NIH_SPENDING_CATS: Contraception/Reproduction;Estrogen;Natural Products;Prevention;Women's Health Research

ORG_CITY: MINNEAPOLIS

ORG_NAME: UNIVERSITY OF MINNESOTA

ORG_STATE: MN

PI_NAMEs: GURVICH, VADIM  (contact)

PROJECT_TERMS: Agonist;analog;Androgens;antagonist;Area;Chemical Agents;chemical synthesis;Chemicals;Clinical Research;Contraceptive Agents;Contraceptive methods;Contractor;Contracts;Development;drug candidate;Estrogens;Evaluation;Female Contraceptive Agents;Fertility Agents;Goals;Good Manufacturing Process;Government;Human;Kilogram;Laboratories;Male Contraceptive Agents;manufacture;men;milligram;Natural Products;new chemical entity;Peptides;Pharmaceutical Preparations;preclinical safety;Preparation;Progestins;Program Development;programs;Proteins;Research Support;Role;safety study;small molecule;Steroids;Testing;Toxicology;unnatural amino acids;Woman

PROJECT_TITLE: CHEMICAL SYNTHESIS FACILITY FOR CONTRACEPTIVE DEVELOPMENT


ADMINISTERING_IC: CA

ARRA_FUNDED: N

FUNDING_MECHANISM: NON SBIR/STTR CONTRACTS

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: FREDERICK

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: LEIDOS BIOMEDICAL RESEARCH, INC.

ORG_STATE: MD

PI_NAMEs: MITRA, GEORGE  (contact)

PROJECT_TERMS: Address;base;Chemistry;clinical development;clinical lot;Clinical Research;Clinical Trials;Data;Development;Freedom;gene therapy;Gene therapy trial;Genes;manufacture;manufacturing process;manufacturing process development;Methods;methylmalonic aciduria;National Center for Advancing Translational Sciences;pre-clinical;Process;Rare Diseases;Technology;technology development;vector;Work

PROJECT_TITLE: CMC SUPPORT FOR NCATS RARE DISEASE PLATFORM GENE THERAPY TRIAL PROJECTS


ACTIVITY: ZIA

ADMINISTERING_IC: AI

FUNDING_MECHANISM: INTRAMURAL RESEARCH

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

NIH_SPENDING_CATS: Antimicrobial Resistance;Biotechnology;Clinical Research;HIV/AIDS;Immunization;Infectious Diseases;Prevention;Vaccine Related;Vaccine Related - AIDS

PI_NAMEs: MOIR, SUSAN  (contact)

PROJECT_TERMS: Address;Adherence;Affect;Anti-Retroviral Agents;Anti-retroviral drug resistance;Antibodies;Antibody Therapy;antiretroviral therapy;Architecture;B-Lymphocytes;Cessation of life;Child;Clinical Management;Clinical Research Protocols;Data;Detection;Developed Countries;Developing Countries;Development;Disease Progression;disorder risk;Elements;Evolution;experience;Formalin;Genomics;Goals;Health;HIV;HIV drug resistance;HIV envelope protein;HIV Infections;HIV resistance;HIV-1;Hospitalization;imaging platform;Immune response;improved;indexing;Infant;Infection;Integrase Inhibitors;lymph node biopsy;Lymph Node Tissue;Lymphoid;Lymphoid Tissue;Modernization;Mozambique;Multi-Drug Resistance;National Institute of Child Health and Human Development;neutralizing antibody;novel;novel therapeutics;Opportunistic Infections;Paraffin;Persons;Pharmaceutical Preparations;Phenotype;Pilot Projects;Plasma;Prevalence;Process;Proteins;Recommendation;Regimen;Research Personnel;Resistance;Resources;RNA;RNA Stability;Role;Sampling;screening;Serum;side effect;Specimen;Technology;Therapeutic;Therapeutic Uses;Toxic effect;transcriptomic profiling;transcriptomics;Treatment Failure;Treatment Protocols;Viral;Viremia;Virus;Virus Replication

PROJECT_TITLE: Development and therapeutic use of broadly neutralizing antibodies in people living with human immunodeficiency virus


NIH_SPENDING_CATS: Genetics;HIV/AIDS;Infectious Diseases

ORG_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

PI_NAMEs: FRASER, IAIN  (contact)

PROJECT_TERMS: Acetylmuramyl-Alanyl-Isoglutamine;Acquired Immunodeficiency Syndrome;beta-Glucans;Biological Assay;Brain;CD4 gene;CD4 Positive T Lymphocytes;Cell Line;Cells;Coculture Techniques;Collaborations;combinatorial;Cytotoxic T-Lymphocytes;Data Analyses;Disease;DNA;Funding;gene repression;Genomics;Goals;Highly Active Antiretroviral Therapy;Histone Deacetylase Inhibitor;Histones;HIV;HIV Genome;Human;Human immunodeficiency virus test;Immune;Immunity;Immunology;Inflammation;Inflammatory;Macaca;Macrophage;Metabolism;metabolomics;Microglia;Modeling;monocyte;Montana;Myeloid Cells;National Center for Advancing Translational Sciences;National Institute of Allergy and Infectious Disease;Natural Killer Cells;North Carolina;novel;Pathogenesis;Patients;Peripheral Blood Mononuclear Cell;Persons;reactivation from latency;Regulation;Research;Rheumatoid Arthritis;Sampling;Scientist;SIV;Small Interfering RNA;small molecule;Stimulus;T-Lymphocyte;Technology;Testing;Training;transcriptome sequencing;transcriptomics;Universities

PROJECT_TITLE: Trained Immunity as a Strategy for HIV Latency Reactivation


PI_NAMEs: CONNORS, MARK  (contact)

PROJECT_TERMS: Animal Model;Antigens;antiretroviral therapy;Autologous;Biological Assay;Candidate Disease Gene;CD4 Positive T Lymphocytes;CD8-Positive T-Lymphocytes;Cell Physiology;Cells;Clinical Trials;CRISPR/Cas technology;Data;Defect;differential expression;Disease;Flow Cytometry;Functional disorder;gene product;Goals;HIV;HIV-1;Immunity;Immunologics;Immunotherapeutic agent;Immunotherapy;Impairment;Interruption;Knowledge;Malignant Neoplasms;Mediating;Monoclonal Antibodies;novel;Patients;perforin;preclinical development;Proliferating;Proteins;Proteomics;Research Personnel;T cell response;Testing;therapeutic vaccine;transcriptomics;Vaccines;Virus;Work

PROJECT_TITLE: Pre-Clinical Development of Novel Immunotherapies for HIV-1


ADMINISTERING_IC: MH

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Clinical Research;Mental Health;Neurosciences

ORG_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

PI_NAMEs: AMARA, SUSAN  (contact)

PROJECT_TERMS: Basic Science;Behavior;Brain;Circadian Rhythms;Clinical;clinical care;clinical development;Clinical Research;cognitive neuroscience;Congresses;Diagnosis;Doctor of Philosophy;Educational workshop;Environment;Ethics;Extramural Activities;Fostering;Funding;genome sequencing;interest;Intramural Research Program;Leadership;member;mental disorder prevention;Mental disorders;Mental Health;Mission;National Institute of Mental Health;neuroimaging;Productivity;Psychiatry;Research;Research Activity;Research Project Grants;Research Subjects;Resources;Scientist;Training;Translational Research;United States National Institutes of Health;whole genome;Work

PROJECT_TITLE: Office of the Scientific Director


NIH_SPENDING_CATS: Attention Deficit Hyperactivity Disorder (ADHD);Behavioral and Social Science;Brain Disorders;Mental Health;Mental Illness;Neurosciences;Schizophrenia;Serious Mental Illness;Stimulant Use and Misuse;Substance Misuse

PROJECT_TERMS: Acute;Address;Affect;Agonist;Amines;Amphetamines;Antipsychotic Agents;Attention Deficit Disorder;Attention deficit hyperactivity disorder;behavioral phenotyping;Biochemical;Biological;Carrier Proteins;Cell membrane;Cell Physiology;Cell surface;cell type;Cells;Chemosensitization;Child;Chronic;Cyclic AMP;Cyclic AMP-Dependent Protein Kinases;Data;Disease;Dopamine;Dopamine D2 Receptor;dopamine transporter;dopaminergic neuron;drug action;Drug usage;ecstasy;Endoplasmic Reticulum;Event;Excision;excitatory amino acid transporter 3;experimental study;extracellular;G-Protein-Coupled Receptors;Gene Expression;Glutamate Transporter;Glutamates;Goals;GTP-Binding Protein alpha Subunits;GTP-Binding Proteins;Homeostasis;Human;Incidence;Ion Channel;Laboratories;Learning;Ligands;Major Depressive Disorder;Mediating;Membrane Proteins;Membrane Transport Proteins;Mental disorders;Methamphetamine;Monomeric GTP-Binding Proteins;Movement;neuronal excitability;Neurons;neuropsychiatric disorder;neurotransmission;neurotransmitter reuptake;neurotransmitter transport;Neurotransmitters;Norepinephrine;novel;Pathway interactions;Pharmaceutical Preparations;Pharmacology;Pharmacotherapy;Phase;Phase II Clinical Trials;Physiological;Post-Traumatic Stress Disorders;presynaptic;Property;protein activation;receptor;Receptor Activation;Regulation;Research;Role;Schizophrenia;sensor;Serotonergic System;Serotonin;Serotonin Receptor 5-HT1A;serotonin transporter;Signal Pathway;Signal Transduction;Structure;subcellular targeting;System;Therapeutic;Therapeutic Effect;transcriptomics;Transgenic Mice;Work

PROJECT_TITLE: Structure, Function and Pharmacology of Neurotransmitter Reuptake Systems


ACTIVITY: ZIC

PROJECT_TERMS: adeno-associated viral vector;Animal Experimentation;Animal Model;Animals;Behavior;Biochemical;blood-brain barrier crossing;Brain;brain cell;brain research;Callithrix;Cells;Circulation;Clustered Regularly Interspaced Short Palindromic Repeats;Collaborations;Complex;Core Facility;Cryopreservation;Derivation procedure;design;Development;Disease;Drug Delivery Systems;Electrophysiology (science);Embryo;Frequencies;Functional disorder;Gene Expression;Genes;genetic manipulation;Genetic study;Genome;Goals;Home;Human;innovation;Institution;International;Laboratories;Link;Liver;Mental disorders;Methods;migration;Monkeys;National Institute of Mental Health;Nervous System Physiology;neural;Neurosciences Research;new technology;Patients;Peripheral;Primates;Production;Rat Transgene;Research;Resources;Rodent;Role;Science;Symptoms;System;Techniques;Therapeutic;Transgenes;Transgenic Animals;Transgenic Mice;Transgenic Model;Transgenic Organisms;United States National Institutes of Health;Variant;vector;Virus

PROJECT_TITLE: Transgenic Resources for Neuroscience Research


ACTIVITY: ZII

NIH_SPENDING_CATS: Behavioral and Social Science;Biomedical Imaging;Mental Health;Neurosciences

PROJECT_TERMS: Behavior;Behavioral;Brain;clinical center;clinical investigation;Cognitive;Collection;Dedications;design;Diagnosis;Environment;Epidemiology;Excision;Functional Imaging;Genetic;Housing;Human;imaging facilities;improved;Intramural Research;Intramural Research Program;Investigational Therapies;Leadership;Magnetic Resonance Imaging;Magnetoencephalography;Maintenance;meetings;Memory;Mental disorders;Modification;Molecular;molecular imaging;National Institute of Mental Health;neurophysiology;Neurosciences;nonhuman primate;Phase;Prevention;Productivity;Research;Research Project Grants;Resources;Scientist;social;sound;System;tissue culture;Work

PROJECT_TITLE: NIMH Space Activation, Maintenance, and Improvement


ADMINISTERING_IC: EB

ED_INST_TYPE: BIOMED ENGR/COL ENGR/ENGR STA

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

ORG_CITY: HOUSTON

ORG_DEPT: ENGINEERING (ALL TYPES)

ORG_NAME: RICE UNIVERSITY

ORG_STATE: TX

PHR: Project Narrative Obesity affects more than 1.4 billion adults worldwide and is a significant risk factor for chronic diseases such as hypertension, diabetes, and cardiovascular diseases. However, present non-operative treatment options of obesity are woefully inadequate – intragastric balloons have been demonstrated to be effective in enabling temporary weight loss (~25-30% of excess body weight) but are fundamentally limited to very selected patients as a temporary treatment or as a bridging intervention to bariatric surgery. The proposed research will overcome the limitations of IGB by creating an ingestible gastric-resident electronic-enhanced metamaterial architecture (iGEM) that can transform obesity treatment with a digital-based personalized and dynamic obesity treatment strategy that can be optimized based on safety consideration, patient’s treatment goals, and the quality of life.

PI_NAMEs: KONG, YONG LIN  (contact)

PROGRAM_OFFICER_NAME: FALCONE, JESSICA

PROJECT_TITLE: Ingestible gastric-resident electronic metamaterials architecture (iGEM) for the treatment of obesity

STUDY_SECTION: ISD

STUDY_SECTION_NAME: Instrumentation and Systems Development Study Section[ISD]


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Pediatric

ORG_CITY: CHICAGO

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

ORG_STATE: IL

PI_NAMEs: GERSHON, RICHARD  (contact)

PROJECT_TERMS: Age Months;Archives;Assessment tool;Child;Child Behavior;Clinical;Cognition;Contractor;Contracts;Data;Data Collection;Development;Equipment and supply inventories;Evaluation;executive function;feasibility testing;Human Resources;Individual;Infant;Informal Social Control;instrument;Language;Learning;Legal Guardians;Manuals;mathematical ability;Measurement;Measures;Motor;Operating System;Output;Participant;Population;Publishing;Reporting;Research;Scientist;screening;Social Functioning;software systems;Standardization;Time;Toddler;tool;Training;United States National Institutes of Health;Validation;web site;Work;Writing

PROJECT_TITLE: MAKE READY THE NIH BABY TOOLBOX FOR END USERS: FINALIZE ALL PARTICIPANT-LEVEL DATA COLLECTION, ANALYSES, AND DISSEMINATION


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Patient Safety;Wound Healing and Care

ORG_CITY: MOUNT PLEASANT

ORG_NAME: XEQUEL BIO, INC.

ORG_STATE: SC

PI_NAMEs: CHATNEKAR, GUATAM  (contact)

PROJECT_TERMS: Acceleration;animal rule;Anti-Inflammatory Agents;Cutaneous;Development;efficacy study;efficacy validation;Gel;medical countermeasure;Peptides;porcine model;Property;Radiation Dose Unit;Radiation Injuries;Research;Safety;safety study;Skin wound healing;Therapeutic;Topical application;Validation

PROJECT_TITLE: GRANEXIN AS A TOPICAL THERAPEUTIC TO MITIGATE CUTANEOUS RADIATION INJURY


NIH_SPENDING_CATS: Brain Disorders;Disability Research;Genetic Testing;Genetics;Intellectual and Developmental Disabilities (IDD);Pediatric;Prevention

ORG_CITY: ATLANTA

ORG_NAME: EMORY UNIVERSITY

ORG_STATE: GA

PI_NAMEs: WILCOX, WILLIAM  (contact)

PROJECT_TERMS: Advisory Committees;Affect;American;Authorization documentation;Cessation of life;Child;Child Health;Clinical;Collaborations;Contracts;Developmental Disabilities;Disabling condition;Disease;Early Diagnosis;Early treatment;Evaluation;Goals;Hereditary Disease;Intellectual functioning disability;Left;Medical Genetics;medical schools;Neonatal Screening;Nervous System Trauma;Newborn Infant;physically handicapped;Pilot Projects;Rare Diseases;Recommendation;Reporting;screening guidelines;Severities;tool

PROJECT_TITLE: SUPPORT FOR THE NEWBORN SCREENING PILOT STUDIES RELATED ACTIVITIES


NIH_SPENDING_CATS: Bioengineering;Biotechnology;Clinical Research;Gene Therapy;Genetics;Orphan Drug;Rare Diseases

PI_NAMEs: MOORE, MAX  (contact)

PROJECT_TERMS: CD4 Positive T Lymphocytes;Clinical;Contractor;cytokine;Development;Failure;gene therapy;Gene Transduction Agent;Human;human subject;immunogenicity;in silico;innovation;National Center for Advancing Translational Sciences;new technology;novel therapeutics;pre-clinical;preclinical development;programs;Protein Sequence Analysis;Rare Diseases;research clinical testing;response;T-Cell Activation;T-Lymphocyte Epitopes;Testing;therapeutic development

PROJECT_TITLE: INSILICO AND EX-VIVO IMMUNOGENICITY ANALYSIS OF NCATS GENE THERAPY TEST


ED_INST_TYPE: SCHOOLS OF MEDICINE

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

PHR: NARRATIVE. Syphilis is a sexually transmitted infection that causes significant human disease throughout the world. New diagnostics that accurately detect the syphilis agent, early in disease, would greatly improve patient outcomes by accelerating access to potentially life-saving treatment. We have discovered that the bacterium that causes syphilis sheds unique pieces of its’ cell-wall into its environment as it grows. In this proposal we will develop a diagnostic tool that specifically detects these unusual, released cell wall fragments, and critically assess its performance in human syphilis patient samples.

PI_NAMEs: JUTRAS, BRANDON LYON (contact)

PROGRAM_OFFICER_NAME: GLOCK, JONATHAN A

PROJECT_TERMS: Acceleration;accurate diagnostics;Animal Experimentation;Animal Model;Animals;Antibiotic Therapy;Antigen Targeting;aptamer;Bacteria;Bacterial Infections;Basic Science;Benchmarking;biobank;Biological Assay;Biological Markers;Biology;Birth;Cell Cycle;cell growth;Cell Wall;Cessation of life;Chemicals;Child;Clinic;Communicable Diseases;Communities;Congenital Syphilis;Data;Detection;Development;Diagnosis;Diagnostic;diagnostic platform;Diagnostic tests;diagnostic tool;Disease;DNA;early detection biomarkers;Early Diagnosis;effective therapy;Environment;Excretory function;Experimental Animal Model;extracellular;fetal;General Population;Generations;Genome;Growth;Health;Hour;Human;human disease;Immune response;Immunocompromised Host;improved;Individual;Infection;Knowledge;Label;Lesion;Life;Location;Lyme Disease;Medical;Methods;Monoclonal Antibodies;next generation;novel;novel diagnostics;novel strategies;Order Spirochaetales;Painless;Parents;Patient-Focused Outcomes;Patients;Peptidoglycan;Performance;point-of-care diagnosis;Populations at Risk;Pregnancy;Proteins;Publishing;Radioisotopes;rapid detection;Recombinants;Recycling;Reporting;Research Personnel;Resolution;response;Sampling;Sensitivity and Specificity;Serology;Serology test;Serum;sex;Sexual Transmission;Sexually Transmitted Diseases;Specificity;stillbirth;success;Syphilis;System;targeted treatment;Technology;Testing;transmission process;Treponema;Treponema pallidum;United States;Urine;virtual

PROJECT_TITLE: Released peptidoglycan fragments are a biomarker for early stages of syphilis


ADMINISTERING_IC: DE

ED_INST_TYPE: SCHOOLS OF DENTISTRY/ORAL HYGN

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Dental, Oral, and Craniofacial Disease;Infectious Diseases;Regenerative Medicine;Stem Cell Research;Stem Cell Research - Nonembryonic - Human;Stem Cell Research - Nonembryonic - Non-Human;Transplantation

ORG_CITY: SAN ANTONIO

ORG_DEPT: DENTISTRY

ORG_NAME: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER

PHR: PROJECT NARRITIVE Periodontal disease remains a significant public health problem, and efforts in regenerating the periodontal tissues have shown limited success due to the inability to resolve inflammation and are insufficient to obtain complete and reliable periodontal regeneration. The goal of this proposal is to test the potential for translation of specialized molecules to control inflammation in stem cell based therapy for periodontal regeneration. The Yorkshire pig will be used as a large animal periodontal regeneration model to test stem cell therapy for periodontal regeneration and expedite the translation of stem cell based regenerative approaches to humans.

PI_NAMEs: RAKIAN, AUDREY  (contact)

PROGRAM_OFFICER_NAME: VERBRIDGE, SCOTT SPENCER

PROJECT_TERMS: Acceleration;Adopted;adult stem cell;Affect;Agonist;alveolar bone;American;Anabolism;Animal Model;Animals;antagonist;Anti-Inflammatory Agents;Area;Autologous;Bacterial Infections;Binding;Biochemical Process;biological systems;BMP2 gene;bone;bone healing;Bone Marrow;Bone Transplantation;CD59 Antigen;Cells;Chronic;chronic inflammatory disease;Clinical;clinical practice;Clinical Trials;Comparative Study;Craniofacial Abnormalities;craniofacial complex;cytokine;Data;Dental;Dentists;design;Development;dysbiosis;Enzyme Inhibitor Drugs;Etiology;Exhibits;Experimental Models;Family suidae;Funding;gene regulatory network;Goals;GPR6 gene;healing;Health;Homeostasis;Human;human disease;human stem cells;Immunology;immunoregulation;implantation;improved outcome;Inflammation;Inflammatory;inflammatory milieu;Inflammatory Response;Injury;innovation;Investigation;Knowledge;Learning;Leucine-Rich Repeat;lipid mediator;Lipoxins;Mediating;Mediator;Mentors;Mentorship;Metabolism;Mission;National Institute of Dental and Craniofacial Research;Natural regeneration;novel;Operative Surgical Procedures;Oral;oral microbiome;Osteoblasts;osteogenic;osteoprogenitor cell;Pain;Pathology;Pathway interactions;Periodontal Diseases;Periodontal Ligament;Periodontitis;Periodontium;Phase;Population;porcine model;Positioning Attribute;Postdoctoral Fellow;preference;Production;Property;Proteins;Public Health;receptor;regeneration model;regenerative;regenerative approach;regenerative therapy;regenerative tissue;Research;Residencies;Resolution;response;Role;Scientist;self-renewal;Signal Transduction;skills;stem cell biomarkers;stem cell therapy;stem cells;Strategic Planning;success;System;Systems Biology;Technology;Testing;Texas;therapeutic evaluation;tissue regeneration;tissue repair;Tissues;Tooth Tissue;Training;transcriptome sequencing;translation to humans;translational potential;Translational Research;Translations;Trauma;United States;United States National Institutes of Health;Universities;wound healing

PROJECT_TITLE: Specialized Proresolving Lipid Mediator-Enhanced Stem Cell Therapy and Tissue Regeneration

STUDY_SECTION: DSR

STUDY_SECTION_NAME: National Institute of Dental and Craniofacial Research Special Grants Review Committee[DSR]


NIH_SPENDING_CATS: Bioengineering;Chronic Pain;Clinical Research;Dental, Oral, and Craniofacial Disease;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Pain Research;Prevention;Racial and Ethnic Minority Health Research;Temporomandibular Muscle/Joint Disorder (TMJD);Women's Health Research

ORG_CITY: CLEMSON

ORG_DEPT: BIOMEDICAL ENGINEERING

ORG_NAME: CLEMSON UNIVERSITY

PHR: Project Narrative  Females experience temporomandibular disorders at higher rates compared to males, and African Americans have higher temporomandibular disorder incidence, yet lower prevalence compared to white Americans; the causes of these sex and race disparities remain largely unknown. The goal of the proposed study is to investigate how sex- and race-specific differences in human temporomandibular lateral capsule-ligament (LCL) complex properties may affect the temporomandibular joint loading environment. Sex- and race-specific differences in human LCL complex properties could result in a temporomandibular loading environment with variable resiliency and sensitivity to pathologic displacements between sexes and racial groups, creating disparities in temporomandibular joint disorder incidence and prevalence.

PI_NAMEs: HILL, CHERICE NATASHA (contact)

PROGRAM_OFFICER_NAME: BACCAGLINI, LORENA

PROJECT_TERMS: Adult;Affect;African American population;Appointment;Articulation;Biochemical;Biological Assay;Biology;biomechanical test;Biomechanics;Biomedical Engineering;capsule;caucasian American;Characteristics;Charge;Chemicals;Chronic;clinical care;Collagen;Complex;craniofacial;density;Development;dimorphism;Dislocations;Disparity;Elements;Environment;Enzyme-Linked Immunosorbent Assay;Etiology;Evaluation;experience;Faculty;Family;Fellowship;Female;Generations;Glycosaminoglycans;Goals;Grant;high risk;Human;Incidence;Investigation;joint destruction;joint loading;Joints;Lateral;Ligaments;Literature;Low Prevalence;male;Mandibular Condyle;Manuscripts;Mechanics;men;Mentors;Microscopy;Modeling;Molecular;Molecular and Cellular Biology;Morphology;Pain;Pathologic;Pathology;Pathway interactions;Patients;Phase;Population Heterogeneity;post-doctoral training;Postdoctoral Fellow;Preparation;Prevalence;programs;Property;Protocols documentation;Race;racial difference;racial disparity;racial population;Relaxation;Reporting;Research;Research Personnel;Research Proposals;resilience;resilience factor;Resource Development;Resources;responsible research conduct;Risk;Risk Assessment;Risk Estimate;Risk Factors;Sampling;second harmonic;sex;sex determination;Sex Differences;sex disparity;sex variable;sexual dimorphism;skill acquisition;social;statistics;Stress;Structure;success;Symptoms;System;Temporal bone structure;Temporomandibular Joint;Temporomandibular Joint Disorders;Testing;Tissues;Training;Translational Research;United States;United States National Institutes of Health;Universities;viscoelasticity;Woman;Work;Writing

PROJECT_TITLE: Tissue structure and mechanical function relationships of the human temporomandibular lateral capsule-ligament: Investigation of sexual and racial dimorphisms


FUNDING_MECHANISM: RESEARCH CENTERS

NIH_SPENDING_CATS: Cancer;Lung;Lung Cancer

PHR: NARRATIVE The Administrative Core provides centralized functions for the Emory University Lung Cancer SPORE program to administer, coordinate, and oversee all meetings, budgets, financial and scientific reports, data management and sharing, project planning and evaluation, identification of new translational opportunities, problem solving, daily operations, and ethical conduct of the SPORE clinical studies. The Core will also provide support and administration for Developmental Research and Career Enhancement Programs, and coordination of the Executive Committee and Internal/External Advisory Boards. Core personnel will collaborate with NCI SPORE officials and with the members of other lung cancer SPORE programs nationally.

PI_NAMEs: RAMALINGAM, SURESH S (contact)

PROGRAM_OFFICER_NAME: UJHAZY, PETER

PROJECT_TERMS: Accounting;Administrative Supplement;Advocate;Basic Science;Budgets;Cancer Patient;career;clinical application;Clinical Ethics;Clinical Research;Clinical Trials;Collaborations;Committee Members;Companions;data management;data sharing;Dedications;design;Development;Educational workshop;Ensure;Ethics;Evaluation;Funding;Goals;Grant;Human Resources;Institution;Malignant neoplasm of lung;meetings;member;Mission;Monitor;operation;organizational structure;patient engagement;Patients;Performance;Pilot Projects;Play;Problem Solving;programs;Progress Reports;Regulation;remediation;Reporting;Research;Research Personnel;Research Project Grants;Resources;Role;Translating;translational potential;Translational Research;Travel;Universities

PROJECT_TITLE: Administrative Core


PHR: PROJECT NARRATIVE The SPORE Pathology Core will provide expertise in lung cancer pathology to ensure efficient and highly- coordinated procurement, archiving, and storage of both fresh and archived lung cancer tissue specimens to support the Emory University Lung Cancer SPORE projects. These efforts will further advance our understanding of the biology of lung cancer, and will help define novel strategies for the treatment of lung cancer.

PI_NAMEs: SICA, GABRIEL LARKIN (contact)

PROJECT_TERMS: Administrative Supplement;American Joint Committee on Cancer;Animals;Antibodies;Archives;biobank;Biological Markers;Biology;biomedical informatics;Biometry;Blood;Cancer Patient;career;Catalogs;Cells;Classification;Clinical Data;Clinical Trials;clinically relevant;Collaborations;Collection;Communication;Confidentiality of Patient Information;Consent;Data;design;design and construction;Development;Diagnostic;Ensure;Equipment;experience;Flow Cytometry;Formalin;Freezing;Fresh Tissue;Funding;Histocytochemistry;Histopathology;human tissue;Immunohistochemistry;Infrastructure;Institution;Investigation;Laboratories;Link;Lung;Lung Neoplasms;Malignant neoplasm of lung;Malignant Neoplasms;Molecular Genetics;novel strategies;Nursing Research;Paraffin Embedding;Pathologic;Pathologist;Pathology;patient derived xenograft model;Patients;Peer Review;Procedures;Process;programs;prospective;Pulmonary Pathology;Recording of previous events;repository;Research;Research Personnel;Research Project Grants;Resources;Sampling;Scientist;Services;Specimen;Specimen Handling;Staging;Stains;Standardization;Technical Expertise;Tissue Banks;Tissue Embedding;Tissue Microarray;Tissue Sample;Tissue Viability;Tissues;Translational Research;translational study;treatment strategy;United States National Institutes of Health;Universities;Validation

PROJECT_TITLE: Core 2:  Pathology Core


PHR: Our group has identified stem-like T cells that undergo proliferation after immune checkpoint inhibition. We will characterize these cells in lung tumors, draining lymph nodes and peripheral blood, and study their correlation with treatment outcome. In addition, we will study a novel combination regimen of mTOR inhibition and PD1 inhibition in lung cancer patients.

PI_NAMEs: AHMED, RAFI  (contact)

PROJECT_TERMS: Address;Adjuvant Study;Administrative Supplement;Aftercare;anti-cancer;Blood;Cancer Patient;cancer therapy;CD28 Antigens;CD28 gene;CD8-Positive T-Lymphocytes;Cells;Characteristics;checkpoint inhibition;Clinical;clinical efficacy;Combined Modality Therapy;cytokine;Data;Deuterium;draining lymph node;Effector Cell;efficacy study;Epigenetic Process;Excision;exhaust;exhaustion;FRAP1 gene;Funding;Genetic Transcription;Goals;Immune checkpoint inhibitor;Immune response;Immunity;Immunofluorescence Immunologic;Immunologic Factors;Immunologics;Immunotherapy;improved;in vivo;Infiltration;Investigation;Label;Location;Lung Neoplasms;Malignant neoplasm of lung;Measures;Monitor;mouse model;mTOR inhibition;mTOR Inhibitor;Neoadjuvant Study;Neoadjuvant Therapy;neoplastic cell;Non-Small-Cell Lung Carcinoma;novel;Operative Surgical Procedures;Patients;PD-1 blockade;peripheral blood;Phenotype;Play;Population;predictive marker;programmed cell death protein 1;Proliferating;Regimen;Resected;response;Role;Signal Transduction;Site;stem;stemness;T cell receptor repertoire sequencing;T-Cell Proliferation;T-Lymphocyte;T-Lymphocyte Subsets;targeted treatment;Techniques;Testing;Therapy trial;Tissues;Treatment outcome;tumor;Tumor Tissue

PROJECT_TITLE: Project 1: Evaluating stem-like T cells and improving efficacy of checkpoint inhibitors in NSCLC


NIH_SPENDING_CATS: Biotechnology;Cancer;Clinical Research;Genetics;Immunotherapy;Lung;Lung Cancer;Precision Medicine

PHR: Project Narrative: This proposal includes a phase 1b clinical trial of MRX-2843 and osimertinib in patients with advanced EGFRMT NSCLC and may lead to development of more effective and less toxic therapies to improve survival and quality of life for lung cancer patients. Correlative studies are included in the trial to identify potential biomarkers that could be used to monitor target inhibition and/or immune response in patients treated with the combination. Preclinical studies will also be conducted using animal models to expand our understanding of the direct and immune-mediated mechanisms by which MERTK contributes to tumorigenesis and resistance to EGFR inhibition in EGFRMT NSCLC.

PI_NAMEs: GRAHAM, DOUGLAS K (contact)

PROJECT_TERMS: ABCG2 gene;Address;Administrative Supplement;Aftercare;Animal Model;Binding;Biological Markers;Biopsy;Biopsy Specimen;Blood;Blood specimen;Bone Marrow;Cancer Etiology;Cancer Model;Cancer Patient;Caring;Cell Culture Techniques;cell killing;Cell Line;Cells;Cessation of life;chemokine;Clinical;clinical application;Clinical Research;Clinical Trials;cohort;Collection;Correlative Study;cytokine;cytotoxic;Cytotoxic Chemotherapy;Data;Dedications;Development;Dose;EGFR inhibition;Enrollment;Epidermal Growth Factor Receptor;Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor;Family;FDA approved;first-in-human;Funding;Generations;Genetic;Guidelines;Human;Immune;immune cell infiltrate;immune function;Immune response;Immune system;Immunologic Markers;Immunosuppression;Implant;improved;improved outcome;inhibitor;inhibitor therapy;Innate Immune Response;International;kinase inhibitor;Knock-out;Knockout Mice;Ligands;Lung;lung cancer cell;Malignant neoplasm of lung;Malignant Neoplasms;Mediating;Mediator;MERTK gene;Modeling;Monitor;mouse model;Multicenter Studies;Mus;mutant;Mutate;Mutation;mutational status;National Comprehensive Cancer Network;Natural Immunity;Neoplasm Metastasis;neoplastic cell;New Agents;Newly Diagnosed;Non-Small-Cell Lung Carcinoma;novel;novel strategies;Oncogenic;patient derived xenograft model;patient response;Patient-Focused Outcomes;Patients;permissiveness;Pharmaceutical Preparations;pharmacodynamic biomarker;Pharmacodynamics;Phase;Phase Ib Clinical Trial;Phenotype;Phosphorylation;potential biomarker;pre-clinical;preclinical study;Prognosis;programs;Quality of life;Receptor Protein-Tyrosine Kinases;Recombinants;Recommendation;Research Personnel;Resistance;Resistance development;resistance mechanism;resistance mutation;response biomarker;Role;Safety;Sampling;Signal Transduction;small hairpin RNA;subcutaneous;targeted treatment;Testing;Therapeutic;Therapeutic Effect;therapeutic target;Translating;tumor;tumor growth;Tumor Immunity;tumor microenvironment;Tumor-associated macrophages;tumorigenesis;Tyrosine Kinase Inhibitor

PROJECT_TITLE: Project 2: Targeting MERTK to improve outcomes for EGFR-mutated NSCLC


ORG_CITY: NEW YORK

ORG_NAME: SLOAN-KETTERING INST CAN RESEARCH

ORG_STATE: NY

PHR: Project Narrative We are applying the latest discoveries in cancer genomics and immunobiology to guide discovery efforts in cancer susceptibility, treatment decision-making, clinical trial development, and drug discovery for patients with urothelial cancer. This program will facilitate the identification and validation of biomarkers designed to guide treatment selection to maximize patient benefit. These comprehensive efforts target the entire spectrum of patients who are affected by urothelial cancer—from those with genomic susceptibility for developing the disease to those at risk for premature death from advanced disease.

PI_NAMEs: ROSENBERG, JONATHAN ERIC (contact);SOLIT, DAVID B.

PROGRAM_OFFICER_NAME: SCROGGINS, BRADLEY TODD

PROJECT_TERMS: Address;advanced disease;Affect;anti-PD-L1;Attenuated;BCG Live;Bioinformatics;Biological Specimen Banks;Biology;biomarker validation;Biometry;Bladder;Blood;Cancer Biology;cancer genetics;cancer genomics;cancer immunobiology;Cancer Patient;career;Caring;Cells;Cessation of life;chemotherapy;Clinical;Clinical Data;Clinical Management;Clinical Research;Clinical Trials;combinatorial;Community Clinical Oncology Program;Computational Biology;Cystectomy;data integration;data platform;Decision Making;design;Development;Diagnosis;Disease;DNA Damage;drug discovery;drug sensitivity;efficacy testing;Ensure;Evolution;Expenditure;FDA approved;Future;Future Generations;Gene Mutation;Genetic Predisposition to Disease;Genomic Instability;genomic signature;Genomics;Genus Mycobacterium;Germ Lines;Germ-Line Mutation;Goals;guided inquiry;Heritability;Heterogeneity;Human;human tissue;Immune;immune checkpoint blockade;Immune checkpoint inhibitor;Immune response;Immune Targeting;Immunologic Stimulation;Immunotherapy;improved;improved outcome;Individual;individual patient;Inherited;insight;Investigational Therapies;Laboratory Research;Localized Disease;Malignant neoplasm of urinary bladder;Malignant Neoplasms;Medical;Mentorship;Minority;Molecular;Molecular Analysis;molecular pathology;Molecular Profiling;Monitor;Morbidity - disease rate;Multicenter Trials;multidisciplinary;muscle invasive bladder cancer;Mutation;mycobacterial;new therapeutic target;non-muscle invasive bladder cancer;novel;novel marker;Organ;Outcome;Palpable;Pathway interactions;patient population;patient subsets;Patients;Pattern;personalized care;predictive marker;predictive signature;Predisposition;premature;Preparation;pressure;Prevalence;Primary Neoplasm;programs;prospective;Public Health;Randomized;Recording of previous events;Recurrence;refractory cancer;Regimen;Renal pelvis;research clinical testing;Research Personnel;Research Project Grants;Resistance;resistance mechanism;response;response biomarker;Risk;screening;Selection for Treatments;Site;Specialized Program of Research Excellence;Systemic Therapy;The Cancer Genome Atlas;Therapeutic;Time;Translational Research;translational scientist;Transurethral Resection;Treatment Cost;treatment response;Tuberculosis;tumor;Tumor Tissue;United States;Ureter;Urethra;Urothelium

PROJECT_TITLE: SPORE in Bladder Cancer


NIH_SPENDING_CATS: Cancer;Urologic Diseases

PHR: PROJECT NARRATIVE The Administrative Core will provide centralized scientific and administrative oversight and management of the SPORE in Bladder Cancer at Memorial Sloan Kettering Cancer Center to facilitate the accomplishment of the translational research objectives of the program.

PI_NAMEs: BAJORIN, DEAN F. (contact)

PROJECT_TERMS: authority;career;Clinical;Collaborations;Communication;Communities;Data;data management;Decision Making;Development;editorial;Education;Ensure;Fostering;Genomics;Grant;Human Resources;Infrastructure;Institution;Link;Malignant neoplasm of urinary bladder;Manuscripts;Medical;meetings;member;Memorial Sloan-Kettering Cancer Center;Molecular;National Cancer Institute;Occupational activity of managing finances;Office of Administrative Management;operation;Patient Compliance;patient privacy;Pilot Projects;Principal Investigator;programs;Publications;Regulation;Reporting;Reproduction spores;Request for Applications;Research;Research Personnel;Research Project Grants;Running;scientific organization;Services;Training;Translational Research;Work


NIH_SPENDING_CATS: Biotechnology;Cancer;Clinical Research;Lung;Lung Cancer;Radiation Oncology

PI_NAMEs: DENG, XINGMING  (contact)

PROJECT_TERMS: Administrative Supplement;Agonist;analog;Animal Cancer Model;anti-cancer;Antineoplastic Agents;Apoptosis;Apoptotic;Attenuated;Bax protein;Binding;Biological;C-terminal;Cancer Patient;cancer therapy;Cell Death;cell killing;Cells;checkpoint inhibition;Chemical Structure;chemoradiation;chemotherapy;Chemotherapy and/or radiation;Cisplatin;Development;draining lymph node;Failure;Family member;Funding;Genetic Engineering;Homo;Human;In Vitro;Induction of Apoptosis;Ionizing radiation;KRAS2 gene;KRASG12D;Lead;Link;lung cancer cell;Lung Neoplasms;Malignant neoplasm of lung;Malignant Neoplasms;MAPK3 gene;Mediating;MEKs;member;Mitochondria;mitochondrial membrane;Modeling;Molecular Conformation;mTOR inhibition;mTOR Inhibitor;mutant;Mutation;Non-Small-Cell Lung Carcinoma;novel;novel strategies;Pathway interactions;patient derived xenograft model;Patients;PDPK1 gene;peripheral blood;Pharmaceutical Preparations;Phosphorylation;Phosphorylation Site;Phosphotransferases;Physiological;PI3K/AKT;PIK3CG gene;Play;predictive marker;Prognostic Marker;programmed cell death protein 1;Proliferating;Property;Protein Dephosphorylation;Proto-Oncogene Proteins c-akt;Radiation;radiation resistance;Radiation therapy;Radio;radioresistant;Regimen;Reporting;Repression;Resistance;Role;Serine;Signal Induction;Signal Transduction;Site;small molecule;stem;T-Lymphocyte;Tail;Testing;Therapeutic Intervention;therapeutic target;therapy resistant;TP53 gene;Treatment outcome;tumor;Tumor Tissue;Xenograft procedure

PROJECT_TITLE: Project 3: Targeting Bax signaling to overcome treatment resistance in NSCLC


NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Clinical Research;Genetics;Human Genome;Immunotherapy;Precision Medicine;Urologic Diseases

PHR: PROJECT NARRATIVE As a public health concern, bladder cancer is the fifth most common cancer in the United States, has a high rate of recurrence, and has limited treatment options for advanced disease. The Biospecimen Repository Core will support the work of the SPORE in Bladder Cancer at Memorial Sloan Kettering Cancer Center to advance our understanding of the clinical, biologic, and genetic basis of urothelial cancer (cancer of the renal pelvis, ureter, bladder, and urethra) to improve patient outcomes by facilitating a range of scientific activities that could lead to new genomic- and proteomic-based interventions and by developing new biomarkers with diagnostic, prognostic, and therapeutic relevance to this disease.

PI_NAMEs: AL-AHMADIE, HIKMAT  (contact)

PROJECT_TERMS: advanced disease;Animals;anti-cancer research;Antibodies;Bacillus Calmette-Guerin Therapy;BCG Live;Bioinformatics;Biological;Biological Assay;Biological Markers;Biological Specimen Banks;Biometry;Blood;Blood specimen;cell free DNA;Cell Separation;Cisplatin;Clinical;Clinical Chemistry;Clinical Laboratory Improvement Amendments;Clinical Research;clinical sequencing;Collaborations;Communities;Consent;Consultations;Data;data quality;design;Diagnostic;digital;Disease;Disease Management;DNA;DNA analysis;DNA Damage;Doctor of Philosophy;Documentation;Ensure;Evaluation;Excision;exome sequencing;exosome;follow-up;Formalin;Freezing;Fresh Tissue;Gene Expression Profiling;Genes;Genetic;genetic analysis;Genomics;Germ Lines;Goals;Guidelines;Heterogeneity;Human;human tissue;Image;immune checkpoint blockade;Immunohistochemistry;improved;In Situ Hybridization;Inherited;Institutional Review Boards;Intervention;Label;Laboratories;laser capture microdissection;Leadership;Malignant neoplasm of ureter;Malignant neoplasm of urinary bladder;Malignant Neoplasms;Measures;Memorial Sloan-Kettering Cancer Center;Methodology;Microdissection;Modeling;Molecular;molecular diagnostics;Morphology;mouse model;Mus;Mutate;Mutation;Needle biopsy procedure;Neoplasm Metastasis;neoplasm resource;next generation sequencing;novel;novel marker;Nucleic Acids;Paraffin Embedding;participant enrollment;Pathologic;Pathology;patient privacy;Patient-Focused Outcomes;Patients;Pelvic Cancer;Phenotype;Pilot Projects;Plasma;Play;predictive marker;Preparation;Process;prognostic;programmed cell death ligand 1;prospective;prospective test;Proteomics;Protocols documentation;Public Health;quality assurance;Quality Control;Radical Cystectomy;Recording of previous events;Recurrence;relational database;Renal Carcinoma;Research;Research Personnel;Research Project Grants;Resource Sharing;response;response biomarker;Risk;RNA;Role;Sampling;Scanning;Serum;Services;Specimen;Standardization;T cell clonality;T cell receptor repertoire sequencing;Therapeutic;Therapeutic Research;tissue archive;Tissue Embedding;Tissue Microarray;Tissue Procurements;Tissue Sample;Tissues;transcriptome sequencing;Translational Research;Transurethral Resection;Tube;tumor;United States;Urethral Cancer;Urethral Neoplasms;Urine;Urothelium;Whole Blood;Work;Xenograft Model

PROJECT_TITLE: Biospecimen Repository Core


PHR: PROJECT NARRATIVE The SPORE Developmental Research Program (DRP) provides funding to support new and innovative pilot projects in lung cancer that have the potential to expand into full research projects in the future, including those of high risk-high reward nature. The DRP aims to foster collaborative research between Emory investigators and investigators at other institutions, and to enhance translational research in lung cancer by increasing the number of meritorious investigators working on lung cancer.

PI_NAMEs: FU, HAIAN  (contact)

PROJECT_TERMS: Administrative Supplement;American Cancer Society;anti-cancer research;Award;career development;Clinical Research;Collaborations;Development;Evolution;Extramural Activities;Fostering;Foundations;Funding;Future;Goals;Grant;Head and Neck Cancer;high reward;high risk;innovation;Institution;Investments;Malignant neoplasm of lung;Malignant Neoplasms;Medical;Monitor;Nature;novel;Outcome;Patient Care;Peer Review;Peer Review Grants;Pilot Projects;preclinical study;Process;Program Research Project Grants;programs;Publications;Request for Proposals;Research;Research Personnel;Research Project Grants;Research Proposals;Series;Source;success;Translational Research;translational study;United States National Institutes of Health;Universities

PROJECT_TITLE: Developmental Research Program


PHR: PROJECT NARRATIVE The Biostatistics and Bioinformatics Core will provide direct support for study design and timely execution of data analysis for all research projects and developmental projects in the MSK SPORE in Bladder Cancer.

PI_NAMEs: OSTROVNAYA, IRINA  (contact)

PROJECT_TERMS: Address;Algorithms;analytical method;Bioinformatics;bioinformatics pipeline;Biological Specimen Banks;Biometry;Clinical Data;Clinical Research;clinical trial analysis;Consult;Data;Data Analyses;data format;Databases;Dedications;Deposition;design;Development;diverse data;Doctor of Philosophy;Ensure;experience;Experimental Designs;Formulation;genomic data;Goals;Graph;human tissue;Individual;Laboratories;laboratory experiment;Leadership;Malignant neoplasm of urinary bladder;Malignant Neoplasms;Manuscripts;member;Methodology;Modification;Molecular;Monitor;Nature;novel;Preparation;public repository;Publications;Reporting;Reproducibility;Research;Research Design;Research Personnel;Research Project Grants;Role;Sample Size;Science;Statistical Data Interpretation;System;translational goal;Urothelium;Validation;Work;Writing

PROJECT_TITLE: Biostatistics and Bioinformatics Core


PHR: PROJECT NARRATIVE The Emory Lung Cancer SPORE Career Enhancement Program (CEP) intends to support pilot projects and the mentoring of early career academic physician-scientists, clinician-investigators, and laboratory-based scientists who wish to develop a career in translational research in the areas of diagnosis, imaging, prevention, treatment, and improvement in quality of life in lung cancer. The proposed CEP aims to provide an environment that enables talented early career investigators to engage in a 2-year mentored research program, to facilitate their success and their academic career development in terms of achieving independent investigator status, and to enhance diversity among the lung cancer research community.

PI_NAMEs: MARCUS, ADAM I. (contact)

PROJECT_TERMS: Academic advising;Administrative Supplement;anti-cancer research;Area;Award;Biology;career;career development;Communities;Dedications;Diagnosis;Disabled Persons;Environment;Fostering;Funding;Goals;Grant;Head and Neck Cancer;Health Sciences;Hematology;Image;improved;Institution;Laboratories;Malignant neoplasm of lung;Malignant Neoplasms;Medical Oncology;medical schools;Mentors;Minority Groups;molecular oncology;Oncology;Peer Review;physician-scientist training program;Physicians;Pilot Projects;Prevention;Program Development;programs;Publishing;Quality of life;Research;Research Personnel;Scientist;Secure;success;Talents;Training;translational physician;Translational Research;United States National Institutes of Health;Universities;Woman

PROJECT_TITLE: Career Enhancement Program


NIH_SPENDING_CATS: Cancer;Cancer Genomics;Clinical Research;Genetics;Human Genome;Precision Medicine;Urologic Diseases

PHR: Project Narrative This project is based on the scientific premise that molecular profiling before treatment can identify patients with muscle-invasive bladder cancer for whom transurethral resection of the bladder tumor and systemic chemotherapy will be curative, without the need for radical cystectomy. Targeted and whole exome sequencing in patients enrolled on a prospective clinical trial will be used to better define the population of patients for whom such an approach would be most appropriate. The project will also investigate the use of cell-free DNA from blood and urine as a platform for early identification of minimal residual disease and to explore tumor heterogeneity as a mechanism of drug resistance.

PI_NAMEs: SOLIT, DAVID B. (contact)

PROJECT_TERMS: Acceleration;Adjuvant Chemotherapy;Basic Science;Bioinformatics;Biological Assay;Biological Markers;Biological Specimen Banks;Biometry;Biopsy;Bladder;Bladder Neoplasm;Blood;Cancer Patient;cell free DNA;Chemoresistance;chemotherapy;Cisplatin;Clinical;Clinical Sciences;Clinical Trials;Clonal Evolution;co-clinical trial;cohort;Collaborations;Combination Drug Therapy;Combined Modality Therapy;curative treatments;Cystectomy;Cystoscopy;Data;Detection of Minimal Residual Disease;Diagnostic;Disease;DNA analysis;DNA Damage;Dose;Drug resistance;Early identification;Eligibility Determination;ERCC2 gene;Exhibits;exome sequencing;Future;gemcitabine;Gene Mutation;Genes;Genomics;Germ Lines;Guidelines;Heritability;Heterogeneity;Image;Immunotherapy;In complete remission;In Vitro;Malignant neoplasm of urinary bladder;Malignant Neoplasms;Mediating;Medical;Methods;Modeling;Molecular;Molecular Profiling;Multi-Institutional Clinical Trial;muscle invasive bladder cancer;Mutation;mutational status;Neoadjuvant Therapy;next generation sequencing;novel;Nucleotide Excision Repair;Oncology;Organ;Organoids;participant enrollment;Pathologic;patient population;patient response;Patient Selection;Patients;predicting response;predictive marker;predictive signature;preservation;primary endpoint;prospective;Publishing;Radical Cystectomy;radiological imaging;Recurrence;Recurrent disease;Residual Neoplasm;response;response biomarker;Sampling;Site;Somatic Mutation;Specific qualifier value;Staging;standard of care;Systemic Therapy;Testing;Therapy trial;Time;Toxicity due to chemotherapy;Transitional Cell Carcinoma;Transurethral Resection;treatment responders;treatment response;tumor;tumor heterogeneity;Urine;Urothelium;variant of unknown significance

PROJECT_TITLE: RP-1: Defining Predictors of Sensitivity to Cisplatin-Based Chemotherapy in Urothelial Cancer


NIH_SPENDING_CATS: Cancer;Clinical Research;Health Services;Skin Cancer

ORG_NAME: NEW YORK UNIVERSITY SCHOOL OF MEDICINE

PHR: PROJECT NARRATIVE SPORE programs are highly complex translational research enterprises that require cohesive organization and effective leadership to meet proposed scientific and programmatic aims. The Admin Core will work directly with research project and core investigators to evaluate progress, facilitate communication, and provide financial management for all activities of the NYU Melanoma SPORE. The Admin Core’s management of the SPORE will ensure the efficient use of NYULH resources, increase inter-SPORE and industry cooperation, and expand outreach to melanoma patients, enhancing our efforts to translate novel personalized biomarkers for melanoma patient management to the clinical setting.

PI_NAMEs: OSMAN, IMAN  (contact)

PROGRAM_OFFICER_NAME: KUZMIN, IGOR A

PROJECT_TERMS: Address;Award;Bioinformatics;Biometry;Body System;Budgets;Cancer Center;career;Clinic;Clinical;Clinical Management;Collaborations;Communication;Communities;community engagement;Complex;Development;Educational workshop;effective therapy;Ensure;Evaluation;expectation;Federal Government;Goals;Health;health administration;Health Policy;Health Resources;Industry;industry partner;Infrastructure;Institution;Institutional Policy;Investigation;Leadership;Local Government;material transfer agreement;meetings;Melanoma;Melanoma patient;National Cancer Institute;New York;novel;Occupational activity of managing finances;outreach;patient outreach;Patients;personalized biomarkers;Policies;programs;Progress Reports;Reproduction spores;Research;Research Personnel;Research Project Grants;Resource Sharing;Resources;Risk;Skin Cancer;Strategic Planning;tool;Translating;Translational Research;translational research program;Travel;United States National Institutes of Health;Universities;Work

PROJECT_TITLE: Admin Core


NIH_SPENDING_CATS: Cancer;Clinical Research;Clinical Trials and Supportive Activities;Skin Cancer

PHR: PROJECT NARRATIVE High quality, annotated biospecimens are critical to support a patient-centered melanoma translational research program. Core B is integrated within the structure of the SPORE, and is well positioned to stimulate research opportunities that uncover novel improvements for melanoma patients by providing researchers with biospecimens and clinical data from patients treated at NYU and internationally as part of phase III trials. We aim to facilitate the development of clinically impactful prognostic and predictive biomarkers for better management of patients with resectable melanoma.

PROJECT_TERMS: Aliquot;biobank;Biological Specimen Banks;Biological Specimen database;Blood;Blood specimen;career;Caring;Cell Separation;Clinical;Clinical Data;clinical development;Clinical Trials;Collaborations;Collection;Communities;Data;Databases;design;Development;Ensure;Feces;follow-up;Goals;Health;Human;Human Resources;improved;Industry;industry partner;Informed Consent;innovation;Institution;International;Link;Lymphocyte;Melanoma;Melanoma patient;Metastatic Melanoma;Mission;Molecular;novel;Nucleic Acids;participant enrollment;Pathologic;Pathology;patient oriented;patient privacy;Patient Rights;Patients;Peripheral Blood Mononuclear Cell;personalized management;Phase III Clinical Trials;phase III trial;Plasma;Positioning Attribute;predictive marker;Preparation;Process;Prognostic Marker;Program Research Project Grants;programs;prospective;Protocols documentation;Quality Control;repository infrastructure;Research;Research Infrastructure;Research Personnel;Research Project Grants;Resectable;Resected;Resources;Scientist;Serum;Services;Site;Skin Cancer;stool sample;Structure;T-Lymphocyte;Tissue Sample;Tissues;tool;Translational Research;translational research program;Unresectable;Whole Blood;Work

PROJECT_TITLE: Core B - Biospecimen/Pathology Core


NIH_SPENDING_CATS: Cancer;Clinical Research;Immunotherapy;Precision Medicine;Urologic Diseases

PHR: Project Narrative  Immune checkpoint blockade is the most important advance in the treatment of urothelial carcinoma in over 20  years, although only a minority of patients benefit from treatment, and robust predictive biomarkers are lacking.  This project will not only test whether antiangiogenic therapy in combination with immune checkpoint blockade  improves outcomes in urothelial cancer in a randomized clinical trial, but also interrogate the tumor  microenvironment and immune system to identify mechanisms of resistance to immune checkpoint blockade.  By identifying potential predictive biomarkers of response and determinants of resistance, this project will  identify new targets that could drive development of more effective combination therapies for metastatic  urothelial cancer.

PI_NAMEs: ROSENBERG, JONATHAN ERIC (contact)

PROJECT_TERMS: acquired drug resistance;Angiogenesis Inhibitors;anti-PD-1;anti-PD1 therapy;Antibodies;antitumor effect;Basic Science;bevacizumab;Binding;Biological Markers;Blood;Blood specimen;Cancer Patient;Cell Physiology;cell type;chemotherapy;Cisplatin;Clinical;clinical decision-making;clinical predictors;Clinical Sciences;Clinical Trials;Clonality;Collection;combinatorial;Combined Modality Therapy;comparative efficacy;Data;Dendritic Cells;Development;Disease;Dissection;Doctor of Philosophy;FDA approved;Genomics;Goals;immune checkpoint blockade;Immune checkpoint inhibitor;Immune system;Immunologic Markers;Immunologics;immunoregulation;Immunotherapy;improved;improved outcome;Malignant neoplasm of urinary bladder;Malignant Neoplasms;Minority;Modeling;Molecular;Monoclonal Antibodies;Multicenter Studies;Mutation;Myeloid-derived suppressor cells;neoantigens;novel therapeutics;Outcome;patient subsets;Patients;Peripheral;Pharmaceutical Preparations;predictive marker;programmed cell death ligand 1;prospective;Randomized;randomized, clinical trials;Recurrence;Regulatory T-Lymphocyte;Research Project Grants;Resistance;Resistance development;resistance mechanism;response;response biomarker;Sampling;Stains;standard of care;T cell clonality;T memory cell;T-Lymphocyte;targeted agent;Testing;The Cancer Genome Atlas;Time;trafficking;Transitional Cell Carcinoma;tumor;tumor microenvironment;tumor-immune system interactions;Urothelium;Vascular Endothelial Growth Factors;Vegf inhibition;Vegf Inhibitor

PROJECT_TITLE: RP-3: Elucidating Mechanisms of Sensitivity and Resistance to Checkpoint Blockade Therapy for Rational Multi-Drug Immunotherapy in Urothelial Cancers


NIH_SPENDING_CATS: Cancer;Cancer Genomics;Clinical Research;Genetics;Human Genome;Immunotherapy;Precision Medicine;Skin Cancer

PHR: PROJECT 2 NARRATIVE A substantial number of patients do not benefit from promising new immune checkpoint inhibitor therapies that stimulate the immune system to target melanoma. In our study, we propose to discover the genomic factors in host immune cells that influence response to these novel therapies, providing an opportunity to significantly improve treatment and survival outcomes for patients with melanoma.

PI_NAMEs: KIRCHHOFF, TOMAS  (contact)

PROJECT_TERMS: Acceleration;Adjuvant;Adjuvant Therapy;Affect;Antitumor Response;Autoimmune;Binding Sites;Biological Markers;biomarker identification;Blood Cells;cancer infiltrating T cells;CD4 Positive T Lymphocytes;CD8-Positive T-Lymphocytes;CD8B1 gene;Cell Physiology;Cells;Cessation of life;checkpoint inhibition;checkpoint therapy;Chromatin;Clinical;Clinical Trials;cohort;CTLA4 gene;cytotoxic;Data;data integration;density;Distant Metastasis;Enhancers;Epigenetic Process;Exhibits;exome sequencing;Freedom;Genes;Genetic;genetic risk factor;Genetic Transcription;Genetic Variation;Genome;genome sequencing;genome-wide analysis;Genomic Imprinting;Genomics;Germ Lines;high risk;Immune;Immune checkpoint inhibitor;Immune system;Immune Targeting;Immunity;Immunologic Adjuvants;Immunologic Stimulation;Immunologics;Immunophenotyping;Immunotherapy;improved;Individual;Infiltration;Inherited;innovation;ipilimumab;Malignant Neoplasms;Maps;Mediating;Melanoma;Melanoma patient;microbiome;Molecular;Mutation;Nivolumab;novel;novel therapeutics;Outcome;outcome prediction;Pathway interactions;Patient-Focused Outcomes;Patients;peripheral blood;personalized predictions;Phase;Phenotype;predictive marker;predictive signature;primary outcome;programmed cell death protein 1;promoter;Proteins;Proteomics;Publishing;rare variant;receptor;Recurrence;Regulation;Regulatory Element;Relapse;relapse patients;relapse prediction;Reporting;Research Design;Resected;Resistance;response;Role;Sampling;Sequence Analysis;survival outcome;T cell differentiation;T-cell diversity;T-Lymphocyte;T-Lymphocyte Subsets;Testing;Time;trait;transcription factor;Transcriptional Regulation;transcriptome;transcriptome sequencing;Treatment outcome;tumor;tumor microenvironment;Untranslated RNA;Validation;Variant;whole genome

PROJECT_TITLE: Project 2


NIH_SPENDING_CATS: Autoimmune Disease;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Immunotherapy;Inflammatory Bowel Disease;Precision Medicine;Prevention;Skin Cancer

PHR: PROJECT 3 NARRATIVE Project 3 has three key goals: 1) Refine and clinically validate a baseline autoantibody signature that identifies melanoma patients at high risk of developing severe immune toxicity from immune checkpoint inhibitors, using pre-treatment sera. 2) Identify a causative role for baseline autoantibodies in toxicity development. 3) Conduct a biomarker-driven phase-II clinical trial testing prophylactic anti-TNF- to mitigate development of immune toxicity from checkpoint inhibitors in patients at high risk of immune-related adverse events.

PI_NAMEs: KROGSGAARD, MICHELLE  (contact)

PROJECT_TERMS: Adjuvant;Adjuvant Study;American;anti-CTLA4;anti-PD-1;Antibodies;Autoantibodies;Autoimmune;Autoimmune Diseases;B-Lymphocytes;Biological Assay;Biological Markers;biomarker driven;biomarker identification;biomarker signature;Bladder;Cancer Patient;cancer type;Certification;checkpoint inhibition;Clinical;Clinical Laboratory Improvement Amendments;Clinical Trials;cohort;Colitis;college;Data;Dermatologic;Development;Diarrhea;Endocrine;experience;experimental study;Exposure to;gastrointestinal;Goals;Hepatic;high risk;Human;humanized mouse;Immune;Immune checkpoint inhibitor;immune-related adverse events;Immunoglobulin G;Immunologic Adjuvants;Immunologic Markers;Immunosuppression;Inflammatory Bowel Diseases;infliximab;interest;ipilimumab;Kidney;Laboratories;Length;Lung;Malignant Neoplasms;Manuscripts;Melanoma;Melanoma patient;Morbidity - disease rate;mouse model;Nivolumab;Oncologist;Organ;Pathogenicity;Pathologist;patient subsets;Patients;pembrolizumab;Phase;phase 2 study;Phase II Clinical Trials;phase II trial;Placebo Control;Placebos;Preclinical Testing;predicting response;predictive test;predictive tools;Predisposition;prevent;Prevention;Prevention strategy;prophylactic;Proteins;Proteome;Proteomics;Publishing;Randomized;Recurrence;Regimen;Renal Cell Carcinoma;Resected;response;Role;Selection for Treatments;Serum;System;T-Lymphocyte;Testing;Therapeutic;Thyroiditis;TNF gene;tool;Toxic effect;treatment optimization;treatment strategy;tumor;Ulcerative Colitis;Validation;Work

PROJECT_TITLE: Project 3


NIH_SPENDING_CATS: Cancer;Colorectal Cancer;Digestive Diseases;Pancreatic Cancer;Rare Diseases

ORG_CITY: NASHVILLE

ORG_NAME: VANDERBILT UNIVERSITY MEDICAL CENTER

ORG_STATE: TN

PHR: PROJECT NARRATIVE: Administrative Core The Administrative Core will be responsible for the organizational, administrative, and scientific management (both basic and clinical research) of the Vanderbilt-Ingram Cancer Center SPORE in Gastrointestinal (GI) Cancer program, which focuses on translational research that will substantially improve the management of colorectal cancer. This management and support will be accomplished through a series of oversight committees and organized administrative and scientific meetings of GI SPORE investigators, institutional representatives, and external advisors.

PI_NAMEs: COFFEY, ROBERT J. (contact)

PROGRAM_OFFICER_NAME: NOTHWEHR, STEVEN F

PROJECT_TERMS: Academic Medical Centers;Advocate;Basic Science;Biological Sciences;Biology;Cancer Center;career;Clinical and Translational Science Awards;Clinical Research;Collaborations;Colorectal Cancer;Communication;Communities;Development;Digestive System Disorders;Education;Ensure;Epithelium;Evaluation;Fostering;gastrointestinal;improved;Institution;Malignant Breast Neoplasm;Malignant neoplasm of gastrointestinal tract;Malignant neoplasm of pancreas;Malignant Neoplasms;medical schools;meetings;Monitor;Mucositis;National Cancer Institute;Occupational activity of managing finances;outreach;Patient advocacy;Patients;Pharmacologic Substance;programs;Regulation;Report (document);Reporting;Reproduction spores;Research;Research Personnel;Research Project Grants;Resources;Schedule;Series;Tennessee;Translational Research;Universities


NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Clinical Research;Colorectal Cancer;Digestive Diseases;Genetics;Human Genome

PHR: PROJECT NARRATIVE: Tissue Pathology and Cellular Analysis Core The Translational Pathology and Cellular Analysis Core plays an essential role by providing annotated human biospecimens, immunohistochemistry, pathology interpretation, and single cell analysis. Without these services, which provide technologies to bridge animal models of cancer and basic science discoveries to patient care, the translational mission of the Vanderbilt GI SPORE to make a profound impact on the prevention, early detection, diagnosis and treatment of colorectal cancer would not be possible.

PI_NAMEs: WASHINGTON, MARY KAY (contact)

PROJECT_TERMS: Academic Medical Centers;Animal Cancer Model;Antibodies;Basic Science;Behavior;biobank;Bioinformatics;Biological Assay;Biological Process;Biometry;cancer biomarkers;Cancer Center;Cancer Science;Cells;cellular imaging;Collaborations;Collection;Colorectal Cancer;colorectal cancer treatment;Colorectal Neoplasms;Computer Analysis;Confidentiality of Patient Information;Consult;Consultations;Cooperative Human Tissue Network;cost effective;Custom;Cytometry;Data;Data Analyses;data de-identification;data quality;Databases;Diagnosis;Digestive System Disorders;digital;Disease;Early Diagnosis;Ensure;Epithelial Cells;Epithelium;Evaluation;flexibility;Formalin;Freezing;Gastrointestinal Neoplasms;Gene Expression;Generations;Genetic Complementation Test;Histologic;Histology;Histopathology;Human;human disease;Image;image processing;Immunofluorescence Immunologic;Immunohistochemistry;Informatics;Informed Consent;Infrastructure;instrument;laser capture microdissection;Malignant neoplasm of gastrointestinal tract;Mission;Molecular;molecular imaging;Morphology;mouse model;Mus;next generation;Normal tissue morphology;novel;operation;Paraffin Embedding;Pathology;Patient Care;Patients;Play;Pre-Clinical Model;Preparation;Prevention;Process;protein expression;Publishing;Qualifying;Quality Control;Reagent;repository;Reproduction spores;Research;Research Activity;Research Personnel;Resource Sharing;Role;Running;Sampling;screening;Services;Signal Transduction;single cell analysis;single-cell RNA sequencing;Specimen;synergism;Technology;The Vanderbilt-Ingram Cancer Center at the Vanderbilt University;Time;Tissue Banks;Tissue Microarray;Tissue Sample;Tissues;tool;translational goal;Translational Research;Validation;Washington;Work

PROJECT_TITLE: Core 1: Tissue Pathology and Cellular Analysis


NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Colorectal Cancer;Digestive Diseases

PHR: PROJECT NARRATIVE: Mouse and Human Molecular Imaging Core The Mouse and Human Molecular Imaging (MHMI) Core will play a central role in the translational research mission of the Vanderbilt-Ingram Cancer Center (VICC) SPORE in Gastrointestinal (GI) Cancer, providing state-of-the-art imaging resources for three projects, future pilot and feasibility studies, and developmental research. The MHMI Core will leverage existing, institutionally-supported equipment and infrastructure to offer a full range of small animal and human functional, molecular, and anatomical imaging resources, including magnetic resonance imaging (MRI), computed tomography (CT), digital X-ray, optical, single photon emission computed tomography (SPECT), and positron emission tomography (PET). A unique feature of this core, the VICC GI SPORE investigators will also have access to novel probe development resources that leverage the capabilities of the Vanderbilt Center for Molecular Probes (CMP), including high-throughput, diversity-oriented synthesis capabilities suitable for developing novel imaging compounds, as well as world-class preclinical and cGMP resources of the CMP radiochemistry facility.

PI_NAMEs: MANNING, HENRY CHARLES (contact)

PROJECT_TERMS: anatomic imaging;animal imaging;Bioinformatics;Biological;Biometry;Cancer Center;Clinical Research;Colorectal Cancer;Coupled;Cyclic GMP;Data;Data Analyses;data de-identification;Development;Digital X-Ray;Equipment;Feasibility Studies;Functional Imaging;Future;gastrointestinal;Genomic approach;Human;human imaging;Human Resources;Image;imaging biomarker;imaging facilities;imaging modality;Individual;Infrastructure;Institution;liquid biopsy;Magnetic Resonance Imaging;Malignant neoplasm of gastrointestinal tract;Measures;Mission;Molecular;molecular imaging;Molecular Probes;Mus;novel;Optics;Pathology;Phenotype;Pilot Projects;Play;Positron-Emission Tomography;pre-clinical;pre-clinical research;Quality Control;Radiochemistry;Reproduction spores;Research;Research Personnel;research study;Resource Development;Resources;Role;single photon emission computed tomography;Specimen;Tissues;translational goal;Translational Research;tumor;Work;X-Ray Computed Tomography

PROJECT_TITLE: Core 2: Mouse and Human Molecular Imaging


PHR: PROJECT NARRATIVE: Biostatistics and Bioinformatics Core The relevance of the Biostatistics and Bioinformatics Core (BBC) lies in our provision of services essential for the conduct of high-quality collaborative gastrointestinal cancer research. Sound biostatistical/bioinformatic inputs are provided throughout the lifespan of a research project, from conception to completion. To ensure the needs of the investigators are met thoroughly and efficiently, key biostatisticians and/or bioinformaticians are assigned to each project.

PI_NAMEs: SHYR, YU  (contact)

PROJECT_TERMS: Animals;anti-cancer research;Bioinformatics;Biometry;Cancer Center;Clinical Research;Collaborations;Conceptions;Data;Data Analyses;data quality;Databases;Development;Ensure;epidemiology study;Experimental Designs;gastrointestinal;Human;Human Resources;Laboratories;life span;Malignant neoplasm of gastrointestinal tract;Manuscripts;member;Methods;molecular imaging;Mus;Participant;Pathology;power analysis;Quality Control;Reporting;Reproduction spores;research and development;Research Design;Research Personnel;Research Project Grants;Sample Size;Service provision;sound;Tissues;translational study;Work;Writing

PROJECT_TITLE: Core 3: Biostatistics and Bioinformatics


NIH_SPENDING_CATS: Cancer;Colorectal Cancer;Digestive Diseases;Stem Cell Research;Stem Cell Research - Nonembryonic - Non-Human

PHR: PROJECT NARRATIVE: P1. Interrogating Distinct Tumor-Initiating Cells Cancer stem cells, designated tumor-initiating cells (TICs) in this application, are thought to have the propensity to resist therapy and induce tumor recurrence. We will use single-cell technologies to interrogate distinct populations of colorectal cancer TICs in response to therapies. Our goal is to understand how these TICs behave in order to design strategies to inhibit their function(s).

PROJECT_TERMS: Ablation;Affect;Aftercare;Alleles;Architecture;Behavior;cancer cell;Cancer Center;Cancer Model;Cancer Prognosis;cancer recurrence;cancer stem cell;cancer therapy;cell behavior;Cells;Cellular biology;Characteristics;chemotherapy;Classification;Clinical Trials;Colon;Colon Carcinoma;Colonoscopy;Colorectal Cancer;combinatorial;conventional therapy;Dependence;design;Distal;EGF gene;Epidermal Growth Factor Receptor;Fluorouracil;Goals;Homeostasis;Human;Immunofluorescence Immunologic;in vivo;Individual;irinotecan;LGR5 gene;Maintenance;Malignant - descriptor;Malignant neoplasm of gastrointestinal tract;Malignant Neoplasms;Maps;Modeling;molecular marker;Monitor;Monoclonal Antibodies;Mus;novel;Optics;Organoids;Pathway interactions;patient response;Patients;Play;Population;predicting response;predictive modeling;Primary Neoplasm;prognostic;Property;prospective;Recurrent tumor;Reporter Genes;repository;response;Role;Sampling;Signal Transduction;single cell technology;single-cell RNA sequencing;Site;stem;stem cell population;stem cells;stemness;System;Testing;Therapeutic;Therapeutic Intervention;therapy resistant;Time;Tissue Microarray;Tissues;tool;transcriptomics;Translating;translational goal;Treatment Efficacy;treatment response;tumor;tumor growth;tumor initiation;tumorigenic;Work

PROJECT_TITLE: Project 1: Interrogating Distinct Tumor-Initiating Cells in CRC


NIH_SPENDING_CATS: Biotechnology;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Colorectal Cancer;Digestive Diseases;Immunization;Precision Medicine

PHR: PROJECT NARRATIVE: P2. Targeting Glutamine Metabolism to Enhance EGFR Blockade in WT RAS CRC Epidermal growth factor receptor (EGFR) neutralizing monoclonal antibodies are approved for treatment of advanced wild-type (WT) RAS colorectal cancer (CRC) and commonly used as targeted therapies for late-stage metastatic CRC. However, durable responses to anti-EGFR monotherapy occur in only 12–17% of patients and resistance to monoclonal antibody (mAb) therapy commonly occurs. Prioritizing glutamine metabolism as an actionable vulnerability in WT RAS CRC, we propose a two-pronged translational approach to optimize EGFR therapy that includes a novel way to prioritize patients for EGFR-targeted therapy, novel positron emission tomography (PET) imaging as a predictive marker, and a novel therapeutic combination.

PI_NAMEs: BERLIN, JORDAN D (contact)

PROJECT_TERMS: Address;Anabolism;Avidity;Biological Assay;Biological Markers;Biological Sciences;cancer cell;Cancer Cell Growth;Cancer Center;Cancer Etiology;Carbon;cell growth;Cell Proliferation;Cessation of life;Cetuximab;chemotherapy;Citric Acid Cycle;Classification;Clinical;Clinical Trials;colon cancer patients;Colorectal Cancer;combinatorial;Combined Modality Therapy;Complex;cytotoxic;Data;Development;Disease;efficacy evaluation;Enzymes;Epidermal Growth Factor Receptor;Exhibits;Future;genetic signature;Glucose;Glutamates;Glutaminase;Glutamine;Goals;Growth;improved;In Vitro;in vivo;inhibitor;Investigation;Laboratory Study;Link;Malignant neoplasm of gastrointestinal tract;Malignant Neoplasms;Mediating;member;Metabolic;Metabolism;metastatic colorectal;Mitochondria;Mitogen-Activated Protein Kinases;Molecular;Monoclonal Antibodies;Monoclonal Antibody Therapy;mouse model;neutralizing monoclonal antibodies;Nitrogen;novel;novel therapeutic intervention;novel therapeutics;Nutrient;panitumumab;participant enrollment;Pathogenesis;Pathway interactions;patient derived xenograft model;Patients;Pharmacodynamics;pharmacologic;Phase I Clinical Trials;Phase II Clinical Trials;Play;Positron-Emission Tomography;precision medicine;preclinical study;predicting response;Prediction of Response to Therapy;predictive marker;Production;Proliferating;proteogenomics;Reactive Oxygen Species;receptor-mediated signaling;Refractory;refractory cancer;Regimen;Resistance;response;Role;Signal Transduction;Solid Neoplasm;Source;statistics;System;targeted treatment;Therapeutic;Tracer;transcriptome sequencing;translational approach;translational goal;Translations;tumor;tumor metabolism

PROJECT_TITLE: Project 2: Targeting Glutamine Metabolism to Enhance EGFR Blockade in Wild-Type RAS CRC


PHR: PROJECT NARRATIVE: P3. Targeting MYC MYC is an oncoprotein and transcription factor that plays a critical pro-tumorigenic role in many cancers, including colorectal cancer (CRC). Although MYC is generally considered undruggable, we have identified a new strategy to target MYC in cancer cells by disrupting interaction with the essential MYC co-factor WDR5. Completion of this project will generate first-in-class MYC WDR5 inhibitors that are validated for efficacy in CRC and ready to proceed to Investigational New Drug (IND)-enabling studies.

PI_NAMEs: BEAUCHAMP, ROBERT DANIEL (contact)

PROJECT_TERMS: Acute;Affinity;Animals;Antineoplastic Agents;APC mutation;Attenuated;Binding;Binding Proteins;Biochemistry;Biological;Biological Markers;Biological Models;cancer cell;Cancer Center;Cancer Model;cancer type;candidate marker;candidate validation;Cells;Characteristics;Chromatin;Clinical;clinical candidate;Clinical Trials;cofactor;colon cancer cell line;colon cancer patients;colon tumorigenesis;Colorectal Cancer;colorectal cancer prevention;colorectal cancer treatment;Dose;Drug Combinations;Drug Design;drug discovery;Drug Kinetics;drug metabolism;Drug or chemical Tissue Distribution;drug-like compound;Effectiveness;efficacy testing;efficacy validation;Functional disorder;Funding;Genes;Genetic;Genome;Genomic approach;Goals;Human;Hydrophobicity;improved;In Vitro;in vivo;in vivo evaluation;inhibitor;innovation;Investigational Drugs;KRAS2 gene;Lead;Malignant neoplasm of gastrointestinal tract;Malignant Neoplasms;Maximum Tolerated Dose;Modeling;Molecular;Molecular Analysis;Monitor;mouse model;Mus;Mutation;nanomolar;Oncogenic;Oncoproteins;Outcome;overexpression;patient derived xenograft model;Pharmaceutical Chemistry;Pharmaceutical Preparations;pharmacodynamic biomarker;Pharmacodynamics;pharmacologic;Play;pre-clinical;preclinical safety;prevent;programs;Property;Recurrence;Reproduction spores;research clinical testing;Resources;response;Role;Safety;safety assessment;Scaffolding Protein;Series;Site;small molecule;structural biology;Structure;Surface;Time;tool;Toxicokinetics;transcription factor;translational goal;tumor;Tumor Promotion;tumorigenic;Variant

PROJECT_TITLE: Project 3: Targeting MYC in CRC


ADMINISTERING_IC: HG

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

NIH_SPENDING_CATS: Clinical Research;Genetics;Human Genome;Infectious Diseases

ORG_CITY: BALTIMORE

ORG_DEPT: MISCELLANEOUS

ORG_NAME: JOHNS HOPKINS UNIVERSITY

PHR: The proposed R25 Research Education Program is devoted to building a 15-month research mentorship program at the Johns Hopkins Berman Institute of Bioethics (BI) for students from diverse, underrepresented groups and backgrounds, to help diversify the pool of ELSI researchers and thus enrich scholarship in genomics and society studies. Trainees will learn research skills, build networks, and gain exposure to the range of possible training and career options in ELSI research. Student trainees will contribute to genomics and society research that 1) examines the ethical, legal, social, historical and policy issues confronting the application of genomics to the prevention, outbreak control, and treatment of infectious diseases, which pose an enormous health burden in the U.S. and globally; and 2) studies the impact of genetic testing for hereditary disease on at-risk families, to help understand and improve how genetic risk information is communicated with families and within them.

PI_NAMEs: MATHEWS, DEBRA JH (contact)

PROGRAM_OFFICER_NAME: STERLING, RENE

PROJECT_TERMS: Area;Baltimore;Bioethics;career;cohort;Communicable Diseases;Communication;Communities;County;Development;Education Projects;education research;ethical, legal, and social implication;Event;experience;Exposure to;Faculty;faculty research;Family;Funding;Future;Genetic Risk;genetic testing;Genomics;Goals;Health;Hereditary Disease;Home;Housing;improved;Individual;infectious disease treatment;Infrastructure;Institution;interest;Learning;Maryland;Mentors;Mentorship;Methods;outbreak control;outreach;Policies;Population;Prevention;programs;Recording of previous events;recruit;Research;Research Personnel;Risk;Scholarship;Science;skill acquisition;skills;Societies;Structure;Student recruitment;Students;summer internship;summer program;Time;Training;Travel;undergraduate research experience;undergraduate student;Underrepresented Populations;Universities

PROJECT_TITLE: Enhancing Diversity among Future ELSI Researchers


NIH_SPENDING_CATS: Biotechnology;Cancer

ORG_CITY: ALBANY

PROJECT_TERMS: Area;assay development;Award;Biological Products;Businesses;Communities;Contractor;Contracts;Development;Development Plans;Documentation;Evaluation;Extramural Activities;Future;Goals;Malignant Neoplasms;manufacture;meetings;Mission;pre-clinical;preclinical development;Preclinical Drug Development;Preventive;Principal Investigator;Procedures;Process;product development;Program Development;programs;Reporting;Research;Research Peer Review;Research Support;Resources;Schedule;Services;Structure;virtual

PROJECT_TITLE: Contract Orientation & Kickoff Meeting for PREVENT Cancer Preclinical Drug Development Program: CGMP Pool


ADMINISTERING_IC: DK

IC_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

PI_NAMEs: KRAUSE, MICHAEL  (contact)

PROJECT_TERMS: Anatomy;Anterior;Biological Models;Blast Cell;Caenorhabditis elegans;Cell Fate Control;cell fate specification;cell type;Cells;Collaborations;Development;Developmental Gene;Ethers;Event;Fertility;forward genetics;Gene Expression;Gene Expression Regulation;Genes;Genetic;genetic approach;Genetic Transcription;Human;Human Development;interest;Knowledge;Laboratories;Logic;loss of function;male fertility;mating behavior;Mediating;Mesoderm Cell;Muscle;mutant;Mutation;Nematoda;O-GlcNAc transferase;Phenotype;Post-Translational Protein Processing;Postembryonic;Proliferating;Regulation;Resolution;reverse genetics;RNA Interference;Role;Sorting;Specific qualifier value;Subcutaneous Tissue;System;Systems Development;Tissues;tool;transcription factor;Transcriptional Regulation;transgene expression;United States National Institutes of Health

PROJECT_TITLE: Developmental Gene Expression In C elegans


ADMINISTERING_IC: NR

IC_NAME: NATIONAL INSTITUTE OF NURSING RESEARCH

NIH_SPENDING_CATS: Aging;Basic Behavioral and Social Science;Behavioral and Social Science;Bioengineering;Biomedical Imaging;Cancer;Chronic Pain;Complementary and Integrative Health;Data Science;Networking and Information Technology R&D (NITRD);Neurosciences;Nutrition;Pain Research;Physical Activity;Prevention;Rehabilitation

ORG_NAME: NATIONAL INSTITUTE OF NURSING RESEARCH

PI_NAMEs: ZENK, SHANNON  (contact)

PROJECT_TERMS: 3-Dimensional;Age;Apple;Articulation;Attention;Behavior;behavior measurement;Biological;Brain;Brain imaging;Cancer Survivor;cancer therapy;Care given by nurses;Chronic;Clinical;Clinical Data;Clinical Research;Cognition;Cognitive;Communities;Complex;Computer software;Consent Forms;Custom;cytokine;Data;Data Science;design;Development;Devices;dietary;dietary restriction;digital;Disease;electronic data;Engineering;Environment;experience;Fatigue;Fatty acid glycerol esters;Feasibility Studies;Food;Functional Magnetic Resonance Imaging;Future;Genes;Goals;Head;Home;Home Care Services;Human;Individual;informant;insight;instrumental activity of daily living;interest;International;Journals;Laboratories;lectures;Managed Care;Manuscripts;Medical;Medical Informatics;Medication Management;Modification;Motion;Music;Noise;Nutrition Labeling;Pain;Paper;Patients;Persons;Physical activity;Physiological;Population;Postbaccalaureate;posters;Potassium;programs;Protocols documentation;Publications;Reporting;Research;Research Personnel;Research Project Grants;response;Retirement;Sampling;Science;Scientist;Self Care;Self Management;Series;Slide;Sodium;Sodium-Restricted Diet;sound;square foot;Technology;technology platform;usability;User-Computer Interface;virtual;virtual environment;virtual reality;virtual reality environment;Visualization;Work

PROJECT_TITLE: Advanced Visualization Branch


NIH_SPENDING_CATS: Bioengineering;Biotechnology

ORG_NAME: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES

PI_NAMEs: ANDERSON, DAVID  (contact)

PROJECT_TERMS: Adopted;Annual Reports;Area;Back;base;Biological;Biopolymers;Calibration;Capital;Chromatography;Communities;Complex;Core Facility;cost;Cost Effectiveness Analysis;crosslink;dalton;Data;Data Analyses;Economics;Elements;Equipment;experience;experimental study;Extramural Activities;Federal Government;Gatekeeping;hazard;high risk;Hybrids;improved;instrument;instrumentation;Isotopes;Label;Ligation;Liquid substance;Liver diseases;macromolecule;mass spectrometer;Mass Spectrum Analysis;Measurement;Measures;member;method development;Methodology;Methods;Modernization;Molecular;Molecular Structure;Molecular Weight;Morals;National Institute of Diabetes and Digestive and Kidney Diseases;National Institute of Drug Abuse;Natural Products;novel strategies;Outsourcing;Peptide Fragments;Performance;Philosophy;Play;Probability;Problem Solving;protein complex;Proteins;Proteomics;Research;Research Project Grants;Resolution;Resources;Rice;Role;Running;Sampling;Science;shift work;small molecule;Software Tools;Structure;Synthesis Chemistry;System;Techniques;Time;tool;Update;Work

PROJECT_TITLE: Advanced Mass Spectrometry Facility


NIH_SPENDING_CATS: Behavioral and Social Science;Cancer;Networking and Information Technology R&D (NITRD);Prevention;Primary Health Care;Social Determinants of Health

PROJECT_TERMS: Admission activity;Applications Grants;Appointment;Area;Autoimmune Diseases;Awareness;Basic Science;Big Data;Brain-Derived Neurotrophic Factor;Breast Cancer survivor;Cancer Survivor;Cells;certificate program;Clinical;clinical application;Clinical Data;Clinical Investigator;Clinical Protocols;Clinical Research;Clustered Regularly Interspaced Short Palindromic Repeats;cognitive function;Communities;community engagement;Community Health;community intervention;Coupling;Credentialing;Cross-Sectional Studies;Data Analytics;Data Collection;data management;Development;Devices;Discipline of Nursing;Disease;Electroporation;Ensure;Environment;Equipment;Event;Fatigue;Feasibility Studies;Generations;Genes;Genetic Polymorphism;genetic variant;Goals;grasp;Hand;Health;health data;health equity;Incentives;Intramural Research;Laboratories;laboratory equipment;Maintenance;Malignant Neoplasms;Manuscripts;Methods;microbiome;Mission;Myoblasts;nasal swab;Nursing Research;Nursing Students;operation;Paper;Pathogen detection;patient engagement;Patients;Peer Review;Pilot Projects;Policies;population health;Postdoctoral Fellow;Prevention;Primary Care;Protocols documentation;Public Health Informatics;Publications;quality assurance;recruit;Research;Research Activity;Research Personnel;Research Support;Safety;sample collection;Sampling;Science;Scientist;Services;Sinusitis;Site;social health determinants;Strategic Planning;Supervision;Symptoms;Technology;tenure track;Testing;Therapeutic;Training;Travel;undergraduate student;Universities;Work

PROJECT_TITLE: Optimizing health for all


ORG_CITY: SAINT LOUIS

ORG_NAME: WASHINGTON UNIVERSITY

ORG_STATE: MO

PROJECT_TITLE: Functional B-cell Epitope Discovery for Arthropod-Borne Diseases


ORG_CITY: PHILADELPHIA

ORG_NAME: INTEGRAL MOLECULAR

ORG_STATE: PA

PROJECT_TITLE: B cell Epitope Discovery and Mechanisms of Antibody Protection for Enterovirus and Bunyavirus Entry Proteins


NIH_SPENDING_CATS: Clinical Research;Stem Cell Research;Stem Cell Research - Embryonic - Human

PROJECT_TITLE: Genetic and Structural Basis for Virus Neutralization of Paramyxoviruses


NIH_SPENDING_CATS: Coronaviruses;Coronaviruses Vaccines;Emerging Infectious Diseases;Immunization;Infectious Diseases;Prevention;Vaccine Related

ORG_CITY: STANFORD

ORG_NAME: STANFORD UNIVERSITY

ORG_STATE: CA

PI_NAMEs: PULENDRAN, BALI  (contact)

PROJECT_TERMS: adaptive immune response;Adjuvant;Antigens;clinically relevant;COVID-19 vaccine;Data Analyses;data management;Fingerprint;Goals;Human;Immune;Immunologics;Innate Immune Response;Mus;Organoids;programs;Side;Tissues;Tonsil;Vaccines;Work

PROJECT_TITLE: Adjuvant Comparison and Characterization


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Lung;Orphan Drug;Pneumonia and Influenza;Prevention;Rare Diseases;Tuberculosis;Tuberculosis Vaccine;Vaccine Related

ORG_CITY: MISSOULA

ORG_NAME: UNIVERSITY OF MONTANA

ORG_STATE: MT

PI_NAMEs: EVANS, JAY  (contact)

PROJECT_TERMS: Adjuvant;aptamer;Contractor;Development;Disease;Formulation;immunogenicity;Infection;influenza virus vaccine;Interleukin-1 Receptors;Libraries;Pharmaceutical Chemistry;Recombinant Vaccines;Side;small molecule;synthetic peptide;Testing;Tuberculosis Vaccines;Vaccine Adjuvant;vaccine evaluation;Vaccines

PROJECT_TITLE: Development of an Optimized Adjuvanted TB Vaccine


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

ORG_CITY: SYDNEY

ORG_COUNTRY: AUSTRALIA

ORG_FIPS: AS

ORG_NAME: UNIVERSITY OF SYDNEY

PI_NAMEs: BRITTON, WARWICK  (contact)

PROJECT_TERMS: Adjuvant;Aerosols;Animals;Antigens;Cause of Death;Cells;clinical candidate;clinical development;Development;Disease;Dose;Evaluation;Formulation;Goals;HIV;Human;Immune;Immunity;Immunologics;In Vitro;Inbred Mouse;Infectious Agent;Macaca mulatta;Modeling;mouse model;Mus;Mycobacterium tuberculosis;Mycobacterium tuberculosis antigens;nonhuman primate;novel;Persons;Preventive;programs;Research;Research Personnel;Risk;Side;Treatment outcome;Tuberculosis;tuberculosis treatment;Tuberculosis Vaccines;Vaccine Adjuvant;Vaccines;Work

PROJECT_TITLE: Advancing Vaccine adjuvant Research for Tuberculosis (TB)


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Coronaviruses;Coronaviruses Therapeutics and Interventions;Emerging Infectious Diseases;Infectious Diseases;Orphan Drug;Rare Diseases

ORG_CITY: DOYLESTOWN

ORG_NAME: BARUCH S. BLUMBERG INSTITUTE

PI_NAMEs: CHANG, JINHONG  (contact)

PROJECT_TERMS: Advanced Development;antiviral drug development;candidate selection;Chemistry;Clinical assessments;combat;Coronavirus;efficacy evaluation;emerging virus;lead optimization;manufacture;pandemic disease;pathogenic virus;pre-clinical;product development;programs;research and development;Research Support;safety assessment;Therapeutic;therapeutic candidate;therapeutic development;Viral;Virus Diseases;Yellow Fever

PROJECT_TITLE: Development of an Antiviral to Combat Viral Infections


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: MENLO PARK

ORG_NAME: CLEAR LABS, INC.

PI_NAMEs: KHAKSAR, RAMIN  (contact)

PROJECT_TERMS: antimicrobial resistant infection;Area;Bacterial Antibiotic Resistance;biodefense;biothreat;Blood;Detection;Development;diagnostic development;diagnostic technologies;Emerging Communicable Diseases;Gram-Negative Bacteria;Gram-Positive Bacteria;improved;in-vitro diagnostics;Infection;Methods;microbial;Nucleic acid sequencing;pathogen;Performance;Proteins;Toxin

PROJECT_TITLE: Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Clinical Research;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: NISKAYUNA

ORG_NAME: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC

PI_NAMEs: LENIGK, RALF  (contact)

PROJECT_TITLE: Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections(AMR), and Emerging Infectious Diseases


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

ORG_CITY: LONG BEACH

ORG_NAME: ANIVIVE LIFESCIENCES, INC

PI_NAMEs: BRUYETTE, DAVID  (contact)

PROJECT_TERMS: Advanced Development;Animal Model;biodefense;Clinical;Coccidioides posadasii;Communicable Diseases;Contracts;Disease Outbreaks;efficacy evaluation;efficacy testing;Emerging Communicable Diseases;Formulation;immunogenicity;Individual;manufacture;response;Safety;stability testing;Toxicology;vaccine candidate;vaccine development;Vaccines

PROJECT_TITLE: Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_CITY: Rockville

ORG_NAME: DIGITAL INFUZION, INC.

PI_NAMEs: BOUR, STEPHAN  (contact)

PROJECT_TERMS: Animals;Basic Science;Cohort Studies;cross immunity;Development;Disease Outcome;Environmental Risk Factor;Evolution;Human;Immune;Immune response;Immunologic Factors;improved;Influenza;influenza infection;Influenza vaccination;influenzavirus;Molecular;National Institute of Allergy and Infectious Disease;Pathogenicity;Research;response;Sampling;transmission process;Vaccination

PROJECT_TITLE: NIAID Centers of Excellence for Influenza Research and Response


PROJECT_TERMS: Animals;Basic Science;Cohort Studies;cross immunity;Development;Disease Outcome;Environmental Risk Factor;Evolution;Human;Immune;Immune response;Immunologic Factors;improved;Influenza;influenza infection;Influenza vaccination;influenzavirus;Molecular;National Institute of Allergy and Infectious Disease;Pathogenicity;Research;Research Activity;response;Sampling;transmission process;universal influenza vaccine;Vaccination

PROJECT_TITLE: NIAID Centers of Excellence for Influenza Research and Response: Universal Influenza Vaccine Research Activities


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Emerging Infectious Diseases;Immunization;Infectious Diseases;Influenza;Pneumonia and Influenza;Prevention;Vaccine Related

ORG_CITY: ATLANTA

ORG_NAME: EMORY UNIVERSITY

PI_NAMEs: LOWEN, ANICE  (contact)


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Alcoholism, Alcohol Use and Health;Behavioral and Social Science;Mental Health;Neurosciences;Pediatric;Prevention;Social Determinants of Health;Substance Misuse

ORG_CITY: ROCKVILLE

ORG_NAME: IQ SOLUTIONS, INC.

PI_NAMEs: QUINTAS, ILEANA  (contact)

PROJECT_TERMS: Adolescence;Adolescent;Adolescent Development;adverse outcome;Affect;Age;Alcohols;Behavioral;Biological;Biological Factors;Biology;Birth;Blood;Brain;Brain imaging;Caffeine;Cannabis;Child;Child Development;Child Health;Childhood;Cognitive;cognitive development;cognitive function;cohort;Country;Data Analyses;Development;early childhood;Emotional;emotional functioning;Enrollment;Environmental Risk Factor;experience;Exposure to;Family;Funding;Genetic;Goals;Growth;healing;Health;Health Professional;Health Promotion;Individual;Infant;Informatics;Injury;Knowledge;Longitudinal Studies;Marijuana;Measures;Medical;Medical History;Mental disorders;Neurosciences;Nicotine;Opioid;Outcome;Participant;perinatal period;Personal Satisfaction;Physical activity;Policy Maker;postnatal;Pregnancy;pregnant;prenatal;promote resilience;Recording of previous events;recruit;Research;research and development;Research Personnel;Research Support;resilience factor;Resources;Role;Sampling;Schools;Scientist;Services;Severities;Site;Sleep;sleep pattern;Smoking;social;social factors;Social Functioning;social media;Sports;stressor;substance use;success;teacher;Technology;Tobacco;Trauma;tv watching;Twin Multiple Birth;United States;United States National Institutes of Health;Urine;Video Games;young adult;Youth

PROJECT_TITLE: RESEARCH SUPPORT SERVICES FOR THE ADOLESCENT BRAIN COGNITIVE DEVELOPENT (ABCD) STUDY AND HEALTHY BRAIN & CHILD DEVELOPMENT (HBCD) STUDY


NIH_SPENDING_CATS: Biotechnology;Maternal Health;Pediatric;Women's Health Research

ORG_CITY: DURHAM

ORG_NAME: DUKE UNIVERSITY

ORG_STATE: NC

PI_NAMEs: BENJAMIN, DANIEL  (contact)

PROJECT_TERMS: Address;Adolescent;Area;artificial intelligence method;assay development;Basic Science;Best Pharmaceuticals for Children Act;Biological Products;Child;Childhood;Clinical;clinical infrastructure;Clinical Research;Clinical Trials;Clinical Trials Network;Collaborations;Community Healthcare;Conduct Clinical Trials;Contracts;Data Science;Devices;Disease;drug development;Ecosystem;Exposure to;flexibility;Funding;Genomics;Human Development;improved;infancy;Infant;Infrastructure;International;knowledge base;Label;Laboratories;Lactation;Lead;Learning;Maternal Health;Medical Device;Mentorship;Methods;Mission;Modeling;multiple omics;National Institute of Child Health and Human Development;novel;Obstetric pharmacology;pediatric pharmacology;Pediatrics;Pharmaceutical Preparations;Pharmacologic Substance;Pharmacology;pharmacometrics;Phenotype;Postpartum Period;Pregnancy;Prevention strategy;Primary Care;programs;regenerative tissue;Reproductive Health;Research;Research Support;Resources;response;Safety;Site;System;Technology;Therapeutic;therapeutic development;Therapeutic Research;Tissue constructs;tool;Training;transition to adulthood;Translational Research;treatment strategy;United States National Institutes of Health;Work

PROJECT_TITLE: NICHD PEDIATRIC AND MATERNAL RESOURCE CENTER: BRIDGING PHARMACOLOGY AND THE REAL WORLD - BPCA PTN


NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Contraception/Reproduction;Estrogen;Prevention;Women's Health Research

ORG_CITY: MORRISVILLE

ORG_NAME: HEALTH DECISIONS, INC.

PI_NAMEs: DART, CLINT  (contact)

PROJECT_TERMS: Affinity;Androgen Receptor;androgenic;Androgens;Binding;cis-male;Clinical;Clinical Research;Clinical Trials;Clinical Trials Design;Clinical Trials Network;Contraceptive Agents;contraceptive efficacy;Contraceptive methods;Contractor;Contracts;Data;Data Analyses;Data Collection;data exchange;Databases;Development;Evaluation;Food and Drug Administration Drug Approval;Gonadotropins;Good Clinical Practice;Guidelines;Hypothalamic structure;Impairment;Levonorgestrel;meetings;men;Mission;Monitor;Multi-Institutional Clinical Trial;Nandrolone;National Clinical Trials Network;National Institute of Child Health and Human Development;New Drug Approvals;novel;Ovarian;Pharmaceutical Preparations;Phase;Pituitary Gland;Population;Population Heterogeneity;preclinical development;Preparation;Product Approvals;Production;Progesterone Receptors;Program Development;Protocols documentation;Qualifying;Regulation;Reporting;research clinical testing;Research Personnel;Safety;Services;Site;Specific qualifier value;sperm cell;volunteer;Woman;Work

PROJECT_TITLE: PROTOCOL FINALIZATION, START-UP, COORDINATION, MONITORING, AND ALL OTHER ASSOCIATED ACTIVITIES FOR CLINICAL TRIALS EVALUATING PROGESTOGENIC ANDROGENS AS CONTRACEPTIVE AGENTS


ORG_CITY: NEW YORK

ORG_NAME: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI

PI_NAMEs: GARCIA-SASTRE, ADOLFO  (contact)


FUNDING_MECHANISM: SBIR/STTR CONTRACTS

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Cancer Genomics;Data Science;Genetics;Human Genome;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD)

ORG_CITY: WASHINGTON

ORG_NAME: OMICSCRAFT, LLC

ORG_STATE: DC

PI_NAMEs: RESSOM, TOM  (contact)

PROJECT_TERMS: Address;Algorithmic Analysis;anti-cancer research;Clinical;cloud based;Complex;computational pipelines;computer framework;Computing Methodologies;Data;Data Analyses;Data Analytics;Data Commons;deep learning;Development;Event;Image;Imaging technology;innovation;Medical Imaging;Methods;Molecular;multimodal data;Multiomic Data;multiple omics;novel;Outcome;Performance;Phenotype;Proteomics;prototype;Research Personnel;Resources;Techniques;Testing;The Cancer Genome Atlas;The Cancer Imaging Archive;tool;tumor

PROJECT_TITLE: ISYSMET: AI-POWERED PLATFORM FOR INTEGRATIVE ANALYSIS OFMULTIMODAL DATA


ED_INST_TYPE: HOSPITALS

ORG_CITY: HOUSTON

ORG_DEPT: PHARMACOLOGY

ORG_NAME: UNIVERSITY OF TX MD ANDERSON CAN CTR

PHR: NARRATIVE Mutant KRAS is frequent driver of lung, pancreatic and colorectal cancers. Our research will establish a novel therapeutic strategy to target the proteostasis reprogramming in KRAS-mutant cancers and improve patient response to KRAS inhibitor.

PI_NAMEs: CHEN, XI  (contact)

PROGRAM_OFFICER_NAME: XU, WANPING

PROJECT_TITLE: Proteostasis Reprogramming in Mutant KRAS-Driven Cancers