Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1386&sort=program_officials
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=program_officials", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1419&sort=program_officials", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1387&sort=program_officials", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1385&sort=program_officials" }, "data": [ { "type": "Grant", "id": "14873", "attributes": { "award_id": "1U18HS029937-01", "title": "Supporting Patients Recovering from COVID-19 (SPaRC)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Agency for Healthcare Research and Quality (AHRQ)" ], "program_reference_codes": [], "program_officials": [ { "id": 31564, "first_name": "Latrice", "last_name": "Vinson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-07-01", "end_date": "2029-06-30", "award_amount": 1000000, "principal_investigator": { "id": 31565, "first_name": "Ann Marie", "last_name": "Parker", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 344, "ror": "https://ror.org/00za53h95", "name": "Johns Hopkins University", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary: Long COVID impacts 10-30% of people after a SARS-CoV-2 infection, with potentially devastating long-term impact on quality of life. Moreover, Long COVID disproportionately affects minority, rural, older, and other at-risk populations. Multidisciplinary Long COVID clinics provide clinical care and offer infrastructure for evaluating promising interventions to improve Long COVID outcomes. The Johns Hopkins Post-Acute COVID-19 Team (JH PACT) is among the country's first and largest Long COVID programs. Via this AHRQ U18 proposal, JH PACT proposes the following Aims: (1) To deliver a comprehensive, multidisciplinary program (Supporting Patients Recovering from COVID, “SPaRC”) to patients with Long COVID, with an expanded focus on underserved populations. The SPaRC program will expand on the existing expertise of the JH PACT multidisciplinary Long COVID outpatient program to increase capacity and decrease wait times, with expanded services to underserved patient populations, including older adult, minority race/ethnicity, socioeconomically disadvantaged, and geographically distant and rural populations via enhanced partnerships with key existing organizations (e.g., Medicine for Greater Good, Center for Clinical Global Health Education). (2) To iteratively evaluate and refine the SPaRC Long COVID program to increase access and improve patient-centered, evidence-based care. The SPaRC program will be evaluated and iteratively refined in quarterly cycles via mixed methods evaluation (via patient data from electronic medical records and semi-structured qualitative interviews of patients/caregivers and staff/clinicians) to inform implementation strategies based on the “Expert Recommendations for Implementing Change” (ERIC) framework within a learning health system. In each review cycle, the implementation team and key SPaRC internal and external stakeholders will evaluate the program and outcomes and select goals for refinement and advancement for the next quarterly review cycle. An external Stakeholder Advisory Council, led by an independent Chair, will provide ongoing feedback via quarterly meetings throughout the project. (3) Partner with regional Long COVID stakeholders, including primary care providers (PCPs), to create and expand access to comprehensive, patient-centered, coordinated Long COVID care across the mid-Atlantic region. We will build a multi-disciplinary Long COVID provider-to-provider e-consult service, customized educational curriculum (delivered via both live and on-demand electronic formats), and continuing education toolkit for PCPs, in conjunction with key stakeholders (e.g., patients, caregivers, community leaders, and PCPs). JH PACT and the SPaRC Team include internationally-recognized experts in Long COVID care, patient outcomes assessment, implementation science, stakeholder/community engagement, and primary care education. JH PACT is ideally positioned to create a Long COVID Center of Excellence, leveraging the outstanding expertise available via Johns Hopkins Medicine, and to optimally engage with the AHRQ Learning Community.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15448", "attributes": { "award_id": "5U18HS029911-02", "title": "Advancing Long COVID Care in our Community through Access, Equity, and Collaboration", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Agency for Healthcare Research and Quality (AHRQ)" ], "program_reference_codes": [], "program_officials": [ { "id": 31564, "first_name": "Latrice", "last_name": "Vinson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-30", "end_date": "2028-09-29", "award_amount": 931222, "principal_investigator": { "id": 28180, "first_name": "Abby Ling-Lee", "last_name": "Cheng", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 28181, "first_name": "Jonas", "last_name": "Marschall", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 28182, "first_name": "Amy", "last_name": "McQueen", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 827, "ror": "", "name": "WASHINGTON UNIVERSITY", "address": "", "city": "", "state": "MO", "zip": "", "country": "United States", "approved": true }, "abstract": "Long COVID manifests differently for each person and can contribute to disabling, life-changing symptoms such as extreme fatigue, cognitive dysfunction, breathing difficulty, and autonomic dysfunction in people across the age spectrum, including in people who were previously healthy and in people who had minimal or no symptoms associated with acute COVID-19 infection. Multidisciplinary Long COVID clinics were a mainstay of patient support during the initial phases of the COVID-19 pandemic, but as the pandemic is shifting to a new phase, care models must also evolve in order to meet the complex medical, rehabilitative, and social needs of the continually growing number of people who are affected by Long COVID. The purpose of this project is to transform an existing, university-based Long COVID clinic into a broader Long COVID community network in order to expand equitable access to care, improve the patient care experience, and support primary care practitioners. This project will invest in two particularly underserved populations: 1) the Black community in St. Louis, Missouri, which is a historically mistreated population who continues to be marginalized by previously sanctioned segregation practices; and 2) rural communities across Missouri. Aim 1 is to expand equitable access to Long COVID care by: 1) building clinical capacity, and 2) removing structural barriers to care. This will be accomplished by: 1) hiring additional clinicians for the Long COVID Clinic in order to reduce wait times; and 2) removing patient requirements for clinic evaluation that disproportionately affect underserved populations. Aim 2 is to improve the Long COVID care experience by: 1) streamlining care that crosses multiple disciplines and physical care sites, and 2) supporting patients’ social needs. This will be accomplished by: 1) supporting a clinical case manager to directly assist patients with coordinating medical care and connecting with community resources, and 2) iteratively assessing and addressing referral challenges between clinics. Aim 3 is to support primary care teams as they care for patients with Long COVID by co-creating: 1) educational resources for PCPs, and 2) streamlined communication and referral pathways between PCPs and specialty clinicians. This will be accomplished by engaging multiple key stakeholders to: 1) develop multi- modality educational materials related to Long COVID patient assessment and management; 2) disseminate materials via culturally and logistically preferred approaches (including via established, trusted community intermediaries and via an established ECHO (Enhanced for Community Healthcare Outcomes) virtual educational infrastructure); and 3) refine existing handoff processes to minimize the administrative workload on PCP teams and facilitate their ability to meet patients’ needs. Continuous stakeholder input, comprehensive data tracking, and iterative needs assessments using mixed methods approaches will facilitate ongoing project evaluation and adaptation in order to respond to the community’s evolving needs.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15475", "attributes": { "award_id": "5U18HS029943-02", "title": "Novel Statewide Response to Post-COVID Care Delivery", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Agency for Healthcare Research and Quality (AHRQ)" ], "program_reference_codes": [], "program_officials": [ { "id": 31564, "first_name": "Latrice", "last_name": "Vinson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-30", "end_date": "2028-09-29", "award_amount": 976981, "principal_investigator": { "id": 28235, "first_name": "Sarah E", "last_name": "Jolley", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 22611, "first_name": "DONALD E", "last_name": "NEASE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 784, "ror": "https://ror.org/02hh7en24", "name": "University of Colorado Denver", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "Long COVID is an important public health threat impacting millions of individuals including 600,000 Coloradans. Current Long COVID care is highly fragmented, variable in nature, and in constant evolution. Creating a novel approach to practice support with continued education and streamlining care for high Long COVID will improve care integration and patient experience. We will implement the Colorado Multidisciplinary Translation Network (CO-MTN) comprised of integrated, multidisciplinary Long COVID care clinics and primary care clinics working together in a tiered care delivery pathway. CO-MTN creates a bidirectional translational care network for integrating expertise, education, referrals, and care between MDCs, PCPs and teams, and their patients. CO-MTN includes 1) the State of Colorado-supported Long COVID Community of Practice comprised of three geographically distributed MDCs, 2) a state-wide practice-based research network representing 280 primary care practices, known as the State Networks of Colorado Ambulatory Practices & Partners, and 3) a proven tele-education system used to provide health care practitioners specialty training, Extension for Community Healthcare Outcomes. CO-MTN includes implementation strategies to support the tiered care pathway including training and learning communities to support PCPs with improved knowledge and capacity and provide exceptional care for Colorado Long COVID patients, and practice facilitation to effectively implement the PCP care in their practice and coordinate with the MDCs. CO-MTN will help Long COVID patients in Colorado and have the potential for scaling to other states. To guide implementation and evaluation, we will utilize the Exploration, Preparation, Implementation and Sustainment dissemination and implementation framework. We will measure sustainment as continued involvement in the network during the final six months of the project period. Using qualitative, quantitative, and mixed methods, we will evaluate the Reach and Effectiveness for patients, and the Adoption, Implementation and Maintenance of the implementation strategies using the RE-AIM framework based on the following aims: Aim 1: Implement an integrated, tiered care delivery pathway with facilitated implementation support via CO-MTN and measure its effect on 1) Reach of Long COVID care to Colorado patients, specifically those described as underserved, and 2) Effectiveness on reducing Long COVID symptom burden and severity for patients engaged. Aim 2: Determine the effect of CO-MTN on 1) Adoption of the CO-MTN tiered care delivery model by primary care clinics and PCPs within these clinics, 2) Implementation of the tiered care pathway, and 3) Maintenance of the tiered care pathway key components past the active project period. Our team is comprised of national experts in Long COIVD care, practice-based research, and implementation science. Together, our multidisciplinary team will partner through CO-MTN structures and support to deliver high quality Long COVID care.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "14880", "attributes": { "award_id": "1R13AI186265-01", "title": "Positive Strand RNA Viruses: Interdisciplinary Advances in Virology, Pathogenesis, Immunology, and Technology 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": [ { "id": 31573, "first_name": "ADELINA EWURA-ABENA", "last_name": "Bartels", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-07-11", "end_date": "2025-06-30", "award_amount": 4000, "principal_investigator": { "id": 27075, "first_name": "TERRY L.", "last_name": "SHEPPARD", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1633, "ror": "", "name": "KEYSTONE SYMPOSIA", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "Support is requested for a Keystone Symposia conference entitled Positive Strand RNA Viruses: Interdisciplinary Advances in Virology, Pathogenesis, Immunology, and Technology Development, organized by Drs. Kizzmekia Corbett-Helaire, William Klimstra and Jolanda Smit. The conference will be held in Killarney, Ireland from October 21–25, 2024. Positive-strand RNA viruses have proven to be an impactful global health priority that is experiencing a unique moment, which is fueled by the momentum of the COVID-19 pandemic and driven by the influx of new knowledge and technologies. Successful scientific breakthroughs in this area are the result of advances in basic virological understanding and molecular genetics, merged with other fields such as human immunology, structural biology, and vaccine development. Together, these alignments have opened new multidisciplinary frontiers and created exciting opportunities for virology research. This conference will take a tour of new knowledge in positive-strand RNA virology starting with virus-host interactions and ending with technological and clinical development. The interdisciplinary nature of the conference will provide novel insights across virology, viral immunity, vaccinology and more. In addition, the conference will feature a diverse array of positive-strand RNA viruses, including understudied viruses, revealing common themes and distinctions that might be leveraged for clinical utility. Throughout the conference, new and emerging young investigators will be highlighted alongside field leaders to bring forth new ideas and perspectives for discussion that will advance the field in innovative directions.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "14912", "attributes": { "award_id": "1R35GM154852-01", "title": "Multidimensional approaches to understand and improve RNA therapeutic design and delivery", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 31602, "first_name": "Sailaja", "last_name": "Koduri", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-06-10", "end_date": "2029-04-30", "award_amount": 371606, "principal_investigator": { "id": 31603, "first_name": "Connie", "last_name": "Wu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 770, "ror": "", "name": "UNIVERSITY OF MICHIGAN AT ANN ARBOR", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "PROJECT SUMMARY: RNA therapeutics are experiencing a renaissance with the clinical successes of the COVID-19 messenger RNA (mRNA) vaccines. In parallel, nanomaterials have emerged as highly promising vehicles for RNA delivery. However, despite considerable scientific advances in nanoparticle therapeutics over the last several decades, few nanoparticle-based RNA therapeutics have been clinically approved. As the RNA therapeutics landscape expands, there remain key understanding gaps that must be addressed to inform the rational design of RNA therapeutic systems across molecular, cellular, and organismal levels and enable broad clinical translation: (1) how RNA cargo parameters, carrier properties, and their combinations govern functional in vivo RNA delivery; (2) how the biological environment of the host alters RNA nanocarriers and their in vivo functionalities; and (3) in turn, how RNA therapeutic systems modify the host. Further exacerbating these knowledge gaps is a lack of high-sensitivity, high-throughput tools for interrogation of functional in vivo RNA delivery, nanoparticle-biomolecule interactions, and the host response. The proposed program will adopt multi- pronged strategies to address these challenges, by integrating our complementary expertise in ultrasensitive biomolecule detection, RNA engineering, and nanoparticle drug delivery. Using mRNA as a representative RNA drug, we seek to elucidate design rules for both RNA nanocarrier and cargo for functional RNA delivery. Leveraging our technology for multiplexed single-molecule detection of low abundance biomolecules, we will pursue orthogonal focus areas: (1) develop and apply an ultrasensitive screening platform for pooled in vivo analysis of mRNA therapeutic systems, to identify RNA cargo and carrier determinants of functional mRNA delivery; (2) understand and predict the host response to RNA therapeutic systems via high-multiplex single- molecule protein detection; and (3) probe the biomolecular interactions of nanocarriers and their effects on in vivo functionality via high-throughput, high-resolution profiling of biomolecule adsorption. These three independent yet synergistic directions align well with NIGMS mission objectives in the application of innovative physical methodologies and quantitative approaches to establish foundations for disease treatment. If successful, this program will build an integrated understanding of RNA therapeutic system design rules and host factors that govern RNA delivery and individual response. The ultrasensitive profiling tools developed in this work will be of broad utility across diverse RNA therapeutic systems and disease applications.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15057", "attributes": { "award_id": "5R44GM149095-02", "title": "Use of Time Series Biomarker and Clinical Data to Construct a Time Trajectory Host Response Map", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 31602, "first_name": "Sailaja", "last_name": "Koduri", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-01", "end_date": "2025-05-31", "award_amount": 1272176, "principal_investigator": { "id": 12385, "first_name": "Bobby", "last_name": "Reddy", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1193, "ror": "", "name": "Prenosis, Inc.", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 2017, "ror": "", "name": "PRENOSIS, INC.", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true }, "abstract": "Principal Investigator/Program Director (Last, first, middle): Reddy, Jr., Bobby Project Summary: Sepsis is an incompletely understood clinical syndrome characterized by a dysregulated host response to infection. In partnership with 8 U.S. hospitals, Prenosis amassed one of the world’s largest datasets and biobanks that combines biomarker and clinical data for patients suspected of infection, housing over 70,000 plasma or serum samples from over 14,000 patients. We also curated a dataset of dense time-series data from each patient’s Electronic Medical Record (EMR), including demographics, vitals, lab results, interventions, outcomes, and many other parameters. To commercialize insights from these data, Prenosis built ImmunixTM, an FHR/HL7 compatible software platform for clinical deployment of diagnostics and clinical decision support tools. Under a previously awarded NIGMS grant (1R44GM139529), Prenosis built a testing pipeline to measure 40 critical protein biomarkers from biobanked samples. To date, we measured these biomarkers on only the initial sample per patient for 6,000 patients and combined these data with EMR clinical parameters to construct 8 endotypes of sepsis. The identification and classification of endotypes—groupings of patients with similar biologic and clinical features—is increasingly becoming recognized as a valuable methodologic approach to assessing patients with sepsis. To complete work for the existing grant, Prenosis will measure the baseline sample for additional patients to total about 10,000 patients to refine and validate the endotypes. In this project, Prenosis proposes to add a critical new dimension to the data by assaying and analyzing longitudinal, time-series biomarker data. We will leverage our pipeline to measure the 40 core biomarkers from 9,000 follow-up samples from ~3,400 patients that we have already collected and stored in the biobank. We will assess the additional value of longitudinal time-series biomarker measurements and clinical data. Initial feasibility data from over 1,000 measured samples demonstrates that longitudinal data provide additional powerful new biologic and prognostic insights. Analytics built upon these data have the potential to improve diagnostic and drug development products for sepsis and COVID. The overall hypothesis of this project is that longitudinal biomarkers will add a valuable biologic and prognostic dimension to endotypes for sepsis; and these longitudinal endotypes will better classify patients who may have a heterogeneous response to sepsis therapies.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15182", "attributes": { "award_id": "1R01GM155729-01", "title": "Zwitterionic polyethylene glycol for therapeutic delivery", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 31602, "first_name": "Sailaja", "last_name": "Koduri", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-05", "end_date": "2026-06-30", "award_amount": 318457, "principal_investigator": { "id": 27922, "first_name": "Hao", "last_name": "Cheng", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 377, "ror": "https://ror.org/04bdffz58", "name": "Drexel University", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "Biologic drugs and nanomedicines with conjugated polyethylene glycol (PEG) show extended circulation in the blood, increasing therapeutic efficacy. The U.S. FDA has approved more than 30 PEGylated biologics, including proteins, nucleotides, and peptides, and a few PEGylated nanomedicines, for example COVID-19 mRNA vaccines. Attached PEG chains increase the hydrodynamic radiuses of these therapeutics to reduce their renal clearance during blood circulation. More importantly, PEG conceals therapeutics from immune cells by repelling plasma proteins, rendering therapeutics stealth behavior. The adsorption of a few types of plasma proteins onto therapeutics can lead to the removal of therapeutics by immune cells. PEG chains are hydrophilic and flexible. They can repel plasma proteins through a thermodynamic-driven entropic repulsion. Despite the unique advantage, the application of PEGylated therapeutics is limited by the presence of anti-PEG antibodies (aPEG Abs). These antibodies not only accelerate the clearance of PEGylated therapeutics and attenuate their efficacies but may also cause severe side effects. Varied percentages of populations were found to have pre- existing aPEG Abs in different studies, with the percentage as high as 40%. The high prevalence is likely due to the broad use of PEG in cosmetic and healthcare products. To further improve the pharmacokinetics of therapeutics and circumvent the problem of aPEG Abs, researchers have strived to find PEG alternatives. Among these alternative polymers, zwitterionic polymers have attracted the most attention. In contrast to PEG, zwitterionic polymers repel protein adsorption by forming a hydration layer around the polymers. We hypothesize that zwitterionic PEG (ZPEG) that combines the advantageous characteristics of both PEG and conventional zwitterionic polymers will be superior to them in extending the circulation of therapeutics and minimize the generation of anti-ZPEG antibodies. To develop a ZPEG to replace PEG for therapeutic delivery, we propose the following research plans: 1) synthesize and characterize ZPEG with different chemical structures and reveal the mechanism of enhanced blood circulation of ZPEG-modified proteins; 2) investigate the immunogenicity of ZPEG; 3) investigate the pharmacokinetics and immune responses of nanoparticles covered with ZPEG. Because of the broad application of PEG, an excellent PEG replacement will generate tremendous societal impact. This project will pave the way to replace PEG with ZPEG in therapeutic delivery for minimized side effects and consistent efficacy.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15627", "attributes": { "award_id": "1R43GM157920-01", "title": "Three-Dimensional Spatio-Temporal Control of Lipid Nanoparticle Manufacturing for Improved Nucleic Acid Delivery", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 31602, "first_name": "Sailaja", "last_name": "Koduri", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-01-01", "end_date": "2025-06-30", "award_amount": 306873, "principal_investigator": { "id": 32127, "first_name": "Po-Lun", "last_name": "Feng", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2551, "ror": "", "name": "OSEM FLUIDICS INC", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "The COVID-19 pandemic has established the importance of nucleic acid-based lipid nanoparticles (LNPs) for the future of global health. The benefits of lipid nanoparticles are multifaceted as they protect sensitive pharmaceutical payloads from enzymatic degradation and allow for the modification of solubility, release kinetics, and bioavailability. While chemical formulation of LNPs has been widely explored, the effects of manufacturing—specifically microfluidics processing—are not currently well-understood. This knowledge gap presents challenges in the production of intricate nanoparticle structures, which require specialized microfluidic systems that produce well-defined and reproducible flow configurations. The proposed research focuses on developing 3D-printed channel architectures to precisely control LNP structure and properties to enhance transfection efficiency without modifying their chemical composition. Aim 1 involves designing, simulating, and testing various 3D channel architectures to manipulate flow conditions and tailor LNP properties. Aim 2 focuses on structural determination via SAXS and CryoTEM, and assesses the impact of LNP structures on mRNA transfection efficiency through in vitro transfection studies. Aim 3 will demonstrate the therapeutic- and disease-agnostic design workflow by robustly encapsulating siRNA and pDNA. This project aims to overcome the limitations of current LNP manufacturing methods which are constrained by fixed geometries and limited control over LNP assembly processes. Development of our enabling technology will offer an additional process parameter - channel architecture, for tuning LNP properties and structure in a rapid and customizable manner that is broadly applicable.", "keywords": [ "3-Dimensional", "3D Print", "Acceleration", "Address", "Affect", "Architecture", "Biological Availability", "COVID-19", "COVID-19 pandemic", "COVID-19 vaccine", "Characteristics", "Chemicals", "Chemistry", "Cholesterol", "Complex", "Development", "Devices", "Disease", "Encapsulated", "Formulation", "Foundations", "Future", "Gene Delivery", "Gene Expression", "Geometry", "Image", "In Vitro", "Kinetics", "Knowledge", "Lipids", "Liquid substance", "Messenger RNA", "Methods", "Microfabrication", "Microfluidic Microchips", "Microfluidics", "Modality", "Modification", "Nucleic Acids", "Outcome", "Pharmacologic Substance", "Phase", "Process", "Production", "Property", "Reproducibility", "Research", "Research Personnel", "Roentgen Rays", "Route", "SARS-CoV-2 spike protein", "Series", "Small Interfering RNA", "Solubility", "Structure", "System", "Technology", "Testing", "Therapeutic", "Time", "Transfection", "United States National Institutes of Health", "clinically relevant", "cost", "design", "experimental study", "fabrication", "fluid flow", "global health", "improved", "in vivo", "innovation", "interest", "lipid nanoparticle", "mRNA lipid nano particle vaccine", "manufacture", "manufacturing systems", "millimeter", "nanoparticle", "novel", "novel therapeutics", "nucleic acid delivery", "nucleic acid structure", "nucleic acid-based therapeutics", "operation", "particle", "pre-clinical", "prevent", "spatiotemporal", "therapeutic development", "tool" ], "approved": true } }, { "type": "Grant", "id": "14927", "attributes": { "award_id": "5R01AA030970-02", "title": "Using patient-level decision modeling to improve use of treatments for alcohol use disorder", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 31606, "first_name": "Brett Thomas", "last_name": "Hagman", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-15", "end_date": "2028-06-30", "award_amount": 635563, "principal_investigator": { "id": 28251, "first_name": "Phuc", "last_name": "Le", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1013, "ror": "", "name": "CLEVELAND CLINIC LERNER COM-CWRU", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true }, "abstract": "Alcohol use disorder (AUD), previously alcohol abuse and dependence, is a significant public health problem. In the US, excessive alcohol use is responsible for 93,000 deaths and 2.7 million years of potential life lost, at a cost of $250 billion annually. In 2012-13, the 12-month and life-time prevalence of AUD in US adults was 14% and 29%, respectively, increasing by more than 40% from a decade earlier. Since the Covid-19 pandemic, alcohol consumption has increased even more. Excessive alcohol consumption affects various bodily organs, leading to many health consequences. Fortunately, AUD is more treatable than commonly believed. Cognitive behavioral therapy, brief interventions, and motivational enhancement therapy are the most widely studied behavioral interventions and are similarly efficacious, while Alcoholics Anonymous (AA) is the most sought out mutual support group. Pharmacotherapy can be combined with behavioral interventions to increase success. However, treatments for AUD are underutilized. The misconception among patients and physicians that treatment is ineffective is an important obstacle to use. Another is the common view that treatment success requires total abstinence. In reality, recovery from AUD can include some heavy drinking, and AUD treatment can be effective. Expressing treatment effectiveness into long-term health benefits could help convince physicians to offer treatment and encourage patients to use it. However, randomized controlled trials (RCTs) alone cannot provide this information because they do not measure long-term health outcomes, nor do they compare all treatments head-to-head, making it difficult to choose among them. Simulation modeling offers a comprehensive approach to comparing treatments, but none of existing AUD models were designed to assess all treatments. We designed a decision aid (DA) describing treatment options, but it does not yet include estimates of long-term benefits due to lack of such data at the time of development. Project objective: To develop, validate, and apply a computer simulation model to inform policy makers, physicians, and patients of the lifetime benefit of treatments for AUD. Aim 1: Develop and validate a microsimulation model of the natural history of alcohol-associated complications accounting for the change in drinking behaviors and AUD status over time. Aim 2: Assess the comparative effectiveness of AUD treatments. Aim 3: Incorporate patient and provider feedback to assess the clarity, content, and acceptability of augmenting an existing DA with comparative effectiveness data. Impact: Our model will offer a better understanding of the expected benefit of AUD treatments and provide an innovative approach to decision modeling and treatment selection. By incorporating long-term effectiveness data into an existing DA, our study will provide physicians and patients with valuable evidence and a tool to support selection of optimal treatments, thereby helping to close the treatment gap. Ultimately, our project will address NIAAA’s research missions while improving the quality of life for tens of millions of US adults suffering from AUD.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "15435", "attributes": { "award_id": "3R01AA031010-02S1", "title": "Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 31606, "first_name": "Brett Thomas", "last_name": "Hagman", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-01", "end_date": "2028-08-31", "award_amount": 70747, "principal_investigator": { "id": 27912, "first_name": "Melissa Lee", "last_name": "Anderson", "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": "In partnership with Deaf-owned agency National Deaf Therapy (NDT), we propose the first-ever full-scale psychotherapy trial conducted in the Deaf community. The U.S. Deaf community – more than 500,000 Americans who communicate using American Sign Language (ASL) – experiences nearly triple the rate of lifetime problem drinking compared to the general population and twice the rate of trauma exposure. Hearing individuals have access to several validated treatments for comorbid alcohol use disorder (AUD) and trauma; yet there are no evidence-based treatments to treat any behavioral health condition with Deaf clients. Available behavioral health treatments fail to meet Deaf clients’ unique language access needs. Deaf people’s median English literacy level falls at the fourth grade and health-related vocabulary parallels non-English- speaking U.S. immigrants. Leveraging extensive community engagement to address these barriers, the PI’s team of Deaf and hearing researchers, clinicians, filmmakers, actors, artists, and Deaf people with AUD/PTSD developed and pilot tested Signs of Safety, a Deaf-accessible toolkit to be used with the Seeking Safety treatment protocol. The Signs of Safety toolkit provides a supplemental therapist guide and population-specific client materials (e.g., visual handouts, filmed ASL teaching stories) to meet Deaf clients’ language needs. Preliminary data from the Signs of Safety single-arm pilot and randomized feasibility pilot showed reductions in alcohol use frequency and PTSD severity from baseline to follow-up. The delivery of the experimental intervention was deemed feasible by study therapists and was well-received by participants, especially when moved to a virtual platform in response to the COVID-19 pandemic – an acceleration of the inevitable development needed to scale Signs of Safety to a national level for the proposed clinical trial. Leveraging the existing infrastructure and robust referral network of NDT, we will enroll 144 Deaf adults with past-month PTSD and problem drinking into a national, full-scale, virtual clinical trial comparing (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control. Primary clinical outcomes at immediate post- treatment and post-treatment follow-up are past 30-day alcohol use frequency/quantity (Alcohol Timeline Followback) and past 30-day PTSD severity (PTSD Checklist for DSM-5). Assessment will occur at baseline, mid-treatment, immediate post-treatment, three-month post-treatment follow-up, and six-month post-treatment follow-up. Additionally, we will analyze potential moderators and mediators that lead to positive outcome, including coping self-efficacy, self-compassion, motivation for treatment, and access to health information. Our proposed aims build on eight years of KL2 and R34 empirical work, moving this program of research from Stage IB (two-arm feasibility and pilot testing) to Stage II/III (real world efficacy). The proposed R01 will potentially validate the first-ever evidence-based therapy for Deaf people, as well as provide future behavioral health researchers with a vital roadmap for conducting community-engaged clinical trials with Deaf people.", "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 1386, "pages": 1419, "count": 14184 } } }