NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Complementary and Integrative Health;Emerging Infectious Diseases;Infectious Diseases;Neurosciences;Patient Safety;Prevention

ORG_CITY: EASLEY

ORG_NAME: VRM LABS INC

ORG_STATE: SC

PHR: Project Narrative Currently used surface disinfectants provide high-level activity over a relatively short period of time, typically less than 4 hours. We developed a novel film-forming disinfectant based on chitosan, alcohol, and a natural antimicrobial, which is slowly released from the coating providing complete protection from microbial contamination for up to 72 hours. Our formulation is superior to currently available long-lasting disinfectants and is expected to provide a longer and higher quality protection of environmental surfaces while requiring less frequent applications.

PI_NAMEs: MEISINGER, DAVID JOHN (contact);VERTEGEL, ALEXEY A

PROJECT_TERMS: Adherence;Affect;Aftercare;Alcohols;Ammonium;anti-viral efficacy;antimicrobial;aqueous;Bacteria;Biocide;care delivery;Caring;Chitin;Chitosan;Clinic;clinically relevant;Collaborations;commercialization readiness;Contractor;Crustacea;Data;Development;Disinfectants;Disinfection;Dryness;efficacy study;Elevator;Environmental Protection;Ethanol;field study;Film;Formulation;Goals;Grant;Growth;Guidelines;Hand;Health;health care settings;healthcare-associated infections;Hospitals;Hour;Hydrogen Peroxide;Hygiene;Hypochlorite;improved;Infection;Infectious Agent;Klebsiella aerogenes;Light;manufacture;Manufacturer;manufacturing process;manufacturing scale-up;Marketing;Medical;Medical Staff;methicillin resistant Staphylococcus aureus;microbial;Midwestern United States;Morbidity - disease rate;mortality;natural antimicrobial;novel;Oils;pathogen;Patients;Performance;Phase;phase 1 study;Polysaccharides;prevent;prisma;Property;Protocols documentation;Quality Control;quaternary ammonium compound;Reproducibility;Residual state;Risk;Sampling;Santalum;scale up;Secondary to;Site;Staphylococcus aureus;Surface;Testing;Time;Touch sensation;Toxic effect;transmission process;Vancomycin resistant enterococcus;Virus;Viscosity;Vision;Water

PROJECT_TITLE: Protective film-forming disinfectant based on chitosan/water/ethanol tertiary solutions


ADMINISTERING_IC: AI

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

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

ORG_CITY: COLLEGE STATION

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: KJ BIOSCIENCES, LLC

ORG_STATE: TX

PHR: Project narrative Salmonella typhi is the major cause of typhoid fever and a significant global health concern. Current conjugate vaccines for controlling this bacterial pathogen are based on the Vi polysaccharide produced through a bacteria-based production system with poor yield. This project seeks to develop a low-molecular weight synthetic Vi conjugate vaccine based on modification of a structurally similar abundantly available plant polysaccharide. This synthetic Vi conjugate will not only be more readily available through its simple and efficient production process but could also be more effective in protection against this bacterial pathogen.

PI_NAMEs: NI, YAWEI  (contact)

PROGRAM_OFFICER_NAME: ALEXANDER, WILLIAM A

PROJECT_TERMS: Acetylation;Acids;Anti-Bacterial Agents;Antibodies;Bacteria;bactericide;Biological Assay;Carrier Proteins;Cells;Cessation of life;Clinical;clinical development;Clinical Research;Complex;Conjugate Vaccines;Country;Cyclic GMP;Development;Disease;DNA-Binding Proteins;Epitopes;Evaluation;Face;Fermentation;Future;galacturonic acid;Generations;global health;Goals;Hydrolysis;immunogenic;immunogenicity;improved;India;Link;manufacture;meter;Modification;Molecular Weight;Mus;nanoparticle;National Institute of Child Health and Human Development;novel;Oryctolagus cuniculus;pathogenic bacteria;Persons;Phase I Clinical Trials;Plants;Polysaccharides;preclinical development;Process;Production;Proteins;Qualifying;Reporting;response;Salmonella;Salmonella typhi;Salmonella Vaccines;Scientist;Secondary Immunization;Series;Specific qualifier value;Starvation;Synthetic Vaccines;System;Typhoid Fever;vaccine candidate;Vaccines;Variant;Vertebral column;Vi antigen

PROJECT_TITLE: Development of a low molecular weight synthetic Vi conjugate vaccine for salmonella typhi

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


ADMINISTERING_IC: MH

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

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

ORG_CITY: BALTIMORE

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

ORG_STATE: MD

PHR: PROJECT NARRATIVE Transgender and gender diverse (TGD) communities face intersecting stigmas and historic discrimination which impacts HIV testing access, including in India, where public HIV clinics only reach about 12% of the estimated 488,000 people who identify as transgender. This mixed methods, participatory study will characterize specific sets of needs around HIV testing and care engagement among TGD people and explore how a person-centered care model can fill these needs. This study collaborates with TGD community members as research partners to produce community-driven findings which can guide the integration of HIV testing and follow-up services with person-centered care to advance health equity for TGD populations and make progress towards HIV epidemic control by 2030.

PI_NAMEs: KAPTCHUK, ROSE POLLARD (contact)

PROGRAM_OFFICER_NAME: KAMATH, SUSANNAH M A

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Area;barrier to care;Behavioral Research;Caring;Client;Clinic;Collaborations;Communities;community based participatory research;community burden;community engagement;Data;Dedications;design;Discrimination;doctoral student;Educational workshop;Ensure;Environment;epidemic response;Equity;experience;Face;Fellowship;follow-up;Friends;Funding;gender affirming care;gender diverse;gender minority community;General Population;Geography;global health;Goals;Government;Health;health equity;Health Services Accessibility;Healthcare;HIV;human centered design;Human immunodeficiency virus test;improved;India;Individual;Injecting drug user;Intervention;Interview;Leadership;member;Mental Health;Mentorship;Methods;Modeling;National Institute of Mental Health;novel;Outcome;person centered;Persons;Population;Population Heterogeneity;Prevalence;programs;Provider;Public Health Schools;Public Sector;Qualitative Methods;Research;Research Personnel;Research Priority;research study;Resources;Respondent;Sampling;Scientific Inquiry;service delivery;Service delivery model;service engagement;Services;Sexual and Gender Minorities;Side;social;social stigma;Statistical Data Interpretation;Stigmatization;Study models;Subgroup;Surveys;Testing;testing access;testing services;testing uptake;Training;transgender;transmission process;United States Public Health Service;Universities;USAID;violence victimization;Voice;Work

PROJECT_TITLE: Aligning HIV services with gender diverse community priorities through person-centered care: a mixed methods study in India

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 F17B-H (20)]


ADMINISTERING_IC: NS

ED_INST_TYPE: SCHOOLS OF PHARMACY

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Brain Disorders;Depression;Genetics;Mental Health;Neurosciences;Physical Injury - Accidents and Adverse Effects;Traumatic Brain Injury (TBI);Traumatic Head and Spine Injury

ORG_CITY: CINCINNATI

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF CINCINNATI

ORG_STATE: OH

PHR: PROJECT NARRATIVE Neuropsychiatric disorders are linked to serotonin (5-HT) neurotransmission and are also a leading comorbidity of traumatic brain injury (TBI). Studies proposed herein seek to determine how TBI alters 5-HT neuron populations within the midbrain raphe nucleus, a brain region preferentially impacted by various forms of closed head injury (CHI); and to delineate whether an inducible transcription factor, NRSF/REST, is associated with TBI-induced alterations in 5-HT neurotransmission and behaviors following TBI. Studies will provide novel insights into the function and regulation of 5-HT neurons following TBI and may provide novel targets for the discovery/development of clinically viable pharmacotherapies for the treatment of TBI-associated neuropsychiatric disorders.

PI_NAMEs: ROBSON, MATTHEW  (contact)

PROGRAM_OFFICER_NAME: AWWAD, HIBAH OMAR

PROJECT_TERMS: Affect;American;Amygdaloid structure;Anatomy;Anxiety;attenuation;Automobile Driving;Behavior;Behavioral;Biological Assay;Brain;Brain Concussion;Brain region;Brain Stem;Candidate Disease Gene;candidate identification;Cell Nucleus;Cell Separation;Cells;Cerebral cortex;Chronic;Clinical;clinical development;Closed head injuries;combinatorial;comorbidity;controlled cortical impact;Coupled;critical period;Data;Data Set;Development;disability;drug discovery;Enzymes;Etiology;Exhibits;Family;Fatigue;FDA approved;Gene Expression Profile;Generations;Genes;Genetic Transcription;Growth;Head;Heterogeneity;Hippocampus;Individual;Informatics;Injury;innovation;insight;Intractable Headaches;Link;Maintenance;Maps;Medial;Mental Depression;Messenger RNA;Midbrain structure;mild traumatic brain injury;Modernization;Molecular;multimodal modeling;Mus;Nervous System Trauma;Neuroanatomy;neurodevelopment;Neurons;neuropsychiatric disorder;neuropsychiatry;neurotransmission;Neurotransmitters;novel;novel therapeutics;Ontology;Penetration;persistent symptom;Pharmaceutical Preparations;pharmacologic;Pharmacotherapy;Physiological;Physiology;Population;Pre-Clinical Model;presynaptic;Process;Production;Public Health;raphe nuclei;receptor;receptor expression;Regulation;Repression;Role;Sampling;Selective Serotonin Reuptake Inhibitor;Seminal;Serotonin;serotonin transporter;Signal Transduction;Sleep disturbances;social;Social Functioning;Space Perception;stem;Symptoms;TBI treatment;Therapeutic;Time;tool;TPH2;Transcript;Transcription Alteration;transcription factor;transcription factor REST;Transcription Repressor;Transcriptional Regulation;transcriptome sequencing;Traumatic Brain Injury;United States;Withdrawal;Work

PROJECT_TITLE: No REST for 5-HT Neurons Following Traumatic Brain Injury

STUDY_SECTION: BINP

STUDY_SECTION_NAME: Brain Injury and Neurovascular Pathologies Study Section[BINP]


ADMINISTERING_IC: NR

IC_NAME: NATIONAL INSTITUTE OF NURSING RESEARCH

NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Clinical Research;Health Services

ORG_CITY: WASHINGTON

ORG_NAME: LINKED SENIOR, INC.

ORG_STATE: DC

PHR: Narrative At any given time approximately 5% of older adults with an average age of 84 years are living in long-term care facilities. Approximately 23% of older adults over the age of 85 live in nursing homes. The 85 and older population is the fastest-growing portion of the US population and is expected to triple by 2030 to 19 million and the number of people living in long-term care facilities is expected to continue to grow as quickly. In 2022, it was estimated that 1.4 million Americans lived in nursing homes. We can project that between 4.2 and 4.4 million older adults will be living in nursing homes. Federal regulations mandate a focus on person-centered care based on knowing and honoring resident preferences. Preliminary research has established there is a significant industry need for a streamlined tool to capture and act upon resident preferences to improve the quality of care in long-term care settings. The digital tool we envision will be called the Care Preference Assessment of Satisfaction or ComPASS™.

PI_NAMEs: STERNS, ANTHONY  (contact)

PROGRAM_OFFICER_NAME: WOLFF, JOSHUA R

PROJECT_TERMS: Administrator;Age;American;Assisted Living Facilities;Bathing;care preference;Caregivers;Caring;Certification;commercialization;Communities;Community Healthcare;community living;Computer software;Data;Data Set;Development;digital;digital tool;Discipline of Nursing;Electronic Health Record;electronic health record system;Elements;Environment;Equipment and supply inventories;Evaluation;field study;flexibility;Focus Groups;Health care facility;implementation barriers;implementation strategy;improved;Incentives;Individual;Industry;Institution;Job Satisfaction;Language;Learning;Leisures;Life;Long-Term Care;Marketing;member;Methods;novel;Nursing Homes;Nursing Staff;older adult;Older Population;operation;Outcome;person centered;personalized care;Persons;Phase;phrases;pleasure;Population;preference;Printing;Quality of Care;Questionnaires;Recreation;Regulation;Reporting;Research;Sampling;satisfaction;service delivery;Services;social contact;Tablets;Technology;Telephone;Testing;Time;tool;Trust;United States Centers for Medicare and Medicaid Services

PROJECT_TITLE: A Novel Tool for Integrating Resident Preferences for Improving Service Delivery and Satisfaction in Long-term Care Settings

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


NIH_SPENDING_CATS: Brain Disorders;HIV/AIDS;Infectious Diseases;Mental Health;Neurosciences;Nutrition;Pediatric;Pediatric - AIDS

ORG_CITY: PHILADELPHIA

ORG_NAME: CHILDREN'S HOSP OF PHILADELPHIA

ORG_STATE: PA

PHR: PROJECT NARRATIVE  Adolescents with human immunodeficiency virus (HIV) often have reduced neurological function that may be linked to abnormal brain myelin, which is a special fat (lipid)-rich insulation that helps brain cells communicate with one another. Because HIV infection and antiretroviral therapy drugs both disturb the balance of lipids in the brain, I will look at whether the cells that make lipids for myelin cannot make the correct amount or types. The results from this study will explore if treatments targeting lipids in these brain cells might improve myelin and neurological function in adolescents living with HIV.

PI_NAMEs: JEFFRIES, MARISA  (contact)

PROJECT_TERMS: Address;Adolescence;Adolescent;Affect;antiretroviral therapy;Apolipoprotein E;Astrocytes;Brain;brain abnormalities;brain cell;Brain region;Cell Communication;Cells;Central Nervous System;Cholesterol;cholesterol biosynthesis;Coculture Techniques;cognitive function;Corpus striatum structure;Data;Development;emtricitabine;enzyme biosynthesis;equilibration disorder;Exhibits;Exposure to;Fatty acid glycerol esters;Fumarates;Genetic Transcription;HIV;HIV Infections;HIV-1;HIV-associated neurocognitive disorder;HIV-infected adolescents;Homeostasis;Human;Impaired cognition;Impairment;improved;In Vitro;in vivo;Inflammation;LDL-Receptor Related Protein 1;Link;lipid biosynthesis;lipid metabolism;lipid transport;Lipids;Macaca;Maintenance;Mediating;Mission;Modeling;Myelin;myelination;National Institute of Mental Health;Nervous System Physiology;neurocognitive disorder;Neuroglia;neuropathology;oligodendrocyte myelination;Oligodendroglia;Pathology;Persons;Pharmaceutical Preparations;Prediction of Response to Therapy;Predictive Factor;Prevention;Production;Publishing;Quality of life;Rat Transgene;Rattus;Recovery;repaired;SIV;Structure;Tenofovir;Testing;therapeutic target;therapy development;Time;transgene expression;uptake;Viral;Virus Diseases;white matter

PROJECT_TITLE: HIV and ART Disruptions in Glial Cell Lipid Metabolism and its Effect on Adolescent Myelination

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


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Endocrine Disruptors;Estrogen;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Networking and Information Technology R&D (NITRD);Nutrition;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: EL CERRITO

ORG_NAME: MILLION MARKER WELLNESS INC.

ORG_STATE: CA

PHR: Project Narrative Currently, there are few mobile apps for raising endocrine disrupting chemical (EDC) awareness and reducing environmental exposures which provide only static general guidelines and consumer product information, and offer limited personalization, interaction, and feedback. Further, none of these apps are designed for use by minority populations and have several systemic barriers (i.e., language, cultural, knowledge, economic) for use by such populations. This work aims to develop a multicultural mobile phone application and environmental health literacy (EHL) materials for raising EDC awareness and literacy and reducing environmental exposures. We propose to do this by assessing a population of African Americans’ routine exposures and providing personalized exposure reduction recommendations (via science-backed research and focus groups); providing culturally appropriate, personalized, interactive environmental health education pertaining to environmental exposures targeted to a minority population; and tracking EHL and lifestyle improvements over time. Completion of this proposal will allow Million Marker to empower individuals in minority communities to increase their EHL and reduce their harmful exposures. This Phase I SBIR funding will allow us to develop and test the feasibility of a multicultural app and improve MM’s product and services. If the aims are achieved, we will be ready for Phase II and further evaluate the efficacy of the app and services, and extend it to other minority/marginalized populations.

PI_NAMEs: HUA, JENNA  (contact)

PROGRAM_OFFICER_NAME: JOHNSON, JARRETT AINSWORTH

PROJECT_TERMS: Affect;African American population;Awareness;Behavior;behavior change;Behavioral Sciences;black men;Black Populations;Black race;black women;Cellular Phone;Chemical Exposure;Chronic Disease;cohort;Collaborations;commercialization;Communities;community advisory board;community based participatory research;community collaboration;consumer product;demographics;design;Development;Diabetes Mellitus;Diet;Disease;E-learning;Economics;Education;education resources;Educational Materials;efficacy evaluation;empowerment;Endocrine Disruptors;Environmental Epidemiology;Environmental Exposure;Environmental Health;evidence base;Exposure to;feasibility testing;Feedback;Fetus;Focus Groups;Fostering;Funding;Goals;Guidelines;Health;Health education;health literacy;Health Promotion;Health Psychology;Hispanic Women;Hypospadias;improved;Individual;Infertility;informant;Institutional Racism;International;Interview;Journals;Knowledge;Language;Learning;Life;Life Style;lifestyle factors;Link;literacy;Low Birth Weight Infant;male;Malignant Breast Neoplasm;marginalized population;member;Metabolic syndrome;Methodology;mHealth;Minority;minority communities;Minority Groups;mobile application;Multicultural Education;Not Hispanic or Latino;Obesity;Occupations;Parabens;Participant;personalized intervention;Persons;Phase;phthalates;Population;Pregnancy;Premature Birth;prevent;Process;programs;Qualifying;Readiness;Recommendation;recruit;Research;Resources;response;Science;Services;Small Business Innovation Research Grant;social disparities;social media;Social Sciences;Source;stem;Surveys;System;systemic barrier;Target Populations;Technology;Testing;Time;tool;Toxicant exposure;Update;Urine;usability;White Women;Work

PROJECT_TITLE: Development of an Environmental Health Literacy Mobile Application to Reduce Toxic Environmental Exposures in Black Communities

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


ED_INST_TYPE: SCHOOLS OF SOCIAL WELFARE/WORK

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;HIV/AIDS;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Infectious Diseases;Networking and Information Technology R&D (NITRD);Prevention;Social Determinants of Health

ORG_CITY: SEATTLE

ORG_NAME: UNIVERSITY OF WASHINGTON

ORG_STATE: WA

PHR: This work will provide public health and clinical researchers with accessible computational tools and easy-to- understand guidance for evaluating treatment-related outcomes in HIV and health-related research that take the form of fractions or percentages, such as medication adherence. The new marginalized zero- and N- inflated binomial (MZNIB) statistical model and companion computational tools are expected to have greater accuracy and sensitivity than existing statistical approaches for identifying effective treatments, which can better inform evidence-based practice and guide treatment recommendations and individual healthcare decisions.

PI_NAMEs: HUH, DAVID  (contact)

PROGRAM_OFFICER_NAME: GEZMU, MISRAK

PROJECT_TERMS: Address;Adherence;AIDS prevention;antiretroviral therapy;Behavior;Behavioral;behavioral health;Benchmarking;Binomial Model;career;Clinical;Clinical Research;Cohort Studies;Communities;Companions;Computer software;computerized tools;Data;Disadvantaged;Dissemination and Implementation;Dose;effective therapy;Effectiveness of Interventions;empowerment;Equation;Equipment and supply inventories;Evaluation;evidence base;Evidence based practice;experience;Family;Floor;frailty;Future;Health;Healthcare;Heterogeneity;HIV;HIV prevention trial;improved;Individual;innovation;insight;interest;Intervention;Intervention Trial;Linear Regressions;Logistic Models;Logistic Regressions;Logistics;marginalization;Measurement;medication compliance;Meta-Analysis;Methods;Modeling;novel;open source;Outcome;Outcomes Research;Paper;Patients;Performance;Pharmaceutical Preparations;Phenotype;Population;Prevention trial;Probability;Public Health;Recommendation;Research;Research Personnel;research study;Risk Behaviors;Sampling Studies;simulation;Statistical Models;substance misuse;substance use;Target Populations;Testing;therapy adherence;therapy development;tool;treatment effect;Treatment outcome;treatment risk;uptake;Work

PROJECT_TITLE: Innovative Computational Tools and Best Practice Recommendations for Analyzing HIV-related Count Outcomes

STUDY_SECTION: PPAH

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


ADMINISTERING_IC: GM

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Biomedical Imaging;Patient Safety

ORG_CITY: OAK CREEK

ORG_NAME: DURAMETRIX LLC

ORG_STATE: WI

PHR: PROJECT NARRATIVE The goal of this STTR Phase II project is to demonstrate an expanded utility of an in vivo imaging-based testing technology, which allows for characterizing and optimizing cancer therapies and for identifying tissue damage induced by drug side effects.

PI_NAMEs: JOHNSON, STEVEN EDWARD (contact)

PROGRAM_OFFICER_NAME: GERSHENSON, ANNE

PROJECT_TERMS: Address;Adverse effects;Antineoplastic Agents;cancer therapy;Cell Death;Cell Survival;Cells;Climate;Clinical Trials;clinically relevant;collaborative environment;Consumption;cost;Cytotoxic agent;design;dosage;drug development;drug market;Drug Side Effects;drug testing;Drug toxicity;duramycin;Early Diagnosis;Entrepreneurship;Extracellular Space;Goals;Grant;Histopathology;Human;imaging approach;Imaging technology;In Vitro;in vivo;in vivo evaluation;in vivo imaging;Industrialization;innovation;Intervention;Investigational Drugs;Investigational New Drug Application;Marketing;Measures;medication safety;Methods;minimally invasive;Molecular Profiling;Normal tissue morphology;Oncology;Pathologic;Pharmaceutical Preparations;pharmacologic;Pharmacologic Substance;pharmacovigilance;Phase;phase 1 study;Phosphatidylethanolamine;Phosphatidylserines;Phospholipids;post-market;pre-clinical;Predisposition;Process;programs;rapid growth;Readiness;Research;research and development;Resources;response;safety study;Sampling Errors;Science;Side;single photon emission computed tomography;Small Business Technology Transfer Research;spatiotemporal;Surveys;Symptoms;Techniques;Technology;Technology Assessment;Testing;Therapeutic;Time;tissue injury;Tissues;tool;Toxic effect;Toxicity Tests;Toxicology;tumor;whole body imaging

PROJECT_TITLE: Establishing the market-readiness of an in vivo technology for assessing drug toxicity-induced tissue damage

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


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Asthma;Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Lung;Neurosciences;Pediatric;Precision Medicine;Racial and Ethnic Minority Health Research;Sleep Research;Social Determinants of Health

ORG_CITY: Atlanta

ORG_NAME: KDH RESEARCH AND COMMUNICATION, INC.

ORG_STATE: GA

PHR: Black teens with asthma experience worse sleep outcomes than White teens with asthma, and lack of sleep can  worsen disease outcomes. KDH Research & Communication (KDHRC), with technical partner Thrust  Interactive, will develop an app-based sleep intervention for Black teens with asthma (ages 14 – 17) that uses casual gaming and intermittent reinforcement to encourage teens to adopt and persist with personalized habits  to improve sleep duration. The PATH-S app will sync to a low-cost wearable biometric device that provides  biometric data and sleep metrics for tracking improvement and reinforcing success. PATH-S’ ultimate goal is to improve sleep duration, which will relate to subsequent improvements in focus, attention, and reduced asthma  symptoms in turn.

PI_NAMEs: TWOMBLY, ERIC CHARLES (contact)

PROGRAM_OFFICER_NAME: DIXIT, SHILPY

PROJECT_TERMS: 14 year old;Achievement;Address;Adopted;Adult;Advisory Committees;Age;Asthma;Attention;base;Behavior;Behavioral;Biological;Biometry;Black race;Brain;Caring;Cellular Phone;commercialization;Communication;Control Groups;coping;cost;Data;Development;Devices;Disease Outcome;Drowsiness;Environmental Risk Factor;evidence base;experience;Face;falls;Feasibility Studies;fitbit;fitness;Foundations;Funding;Goals;group intervention;Habits;Health;health care delivery;health care service organization;Health Disparities Research;health disparity;health equity;Health Promotion;Health Technology;High School Student;Home;Human;improved;improvement on sleep;Insurance;interest;Intervention;intervention delivery;Learning;Marketing;Modeling;Names;National Heart, Lung, and Blood Institute;National Institute on Minority Health and Health Disparities;operation;Outcome;Participant;Personal Satisfaction;personalized approach;Persons;Phase;poor sleep;Productivity;prototype;Psychological reinforcement;Quality of life;Recommendation;Reporting;Request for Applications;Research;Research Proposals;resilience;Respondent;Risk;Sales;Schools;Sleep;sleep behavior;Sleep Deprivation;Sleep Disorders;Sleep disturbances;Small Business Innovation Research Grant;social health determinants;Solid;success;Symptoms;Techniques;Technology;Teenagers;Testing;Time;usability;Vendor;wearable device;Wheezing

PROJECT_TITLE: Personalized Approach To Habits-Sleep (PATH-S), an app to improve sleep for Black teens (ages 14-17) with asthma

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


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Endocrine Disruptors;Foodborne Illness

ORG_CITY: CARRBORO

ORG_NAME: SORBENTA INC

ORG_STATE: NC

PHR: Narrative The annual cost burden associated with PFAS exposure is estimated to be at least $62.6B in the U.S., with related disease conditions including cancer, thyroid disease, pregnancy-induced hypertension and preeclampsia, and many others still under investigation. Despite increasing regulation and rising concern, methods to adequately remove PFAS from water remain limited because PFAS are commonly present at orders of magnitude lower concentration than natural organic matter and ions found in water, making PFAS removal equivalent to removing a “needle in a haystack.” Sorbenta’s IF sorbents deliver four key benefits over today’s state-of-the-art, which combined provide performance and economic advantages: 1) high capacity for PFAS removal; 2) selectivity for PFAS in complex water matrices, thus prioritizing capacity for the targeted PFAS compounds; 3) best-in-class, broad capability to capture most long and short PFAS compounds, the latter of which are not effectively removed by most current approaches; and 4) on-site regenerability without apparent loss of performance, enabling advantages in total cost of ownership.

PI_NAMEs: CORONELL NIETO, ORLANDO ;LEIBFARTH, FRANK ALBERT;WEITKAMP, ROBIN  (contact)

PROGRAM_OFFICER_NAME: HENRY, HEATHER F

PROJECT_TITLE: Novel sorbents for removal of PFAS from water

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


NIH_SPENDING_CATS: Acute Respiratory Distress Syndrome;Bioengineering;Lung;Networking and Information Technology R&D (NITRD);Patient Safety;Precision Medicine;Prevention;Rare Diseases

ORG_CITY: Gainesville

ORG_NAME: CONVERGENT ENGINEERING, INC.

ORG_STATE: FL

PHR: PROJECT NARRATIVE Mechanical ventilation is an essential intervention for many patients but is associated with a significant risk of preventable complications including ventilator induced lung injury, ventilator associated pneumonia, extended ICU stay, and mortality. Esophageal manometry provides important physiologic data such as transpulmonary pressure, effort to breathe, patient-ventilator asynchrony, intrinsic PEEP, and other parameters that can reduce lung injury and shorten time on the ventilator, but its use is severely limited due to the time consuming and difficult effort required for proper use and interpretation. This project will develop a system including patented hardware and decision support software that will automate and simplify the use of esophageal manometry to improve accessibility and clinician adoption leading to personalized care of ventilated patients that can improve patient outcomes in the critically ill.

PI_NAMEs: EULIANO, NEIL R. (contact)

PROGRAM_OFFICER_NAME: ZHOU, GUOFEI

PROJECT_TERMS: Accounting;Acute Respiratory Distress Syndrome;Admission activity;Adoption;arm;atelectrauma;Atrophic;attributable risk;Automobile Driving;Benchmarking;Breathing;Caring;Chest wall structure;Clinical;clinical care;Computer software;Consumption;Critical Illness;Data;Decision Support Systems;design;Disease;effectiveness evaluation;Ensure;Esophagus;esophagus pressure;experience;expiration;Fatigue;Frequencies;Goals;Grant;Hospitals;improved;Injury;insight;Intensive Care Units;Intervention;Legal patent;Life;Lung;lung injury;lung pressure;Manometry;Measurement;Measures;Mechanical ventilation;Mechanical Ventilators;Mechanics;Monitor;Morbidity - disease rate;mortality;Multicenter Studies;Outcome;patient variability;Patient-Focused Outcomes;Patients;Performance;Periodicity;personalized care;Phase;Phase II Clinical Trials;Physiological;Pleural;Positive-Pressure Respiration;pressure;prevent;Protocols documentation;prototype;provider adoption;respiratory;Respiratory Diaphragm;Respiratory physiology;Respiratory System;Risk;Risk Reduction;Sedation procedure;Self-Help Devices;Shock;Small Business Innovation Research Grant;software systems;standard of care;Standardization;success;System;Technology;Tidal Volume;Time;Titrations;Training;usability;Validation;ventilation;Ventilator;ventilator-associated pneumonia;Ventilator-induced lung injury;Weaning;Work;Work of Breathing;Workload

PROJECT_TITLE: Decision Support System for Personalized Care of Ventilated Patients using Esophageal Pressure

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


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

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

ORG_CITY: San Diego

ORG_NAME: VIVREON BIOSCIENCES, LLC

PHR: Vivreon Biosciences, LLC 4940 Carroll Canyon Rd. Suite 110  San Diego, CA 92121 milton@vivreonbiosciences.com Vivreon Biosciences – NIAMS PA-23-230 Project Narrative Dystrophinopathies, including Duchenne muscular dystrophy (DMD), are inherited diseases characterized by progressive muscle weakness resulting in difficulty walking and often requiring a wheelchair by age 12. Currently therapies provide meager clinical benefit, and this grant project aims to test a novel small molecule therapy in a well-defined model of DMD with potential to preserve muscle strength. Should the results achieve statistical significance in this model, we will continue candidate development for this debilitating indication.

PI_NAMEs: GREENBERG, MILTON L (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Acceleration;Age;aged;Animal Model;Animals;appropriate dose;Attenuated;attenuation;Biological Availability;Biological Sciences;Calcium Channel;Calpain;capsule;Cells;Cessation of life;Chemicals;Chronic;Clinical;commercialization;Complex;Creatine Kinase;Cytochrome P450;cytotoxic;Development;Disease;disease model;Disease Progression;DNA Sequence Alteration;Dosage Forms;drug candidate;Drug Kinetics;Drug Targeting;Duchenne muscular dystrophy;Dystrophin;dystrophinopathy;efficacy study;efficacy testing;efficacy validation;enzyme activity;Face;Fibrosis;Funding;Gatekeeping;Generations;Genes;Goals;Grant;Hereditary Disease;Histology;Immune;immune cell infiltrate;Immunity;improved;In Situ;in vivo;infection risk;Infiltration;Inflammation;Inflammatory;Inflammatory Infiltrate;innovation;Intercept;Knock-out;knockout animal;Lead;lead candidate;Leucocytic infiltrate;Leukocytes;Link;loss of function mutation;Macrophage;Mission;Modeling;Muscle;Muscle Fibers;Muscle function;muscle strength;Muscle Weakness;muscular structure;mutant;nanomolar;National Institute of Arthritis, and Musculoskeletal, and Skin Diseases;Necrosis;neutrophil;novel;nuclear factors of activated T-cells;Oral;Pathologic;Pathologic Processes;Pathology;patient population;Patients;Peptide Hydrolases;Peripheral;Pharmaceutical Preparations;pharmacologic;Phase II Clinical Trials;Phenotype;Population;Pre-Clinical Model;Preparation;preservation;prevent;Process;Production;programs;Property;recruit;Regimen;Regulatory T-Lymphocyte;Risk;Role;Safety;Sarcolemma;Sarcoplasm;Schedule;Secondary to;Serum;side effect;Signal Transduction;Skeletal Muscle;Small Business Innovation Research Grant;small molecule;small molecule therapeutics;Structural Protein;System;Tablets;Testing;Therapeutic;therapeutic candidate;Toxic effect;transcription factor;treatment duration;Up-Regulation;Validation;Virus Diseases;Walking;Wheelchairs

PROJECT_TITLE: Development of a Novel Calcium Channel Therapeutic for Dystrophinopathies

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


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

NIH_SPENDING_CATS: Digestive Diseases

ORG_CITY: Durham

ORG_NAME: LAMASSU PHARMA INC.

PHR: Project narrative Acute pancreatitis is a major unmet medical need in the United States, resulting in over 250,000 hospital admissions per year with no available treatment, and also has a prevalence of up to 2% in dogs. We propose development of a new treatment approach that will mitigate the systemic toxicity and organ failure that causes lengthy hospitalization, organ failure, and death.

PI_NAMEs: HANNA, GABI  (contact)

PROGRAM_OFFICER_NAME: LUNSFORD, DWAYNE

PROJECT_TERMS: Acceleration;Acute;acute pancreatitis;Adipose tissue;Animal Model;Animals;Automobile Driving;Blinded;Businesses;C-reactive protein;Canis familiaris;Cardiovascular system;Cessation of life;Client;Clinical;clinical care;Clinical Data;clinical development;Clinical Management;Clinical Research;clinical trial recruitment;Clinical Trials;clinically relevant;Collection;companion animal;Companions;comparative trial;Data;data modeling;Death Rate;Development;Development Plans;Diagnosis;Disease;disease model;Disease Progression;Dose;effective therapy;efficacy evaluation;Emergency department visit;Enrollment;Entrepreneurship;Environmental Health;Evidence Based Medicine;experience;Experimental Animal Model;Experimental Models;Functional disorder;gastrointestinal;gastrointestinal sign;Goals;Health;holistic approach;Hospitalization;Human;Human Volunteers;Hypertriglyceridemia;improved;In Vitro;in vivo;Inflammatory;inhibitor;intraperitoneal;Kidney;Lead;Light;Lipase;Lipolysis;Liquid substance;Lung;manufacture;Medical;Modeling;Monitor;mouse model;Necrosis;Nonesterified Fatty Acids;novel;novel therapeutic intervention;novel therapeutics;Oncology;Organ failure;Outcome;Pancreas;Pancreatic Diseases;Pancreatitis;Patient Admission;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Placebo Control;Positioning Attribute;pre-clinical;Pre-Clinical Model;preclinical efficacy;Preparation;Prevalence;prevent;Production;prognostic indicator;programs;randomized placebo-controlled clinical trial;Rattus;Regimen;Reporting;Research;response;Route;safety study;Schedule;Seminal;Severity of illness;Small Business Innovation Research Grant;Supportive care;Systemic Inflammatory Response Syndrome;systemic toxicity;Therapeutic;Time;tissue injury;Toxic effect;translational goal;Translational Research;Treatment Efficacy;treatment group;treatment optimization;Treatment Protocols;treatment response;treatment strategy;Triglycerides;United States;United States National Institutes of Health;Veterinary Medicine;Visceral;Work

PROJECT_TITLE: One Health Advancement of RABI-767 for the Management of Acute Pancreatitis

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 KUDS-R (10)]


NIH_SPENDING_CATS: Assistive Technology;Bioengineering;Brain Disorders;Cerebrovascular;Hydrocephalus;Neurosciences;Rare Diseases

ORG_CITY: ROCHESTER

ORG_NAME: CONWAY MEDICAL LLC

ORG_STATE: MN

PHR: PROJECT NARRATIVE This project’s goal is to develop a novel Lumbo-venous CSF Shunt for the drainage of CSF into the venous system for treatment of communicating hydrocephalus, normal pressure hydrocephalus and idiopathic intracranial hypertension. Our proposed system will improve patient outcomes by allowing for the safe delivery of a catheter into the lumbar CSF space thus allowing CSF drainage and equilibration with the common iliac vein. The use of this system will allow physicians perform CSF diversion procedures in a minimally invasive fashion, limit shunt revisions and reduce complications.

PI_NAMEs: BRINJIKJI, WALEED  (contact)

PROGRAM_OFFICER_NAME: AUBRECHT, TARYN GRACE

PROJECT_TERMS: Acute;Adherence;Anatomy;Animal Model;Animal Testing;Animals;basilar artery;Blood Vessels;Brain Stem;Cadaver;Catheters;cerebellopontine angle;Cerebellum;cerebral vein;Cerebrospinal fluid shunts procedure;Cerebrum;Clinical;common iliac vein;Communicating Hydrocephalus;Communication;Craniotomy;Creation of ventriculo-peritoneal shunt;Data;design;Development;Device Designs;Devices;Diameter;Disease;Drainage procedure;Equipment Malfunction;experience;Failure;Family suidae;Fistula;Freezing;Goals;Greater sac of peritoneum;hemodynamics;Hemorrhage;implant design;improved;In Vitro;in vivo;in vivo evaluation;Indwelling Catheter;Infection;infection rate;Inferior;injured;innovation;Intellectual Property;Internal jugular vein structure;Intracranial Hypertension;Intracranial Pressure;invention;Length;Marketing;Medical;member;minimally invasive;Modeling;multidisciplinary;Needles;Neurologic;Neurosurgical Procedures;new technology;Normal Pressure Hydrocephalus;novel;Obstruction;Pathway interactions;Patient Care;Patient-Focused Outcomes;Patients;Performance;Phase;Phase I Clinical Trials;Physicians;Physiological;pressure;Procedures;programs;prototype;Pseudotumor Cerebri;Publishing;Puncture procedure;Reflux;Resistance;Safety;Second Look Surgery;Shunt Device;Silicon;Sinus;skull base;Small Business Technology Transfer Research;Spinal;Structure;Structure of jugular vein;Subcutaneous Tissue;System;Techniques;Technology;Testing;thrombogenesis;thrombotic;United States;Veins;Venous;Venous system;Vertebral column

PROJECT_TITLE: Lumbo-venous CSF Shunt for Treatment of Communicating Hydrocephalus.

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


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Arthritis;Assistive Technology;Bioengineering;Chronic Pain;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Neurosciences;Opioid Misuse and Addiction;Opioids;Pain Research;Patient Safety;Physical Rehabilitation;Rehabilitation;Substance Misuse

ORG_CITY: HEBER CITY

ORG_NAME: NCAP MEDICAL, LLC

ORG_STATE: UT

PHR: PROJECT NARRATIVE More than 10 million Americans have osteoarthritis of the knee, one of the most common causes of disability in Americans leading to >1 million knee replacements (TKA) annually. Current postoperative pain management for TKA is a major public health problem as it often leads to excessive opioid use/misuse, delay in functional recovery, chronic persistent surgical pain, and costly perioperative care. nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.

PI_NAMEs: CHELLY, JACQUES E. (contact);SADHASIVAM, SENTHILKUMAR

PROGRAM_OFFICER_NAME: SABIRZHANOV, BORIS YEVGENYEVICH

PROJECT_TERMS: absorption;Acupuncture Therapy;Address;Adverse effects;Adverse event;Affect;Age;aging population;American;Area;arthritic pain;Articular Range of Motion;Blinded;Businesses;care costs;Chronic;Clinical Trials;Collaborations;cost;cost effective;COVID-19 pandemic;Data;Day Surgery;design;Development;Devices;disability;Dose;Economic Burden;Effectiveness;effectiveness evaluation;Elective Surgical Procedures;Electromagnetic Energy;Emergency department visit;experience;Exposure to;femoral nerve;Food and Drug Administration Device Approval;Goals;group intervention;hip replacement arthroplasty;Hospitals;Human;Implant;improved;Individual;innovation;Institutional Review Boards;Knee;Knee Osteoarthritis;knee replacement arthroplasty;Legal patent;Length of Stay;Life;Medical;Medical Care Costs;Medical center;meetings;Mental disorders;Mood Disorders;Movement;multimodality;Musculoskeletal Pain;Nanotechnology;Nerve Block;Nociceptors;non-opioid analgesic;older patient;Operative Surgical Procedures;Opioid;opioid epidemic;opioid mortality;opioid sparing;opioid use;opioid use disorder;Pain;Pain management;pain reduction;pain relief;pain scale;pain signal;painful neuropathy;patient population;Patients;Perioperative Care;Persons;Phase;Physical therapy;Pilot Projects;Placebo Control;placebo group;Placebos;Population;Postoperative Pain;Postoperative Period;postoperative recovery;prescription opioid;primary endpoint;Procedures;programs;prospective;Protocols documentation;Public Health;Quality of life;Randomized;randomized placebo-controlled clinical trial;Recommendation;Recovery;Recovery of Function;Research;Rest;Risk;secondary endpoint;Site;Small Business Technology Transfer Research;socioeconomics;Spine surgery;standard of care;Standardization;study population;surgical pain;Techniques;Technology;Testing;Thigh structure;Time;tool;Training;Transcutaneous Electric Nerve Stimulation;transmission process;treatment group;Universities;Ventilatory Depression;Walking

PROJECT_TITLE: Enhancing pain management for knee replacement patients through an innovative non-invasive and opioid-sparing device

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


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Coronaviruses;Emergency Care;Emerging Infectious Diseases;Health Services;Infectious Diseases;Lung;Patient Safety;Prevention;Rare Diseases;Tuberculosis

ORG_CITY: ANN ARBOR

ORG_NAME: INSPIRE RX LLC

ORG_STATE: MI

PHR: PROJECT NARRATIVE The COVID-19 pandemic demonstrated the need to develop solutions that allow for safe transport and treatment of patients with highly transmissible infectious diseases. The proposed project will refine, manufacture, and test a compact, portable, personal negative pressure device called the AerosolVE™ BioHelmet, which will serve as PPE for the patient. The BioHelmet will prevent the spread of aerosolized pathogens, allowing patients to safely receive non-invasive oxygen treatments and visit with family and friends, while also keeping healthcare workers safe when treating infected patients.

PI_NAMEs: KOTA, SRIDHAR  (contact)

PROGRAM_OFFICER_NAME: MONGODIN, EMMANUEL FRANCK

PROJECT_TERMS: aerosolized;Aerosols;Air;Air Ambulances;Ambulances;Body Weight decreased;Breathing;care delivery;Chickenpox;Clinical;Collaborations;commercialization;Communicable Diseases;Continuous Positive Airway Pressure;cost;COVID-19;COVID-19 pandemic;Data;design;Devices;Effectiveness;Ensure;Environment;Evaluation;evaluation/testing;Extravasation;Family;FDA approved;Feedback;fighting;Filtration;Friends;future epidemic;future pandemic;Goals;Guidelines;health care settings;Health Personnel;Health protection;Helicopter;Helmet;Hospital Administrators;Hospitals;Hour;Human Resources;improved;Individual;Infection;Influenza;innovation;innovative technologies;Instruction;Life;manufacture;Measles;Medical;meetings;Michigan;Modification;Motor;Noise;novel;Nurses;Oxygen;Oxygen Therapy Care;particle;Particulate;pathogen;Pathogenicity;Patient Care;Patient Isolation;Patients;Performance;Physicians;portability;pressure;prevent;Procedures;Production;prototype;Provider;Pump;Qualifying;Readiness;research clinical testing;Research Personnel;Resources;respiratory;Respiratory Disease;respiratory pathogen;Risk;Safety;safety testing;Severities;success;System;Technology;Testing;tool;transmission process;Transportation;Transportation of Patients;Tuberculosis;Universities;Validation;Viral Respiratory Tract Infection;viral transmission;Virion;Virus;Visit;Weight;Work;worker safety

PROJECT_TITLE: Personal Respiratory Isolation System for Safe Transport and Treatment of Patients with Highly Transmissible Infectious Diseases


ADMINISTERING_IC: OH

IC_NAME: NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

PHR: PROJECT NARRATIVE The COVID-19 pandemic demonstrated the need to develop solutions that allow for safe transport and treatment of patients with highly transmissible infectious diseases. The proposed project will design, manufacture, and test a compact, portable, personal negative pressure device called the AerosolVE™ BioHelmet, which will immediately quarantine infected patients in plain sight. The BioHelmet will prevent the spread of aerosolized pathogens, allowing patients to safely receive non-invasive oxygen treatments while keeping healthcare workers and others in the immediate vicinity safe and also allowing family visitations.

PROGRAM_OFFICER_NAME: WRIGHT, MARCIENNE

PROJECT_TITLE: Protecting Healthcare Workers Using a Patient-Worn Negative Pressure System to Prevent the Spread of Highly Transmissible Infectious Diseases


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Genetics;Human Genome;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Prevention

ORG_CITY: HIALEAH

ORG_NAME: GALATEA BIO INC

PHR: NARRATIVE Predicting who is most likely to develop a complex disease later in life is a crucial component of providing individualized health care, and can affect the optimal frequency of health care actions such as preventative screening. This proposal focuses on developing better methods for risk prediction in non-European populations, since current approaches are only effective in European ancestry individuals.

PI_NAMEs: BUSTAMANTE, CARLOS DANIEL;IOANNIDIS, ALEXANDER ;WALL, JEFFREY D (contact)

PROGRAM_OFFICER_NAME: RIDER, RENEE ANNE

PROJECT_TERMS: Address;Affect;Algorithms;Americas;biobank;Catalogs;China;Clinical;Clinical Data;clinical risk;cohort;Collection;Companions;Complex;dashboard;Data;data dashboard;data visualization;Development;Disease;disorder risk;diverse data;effectiveness evaluation;Ensure;European;European ancestry;Evaluation;exome;Frequencies;Funding;Future;Genetic;Genetic Predisposition to Disease;Genetic Structures;Genetic study;genetic testing;genetic variant;Genome;Genotype;Goals;Healthcare;improved;Indigenous;Indigenous American;Individual;insight;Insulin-Dependent Diabetes Mellitus;Life;Life Style Modification;Machine Learning;Malignant Breast Neoplasm;Marketing;Medical;Meta-Analysis;Methodology;Methods;Mission;Modeling;Monitor;Non-Insulin-Dependent Diabetes Mellitus;novel;novel strategies;Patient Self-Report;Performance;personalized medicine;Persons;Phenotype;phenotypic data;polygenic risk score;Population;Population Genetics;Population Heterogeneity;Positioning Attribute;Preventive healthcare;Preventive screening;programs;Protocols documentation;Risk;Risk Estimate;risk prediction;Sampling;Source;Taiwan;Testing;tool;Training;University Hospitals;Use Effectiveness;Validation;Visualization software;Work

PROJECT_TITLE: Development and application of machine learning-based approaches for estimating disease risk in diverse and admixed populations.


ORG_CITY: HALETHORPE

ORG_NAME: CHESAPEAKE GENOMIC SYSTEMS LLC

PHR: PROJECT NARRATIVE The proposed research is relevant to public health because it will provide a new technology to generate completely synthetic DNA molecules that lack a plasmid backbone and that are in a supercoiled conformation. This project is relevant to NIH’s mission because this technology can be used to increase the safety and efficiency of lentivirus based and adeno-associated virus based gene therapies.

PI_NAMEs: BAI, HAIBO  (contact)

PROGRAM_OFFICER_NAME: SAKALIAN, MICHAEL

PROJECT_TERMS: Adenoviruses;Affect;Antibiotic Resistance;Bacteria;Cell Line;Cells;Cicatrix;Circular DNA;Collaborations;cost;Coupled;Cytomegalovirus;Dependovirus;design;DNA;DNA cassette;DNA Gyrase;DNA Ligases;DNA Ligation;DNA Restriction Enzymes;ds-DNA;Endosomes;Endotoxins;Enzymes;exodeoxyribonuclease;Gene Expression;gene product;gene therapy;Genetic Recombination;Goals;Green Fluorescent Proteins;Heteroduplex DNA;improved;In Vitro;in vivo;Industry Standard;innovation;interest;Length;Lentivirus;Ligation;Mammalian Cell;manufacture;milligram;Mission;Molecular Conformation;new technology;non-viral gene delivery;Nuclear;Open Reading Frames;Performance;Periodicity;Phase;Plasmid Cloning Vector;Plasmids;Production;Protocols documentation;Public Health;Reaction;Reporter Genes;Research;resistance gene;RNA;Safety;Source;Standardization;Superhelical DNA;synthetic construct;System;TCF3 gene;Technology;Therapeutic;therapeutic gene;thermostability;Transfection;transmission process;United States National Institutes of Health;uptake;vector;Vertebral column;Viral;viral gene delivery;Viral Genes;Viral Packaging;Virion;Work

PROJECT_TITLE: Vectorless supercoiled DNA: a new scalable abacterial in vitro system to improve gene therapy safety and production efficiency

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


NIH_SPENDING_CATS: Biotechnology;Breast Cancer;Cancer;Cardiovascular;Heart Disease;Prevention;Women's Health Research

ORG_CITY: SAN DIEGO

ORG_NAME: NOVOMEDIX, INC.

PHR: Project Narrative The goal of this program is to commercialize a novel small molecule that improves both short- and long-term clinical outcomes for those with triple negative or advanced/metastatic breast cancer by increasing overall survival and decreasing long-term mortality from adverse cardiac events resulting from chemotherapy agents, which is the leading cause of death in breast cancer survivors.

PI_NAMEs: SWINDLEHURST, CATHY A (contact)

PROGRAM_OFFICER_NAME: ADHIKARI, BISHOW B

PROJECT_TERMS: Adriamycin PFS;advanced disease;Advanced Malignant Neoplasm;Agonist;Anthracycline;anticancer activity;antitumor effect;Breast Cancer Patient;Breast Cancer survivor;Breast Cancer therapy;Breast Cancer Treatment;cancer cell;cancer diagnosis;Cancer Etiology;Cancer Patient;cancer therapy;Canis familiaris;Cardiac;Cardiomyopathies;cardioprotection;Cardiotoxicity;Cardiovascular Diseases;cardiovascular risk factor;Categories;Cause of Death;Cell Proliferation;Cessation of life;chemotherapy;Clinical;clinical efficacy;Collaborations;Colorectal Cancer;commercialization;Development;Diagnosis;Disease;Disseminated Malignant Neoplasm;Distant;Dose;Doxorubicin;Drug Kinetics;Drug resistance;Epidermal Growth Factor Receptor;Estrogen Receptors;Event;falls;Fibrosis;Formulation;Future;Goals;Heart;heart disease risk;Heart Diseases;Heart failure;Hormonal;Human;Immunotherapy;improved;in vivo;Inflammasome;Inflammation;inhibitor;Interleukin-11;Invaded;Lead;Left Ventricular Dysfunction;Legal patent;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant Neoplasms;Medicine;Metastatic breast cancer;method development;Methods;migration;Modality;mortality;mouse model;mTOR inhibition;Mus;Neoplasm Metastasis;novel;novel therapeutics;Oral;Outcome;overexpression;Patients;Pharmaceutical Preparations;Phase;Phase I Clinical Trials;phase I trial;phase II trial;Plasma;prevent;Progesterone Receptors;Prognosis;programs;Property;Rattus;Recommendation;Recording of previous events;Recovery;Recurrence;Regimen;Risk;Risk Factors;Safety;safety assessment;Salamandra;Small Business Innovation Research Grant;small molecule;Solid Neoplasm;Stage at Diagnosis;standard of care;Survival Rate;synergism;targeted treatment;Toxic effect;Toxicology;Treatment outcome;triple-negative invasive breast carcinoma;tumor;Universities;Validation;Virginia;Withholding Treatment;Woman;Women's mortality;Xenograft procedure

PROJECT_TITLE: Definitive (GLP) Toxicity and Toxicology Studies for a Novel Small Molecule for Protection Against Cardiotoxicity in Triple Negative Breast Cancer

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


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

ORG_CITY: CHALFONT

ORG_NAME: POLYGON HEALTH ANALYTICS LLC

PHR: Systemic lupus erythematosus (SLE) is a highly heterogeneous disease posing significant management challenges for patients and providers, with worse outcomes for Black and Hispanic women and those with inadequate social determinants of health (SDoH). Advancements in real-world data and artificial intelligence provide a unique opportunity to develop novel technological solutions, that integrates social care into traditional clinical care and facilitates a much-needed paradigm shift in the US health care delivery. This proposed SBIR Phase I project aims to develop an individualized social risk management algorithm and implement it in a software prototype to help SLE patients to manage their social needs and improve their SLE outcomes.

PI_NAMEs: BIAN, JIANG ;GUO, JINGCHUAN ;YAO, LIXIA  (contact)

PROGRAM_OFFICER_NAME: LAI, GABRIEL Y

PROJECT_TERMS: Address;Administrator;Advisory Committees;Affect;Alabama;Algorithms;Artificial Intelligence;artificial intelligence method;artificial intelligence model;Behavioral;Black Populations;black women;Body System;Businesses;Cardiovascular system;Caregivers;Caring;chronic autoimmune disease;Clinical;clinical care;cohort;Collaborations;commercialization;Communities;Complex;Computer software;Crime;Data;Data Analytics;data resource;Databases;Death Rate;design;Deterioration;digital health;Disease;Disease Management;Disparity;Disparity population;Doctor of Philosophy;Education;Electronic Health Record;ethnic minority;Exhibits;Flare;Florida;Focus Groups;Future;Health;health care delivery;health data;health disparity;Health system;Heterogeneity;Hispanic Populations;Hispanic Women;implementation strategy;improved;Individual;Information Services;innovation;interdisciplinary collaboration;Intervention;Link;Lupus;Lupus Erythematosus;Machine Learning;machine learning algorithm;machine learning model;Medicaid;Medical;Methods;Modeling;mortality;Names;Natural Language Processing;Natural Language Processing pipeline;Neighborhoods;new technology;novel;Outcome;Patients;Persons;Phase;Physical environment;preference;Pregnancy;programs;prototype;Provider;Psychological Factors;psychosocial;Public Health;Quality of life;racial discrimination;racial minority;Recommendation;Research Design;Research Personnel;Resources;Retrospective Studies;Risk;Risk Management;Role;rural residence;Small Business Innovation Research Grant;social;social disparities;Social Environment;social health determinants;social interventions;social stressor;Social support;Social Work;software development;stem;Systemic Lupus Erythematosus;Technology;tool;Transportation;Universities;user centered design;walkability;Work

PROJECT_TITLE: Addressing Social Determinants of Health in Systemic Lupus Erythematosus


ADMINISTERING_IC: DE

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Bioengineering;Childhood Injury;Dental, Oral, and Craniofacial Disease;Pediatric;Regenerative Medicine

ORG_CITY: FAYETTEVILLE

ORG_NAME: VIC FOUNDRY, INC.

ORG_STATE: AR

PHR: PROJECT NARRATIVE Over half of all children severely hurt their teeth through physical injury or carious legion, resulting in the performance of 4.7M endodontic procedures per year in the pediatric and young adult population. Maintenance of vital pulp in the tooth is critical for the ability to fight future infections, to prevent fracture, and to retain the tooth, particularly for immature permanent teeth without fully developed roots. This project works to drive commercialization of Vital-Dent, an acellular, drug-free hydrogel device that when used in conjunction with endodontic therapy, promotes revitalization and continued growth of immature permanent teeth.

PI_NAMEs: SU, XIAOLI  (contact)

PROGRAM_OFFICER_NAME: VERBRIDGE, SCOTT SPENCER

PROJECT_TERMS: Acute;Adolescent;Adoption;Adverse event;Animals;Apical;Biological;biomacromolecule;biomaterial compatibility;Biopolymers;Blood;Blood coagulation;Buffers;calcification;canine model;Canis familiaris;cell motility;Cell Survival;Cells;cGMP production;Child;Childhood;Clinic;Clinical;commercialization;Cyclic GMP;cytotoxicity;Debridement;Dental;Dental Pulp;Dentin;design;Development;Devices;Effectiveness;effectiveness evaluation;Endodontics;Endotoxins;Ensure;Evaluation;Family suidae;fighting;Formulation;Fracture;Freeze Drying;Future;Gel;Gelatin;genotoxicity;Goals;Growth;Heparin;Hour;Hydrogels;In Vitro;in vivo;in vivo Model;Incidence;Infection;Inflammatory Response;Injury;innovation;irritation;Length;Liquid substance;Maintenance;manufacture;manufacturing process;mechanical properties;Mechanics;Methacrylates;Methods;Modulus;Molecular Weight;Natural regeneration;Necrosis;Nerve;nerve supply;Outcome;Performance;periapical;permanent tooth;Pharmaceutical Preparations;Phase;Phenotype;Phosphate Buffer;physical property;Plant Resins;Polymers;Population;preservation;prevent;Procedures;Process;Property;Protocols documentation;prototype;Pulp Canals;Pulpectomy;Pulpitis;Pulpotomy;Qi;regenerative;Relaxation;Reproducibility;Resistance;restoration;revascularization;Risk;Root Canal Therapy;Safety;Saline;scaffold;scale up;Source;Sterility;sterility testing;Swelling;Testing;Thrombus;Time;Tissues;Tooth root structure;Tooth structure;Toxic effect;Toxicity Tests;Translating;Vascularization;Work;young adult

PROJECT_TITLE: Commercialization of the Vital-Dent Regenerative Pulp Therapy


ADMINISTERING_IC: CA

IC_NAME: NATIONAL CANCER INSTITUTE

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

ORG_CITY: BALTIMORE

ORG_NAME: RADIOPHARMACEUTICAL IMAGING AND DOSIMETRY, LLC

PHR: Proj Narrative Radiopharmaceutical therapy (RPT) – the use of targeted radionuclides to deliver radiation specifically to cancer cells and their microenvironment – is a growing area with a substantial number of large and small pharmaceuticals companies developing products in this area. The dosimetric evaluation of therapeutic radiopharmaceuticals is a key requirement for safe and effective therapy with these agents, especially for alpha-particle emitters. In this proposal, we will calculate microscale S values and implement a methodology specifically to address the requirements of alpha-emitter dosimetry in RPT.

PI_NAMEs: FREY, ERIC C.;GHALY, MICHAEL  (contact)

PROGRAM_OFFICER_NAME: ZHAO, MING

PROJECT_TERMS: 3-Dimensional;absorption;Address;Alpha Particle Emitter;Alpha Particles;Anatomy;Antibodies;Area;authority;Biological;Bone Marrow;Businesses;cancer cell;Cancer Patient;cancer therapy;Client;cloud based;Cloud Computing;Communities;Computer software;Daughter;design;Development;Diagnostic;Diagnostic Imaging;Dimensions;Distributional Activity;Dose;Dose Limiting;dosimetry;Drug Kinetics;E-learning;Educational Materials;effective therapy;Elements;Expert Systems;Florida;Future;Geometry;Grant;Human;human tissue;Imaging technology;interest;internal radiation;Kidney;Libraries;Licensing;Maps;Marketing;Measurement;Medical;Methodology;Methods;Microscopic;Modality;Modeling;Names;Normal tissue morphology;Organ;Output;particle;particle therapy;Patient imaging;Patients;Peptides;Pharmaceutical Preparations;Pharmacologic Substance;Phase;Property;Publishing;Radiation;Radiation Dose Unit;Radioisotopes;Radiology Specialty;Radiopharmaceuticals;Salivary Glands;Series;Services;Slide;Small Business Innovation Research Grant;small molecule;software systems;Source;Structure;success;System;Technology;Testing;Therapeutic Effect;therapeutic evaluation;Time;Tissues;tool;Toxic effect;Treatment Efficacy;treatment planning;Uncertainty;Universities;web based software;Work

PROJECT_TITLE: Cloud/Subscription based, Customer-Responsive Dosimetry Tool for alpha-Particle Emitters

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1 CTH-E (11)]


ED_INST_TYPE: SCHOOLS OF MEDICINE

NIH_SPENDING_CATS: Genetics;HIV/AIDS;Infectious Diseases

ORG_CITY: CLEVELAND

ORG_DEPT: BIOCHEMISTRY

ORG_NAME: CASE WESTERN RESERVE UNIVERSITY

PHR: PROJECT NARRATIVE Current latency reversing agents (LRAs) for the “shock and kill” strategy for an HIV cure do not target post- transcriptional steps of HIV replication, and thus, cannot optimally reactivate latent HIV infections. Little is known about the post-transcriptional processing of HIV transcripts and whether these processes can be targeted as a latency reversal method. The goal of the proposed study is to investigate the role of m6A modifications on HIV transcripts in the nuclear localization and trafficking of these RNA species and how modulating this modification can affect HIV RNA expression.

PI_NAMEs: HONEYCUTT, ETHAN  (contact)

PROGRAM_OFFICER_NAME: REFSLAND, ERIC WILLIAM

PROJECT_TERMS: 3' Untranslated Regions;5' Untranslated Regions;Acute;Address;Affect;Area;Binding Proteins;Binding Sites;Cell Line;Cell model;Cell Nucleus;Cells;cis acting element;cofactor;Complex;crosslinking and immunoprecipitation sequencing;Cytoplasm;Data;design;env Gene Products;Enzymes;experimental study;Fluorescent in Situ Hybridization;gag Gene Products;Genetic;Genetic Transcription;Goals;Heterogeneous-Nuclear Ribonucleoproteins;HIV;HIV Infections;Infection;insight;Integration Host Factors;knock-down;Laboratories;latent HIV reservoir;Length;Maps;Mediating;Methods;Methylation;Modification;Molecular Chaperones;nanopore;nef Protein;novel;novel therapeutics;Nuclear;Nuclear Export;Nuclear RNA;Pathway interactions;Patients;Pattern;pol Gene Products;posttranscriptional;prevent;Primary Cell Cultures;Process;Production;Protein Family;Proteins;Protocols documentation;Reader;Reporting;Research;Response Elements;rev Protein;RNA;RNA Splicing;RNA Stability;RNA-Binding Proteins;Role;Shock;Site;Small Interfering RNA;SRC-associated p68 protein;T-Lymphocyte;tat Protein;Testing;trafficking;Transcript;transcriptome;transcriptome sequencing;Translating;vif Gene Products;Viral;Virion;Visualization;vpu Protein

PROJECT_TITLE: m6A Modification of HIV RNA Affects its Post-transcriptional Processing


ORG_CITY: NEW YORK

ORG_NAME: CORIDEA, LLC

ORG_STATE: NY

PHR: Project Narrative: We are developing a novel neuromodulation system to aid in hemodynamic support reduce the dosage requirements of vasopressors to safe and tolerable levels in the management of septic shock. If realized, our innovative device will minimize the risk of causing irreversible damage to vital organ systems due to high pressor dosage, specifically to the kidneys, liver, lower intestines, and extremities.

PI_NAMEs: LEVIN, HOWARD  (contact)

PROGRAM_OFFICER_NAME: KODURI, SAILAJA

PROJECT_TERMS: Adult;Adverse effects;Antibiotics;Arrhythmia;Biological Markers;Blood Pressure;blood pressure control;Body System;Cardiac Output;Caring;Cessation of life;Clinical;comparison control;design;Development;Devices;dosage;Dose;Electrocardiogram;Failure;Fingers;Future;Goals;Grant;Health;Heart Rate;hemodynamics;Hour;Hypertension;improved;improved outcome;Injury;Injury to Kidney;innovation;Intestines;Ischemia;Kidney;Lead;Left;limb injury;Limb structure;Liquid substance;Liver;Liver Disease Shock Liver;meetings;Methods;minimally invasive;Modeling;Morbidity - disease rate;mortality;Multiple Organ Failure;Nerve;neuroregulation;novel;Organ;Patient-Focused Outcomes;Patients;Perfusion;Peripheral;Phase;Physiological;Pre-Clinical Model;pressure;Randomized;risk minimization;secondary outcome;Sepsis;septic;Septic Shock;side effect;Small Business Innovation Research Grant;Source;standard of care;Structure of stellate ganglion;success;Survivors;System;Techniques;Technology;Time;Toes;Vasoconstrictor Agents;verification and validation

PROJECT_TITLE: Stellate Ganglion Stimulation in Septic Shock to Improve Hemodynamics and Vasopressor Requirements

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


ADMINISTERING_IC: EY

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Brain Disorders;Clinical Research;Congenital Structural Anomalies;Data Science;Eye Disease and Disorders of Vision;Health Services;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Neurosciences;Pediatric;Prevention;Primary Health Care

ORG_CITY: Kissimmee

ORG_NAME: THER-AI LLC

PHR: NARRATIVE Strabismus, also known as "crossed eyes" or "squint," causes misaligned eyes and affects 2% of children in both developing and developed countries, also the lifetime risk of new-onset strabismus in adults is 1-in-25. These misalignments result in headaches, abnormal head posture, and, most importantly, if not diagnosed and treated on time, permanent loss of vision, called amblyopia. The scarcity of skilled screeners, which include optometrists, ophthalmologists, pediatricians, neurologists, and primary care physicians, especially in underdeveloped regions/countries, limits strabismus detection and treatment. For this global problem, our goal in this Phase-I SBIR project is to develop a smartphone application (app) called iLIGN, to perform automated pre-screening for ocular misalignment by individuals without specialty training in eye disease, such as parents, school personnel, and teachers.

PI_NAMEs: SHAIKH, SAAD  (contact)

PROGRAM_OFFICER_NAME: LEE, PAEK-GYU

PROJECT_TERMS: 3 year old;5 year old;Academy;Achievement;Adult;Affect;Age;Algorithms;Amblyopia;American;Artificial Intelligence;artificial intelligence model;automated image analysis;Binocular Vision;Blindness;Caring;Cellular Phone;Child;Classification;clinical examination;Computer software;Cornea;cost;Country;Data;Data Analyses;data curation;data harmonization;deep learning;deep learning algorithm;deep learning model;demographics;design;Detection;Developed Countries;Developing Countries;Development;Developmental Delay Disorders;Devices;Diagnosis;diagnostic strategy;Early Diagnosis;early screening;Early treatment;empowerment;Esotropia;Esthetics;Evaluation;Exotropia;Eye;Eye Color;Eye diseases;Eye Segment;Eyeglasses;Face;Future;General Practices;Glass;Goals;Government;Guidelines;Head;Headache;Health Personnel;Health Professional;Healthcare;Heterogeneity;Human Resources;Hypertropias;Image;Image Analysis;improved;Individual;Infrastructure;innovation;instrument;intelligent diagnosis;International;Internet;lifetime risk;Light;Lighting;Measurement;medical specialties;Methodology;Methods;mobile application;Modeling;Morbidity - disease rate;Morphology;Motility;multi-task learning;multitask;Neurologist;Notification;novel;Operative Surgical Procedures;Ophthalmologist;Ophthalmology;Optometrist;Outcome;outcome disparities;pandemic disease;Parents;parity;patient screening;Patients;pediatrician;Pediatrics;Performance;Phase;Physicians;Population;Positioning Attribute;Posture;Prevalence;prevent;Primary Care Physician;Privatization;Protocols documentation;Provider;Qualifying;Reader;Recommendation;Reflex action;remote diagnosis;Resources;Rotation;Schools;screening;self esteem;sex;Shapes;Site;skills;skin color;Small Business Innovation Research Grant;smartphone application;social;software development;Source;Specialist;Specificity;Strabismus;success;System;teacher;Time;Toddler;tool;Training;Uncertainty;Validation;Vision;Vision Screening;Visual;Visual Acuity;Visual impairment;web platform;Workplace;Writing

PROJECT_TITLE: iLIGN - Artificial Intelligence Driven Strabismus Pre-Screening System

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


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Bioengineering;Biotechnology;Emerging Infectious Diseases;Immunization;Infectious Diseases;Lyme Disease;Nanotechnology;Orphan Drug;Prevention;Rare Diseases;Tickborne Diseases;Vaccine Related;Vector-Borne Diseases

ORG_CITY: NEW HAVEN

ORG_NAME: L2 DIAGNOSTICS, LLC

ORG_STATE: CT

PHR: NARRATIVE This Phase I proposal will utilize the mRNA vaccine delivery platform to develop a novel anti-I. scapularis vaccine to prevent tick feeding and consequently impair the transmission of multiple I. scapularis-transmitted pathogens. The success of this approach also brings a robust paradigm to the development of vaccines against other arthropod-borne pathogens.

PI_NAMEs: FIKRIG, EROL ;NARASIMHAN, SUKANYA  (contact)

PROGRAM_OFFICER_NAME: BOWDEN, NADINE

PROJECT_TERMS: Amblyomma;Anaplasma phagocytophilum;Anaplasmosis;Animals;anti-tick vaccine;Antibody titer measurement;Antigens;arthropod-borne;Babesia microti;Babesiosis;Bite;Black-legged Tick;Borrelia burgdorferi;Borrelia miyamotoi;Cavia;cross reactivity;Dermacentor;Disease;dosage;Dose;efficacy evaluation;Ehrlichiosis;Encapsulated;Erythema;experimental study;Formulation;Frequencies;Genetic Predisposition to Disease;Geography;Goals;Human;human pathogen;Immune response;Immunization;Immunize;Immunodominant Antigens;Immunologics;Impairment;improved;Incidence;Individual;Intramuscular;Ixodidae;Journals;lipid nanoparticle;Lyme Disease;Measures;Messenger RNA;Modeling;mRNA lipid nano particle vaccine;nonhuman primate;novel;novel vaccines;Oryctolagus cuniculus;OspA protein;OspA vaccine;pathogen;Phase;phase 1 study;phase 2 study;phase 3 study;Powassan virus;prevent;Prevention;Publishing;Reaction;Regimen;Resistance;response;Route;Safety;Salivary;Salivary Proteins;Site;success;System;Techniques;tick bite;tick feeding;Tick Infestations;tick transmission;Tick-Borne Infections;tick-borne pathogen;Ticks;translational medicine;Translational Research;transmission blocking;transmission process;vaccine delivery;vaccine development;vaccine efficacy;vaccine safety;Vaccines;vector;Viral;Virus Diseases;Weight

PROJECT_TITLE: A Multivalent mRNA Vaccine to Prevent Transmission of Tick-bornePathogens

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


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Natural Products;Sexually Transmitted Infections

ORG_CITY: HUNTSVILLE

ORG_NAME: CFD RESEARCH CORPORATION

ORG_STATE: AL

PHR: Project Narrative: The goal of this project is to develop our novel natural product into a new class of antibiotics to combat drug-resistant Neisseria gonorrhoeae infections.

PI_NAMEs: SINGHAL, AJ  (contact)

PROGRAM_OFFICER_NAME: CONNOLLY, KRISTIE LEE

PROJECT_TERMS: absorption;Active Sites;Agar;analog;Antibiotic Therapy;Antibiotics;antimicrobial;Award;Azithromycin;Bacillus anthracis;Biological Assay;Biological Availability;branched chain fatty acid;Branched-Chain Amino Acids;Categories;Ceftriaxone;Cells;Ciprofloxacin;Clinical Trials;combat;Contracts;cytotoxicity;Data;design;Dose;Drug Kinetics;drug resistance development;drug-resistant gonorrhea;Drug-resistant Neisseria Gonorrhoeae;efficacy study;enzyme activity;Estradiol;fatty acid biosynthesis;Female;first-in-human;Francisella tularensis;Frequencies;Goals;Gonorrhea;HepG2;improved;In Vitro;in vivo;in vivo evaluation;Inbred BALB C Mice;Incidence;indexing;Infection;Lead;lead optimization;lead series;lipophilicity;Liver Microsomes;male;Maximum Tolerated Dose;Measures;Medical;Metabolic;Microsomes;Monitor;mouse model;Mus;Natural Products;Neisseria gonorrhoeae;New Agents;novel;novel antibiotic class;Oral;Oral Administration;Organism;Penicillins;Pharmaceutical Chemistry;Pharmaceutical Preparations;Phase;phase 1 study;Plasma;pre-clinical;pre-Investigational New Drug meeting;preclinical development;Predisposition;Prodrugs;programs;Property;Proteins;Public Health;Regimen;Reporting;Research;Resistance;resistance frequency;Route;scaffold;Series;Small Business Innovation Research Grant;small molecule;Sodium Chloride;Solubility;standard of care;Staphylococcus aureus;Streptococcus Group B;Structure-Activity Relationship;Sulfur;Swab;Testing;therapy resistant;Toxic effect;transcriptomics;United States;Vagina;Work

PROJECT_TITLE: A Novel Mechanism of Action Natural Product for Treatment of Drug-Resistant Gonorrhea

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


ADMINISTERING_IC: AT

IC_NAME: NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH

NIH_SPENDING_CATS: Complementary and Integrative Health;Eczema / Atopic Dermatitis;Infectious Diseases;Microbiome

PHR: Project Narrative: This project aims to develop controlled-release skin microbiome-balancing antimicrobial cotton fabrics to use as bandages in the treatment of atopic dermatitis and eczema infections.

PROGRAM_OFFICER_NAME: KIM, HYE-SOOK

PROJECT_TERMS: Acceleration;Adopted;Adult;Affect;analytical method;Anti-Bacterial Agents;antimicrobial;Atopic Dermatitis;Atrophic;Bacteria;Bandage;Betamethasone;Biological Assay;Biological Testing;Blood;Cellulose;Chemistry;Child;Chronic;Clinical;clinical candidate;Clinical Data;Clinical Trials Design;commensal bacteria;comparative efficacy;controlled release;Corynebacterium;Cream;Data;design;Disease;Dose;drug clearance;dysbiosis;Eczema;efficacy study;Enzyme-Linked Immunosorbent Assay;Excipients;Exhibits;FDA approved;Flare;Gel;Glycyrrhetinic Acid;Gossypium;Health Care Costs;Hour;Immune;improved;in vivo;Incidence;Infection;Inflammatory;Interleukin-1;Interleukin-10;Interleukin-13;Interleukin-6;Interleukins;Legal patent;Lesion;Leukotriene B4;Licorice;Life;manufacture;manufacturing process;Measures;Methods;Methylprednisolone;microbiome;Modeling;Molecular;Monograph;mouse model;Mucous Membrane;Natural Compound;Natural Products;novel;Ointments;Oxazolone;pathogen;pathogenic bacteria;Patient-Focused Outcomes;Patients;Pharmaceutical Preparations;pharmacologic;Phase;Physicians;Population;pre-clinical;pre-Investigational New Drug meeting;prevent;Process;Production;programs;prototype;Publishing;Relapse;Research;Rosacea;Roseomonas;Route;Safety;side effect;Site;Skin;Skin Absorption;skin microbiome;standard of care;Staphylococcus aureus;steroid dependence;Steroids;Stream;Substance Withdrawal Syndrome;Technology;Testing;Textiles;Therapeutic;Toxicology

PROJECT_TITLE: Controlled Release Eczema Bandage (CREB)


ORG_CITY: COLLEGE STATION

ORG_NAME: LYNNTECH, INC.

ORG_STATE: TX

PHR: PROJECT NARRATIVE Self-amplifying RNAs are a promising tool which can increase the expression level of genes encoding the proteins of interest, often a vaccine antigen or therapeutic protein. Lynntech is developing an approach to optimize the RNA for the gene of interest, to increase RNA replication and thus protein expression. Our approach can be used in combination with other strategies to synergize translation and prolong the expression of self-amplifying RNA-encoded immunostimulants and therapeutic proteins.

PI_NAMEs: GORZELNIK, KARL  (contact);HARLOW, MARK LEE

PROGRAM_OFFICER_NAME: NGUYEN, HAN

PROJECT_TERMS: Address;Biology;Cells;Clinical Trials;Codon Nucleotides;Communicable Diseases;Computer software;Data;Development;DNA Sequence;Future;Gene Expression;Generations;Genes;Genetic;Goals;Health;Human;Immunologic Adjuvants;In Vitro;in vivo;Individual;interest;Knowledge;Lactase;Left;Luciferases;Machine Learning;Malignant Neoplasms;Messenger RNA;Methodology;Moderna COVID-19 vaccine;Mutation;Nonstructural Protein;Pharmacologic Substance;Process;Production;programs;protein aminoacid sequence;protein expression;Proteins;Publications;replicase;Research;response;RNA;RNA amplification;RNA replication;RNA Sequences;RNA vaccine;RNA Viruses;Self Administration;software development;Solid;Speed;Structural Protein;structural viral genes;Structure;success;synergism;System;Techniques;Testing;Therapeutic;therapeutic protein;therapeutic RNA;tool;Training;Translating;Translations;Vaccine Antigen;Vaccines;vector;Vertebral column;Viral;Viral Genes;viral RNA;Viral Structural Proteins;Virus

PROJECT_TITLE: Make an OFERR: Optimization for Enhanced RNA Replication

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


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Biotechnology;Digestive Diseases;Infant Mortality;Orphan Drug;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Preterm, Low Birth Weight and Health of the Newborn;Prevention;Rare Diseases

ORG_CITY: PFAFFTOWN

ORG_NAME: PLAKOUS THERAPEUTICS, INC.

PHR: PROJECT NARRATIVE Necrotizing enterocolitis (NEC) is a devastating intestinal disease that affects ~6% of preterm neonates, has high mortality rates (30–50%), and lacks a cure. Plakous has developed a cell-free preparation of full-term, post-delivery human placenta that closely resembles second trimester amniotic fluid that can bolster and sustain gut maturation to prevent NEC. In this SBIR, Plakous will conduct a GLP toxicity study for inclusion in a subsequent IND filing and scale manufacturing to clinical lot size to improve efficiency and reduce variance lot-to-lot.

PI_NAMEs: BERGER, MICHAEL BENTLEY (contact)

PROGRAM_OFFICER_NAME: SANTOS SCHMIDT, AUGUSTO FREDERICO

PROJECT_TERMS: Acute;Adolescent;Adoption;Affect;Amniotic Fluid;Anti-Inflammatory Agents;Antibiotics;Biological;Biological Products;Biological Response Modifier Therapy;Birth;Caring;Cell Count;Cell Differentiation process;Cells;chemokine;Clinical;clinical lot;Clinical Pathways;Clinical Trials;commercial application;Complex;cost;cost effective;cytokine;Data;Death Rate;Deglutition;Development;Diagnosis;diagnostic biomarker;Disease;disease model;Dose;Emergency Situation;Ethics;Exposure to;extreme prematurity;Failure;FDA approved;Feedback;feeding;fetal;Freeze Drying;gastrointestinal;gastrointestinal system;Grant;Growth Factor;gut inflammation;Histologic;Hospitals;Human;improved;in utero;in vivo;Infant;Infection prevention;Inflammation;Inflammatory;inflammatory milieu;Injury;insight;Intestinal Diseases;Intestinal Mucosa;Intestines;Investigational Drugs;Knowledge;Legal patent;Licensing;Life;Lipopolysaccharides;Liquid substance;manufacture;manufacturing process;manufacturing scale-up;Marketing;Measures;Methods;Modeling;mortality;Necrosis;Necrotizing Enterocolitis;Neonatal;neonatal care;Neonatal Intensive Care Units;Operative Surgical Procedures;Oral;Oral Administration;Outcome;Pathologic;Patient-Focused Outcomes;Phase;Placenta;Placental Extracts;Population;Populations at Risk;porcine model;Powder dose form;predictive marker;Pregnancy;premature;Premature Infant;Preparation;preservation;preterm newborn;prevent;Prevention approach;Prevention strategy;Process;process optimization;Production;prophylactic;Proteins;reconstitution;regenerative;Regulatory Pathway;repaired;Reporting;response;Rest;Risk;Risk Reduction;Safety;Second Pregnancy Trimester;Severities;Severity of illness;Small Business Innovation Research Grant;standard of care;System;Target Populations;technological innovation;Testing;Therapeutic;Time;Tissues;TNF gene;Toxic effect;Toxicity Tests;Toxicology;Very Low Birth Weight Infant

PROJECT_TITLE: IND Enabling Studies and Manufacturing Scale Up of Human Placental Extract to Prevent Surgical Necrotizing Enterocolitis


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Dental, Oral, and Craniofacial Disease;Genetics

ORG_CITY: CAMBRIDGE

ORG_NAME: WHITEHEAD INSTITUTE FOR BIOMEDICAL RES

ORG_STATE: MA

PHR: 8. PROJECT NARRATIVE The ability to deliver macromolecules into cells within the body is required for many emerging therapeutic modalities, including genome editing therapies, but there are few available methods for safe and efficient macromolecular delivery. The proposed work will explore the use of cell-derived bioparticles for therapeutic macromolecular delivery, with a focus on (1) understanding cellular factors that influence bioparticle formation and (2) developing new strategies for highly efficient bioparticle production. These advances would overcome the key limitations that currently prevent the widespread use of cell-derived bioparticles, unlocking the potential of these bioparticles to serve as next-generation therapeutic delivery vehicles to treat a wide range of diseases.

PI_NAMEs: RAGURAM, ADITYA  (contact)

PROGRAM_OFFICER_NAME: MILLER, BECKY

PROJECT_TERMS: Achievement;Biological;Biology;Boston;career;Cell Line;cell type;Cells;cellular engineering;clinical translation;Collaborations;delivery vehicle;design;Development;Disease;Ecosystem;Engineering;Equipment;experience;extracellular vesicles;Faculty;faculty community;Focus Groups;Foundations;Funding;Gene Expression;Genes;Genetic;Genetic Engineering;genetic manipulation;genome editing;genome wide screen;genome-wide;Goals;graduate student;high reward;high risk;Immune;immunoengineering;improved;innovation;insight;Institution;Investigation;knock-down;Leadership;macromolecule;manufacturability;Massachusetts;member;Messenger RNA;Methods;Modality;Molecular;nanoparticle;next generation;novel therapeutics;particle;Patients;Positioning Attribute;post-doctoral training;Postdoctoral Fellow;prevent;Principal Investigator;Process;Production;programs;Property;Proteins;Research;Research Personnel;research study;Resources;Ribonucleoproteins;RNA;student mentoring;success;Technical Expertise;Techniques;Technology;Therapeutic;therapeutic genome editing;Transplantation;Viral;Viral Packaging;Viral Vector;Virus-like particle;Work

PROJECT_TITLE: Leveraging cell-derived bioparticles for macromolecular delivery

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


ADMINISTERING_IC: DC

IC_NAME: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

NIH_SPENDING_CATS: Bioengineering;Clinical Research;Data Science;Health Services;Infectious Diseases;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Otitis Media;Pain Research;Pediatric;Telehealth

ORG_CITY: BOTHELL

ORG_NAME: REMMIE, INC.

PHR: PROJECT NARRATIVE The Remmie.ai project seeks to address the pressing issue of Otitis Media with effusion (OME), Acute Otitis Media (AOM), Otitis media with effusion (OME) is a condition characterized by the presence of fluid behind the eardrum, perforated eardrum, and tympanosclerosis, which are common causes of infection in children and can contribute to hearing loss. To bridge the gap in timely diagnosis and management, this Phase II initiative aims to refine Remmie.ai, an advanced telemedicine platform, for accurate ENT diagnosis support. Through expanding AI models, conducting real-world testing, and building a regulatory-compliant cloud infrastructure and app, Remmie.ai strives to develop accessible, high-quality healthcare solutions and contribute to improved ENT condition care.

PI_NAMEs: ZHANG, JANE  (contact)

PROGRAM_OFFICER_NAME: MILLER, ROGER

PROJECT_TERMS: 6 year old;Acute;Address;Advanced Development;Agreement;Antibiotics;Artificial Intelligence enhanced;artificial intelligence model;Artificial Intelligence platform;burden of illness;Caring;Child;Classification;Clinical;clinical imaging;clinical practice;clinically relevant;Cloud Computing;cohort;computerized data processing;Data;Data Collection;data harmonization;data infrastructure;data privacy;Data Security;Data Storage and Retrieval;deep learning;Descriptor;design;Diagnosis;Diagnostic;diagnostic accuracy;Disease;Ear;ear infection;Earache;Effectiveness;empowerment;Ensure;Family;Feedback;Fever;Fortification;Goals;Guidelines;Health Care Costs;health care quality;Health Insurance Portability and Accountability Act;Healthcare;hearing impairment;Image;improved;Individual;Infection;innovation;large datasets;Left;Liquid substance;Medical History;meetings;Methodology;mHealth;Modeling;next generation;Nose;Otitis Media;Otitis Media with Effusion;Otolaryngology;Outcome;Pain;Patient Care;patient privacy;Patients;Perforation;Performance;performance tests;Persons;Pharyngeal structure;Phase;phase 1 study;Physicians;prevent;Recommendation;Records;recruit;research clinical testing;satisfaction;Secure;software as a medical device;Specialist;Symptoms;Telemedicine;Testing;Text;Time;Training;Trust;Tympanic membrane;usability;user-friendly;Validation;virtual visit;Visit;Visual

PROJECT_TITLE: Remmie.ai a deep learning diagnostic engine for ear-nose throat disease

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


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Gene Therapy;Genetics;Immunotherapy;Orphan Drug;Ovarian Cancer;Rare Diseases;Women's Health Research

ORG_CITY: MINNEAPOLIS

ORG_NAME: LUMINARY THERAPEUTICS, INC.

PHR: This proposal describes experiments to test an off-the-shelf CAR T cell therapy to treat ovarian cancer. The T cells will target 2 separate molecules expressed by ovarian cancer tumors and will activate through a novel, more robust mechanism than traditional CARs. The T cells will also express a molecule that helps them remain active near the tumor, an environment that normally suppresses T cells.

PI_NAMEs: HICKENLOOPER, SAMUEL  (contact)

PROJECT_TERMS: Address;Adoptive Cell Transfers;Allogenic;anti-cancer;antigen binding;Antigen Targeting;Antigens;Binding;Biological Assay;Biotechnology;Cancer Patient;CAR T cell therapy;CD28 gene;cell killing;Cell Line;Cell Survival;Cells;Cetuximab;chemotherapy;chimeric antigen receptor T cells;Chondroitin Sulfate A;Chondroitin Sulfate Proteoglycan;Clinical;Coculture Techniques;cost effective;Cultured Cells;cytokine;Cytolysis;D Cells;design;Dimerization;Disease remission;DNA cassette;Dominant-Negative Mutation;Elements;engineered T cells;Engineering;Environment;Epithelium;exhaustion;experience;Experimental Designs;experimental study;Exposure to;Failure;Gene Delivery;gene delivery system;graft vs host disease;Health;Hematologic Neoplasms;Heterodimerization;Human Resources;Immunocompromised Host;Immunology;Immunotherapy;improved;In Vitro;in vivo;Individual;innovation;Investigational Drugs;Lead;Life;Ligands;Malignant neoplasm of ovary;Malignant Neoplasms;Mantle Cell Lymphoma;manufacture;Marketing;Measures;mesothelin;metabolic fitness;Methods;mouse model;Multiple Myeloma;Mus;neoplastic cell;New Drug Approvals;non-viral gene delivery;novel;Outcome;Ovarian Carcinoma;overexpression;Pathway interactions;Patients;Phase;Platinum;preclinical study;Production;Prognosis;Proliferating;Property;Publications;Recurrence;Remission Induction Therapy;Research;response;Safety;side effect;Solid Neoplasm;Source;Stress;success;Suicide;Survival Rate;System;T cell therapy;T-Lymphocyte;Techniques;Technology;Testing;TGFBR2 gene;Therapeutic;timeline;Toxic effect;Transforming Growth Factor beta;Transgenes;treatment group;tumor;Tumor Antigens;tumor-immune system interactions;Viral;γδ T cells

PROJECT_TITLE: An allogeneic gamma/delta armored Dual-Targeting CAR with Split Costimulatory Domains to Target Epithelial Ovarian Carcinoma

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


NIH_SPENDING_CATS: Bioengineering;Endocrine Disruptors

ORG_CITY: DAYTON

ORG_NAME: ADVANCED & INNOVATIVE MULTIFUNCTIONAL MATERIALS LLC

ORG_STATE: OH

PHR: PROJECT NARRATIVE Per- and polyfluoroalkyl substances (PFASs) have been shown to have negative impacts on human health and be in almost everyone’s bloodstream. In this study AIMM will continue to modify our proprietary, patent pending innovation to improve PFAS removal in several ways: increased removal speed, increased range of PFAS removal to include short chain and ultra short chain PFAS as well as the traditional long chain PFAS and demonstrate the ability of AIMM’s materials to be reused/regenerated. This work will lead to the eventual fabrication of improved commercial-ready PFAS treatment systems.

PI_NAMEs: ESTEVEZ, LUIS  (contact)

PROGRAM_OFFICER_NAME: HENRY, HEATHER F

PROJECT_TITLE: Short Chain PFAS Adsorption via AimmSorb

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


NIH_SPENDING_CATS: Bioengineering;Clinical Research;Networking and Information Technology R&D (NITRD);Rehabilitation

ORG_CITY: LYONS

ORG_NAME: ORTHO HAUS LLC

ORG_STATE: CO

PHR: Project Narrative Patellar instability is a common knee injury that typically affects younger, active individuals. Surgical interventions to treat patellar instability have poor outcomes – 50% of patients who undergo an initial surgery require subsequent surgeries or continue to suffer from swelling, anterior knee pain, subluxation and/or recurrent dislocation. In this Phase I project, we will demonstrate the ability of our computational approach to support the development of a pre-operative planning software that uses patient-specific medical imaging to guide the surgeon on optimal treatment pathways based on the patient’s pathoanatomy.

PI_NAMEs: CLARY, CHADD ;FITZPATRICK, CLARE  (contact)

PROGRAM_OFFICER_NAME: WANG, XIBIN

PROJECT_TERMS: Activities of Daily Living;Acute;Affect;Anatomy;Anterior;Assessment tool;automated assessment;Cadaver;Chronic;Classification;classification algorithm;Clinical;comparative;Computer Models;Computer software;Consensus;Data;Deformity;Degenerative polyarthritis;Development;Dislocations;early onset;Elements;Event;experience;experimental study;Failure;Freedom;Functional impairment;Generations;Goals;Height;human subject;Impairment;In Vitro;in vivo;Incidence;Individual;joint biomechanics;Joints;kinematics;Knee bone;Knee Injuries;Knee joint;knee pain;Knowledge;late life;Lateral;Ligaments;Literature;Machine Learning;Marketing;Medial;Medical Imaging;Modeling;Multiple Abnormalities;Operative Surgical Procedures;optimal treatments;Osteotomy;Outcome;Participant;Patellar Dislocation;Pathologic;Pathway interactions;Patients;Persons;Phase;Positioning Attribute;Postoperative Period;predictive modeling;prevent;Procedures;Protocols documentation;quadriceps muscle;Quality of life;radiological imaging;reconstruction;Recovery;Recurrence;Rehabilitation therapy;repaired;Risk Factors;Rupture;Software Tools;Speed;subluxation;success;Surgeon;surgery outcome;Swelling;Teenagers;Testing;tool;Translating;treatment planning;Trochlear dysplasia;Validation;Work

PROJECT_TITLE: Pre-operative planning for surgical treatment of patellar instability


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

ORG_CITY: AUBURN

ORG_NAME: VIVOSPHERE LLC

PHR: NARRATIVE For preclinical drug discovery, new in vitro models are needed to obtain more translatable study outcomes in a low-cost and high-throughput manner. The outcome of this project will be tissue engineered spheroids, or VivoSpheres, that better model human biology than current commercial products for high-throughput screening. As a platform technology, the VivoSpheres can be used for a wide range of disease and tissue modeling and generate high quality drug response data to make translational research more efficient.

PI_NAMEs: GREENE, MICHAEL W;LIPKE, ELIZABETH A;TIAN, YUAN  (contact)

PROGRAM_OFFICER_NAME: HARGROVE, PASSLEY R

PROJECT_TERMS: 3-Dimensional;Acceleration;Adoption;Antibodies;Antineoplastic Agents;assay development;Benchmarking;Biochemical Process;Biological Assay;Cancer Biology;cancer cell;Cancer cell line;Cancer Model;Cell Aggregation;Cell Count;Cell Density;Cell model;Cell Physiology;cell type;Cell-Cell Adhesion;Cells;Cellular Morphology;Characteristics;Clinical Trials;cost;Coupling;Data;design;Detection;Development;Device Designs;Diameter;Disease;disease model;Disease Progression;Drug Compounding;drug discovery;Drug Modelings;drug quality;Drug Screening;Encapsulated;Engineering;Equipment;Exhibits;Extracellular Matrix;Fibrinogen;flexibility;Gene Expression;Generations;Geometry;Goals;Heterogeneity;high throughput screening;Human Biology;human disease;human model;Hydrogels;immune cell infiltrate;Immunooncology;improved;In Vitro;in vitro Model;Influentials;Legal patent;Malignant - descriptor;Malignant Neoplasms;Marketing;Microfluidic Microchips;Microfluidics;Microspheres;Modeling;Outcome;Outcome Study;Pathologic;Penetration;performance tests;Phenotype;Physiological;Play;pre-clinical;Production;Protocols documentation;Reproducibility;Research;response;Role;Shapes;spheroids;Structure;success;System;Techniques;Technology;technology platform;Testing;three-dimensional modeling;Time;Tissue Engineering;Tissue Model;Tissues;tool;Translational Research;tumor;tumor microenvironment;two-dimensional;Validation;Variant;Work

PROJECT_TITLE: VivoSpheres: Tissue-Engineered Spheroidal Models for High-Throughput Screening

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


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Antimicrobial Resistance;Biotechnology;Clinical Research;HIV/AIDS;Infectious Diseases;Pediatric;Pediatric - AIDS

ORG_CITY: BOSTON

ORG_NAME: BRIGHAM AND WOMEN'S HOSPITAL

PHR: PROJECT NARRATIVE Dolutegravir, an integrase inhibitor, is widely used for HIV treatment globally, yet data on integrase inhibitor resistance after treatment failure among children are scarce. To address this knowledge gap, we will quantify integrase inhibitor resistance in a population of children failing dolutegravir treatment in Nigeria and utilize these data to develop two rapid, low-cost drug resistance tests in collaboration with Nigerian colleagues. This combination of studies will address the call by the World Health Organization for surveillance of resistance and access to resistance testing for integrase inhibitors, develop local technical capacity for diagnostics development, and inform future studies of optimal dolutegravir use and targeted integrase inhibitor resistance testing for children.

PI_NAMEs: LUTZ, BARRY RYAN;RAWIZZA, HOLLY ELIZABETH (contact)

PROGRAM_OFFICER_NAME: CHIOU, CHEN-CHIA CHRISTINE C

PROJECT_TERMS: abacavir;Address;Adult;Aftercare;Age Months;Anti-Retroviral Agents;antiretroviral therapy;barrier to testing;Biological Assay;Caring;Child;Childhood;Clinical;cohort;Collaborations;Companions;cost;Country;Data;design;detection test;Development;Diagnostic;diagnostic development;Disease;Dose;Drug Costs;Drug resistance;Evolution;Exonuclease;experience;experimental study;Failure;Future;Genetic Polymorphism;Goals;high throughput screening;HIV;HIV anti-retroviral;HIV drug resistance;Home;Immunocompromised Host;improved;Infant;inhibitor;Integrase;Integrase Inhibitors;International;Knowledge;Lamivudine;lateral flow assay;Lead;Learning;Ligation;low and middle-income countries;Malawi;meetings;melting;Methods;Minority;Mutation;Mutation Detection;next generation sequencing;Nigeria;Nigerian;novel;Oligonucleotides;panacea;Pediatric cohort;Persons;Pharmaceutical Preparations;point of care;Population;Positioning Attribute;Public Health;Rapid diagnostics;Recommendation;Regimen;Reporting;Resistance;Resistance development;resistance mutation;Reverse Transcriptase Inhibitors;Risk;Risk Factors;Sampling;Science;Scientist;Sensitivity and Specificity;Signal Transduction;Site;Specimen;Surveys;Tablets;Technical Expertise;Technology;Testing;therapy duration;Time;Treatment Failure;Validation;Variant;Vertebral column;Viral;Viral Load result;Viremia;Vulnerable Populations;World Health Organization

PROJECT_TITLE: Quantifying integrase resistance among Nigerian children failing dolutegravir to inform rapid diagnostic development in partnership with Nigerian scientists

STUDY_SECTION: HCCS

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