;Deterioration;Development;Developmental Delay Disorders;Diagnosis;Discipline;Disease;Disease Progression;disorder subtype;Dose;economic impact;efficacy evaluation;Enrollment;enzyme deficiency;enzyme replacement therapy;enzyme substrate;Ethics;Evaluation Studies;expectation;Family;Foundations;France;Funding;Future;GAG Gene;gene therapy;Geography;Goals;Grant;health economics;Healthcare Systems;Heparitin Sulfate;Immobilization;Impaired cognition;Individual;Inherited;innovation;Intervention;Intervention Studies;Intervention Trial;Investigational Therapies;Life;Literature;Lysosomal Storage Diseases;Measures;Medical;Medical center;Membrane;Metabolic Diseases;Methods;molecular marker;Monitor;Motor Skills;Mucopolysaccharidoses;Mucopolysaccharidosis III;Mus;Natural History;Nerve Degeneration;neurobehavioral;Neurocognitive;Neurodegenerative Disorders;Neurologic;Neurons;novel;Online Mendelian Inheritance In Man;Onset of illness;Outcome;Outcome Measure;participant enrollment;Pathology;Patient Outcomes Assessments;patient population;Patients;pharmacologic;Phase;Physical therapy;Population;potential biomarker;pre-clinical;Preparation;Problem behavior;programs;prospective;Proteins;Proteoglycan;Protocols documentation;Publications;Published Comment;Qualifying;Rare Diseases;real world application;Recommendation;Records;reduce symptoms;Research;Research Design;response;safety assessment;Sampling;Scientist;service providers;Severities;Severity of illness;Site;Small Business Innovation Research Grant;socioeconomics;Sodium Chloride;Speech;Statistical Data Interpretation;Supportive care;Surrogate Markers;Surveys;Symptoms;System;Texas;Therapeutic;Time;timeline;Tissues;tool;Toxicology;Treatment Efficacy;trial design;Universities;Urine;verbal;Video Recording;Visit;Walking;Work

PROJECT_TITLE: Identification of Potential Biomarkers and Clinical Tools for use in Mucopolysaccharidosis IIIC Patients.

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


ORG_CITY: Marietta

ORG_NAME: MOONLIGHT THERAPEUTICS, INC.

ORG_STATE: GA

PHR: Narrative This is a Commercialization Readiness Pilot (CRP) SBIR grant (SB1) application. The grant is for the development of an automated coating system for Moonlight Therapeutics’ microneedle drug delivery platform. The coating system would allow for large scale production of the company’s peanut allergy treatment, MOON101, for use in human clinical trials and expand its capability to coat multiple allergens onto a single array.

PI_NAMEs: PATEL, SAMIRKUMAR  (contact)

PROGRAM_OFFICER_NAME: MINNICOZZI, MICHAEL

PROJECT_TERMS: Accidents;Address;Adverse reactions;Affect;Age;Allergen Immunotherapy;Allergens;Allergic;Allergy to peanuts;Anaphylaxis;Applications Grants;Biological Assay;Cells;Cessation of life;Child;Clinical;Clinical Research;Clinical Trials;Clinical Trials Design;commercialization readiness;Cutaneous;Data;Dendritic Cells;Dermal;desensitization;Development;Diet;Dose;Drops;Drug Delivery Systems;efficacy evaluation;Environment;Equation;Equipment;equipment acquisition;Europe;Evaluation;Family;FDA approved;Feedback;Food Hypersensitivity;Formulation;Funding;Future;Government;Grant;Hour;Human;Hypersensitivity;Immune;Immune system;immunoregulation;Immunotherapy;improved;Investigation;Juglans;large scale production;Life;Malnutrition;manufacturing scale-up;Marketing;meetings;Metals;Methods;Mind;minimally invasive;mouse model;Mus;Needles;novel therapeutics;Patients;peace;Persons;Phase;Phase I Clinical Trials;Phase II Clinical Trials;Phase III Clinical Trials;Population;pre-clinical;preclinical development;Printing;Procedures;Production;Proteins;Quality of life;Reproducibility;research clinical testing;Risk Reduction;Safety;Skin;Small Business Innovation Research Grant;Small Business Technology Transfer Research;social;Solid;Sterility;System;Technology;Testing;Therapeutic

PROJECT_TITLE: Scale-up manufacturing of microneedle stamp for peanut allergen immunotherapy

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


NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Disability Research;Physical Activity;Physical Rehabilitation;Prevention;Rehabilitation;Social Determinants of Health

ORG_CITY: WEAVERVILLE

ORG_NAME: VORTANT TECHNOLOGIES, LLC

PHR: Project Narrative The overarching goal of this Phase I SBIR project is to provide improved exercise opportunities for people with physical disabilities, who currently experience a health-related disparity in terms of access to engaging interactive workout experiences. The resulting product is expected to provide improved and affordable options for the target population to participate in interactive group and individual workout environments.

PI_NAMEs: SCHAEFER, PHILIP R (contact)

PROGRAM_OFFICER_NAME: SHIROMA, ERIC JITSUO

PROJECT_TERMS: Address;Adherence;Alabama;Bluetooth;Chronic;Clinical;collaborative environment;commercialization;Communication;cost;cost effective;Custom;Data;Devices;disability;Disabled Persons;Disparity;Environment;Equipment;Event;Exercise;exercise program;exercise regimen;experience;experimental study;Face;Feedback;Funding;Future;General Population;Goals;Guidelines;hands-on learning;Health;Home;improved;Incidence;Individual;Individuals with physical disabilities;Legal patent;Marketing;Measurement;Measures;meetings;Monitor;Motivation;Names;Performance;Persons;Phase;Physical activity;physical inactivity;physically handicapped;Population;preference;prototype;Quality of life;quantum;Race;Research;Sampling;sensor;simulation;skills;Small Business Innovation Research Grant;social;social media;Social Network;Speed;statistics;Target Populations;Technology;tool;Travel;Underemployment;Unemployment;Universities;usability;Video Games;virtual

PROJECT_TITLE: Engaging and affordable home exercise environments for people with disabilities

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


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Hearing Loss;Neurosciences;Patient Safety;Physical Injury - Accidents and Adverse Effects;Prevention

ORG_CITY: Bozeman

ORG_NAME: RESTOREAR DEVICES, LLC

ORG_STATE: MT

PHR: Public health relevance: RestorEar Devices LLC aims to bring applications of localized mild therapeutic hypothermia delivered to the inner ear for protection of residual hearing following hazardous noise exposure. In collaboration with the University of Miami, the safety and efficacy of hypothermia treatment to mitigate changes in hearing after a noise exposure will be validated in an occupationally at-risk population of firefighters and age- and sex-matched controls. Successful completion of the study will provide novel insights and results leading to a major therapeutic advancement for hidden hearing loss and sensorineural changes in the inner ear that afflict a large, global population of subjects exposed to hazardous noise.

PI_NAMEs: KING, CURTIS SCOTT (contact);RAJGURU, SUHRUD M.

PROGRAM_OFFICER_NAME: MILLER, ROGER

PROJECT_TERMS: Acute;Adult;Adverse effects;Affect;Aftercare;Age;American;Audiology;Auditory;Auditory Brainstem Responses;Award;Binding;Cadaver;Calibration;Cells;Centers for Disease Control and Prevention (U.S.);Chronic;Clinical;Clinical Research;Cochlea;Cochlear Implants;Cochlear Nerve;Collaborations;Computer Models;Control Groups;design;design,build,test;Devices;disability;Disabling;dosage;Ear;efficacy testing;efficacy validation;Electrocochleographies;Elements;Equilibrium;Evaluation;experience;Exposure to;FDA approved;fire fighter;first-in-human;Florida;Gel;global health;Hair Cells;Health;healthcare burden;Healthcare Systems;Hearing;hearing impairment;hearing preservation;Hearing Protection;hidden hearing loss;High Prevalence;Human;human subject;Impairment;Injury;insight;Labyrinth;Legal patent;life time cost;Loudness;Marketing;Mastoid process;Measures;member;Military Personnel;natural hypothermia;neural;neuroprotection;Noise;noise exposure;Noise-Induced Hearing Loss;non-invasive system;novel;Occupational;Occupational Noise;Operative Surgical Procedures;otoacoustic emission;ototoxicity;Outcome;Performance;Persons;Pharmacologic Substance;Phase;Placebos;Population;Populations at Risk;Positioning Attribute;preservation;Prevalence;prevent;protective effect;Protocols documentation;Public Health;public health relevance;Publishing;Pure-Tone Audiometry;Quality of life;Randomized;Recreation;Reporting;Research;Residual state;Risk;Safety;safety testing;Savings;Sensory;service member;Services;sex;Small Business Innovation Research Grant;sound;spiral ganglion;Structure;Surface;Synapses;System;Teenagers;Temporal bone structure;Temporary Threshold Shift;Testing;Therapeutic;Time;Tinnitus;Translating;translational potential;Trauma;treatment group;United States;Universities;vestibular system

PROJECT_TITLE: Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

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


ADMINISTERING_IC: VA

IC_NAME: Veterans Affairs

ORG_CITY: MADISON

ORG_NAME: WM S. MIDDLETON MEMORIAL VETERANS HOSP

ORG_STATE: WI

PHR: Diabetes affects nearly 25% of Veterans, at rates much higher than in the general population. A key part of the pathogenesis of diabetes is the loss of function b-cells, partly through increased b-cell apoptosis. This project is relevant to the mission of the Department of Veterans Affairs in combating diabetes in Veterans by providing fundamental knowledge about novel pathways to protect b-cells from death.

PI_NAMEs: DAVIS, DAWN B (contact)

PROJECT_TERMS: Affect;Agonist;Apoptosis;B-Lymphocyte Subsets;B-Lymphocytes;biological adaptation to stress;Caring;Cell Death;Cell Physiology;Cell Survival;Cells;Cellular Stress;Characteristics;Cholecystokinin;Cholecystokinin Receptor;Critical Pathways;Cyclic AMP;Data;Development;Diabetes Mellitus;diabetes mellitus therapy;diabetes pathogenesis;Diabetes prevention;Functional disorder;Gastrins;General Population;Genetic Transcription;glucagon-like peptide 1;Glucose;Goals;Graft Survival;Health;Heterogeneity;Homeostasis;hormonal signals;Hormones;Human;Hyperglycemia;Hypoxia;improved;Incubated;Inflammation;innovation;insight;Insulin Resistance;Investigation;islet;Islet Cell;Islets of Langerhans;Islets of Langerhans Transplantation;Knowledge;Laboratories;live cell imaging;loss of function;Mature B-Lymphocyte;Metabolic stress;Mission;mouse model;Mus;new therapeutic target;novel;Obesity;paracrine;Paracrine Communication;Pathway interactions;peptide hormone;pharmacologic;preservation;prevent;Prevention;Production;programs;promoter;receptor;Receptor Signaling;Regulation;Regulatory Pathway;Research;response;RNA;Role;side effect;Signal Pathway;Signal Transduction;single cell sequencing;Stress;Structure of beta Cell of islet;synergism;targeted treatment;Techniques;Testing;Therapeutic;Transcriptional Regulation;transcriptomics;Translations;Transplantation;type I and type II diabetes;United States Department of Veterans Affairs;Veterans;Work

PROJECT_TITLE: The impact of cholecystokinin on pancreatic beta-cell survival through paracrine and pharmacologic signaling

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 ENDA-L (01)]


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Biotechnology;Cancer;Networking and Information Technology R&D (NITRD)

ORG_CITY: DURHAM

ORG_NAME: RAMONA OPTICS, INC.

ORG_STATE: NC

PHR: 3D organoids are an increasingly popular platform for high-throughput biomedical and cancer research, but their 3D heterogenous nature presents significant challenges for effective morphological characterization by today’s optical microscopes. In this proposal, Ramona Optics Inc., in collaboration with the Rajagopalan Lab at Virginia Tech and the Soker Lab at Wake Forest, will develop and validate a parallelized, 96-camera 3D microscope and associated software for rapid live-cell 3D fluorescence imaging of organoids within 96 well plates. We will demonstrate how this new technology can uniquely obtain time-lapse measurements (e.g., of cell viability and migration) as well as novel video assays of in vitro tumor organoid growth and dynamics at high throughput.

PI_NAMEs: HARFOUCHE, MARK  (contact)

PROGRAM_OFFICER_NAME: REGMI, SAROJ GOPAL

PROJECT_TERMS: 3-Dimensional;Animal Model;anti-cancer research;assay development;base;Benchmarking;Biological Assay;Biological Models;Biomedical Research;Brain;Calcium;Calibration;cancer therapy;Cardiac;cell motility;Cell Physiology;Cell Survival;Cells;Cellular Morphology;chemotherapy;clinically relevant;Coculture Techniques;Collaborations;Computer software;cytotoxic;Data;Databases;Development;Devices;Diffusion;Dose;drug discovery;Dyes;experimental study;extracellular;Fluorescence;fluorescence imaging;Genetic;Growth;high throughput analysis;high throughput screening;Hour;Human;human model;human tissue;Image;Image Analysis;image registration;imager;Imagery;imaging system;Imaging technology;Immunotherapy;In Vitro;in vitro Assay;Individual;Label;Laboratories;Lateral;Light;Liver;Market Research;Marketing;MCAM gene;Measurement;Measures;meter;Microscope;Microscopy;miniaturize;Modeling;Molecular;Monitor;Morphology;Mus;Nature;neoplastic cell;new technology;novel;open source;Optics;Organoids;parallelization;Patient imaging;Patients;Performance;Permeability;Pharmaceutical Preparations;Phase;physical process;Physiological;Play;Preparation;Process;Property;Proteomics;rapid detection;Regenerative Medicine;Resolution;Role;Sampling;Scanning;Series;software development;Software Validation;Solid;Specificity;Specimen;Speed;statistics;Stream;System;T-Lymphocyte;Technology;Testing;three dimensional cell culture;Three-dimensional analysis;Three-Dimensional Image;Three-Dimensional Imaging;Time;tomography;tool;Toxic effect;tumor;Video Recording;Virginia;Work

PROJECT_TITLE: A parallelized computational microscope platform for high-throughput live imaging of patient-derived organoids

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


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Coronaviruses;Coronaviruses Vaccines;Emerging Infectious Diseases;Genetics;Immunization;Infectious Diseases;Nanotechnology;Prevention;Vaccine Related

ORG_NAME: ORLANCE, INC.

PHR: PROJECT NARRATIVE Current RNA vaccines are formulated with lipid nanoparticles (LNPs) to protect them from degradation and to enable efficient delivery into cells, however, RNA formulations in LNPs require ultra-cold storage and may contribute to adverse reactions to RNA vaccines. Here, we will develop an alternative, room temperature stable, needle-free and pain-free method to deliver RNA vaccines using a gene gun. If successful, this project will lead to an alternative method to deliver RNA vaccines using a gene gun.

PI_NAMEs: FRIZZELL, HANNAH  (contact)

PROGRAM_OFFICER_NAME: GORDON, JENNIFER L

PROJECT_TERMS: 2019-nCoV;Adverse event;Adverse reactions;Antibodies;Antibody Response;Antigen-Presenting Cells;Antigens;Cells;Clinic;Clinical;Clinical Trials;COVID-19;COVID-19 vaccine;Cryopreservation;Developing Countries;Devices;disease transmission;DNA;DNA delivery;DNA Vaccines;Dose;Dryness;Electroporation;Engineering;Environment;Epidermis;epidermis cell;Formulation;Friends;gene gun;Glutathione;Gold;Human;Immune;Immune response;Immunity;Immunocompetent;immunogenic;immunogenicity;improved;In Vitro;Influenza;Influenza Hemagglutinin;Intramuscular;Lead;Licensing;Life;lipid nanoparticle;Macaca;Messenger RNA;Methods;Microinjections;Modeling;mRNA lipid nano particle vaccine;mRNA Transcript Degradation;Mucosal Immune Responses;Mucosal Immunity;Mucous Membrane;Mus;Muscle;Myocarditis;Names;nanoparticle delivery;Needles;next generation;nuclease;Nucleic Acids;Pain;Pain Free;Painless;pandemic disease;particle;Phase;Plasmids;prevent;Protamines;Protocols documentation;prototype;Replicon;response;Risk;RNA;RNA Degradation;RNA delivery;RNA Stability;RNA vaccine;Route;Safety;Skin;Small Business Innovation Research Grant;success;systemic inflammatory response;T cell response;Technology;Temperature;Time;Transfection;Vaccine Antigen;vaccine delivery;vaccine development;vaccine hesitancy;vaccine immunogenicity;Vaccines

PROJECT_TITLE: Gene Gun-delivered RNA vaccines.

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


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Lung;Natural Products;Pneumonia;Pneumonia and Influenza;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: MONMOUTH JUNCTION

ORG_NAME: TAXIS PHARMACEUTICALS, INC.

PHR: Proposal Title: Lead optimization of a novel cyclic aryl-indole efflux pump inhibitor (EPI) series in combination with levofloxacin against Pseudomonas aeruginosa Project Narrative: The ineffectiveness of existing antibiotics against multidrug-resistant Pseudomonas aeruginosa infections possesses a major challenge for the treatment of Hospital Acquired Pneumonia (HAP) and Ventilator Associated Pneumonia (VAP), leading to almost 27,000 deaths annually in the United States alone. With a commitment to developing a counterstrategy involving novel efflux pump inhibitors (EPI) as an adjunctive to levofloxacin, TAXIS pharmaceuticals has identified a lead compound TXA14007, with remarkable in vivo efficacy (in murine model) and a relatively safe toxicology profile. The goal of this SBIR proposal is to optimize the lead compound TXA14007 by multiparametric structure–activity relationship (SAR) study to improve its effectiveness and diminish toxicity which might culminate in the identification of a preclinical candidate.

PI_NAMEs: PARHI, AJIT K (contact)

PROGRAM_OFFICER_NAME: XU, ZUOYU

PROJECT_TERMS: acute toxicity;Affect;Amines;analog;Antibiotics;antimicrobial;Biological Markers;candidate selection;Cardiotoxicity;Cessation of life;Chemosensitization;Clinic;Clinical;clinical development;Collection;Country;CYP2D6 gene;Cytology;cytotoxicity;Development;Diamines;DNA;Dose;Drug Efflux;Drug Kinetics;Effectiveness;efficacy study;efflux pump;Ensure;Evaluation;Exhibits;experimental study;Exposure to;Genetic;genotoxicity;Goals;Histologic;Homidium Bromide;Hospitals;human induced pluripotent stem cells;improved;In Vitro;in vitro activity;in vivo;Indoles;induced pluripotent stem cell derived cardiomyocytes;Infection;inhibitor;Injury to Kidney;Investigation;Kidney;Lead;lead optimization;Levaquin;Lung infections;Maximum Tolerated Dose;member;Membrane;Methods;Modeling;Molecular;Monitor;mouse model;Multi-Drug Resistance;multidrug-resistant Pseudomonas aeruginosa;Mus;nephrotoxicity;Nosocomial pneumonia;novel;overexpression;pathogen;Periodicity;Pharmacodynamics;Pharmacologic Substance;Phase;Plasma;pre-clinical;programs;Property;Pseudomonas aeruginosa;Pseudomonas aeruginosa infection;receptor binding;Resistance;resistant strain;response;Safety;safety assessment;Sampling;Series;Side;Small Business Innovation Research Grant;Structure-Activity Relationship;synergism;System;Time;Tissues;Toxic effect;Toxicology;transcriptome sequencing;United States;Up-Regulation;ventilator-associated pneumonia

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


ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Bioengineering;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Infectious Diseases;Machine Learning and Artificial Intelligence;Mental Health;Mental Illness;Networking and Information Technology R&D (NITRD);Prevention;Suicide;Suicide Prevention

ORG_CITY: Newark

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: RUTGERS BIOMEDICAL AND HEALTH SCIENCES

PHR: Narrative One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, we will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, CareAngel.

PI_NAMEs: KOZLOV, ELISSA K (contact)

PROGRAM_OFFICER_NAME: SENN, THERESA ELAINE

PROJECT_TERMS: Address;Adult;advanced disease;aged;Ageism;anti-viral efficacy;Anti-viral Therapy;Applications Grants;Artificial Intelligence;Behavior Therapy;Behavioral;biopsychosocial;care costs;care delivery;care seeking;Caring;chatbot;Clinic;Clinical;Clinical Trials;cohort;Communicable Diseases;Control Groups;design;Dialectical behavior therapy;Ecological momentary assessment;effective intervention;Elderly;eligible participant;Emotions;evidence base;Evidence based intervention;experience;Face;feasibility trial;Feedback;Feeling suicidal;Focus Groups;General Population;Gerontology;group intervention;Guidelines;Health;Health Technology;HIV;HIV/AIDS;Hybrids;improved;Incidence;Individual;industry partner;innovation;interest;internalized stigma;Intervention;Intervention Studies;Intervention Trial;Interview;Language;late life;Link;Literature;Logic;Longevity;Medical;medication compliance;Mental Depression;Mental Health Services;mhealth interventions;Modality;Modeling;Moods;mortality risk;Natural Language Processing;older adult;Older Population;Outcome;participant enrollment;patient population;Patients;Persons;Phase;Population;Population Heterogeneity;Prevention;preventive intervention;Protocols documentation;psychological outcomes;Psychotherapy;Public Health;Randomized;Randomized, Controlled Trials;Recording of previous events;reducing suicide;Reporting;Research;Resources;response;Risk;Risk Factors;Sampling;Science;Self Efficacy;skills;social;social stigma;stressor;suicidal behavior;suicidal morbidity;suicidal risk;Suicide;Suicide attempt;suicide mortality;Suicide prevention;Surveys;Technology;Telephone;Testing;Text;therapy development;treatment adherence;treatment as usual;Treatment Efficacy;United States;United States National Institutes of Health;usability;Work

PROJECT_TITLE: Adapting DBT for Persons Living with HIV/AIDS Using an Artificial Intelligence-Powered Conversational Agent

STUDY_SECTION: HIBI

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


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Clinical Research;Clinical Trials and Supportive Activities;Machine Learning and Artificial Intelligence;Muscular Dystrophy;Orphan Drug;Rare Diseases

ORG_CITY: Brookline

ORG_NAME: MYOLEX, INC.

PHR: Project Narrative  Magnetic resonance imaging (MRI) provides detailed information on muscle pathology but is costly and inconvenient to use and the acquired images challenging and time-consuming to analyze. Another technology, electrical impedance myography (EIM), offers a simpler, cheaper, and more efficient approach for quantifying muscle pathology but remains relatively undeveloped for this purpose. In this study, the investigators propose to use machine learning analytics to train EIM to provide quantification of muscle pathology based on MRI imaging. At the conclusion of this work, we will be able to provide clinicians and drug developers a powerful new technology for monitoring muscle disease and response to therapy.

PI_NAMEs: DICKINSON, DAVID P. (contact);NARAYANASWAMI, PUSHPA

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Age;Aging;Algorithms;Atrophic;Autoimmune;Bilateral;Biological Markers;Biopsy;Boston;Caring;Chronic;Clinical;Clinical Trials;cloud based;cohort;Collaborations;Complex;Consumption;cost;Data;Data Science;Data Set;deconditioning;Deposition;Development;Devices;Diagnostic;Disease;Disease Progression;drug development;Duchenne muscular dystrophy;Edema;electric impedance;Evaluation;Fatty acid glycerol esters;Fiber;flexibility;Frequencies;Future;handheld equipment;Health;Image;Image Analysis;image processing;Impairment;improved;Individual;individual patient;Infiltration;Inflammation;Inherited;Injury;insight;Institution;Israel;Libraries;Lower Extremity;Machine Learning;Magnetic Resonance Imaging;Measurement;Measures;Medical center;medical schools;Modeling;Modernization;Monitor;Muscle;Muscular Dystrophies;Myography;Myopathy;Myositis;Neuromuscular Diseases;new technology;Outcome;Participant;Pathologic;Pathology;Patient Care;Patients;Pharmaceutical Preparations;Phase;Physicians;prediction algorithm;prevent;Process;Protocols documentation;Proxy;Research Personnel;Respiratory physiology;response;Secondary to;Severities;Severity of illness;Side;Skeletal Muscle;Small Business Innovation Research Grant;Speed;Standardization;success;Surface;System;Techniques;Technology;Testing;Therapeutic;Therapeutic Clinical Trial;Therapeutic Intervention;Therapeutic Trials;Time;tool;Training;treatment response;Upper Extremity;Validation;voltage;Work

PROJECT_TITLE: Convenient quantification of myopathic change in muscle via electrical impedance myography

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


NIH_SPENDING_CATS: Clinical Research;Digestive Diseases;Hematology;Infant Mortality;Infectious Diseases;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Prevention;Rare Diseases;Sepsis

ORG_CITY: PROVIDENCE

ORG_NAME: PROTHERA BIOLOGICS, LLC

ORG_STATE: RI

PHR: The goal of this proposed research is to develop a rapid test based on Inter-alpha inhibitor proteins that can detect infants with life-threatening whole body infection (sepsis) and necrotizing enterocolitis using a simple device suitable for a bedside testing. The rapid test is useful to help clinicians in making treatment decision and to reduce unnecessary long-term, broad-spectrum antibiotic use in infants.

PI_NAMEs: LIM, YOW-PIN  (contact);PADBURY, JAMES F

PROJECT_TERMS: Acute;Adult;Antibiotic Therapy;Antibiotics;Award;Bedside Testings;Biological Markers;Blood;Blood specimen;blood-based biomarker;Body part;C-reactive protein;Characteristics;Clinical;clinical decision-making;Clinical Research;Consumption;design;Devices;Discrimination;Disease;disease diagnosis;Early Diagnosis;Enrollment;Enzyme-Linked Immunosorbent Assay;Evaluation;Event;Excretory function;Exposure to;Future;Goals;Head;high risk infant;Hour;Human;Immune response;Immune system;Immunoassay;immunological status;Infant;Infection;inter-alpha-inhibitor;Laboratories;Lateral;Life;Light;Logistic Regressions;manufacturing scale-up;Measurement;Measures;Meta-Analysis;Morbidity - disease rate;mortality;Natural History;Necrotizing Enterocolitis;Neonatal;Neonatal Intensive Care;Neonatal Intensive Care Units;neonatal sepsis;Neonatology;Observational Study;Outcome;Outcome Study;Pathologic;Performance;Phase;phase 2 study;Physicians;Plasma;point of care;point of care testing;portability;predictive marker;Predictive Value;procalcitonin;Process;prospective;Proteins;Protocols documentation;prototype;rapid test;Reagent;Research;research clinical testing;response biomarker;Risk Assessment;ROC Curve;Role;Sampling;Sepsis;Serine Proteinase Inhibitors;Severity of illness;Small Business Innovation Research Grant;Specificity;Spontaneous intestinal perforation;Symptoms;systemic inflammatory response;Test Result;Testing;tool;urinary;user-friendly;Validation;Very Low Birth Weight Infant

PROJECT_TITLE: Rapid Test to Assist Therapy in Neonatal Sepsis and Necrotizing Enterocolitis

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


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Chronic Pain;Clinical Research;Contraception/Reproduction;Networking and Information Technology R&D (NITRD);Neurosciences;Pain Research;Rehabilitation;Women's Health Research

ORG_CITY: ORLANDO

ORG_NAME: BOLD TYPE LLC

ORG_STATE: FL

PHR: 1 Narrative 2 Bold Type’s Violet system offers chronic pelvic pain (CPP) and high tone pelvic floor dysfunction (HTPFD) 3 patients a critically needed, wearable, controllable device optimized for the relaxation and myofascial release of 4 muscles throughout the day. Our novel CPP solution will aid the growth of the United States economy by 5 contributing the Violet system to the medical device market, thus increasing the market size, and creating jobs 6 associated with the production, shipping, and sales of Violet devices. Bold Type’s wearable device for on- 7 demand therapy throughout the day will also enhance the quality of life of CPP and HTPFD patients by providing 8 pain relief when and where it is most needed in a discreet, convenient way.

PI_NAMEs: BOHORQUEZ, JOSE LUIS (contact)

PROGRAM_OFFICER_NAME: TINGEN, CANDACE M

PROJECT_TERMS: absorption;Acoustics;Address;Affect;biomaterial compatibility;birth control;Blood flow;Bluetooth;body position;Brain;Cellular Phone;Certification;chronic pelvic pain;Circulation;Commercial grade;Communication;comorbidity;Computer software;Data;data communication;data exchange;design;Development;Device or Instrument Development;Devices;Dimensions;Dyspareunia;efficacy evaluation;efficacy study;Electric Stimulation;Electronics;Endorphins;ergonomics;Excision;Exercise;experience;flexibility;Functional disorder;Growth;handheld mobile device;Housing;Human;human tissue;impression;Individual;innovation;Intestines;Longitudinal Studies;Marketing;Measures;Mechanics;Medical Device;microphone;mobile application;Motion;Motor;Muscle;Muscle Fibers;Muscle relaxation phase;Muscle Tension;Myalgia;Myofascial Pain Syndromes;Nerve;novel;Occupations;Pain Disorder;Pain management;pain perception;pain reduction;pain relief;pain signal;Participant;Patients;Pelvic floor dysfunction;Pelvic Floor Muscle;Pelvic floor structure;Pelvic Pain;Performance;Phase;Play;Positioning Attribute;Process;product development;Production;prototype;Quality of life;Questionnaires;radio frequency;rechargeable battery;Recovery;recruit;Regulation;Regulatory Affairs;Relaxation;Resources;Role;Sales;sensor;Shapes;Shipping;Signal Transduction;software development;success;Symptoms;System;Telephone;Temperature;Testing;transmission process;United States;Update;usability;Vagina;Validation;vibration;Viola;wearable device;wireless;wireless communication;Woman;women's treatment

PROJECT_TITLE: An intravaginal, wearable device for treating women with pelvic floor myofascial pain

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


ED_INST_TYPE: UNIVERSITY-WIDE

NIH_SPENDING_CATS: HIV/AIDS;Immunotherapy;Infectious Diseases;Pediatric;Pediatric - AIDS

ORG_CITY: PORTLAND

ORG_NAME: OREGON HEALTH & SCIENCE UNIVERSITY

ORG_STATE: OR

PHR: PROJECT NARRATIVE These exploratory studies will provide important information about the persistence of HIV-specific CD8+ T cell responses in children who started early antiretroviral therapy. They may provide critical insight into differences in the phenotype and function of HIV-specific CD8+ T cells in children compared to adults that would affect their response to therapeutic interventions or viral rebound during treatment interruptions.

PI_NAMEs: MITCHELL, JULIE  (contact)

PROGRAM_OFFICER_NAME: LOMBO RODRIGUEZ, TANIA

PROJECT_TERMS: Acute;adaptive immune response;Address;Adherence;Adult;Affect;Age Months;antigen-specific T cells;antiretroviral therapy;Biological Assay;Blood specimen;CD8-Positive T-Lymphocytes;Cell Differentiation process;Cells;Characteristics;Child;Childhood;cohort;cytokine;cytotoxic;cytotoxicity;Data;Death Rate;Development;Diagnosis;differential expression;Enrollment;experience;Flow Cytometry;follow-up;Frequencies;Genes;Goals;HIV;HIV diagnosis;HIV Genome;HIV Infections;Immune;Immune response;Immune system;Immunity;Immunotherapeutic agent;Immunotherapy;Impairment;In Vitro;infancy;Infant;infant infection;Infection;insight;Interruption;Intervention;Length;Life;Measures;Memory;Morbidity - disease rate;mortality;Natural Killer Cells;Neonatal;Newborn Infant;Peptides;Perinatal;perinatal HIV;Phenotype;Population;pressure;Production;programs;Proliferating;Research;response;Rest;Sampling;single-cell RNA sequencing;Sorting;Stains;T cell differentiation;T cell receptor repertoire sequencing;T cell response;T-cell receptor repertoire;T-Lymphocyte;targeted treatment;Testing;Thailand;Therapeutic Intervention;therapy design;Time;transcriptome;transcriptomics;Vaccination;Vaccine Design;Vaccines;Viral;viral rebound;Viral reservoir;Virus

PROJECT_TITLE: Persistence of HIV-specific CD8+ T cell responses after long-term ART in early treated Thai children

STUDY_SECTION: HIVD

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


NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Kidney Disease;Rural Health;Social Determinants of Health

ORG_CITY: SAN RAMON

ORG_NAME: SILICON KIDNEY, LLC

ORG_STATE: CA

PHR: End-Stage Kidney Disease (ESKD) affects over 800,000 people in the US and rural and remote ESKD patients have higher mortality than urban ESKD patients creating a mortality health disparity. Silicon Kidney is developing a new home hemodialysis system (iHemo) that will eliminate this health disparity plaguing rural and remote ESKD patients.

PI_NAMEs: BLAHA, CHARLES  (contact)

PROGRAM_OFFICER_NAME: GOSSETT, DANIEL ROBERT

PROJECT_TERMS: Adsorption;Affect;Area;Blood;Cannulations;Carbon;Caregivers;Catheters;Circulation;Clinic;Clinical;Dialysis procedure;Drops;End stage renal failure;Excision;Filtration;Geographic Locations;Grant;health disparity;Heart;Hemodialysis;Home;Home Hemodialysis;Implant;Infection;innovation;inorganic phosphate;Ions;Kidney;Kinetics;Life;mortality;mortality disparity;National Institute of Diabetes and Digestive and Kidney Diseases;Natural regeneration;patient oriented;Patients;Persons;Phase;Potassium;pressure;prototype;Pump;Resistance;Resource-limited setting;Resources;Risk;Rural;rural health disparities;Silicon;Small Business Innovation Research Grant;System;Testing;Time;Toxin;Travel;Tube;Urea;Uremia;Water;Zeolites

PROJECT_TITLE: The intracorporeal hemodialysis system (iHemo) for eliminating the mortality health disparity of rural and remote End-stage Kidney Disease patients

STUDY_SECTION_NAME: Special Emphasis Panel[ZMD1 JT (J1)]


NIH_SPENDING_CATS: Clinical Research;Digestive Diseases;Genetics;HIV/AIDS;Infectious Diseases

ORG_CITY: SEATTLE

ORG_DEPT: OBSTETRICS & GYNECOLOGY

ORG_NAME: UNIVERSITY OF WASHINGTON

PHR: PROJECT NARRATIVE Currently available drugs to treat HIV infection do not completely eliminate the virus from the body: HIV persists in cells from different tissues, especially in the gastrointestinal tract, and it will reactivate if the patient stops taking antiretroviral medication. In order to find a permanent HIV cure, we need to understand why HIV persists and which cell signals drive HIV reactivation. We will investigate the hypothesis that a group of specialized cells from the gut are responsible for HIV persistence and for driving viral reactivation if treatment is stopped.

PI_NAMEs: GORNALUSSE, GERMAN GUSTAVO (contact)

PROGRAM_OFFICER_NAME: LAWRENCE, DIANE M

PROJECT_TERMS: Anatomy;Anti-Retroviral Agents;antiretroviral therapy;Automobile Driving;Autopsy;Binding;Biopsy;CD4 Positive T Lymphocytes;Cell Culture Techniques;Cell Physiology;Cells;cellular imaging;Clinical;Clinical Research;Clinical Trials;Clonality;Coculture Techniques;Data;Development;digital;DNA;Duodenum;Effectiveness;Enterocytes;Environment;Epithelial Cells;Exhibits;Fostering;gastrointestinal;Gastrointestinal tract structure;Gene Activation;Gene Expression;Gene Expression Profile;Genes;Genome;Glycoproteins;Goals;Grant;Gut Mucosa;HIV;HIV Infections;HIV-1;humanized mouse;Hyperactivity;Immune;immune activation;Immunity;Immunobiology;Immunologics;In Situ;In Vitro;in vitro Model;in vivo;Individual;Inflammation;innovation;Interferon alpha;Interferon Type I;Interferons;intestinal epithelium;Intestinal Mucosa;Intestines;latent HIV reservoir;Longevity;Macrophage;Maintenance;Messenger RNA;Modeling;Molecular;Mucous Membrane;multiple omics;Mus;nano-string;National Institute of Allergy and Infectious Disease;NIH Program Announcements;nonhuman primate;novel;Operative Surgical Procedures;Organoids;pathogen;Pathway interactions;Patients;Persons;Phagocytosis;Pharmaceutical Preparations;Physiology;Population;prevent;Proliferating;Proteins;Proteomics;Proviruses;Rectum;Research;Research Personnel;Risk;Role;Signal Transduction;Source;spatial relationship;System;T cell clonality;T-Cell Proliferation;T-Lymphocyte;Testing;tissue culture;Tissues;Transcript;transcriptome;transcriptome sequencing;transcriptomics;transcytosis;Viral;viral rebound;Viral reservoir;Viremia;Virus;Work

PROJECT_TITLE: Role of intestinal microfold (M) cells in creating a hotspot environment for HIV reservoir persistence and reactivation


ADMINISTERING_IC: CK

IC_NAME: National Center for Emerging and Zoonotic Infectious Diseases

ORG_CITY: SPOKANE

ORG_NAME: IASIS MOLECULAR SCIENCES, INC

PHR: Project Narrative  In the United States, approximately 1.7 million health care-associated infections (HAIs) occur in hospitals annually. Many of the implicated organisms are transmitted to the patient by a health care worker via an intermediary in the hospital environment, i.e., a fomite. Fomites are nonliving objects, substances, and surfaces capable of carrying infectious organisms. With costs to treat these infections requiring more than billions of dollars annually, improved methods of preventing HAIs are needed.  The proposed project addresses this complex problem with the development and testing of two first-in-class solutions that will address bacterial, fungal and viral threats within the clinical and other environments.

PI_NAMEs: VACHON, DAVID JOHN (contact)

PROJECT_TITLE: Clinical Ecosystem Surfaces for Improved Disinfection Outcomes and the Prevention of HAI Transmission


NIH_SPENDING_CATS: Biotechnology;Cancer

ORG_CITY: BOSTON

ORG_NAME: ADEPTRIX CORPORATION

PHR: NARRATIVE This project aims to initiate development of a protein immunoassay for measuring molecular markers of multiple cancer pathways in cell culture-based assays. The proposed assay will be marketed to researchers in cancer biology, pre-clinical drug development and oncology biomarker discovery as it will replace dozens of currently used individual assays with a single, broad coverage multiplexed assay, which is fast, inexpensive and easy to use.

PI_NAMEs: BERGO, VLADISLAV  (contact)

PROGRAM_OFFICER_NAME: POND, MONIQUE ADRIANNE

PROJECT_TERMS: AKT1 gene;Animal Model;Antibodies;antibody conjugate;Automation;beta catenin;Binding;Biological;Biological Assay;biomarker discovery;BRAF gene;Cancer Biology;Cancer cell line;Cell Culture Techniques;Cell Cycle;Cell Line;Cells;Clinical Trials;Combined Modality Therapy;Complex;cost;Data;data acquisition;Detection;detection assay;Development;Diabetes Mellitus;Disease;Disease Pathway;DNA Sequence Alteration;Drug Combinations;Drug Targeting;Ensure;Event;follow-up;Freeze Drying;Frequencies;Future;HT29 Cells;Human;human tissue;Immunoassay;in silico;Individual;inhibitor;interest;Isotope Labeling;kinase inhibitor;Malignant Neoplasms;MAP2K1 gene;MAPK1 gene;MAPK3 gene;Marketing;Mass Spectrum Analysis;Measures;MEKs;Methods;Mitogen-Activated Protein Kinase Kinases;Mitogen-Activated Protein Kinases;Modeling;Modification;molecular marker;Molecular Profiling;Molecular Weight;Monitor;multiplex assay;mutant;Mutation;Mutation Detection;Noise;notch protein;novel therapeutics;Oncology;Pathway interactions;patient derived xenograft model;Peptides;Pharmaceutical Preparations;Phase;Phospho-Specific Antibodies;Phosphorylation;Phosphorylation Site;Phosphotransferases;PIK3CG gene;Population;pre-clinical research;Preclinical Drug Development;preclinical study;Preparation;pressure;product development;protein degradation;Protein Fragment;Protein Isoforms;Protein Region;Proteins;Proteomics;Proto-Oncogene Proteins c-akt;Protocols documentation;Reaction;Regimen;Reporting;Reproducibility;Research Personnel;Ribosomal Protein S6;routine screening;Sampling;Signal Pathway;Signal Transduction;Site;Specificity;Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization;Standardization;synthetic peptide;Technology;Testing;The Cancer Genome Atlas;Time;Tissue Model;TP53 gene;Transforming Growth Factor beta;Western Blotting;Work

PROJECT_TITLE: Immunoassay for Measuring Mutation Activated Kinases Across Multiple Cell Signaling Pathways


NIH_SPENDING_CATS: Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Disability Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Intellectual and Developmental Disabilities (IDD);Mental Health

ORG_CITY: COLORADO SPRINGS

ORG_NAME: ABLELINK SMART LIVING TECHNOLOGIES LLC

PHR: Project Narrative The goal of the project is to build the WayFinder Ride application and its supporting tools to support independent access to ridesharing services such as Uber, Lyft, or emerging driverless vehicles services for individuals with intellectual and developmental disabilities (IDD). This universally designed prototype system will address functional limitations in reserving, requesting, and riding in ridesharing service vehicles, as well as features to address safety and security concerns. Relevance to public health can be seen in the opportunity for enhanced quality of life for people with IDD through greater access to the health, employment, education, socialization, recreation, consumerism, and other benefits of community participation experienced by the greater citizenry.

PI_NAMEs: DAVIES, DANIEL K (contact)

PROGRAM_OFFICER_NAME: OREILLY, JULIA JIAQI

PROJECT_TERMS: access disparities;Address;Adoption;Affect;Americans with Disabilities Act;Area;Automobiles;Cognitive;cognitive disability;Communities;community involvement;Community Participation;Computer software;cost;design;Destinations;Development;disability;Disabled Persons;Disparity;Documentation;Drops;Ecosystem;Education;efficacy evaluation;Emergency Situation;Employment;Equity;Evaluation;experience;Face;Family;field study;Frequencies;Friends;Future;General Population;Goals;Health;Health Service Area;Hour;Image;improved;Individual;Intellectual functioning disability;interest;Left;Life;Mainstreaming;medical appointment;Online Systems;outcome disparities;Persons;Phase;Pilot Projects;Population;Process;prototype;Public Health;Quality of life;Recreation;Research;Research Peer Review;Resources;Respondent;response;Safety;San Francisco;Security;Self Determination;Services;skills;Small Business Innovation Research Grant;social;Socialization;Societies;software development;Specific qualifier value;Support System;support tools;Surveys;System;Techniques;Technology;Testing;Text;tool;Training;Transportation;transportation access;Travel;Universities;usability;virtual;Visit;Vocation;Walking;web app;web-based tool;Work

PROJECT_TITLE: Development and Evaluation of Technology and Safety Supports for Individuals with Intellectual and Developmental Disabilities to Independently Use Driverless and Driver Supported Ridehailing Services

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