Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=5&sort=-abstract
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-abstract", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1442&sort=-abstract", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=6&sort=-abstract", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=4&sort=-abstract" }, "data": [ { "type": "Grant", "id": "10671", "attributes": { "award_id": "1U01IP001194-01", "title": "RFA-IP-22-004, US Platform to Measure Effectiveness of Seasonal Influenza, COVID-19 and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-09-30", "end_date": "2027-09-29", "award_amount": 987989, "principal_investigator": { "id": 26731, "first_name": "EMMANUEL B", "last_name": "WALTER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "– Duke Human Vaccine Institute Duke University is pleased to respond to RFA-IP-22-004 entitled “US Platform to Measure the Effectiveness of Seasonal Influenza, COVID-19 and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings” by submitting the application for Component B. Duke University will coordinate the activities of the Centers for Disease Control and Prevention’s Respiratory Virus Vaccine Effectiveness Network incorporating the collective breadth of scientific, program management, regulatory, data management, statistical, and information technology expertise of the Duke Human Vaccine Institute (DHVI). In particular, we will leverage our vast prior experience coordinating clinical investigations for both NIAID and the CDC to help facilitate the work of this project. The Duke Network Coordinating Center (NCC) will provide logistical and coordinating support by facilitating network communications through hosting video and in-person conferences, hosting a network SharePoint, providing reports and project updates and establishing a clear communication plan for network activities. As the NCC, The DHVI will help facilitate protocol development and establish standard operating procedures for network investigations. Studies will include evaluations of both influenza and SARS-CoV-2 vaccine effectiveness at preventing symptomatic respiratory infection in the community and household settings. As the NCC, the DHVI is also well poised to support network studies assessing vaccine immunogenicity in addition to studies using more complex virologic and immunologic influenza assays to detect influenza virus infection and the host immune response to infection. Working with the Duke University Health System IRB, the Duke NCC will provide the regulatory support to facilitate single IRB requirements. Through our established quality management programs, we will also assure that network studies are performed in a manner which adhere to good clinical practice. The Duke NCC will provide data management and statistical support for network studies. Duke will build and host project specific REDCap databases from which information can be readily exported to provide project updates through dashboards. Data exports will also be utilized to create reports, presentations and manuscripts to disseminate information regarding the current effectiveness of the respiratory virus vaccine being evaluated given the circulating virus strains or variants.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "6775", "attributes": { "award_id": "1U19AI171403-01", "title": "Core F – High-Throughput Screening", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2022-05-16", "end_date": "2025-04-30", "award_amount": 2817180, "principal_investigator": { "id": 22580, "first_name": "Robert Marsden", "last_name": "Cox", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 265, "ror": "https://ror.org/03czfpz43", "name": "Emory University", "address": "", "city": "", "state": "GA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 265, "ror": "https://ror.org/03czfpz43", "name": "Emory University", "address": "", "city": "", "state": "GA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Core F The coronavirus disease (COVID-19) pandemic has led to devastating impacts on public health and the global economy. Without effective means of controlling the spread of severe acute respiratory virus 2 (SARS- CoV-2), the etiological agent of COVID-19, the number of new infections exploded in early 2020. In less than two years, over 230 million individuals have been infected, leading to more than 4.7 million deaths. The lack of effective antiviral countermeasures contributed greatly to the inability of public health organizations to halt the initial spread of SARS-CoV-2. While efficacious vaccines are currently available, key factors, such as vaccine hesitancy and the rise of SARS-CoV-2 variants capable of escaping natural and vaccine induced immunity, have limited our ability decrease the spread of new SARS-CoV-2 cases and end the current pandemic. The COVID- 19 pandemic has underscored the urgent need for effective antiviral countermeasures to limit the spread and severity of current and future viral threats. Orally-available direct-acting antivirals (DAA) would provide a valuable weapon in the war to halt COVID-19. The objective of the Antiviral Countermeasure Development Center (AC/DC) will be to identify and develop DAA therapeutics to mitigate current and future viral threats. To fulfill this objective and identify new DAA chemotypes, the AC/DC High-Throughput Screening (HTS) Core (Core F) will perform high-throughput screening campaigns against the various pathogens of concern investigated within AC/DC. Building on our expertise in drug discovery and previous success in identifying and developing orally available antivirals, such molnupiravir/EIDD-2801, EIDD-2749, GS-621763, GHP-88309, ERDRP-0519, and AVG-233, Core F will utilize a state-of-the-art HTS facility under BSL3 conditions to identify new antiviral hit candidates against various RNA viruses of pandemic potential under investigation within AC/DC. Core F will work individual AC/DC research projects to miniaturize, optimize, and validate assays for use in HTS campaigns. We will implement fully automated HTS protocols to screen our extensive library of small molecules to identify new hit scaffolds for further development within AC/DC (specific aim 1). In pilot studies with Research Projects 1 and 3, we have developed and optimized fully automated HTS assays using Cedar henipavirus (CedV) and SARS-CoV-2 luciferase reporter viruses. We then implemented these HTS protocols and completed successful screening campaigns against CedV and SARS-CoV-2, identifying several promising hit scaffolds for future mechanistic characterization and synthetic optimization. In addition to screening, Core F will generate bioactivity profiles of new analogs of hit candidates created by Core B to promote cross-core cooperation to significantly increase the speed of hit-to-lead development (specific aim 2). Core F will also acquire and perform HTS on new compound libraries, providing an additional mechanism for expansion of the AC/DC hit-to-lead pipeline, ensuring that the key goals of AC/DC are fulfilled (specific aim 3).", "keywords": [ "2019-nCoV", "Acute", "Antiviral Agents", "Antiviral Therapy", "Biological Assay", "COVID-19", "COVID-19 pandemic", "Cessation of life", "Chemicals", "Collaborations", "Communities", "Data", "Development", "Disease Outbreaks", "Drug Design", "Eligibility Determination", "Ensure", "Etiology", "Future", "Generations", "Goals", "Henipavirus", "Individual", "Infection", "Investigation", "Knowledge", "Lead", "Libraries", "Luciferases", "Medical", "Methods", "Oral", "Pharmaceutical Chemistry", "Pilot Projects", "Protocols documentation", "Public Health", "Quarantine", "RNA Viruses", "Reporter", "Research Project Grants", "SARS-CoV-2 variant", "Severities", "Severity of illness", "Speed", "Testing", "Therapeutic", "Time", "Toxic effect", "Vaccines", "Variant", "Viral", "Virus", "War", "Work", "acquired immunity", "analog", "assay development", "combat", "coronavirus disease", "drug discovery", "experience", "health organization", "high throughput screening", "in silico", "miniaturize", "novel", "pandemic disease", "pathogen", "preclinical development", "programs", "respiratory virus", "routine screening", "scaffold", "screening", "small molecule", "small molecule libraries", "success", "synergism", "tool", "vaccination strategy", "vaccine hesitancy", "vaccine-induced immunity", "weapons" ], "approved": true } }, { "type": "Grant", "id": "15234", "attributes": { "award_id": "1U19AI181881-01", "title": "Core C: Vaccine production and process development", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2024-08-12", "end_date": "2027-07-31", "award_amount": 5637003, "principal_investigator": { "id": 31818, "first_name": "Lauren", "last_name": "Carter", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 159, "ror": "https://ror.org/00cvxb145", "name": "University of Washington", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "– CORE C: VACCINE PRODUCTION AND PROCESS DEVELOPMENT The Vaccine Production and Process Development Core will provide both high-throughput and scalable biologics production and characterization as well as comprehensive process development to support protein- and mRNA-based vaccine development in our Center and the broader ReVAMPP network. Protein production and characterization efforts will leverage the expansive facilities, high-tech equipment, and unique expertise in designed proteins and nanoparticle immunogens at UW’s Institute for Protein Design (IPD). In addition to the designed antigens and nanoparticle vaccines produced to support Projects 3-5 of our Center, the Core will produce and provide to the ReVAMPP network high-quality protein reagents such as monoclonal antibodies, viral entry receptors, and benchmark antigens to accelerate vaccine design and evaluation broadly. mRNA vaccine production and characterization will take place in a newly formed mRNA Core Laboratory at the IPD built on cutting-edge equipment and production processes from Quantoom Biosciences, as well as lipid nanoparticle formulation through an ongoing collaboration with Acuitas Therapeutics. Core C will also perform detailed and comprehensive process development on our lead vaccine candidates, building on the IPD’s proven track record in translating innovative protein-based medicines and vaccines to industry and government partners. A dedicated team at the IPD will develop the methods, data, and documentation for comprehensive technology transfer packages that will speed preclinical and clinical development of our arenavirus, phenuivirus, and paramyxovirus vaccines. Our team has successfully transferred eight computationally designed protein medicines to industry or government partners for cGMP manufacturing and clinical development, including three nanoparticle vaccines that have all entered clinical trials, one of which, our RBD nanoparticle vaccine for SARS-CoV-2, has been licensed for use in multiple countries. The unique expertise, scale, and capabilities of Core C will be a key component of our Center that, moving forward, will provide a flexible and responsive infrastructure that can rapidly respond to emerging threats.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "10316", "attributes": { "award_id": "1P01AI167966-01", "title": "Core B: Virology Core", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2022-09-02", "end_date": "2025-08-31", "award_amount": 2153145, "principal_investigator": { "id": 6339, "first_name": "Ralph S", "last_name": "Baric", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 456, "ror": "https://ror.org/05dq2gs74", "name": "Vanderbilt University Medical Center", "address": "", "city": "", "state": "TN", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 159, "ror": "https://ror.org/00cvxb145", "name": "University of Washington", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "– CORE B: VIROLOGY Zoonotic coronaviruses (CoV) are responsible for three major epidemics/pandemics in the 21st century, including Severe Acute Respiratory Coronavirus (SARS-CoV) in 2003 and Middle East Respiratory coronavirus (MERS- CoV) in 2012. In December 2019 a third novel coronavirus designated SARS-CoV-2 emerged in Wuhan China, and in the space of 18 months has caused over 170 million cases and 3,500,000 deaths in more than 220 countries. About one-sixth of these total cases have been reported in the US, resulting in over 600,000 deaths. Of concern, multiple distinct SARS-like and MERS-like CoV strains reside in bats and other species and are poised to emerge in the future, creating a critical need for broadly protective vaccines. We seek to develop a pan-betacoronavirus vaccine that will universally protect against viruses from the sarbecovirus, merbecovirus, and embecovirus subgenera. The goals of Core B (Virology, Baric) are to: i) provide group sarbecovirus, merbecovirus, and embecovirus animal models of human disease for evaluating vaccine performance; ii) develop reverse genetic platforms, recombinant viruses, and animal models to other high risk zoonotic coronaviruses; iii) evaluate virus evolution in the expanding SARS-CoV-22 pandemic and create appropriate reagents to evaluate pan-betacoronavirus vaccine performance in vivo; and iv) evaluate the mechanisms regulating protective or pathogenic immune responses after homologous (i.e., vaccine-strain) and heterologous challenge. The overall goal is to identify high-performance pan-sarbecovirus and pan-betacoronavirus vaccine candidates that provide robust protective immune responses in at least two animal models.", "keywords": [ "2019-nCoV", "Acute Respiratory Distress Syndrome", "Adverse reactions", "Animal Model", "Antibodies", "Biological Assay", "Blood Coagulation Disorders", "COVID-19", "Cessation of life", "China", "Chiroptera", "Clinical", "Collaborations", "Coronavirus", "Country", "Data", "Disease", "Distant", "Ensure", "Epidemic", "Epitopes", "Evolution", "Future", "Generations", "Goals", "Human", "Immune", "Immune Sera", "Immune System Diseases", "Immune response", "Immunity", "Immunotherapeutic agent", "Infection", "Laboratories", "Leukocytes", "Maps", "Merbecovirus", "Middle East", "Middle East Respiratory Syndrome", "Middle East Respiratory Syndrome Coronavirus", "Mus", "Outcome", "Pathogenesis", "Pathogenicity", "Performance", "Pneumonia", "Primates", "Production", "Program Research Project Grants", "Reagent", "Recombinants", "Reporting", "Respiratory physiology", "SARS coronavirus", "SARS-CoV-2 B.1.1.7", "SARS-CoV-2 B.1.351", "Sampling", "Sarbecovirus", "Serum", "Severe Acute Respiratory Syndrome", "Shock", "Stroke", "Structure", "Syndrome", "Talents", "Tropism", "Vaccine Design", "Vaccines", "Variant", "Viral", "Virulent", "Virus", "Zoonoses", "aged", "animal coronavirus", "animal model development", "base", "betacoronavirus", "betacoronavirus vaccine", "comparative", "coronavirus vaccine", "cytokine", "design", "high risk", "human disease", "human model", "in vivo", "model development", "mouse model", "nanoluciferase", "nanoparticle", "neutralizing antibody", "nonhuman primate", "novel", "novel coronavirus", "pandemic disease", "programs", "recombinant virus", "recruit", "respiratory", "response", "reverse genetics", "structural biology", "universal vaccine", "vaccine candidate", "vaccine evaluation", "vaccine platform", "vaccine response", "vaccine-induced antibodies", "vaccinology", "variants of concern", "virology", "zoonotic coronavirus" ], "approved": true } }, { "type": "Grant", "id": "10571", "attributes": { "award_id": "1U01IP001182-01", "title": "RFA-IP-22-004, Multidisciplinary Approach to Understanding Vaccine Efficacy and Transmission of Viral Respiratory Tract Infections in the Real World", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-09-30", "end_date": "2027-09-29", "award_amount": 2483947, "principal_investigator": { "id": 26592, "first_name": "Stacey", "last_name": "House", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 827, "ror": "", "name": "WASHINGTON UNIVERSITY", "address": "", "city": "", "state": "MO", "zip": "", "country": "United States", "approved": true }, "abstract": "– COMPONENT A Influenza and SARS-CoV-2 are major causes of morbidity and mortality and constitute the leading causes of vaccine preventable deaths in the United States. A better understanding of vaccine effectiveness for these viral pathogens is critical to drive public health decisions and interventions. We propose utilizing a multidisciplinary approach to conduct a test-negative study to determine influenza and SARS-CoV-2 vaccine effectiveness in ambulatory patients with respiratory tract infections. The team of investigators includes experts in emergency medicine, infectious disease, pediatrics, epidemiology, information technology, molecular microbiology, virology, and genetics. This team has extensive experience in automated electronic medical record alerts, high-volume subject recruitment of ambulatory patients with respiratory tract infections, rapid escalation/de-escalation of recruitment efforts to match viral circulation patterns, respiratory and blood sample processing and shipment, quality data collection and verification, and viral genomic sequencing necessary to ensure the success of this project. The proposed study will encompass the following specific aims: 1)Utilize innovative automated alerting strategies to identify and recruit a diverse population of ambulatory patients with acute respiratory illnesses; 2) Estimate influenza and SARS-CoV-2 vaccine effectiveness using a test- negative study design in the general population as well as different demographic subgroups.; 3) Explore factors that influence influenza and SARS-CoV-2 vaccine effectiveness such as co-morbidities, vaccination type and schedule, and social determinants of health; 4) Determine effect of viral vaccination status on health outcomes in ambulatory patients with influenza and SARS-CoV-2 infection; 5) Contribute biospecimens and viral genomic sequencing data to a national repository of subjects with PCR-confirmed influenza or SARS-CoV-2 infection. To accomplish these goals, we will enroll at least 1000 ambulatory patients/year with acute respiratory tract infections in the proposed study. The subject population will be identified from the emergency departments of 3 large hospitals in the St. Louis area and their associated outpatient clinics. The available patient population at these enrolling sites is diverse with respect to race, ethnicity, age, socioeconomic status, and medical care access which will enhance the generalizability of the study outcomes to the US population.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "10692", "attributes": { "award_id": "1U01IP001184-01", "title": "RFA-IP-22-004, Evaluating respiratory virus vaccine effectiveness in a large, diverse healthcare system", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-09-30", "end_date": "2027-09-30", "award_amount": 2495017, "principal_investigator": { "id": 26748, "first_name": "RICHARD K", "last_name": "ZIMMERMAN", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Component A We are applying for RFA components A and D. This abstract refers to Component A. Influenza/pneumonia comprise the 9th and COVID-19 the 3rd leading cause of death in the U.S., with the pandemic entering its 3rd year. Vaccine effectiveness (VE) estimates vary by host factors, viral clade, match to circulating virus, time since vaccination (i.e., waning) and specific vaccine characteristics. PittVax and collaborators have been integral to the US Flu VE Network for 12 years, contributing to influ- enza and COVID-19 VE estimates. Among the current 7 Network sites, PittVax ranks #2 in enrollments, #2 in bloodspot collections, and #1 in follow-up survey completion, while exceeding enrollment goals. PittVax has published >300 peer-reviewed articles in the field. We propose a test-negative case-control design (TND) study among UPMC and federally qualified health center (FQHC) outpatients to determine influenza, COVID-19 and possibly, other respiratory virus VE. Our specific aims are: 1) Determine VE against laboratory-confirmed, medically-attended, acute respiratory in- fections among 1000-1200 outpatients during the influenza season in age groups: 6 mos-18 yrs, 19-49 yrs, and ≥50 yrs, using test negative design in onsite enrollment during respiratory season plus remote enroll- ment outside of influenza season (another 400-900 if COVID-19 persists); 2) provide genetic sequencing on selected specimens for biweekly trends in clade; and 3) determine the annual, population-based burden of influenza and COVID-19 for Allegheny County (Pittsburgh) from the UPMC Health Plan. For determining prior infection for SARS-CoV-2 (e.g., N protein) in the highest proportion of participants, we propose finger- stick bloodspots, supplemented by sera on a subset, for more in-depth studies. The Williams lab, using vali- dated 96-well plate instruments for RT-PCR, which analyzed >10,000 specimens over the last 6 years for influenza, SARS-CoV-2 and other respiratory viruses, will determine presence of infecting viruses. The ex- perienced Harrison lab will perform viral genomic sequencing. We will obtain immunization records from the state’s registry and from UPMC’s and the FQHC’s electronic records. UPMC Health Plan is the largest insurer in Allegheny County and at UPMC in 2021-22, >126,000 county residents were clinically tested for SARS-CoV-2. Annually, UPMC records >5.6 million outpatient visits. Over 1.4 million UPMC acute care visits a year are assessed at Emergency Departments (EDs) and Urgent Care clinics through a common structure and e-record with 305,751 ED visits in 2021 among our four recruiting EDs. UPMC has been rated one of the most wired health systems for 23 years. To address health equity, we add FQHC offices serving mostly persons of color and leadership from the Black Equity Coalition to our multidisciplinary team to assist with culturally competent script/survey development, inclusion of social deter- minants of health data and dissemination of findings with a health equity perspective.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "9813", "attributes": { "award_id": "1P30AI168440-01", "title": "UCSF-UCB TRAC Clinical Sciences Core", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2022-08-02", "end_date": "2027-05-31", "award_amount": 207465, "principal_investigator": { "id": 25673, "first_name": "Priya B.", "last_name": "Shete", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 768, "ror": "https://ror.org/043mz5j54", "name": "University of California, San Francisco", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Clinical Science Core Progress towards meeting global public health tuberculosis (TB) targets for reductions in incidence, mortality and catastrophic costs have been slow, and appear to have stagnated due the recent COVID-19 pandemic. Without reinvigorating TB clinical research with an infusion of new investigators, novel perspectives, and cutting-edge innovation, we remain at risk of allowing the TB pandemic to continue unabated. The goal of the Clinical Science Core of the UCSF-UCB TRAC is to augment existing UCSF and UCB resources to accelerate clinical research by engaging New Investigators and established investigators new-to-TB, and by reducing the barrier to conducting high-quality, innovating clinical research. UCSF-UCB TRAC Clinical Science Core will support investigators by 1) providing consultation on key aspects of TB clinical research; 2) providing consultation about novel methodologic approaches in clinical research that may be applied to TB; 3) facilitating access to clinical cohorts, datasets, bio-specimens, and clinical research tools; 4) supporting meaningful community engagement via a TRAC TB Community Advisory Board; 5) supporting career development of new investigators with targeted mentorship. The Clinical Science Core will encourage an interdisciplinary approach to TB clinical research by making services and resources available for researchers from diverse fields including basic sciences, epidemiology, bioinformatics, public health, social sciences and clinical sciences. The Clinical Science Core hopes to attract and inspire a new generation of TB scientists to accelerate TB biomedical and clinical research with the support of UCSF-UCB TRAC faculty who are leaders in TB clinical sciences.", "keywords": [ "Affect", "Area", "Basic Science", "Bioinformatics", "Biological", "Biomedical Research", "Biometry", "COVID-19 pandemic", "Caring", "Clinical", "Clinical Research", "Clinical Sciences", "Collaborations", "Communities", "Conceptions", "Consultations", "Data", "Data Science", "Data Set", "Databases", "Development", "Discipline", "Disease", "Dissemination and Implementation", "Doctor of Philosophy", "Ecosystem", "Epidemiology", "Evaluation", "Faculty", "Feedback", "Fostering", "Generations", "Goals", "Health Status", "Human", "Human Subject Research", "Incidence", "Individual", "Infrastructure", "Infusion procedures", "International", "Intervention Trial", "Investigation", "Link", "Mentors", "Mentorship", "Methodology", "Methods", "Outcome", "Participant", "Population Sciences", "Populations at Risk", "Prevention", "Prospective cohort", "Public Health", "Research", "Research Design", "Research Methodology", "Research Personnel", "Resources", "Risk", "Scientist", "Services", "Social Sciences", "Source", "Specimen", "Statistical Data Interpretation", "Training", "Tuberculosis", "base", "bench to bedside", "career development", "clinical center", "clinical research site", "cohort", "community center", "community engagement", "cost", "data management", "design", "experience", "improved", "innovation", "interdisciplinary approach", "meetings", "mortality", "multidisciplinary", "novel", "pandemic disease", "population health", "programs", "repository", "research study", "scale up", "searchable database", "tool", "translational study" ], "approved": true } }, { "type": "Grant", "id": "11493", "attributes": { "award_id": "5P30AI168440-02", "title": "UCSF-UCB TRAC Clinical Sciences Core", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2022-08-02", "end_date": "2027-05-31", "award_amount": 192976, "principal_investigator": { "id": 25673, "first_name": "Priya B.", "last_name": "Shete", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 768, "ror": "https://ror.org/043mz5j54", "name": "University of California, San Francisco", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Clinical Science Core Progress towards meeting global public health tuberculosis (TB) targets for reductions in incidence, mortality and catastrophic costs have been slow, and appear to have stagnated due the recent COVID-19 pandemic. Without reinvigorating TB clinical research with an infusion of new investigators, novel perspectives, and cutting-edge innovation, we remain at risk of allowing the TB pandemic to continue unabated. The goal of the Clinical Science Core of the UCSF-UCB TRAC is to augment existing UCSF and UCB resources to accelerate clinical research by engaging New Investigators and established investigators new-to-TB, and by reducing the barrier to conducting high-quality, innovating clinical research. UCSF-UCB TRAC Clinical Science Core will support investigators by 1) providing consultation on key aspects of TB clinical research; 2) providing consultation about novel methodologic approaches in clinical research that may be applied to TB; 3) facilitating access to clinical cohorts, datasets, bio-specimens, and clinical research tools; 4) supporting meaningful community engagement via a TRAC TB Community Advisory Board; 5) supporting career development of new investigators with targeted mentorship. The Clinical Science Core will encourage an interdisciplinary approach to TB clinical research by making services and resources available for researchers from diverse fields including basic sciences, epidemiology, bioinformatics, public health, social sciences and clinical sciences. The Clinical Science Core hopes to attract and inspire a new generation of TB scientists to accelerate TB biomedical and clinical research with the support of UCSF-UCB TRAC faculty who are leaders in TB clinical sciences.", "keywords": [ "Acceleration", "Affect", "Area", "Basic Science", "Bioinformatics", "Biological", "Biomedical Research", "Biometry", "COVID-19 pandemic", "Caring", "Clinical", "Clinical Research", "Clinical Sciences", "Collaborations", "Communities", "Conceptions", "Consultations", "Data", "Data Science", "Data Set", "Databases", "Development", "Discipline", "Disease", "Dissemination and Implementation", "Doctor of Philosophy", "Ecosystem", "Epidemiology", "Evaluation", "Faculty", "Feedback", "Fostering", "Generations", "Goals", "Health Status", "Human", "Human Subject Research", "Incidence", "Individual", "Infrastructure", "Infusion procedures", "International", "Intervention Trial", "Investigation", "Link", "Mentors", "Mentorship", "Methodology", "Methods", "Outcome", "Participant", "Population Sciences", "Populations at Risk", "Prevention", "Prospective cohort study", "Public Health", "Research", "Research Design", "Research Methodology", "Research Personnel", "Resources", "Risk", "Scientist", "Services", "Social Sciences", "Source", "Specimen", "Statistical Data Interpretation", "Training", "Tuberculosis", "bench-to-bedside translation", "career development", "clinical center", "clinical research site", "cohort", "community center", "community engagement", "cost", "data management", "design", "experience", "improved", "innovation", "interdisciplinary approach", "meetings", "mortality", "multidisciplinary", "novel", "pandemic disease", "population health", "programs", "repository", "research study", "scale up", "searchable database", "tool", "translational study" ], "approved": true } }, { "type": "Grant", "id": "12250", "attributes": { "award_id": "2U54HL143541-06", "title": "Clinical Core", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 24882, "first_name": "JUE", "last_name": "CHEN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-07-01", "end_date": "2028-08-31", "award_amount": 255598, "principal_investigator": { "id": 24884, "first_name": "David D.", "last_name": "McManus", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 790, "ror": "", "name": "UNIV OF MASSACHUSETTS MED SCH WORCESTER", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Clinical Core Point-of-care (POC) and home-based technologies are increasingly important tools for patients, caregivers, and healthcare providers to diagnose and treat critical health issues. In acute care settings, clinicians and caregivers need real-time data to guide management of potentially rapidly changing health conditions; in home settings, providers seek new ways to better communicate and engage patients in promoting health and managing chronic conditions. The commercialization and adoption of technologies sold over the counter and intended for home use has been accelerated by the COVID-19 pandemic and increasingly allows for the realization of more empowered and proactive patient care. As a Technology Research and Development Center (TRDC), the goal of the Center for Advancing Point of Care Technologies (CAPCaT) is to develop and optimize novel POC and home-based technologies to improve the diagnosis and treatment of Heart, Lung, Blood and Sleep (HLBS) disorders. The CAPCaT Clinical Core will contribute to this goal by leveraging core competencies to facilitate clinical validation and usability studies, especially those that address health inequity and can be used in underserved communities. As the primary POC Technology Research Network (POCTRN) member responsible for leading clinicals studies for RADx Tech, CAPCaT partnered with community organizations, practice-based and academic clinical trial networks, members of the FDA and other regulators, and industry partners to design and execute inclusive clinical studies involving over 15,000 participants from racially and geographically diverse backgrounds.(1) The CAPCaT Clinical Core will capitalize on its unique infrastructure and expert team to continue to provide support for the design and execution of clinical studies to demonstrate the usability and efficacy of devices that advance disease management. To date, the CAPCaT Clinical Core has worked successfully with its External Advisory Committee and Data Safety Monitoring Board to monitor, engage, and support 23 HLBS innovators by providing technical, logistical, and operational support to CAPCaT teams conducting later-stage clinical validation and usability studies, including demonstration studies that adapt technologies for use in lower resource environments. Our team, experience and competencies make us uniquely suited to provide the broad array of services that facilitate clinical research and support the development of devices to improve the diagnosis and treatment of HLBS disorders and promote health equity. Our objectives in achieving this goal are to continue: 1) Select clinically relevant POC and home-based technologies and design innovative and inclusive clinical validation and usability studies; 2) Support CAPCaT clinical validation and usability studies that engage key stakeholders to contextualize study findings and promote implementation.", "keywords": [ "Acceleration", "Address", "Adherence", "Adoption", "Advisory Committees", "Antigens", "Blood", "COVID-19", "COVID-19 pandemic", "COVID-19 test", "Caregivers", "Chronic", "Clinical", "Clinical Research", "Clinical Trials", "Clinical Trials Data Monitoring Committees", "Clinical Trials Network", "Communication", "Community Health Networks", "Competence", "Data", "Data Collection", "Device or Instrument Development", "Devices", "Diagnosis", "Disease Management", "Elements", "Enrollment", "Ensure", "Evaluation", "Geography", "Goals", "Health", "Health Personnel", "Health Promotion", "Health system", "Heart", "Heart Diseases", "Hematological Disease", "Home", "Informatics", "Infrastructure", "Investments", "Lung", "Lung diseases", "Methods", "Monitor", "Participant", "Patient Care", "Patient Recruitments", "Patients", "Point of Care Technology", "Practice Guidelines", "Process", "Provider", "RADx Tech", "Race", "Reporting", "Research", "Resource-limited setting", "Resources", "SARS-CoV-2 infection", "Services", "Sleep", "Sleep Disorders", "Technology", "Testing", "Time", "Translations", "United States National Institutes of Health", "Validation", "Work", "acute care", "advanced disease", "clinically relevant", "commercialization", "community organizations", "design", "digital", "digital health", "empowerment", "ethnic diversity", "experience", "health equity", "health equity promotion", "health inequalities", "home test", "improved", "industry partner", "innovation", "member", "new technology", "novel", "operation", "patient advocacy group", "patient engagement", "patient oriented", "point of care", "pragmatic study", "prevent", "racial diversity", "success", "technology research and development", "tool", "trial design", "underserved community", "usability", "validation studies" ], "approved": true } }, { "type": "Grant", "id": "8554", "attributes": { "award_id": "1PL1HD105462-01", "title": "Collaborative Pediatric Critical Care Research Network - Clinical Site", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2021-08-13", "end_date": "2026-07-31", "award_amount": 86490, "principal_investigator": { "id": 24323, "first_name": "Ayse", "last_name": "Akcan Arikan", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 202, "ror": "https://ror.org/03r0ha626", "name": "University of Utah", "address": "", "city": "", "state": "UT", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 202, "ror": "https://ror.org/03r0ha626", "name": "University of Utah", "address": "", "city": "", "state": "UT", "zip": "", "country": "United States", "approved": true }, "abstract": "– Baylor College of Medicine/Texas Children's Hospital The goals of the current proposal are to reorganize and expand the Collaborative Pediatric Critical Care Research Network (CPCCRN), to mentor young investigators in CPCCRN to become independent investigators, and to implement the multi-center randomized controlled “Personalized Immunomodulation in Sepsis-Induced Multiple Organ Dysfunction” interventional trial. The newly organized CPCCRN will expand from 7 to 24 clinical sites (12 Primary and 12 Ancillary sites), which will be the largest NIH Pediatric Critical Care Research Network to date. We at Baylor College of Medicine (BCM) - Texas Children's Hospital (TCH; Primary Site) and Children's Hospital of San Antonio (CHofSA; Ancillary Site) are very enthusiastic about participating as new sites. TCH is the largest freestanding children's hospital system in the U.S. and is one of the best (Rank #4 Children's Hospital by U.S. News & World Report 2020-2021). We have every pediatric subspecialty and offer every service expected in a quaternary pediatric center. We have an extensive track record of successful collaboration in multi-center clinical trials such as the Pediatric Acute Lung Injury and Sepsis Investigators and the Pediatric Heart Network. In combination with our CHofSA partner, we will provide access to 163+24 beds with 6000 annual admissions, enabling us to participate fully in the “Personalized Immunomodulation in Sepsis-induced Multiple Organ Dysfunction (MODS)” trial described in the Overall Component of this application. Our sites have several highly talented young faculty, who have career development grants with innovative translational research projects, and will contribute to the success of CPCCRN. For example, Dr. Desai (K12 recipient) pioneered the field of pediatric cirrhotic cardiomyopathy and bile acid-myocardial interaction (cholecardia). His aim is to improve outcomes of pediatric liver failure through decreasing circulating pathologic bile acids by novel bile acid sequestrants and blood purification techniques. Dr. Lam (K08 recipient) develops novel protein to attenuate inflammation through inhibiting leukocyte-platelet- endothelial interactions. His aim is to improve outcomes in pediatric liver failure and more recently, COVID19- induced inflammation. Dr. Nguyen, our Co-Investigator, is R01 funded to study mechanisms of sepsis-induced MODS and to develop targeted novel agent for this deadly disease. His aim is to obtain Investigational New Drug status for his novel A2 Protein from the Food and Drug Administration, and subsequently, to enter A2 Protein in clinical trials such as CPCCRN. Dr. Arikan, our site Principle Investigator, plans to study the impact of extracorporeal therapies in immunomodulation and pharmacokinetics of novel therapeutics to build on her previous work in pediatric MODS with a special emphasis on interaction of acute kidney injury, acquired immune dysfunction, and MODS phenotypes.", "keywords": [ "Acute Lung Injury", "Acute Renal Failure with Renal Papillary Necrosis", "Admission activity", "Area", "Arrhythmia", "Attenuated", "Beds", "Bile Acids", "Blood", "Blood Platelets", "COVID-19", "Cardiac", "Cardiomyopathies", "Cardiovascular system", "Catchment Area", "Center for Translational Science Activities", "Child", "Childhood", "Cirrhosis", "Clinical Medicine", "Clinical Research", "Clinical Trials", "Clinical Trials Data Monitoring Committees", "Collaborations", "Communities", "Contracts", "Critical Care", "Critical Illness", "Data", "Data Coordinating Center", "Development", "Digestive System Disorders", "Disease", "Drug Kinetics", "Endothelium", "Enrollment", "Ethics", "Ethnic Origin", "Extramural Activities", "Faculty", "Family suidae", "Fostering", "Functional disorder", "Funding", "Goals", "Good Clinical Practice", "Grant", "Heart", "Hematology", "Hispanics", "Hospitals", "Immune", "Immune System Diseases", "Individual", "Infant", "Inflammation", "Inflammatory", "Intensive Care", "International", "Intervention Trial", "Investigational Drugs", "Kidney", "Leadership", "Leukocytes", "Life", "Liver", "Liver Failure", "Mechanics", "Medical center", "Medicine", "Mentors", "Mission", "Modeling", "Morbidity - disease rate", "Multi-Institutional Clinical Trial", "Multicenter Trials", "Multiple Organ Failure", "Myocardial", "National Institute of Child Health and Human Development", "Neonatal", "Nephrology", "Oncology", "Operative Surgical Procedures", "Organ", "Outcome", "Pathologic", "Patients", "Pediatric Acute Lung Injury", "Pediatric Hospitals", "Performance", "Phenotype", "Population", "Population Heterogeneity", "Principal Investigator", "Procedures", "Proteins", "Protocols documentation", "Publications", "Randomized", "Recording of previous events", "Reporting", "Research", "Research Institute", "Research Personnel", "Research Project Grants", "Research Training", "Resources", "Respiratory Diaphragm", "SECTM1 gene", "Scientist", "Sepsis", "Services", "Site", "System", "Talents", "Techniques", "Texas", "Therapeutic Agents", "Thrombosis", "Training", "Training Programs", "Translational Research", "United States", "United States Food and Drug Administration", "United States National Institutes of Health", "Work", "career development", "clinical research site", "cohort", "college", "ethnic diversity", "expectation", "immunoregulation", "improved outc" ], "approved": true } } ], "meta": { "pagination": { "page": 5, "pages": 1442, "count": 14420 } } }