NIH_SPENDING_CATS: Cancer;Digestive Diseases;Nutrition;Orphan Drug;Pancreatic Cancer;Rare Diseases

PHR: Gabriella Chatman & Dr. Kacper Rogala NCI Diversity Supplement | Project Narrative | March 31, 2024 Aggressive tumors acquire the ability to scavenge and eat nutrients from their environment, which allows them to face starvation and survive even the harshest chemotherapy treatments. The Rogala Lab at Stanford is working on establishing protein transporter SLC38A9 as a potential therapeutic target against aggressive pancreatic cancers. The goal of this supplement is to explore whether pharmacological inhibition of SLC38A9 can also work for other cancer types that exhibit nutrient-eating habits similar to those initially discovered in pancreas cancer.

PI_NAMEs: ROGALA, KACPER  (contact)

PROGRAM_OFFICER_NAME: COUCH, JENNIFER A

PROJECT_TERMS: Amino Acids;anti-cancer;Autophagocytosis;Back;cancer cell;cancer type;career;Carrier Proteins;cell growth;Cells;chemotherapy;Cytotoxic Chemotherapy;Diet;Diet Habits;Eating;Environment;Exhibits;expectation;Extracellular Protein;Face;Future;Genetic;Goals;Growth;Impairment;insight;Knock-out;Lysosomes;Malignant neoplasm of pancreas;Malignant Neoplasms;Metabolic;Mutation;Normal Cell;novel therapeutics;Nutrient;pancreatic cancer cells;parent grant;pharmacologic;Postbaccalaureate;programs;Proteins;recruit;Recycling;Research;Starvation;Students;Testing;therapeutic target;Training;tumor;tumor growth;WNT Signaling Pathway;Work

PROJECT_TITLE: Mechanistic insights into lysosomal nutrient efflux in cancer

STUDY_SECTION: NCI

STUDY_SECTION_NAME: Transition to Independence Study Section (I)[NCI-I]


ADMINISTERING_IC: FD

ARRA_FUNDED: N

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: FOOD AND DRUG ADMINISTRATION

ORG_CITY: WILMINGTON

ORG_COUNTRY: UNITED STATES

ORG_FIPS: US

ORG_NAME: EN SOLUCION, INC.

ORG_STATE: DE

PHR: Project Narrative. Irrigation with untreated surface water has been repeatedly identified as a cause of foodborne illness outbreaks linked to fresh produce. In response, the FDA has proposed revisions to the Food Safety Modernization Act (FSMA) Produce Safety Rule to address the heightened risk. En Solución proposes to innovative beyond existing irrigation water treatment methods to provide a cost-effective, easily implemented, chemical and residual free irrigation water treatment system that utilizes ozone nanobubbles to neutralize pathogens and provide a much needed enhancement of public health outcomes for field grown produce safety.

PI_NAMEs: THIELE, DIRK  (contact)

PROJECT_TITLE: Ozone Nanobubble Treatment of Open Water Irrigation Sources for Improved Food Safety and Plant Health

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


ADMINISTERING_IC: AI

ED_INST_TYPE: SCHOOLS OF MEDICINE

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

ORG_CITY: ATLANTA

ORG_DEPT: PATHOLOGY

ORG_NAME: EMORY UNIVERSITY

ORG_STATE: GA

PHR: Memory CD4+ T cells arise from naïve CD4+ T cells after exposure to infectious agents; they are considered to be the most important HIV reservoir. This proposal studies the earliest stages of the HIV reservoir and models this stage ex vivo using a barcoded virus to dissect the important role of a previously ignored reservoir in disguise within naïve CD4+ T cells.

PI_NAMEs: O'DOHERTY, UNA T (contact)

PROGRAM_OFFICER_NAME: LAWRENCE, DIANE M

PROJECT_TERMS: Acute;Antigens;Bar Codes;CD4 Positive T Lymphocytes;CD8B1 gene;Cells;Cessation of life;Chronic;Clonality;Coculture Techniques;cohort;Cohort Analysis;Data;design;Early treatment;Exons;experience;experimental study;Exposure to;Failure;Frequencies;Future;Goals;Half-Life;HIV;immune clearance;in vivo;Individual;Infection;Infectious Agent;Inflammatory;innovation;insight;integration site;Link;Maintenance;mathematical model;Measurement;Measures;Memory;memory CD4 T lymphocyte;Methods;Modeling;novel;novel strategies;pharmacologic;Phenotype;Play;Population;Positioning Attribute;Pre-Clinical Model;Preclinical Testing;Proliferating;Property;Provirus Integration;Proviruses;Resistance;response;Role;Sample Size;Sampling;System;T memory cell;T-Lymphocyte;T-Lymphocyte Subsets;Testing;time use;Tropism;Viral;Virus;Work

PROJECT_TITLE: The barcode project: a strategy to track the early naïve reservoir

STUDY_SECTION: HVCD

STUDY_SECTION_NAME: HIV Molecular Virology, Cell Biology, and Drug Development Study Section[HVCD]


PHR: HIV previously research than investigate participants,  infection can hide in resting T cells, which come in two types: memory and naïve. It was thought that the HIV levels in naïve cells were so small as to be unimportant, but our has shown that the HIV-infected naïve T cell pool is much larger, and more significant,  previously thought, and represents a critical barrier to an HIV cure. This project will the size and characteristics of the pool of HIV-infected naïve T cells in HIV-infected and investigate the properties of naïve T cells that allow them to become infected.

PI_NAMEs: LEVY, DAVID N;O'DOHERTY, UNA T (contact)

PROGRAM_OFFICER_NAME: SHANKAR, UDAY K

PROJECT_TERMS: Antibodies;Attention;Bar Codes;Bioinformatics;Biology;Blood;Blood Cells;CCR5 gene;CD4 Positive T Lymphocytes;cell type;Cells;Characteristics;Chronic;Clonal Expansion;cohort;Data;data curation;design;Disease Progression;Dissection;DNA;Doctor of Philosophy;Event;experimental study;Heterogeneity;HIV;HIV Infections;Immune;In Vitro;in vivo;Infection;insight;integration site;Laboratories;life span;Light;Longevity;lymph nodes;Lymphoid;Lymphoid Tissue;Maintenance;mathematical model;Mature T-Lymphocyte;Memory;Methods;Monitor;multiple omics;Nature;Participant;Pattern;peripheral blood;Peripheral Blood Mononuclear Cell;Phenotype;Play;Predisposition;pressure;prognostic indicator;Property;Provirus Integration;Proviruses;receptor;Research;Resistance;Rest;Role;Signal Pathway;Signal Transduction;single-cell RNA sequencing;Sorting;Stains;Statistical Data Interpretation;Statistical Models;stem;T cell differentiation;T memory cell;T-Lymphocyte;T-Lymphocyte Subsets;Techniques;Testing;Tonsil;transcriptome sequencing;Tropism;Up-Regulation;Viral;Viremia;Virus;Virus Diseases;Work

PROJECT_TITLE: Probing the unique attributes of the naïve reservoir

STUDY_SECTION: HIVD

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


ADMINISTERING_IC: HL

FUNDING_MECHANISM: NON SBIR/STTR CONTRACTS

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

ORG_CITY: BOSTON

ORG_NAME: BOSTON UNIVERSITY MEDICAL CAMPUS

ORG_STATE: MA

PI_NAMEs: RAMACHANDRAN, VASAN  (contact)

PROJECT_TERMS: Aging;Ancillary Study;base;Biological Specimen Banks;Clinical;clinical examination;clinical predictors;Communities;Data;data repository;Disease;Disease Progression;Event;follow-up;Framingham Heart Study;Functional disorder;Goals;health determinants;Heart Diseases;Hematological Disease;Knowledge;Lung Diseases;Participant;progression risk;Research Personnel;Resources;Risk Factors;Sleep Disorders

PROJECT_TITLE: FRAMINGHAM HEART STUDY TASK ORDER 1 - BASE PERIOD


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Rare Diseases

ORG_CITY: GALVESTON

ORG_NAME: UNIVERSITY OF TEXAS MED BR GALVESTON

ORG_STATE: TX

PI_NAMEs: BEASLEY, DAVID  (contact)

PROJECT_TERMS: Contracts;Development;Evaluation;Filovirus;infectious disease model;Rodent Model;therapeutic development;therapeutic evaluation

PROJECT_TITLE: Task A66: Rodent Models for Testing Therapeutics Against Filoviruses


NIH_SPENDING_CATS: Biodefense and Related Countermeasures;Clinical Research;Clinical Trials and Supportive Activities;Coronaviruses;Coronaviruses Therapeutics and Interventions;Emerging Infectious Diseases;Infectious Diseases

ORG_CITY: SOUTH SAN FRANCISCO

ORG_NAME: ALIGOS THERAPEUTICS, INC.

ORG_STATE: CA

PI_NAMEs: WANG, STANLEY  (contact)

PROJECT_TERMS: Advanced Development;candidate selection;Chemistry;Clinical assessments;clinical development;Clinical Trials;COVID-19 therapeutics;efficacy evaluation;Evaluation;Hepatic;Impairment;Kidney;lead optimization;manufacture;pandemic disease;Patients;Phase I Clinical Trials;pre-clinical;product development;programs;research and development;Research Support;safety assessment;Therapeutic;therapeutic candidate;therapeutic development;Viral;Virus

PROJECT_TITLE: Clinical Development of COVID-19 Therapeutics


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.

ORG_STATE: MD

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

PROJECT_TERMS: 2019-nCoV;Animals;Basic Science;Cohort Studies;computerized data processing;Coronavirus;cross immunity;data communication;Disease Outcome;Environmental Risk Factor;Evolution;Human;Immune;Immune response;Immunologic Factors;improved;Infection;Molecular;Pathogenicity;respiratory virus;response;Sampling;transmission process;Vaccination;vaccine development;Vaccine Research;Virus

PROJECT_TITLE: CEIRR Data Processing and Communications Center Activities for SARS-CoV-2


ADMINISTERING_IC: MH

ED_INST_TYPE: SCHOOL OF MEDICINE & DENTISTRY

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Mental Illness;Prevention;Social Determinants of Health;Suicide;Suicide Prevention

ORG_CITY: ROCHESTER

ORG_DEPT: PSYCHIATRY

ORG_NAME: UNIVERSITY OF ROCHESTER

ORG_STATE: NY

PHR: PROJECT NARRATIVE Suicide rates among U.S. Hispanics have increased by approximately 20% since 2000 and the Hispanic population is expected to double in the coming decades, indicating that suicide among Hispanics is an issue of pressing public health concern. However, empirical data indicating how to prevent suicide among this population, especially for Spanish-speaking adults in the U.S., are notably lacking. This proposal forms the basis of a program of research focused on suicide prevention for geographically and linguistically isolated Hispanics, with a particular emphasis on the role of cultural-social engagement in the prevention of suicide among this population.

PI_NAMEs: SILVA, CAROLINE  (contact)

PROGRAM_OFFICER_NAME: SWEENEY, MARY MARGARET

PROJECT_TERMS: Adult;Aftercare;Behavior Therapy;career development;Cellular Phone;Clinical;Clinical Trials;Coupled;Data;Development;Ethics;Expectancy;Feedback;Feeling suicidal;follow-up;Funding;Geography;Goals;health determinants;Hispanic;Hispanic Populations;human centered design;ideation;Intervention;Interview;Investigational Therapies;Linguistics;Measures;Mentors;Methodology;novel;Outcome;Participant;Population;Prevention Research;preventive intervention;programs;Public Health;Randomized;randomized, clinical trials;rapid growth;Reporting;Research;Research Project Grants;research study;Risk;Role;skill acquisition;social culture;social engagement;Spanish;Structure;suicidal risk;Suicide;Suicide prevention;suicide rate;Technology;Testing;Time;Training;Treatment Protocols;United States;usability

PROJECT_TITLE: Cultural-Social Engagement and Suicideamong Hispanics

STUDY_SECTION: SERV

STUDY_SECTION_NAME: Mental Health Services Study Section[SERV]


ADMINISTERING_IC: CA

ED_INST_TYPE: UNIVERSITY-WIDE

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: NATIONAL CANCER INSTITUTE

ORG_CITY: MANGILAO

ORG_NAME: UNIVERSITY OF GUAM

ORG_STATE: GU

PHR: PROPOSAL TITLE: Establishing UOG Data Science Center. INVESTIGATORS: Rachael Leon Guerrero (PI), Yvette Paulino (PI), Grazyna Badowski (Co-I), Leslie Aquino (Co-I) Project type: Administrative Supplements to Enhance Institutional Data Science Capacity. NOT-OD-23-123 Specific Aims  This supplement application addresses the need to better prepare researchers in Guam and Micronesia, particularly in data science, so they can pursue careers in cancer health disparities and other biomedical fields. Pacific Islanders are extremely underrepresented in the nation’s biomedical workforce, both on the faculty of universities and research institutions as well as in hospitals and public health departments. The limited number of Pacific Islanders with graduate degrees continues to impede progress in research and prevention of cancer health disparities. The Pacific Island Partnership for Cancer Health Equity (PIPCHE) is the National Cancer Institute’s only U54 partnership that advances cancer health equity in Pacific Islands Populations (PIP). PIPCHE’s overarching goal is to promote cancer health equity and mitigate the impact of cancer on PIP through increasing cancer research leadership and capacity in Hawai‘i, Guam and the USAPI. The University of Guam (UOG) is the minority-serving institution (MSI) within PIPCHE and is a USDA land- grant institution whose student population is 90% Asian Pacific Islander, of whom 51% are native Pacific Islanders. UOG is uniquely situated to recruit and inspire future professionals from these Pacific Islander groups as well as conduct research with the diverse communities living in Guam and other Micronesian islands.  The current goal of PIPCHE’s Research Education Core (REC) is to train graduate students committed to addressing health disparities in Pacific indigenous populations. Despite the success of the PIPCHE-REC in training PIP students to pursue and complete graduate degrees, there remains a dearth of researchers competent in data science in Guam. Additionally, UOG has limited faculty with expertise in math, statistics, and data science, all burdened with full teaching schedules. Furthermore, UOG graduate students funded by PIPCHE-REC extensively utilized PIPCHE's Biostatistics Shared Resource (BSR) for thesis project data analysis due to their limited experience in statistics and data science. A new graduate program in Data Science has been developed at UOG, which would equip students with the technical skills to collect, manage, analyze, and interpret data, and will also be proficient in programming languages such as R and Python, and statistical analysis tools such as SAS and SPSS. The anticipated start of the program is Fall 2024.  The proposed supplement seeks to support the establishment of a Data Science Center at the UOG, designed to complement the MS in Data Science program and bolster the region's data science capabilities. Integral to this program is the mandatory capstone course entitled "Statistical Research and Consulting." Within this course, students will undertake internships at the Data Science Center, engaging in collaborative projects with UOG researchers or partnering with government agencies. The Center will serve as a hub for additional support, offering students enhanced opportunities to gain valuable research skills and practical experience.  As part of this initiative, we aim to enhance UOG's data science capabilities by upgrading our infrastructure with high-performance workstations and developing a comprehensive cancer database. We intend to investigate the feasibility of linking the Guam Cancer Registry (GCR) with data from Guam's Medicare, Medicaid, and Medically Indigent Program (MIP) recipients. This integrated dataset is expected to be a valuable resource for researchers. Furthermore, we plan to forge partnerships with regional community colleges to offer summer data science workshops. Aim 1: Establish the first regional Data Science Center in synergy with the MS in Data Science at UOG. The center will provide research support and advance education in data science in Guam and Micronesia. Aim 2: Establish infrastructure, security protocols and agreements necessary for the data linkage between Guam Cancer Registry and Medicare, Medicaid and MPI. The linkage would improve the completeness of GCR treatment data and will be the source for future studies, for example adherence to treatment and its impact on survival. Aim 3: Build data science education and training partnerships with the Northern Marianas College (NMC) and Palau Community College (PCC). These partnerships will enhance data science knowledge and skills of the researchers and students in NMC and PCC and create the pipeline for the data science path at UOG. We hypothesize that the establishment of the Data Science Center will significantly increase the number of underrepresented students, particularly Pacific Islanders, trained in statistics and data science. Impact: This supplement will greatly enhance the research and data science capacity of UOG, Guam and the greater Micronesian region. Students trained in the proposed program would be equipped with the necessary skills to work as data analysts in both academic, healthcare, and industry settings. RESEARCH STRATEGY Background and Significance  A new graduate program in Data Science has been proposed at UOG with the anticipated start in Fall 2024. This 30-credit, cohort-based graduate program aims to equip students with skills in statistical modeling, machine learning, optimization, and big data analysis, catering to the urgent demand for data science professionals. The program's relevance is highlighted by the critical role of data analytics in public health, especially evident during the COVID-19 pandemic when a UOG math student contributed to analyzing COVID data for public health efforts. This new program addresses the need for experts who can harness data for impactful decisions, signaling a significant advancement in local and regional education and workforce development. The MS in Data Science program at UOG could draw students from various disciplines, including Mathematics, Computer Science, Biology, Chemistry, Health Science, and Psychology. Table 1 details enrollment numbers and degrees granted in these fields at UOG in recent years. Additionally, a preliminary survey was conducted among seniors and recent graduates to gauge interest in the forthcoming Academic year Health Science +Psychology 250 228 215 230 2018 2019 2020 2021 Declared Majors Math+CS+Biology +Chem 406 406 379 332 Number  of Degrees Granted Math+CS+Biology +Chem 60 66 77 62Health Science +Psychology 43 51 40 31 Data Science program. Out of 53 student respondents, 66% expressed high interest in enrolling in the program. Until recently, students from Guam, PIPCHE biostatistics trainees, had to travel to the mainland U.S. to pursue their graduate degrees. While they have been successful, most have not returned to Guam. For instance, Louis Dulana, who earned an MS in Applied Statistics from Loyola University Chicago in 2021, is now a Behavioral Health Research Analyst with the Oregon Health Authority. Dwight Sablan, who earned MS in Data Science at the University of Washington in 2022, works as a computer scientist for the Air Force. Regina- Mae Dominguez, who completed her MS in Data Science at the University of Washington in 2023, works as a Data Analyst at the Institute for Health Metrics & Evaluation in Seattle, WA. The new program, which includes an internship at the Data Science Center, aims to prevent this brain drain by retaining talented students in Guam to pursue their graduate degree.  Current trainees in the PIPCHE Biostatistics program have focused on analyzing Guam Cancer Registry Data (GCR), particularly looking into incidence trends (1) and survival analysis (2). They observed ethnic disparities in cancer incidence and survival rates in Guam. Specifically, CHamoru and Other Micronesians have the lowest 5-year survival rates for lung cancer, at 15.6% and 18.7% respectively. For breast cancer, Other Micronesian women have the lowest 5-year survival rate at 55.9%, with CHamoru women following at 81.1%. However, the analyses are primarily descriptive due to limitations in the GCR data. The GCR is affiliated with both the North American Association of Central Cancer Registries (NAACCR) and the US Pacific Regional Central Cancer Registry and adheres to the stringent data quality standards established by the NAACCR and the NCI SEER programs. The GCR includes comprehensive demographic, tumor, and survival data for all diagnosed cancer cases in Guam (3). However, the data on risk factors (smoking, drinking, BMI) and treatment information are mostly missing. For example, the treatment data for breast cancer cases is incomplete, with missing values ranging between 41% for diagnostic procedures and 58% for radiation therapy. Without the risk factors and treatment data it is impossible to investigate underlying causes for the disparities in cancer outcomes.  In 1991, a collaboration between the National Cancer Institute (NCI) and the Centers for Medicare and Medicaid Services (CMS) enabled the linkage of NCI's Surveillance, Epidemiology, and End Results (SEER) cancer registry data with Medicare's enrollment and claims data, creating the SEER-Medicare database. Due to the significant interest in the cancer research community, the NCI, CMS, and SEER registries agreed that the NCI should oversee the database, ensuring its availability to researchers upon meeting confidentiality requirements. Today, the SEER-Medicare database remains a vital tool for evaluating cancer care and outcomes in the United States (4, 5). The Guam Cancer Registry (GCR) is not linked with Medicare because it is not a part of the SEER registry. According to the 2020 Guam Census, 20.2% of the population lives below the poverty level, 23.2% do not have health insurance, and the median household income is $58,289. Medicaid and Medicare programs are available in Guam, and there is also a locally funded Medically Indigent Program (MIP) designed to pay for medical expenses of low-income families without health insurance. Approximately 24% of Guam’s population was enrolled in Medicaid at the end of 2018. Obtaining Medicare’s enrollment and claims data will enrich the Guam Cancer Registry by incorporating not only treatment information but also social determinants of health which are important factors for understanding cancer treatment outcomes and survival disparities (6, 7). This integrated dataset will serve as a significant resource for researchers and students.  Pacific Islanders, specifically Micronesians, are not only a small ethnic minority but highly underrepresented in STEM the biomedical research community. A survey of PhD degrees awarded in biological sciences in a one-year period in the US showed that not a single Pacific Islander received a PhD (Science, Vol 311, p 378, 2006), a dire problem that we have successfully started to address with PIPCHE. Moreover, a recent report by the National Commission on Asian American and Pacific Islander Research in Education (published by Educational Testing Service (ETS) in 2013), showed that, in contrast to the US average, educational attainment of the younger generation of Pacific Islanders is lower than that of their parents, and that the gap between the US average and Pacific Islanders widens. The UOG is characterized by a very high percentage of minority students (approximately 90%), almost all of whom are CHamorus and other Micronesians. The UOG is the only minority institution in the country where Pacific Islanders constitute the majority of the student body. Yet, there is no established pathway for students from regional community colleges to transition to UOG. Very small number of students from Northern Marianas College (NMC) and Palau Community College (PCC) continue their undergraduate or graduate education at UOG. In Fall 2021, just 9 students from NMC and 5 from PCC enrolled at UOG. PCC offers the Associate of Community and Public Health program, featuring courses like Principles of Epidemiology, which covers epidemiology's foundational principles and their application to disease distribution and determinants in populations. Another course, Epidemiological Surveillance & Public Health Information System, focuses on the basics of epidemiological surveillance for monitoring infectious pathogens. Similarly, the Science, Math, Health & Athletics department at NMC offers courses such as Introductory Statistics, Introduction to Programming, and Database Applications. Students from these programs are well-positioned for data science training and further education at UOG. Significance The establishment of the Data Science Center will create infrastructure for data curation, analysis, and science training, fostering increased collaboration among UOG faculty and students, as well as with their counterparts in the Micronesia region. Research Design and Methods Our proposal builds upon the achievements of the PICPCHE REC, the Biostatistics Cores, and the UOG Division of Mathematics and Computer Science (DMCS), and UOG's long-standing commitment to undergraduate research and student mentoring. Dr. Badowski, co-leader of the PIPCHE Biostatistics Core, has successfully mentored 27 students, supported by PIPCHE or other programs, to notable achievements: one completed a PhD, while 12 obtained MS degrees in Statistics or Data Science. These students presented at 29 research conferences. She also led a Problem Based Learning workshop for students from Japan's Shibaura Institute of Technology. Dr. Aquino, DMCS chair and the first CHamoru woman to earn a PhD in Mathematics, has significantly contributed to undergraduate math research for underrepresented minorities through programs funded by Mathematical Association of America (MAA), NASA-funded Established Program to Stimulate Competitive Research (EPSCoR), and National Science Foundations (NSF). Along with DMCS faculty, she has mentored over 30 students in the summer Research Experience for Undergraduates (REU) programs over the past four years. Additionally, the plan for the Data Science Center aligns with UOG’s strategic plan, “Para Hulo’”—the CHamoru phrase for “Ever Upward.” This plan positions the university as a research institution grounded in island wisdom. Aim 1. Establish the first regional Data Science Center at the University of Guam. The Data Science Center, to be established at UOG, will feature advanced workstations and laptops designed for big data analytics. MS in Data Science students will intern at the Center, collaborating with UOG researchers and/or government health agencies, such as the Guam Department of Public Health and Social Sciences, Guam Behavioral Health, Guam Memorial Hospital Authority, and Bureau of Statics and Planning. Their involvement will include contributing to new research proposals, focusing on statistical methodologies and power calculations, and participating in data analysis for manuscript preparation, with the goal of earning co-authorship on submissions. This Center aims to enhance research skills and offer experiences particularly beneficial for those interested in addressing cancer health disparities in the Pacific, among other data science applications. Our commitment extends to developing a diverse workforce proficient in data science, especially within healthcare contexts. By integrating students into active research projects, we aim to provide substantial hands-on experience and mentorship, nurturing their development into skilled professionals. The aim 1 of our proposal fulfills objective 1 of FOA: “Grow human capital with data science competencies, such as knowledge, skills, abilities, and behaviors.” Evaluation and Sustainability: For our first cohort, starting Fall 2024, we aim for 6-8 students in the program, all expected to complete their internships at the Data Science Center and graduate within 2 years. The next cohort is set to begin in Fall 2026. UOG boasts a diverse research portfolio, supported by grants from various agencies, including the NSF-funded EPSCoR-GECCO grant, the NCI-funded Pacific Island Partnership for Cancer Health Equity (U54-PIPCHE) grant, the NOAA-funded Sea Grant, USDA-funded Land Grant programs and projects, CEDDERS funding, and NASA EPSCoR Research Infrastructure Development funding. We plan to continue seeking these grants to support our graduate data science students. Additionally, some students will have the opportunity to apply for teaching assistantships positions at UOG College of Natural and Applied Sciences. Aim 2. Establish infrastructure, security protocols and agreements necessary for the data linkage between Guam Cancer Registry and Medicare, Medicaid and MPI. In Year 1, with the help of PIPCHE IT Shared Resource Core and UOG Office of Information Technology, we will collaborate with the Guam Cancer Registry and the Guam Department of Public Health and Social Services (DPHSS) to:  • Establish data sharing agreements with DPHSS and Guam Cancer Registry.  • Establish a secure infrastructure for data transfer and storage at UOG. In partnership with UOG's Office  of Information Technology (OIT) and the Micronesian Data Laboratory, we aim to utilize expertise and  best practices to create a secure, on-site data storage system compliant with NIST and NIH data  management policies. This initiative will also enhance our ability to manage healthcare data and offer  computer science internships with OIT, further supporting this project.  • Prepare secure protocol for the data transfer directly from Guam Cancer Registry (GCR) and DPHSS.  As we establish data sharing agreements with GCR and DPHSS, we will establish the protocols and  determine the best methods for secure transfer of data from GCR and DPHSS to UOG based on nature  and format of the data. Given that the database will temporarily store personally identifiable patient information, it's crucial to meet HIPAA standards for data storage and transmission. We will adhere to HIPAA compliance in all our protocols. Our strategy includes hosting the database behind the OIT’s firewall to limit access, monitor all traffic, and encrypt database backups before storage. In Year 2, for the data linkage, we will use 2007-2022 GCR data, which includes a total of 5,728 cases recorded during that period. We will link the individuals documented in the GCR with their corresponding Medicare, Medicaid, and MIP enrollment data using the Link Plus Software, which is available at no cost from the CDC. It uses a deterministic algorithm based on social security number (SSN), name, sex, date of birth, and, if applicable, date of death. We will also use this opportunity to include noncancer controls, a random sample of Medicare, Medicaid, MIP beneficiaries that are not included in GCR data. To protect the identities of the cancer patients and noncancer controls included in this data, personally identifiable information that is used to link the GCR and Medicare data (eg, SSN, names, and full date of birth) will be removed from the integrated database after the linkage is completed. Instead, each beneficiary will be assigned a unique, nonidentifiable number, which will allow the same individual to be tracked across data files and time. This aim of our proposal addresses Objective 2 of FOA: “Develop or expand infrastructure to support data science research, training, and education” by creating the rich cancer data set that researchers can use for creating hypotheses, or as preliminary data source. The integrated GCR-Medicare database will serve as a valuable resource for researchers. It will contain patient demographics (e.g., age, race-ethnicity, sex), comprehensive clinical cancer details (e.g., diagnosis date, site, histology, stage), and detailed health-care use and cost information that will allow for the identification and comparison of cancer treatment and outcomes across different populations within the dataset. Its longitudinal structure, capturing data before and after a cancer diagnosis, will enable the analysis of time-dependent measures like comorbidity indices, multi-course treatments (e.g., surgery, radiation, systemic therapy), and outcomes such as time to a subsequent event or death. Additionally, this database can also support student training by serving as a practical dataset for educational purposes. Impact and Sustainability. The integration of GCR and Medicare datasets, encompassing social factors, risk factors, and cancer treatment data, will markedly improve both the quality of research and the depth of manuscripts derived from this data. It will aid in identifying the causes of disparities and generating hypotheses for future research. Upon establishing data transfer agreements and data storage infrastructure, we can periodically update the linkage, every two years. Aim 3. Build data science education and training partnerships with the Northern Marianas College (NMC) and Palau Community College (PCC). We plan to hold a two-week workshop titled "Introduction to Data Science with R" in Saipan and Palau, targeting community college and high school students, as well as faculty members, with a cap of 8 participants per location. This beginner-level course emphasizes practical engagement and doesn’t require any prior background, utilizing the open-source software R. Initially, attendees will be guided through the installation of R, its tools, and RStudio. Participants will be given access to de-identified datasets from PIPCHE, research projects, GCR, and Guam BRFSS, enabling them to construct and apply a framework for statistical analysis. The course is structured into six modules. The first module introduces cancer and health disparities research, using findings from PIPCHE to guide students in formulating their research questions. It will also use some of the lectures developed for the new graduate course Cancer Disparities (funded by U54). Module 2 focuses on data visualization using R, covering the basics of ggplot and presenting examples of various graphs such as histograms, bar plots, violin plots, and scatter plots along with attached R scripts on how to run these in R. Subsequent modules (3 to 5) will cover descriptive statistics, linear regression, and logistic regression, respectively. These sections include lab exercises for interpreting results from provided sample data and executing analyses using attached R scripts. In the final module, Module 6, participants will brainstorm research ideas and collaborate in groups, fostering an environment of collective learning and innovation. Course Objectives:  1. Understand how to properly prepare datasets for use in computing workspaces.  2. Understand disparities in cancer and cardiovascular-related risk factors and outcomes.  3. Recognize and articulate a research problem.  4. Describe some models used in data science and the benefits and limitations of these approaches.  5. Gain hands-on experience coding in R and analyzing data sets gathered in past PIPCHE projects.  6. An increased proficiency of student research skills including those used in: literature review,  understanding ethical issues, using computer software, and oral and written communication of data  science research.  7. An awareness of career options in academics, industry, and/or government. Evaluation and Sustainability. The workshop's evaluation will adopt a formative and summative approach, aiming to gather feedback on the current program's quality and guide improvements for future workshops. The evaluation will be twofold:  1. Students’ self-evaluation, conducted before and after the workshop.  2. Students’ assessment of their workshop experience. The surveys will assess students' perspectives on several key areas, including their understanding of data science career paths, skills in interpreting results, resilience in overcoming research obstacles, preparedness for advanced research, comprehension of knowledge construction, grasp of the research process, insight into how data scientists tackle real-world problems, and proficiency in data analysis. A pre/post evaluation design will be implemented to gauge self-reported improvements in participants' skills and knowledge following their participation in the program. The evaluation will include questions such as: 1. How satisfied were participants with the program overall? 2. Did the research experience meet participant expectations? 3. Did the research experience impact participant plans to pursue career in data science? 4. To what extent did participants increase their research skills during the program? 5. To what extent do participants feel they gained knowledge about the research process? 6. What changes should we make to the program for next year? Aim 3 of our proposal meets the third objective of the supplement program, “Build data science partnerships” particularly focusing on the second point: “Activities that establish learning communities to help participants such as students, educators, and community partners to develop data science identity, equitable data practices, and sense of belonging to the data science community.” For each workshop, our plan includes recruiting one faculty member from each participating institution. In the first year, this faculty member will acquire the necessary skills and knowledge; in the second year, they will help co-facilitate the workshop, gaining hands-on experience in conducting a data science workshop. We will provide these faculty members with all the workshop materials, enabling them to independently run the workshop in the future, even beyond the duration of the supplement. Additionally, we aim to support one student from Saipan and one from Palau in submitting an abstract to a national conference and presenting their research during the second year of funding. This effort is intended to motivate students to pursue further education in data science. Furthermore, while in Saipan and Palau, we plan to engage with the leadership of both institutions to explore creating pathways for students to continue their studies at UOG. REFERENCES  1. Aguon A, Dulana LJ, Teria R, Cruz A, Jin SB, Badowski G. A trend analysis of cancer incidence in  Guam from 2002-2018 [abstract]. In: Proceedings of the 16th AACR Conference on the Science of  Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct  2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12  Suppl):Abstract nr B117.  2. Badowski G, Teria R, Dulana L, Aguon C, Wilkens L, Shvetsov Y, Novotny R, Leon Guerrero RT;  Abstract 6493: Ethnic disparities in breast cancer survival in Guam. Cancer Res 1 April 2023; 83  (7_Supplement): 6493. https://doi.org/10.1158/1538-7445.AM2023-6493. 3. Leon Guerrero RT, Badowski G, Yamanaka A, Blas-Laguana M, Bordallo R, et al. University of Hawai'i  Cancer Center connection: The vital role of cancer registries in the recruitment of an understudied  minority population into a breast cancer study: Breast Cancer Risk Model for the Pacific. Hawaii J Med  Public Health. 2014 Oct;73(10):335-40. PubMed PMID: 25337453; PubMed Central PMCID: PMC4203456. 4. National Cancer Institute, Division of Cancer Control and Population Sciences, Healthcare Delivery  Research Program. Search SEER Linkage  Publications https://healthcaredelivery.cancer.gov/publications/. Accessed March, 2024. 5. Enewold L, Parsons H, Zhao L, Bott D, Rivera DR, Barrett MJ, Virnig BA, Warren JL. Updated  Overview of the SEER-Medicare Data: Enhanced Content and Applications. J Natl Cancer Inst Monogr.  2020 May 1;2020(55):3-13. doi: 10.1093/jncimonographs/lgz029. PMID: 32412076; PMCID: PMC7225666. 6. Shin D, Fishman MDC, Ngo M, Wang J, LeBedis CA. The Impact of Social Determinants of Health on  Lung Cancer Screening Utilization. J Am Coll Radiol. 2022 Jan;19(1 Pt B):122-130. doi:  10.1016/j.jacr.2021.08.026. PMID: 35033299; PMCID: PMC8820269. 7. Yu Z, Yang X, Guo Y, Bian J, Wu Y. Assessing the Documentation of Social Determinants of Health for  Lung Cancer Patients in Clinical Narratives. Front Public Health. 2022 Mar 28;10:778463. doi:  10.3389/fpubh.2022.778463. PMID: 35419333; PMCID: PMC8995779. 8. Marron, J. Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule:  A Cybersecurity Resource Guide. https://doi.org/10.6028/NIST.SP.800-66r2. Accessed March 2024. 9. NIH, Data Management and Sharing Policy, https://sharing.nih.gov/data-management-and-sharing-  policy. Accessed March 2024.

PI_NAMEs: HATTORI, MARGARET P;LEON GUERRERO, RACHAEL T (contact);PALAFOX, NEAL A.;PAULINO, YVETTE C

PROGRAM_OFFICER_NAME: GHOSH, SANGEETA AHUJA

PROJECT_TERMS: Achievement;Address;Adherence;Administrative Supplement;Adopted;Advanced Malignant Neoplasm;Age;Agreement;Air;Algorithms;American;American Association of Cancer Research;anti-cancer research;Applied Research;Area;Articulation;Asian Americans;Asian Pacific Islander;Assistantship;Athletic;authority;Award;Behavior;behavioral health;Behavioral Risk Factor Surveillance System;beneficiary;Big Data;Big Data Methods;Biological Markers;Biological Sciences;Biology;Biomedical Research;Biometry;Biostatistics Core;Biostatistics Shared Resource;Body mass index;Brain Drains;Breast Cancer Risk Factor;breast cancer survival;cancer care;Cancer Center;cancer diagnosis;cancer health disparity;Cancer health equity;Cancer Patient;cancer prevention;Cancer Science;cancer therapy;Cardiovascular system;career;career awareness;Career Choice;Censuses;Cessation of life;Chemistry;Chicago;Clinical;Code;cohort;Collaborations;college;Communities;community college;Community Health;community living;community partners;comorbidity Index;Competence;Complement;Comprehension;computer science;computer scientist;Computer software;cost;Country;COVID-19;COVID-19 pandemic;cyber security;Data;Data Analyses;Data Analytics;data communication;data curation;data de-identification;data exchange;Data Files;data format;data infrastructure;data integration;Data Linkages;data management;data pipeline;data quality;data registry;Data Science;data science education;Data Scientist;Data Set;data sharing;Data Sources;data standards;Data Storage and Retrieval;data storage site;data visualization;Databases;Date of birth;demographics;design;Development;Diagnosis;Diagnostic Procedure;Discipline;Disease;Disparity;Diverse Workforce;Division of Cancer Control and Population Sciences;Doctor of Philosophy;Documentation;drinking;Education;education research;Educational process of instructing;Educational workshop;encryption;Enrollment;Ensure;Environment;Epidemiologic Monitoring;Epidemiology;Equity;Ethical Issues;ethnic disparity;ethnic minority;Ethnic Origin;Evaluation;Event;Exercise;expectation;experience;Faculty;falls;Feedback;firewall;forging;Fostering;Foundations;Funding;Future;Generations;Goals;Government;Government Agencies;Graduate Degree;Graduate Education;graduate student;Grant;Graph;grasp;Guam;Hawaii;Health;health care delivery;Health Disparities Research;health disparity;Health equity research;Health Information System;Health Insurance;Health Insurance Portability and Accountability Act;health management;Health Sciences;Healthcare;High School Student;Histology;Hospitals;Household;human capital;improved;Incidence;Income;Individual;Industry;Information Technology;Infrastructure;infrastructure development;innovation;insight;Institution;interest;Internships;Island;Japan;Knowledge;Laboratories;laptop;Leadership;Learning;learning community;lectures;Linear Regressions;Link;Location;Logistic Regressions;lower income families;lung cancer screening;Machine Learning;Malignant Breast Neoplasm;Malignant neoplasm of lung;Malignant Neoplasms;Manuscripts;mathematical sciences;Mathematics;Measures;Medicaid;Medical Care Costs;Medical Indigency;medically underserved;Medicare;Medicare/Medicaid;meetings;member;Mentors;Mentorship;Methodology;Methods;Micronesia;Minority Groups;minority student;Minority-Serving Institution;Modeling;Monitor;Names;National Cancer Institute;National Oceanic and Atmospheric Administration;Native-Born;Natural Sciences;Nature;neoplasm registry;open source;Operative Surgical Procedures;Oral;Oregon;Outcome;outcome disparities;Pacific Islander;Pacific Islands;Palau;Parents;Participant;pathogen;Pathway interactions;Patient Self-Report;Patients;Performance;Personally Identifiable Information;Philadelphia;phrases;Policies;Population;Positioning Attribute;Poverty;Preparation;prevent;Problem-Based Learning;Process;Programming Languages;programs;Protocols documentation;Psychology;Public Health;Publications;Publishing;PubMed;Pythons;Race;racial disparity;racial minority;Radiation;Radiation therapy;Readiness;recruit;Registries;Reporting;Research;Research Design;Research Infrastructure;Research Methodology;Research Personnel;Research Project Grants;Research Proposals;Research Support;resilience;resource guides;Resource Sharing;Resources;Respondent;Review Literature;Risk Factors;Role;Running;Sampling;Schedule;Science;science teacher;Sea;Secure;Security;SEER Program;Self-Examination;sex;Signal Transduction;Site;skills;Smoking;social factors;social health determinants;Social Sciences;Social Security Number;Social Work;Source;Statistical Data Interpretation;Statistical Models;statistics;Strategic Planning;Structure;student mentoring;student training;Students;success;summer research;Surveys;Survival Analysis;survival disparity;Survival Rate;symposium;synergism;System;Systemic Therapy;Talents;Technical Expertise;Technology;testing services;Time;tool;Training;Training and Education;Transfer Agreement;Travel;treatment and outcome;treatment disparity;trend;trend analysis;tumor;undergraduate education;undergraduate research;undergraduate research experience;undergraduate student;Underrepresented Minority;Underrepresented Students;United States;United States Centers for Medicare and Medicaid Services;United States Department of Agriculture;United States National Aeronautics and Space Administration;United States National Institutes of Health;United States Public Health Service;Universities;Update;Washington;Woman;Work;Workforce Development;Writing

PROJECT_TITLE: (2/2) Pacific Island Partnership for Cancer Health Equity (PIPCHE)


ADMINISTERING_IC: DE

ED_INST_TYPE: SCHOOLS OF DENTISTRY/ORAL HYGN

IC_NAME: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH

NIH_SPENDING_CATS: Bioengineering;Biotechnology;Cancer;Dental, Oral, and Craniofacial Disease;Immunotherapy;Nanotechnology;Orphan Drug;Radiation Oncology;Rare Diseases

ORG_CITY: HOUSTON

ORG_DEPT: DENTISTRY

ORG_NAME: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON

PHR: PROJECT NARRATIVE. The overall 5-year survival rate for head and neck cancer has not improved much over the last few decades with both conventional multimodal treatment and emerging immunotherapies known to have an adverse (and sometimes fatal) impact on quality of life. The goal of this proposal is to investigate the mechanisms driving the effectiveness of a novel immunotherapy for head and neck cancer we call “SynerGel” and determine how it can be used in combination with standard-of-care radiation therapy to reduce treatment toxicity. By doing so, we aim to enhance our understanding of how both tumor and immune cells in the tumor environment can be manipulated to produce a strong anti-tumor effect while reducing the side effects of treatment.

PI_NAMEs: YOUNG, SIMON  (contact)

PROGRAM_OFFICER_NAME: CHEN, ZHONG

PROJECT_TERMS: Activities of Daily Living;Acute;Address;antitumor effect;Automobile Driving;Biocompatible Materials;cancer immunotherapy;cancer type;Cells;chemotherapy;Combination immunotherapy;Combined Modality Therapy;cytokine;cytotoxic;Data;Dendritic Cells;design;Dose;effective therapy;Effectiveness;Effector Cell;Environment;exhaustion;FDA approved;Generations;Goals;Head and Neck Cancer;Hydrogels;Immune;immune checkpoint blockade;Immune checkpoint inhibitor;Immune response;immune-related adverse events;Immunity;Immunologic Adjuvants;Immunologic Stimulation;Immunologics;Immunomodulators;immunomodulatory therapies;Immunophenotyping;immunoregulation;Immunotherapeutic agent;Immunotherapy;improved;In Situ;Inflammatory Response;Injectable;Injections;insight;Interferons;Lymphocyte;malignant mouth neoplasm;Malignant Neoplasms;Mediating;Molecular;Myeloid Cells;Myeloid-derived suppressor cells;nanofiber;Nature;next generation;NOS2A gene;novel;novel therapeutic intervention;Pathway interactions;Patients;Peptides;Pharmaceutical Preparations;Pre-Clinical Model;Predisposition;Quality of life;Radiation therapy;rational design;recruit;Refractory;Regulatory T-Lymphocyte;Resistance;response;Risk;self assembly;Severities;Signal Transduction;Solid Neoplasm;spatiotemporal;standard of care;Survival Rate;System;systemic toxicity;T cell response;T memory cell;T-Lymphocyte;Technology;Tertiary Protein Structure;Testing;Toxic effect;Treatment Side Effects;Treatment-related toxicity;tumor;tumor heterogeneity;tumor microenvironment;tumor-immune system interactions

PROJECT_TITLE: SynerGel: A Novel Tumor Microenvironment-Modulating Hydrogel for Local Immunotherapy

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-OTC-M(08)F]


ADMINISTERING_IC: OD

IC_NAME: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

NIH_SPENDING_CATS: Neurosciences

PHR: OVERALL – NARRATIVE This competitive renewal application seeks five years of continued support for the Yerkes National Primate Research Center of Emory University. The Yerkes Center’s mission is to conduct and support innovative biomedical and behavioral research by Core and Affiliated Scientists in order to improve the health and well- being of human and nonhuman primates.

PI_NAMEs: THADHANI, RAVI  (contact)

PROGRAM_OFFICER_NAME: BUHRING, BETTINA D

PROJECT_TERMS: animal facility;Animal Housing;animal resource;base;Basic Science;Behavioral;Behavioral Research;Biocompatible Materials;Biology;Biomedical Research;Breeding;cognitive neuroscience;Communities;data resource;Development;Discipline;Ensure;Faculty;Funding;Genetic;Goals;graduate student;Grant;Guidelines;Health;Housing;Human;Humanities;Immunology;improved;Infrastructure;innovation;International;Knowledge;Laboratories;Laboratory Research;medical specialties;member;Mental disorders;Microbiology;Mission;multidisciplinary;Nervous System Disorder;Neuropharmacology;Neurosciences;nonhuman primate;operation;Pathology;Personal Satisfaction;Postdoctoral Fellow;Primates;Process;programs;Publications;Reporting;Research;Research Infrastructure;Research Personnel;Research Training;Resources;Role;Scientist;Services;Social Behavior;Strategic Planning;training opportunity;Translational Research;undergraduate student;United States National Institutes of Health;Universities;Visit

PROJECT_TITLE: Emory National Primate Research Center


ADMINISTERING_IC: EY

ED_INST_TYPE: SCHOOLS OF OPTOMETRY/OPHT TECH

IC_NAME: NATIONAL EYE INSTITUTE

NIH_SPENDING_CATS: Clinical Research;Eye Disease and Disorders of Vision;Neurosciences;Pediatric;Prevention

ORG_NAME: NEW ENGLAND COLLEGE OF OPTOMETRY

PHR: Project Narrative The Project Narrative remains unchanged from the original submission. The proposed study is relevant to public health because here is an urgent need to prevent juvenile myopia (nearsightedness) — projections indicate that over 50% of the world’s population will have myopia by the year 2050. Furthermore, the increasingly earlier onset of myopia in children with consequent higher progression rates is generating an epidemic of potentially blinding, high myopia. As a necessary step in developing successful myopia prevention programs, this longitudinal project will help understand the ocular structure and visual function characteristics of myopia development in children with an investigation of ocular, retinal and visual processing factors prior to and after the development of myopia in children. 1

PI_NAMEs: VERA-DIAZ, FUENSANTA ASCENSION (contact)

PROGRAM_OFFICER_NAME: WIGGS, CHERI

PROJECT_TERMS: Adolescent;Affect;aged;Caring;catalyst;Characteristics;Child;Childhood;Clinical;Clinical Research;Clinical Trials;Complex;Contrast Sensitivity;Data;Data Analyses;design;Detection;Development;Discrimination;early onset;Electrodes;Electrophysiology (science);Electroretinography;Eligibility Determination;emmetropization;epidemic potential;Evaluation;experimental analysis;Eye;Failure;Future;Growth;high risk;Human;Image;Impairment;Individual;Intervention;Investigation;Knowledge;Lead;longitudinal, prospective study;Measures;Modeling;Myopia;neural;novel;Only Child;optical imaging;Optics;Pattern;Perception;Polynomial Models;Population;predictive modeling;prevent;Prevention;Prevention program;Procedures;Process;Psychophysics;Public Health;Pupil;recruit;Research;Research Personnel;response;Retina;retinal imaging;Risk;sample fixation;Scanning;Signal Transduction;Skin;Structure;Testing;Vision;Visual;Visual Fields;visual processing;Visual Psychophysics;visual tracking

PROJECT_TITLE: Longitudinal evaluation of optical and neural factors leading to juvenile myopia


NIH_SPENDING_CATS: Cancer

ORG_CITY: SEATTLE

ORG_NAME: FRED HUTCHINSON CANCER CENTER

ORG_STATE: WA

PHR: Project Narrative Per the NCI Diversity Supplement Guidelines, this section is not required. The research supplement proposal does not change the activities of the Parent Award.

PI_NAMEs: HOLLAND, ERIC C. (contact)

PROGRAM_OFFICER_NAME: MILLER, DAVID J

PROJECT_TERMS: Drug Targeting;Guidelines;parent project;Pathway interactions;Research

PROJECT_TITLE: Exploring Drugs Targeting Hippo Pathway


ED_INST_TYPE: SCHOOLS OF NURSING

ORG_CITY: GAINESVILLE

ORG_DEPT: OTHER HEALTH PROFESSIONS

ORG_NAME: UNIVERSITY OF FLORIDA

ORG_STATE: FL

PHR: Contact PD/PI: WILKIE, DIANA J PROJECT NARRATIVE – OVERALL COMPONENT The long term goals of the CaRE2 center are to reduce cancer disparities in Black/African American and Hispanic/Latinx individuals, to train and increase the pool of 120 underrepresented Black/African American and Hispanic/Latinx scientists conducting health disparity research, to increase research capacity at an HBCU (FAMU), and to increase cancer disparity research at UF and USC-NCCC. The proposed two full projects and pilot project include investigators from the three institutions and will leverage on specimens collected across the partnership from Black/African American and Hispanic/Latinx, representing a wide range of subpopulations within these minority groups. Thus, our studies will reveal unprecedented findings about these two understudied minority populations, will be instrumental in transferring cutting edge and innovative technologies to FAMU, and will expand in a significant way the research focus at UF and USC-NCCC to address cancer health disparities in pancreas and lung cancers. Project Narrative Page 189

PI_NAMEs: HUGHES-HALBERT, CHANITA A.;REAMS, ROMONIA RENEE;REDDA, KINFE KEN;STERN, MARIANA C;WILKIE, DIANA J (contact)

PROGRAM_OFFICER_NAME: BARFIELD-STEWARD, WHITNEY

PROJECT_TERMS: Address;African;African American;American;anti-cancer research;Bioinformatics;Biological;Biomedical Research;Black Populations;Black race;California;cancer health disparity;Caribbean region;Caring;Central American;Communities;community partnership;Comprehensive Cancer Center;Disparity;Education;education research;Evaluation;Florida;Goals;Health Disparities Research;health equity;Heterogeneity;Hispanic;improved;Incidence;Infrastructure;innovation;innovative technologies;Institution;Latino;Latino Population;Latinx;Latinx population;Leadership;Location;Malignant neoplasm of lung;Malignant neoplasm of pancreas;Malignant neoplasm of prostate;Malignant Neoplasms;Methodology;Mexican Americans;Minority Groups;mortality;outreach;Pilot Projects;Population Heterogeneity;Research;Research Personnel;Research Project Grants;Research Training;Resource Sharing;Resources;Scientist;South American;Specimen;Students;Tissue Model;tool;Training;Translational Research;Universities;US State;Use Effectiveness;Work

PROJECT_TITLE: CaRE2 NCI Diversity Supplement


ADMINISTERING_IC: HD

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

NIH_SPENDING_CATS: Clinical Research;Clinical Trials and Supportive Activities;Emergency Care;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Networking and Information Technology R&D (NITRD);Pediatric;Telehealth

ORG_CITY: NEW YORK

ORG_DEPT: EMERGENCY MEDICINE

ORG_NAME: WEILL MEDICAL COLL OF CORNELL UNIV

PI_NAMEs: RAZZAK, JUNAID ABDUL (contact)

PROGRAM_OFFICER_NAME: DIXON, CINNAMON ANNE

PROJECT_TERMS: Accident and Emergency department;Acute;acute care;Address;Ambulances;care systems;Caring;Child;Childhood;Clinical Trials;Clinical Trials Data Monitoring Committees;Cluster randomized trial;Communities;Computerized Medical Record;Consent;Country;Data;Data Collection;data sharing;design;Educational workshop;efficacy testing;Emergency Care;Emergency department visit;Emergency Situation;Enrollment;Ensure;follow-up;Foundations;Goals;Health;Health Personnel;Hospitals;improved;Income;Informed Consent;Injury;insight;Institution;international center;Intervention;low and middle-income countries;Measures;Methodology;mHealth;Modernization;Morbidity - disease rate;mortality;Outcome;Pakistan;pediatric department;pediatric emergency;Phase;Physicians;Pre-hospitalization care;primary outcome;Process;prospective;Research;Research Project Grants;Rest;Resuscitation;Rural Community;rural underserved;Safety;Sample Size;Sampling;satisfaction;secondary outcome;Services;teleconsultation;telehealth;Telemedicine;Testing;Time;Training;Training Support;Transportation;Triage;United States;Update;Visit;volunteer;webinar;Work

PROJECT_TITLE: Feasibility and Efficacy of Ambulance-Based mhealth for Pediatric Emergencies (FEAMER) Trial

STUDY_SECTION: NSS

STUDY_SECTION_NAME: NSS


ADMINISTERING_IC: TR

IC_NAME: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

NIH_SPENDING_CATS: Behavioral and Social Science;Clinical Research;Clinical Trials and Supportive Activities;Social Determinants of Health

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: COLUMBIA UNIVERSITY HEALTH SCIENCES

PHR: Project Narrative In this application for an Administrative Supplement to conduct research on bioethical issues on return of individual research results, we propose to survey a large and unusual existing sample of diverse participants with the lived experience of having received their genetic/genomic results as part of the NHGRI-sponsored eMERGE-IV study. Expanding the focus to a broader range of research results (e.g. biomedical markers of health, behavior and environmental exposures), we will elicit their views on which results should be offered for return, when results should be returned, how results should be returned, and what participant characteristics may help to identify and satisfy preferences. Our results will inform future studies, policies, and practices for the return of study results at Columbia University, within the CTSA consortium, and across the larger biomedical community.

PI_NAMEs: REILLY, MUREDACH P (contact)

PROGRAM_OFFICER_NAME: ATIENZA, AUDIE A

PROJECT_TERMS: Address;Administrative Supplement;adverse outcome;Affect;Area;Behavior;Behavioral;Beneficence;Benefits and Risks;Benign;Bioethical Issues;Biological Markers;Caring;Characteristics;Clinical and Translational Science Awards;Communities;Consensus;Data;Decision Making;Development;Disclosure;Disease;Education;Electronics;Engineering;Environmental Exposure;Ethical Analysis;Ethics;Ethnic Origin;evidence base;experience;Family member;follow-up;Future;General Population;Generations;Genetic;Genetic Research;genomic data;Genomics;Health;Health Insurance;income insurance;Individual;Institutional Review Boards;Insurance Coverage;interest;Justice;Knowledge;Life;Literature;Lived experience;Medical;Medical center;Medicine;member;Methods;National Human Genome Research Institute;Nonmaleficence;Outcome;Participant;Perception;Persons;Play;Policies;Predictive Value;preference;Preventive;Race;Regrets;Reporting;reproductive;Research;Research Personnel;Respondent;response;Role;Sampling;social culture;Surveys;transmission process;Uncertainty;United States National Academy of Sciences;Universities


ADMINISTERING_IC: HS

FUNDING_MECHANISM: TRAINING, INDIVIDUAL

IC_NAME: AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

ORG_CITY: DENVER

ORG_NAME: DENVER HEALTH AND HOSPITAL AUTHORITY

ORG_STATE: CO

PHR: PROJECT NARRATIVE Persons experiencing homelessness (PEH) suffer from high rates of morbidity and mortality, often lack access to primary care, and disproportionately rely on emergency departments (EDs) for both acute medical and social needs, resulting in poor care coordination and fragmented care. One potential solution to address the fragmented care PEH receive is linkage from the ED to physician-led, team-based street medicine clinics, which provide mobile primary care to PEH. The project proposed in this application aims to improve linkage-to- care for PEH following ED discharge through engagement of both patients and key stakeholders and deployment of a novel ED-based referral process to an existing street medicine program evaluated using a quasi-experimental study design.

PI_NAMEs: JOSEPH, KATHLEEN  (contact)

PROGRAM_OFFICER_NAME: WYATT, DERRICK

PROJECT_TITLE: Emergency Department Linkage to Care for Patients Experiencing Homelessness

STUDY_SECTION: HCRT

STUDY_SECTION_NAME: Healthcare Research Training [HCRT (02)]


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Cannabinoid Research;Drug Abuse (NIDA only);Endocannabinoid System Research;Neurosciences;Opioid Misuse and Addiction;Opioids;Pain Research;Substance Misuse;Women's Health Research

ORG_CITY: BALTIMORE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

PHR: Treatment of Opioid Use Disorder (OUD) often includes tapering individuals off of opioid drugs, but after chronic use, opioid abstinence causes severe withdrawal symptoms which can lead people to reinitiate drug use. This exploratory project focuses on a medication targeting a novel mechanism to lessen opioid withdrawal symptoms in a multidimensional animal model of opioid physical dependence. Results from this research would aid in developing new non-opioid medications for treatment of OUD.

PI_NAMEs: CUNNINGHAM, CHRISTOPHER W;MOORE, CATHERINE FRANCES (contact)

PROGRAM_OFFICER_NAME: LE, HOANG VAN

PROJECT_TERMS: Abstinence;abuse liability;Ache;Administrative Supplement;Agitation;Agonist;Animal Model;antagonist;Anxiety;anxiety symptoms;Attenuated;Award;Behavior;Binding Proteins;Birth;Blinded;Body Weight;Body Weight decreased;Canis familiaris;cannabimimetics;Carrier Proteins;Cessation of life;Child;Chronic;CNR1 gene;cohort;Cohort Studies;Compensation;Control Groups;Data;Data Collection;Development;Diarrhea;Dimensions;Dose;Drug usage;Eating;economic cost;efficacy evaluation;emotional behavior;emotional symptom;Endocannabinoids;endogenous cannabinoid system;Event;experience;Female;Funding;gastrointestinal;Goals;Grooming;Helping to End Addiction Long-term;High-dimensional Modeling;Hyperalgesia;In Vitro;Individual;inhibitor;Injections;Lead;Life;Maintenance;male;Maternity leave;Mechanics;Mediating;Medical;medical schools;Medication Management;Metabolic;Modeling;Morphine;motor impairment;National Institute of Drug Abuse;natural hypothermia;non-opioid analgesic;non-specific lipid transfer protein;novel;Opiate Addiction;Opioid;opioid epidemic;opioid misuse;opioid use;opioid use disorder;opioid withdrawal;Pain;pain sensitivity;parent grant;Persons;Pharmaceutical Preparations;Physical Dependence;pre-clinical;pre-clinical assessment;Procedures;Productivity;Ptosis;Public Health;Rattus;Research;Research Project Grants;rimonabant;Rodent;Running;Saline;Schedule;SCP 1;Severities;side effect;Site;Strategic Planning;Substance Withdrawal Syndrome;Symptoms;Testing;Tetrahydrocannabinol;Time;tool;transport inhibitor;Tremor;United States;United States National Institutes of Health;Universities;Withdrawal;Withdrawal Symptom

PROJECT_TITLE: Preclinical assessment of a Sterol Carrier Protein-2 inhibitor in multidimensional opioid withdrawal.


ADMINISTERING_IC: GM

ED_INST_TYPE: SCHOOLS OF ARTS AND SCIENCES

IC_NAME: NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

NIH_SPENDING_CATS: Biotechnology

ORG_CITY: CAMBRIDGE

ORG_DEPT: CHEMISTRY

ORG_NAME: MASSACHUSETTS INSTITUTE OF TECHNOLOGY

PHR: Project Narrative  Directed evolution is a valuable technique for the development and optimization of proteins with valua- ble new functions, as well as for the elucidation of fundamental biological mechanisms that impact the ability of proteins to robustly explore mutational space. A major issue that currently limits the power of these ap- proaches, however, is that current directed evolution workflows are currently performed almost exclusively in simple systems such as test tubes, yeast, or bacteria. This research will (1) build and apply next-generation, human cell-based directed evolution platforms to open new doors in research and biotechnology and (2) apply evolution strategies in human cells to illuminate how the proteostasis network impacts protein evolution, espe- cially as it relates to diseases like cancer.

PI_NAMEs: SHOULDERS, MATTHEW DONALD (contact)

PROGRAM_OFFICER_NAME: SIMONOVIC, MILJAN

PROJECT_TERMS: Acceleration;Address;anti-cancer research;Area;Bacteria;Biological;Biology;Biophysics;Biotechnology;Cells;Charge;chemical genetics;Chemicals;Complex;Directed Molecular Evolution;Disease;drug development;drug resistance development;Ensure;Environment;Escherichia coli;Evolution;G-Protein-Coupled Receptors;Human;inhibitor;insight;interest;Laboratories;Libraries;Lower Organism;Malignant Neoplasms;Methodology;Molecular Chaperones;mutant;Mutation;National Institute of General Medical Sciences;Neurosciences;next generation;novel;Oncogenes;Organism;Process;protein folding;Proteins;proteostasis;Research;Role;Signal Pathway;System;technique development;Testing;tool;Tube;tumorigenesis;unnatural amino acids;Variant;Yeasts

PROJECT_TITLE: Leveraging Next-Generation Directed Evolution Platforms and Chemical Control of Proteostasis to Deliver Robust Biotechnologies and Illuminate Roles of Chaperone Networks in Protein Evolution

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1-CB-K(55)R]


ORG_CITY: TAMPA

ORG_NAME: H. LEE MOFFITT CANCER CTR & RES INST

PHR: NARRATIVE Tumors are not simply collections of mutated cells that grow in isolation; rather, they respond to and modify both the physical microenvironment and a variety of host cells in the organ they are invading. These changes in ecology ("Δ-Ecology") are key to understanding tumor progression and the response to therapy- particularly the development of resistance. We focus on NSCLC, the most common and among the most lethal of human cancers and will define the ecological and evolutionary dynamics that govern disease progression and treatment, with the goal of driving novel therapeutic strategies that exploit this Δ-Ecology.

PI_NAMEs: ANDERSON, ALEXANDER ROBERTSON ALLAN (contact);GATENBY, ROBERT A

PROGRAM_OFFICER_NAME: ZAMISCH, MONICA

PROJECT_TERMS: Address;Allografting;analysis pipeline;Automobile Driving;Biological Models;Birth;Calibration;cancer cell;cancer therapy;carcinogenesis;Cell Survival;Cells;Cessation of life;Clinical Data;Collection;Computing Methodologies;CRISPR library;data repository;digital pathology;Disease Progression;Disease remission;DNA Sequence Alteration;driver mutation;Ecology;Ecosystem;Epidermal Growth Factor Receptor;Epigenetic Process;Evolution;experimental study;Failure;functional genomics;Genetic Programming;Goals;Grant;Growth;Guide RNA;Human;Immune;Immunotherapy;improved;in silico;In Vitro;in vivo;inhibitor;inhibitor therapy;insight;Invaded;Knowledge;KRAS2 gene;Lentivirus Vector;Lung;Lung Neoplasms;Malignant Neoplasms;mathematical methods;Mathematics;Modeling;Molecular;mouse model;Mus;mutant;Mutate;Mutation;neoplastic cell;Non-Small-Cell Lung Carcinoma;novel;novel therapeutic intervention;Organ;Outcome;outcome prediction;Patients;pharmacologic;Phenotype;Population;predictive modeling;Probability;Process;Proliferating;Relapse;Research;research and development;Residual Neoplasm;Residual state;Resistance;Resistance development;resistance mutation;Resource Sharing;response;Sampling;Shapes;Signal Transduction;spatiotemporal;Speed;success;System;targeted treatment;Testing;Therapeutic;therapeutic development;Therapeutic Intervention;Time;tool;transcriptomics;treatment response;treatment strategy;tumor;tumor growth;tumor microenvironment;tumor progression;Vertebral column;Xenograft procedure

PROJECT_TITLE: The Delta Ecology of NSCLC Treatment


ADMINISTERING_IC: HG

IC_NAME: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

ORG_CITY: NEW HAVEN

ORG_NAME: YALE UNIVERSITY

ORG_STATE: CT

PHR: Bridge2AI: a FAIR AI BRIDGE Center (FABRIC) Overall Narrative We will organize the Bridge to AI Consortium by integrating the work of six major teams working on administration, team science, ethics, standards, tools and training. These teams will interact with those of data generation projects to accelerate AI research related to human health.

PI_NAMEs: OHNO-MACHADO, LUCILA  (contact)

PROGRAM_OFFICER_NAME: SEN, SHURJO KUMAR

PROJECT_TERMS: Acceleration;Adherence;Affect;Agreement;Anthropology;Artificial Intelligence;artificial intelligence algorithm;artificial intelligence model;Big Data to Knowledge;Biomedical Research;blockchain;Bridge to Artificial Intelligence;California;Catalogs;cloud based;Collaborations;Communities;Computer software;Data;data access;design;digital;Educational Activities;Educational Materials;effectiveness evaluation;Ensure;Environment;ethical, legal, and social implication;Ethics;Evaluation;experience;FAIR principles;Funding;Generations;Goals;Guidelines;Health;Human;Humanities;indexing;Individual;innovation;Institution;Learning;Life Cycle Stages;Logistics;Measures;Metadata;novel;outreach;Participant;Persons;Policies;Privacy;privacy preservation;Problem behavior;Process;programs;Psychology;Research;Research Personnel;responsible artificial intelligence;Science;Series;skill acquisition;Social Sciences;software development;Standardization;Structure;Technology;Texas;Thinness;tool;Training;Training Activity;United States National Institutes of Health;Universities;Vision;Work;Workforce Development

PROJECT_TITLE: A FAIR Bridge2AI Center (FABRIC)

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


ADMINISTERING_IC: AR

IC_NAME: NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

NIH_SPENDING_CATS: Clinical Research;Genetics;Rare Diseases;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_CITY: SAN FRANCISCO

ORG_NAME: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

PHR: PROJECT NARRATIVE This project improves public health by supporting the career development of an underrepresented candidate in the medical and scientific research fields. It also provides potential strategies for manipulating key hormonal pathways that cause severe bone diseases in humans, which currently have no directed therapies.

PI_NAMEs: HSIAO, EDWARD C (contact);NISSENSON, ROBERT

PROGRAM_OFFICER_NAME: CHEN, FAYE H

PROJECT_TERMS: ACVR1 gene;Address;Affect;Biological;Biological Models;Biological Process;Biological Sciences;Bone Diseases;career development;Cell Line;Cellular biology;Disease Management;experience;Exposure to;Fibrous Dysplasia;Future;gene-editing approach;Genes;Genetic;Genetic study;Goals;Graduate Degree;Grant;Hormonal;Human;human induced pluripotent stem cells;improved;induced pluripotent stem cell;laboratory experience;Medical;Mentors;Methods;Modification;Molecular Biology;novel;novel strategies;Pathway interactions;pharmacologic;Positioning Attribute;Process;programs;Public Health;Reproducibility;Research;Science;screening;Series;skeletal disorder;skills;stem cell model;Training;Translational Research;Work

PROJECT_TITLE: Novel Strategies for Understanding and Treating Fibrous Dysplasia

STUDY_SECTION: SBDD

STUDY_SECTION_NAME: Skeletal Biology Development and Disease Study Section[SBDD]


ADMINISTERING_IC: TW

IC_NAME: FOGARTY INTERNATIONAL CENTER

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Clinical Research;Health Services;Hematology;Infectious Diseases;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Pediatric;Sepsis;Telehealth

ORG_CITY: PROVIDENCE

ORG_NAME: RHODE ISLAND HOSPITAL

ORG_STATE: RI

PHR: Project Narrative The proposed research will build new aims related to bioethics onto the parent study “Development of a Mobile Health Personalized Physiologic Analytics Tool for Pediatric Patients with Sepsis” (R33 TW012211). We will examine and elucidate the ethical concerns of caregivers of children with sepsis eligible for enrollment in the parent study, as well as stakeholders in bioethical research decision-making (clinicians, researchers, ethical review board members, administrators), related to research using digital health technologies for clinical care among children with sepsis and critical illnesses in low- and middle-income countries.

PI_NAMEs: GARBERN, STEPHANIE CHOW (contact);LEVINE, ADAM CARL

PROGRAM_OFFICER_NAME: NEWSOME, BRAD

PROJECT_TERMS: Administrator;analytical tool;Artificial Intelligence;Asia;Attitude;Award;Awareness;Bangladesh;Belief;Bioethics;Caregivers;Cessation of life;Child;Child Care;Child Mortality;Childhood;Clinical;clinical care;clinical decision support;Clinical Decision Support Systems;clinical predictors;Clinical Research;cloud based;Collection;Committee Members;Critical Illness;Critically ill children;Data;Data Collection;data management;Data Security;Decision Making;decision research;design;Development;diarrheal disease;digital health;digital technology;digital tool;Eligibility Determination;Emerging Technologies;Enrollment;Ensure;Ethical Issues;Ethical Review;Ethics;evidence base;Exposure to;Funding;Future;Growth;Health;health data;Health Technology;Healthcare Systems;Hospitalization;Hospitals;Human Resources;improved;improved outcome;Infection;Informed Consent;international center;Intervention;Knowledge;Link;low and middle-income countries;Machine Learning;machine learning model;machine learning prediction;Medical;member;Methods;mHealth;Modeling;new technology;novel;Outcome;Parents;Patients;pediatric patients;pediatric sepsis;Physiological;Policies;Population;preference;Privacy;Randomized, Controlled Trials;Research;Research Ethics;Research Personnel;research study;Resources;Review Committee;Rhode Island;Sepsis;Special Population;support tools;Technology;Time;tool;Trust;United States National Institutes of Health;Universities;wearable device;wearable sensor technology

PROJECT_TITLE: Supplement to Development of a Mobile Health Personalized Physiologic Analytics Tool for Pediatric Patients with Sepsis

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


ORG_CITY: LANCASTER

ORG_NAME: SIMULATIONS PLUS, INC.

PHR: From Bench to Bioequivalence: In Vitro Mechanistic Understanding of ASD Drug Products in Simulated Gastrointestinal Conditions – Narrative The use of amorphous solid dispersions (ASDs) in drug formulations presents a promising solution for enhancing drug solubility and absorption, hence reducing the tablet burden on patients. However, ASD formulations are complex and prone to crystallization, leading to variable in vivo performance particularly associated with food effects and pH- dependent drug interactions. This project will develop an in vitro-in vivo correlation for ASDs to streamline the development of generic ASD formulations while ensuring therapeutic equivalence and public health safety.

PI_NAMEs: LE MERDY, MAXIME  (contact)

PROGRAM_OFFICER_NAME: LIM, HYE LIM

STUDY_SECTION_NAME: Special Emphasis Panel[ZFD1 CDER-T (06)]


NIH_SPENDING_CATS: Aging;Behavioral and Social Science;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Colorectal Cancer;Digestive Diseases;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Prevention;Primary Health Care;Social Determinants of Health

ORG_CITY: PHILADELPHIA

ORG_NAME: UNIVERSITY OF PENNSYLVANIA

ORG_STATE: PA

PHR: PROJECT NARRATIVE  Colorectal cancer is the 2nd leading cause of cancer death, and despite effective methods for prevention and early detection, screening rates remain low. Recent insights from behavioral economics have shown that reducing effort and providing timely nudges can encourage clinicians and patients to engage with preventive health activities. We will conduct a pragmatic trial evaluating if offering a sequential choice of screening options during clinic visits and through direct patient outreach can increase colorectal cancer screening completion.

PI_NAMEs: MEHTA, SHIVAN JATIN (contact)

PROGRAM_OFFICER_NAME: WEAVER, SALLIE JAYNE

PROJECT_TERMS: Address;Adherence;Adult;Affect;Age;age group;aged;American;Behavior;Behavior Therapy;Behavioral;behavioral economics;Cancer Etiology;Cessation of life;Clinic;Clinic Visits;Clinical;Clinical Trials;Cognitive;Colonoscopy;Colorectal Cancer;colorectal cancer screening;comorbidity Index;cost;Data;design;Development;Early Diagnosis;Effectiveness;effectiveness evaluation;Electronic Health Record;Equity;ethnic disparity;experience;Friction;Future;Goals;Guidelines;Health;Health behavior;health care delivery;Health system;Healthcare Systems;Home;Incidence;Individual;insight;Intervention;K-Series Research Career Programs;Methods;older adult;older patient;operation;outreach;parent grant;Parents;patient outreach;Patients;Pennsylvania;Policies;Population;population based;Population Heterogeneity;Pragmatic clinical trial;pragmatic trial;Prevention;Preventive;Preventive care;Primary Care;primary care practice;primary outcome;Problem behavior;programs;provider factors;public health priorities;racial disparity;Randomized;Randomized, Controlled Trials;Recommendation;Research;Research Personnel;Risk;Risk Factors;Science;screening;Screening for cancer;sex;success;System;Testing;testing uptake;Time;treatment as usual;United States;Universities;uptake;Visit;Work;young adult

PROJECT_TITLE: Behavioral Economic Approaches for Population-based Colorectal Cancer Screening


NIH_SPENDING_CATS: Brain Disorders;Mental Health;Mental Illness;Neurosciences;Nutrition;Pediatric;Prevention

ORG_NAME: UNIVERSITY OF WASHINGTON

PHR: NARRATIVE (from parent award) Maternal immune activation (MIA) is a primer for long-term neuropsychiatric consequences in offspring, although the exact mechanisms underlying offspring neurodevelopmental defects resulting from these maternal immune insults are unknown. Here, we provide evidence that MIA-induced changes in the developing offspring’s extracellular chondroitin and dermatan sulfate glycosaminoglycan (CS/DS-GAG) sulfation patterning, which are key regulator of axonal guidance and synaptogenesis during neurodevelopment, may result in developmental defects that predispose the offspring to mental health disorders in the adult, and studies outlined within this proposal aim to further investigate this possibility.

PI_NAMEs: ALONGE, KIMBERLY MICHELE (contact)

PROGRAM_OFFICER_NAME: PRABHUDAS, MERCY R

PROJECT_TERMS: Acceleration;Adolescent;Adult;Affect;American;Anabolism;ATP phosphohydrolase;autism spectrum disorder;Axon;axon growth;axon guidance;axonal pathfinding;Behavior;Behavioral;Binding;Binding Proteins;Biochemical;Biological;Biology;biophysical properties;Bipolar Disorder;Brain;brain volume;cell motility;Chemicals;Child;Childhood;Chondroitin Sulfate A;Chondroitin Sulfate C;Chondroitin Sulfates;Classification;Clinical Research;Code;Coupled;critical period;Cues;Data;Defect;Dermatan Sulfate;dermatan sulfate chondroitin sulfate;Detection;Development;Disease;disorder risk;Elements;Engineering;epidemiology study;Event;Exhibits;Exposure to;extracellular;Extracellular Matrix;fetal;Fiber;Functional impairment;Funding;Genes;genetic signature;Glycosaminoglycans;Growth Factor;High Fat Diet;Hippocampus;Hypersensitivity;Immune;immune activation;Interneurons;Intervention;Isomerism;Lactation;laser capture microdissection;Length;Life;Link;Mass Spectrum Analysis;mechanotransduction;Mediating;Mediator;Mental Depression;Mental disorders;Mental Health;Methodology;Methods;Microglia;migration;Modeling;mother nutrition;Motor;multidisciplinary;Mus;nanopore;neurodevelopment;Neurodevelopmental Disorder;Neuroimmune;neuropathology;neuropsychiatric disorder;neuropsychiatry;nonhuman primate;novel;offspring;parent project;Patients;Pattern;Polymers;Polysaccharides;polysulfated glycosaminoglycan;postnatal;postnatal development;preclinical study;Pregnancy;prenatal;Prevalence;prevent;Prevention;Process;Proteins;regional difference;Regulation;Reporting;Resolution;response;Risk;Rodent;Schizophrenia;sensor;severe mental illness;single molecule;spatiotemporal;Stimulus;Structure;Sulfate;synaptogenesis;Technology;theories;translational potential;Zika Virus

PROJECT_TITLE: Maternal immune activation remodeling of offspring glycosaminoglycan sulfation patterns during neurodevelopment


NIH_SPENDING_CATS: Autism;Brain Disorders;Intellectual and Developmental Disabilities (IDD);Maternal Health;Maternal Morbidity and Mortality;Mental Health;Women's Health Research

ORG_NAME: NEW YORK UNIVERSITY SCHOOL OF MEDICINE

PHR: PROJECT NARRATIVE No change from original submission

PI_NAMEs: JANECKA, MAGDALENA  (contact)

PROGRAM_OFFICER_NAME: PEVSNER, JONATHAN ABRAM

PROJECT_TERMS: Administrative Supplement;autism spectrum disorder;Genetic Risk;Maternal Health;non-genetic;Pregnancy

PROJECT_TITLE: Maternal health in pregnancy and autism risk - genetic and non-genetic mechanisms - Administrative Supplement


NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Brain Disorders;Clinical Research;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Mental Health;Mental Illness;Neurosciences;Pediatric;Prevention;Racial and Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: CHAPEL HILL

ORG_DEPT: PSYCHOLOGY

ORG_NAME: UNIV OF NORTH CAROLINA CHAPEL HILL

ORG_STATE: NC

PHR: Project Narrative Both adversity and psychopathology experienced in early childhood are profound, yet nonspecific, risk factors for adolescent mental health problems. Identifying neural pathways through which early adversity and psychopathology lead to this risk may improve our prediction models, directly addressing prevention and intervention science. The current study, building on a large and well-characterized existing cohort, is efficiently designed to test specific neural pathways linking adversity and psychopathology in preschool to adolescent psychopathology individually and interactively.

PI_NAMEs: CARPENTER, KIMBERLY L H;COPELAND, WILLIAM ;SHERIDAN, MARGARET ANN (contact)

PROGRAM_OFFICER_NAME: THOMAS, LAURA ANDERSON

PROJECT_TERMS: 10 year old;Address;Adolescence;Adolescent;adolescent mental health;adverse childhood events;Age;aged;Amygdaloid structure;Anterior;Anxiety;Anxiety Disorders;Attention;Attention deficit hyperactivity disorder;Awareness;Behavior;Biological;Black American;Black Populations;Black race;Brain;brain shape;Child;Childhood;childhood adversity;cingulate cortex;Cognitive;cognitive function;cohort;comorbidity;cost effective;critical period;Data;deprivation;design;Detection;Development;Diagnosis;Diagnostic;Dimensions;Disease;Dorsal;early childhood;early life adversity;emerging adult;emerging adulthood;Evaluation;experience;Exposure to;Functional Imaging;Future;health inequalities;Impairment;improved;Individual;innovation;Insula of Reil;Interpersonal Violence;Intervention;Knowledge;Lead;Link;member;Mental Health;Methods;Minority Groups;minority stress;Modeling;National Institute of Mental Health;neural;neural circuit;Neural Pathways;neuroimaging;neuromechanism;Neurophysiology - biologic function;novel;Nursery Schools;Outcome;parent grant;Pathway interactions;Patient Self-Report;peer;Peripheral;physical conditioning;Physiological;predictive modeling;Preschool Child;Prevention;Process;Psychopathology;Race;racial identity;racism;Research;Resources;response;Rest;Risk;Risk Factors;Sampling;Science;Shapes;social;Social Interaction;Societies;Strategic Planning;Stress;stressor;structural imaging;System;Testing;theories;Vulnerable Populations;Work;Youth

PROJECT_TITLE: Neural pathways linking early adversity and preschool psychopathology to adolescent mental health

STUDY_SECTION: PDRP

STUDY_SECTION_NAME: Psychosocial Development, Risk and Prevention Study Section[PDRP]


NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Climate-Related Exposures and Conditions;Genetics;Health Disparities and Racial or Ethnic Minority Health Research;Human Genome;Prevention;Racial and Ethnic Minority Health Research;Skin Cancer

ORG_DEPT: DERMATOLOGY

PHR: Project Narrative Compared to other cancer subtypes with similar incidences, mortalities, and economic burdens, little is known about the genetic landscape and evolution of cutaneous squamous cell carcinoma. For this grant, we will address these gaps in knowledge. Completion of these studies will overcome major obstacles that are currently hindering the development of new therapies and prevention strategies.

PI_NAMEs: SHAIN, ALAN HUNTER (contact)

PROGRAM_OFFICER_NAME: JOHNSON, RONALD L

PROJECT_TERMS: Accounting;Actinic keratosis;Address;Affect;African American population;African ancestry;albino mouse;Animal Model;Animals;Area;Asian Indian;Asian population;Automobile Driving;Basal cell carcinoma;Benign;Biological Markers;cancer risk;cancer subtypes;carcinogenesis;Catalogs;Cells;Cessation of life;Chinese;Clonal Expansion;Color;Communities;Cytosine;Darkness;Data;deep sequencing;Dermatology;Development;Disease;Disease Progression;DNA Damage;DNA Sequence;DNA Sequence Alteration;driver mutation;Economic Burden;epidemiology study;Epidermis;Event;Evolution;exome sequencing;experimental study;Exposure to;Genetic;genetic evolution;genome sequencing;Genomics;Genotype;Goals;Grant;Guidelines;Hair;High Prevalence;Hispanic Populations;Human;Incidence;Individual;innovation;insight;Institution;Intervention;keratinocyte;Keratinocyte cancer;Knowledge;Laboratories;Lesion;Light;Light Cell;Link;Malignant Epithelial Cell;Malignant Neoplasms;malignant state;Measures;Melanins;melanocyte;Melanoma;Methodology;Methods;mortality;Mus;Mutagenesis;Mutagens;Mutation;Mutation Detection;Neoplastic Keratinocyte;Normal tissue morphology;novel therapeutic intervention;novel therapeutics;Observational epidemiology;Pathologic Mutagenesis;Patients;Persons;Phenotype;pheomelanin;Pigmentation physiologic function;Population;Predisposition;Prevention;Prevention strategy;Public Health;Publishing;Reactive Oxygen Species;Research;Resistance;Resolution;response;Risk;Risk Factors;Role;Sensitivity and Specificity;Signal Transduction;Site;Skin;Skin Cancer;Skin Carcinogenesis;Skin Pigmentation;skin squamous cell carcinoma;Somatic Mutation;Source;Squamous cell carcinoma;stem;Sun Exposure;Sunlight;Testing;Therapeutic;Thymine;Time;Ultraviolet B Radiation;ultraviolet damage;Ultraviolet Rays;Uncertainty;United States;UV induced;UV protection;UV Radiation Exposure

PROJECT_TITLE: The genomic landscape and evolution of cutaneous squamous cell carcinoma

STUDY_SECTION: CG

STUDY_SECTION_NAME: Cancer Genetics Study Section[CG]


NIH_SPENDING_CATS: Cancer;Genetics

ORG_DEPT: PEDIATRICS

PHR: Narrative The supplement seeks funds to support the post- baccalaureate training of first-generation college students. Specifically, the training will allow Miss Li to gain valuable research experience for future Ph.D. studies. The research project is related to Aim 2.2. of parental grants and will determine the role of KU on RNA metabolisms in human cells. and Characterize the evolution of KU in human cells that facilitates its RNA-dependent function and high expression.

PI_NAMEs: ZHA, SHAN  (contact)

PROGRAM_OFFICER_NAME: WITKIN, KEREN L

PROJECT_TERMS: Acute;Address;Binding;Bioinformatics;Biomedical Research;C-terminal;cancer therapy;Cells;Cellular biology;college;Critical Thinking;Data;Data Analyses;design;Development;DNA Binding;DNA Repair;DNA-dependent protein kinase;DNA-PKcs;Doctor of Philosophy;Double-Stranded RNA;Evolution;experience;Family;First Generation College Students;Funding;Future;Genetic;Genetic Transcription;Grant;Hematopoiesis;Human;Innate Immune Response;Interferons;kinase inhibitor;Knowledge;Ku Protein;Laboratories;leukemia/lymphoma;Lymphocyte;Malignant - descriptor;Mediating;Mentors;Molecular Biology;Pathway interactions;Physiological;Postbaccalaureate;posttranscriptional;Research;Research Personnel;Research Project Grants;response;RNA;RNA Binding;RNA metabolism;Role;single molecule;skills;Structure;System;Tail;targeted cancer therapy;Testing;Training;Transcript;Tumor Suppression;XRCC5 gene

PROJECT_TITLE: The role of DNA-PKcs in DNA repair, lymphocyte development, RNA metabolism and tumor suppression

STUDY_SECTION: CE

STUDY_SECTION_NAME: Cancer Etiology Study Section[CE]


NIH_SPENDING_CATS: Biotechnology;Cancer;Cancer Genomics;Data Science;Emerging Infectious Diseases;Genetics;Human Genome;Infectious Diseases

ORG_CITY: PITTSBURGH

ORG_NAME: UNIVERSITY OF PITTSBURGH AT PITTSBURGH

PHR: Project Narrative  This project will develop the m6A-Suite informatics pipeline and the m6A-KB knowledgebase to enable global and unbiased delineation of the mechanistic roles of m6A epitranscriptome in cancer. m6A-Suite and m6A-KB address the unmet informatics needs for bridging the knowledge gaps in our understanding of m6A’s roles in cancer biology. They will have a transformative impact on m6A research and provide insights into m6A-based therapeutics.

PI_NAMEs: HUANG, YUFEI  (contact)

PROGRAM_OFFICER_NAME: LI, JERRY

PROJECT_TERMS: Address;anti-cancer research;Area;base;Cancer Biology;cancer cell;Cancer cell line;Catalogs;Cell Line;Cells;Collaborations;Collection;Communities;Data;Data Set;Databases;Detection;epitranscriptome;Feedback;Gene Expression Regulation;Growth;Human;Human Herpesvirus 8;improved;Informatics;informatics tool;insight;Knowledge;knowledgebase;Link;Malignant Neoplasms;Mammalian Cell;Mediating;Messenger RNA;Methylation;Mus;nanopore;Nature;Normal Cell;Normal tissue morphology;Oncogenic Viruses;Pathway interactions;Phenotype;programs;Reader;Research;Resources;RNA Decay;RNA Splicing;Role;Sampling;Site;Testing;Therapeutic;Tissues;tool;training data;Tumor Tissue;Viral;Work

PROJECT_TITLE: m6A-suite: an informatics pipeline and resource for elucidating roles of m6A epitranscriptome in cancer


ADMINISTERING_IC: MD

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

ORG_CITY: ATLANTA

ORG_DEPT: MICROBIOLOGY/IMMUN/VIROLOGY

ORG_NAME: MOREHOUSE SCHOOL OF MEDICINE

PHR: PROJECT NARRATIVE One area where biomedical data science has the real potential to address health disparities is in genomics/multi- omics research which has ushered in a new era of precision medicine and personalized healthcare. The Morehouse School of Medicine (MSM) U54 Center for Translational Research in Health Disparities (CTRHD) is uniquely positioned to leverage genomics/multi-omics to address health disparities as well as training biomedical data scientists from groups underrepresented in the biomedical sciences. We propose a continued collaboration between the MSM and the Florida International University RCMI centers to develop curriculum and a train the trainers program with the goal of upskilling junior investigators in data science best practices and technologies, developing a new cadre of biomedical data scientists to support translational projects and enhance informatics education and training opportunities across Minority Serving Institutions.

PI_NAMEs: KIMBRO, KEVIN SEAN (contact)

PROGRAM_OFFICER_NAME: MUJURU, PRISCAH

PROJECT_TERMS: Address;Administrative Supplement;aging related disease;Area;Artificial Intelligence;Basic Science;Behavioral;Bioinformatics;biomedical data science;Biomedical Research;Black race;Center for Translational Science Activities;cloud based;cohort;Collaborations;collaboratory;Communities;Computer Literacy;Computer software;Data;Data Analyses;data infrastructure;Data Science;data science education;Data Scientist;Data Security;Disparity;Education;Educational Curriculum;Educational process of instructing;Educational workshop;Ethics;Etiology;Exclusion;experience;Female;Florida;Fostering;Funding;Genomics;Goals;hands-on learning;Health;health data;Health Disparities Research;health disparity;health equity promotion;Healthcare;Hispanic;improved;Informatics;Infrastructure;Institution;institutional capacity;Instruction;instructor;International;Investments;Knowledge;Latinx;Machine Learning;Malignant Neoplasms;Marketing;Mentors;minority health;minority health disparity;Minority-Serving Institution;Morehouse School of Medicine;multidisciplinary;multiple omics;National Institute on Minority Health and Health Disparities;next generation;parent project;Pathway interactions;personalized health care;Population;Positioning Attribute;precision medicine;programs;R programming language;Recording of previous events;recruit;Reporting;Reproducibility;Research;Research Personnel;Resources;Science;Scientist;Self Efficacy;Series;skills;Solid;success;Teacher Professional Development;Techniques;technological innovation;Technology;tool;Trainers Training;Training;Training and Education;training opportunity;Training Programs;Underrepresented Populations;Underrepresented Students;United States National Institutes of Health;Universities;virtual

PROJECT_TITLE: Training the Trainers: Building Institutional Data Science Capacity to Support Health Disparities Research


NIH_SPENDING_CATS: Biotechnology;Clinical Research;Genetics;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Human Genome;Social Determinants of Health

PHR: PROJECT NARRATIVE This project aims to build capacity in bioethics through sustained and systematic multidisciplinary explorations of frameworks of justice and their applications to bioethics research on the ethical and equitable development and deployment of biotechnologies, including in genomics, AI and precision medicine. We will create a hybrid series Justice Dialogues and related educational resources to support justice-forward bioethics research and researchers.

PI_NAMEs: CALLIER, SHAWNEEQUA ;LEE, SANDRA SOO-JIN (contact);SHIM, JANET K

PROGRAM_OFFICER_NAME: STERLING, RENE

PROJECT_TITLE: Just Inclusion and Equity: Negotiating Community-Research Partnerships in Genomics Research (JUSTICE)

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1(80)-R]


NIH_SPENDING_CATS: Cancer;Immunotherapy

PHR: PROJECT NARRATIVE Some patients’ immune system can be triggered with immunotherapies, leading to their cure. Those patients have a collection of ‘reactive’ immune cells in their tumors, and this proposal will figure out how a particular molecule functions within those cells, leading to cures. The project will also result in the training of an outstanding young scientist.

PI_NAMEs: KRUMMEL, MATTHEW F (contact)

PROGRAM_OFFICER_NAME: LIU, YIN

PROJECT_TITLE: The Tumor Microenvironment Niche of Type I conventional Dendritic Cells

STUDY_SECTION_NAME: Special Emphasis Panel[ZRG1(80)-S]


ADMINISTERING_IC: EB

IC_NAME: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

NIH_SPENDING_CATS: Behavioral and Social Science;Bioengineering;Biotechnology;Machine Learning and Artificial Intelligence;Networking and Information Technology R&D (NITRD);Prevention;Social Determinants of Health

ORG_CITY: MEMPHIS

ORG_DEPT: BIOSTATISTICS & OTHER MATH SCI

ORG_NAME: UNIVERSITY OF MEMPHIS

ORG_STATE: TN

PHR: Administrative Supplement to P41EB028242 award (The mDOT Center): WristPrint: Bioethical Policy Implications of the Emerging Re-identifiability Risks from Wrist-worn Activity Data. Principal Investigator: Santosh Kumar, PhD Project Narrative/Public Health Relevance: Wrist-worn wearables hold tremendous public health potential by providing unprecedented visibility into and promoting health-related daily behaviors via passive and continuous measurements at a large scale. Open data sets are critical to accelerate this scientific progress and the adoption among people for health care and self- care. By ensuring that emerging new bioethics risks of re-identifiability from the sharing of wrist-worn motion data are well understood, widely acknowledged, and adequately mitigated, this project will contribute to supporting the advancement in public health from the growing capabilities and adoption of these wearables.

PI_NAMEs: KUMAR, SANTOSH  (contact)

PROGRAM_OFFICER_NAME: LASH, TIFFANI BAILEY

PROJECT_TERMS: Acceleration;Accelerometer;Address;Administrative Supplement;Adoption;Archives;Artificial Intelligence;Award;Awareness;Behavior;Bioethics;Biological Markers;Characteristics;Chronic Disease;Code;cohort;Collaborations;Communities;Country;course module;Data;Data Collection;Data Science;Data Set;data sharing;design;Development;Devices;dissemination strategy;Doctor of Philosophy;Education;Educational workshop;Ensure;Ethics;Evaluation;Evolution;Faculty;Funding;Future;generative artificial intelligence;Goals;Health;Health behavior;Health Promotion;Healthcare;Hour;Human;Human Subject Research;Informed Consent;Infrastructure;Institution;Institutional Review Boards;Intervention;Joints;Language;large language model;learning algorithm;Learning Module;lectures;Link;Location;Machine Learning;marijuana use;Measurement;meetings;Methods;mHealth;mhealth interventions;Modeling;Motion;motion sensor;open data;Oral health;parent project;Participant;Persons;Policies;policy implication;Policy Maker;prevent;Principal Investigator;Privacy;protocol development;Protocols documentation;Psychological reinforcement;Public Health;public health relevance;Public Policy;Publishing;Research;Research Personnel;research study;research vision;Resources;Rights;Risk;risk sharing;Science;Science Policy;Self Care;sensor;Services;Site;smart watch;Smoking;social media;Stress;Structure;Surveys;technology research and development;technology training;Time;tool;Training;Translations;Trust;Uncertainty;United States National Institutes of Health;wearable data;wearable device;webinar;welfare;Work;Wrist