Browsing by Author "Garcia, Kara"
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Item 472 Indiana CTSI Think Tank Program(Cambridge University Press, 2022) Garcia, Kara; Portonovo, Padma; Garci, Kara; Medicine, School of MedicineOBJECTIVES/GOALS: The Think Tanks’ aim to assist faculty innovators along the path from discovery to commercialization; serving as a one-stop-shop where investigators can access advice, pilot funds, and direction toward other available resources within the Indiana CTSI. METHODS/STUDY POPULATION: Faculty receive guidance from a pool of advisors in the drug and device industry, as well as their respective university commercialization offices; who serve as an essential resource for a wide range of scientific, technical, clinical, business, and regulatory questions. Investigators submit a simple intake form to connect with a project facilitator for detailed guidance prior to formal meetings. Projects are guided from start to finish with robust tracking and milestone-based funding to help generate data for Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Project tracking is conducted using REDCap, which is used for all investigator submissions, with internal processes also tracked in REDCap. RESULTS/ANTICIPATED RESULTS: From Feb-Aug 2021; the Think Tanks provided feedback to 15 drug projects and 6 medical device projects. This included 12 from Indiana University; 4 from Purdue University; and 5 from the University of Notre Dame. Interestingly; drug innovations were submitted primarily by tenure track faculty (100%) with a history of NIH/NSF funding (50%); while device innovations were submitted primarily by clinical faculty without a history of NIH/NSF funding (66%). Based on first-round feedback, a total of approximately $3;400 in pilot funds were provided. Efforts are underway to obtain survey-based feedback from all applicants to date; which will be used to inform future program modifications. DISCUSSION/SIGNIFICANCE: The budding “Think Tank” program provides faculty with a broad perspective of the entire drug and medical device development process, helping investigators understand the critical interplay development stages. Future work seeks to enhance faculty engagement in, and understanding of the commercialization process across Indiana CTSI institutions.Item Advancing medical technology innovation and clinical translation via a model of industry-enabled technical and educational support: Indiana Clinical and Translational Sciences Institute’s Medical Technology Advance Program(Cambridge University Press, 2021-01-19) Brightman, Andrew O.; Coffee, R. Lane, Jr.; Garcia, Kara; Lottes, Aaron E.; Sors, Thomas G.; Moe, Sharon M.; Wodika, George R.; Medicine, School of MedicineThe success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the “translational valleys of death” requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine–engineering–industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.Item Brain folding increases in sharpness and complexity over third trimester-equivalent development(2022-07-28) Basinski, Christopher; Garcia, KaraBrain folding increases in sharpness and complexity over third trimester-equivalent development Christopher Basinski [1], Kara Garcia [2] [1] Indiana University School of Medicine; [2] Indiana University School of Medicine, Department of Radiology and Imaging Sciences >> Background and Hypothesis: Gyrification, or convolution, of the cerebral cortex is a promising transdiagnostic marker for early neurodevelopment. Previous studies have related differences in sulcogyral shape to schizophrenia, bipolar disorder, and autism spectrum disorder, but the physical mechanisms underlying these differences remain poorly understood. The focus of this study was to explore decomposed curvature metrics, the principal curvatures, as physically meaningful quantitative biomarkers to track brain development. We hypothesize that the average sharpness and complexity of sulci and gyri, reflected by principal curvatures, increase throughout third trimester-equivalent development. Methods: Cortical surfaces generated from magnetic resonance imaging (MRI) were obtained from the developing Human Connectome Project. Global sharpness was calculated from the principal curvature of maximum magnitude, with average sharpness defined separately for gyral (positive) and sulcal (negative) curvatures. Global complexity of folds (eg., curviness along the length of a fold) was calculated from variance in the principal curvature with minimum magnitude. Trajectory of each summary metric was fit over time using polynomial regression. Results: Forty-three subjects were removed due to incomplete curvature analysis or missing subject information, such that 541 preterm and term-born infants were evaluated with scan age ranging from 27 to 45 weeks postmenstrual age (PMA). Across this developmental range, sharpness and complexity increased until a plateau around term-equivalent. Average sharpness of gyri was best correlated with age of scan (R2 = 0.877). Conclusion and Potential Impact: During the pre- and postnatal development period, total cortical surface area continues to increase after birth, but the overall sharpness and complexity of folding plateaus at ~37 weeks post-menstrual age. Exploring these physically meaningful curvature metrics can provide improved parameters for comparison to mechanistic models of brain folding.Item Children born very preterm experience altered cortical expansion over the first decade of life(Oxford University Press, 2024-09-17) Gorham, Lisa S.; Latham, Aidan R.; Alexopoulos, Dimitrios; Kenley, Jeanette K.; Iannopollo, Emily; Lean, Rachel E.; Loseille, David; Smyser, Tara A.; Neil, Jeffrey J.; Rogers, Cynthia E.; Smyser, Christopher D.; Garcia, Kara; Radiology and Imaging Sciences, School of MedicineThe brain develops rapidly from the final trimester of gestation through childhood, with cortical surface area expanding greatly in the first decade of life. However, it is unclear exactly where and how cortical surface area changes after birth, or how prematurity affects these developmental trajectories. Fifty-two very preterm (gestational age at birth = 26 ± 1.6 weeks) and 41 full-term (gestational age at birth = 39 ± 1.2 weeks) infants were scanned using structural magnetic resonance imaging at term-equivalent age and again at 9/10 years of age. Individual cortical surface reconstructions were extracted for each scan. Infant and 9/10 cortical surfaces were aligned using anatomically constrained Multimodal Surface Matching (aMSM), a technique that allows calculation of local expansion gradients across the cortical surface for each individual subject. At the neonatal time point, very preterm infants had significantly smaller surface area than their full-term peers (P < 0.001), but at the age 9/10-year time point, very preterm and full-term children had comparable surface area (P > 0.05). Across all subjects, cortical expansion by age 9/10 years was most pronounced in frontal, temporal, and supramarginal/inferior parietal junction areas, which are key association cortices (PSpin < 0.001). Very preterm children showed greater cortical surface area expansion between term-equivalent age and age 9/10 compared to their full-term peers in the medial and lateral frontal areas, precuneus, and middle temporal/banks of the superior sulcus junction (P < 0.05). Furthermore, within the very preterm group, expansion was highly variable within the orbitofrontal cortex and posterior regions of the brain. By mapping these patterns across the cortex, we identify differences in association cortices that are known to be important for executive functioning, emotion processing, and social cognition. Additional longitudinal work will be needed to understand if increased expansion in very preterm children is adaptive, or if differences persist into adulthood.Item Enhanced detection of cortical atrophy in Alzheimer's disease using structural MRI with anatomically constrained longitudinal registration(Wiley, 2021-08) Iannopollo, Emily; Garcia, Kara; Radiology and Imaging Sciences, School of MedicineCortical atrophy is a defining feature of Alzheimer's disease (AD), often detectable before symptoms arise. In surface-based analyses, studies have commonly focused on cortical thinning while overlooking the impact of loss in surface area. To capture the impact of both cortical thinning and surface area loss, we used anatomically constrained Multimodal Surface Matching (aMSM), a recently developed tool for mapping change in surface area. We examined cortical atrophy over 2 years in cognitively normal subjects and subjects with diagnoses of stable mild cognitive impairment, mild cognitive impairment that converted to AD, and AD. Magnetic resonance imaging scans were segmented and registered to a common atlas using previously described techniques (FreeSurfer and ciftify), then longitudinally registered with aMSM. Changes in cortical thickness, surface area, and volume were mapped within each diagnostic group, and groups were compared statistically. Changes in thickness and surface area detected atrophy at similar levels of significance, though regions of atrophy somewhat differed. Furthermore, we found that surface area maps offered greater consistency across scanners (3.0 vs. 1.5 T). Comparisons to the FreeSurfer longitudinal pipeline and parcellation-based (region-of-interest) analysis suggest that aMSM may allow more robust detection of atrophy, particularly in earlier disease stages and using smaller sample sizes.Item Erratum: Advancing medical technology innovation and clinical translation via a model of industry-enabled technical and educational support: Indiana Clinical and Translational Sciences Institute's Medical Technology Advance Program(Cambridge University Press, 2021-07-22) Brightman, Andrew O.; Coffee, R. Lane, Jr.; Garcia, Kara; Lottes, Aaron E.; Sors, Thomas G.; Moe, Sharon M.; Wodicka, George R.; Medicine, School of Medicine[This corrects the article DOI: 10.1017/cts.2021.1.].Item Indiana CTSI Preclinical Innovation Think Tank Program(Association for Clinical and Translational Sciences, 2022-04-21) Portonovo, Padma; Garcia, Kara; Moe, SharonThe skills and knowledge required for successful commercialization of new technologies (intellectual property protection, SBIR/STTR funding, and startup creation) are very different than those for traditional academic research (scientific publication and R01-style grant funding). The Indiana CTSI Think Tank Program is designed to provide early guidance to academic and clinical investigators interested in advancing their discoveries to the market. The program is open to investigators from Indiana University (IU), Purdue University, or the University of Notre Dame; and includes a pool of advisors across these universities and industry around the state to provide investigators with a wide range of expertise and perspectives.Item Use of SGLT2 Inhibitors Reduces Heart Failure and Hospitalization: A Multicenter, Real-World Evidence Study(Kaiser Permanente, 2023) Blanco, Christopher Antonio; Garcia, Kara; Singson, Adrian; Smith, William R.; Medicine, School of MedicineBackground: New research has produced evidence to support the use of diabetic drugs to prevent heart failure (HF). However, evidence of their effect in real-world clinical practice is limited. Objective: The objective of this study is to establish whether real-world evidence supports clinical trial findings that use of sodium-glucose cotransporter-2 inhibitor (SGLT2i) reduces rate of hospitalization and incidence of HF for patients with cardiovascular disease and type 2 diabetes. Methods: This retrospective study used electronic medical records to compare rate of hospitalization and incidence of HF among 37,231 patients with cardiovascular disease and type 2 diabetes under treatment with SGLT2i, glucagon-like peptide-1 receptor agonist (GLP1-RA), both, or neither. Results: Significant differences were found between medication class prescribed and number of hospitalizations (p < 0.0001) and incidence of HF (p < 0.0001). Post-hoc tests revealed reduced incidence of HF in the group treated with SGLT2i relative to GLP1-RA alone (p = 0.004) or neither of these key drugs (p < 0.001). No significant differences were observed between the group receiving both drug classes compared to SGLT2i alone. Discussion: Results of this real-world analysis are consistent with clinical trial findings that SGLT2i therapy reduces incidence of HF. The findings also suggest the need for further points of research in demographic and socioeconomic status differences. Conclusion: Real-world evidence supports clinical trial findings of SGLT2i reducing both incidence of HF and rate of hospitalization.Item Use of SGLT2 Inhibitors Reduces Heart Failures and Hospitalization: A Multicenter, Real-World Evidence Study(2023-04-28) Blanco, Christopher; Garcia, Kara; Singson, Adrian; Smith, WilliamBACKGROUND: New research has produced evidence to support the use of diabetic drugs to prevent heart failure (HF). However, evidence of their effect in real-world clinical practice is limited. OBJECTIVE: The objective of this study is to establish whether real-world evidence supports clinical trial findings that use of sodium-glucose cotransporter-2 inhibitor (SGLT2i) reduces rate of hospitalization and incidence of HF for patients with cardiovascular disease and type 2 diabetes. METHODS: This retrospective study used electronic medical records to compare rate of hospitalization and incidence of HF among 37,231 patients with cardiovascular disease and type 2 diabetes under treatment with SGLT2i, glucagon-like peptide-1 receptor agonist (GLP1-RA), both, or neither. RESULTS: Significant differences were found between medication class prescribed and number of hospitalizations (p < 0.0001) and incidence of HF (p < 0.0001). Post-hoc tests revealed reduced incidence of HF in the group treated with SGLT2i relative to GLP1-RA alone (p = 0.004) or neither of these key drugs (p < 0.001). No significant differences were observed between the group receiving both drug classes compared to SGLT2i alone. DISCUSSION: Results of this real-world analysis are consistent with clinical trial findings that SGLT2i therapy reduces incidence of HF. The findings also suggest the need for further points of research in demographic and socioeconomic status differences. CONCLUSION: Real-world evidence supports clinical trial findings of SGLT2i reducing both incidence of HF and rate of hospitalization.