Clinical Research Resource Core 2 (CRRC2)
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Established in 2015, the San Antonio Claude D. Pepper Older Americans Independence Center (SA OAIC) is the first focused on the concept of geroscience. It has spearheaded high impact research in humans and nonhuman primates on virtually all hallmarks of aging, including groundbreaking first-in-human trials of senolytics, repurposing drugs to target age-related diseases and frailty, lifestyle interventions to improve health outcomes in older adults, and identification of new targets for interventions. Based on its theme, “Translational geroscience to improve the health and functional independence of all older adults”, the SA OAIC will pursue four programmatic Specific Aims: 1. Move basic geroscience discoveries into interventions to improve the health and functional independence in all populations of older adults. 2. Develop the future leaders in translational geroscience and geriatrics. 3. Partner with other OAICs, NIA/NIH Centers, and institutions on geroscience and clinical trial initiatives. 4. Broadly disseminate discoveries and innovations in translational geroscience. The SA OAIC renewal builds on the considerable scientific accomplishments achieved in the current cycle (2020-2024) by supporting 13 early career investigators, 19 pilot studies and developmental projects, and 41 externally funded projects, and the new opportunities provided by the recruitment of new talent to the OAIC program. The SA OAIC will increase its focus on function, with new emphasis on health outcomes variability in the populations of South Texas, which experience an earlier onset of age-related morbidities and functional decline. Thus, geroscience strategies may have a greater impact in this population. SA OAIC will also leverage the new fullservice drug development and testing pipeline created in collaboration with other institutional programs to identify new targets and develop new age-modulating drugs for rapid testing in unique preclinical primate models and first-in-human trials. The SA OAIC will advance its aims by supporting four Scholars, five pilot studies, eight developmental and 16 externally funded projects and enhanced core infrastructure which includes four highly productive Resource Cores: Preclinical Research, Clinical Research, Molecular Phenotyping, and Biostatistics and Informatics. Under the dedicated leadership of Drs. Elena Volpi, Randy Strong and Rebeca Wong, the Leadership and Administrative Core will coordinate resource core activities with those of the Research Education Component and the Pilot and Exploratory Studies Core.
PROJECT SUMMARY/ABSTRACT – CLINICAL RESEARCH RESOURCE CORE 2 The SA OAIC Clinical Research Resource Core (CRRC2) is the primary resource that supports Good Clinical Practice compliant pharmacologic trials and other clinical studies. It provides: study design and planning consultations; recruitment, tracking and retention services; standardized testing; support for pharmacokinetics/ pharmacodynamics studies; tissue sampling; safety monitoring; education; and method development. In the next cycle, the core will support clinical trials of geroscience based interventions, including new and repurposed drugs, lifestyle interventions, implementation trials, and cohort studies. All CRRC2 activities will significantly contribute to the SA OAIC theme: “Translational geroscience to improve the health and functional independence of all older adults”. The Specific Aims of the CRRC2 are: 1. Catalyze innovative clinical research by providing expertise for investigators to plan and design novel clinical trials that rigorously test geroscience interventions to improve health, function and independence. 2. Enhance the infrastructure to support recruitment, tracking, and retention of cohorts of older adults from South Texas for SA OAIC projects, OAIC Network studies, and other multisite clinical studies on aging. 3. Provide core services, including standardized health screenings, functional phenotyping, nutrition and body composition assessments, exercise testing and training, PK/PD testing, and tissue sampling. 4. Monitor and support compliance of SA OAIC studies with regulations governing clinical investigations with human subjects and ensure participant safety through our Data Safety and Monitoring Board (DSMB). 5. Provide education and training in clinical trials, recruitment, retention, and study procedures. 6. Develop and disseminate novel methods to improve recruitment and retention of all older adults from South Texas in geroscience trials. In the current cycle CRRC2 has supported first-in-human trials of seven drugs targeting the basic mechanisms of aging, as well as exercise and other behavioral interventions, and cohort studies: 13 pilot and developmental projects, 8 Scholars’ projects, and 33 external projects, including large multisite clinical trials. Over the next cycle, we will further enhance CRRC2 services to support inclusive, geroscience-focused clinical research to improve the health and functional independence of all older adults, especially in the South Texas population we serve. The CRRC2 will continue to enhance the OAIC clinical research quality, efficiency, productivity, and provide developmental opportunities for scholars and other investigators.
PROJECT SUMMARY/ABSTRACT – LEADERSHIP AND ADMINISTRATIVE CORE (LAC) The SA OAIC LAC provides scientific leadership, administrative infrastructure, financial, and regulatory oversight in support of the activities and growth of our center, employing an established shared leadership model that optimizes efficiency, productivity, team science, multidisciplinarity, and coherence with the theme: “Translational geroscience to improve the health and functional independence of all older adults.” The LAC’s Specific Aims are to: 1. Provide scientific leadership and direction, stimulating and sustaining new research and collaborations, and attracting new, multitalented investigators to stimulate progress toward the OAIC overall goals. 2. Coordinate, integrate, and monitor core functions, leveraging resources, promoting access, scientific coherence, operational cohesiveness, and new utilization of core resources. 3. Manage and evaluate the SA OAIC program in compliance with applicable regulations and policies. 4. Increase the SA OAIC’s impact locally and nationally, disseminate advancements in translational geroscience to the scientific and lay community, and to policymakers to improve the health and functional independence of all older Americans. Since 2015, the LAC has been the fulcrum of the SA OAIC, ensuring the seamless integration of all activities, leading to publication of over 480 papers, training 20 early-career Scholars, supporting 37 pilot/developmental projects. 90% of past Scholars achieved external funding, 74% of pilot projects led to external funding. In the current cycle, the SA OAIC has supported 41 external projects bringing a high external funding level ($85M). LAC networking activities have led to many collaborations with other OAICs, NIA/NIH centers and institutions, and increased participation in large OAIC network clinical trials, Research Centers Collaborative Network (RCCN) and ClinSTAR activities. In the next cycle, LAC will continue to catalyze new local and national research collaborations, with input from the Internal Advisory Committee, the External Advisory Board, and the REC Advisory Committee. It will: attract new investigators; strategically collaborate with other institutional programs and local partners to support the enhanced theme; coordinate and integrate core functions, promoting scientific coherence, access, and new utilization of core resources; coordinate and leverage OAIC cores with other institutional programs, OAIC network, and RCCN network resources; track and evaluate core utilization, productivity, quality and efficiency with reallocation of resources as appropriate; assure compliance with research policies; monitor human subject safety; support active participation of OAIC investigators at the annual national meeting; communicate with the NIA and the OAIC coordinating center; support community outreach through multipronged means; and broadly disseminate the discoveries in translational geroscience for all older adults.
PROJECT SUMMARY/ABSTRACT – MOLECULAR PHENOTYPING RESOURCE CORE 3 The SA OAIC Molecular Phenotyping Resource Core 3 (MPRC3) is a new resource that provides essential tools to determine the dynamic changes in molecular and metabolic phenotyping that occur at the whole-body, tissue, cellular and subcellular levels in older individuals. The MPRC3 will also support quantification of the metabolic effects of age, disease, physical activity, and geroscience interventions; determine the basic mechanisms that underlie these changes; and identify novel biomarkers and predictors of the responses to interventions. The key services include support for measures of metabolic and other molecular phenotyping such as targeted metabolomics, functional lipidomics, mitochondrial function, metabolic flux, energy expenditure, protein turnover, biomarkers of aging, pathology and histology, cellular senescence, single cell and single nucleus RNAseq, ATAC-seq, and epigenetics of aging. The MPRC3 will promote the integration of molecular, cellular, histologic, and tracer methodologies within individual experiments in non-human primates and humans, to discover the mechanisms that underlie specific pathophysiologic responses in older adults. Overall, MPRC3 will promote and support basic and translational research relevant to the SA OAIC theme: “Translational geroscience to improve the health and functional independence of all older adults.” The Specific Aims of the MPRC3 are: 1. Provide analytical support to discover new biomarkers and determine the efficacy of geroscience interventions on molecular targets. 2. Develop new methods to study the basic mechanisms underlying translational geroscience. 3. Train early-stage investigators in the analytic and methodologic aspects of translational geroscience to improve function and health in older adults. In the first year of the next cycle, we will support two Pilot studies, three Developmental projects, three Scholars' projects, and seven externally funded projects. We will also develop novel translational methods and test the molecular impact of novel gerotherapeutics. MPRC3 support will yield new analytical data crucial to external funding. We will innovate and enhance our new resource core to further promote basic and translational research to achieve our OAIC goal to increase scientific knowledge to improve the health and functional independence of all older adults.
PROJECT SUMMARY/ABSTRACT – PILOT/EXPLORATORY STUDIES The overall goal of the Pilot / Exploratory Studies Core (PESC) is to provide critical initial funding, infrastructure, and support for early-stage, potentially groundbreaking pilot and exploratory studies (PES) consistent with the San Antonio Claude D. Pepper Older Americans Independence Center (SA OAIC) theme: “Translational geroscience to improve the health and functional independence of all older adults”. The PESC plays a key role in the SA OAIC by supporting projects that move basic translational geroscience discoveries on aging into interventions to improve the health and functional independence in older adults. The PESC leverages the features of the Leadership and Administrative Core (LAC), Research Education Core (REC), and Resource Cores to achieve its goals through the following Specific Aims: 1. To solicit and award innovative, multidisciplinary research that tests translational geroscience interventions to improve healthy aging and independence in preclinical marmoset and human studies 2. To stimulate research that will develop and apply novel methods and technologies in older adults 3. To work closely with the Resource Cores and REC to provide infrastructure, scientific support, and funding for innovative pilot proposals from mentored, early career and established investigators 4. To build and sustain effective processes to ensure pilot study completion, robust tracking of outcomes and downstream impact, and optimal dissemination to maximize impact and translation The PESC provides peer-reviewed, merit-based support for up to five rigorously designed pilot studies in-line with the translational geroscience theme annually. Supported projects include, but are not limited to, those that test the efficacy and side effects of promising cell-based, pharmacologic, and non-pharmacologic interventions in marmosets, early human clinical trials, and other types of clinical, or population health research such as population or community-based studies. PESC has supported 32 pilot projects. 74% of the completed 26 projects have led to external funding (estimated return on investment 19:1). PESC will seek proposals in areas of rapid aging-related scientific advancement, emerging technologies, and those that aim to address health outcomes variability in South Texas. The Core leaders, having a great deal of experience directing successful pilot project programs, promote key alignments and interactions of PESC investigators with OAIC Resource Cores and resources in the broader scientific community. The Core provides close oversight and guidance to PESCsupported studies from inception, during the investigative and analytical phases, through publication, and through the submission of grant proposals. PESC is poised to sustain its robust return on investment and make a significant impact on translational geroscience regionally and nationwide.
