Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public–private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) clearances and innovative product introductions. An overview of the mTBI problem and landscape was performed. A detailed situation analysis of an example of a PPP yielding an innovative product was further demonstrated. The example of PPP has led to multiple FDA clearances and product introductions in the TBI diagnostic product category where there was an urgent military and public need. Important lessons included defining the primary public and military health objective for new product introduction, the importance of the government–academia–industry PPP triad with a “collaboration towards solutions” Quality-by-Design (QbD) mindset to assure clinical validity with regulatory compliance, the development of device comparators and integration of measurements into a robust, evidence-based statistical and FDA pathway, and the utility of top-down, flexible, practical action while operating within governmental guidelines and patient safety.

Institutional Development Awards for Clinical and Translational Research (IDeA-CTR) networks, funded by NIH/NIGMS, aim to advance CTR infrastructure to address historically unmet state and regional health needs. Success depends on the response to actionable feedback to IDeA-CTR leadership from network partners and governance groups through annual surveys, interviews, and governance body recommendations. The Great Plains IDeA-CTR applied internal formative meta-evaluation to evaluate dispositions of 172 governance recommendations from 2017 to 2021. Results provided insights to improve the classification and quality of recommendations, credibility of evaluation processes, responsiveness to recommendations, and communications and governance in a complex CTR network comprising multiple coalitions.

OBJECTIVES/GOALS: Community-based residency programs often lack formal training in research scholarship required by ACGME. To address this need, UCSF’s CTSI collaborated with residency leaders to implement a self-paced online curriculum for residents called Training in Practice Based Research (TIPR). We describe characteristics of the initial trainee cohort. METHODS/STUDY POPULATION: In the 2022-23 academic year, TIPR was offered to 10 UCSF-affiliated family medicine residency programs across Northern California and the Central Valley, and 8 chose to participate. An additional community-based psychiatry residency independently contacted our team and was also granted permission to participate. We conducted baseline surveys with participants to understand their prior research experience and motivation to join TIPR. Descriptive data for demographics of trainees and their prior research experience were collected using Qualtrics. Thematic analyses were conducted on qualitative responses. RESULTS/ANTICIPATED RESULTS: Of 32 participants, 29 completed the survey (91%). Learners identified as 40% non-Hispanic White, 28% Asian, 16% Hispanic, 9% non-Hispanic Black, and 15% non-Hispanic other. 28% were motivated to participate in the program because it was a residency requirement, 31% wanted to improve their scholarly skills and confidence, 16% were interested in career development, and 6% were interested in networking. 19% reported no research experience. Participants are currently working on scholarly projects designed during the first year of TIPR. In 2023-2024, with the addition of two new family medicine residency programs, an additional 40 residents have enrolled in TIPR. In April 2024, we will present data on projects completed, and demographics of the full cohort. DISCUSSION/SIGNIFICANCE: With CTSI support, TIPR has reached a large cohort of ethnically diverse physician trainees in community-based settings. Future evaluation will focus on whether TIPR increases the quantity and quality of practice-based research within residency training programs served by this program.

OBJECTIVES/GOALS: Autologous periodontal ligament cells (PDLCs) are a promising tool for rebuilding tooth-supporting (periodontal) tissues but require scaffolds that enable delivery while maintaining PDLC bioactivity. The goal of this study was to design a synthetic hydrogel that fulfilled these criteria to support clinical translation of PDLC delivery. METHODS/STUDY POPULATION: Hydrogels were formed using poly(ethylene glycol) (PEG) polymers and synthetic peptides. PDLCs were isolated from human 3rd molars following informed consent and were cultured using established techniques. Integrin-binding peptides were utilized to promote specific PDLC behaviors, testing PDLCs from 3 human donors in a design of experiments (DOE) approach. Two promising hydrogel designs, identified in the DOE, were selected for validation testing using PDLCs from 3 additional donors. Finally, a small animal model for hydrogel-mediated PDLC delivery was used to determine if benchtop outcomes could predict in vivo tissue regeneration. RESULTS/ANTICIPATED RESULTS: Hydrogel scaffolds maintained high PDLC viability and controlled differentiation of each donor’s PDLCs based on differential presentation of integrin-binding peptides RGD and GFOGER. Two hydrogel designs were selected that optimized either PDLC alkaline phosphatase (ALP) activity or matrix mineralization, outcomes typically associated with cementum and bone formation. ALP activity-optimized hydrogels displayed enhanced PDLC pyrophosphate regulation while mineralization-optimized hydrogels promoted PDLC osteogenic differentiation. When used to deliver PDLCs to periodontal defects, both ALP activity-optimized and mineralization-optimized hydrogels stimulated new cementum formation with inserting PDL fibers, while mineralization-optimized hydrogels promoted enhanced bone formation. DISCUSSION/SIGNIFICANCE: Numerous challenges remain for translating PDLC regenerative potential to clinical practice. This study demonstrates that a synthetic hydrogel scaffold could overcome certain barriers, including controlling PDLC bioactivity with a simplified fabrication and delivery scheme, and may be a promising scaffold for periodontal tissue regeneration.

OBJECTIVES/SPECIFIC AIMS: Skillful research staff members are critical to productive translational research teams and yet their ongoing professional development is rarely formally addressed. Through the Strategic Teamwork for Effective Practice-Mentor Development Program (STEP-MDP), we aimed to both create a community of practice (COP) for research staff and build the skills needed to enhance research team performance. METHODS/STUDY POPULATION: We selected 16 participants of 32 staff-level applicants from among the NYU Schools of Medicine, Social Work and Nursing for the first STEP-MDP cohort. Participants included research assistants, coordinators, managers, and directors. We delivered 3, two-hour workshops, scheduled 3 weeks apart, focused on team communication, identifying team areas for improvement, and mentorship/coaching skills. Peer-Coaching Teams (PCTs) were created by pairing participants at the same position level, and PCTs worked together at each session to explore and practice learned skills. Sessions featured brief didactics, group-based learning and exercises based on participants’ real issues. A variety of active learning techniques such as brainstorming, role-playing, problem solving, and peer coaching were used. Practical core readings, worksheets, and summary cards were provided. PCTs met between sessions to practice coaching skills, and troubleshoot problems. RESULTS/ANTICIPATED RESULTS: Participants (n=16) completed a 37-item retrospective pre/post self-assessment of team behaviors and skills, and a STEP-MDP evaluation survey at the end. We saw pre-post improvements in each of 5 self-assessment domains: Communication (4 items, pre-mean 2.66, post mean 3.36, p≤0.001), Leadership (8 items, pre-mean 2.76, post mean 3.55, p≤0.001), Empowerment and Motivation (12 items, pre-mean 2.86, post mean 3.51, p≤0.001), Coaching (6 items, pre-mean 2.40, post mean 3.58, p≤0.001), and Community (3 items, pre-mean 2.33, post mean 3.76, p≤0.001). On average, PCTs met twice (range 2–4 times) between workshop sessions. Learners valued the PCTs, and 1 commented on the value of working with peers in PCTs, having no one in a similar position within his immediate work environment. Participants’ written comments strongly endorsed the value of the workshops for their work, with the coaching skills session seen as the most valuable. Some participants worry that skills will decrease over time without continued reinforcement. All but 1 participant reported that they planned to continue with the PCT. DISCUSSION/SIGNIFICANCE OF IMPACT: The number of applicants to our program suggests a need and motivation for staff to participate in the STEP-MDP. Participants’ reported improved skills and sense of community. To maintain the COP and address worry about degradation of skills we are planning to remind PCTs to meet once a month and will follow-up with them 3 and 6 months post intervention to evaluate their continued development. This spring a second cohort will receive the training. We believe developing these core teamwork skills will lead to more collaborative, efficient, and innovative research. We have implemented a successful program targeting critical members of research teams with potential to facilitate expansion of institutional capacity for translational research. It will be important to understand the long-term impact of the program on individuals, on team science, on research, and ultimately on the health of the public.

OBJECTIVES/SPECIFIC AIMS: Therapeutic hypothermia (TH) is a neuroprotective therapy regularly used in newborn infants following traumatic births. The infant’s temperature is maintained at 33.5°C for 72 hours by a cooling blanket upon which the infant is placed. Parents are not permitted to hold their infant while TH is ongoing due to concerns for unintentional rewarming or accidental dislodging of catheters or other monitoring equipment. Our prior qualitative research with nurse and parent interviews described the inability to hold an infant during TH as a significant source of stress. We assessed the feasibility of a 30-minute period of maternal holding for infants being actively treated with TH and assessed both the maternal experience of holding and the nurse experience of supporting holding. METHODS/STUDY POPULATION: This was a feasibility study employing a mixed-methods approach. Inclusion criteria were gestational age at birth of 35 weeks or greater, absence of clinical or electrographic seizures during the first 24 hours of TH, and designation as “clinically stable” by the attending neonatologist with the infant on room air, nasal cannula, or continuous positive airway pressure. Quantitative data were obtained from vital sign monitoring every 2 minutes before, during and after holding and from maternal and nurse research surveys. Qualitative data were obtained from nurse surveys. Infant rewarming was prevented through use of a thin foam insulating barrier placed between mother and infant during holding. Adverse events were defined as a change in infant temperature greater than 0.5°C above or below 33.5°C, accidental dislodging of central lines/disruption of EEG leads or early termination of holding due vital sign instability present for greater than 2 recorded measurements including infant bradycardia defined as heart rate less than 80 beats per minute, hypotension defined as mean arterial pressure less than 40 mmHg or oxygen saturation of less than 93%. RESULTS/ANTICIPATED RESULTS: There were 10 newborn infants undergoing TH for neonatal encephalopathy (median gestational age 39.4 weeks) and their mothers (median age=31 years) were recruited. Infants remained on the hypothermia blanket during holding and were transferred safely to their mother’s arms without medical equipment malfunction/dislodgement. Holding occurred at a median of 47 hours of life. The mean temperature prior to holding was 33.4°C and at completion of holding the mean temperature was 33.5°C (p=0.18). There were no significant bradycardia, hypotension or oxygen desaturation events. In total, 80% of mothers reported difficulty bonding with their baby prior to holding and 90% reported a high level of stress before holding. After holding, all mothers felt their bond was “stronger” or “much stronger” and all felt “less stressed” or “much less stressed.” After holding, 75% of nurses reported that they felt a more positive emotional response to the infant. One nurse stated, “being a part of this emotional experience made me feel closer and more connected to this family and gave me a different perspective on just what they had been dealing with and feeling since giving birth to their child.” In free text responses, on 5 separate occasions, nurses commented on the relaxed, calmed or less irritable appearance of the infant while being held during TH. DISCUSSION/SIGNIFICANCE OF IMPACT: In this sample of term infants treated with TH, a 30-minute period of maternal holding was not associated with increased temperature or other adverse events. Holding during TH was associated with extremely positive feedback from mothers and nurses. Future larger studies could consider assessing the impact of holding on endocrinological markers of stress and bonding, on infant glycemic control, on breastfeeding success rates, and the impact of earlier and improved bonding on the developmental outcomes of children held during their treatment with TH. Increasing the duration of holding and allowing both parents to hold on more than one occasion during the 72 hours of TH may increase the proposed benefits of this intervention.

OBJECTIVES/GOALS: To describe team science training that can be tailored to specific audiences, in this case, Clinical Research Professionals (CRP) using discipline-specific vignettes, and to highlight the benefits of audience-specific training in team science. METHODS/STUDY POPULATION: Translational science teams are comprised of members from various disciplines. All members can benefit from team science training. Our education team has incorporated discipline-specific training into educational offerings. This project focuses on education tailored to CRPs and their role in clinical research. Historically, team science training has been focused on faculty and trainees. The exclusion of CRPs can limit the impact of this training. We’ve created workshops specifically geared toward CRPs. This presentation demonstrates how we tailor team science training to CRPs by using relevant examples and real-world vignettes to highlight concepts. RESULTS/ANTICIPATED RESULTS: The team science workshops conducted specifically for CRPs have been well received. CRPs have been eager to engage with team science-related material. The number of team science workshops requested by CRP groups is continuing to increase. We will share both quantitative and qualitative evaluation results from several team science workshops conducted to-date. The inclusion of scenarios that relate to common situations encountered by CRPs has been especially helpful in demonstrating team science concepts they have personally experienced. DISCUSSION/SIGNIFICANCE: Helping CRPs directly apply team science concepts to their work is very valuable for improving high-functioning team behavior. CRPs can use new knowledge and skills to enhance efficiency and reduce stress and burnout. The impact of team science is maximized when all members of the team are trained.

OBJECTIVES/SPECIFIC AIMS: Cesarean delivery is typically performed in the extremely preterm period (23 to 28 weeks) when the fetus is in breech presentation to avoid the potential risk of head entrapment by an insufficiently dilated cervix during a vaginal delivery. Assessment of the prevalence of extremely preterm breech cesarean delivery would help to appropriately guide future clinical interventions designed to increase the feasibility of vaginal delivery for this sub-group of patients. METHODS/STUDY POPULATION: We performed a cross-sectional study of the 2106 U.S. National Vital Statistics birth certificate database to estimate the prevalence of cesarean deliveries performed during the period of gestation from 23 to 28 weeks with a fetus in breech presentation. RESULTS/ANTICIPATED RESULTS: An analysis of the total births in the 2016 registry (3,945,875) was performed. The gestational age was limited to the target range of 23 0/7 to 27 6/7 weeks. Multiple gestation deliveries were excluded. This yielded 16,092 births of which 4,849 were noted to have breech presentation. The proportion of cesarean deliveries performed for singleton breech fetuses at this gestational range was 87% (4,203/4,849). DISCUSSION/SIGNIFICANCE OF IMPACT: The probability of undergoing a cesarean delivery for an extremely preterm fetus in breech presentation is notably higher (87%) when compared to an overall cesarean delivery rate of 31.9%. Specific interventions to allow for vaginal delivery in this particular sub-group of the obstetric population would be useful to reduce maternal morbidity by increasing vaginal deliveries. Future work will attempt to address innovative solutions to prevent head entrapment by the cervix in this particular population and ultimately avoid cesarean delivery.

Objectives/Goals: Cervical cancer is preventable through HPV vaccination and the detection/removal of precancerous lesions. Incidence and mortality rates have only decreased by 3–4% in the past decade. Despite having the tools to prevent all cervical cancers, they are not being fully utilized. Our goal is to identify barriers and design strategies to overcome them. Methods/Study Population: Women in urban (750) and rural (750) settings will be screened for the presence of high-oncogenic risk HPV (hrHPV) by self-vaginal swab, complete the Monitoring Blunting Style Scale, a validation scale to determine attentional style, and a structural barrier to care survey. A subset (Results/Anticipated Results: The study, launched in September 2024 at the Medicine Primary Care Clinic at UMC in New Orleans, has enrolled 16 women. Sample adequacy was high (82%), with 5 women having hrHPV present. Participants expressed high satisfaction and acceptance of the self-administered vaginal swab, with most samples demonstrating high quality. Surveys have been collected, and hrHPV-positive women have been referred for gynecological follow-up. Shreveport site will recruit women across over 20 rural clinical sites using a Mobile Health Unit to increase access in rural and underserved communities. Discussion/Significance of Impact: The baseline study will take 12–18 months. We will identify and address key barriers to follow-up gynecological care, including logistical issues (improving access and navigation), educational needs (developing culturally sensitive materials), and emotional support. We will create a care delivery model to eliminate cervical cancer in Louisiana.

OBJECTIVES/GOALS: Using the covariate-rich Veteran Health Administration data, estimate the association between Proton Pump Inhibitor (PPI) use and severe COVID-19, rigorously adjusting for confounding using propensity score (PS)-weighting. METHODS/STUDY POPULATION: We assembled a national retrospective cohort of United States veterans who tested positive for SARS-CoV-2, with information on 33 covariates including comorbidity diagnoses, lab values, and medications. Current outpatient PPI use was compared to non-use (two or more fills and pills on hand at admission vs no PPI prescription fill in prior year). The primary composite outcome was mechanical ventilation use or death within 60 days; the secondary composite outcome included ICU admission. PS-weighting mimicked a 1:1 matching cohort, allowing inclusion of all patients while achieving good covariate balance. The weighted cohort was analyzed using logistic regression. RESULTS/ANTICIPATED RESULTS: Our analytic cohort included 97,674 veterans with SARS-CoV-2 testing, of whom 14,958 (15.3%) tested positive (6,262 [41.9%] current PPI-users, 8,696 [58.1%] non-users). After weighting, all covariates were well-balanced with standardized mean differences less than a threshold of 0.1. Prior to PS-weighting (no covariate adjustment), we observed higher odds of the primary (9.3% vs 7.5%; OR 1.27, 95% CI 1.13-1.43) and secondary (25.8% vs 21.4%; OR 1.27, 95% CI 1.18-1.37) outcomes among PPI users vs non-users. After PS-weighting, PPI use vs non-use was not associated with the primary (8.2% vs 8.0%; OR 1.03, 95% CI 0.91-1.16) or secondary (23.4% vs 22.9%;OR 1.03, 95% CI 0.95-1.12) outcomes. DISCUSSION/SIGNIFICANCE: The associations between PPI use and severe COVID-19 outcomes that have been previously reported may be due to limitations in the covariates available for adjustment. With respect to COVID-19, our robust PS-weighted analysis provides patients and providers with further evidence for PPI safety.

OBJECTIVES/GOALS: The development of early university technologies for commercialization is largely inefficient and exhibits a high rate of failure, often due to a lack of researcher time and commercialization experience. We have created the Translational Fellow role to address these needs and increase the throughput of university technology transfer. METHODS/STUDY POPULATION: Translational Fellows will first build their initial competencies to identify, evaluate, and develop new technologies through internships with intake organizations within the university ecosystem, including the Office of Technology Management, the LEAP gap-funding mechanism, and local venture capital firms. Following this training, Fellows will provide tailored support to validated projects by establishing development milestones, liaising with industry experts, navigating regulatory requirements, and drafting marketing materials such as executive summaries and financial projections. Lastly, Fellows will partner with a highly developed project to facilitate the commercialization of the technology, whether through a SBIR/STTR grant, direct licensing event, or startup creation. RESULTS/ANTICIPATED RESULTS: We anticipate that implementation of this mechanism will increase the proportion of university-generated inventions that undergo successful commercialization events, as well as increase the rate at which these projects develop after initial validation. Furthermore, we expect that the skills acquired through this program will allow Fellows to successfully transition to a variety of roles in the biotech space. We also expect that Fellows will be capable of training other scientific teams in the preparation of SBIR/STTR grants, further expanding opportunities for commercialization in the research space. DISCUSSION/SIGNIFICANCE OF IMPACT: Translational Fellows fill a unique interdisciplinary niche, allowing them to address common barriers faced by academic inventors. Improving commercialization throughput further capitalizes on the wealth of ideas generated in universities, thereby driving innovation in the biomedical space and directly contributing to improved human health. CONFLICT OF INTEREST DESCRIPTION: The authors have no conflicts of interest.

OBJECTIVES/SPECIFIC AIMS: Alcohol use disorder (AUD) has been associated with greater discounting of delayed rewards relative to healthy controls. The relationship, however, has been inconsistent, likely because previous studies had relatively small sample sizes and inadequately controlled for comorbid psychopathology and substance use. In the present study, we analyzed one of the largest clinical research samples to date to assess the influence of alcohol use on delay discounting, and examine the influence of confounding variables including substance use disorder. METHODS/STUDY POPULATION: In total, 801 participants completed a delay discounting task where they chose between smaller, immediately available monetary amounts ($0–$90) and $100 available after a delay of 7–30 days. Delay discounting behavior was summarized as the natural log of k, a constant derived from a hyperbolic discounting equation. Participants also completed Structured Clinical Interviews for DSM-IV disorders, 90-day Timeline Followback interviews, and the Fagerström Test for Nicotine Dependence. Participants were divided into 4 groups: healthy controls (n=298), past AUD (n=69), and current AUD with (n=224) and without (n=210) comorbid psychopathology or substance use disorder. Kruskal-Wallis test was used to examine the effect of group on delay discounting. RESULTS/ANTICIPATED RESULTS: There were significant differences in the distribution of delay discounting scores by group (H=80.195, p<0.001). Healthy controls and past AUD showed lower levels of delay discounting than current AUD and current AUD+comorbidity groups with medium effect sizes (Cohen’s d=−0.635 and Cohen’s d=−0.614, respectively). There were nearly no differences between current AUD with and without comorbid psychopathology groups (Cohen’s d=−0.024). The past AUD group showed almost no difference relative to the healthy control group (Cohen’s d=0.007). DISCUSSION/SIGNIFICANCE OF IMPACT: Individuals with current AUD were shown to discount rewards greater than those without current AUD, although comorbid psychopathology did not significantly affect discounting. Surprisingly, individuals with past AUD were more similar to controls than to those with current AUD. Our findings suggest that current problematic alcohol use is related to greater discounting of delayed rewards, but comorbid diagnoses do not significantly impact this relationship. However, once problematic patterns of alcohol use cease, delay discounting appears to return to levels comparable to healthy controls.

Objectives/Goals: The primary objectives of this project were to create a user-friendly website that • Shares details of ongoing studies in an easily searchable and filterable format. • Provides lay summaries of study results. • Highlights our volunteer registry. • Offers a platform for community engagement and feedback on research interests. Methods/Study Population: The website, developed using DRUPAL 10 and launched in June 2024, was created with input from faculty, staff, research participants, and community partners. It targets potential participants, community members, providers, and other Academic Medical Centers. The development process included focus groups to identify design and feature needs, design iterations and usability testing, and an external accessibility review. Study information is automatically updated from the Study Information Portal (SIP) in OnCore and a custom REDCap survey. Features include a research volunteer registry, study results in lay terms, educational content about research, and multiple ways for community engagement. The site supports English and Spanish and follows best practices for accessibility. Results/Anticipated Results: Community feedback on the site has been very positive, with positive comments about ease of navigation and the improved appearance of the website. It is still early, but we have seen a notable increase in enrollment in the Volunteer Registry since the launch of the website. We track referral sources for the registry, and to date, we have seen 98 individuals enrolled who were directed to us through the website since it launched. This equates to an average of 5 people a week, more than any other referral source. This rate increases to almost 7 per week if we look solely at the period since we started the promotion of the website in early August. As the site awareness expands, we will also be getting feedback from individual studies and are tracking email communication generated from the site as well. Discussion/Significance of Impact: The development of this website represents a significant step toward improving community engagement in clinical research at Duke. By providing a centralized platform for study information, results, and community feedback, we aim to foster a more informed and involved participant base, ultimately enhancing the impact and reach of our research.

OBJECTIVES/GOALS: (1) Assess challenges with our current continuous improvement processes via stakeholders. (2) Implement a revised continuous improvement process. (3) Evaluate the revised processes to assess implementation and use for strategic improvement. (4) Implement analysis mechanisms for new process to assess trends across the CTSI. METHODS/STUDY POPULATION: We used a mixed-methods, multi-phased, stakeholder-engaged approach with different processes per objective. Obj. 1: We implemented focus groups, surveys, and listening sessions incorporating two populations: both teams required to participate in reporting process, and CTSI leadership. Obj. 2: We utilized data from Obj. 1 processes to develop a revised continuous improvement process. Obj. 3: We integrated qualitative feedback processes onto the structure of continuous improvement processes, and we implemented a survey to assess use and value for the new process. Obj. 4: We developed a qualitative coding schema to assess key trends across teams and over time. RESULTS/ANTICIPATED RESULTS: Obj. 1: Numerous challenges in metrics format and process, including significant limitations in data use to inform decision-making and appropriately assess impact. Obj. 2: Resultant changes to continuous improvement processes, including a restructured reporting format and use-oriented approach that enhanced organizational integration; changes included added focus on facilitators of success, challenge, and key opportunities to better inform decision-making. Obj. 3: The majority of teams experienced the new quarterly process as a better tool for program monitoring and communicating program needs to leadership, but that fuller integration into vertical communication is needed. Obj. 4: Implementation of new analysis process enabling examination of trends and themes across diverse teams within the CTSI. DISCUSSION/SIGNIFICANCE: This work has particular relevance within ACTS given our focus on a clinical and translational research enterprise, the complexity in evaluating the diverse work of translation research entities, and limitations in a commonly-used metrics-monitoring approach. Our focus on improving translational processes advances translational science.

ABSTRACT IMPACT: This work will standardize necessary image pre-processing for diagnostic and prognostic clinical workflows dependent on quantitative analysis of conventional magnetic resonance imaging. OBJECTIVES/GOALS: Conventional magnetic resonance imaging (MRI) poses challenges for quantitative analysis due to a lack of uniform inter-scanner voxel intensity values. Head and neck cancer (HNC) applications in particular have not been well investigated. This project aims to systematically evaluate voxel intensity standardization (VIS) methods for HNC MRI. METHODS/STUDY POPULATION: We utilize two separate cohorts of HNC patients, where T2-weighted (T2-w) MRI sequences were acquired before beginning radiotherapy for five patients in each cohort. The first cohort corresponds to patients with images taken at various institutions with a variety of non-uniform acquisition scanners and parameters. The second cohort corresponds to patients from a prospective clinical trial with uniformity in both scanner and acquisition parameters. Regions of interest from a variety of healthy tissues assumed to have minimal interpatient variation were manually contoured for each image and used to compare differences between a variety of VIS methods for each cohort. Towards this end, we implement a new metric for cohort intensity distributional overlap to compare region of interest similarity in a given cohort. RESULTS/ANTICIPATED RESULTS: Using a simple and interpretable metric, we have systematically investigated the effects of various commonly implementable VIS methods on T2-w sequences for two independent cohorts of HNC patients based on region of interest intensity similarity. We demonstrate VIS has a substantial effect on T2-w images where non-uniform acquisition parameters and scanners are utilized. Oppositely, it has a modest to minimal impact on T2-w images generated from the same scanner with the same acquisition parameters. Moreover, with a few notable exceptions, there does not seem to be a clear advantage or disadvantage to using one VIS method over another for T2-w images with non-uniform acquisition parameters. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our results inform which VIS methods should be favored in HNC MRI and may indicate VIS is not a critical factor to consider in circumstances where similar acquisition parameters can be utilized. Moreover, our results can help guide downstream quantitative imaging tasks that may one day be implemented in clinical workflows.

OBJECTIVES/SPECIFIC AIMS: In this study, we propose to investigate effectiveness of 2 core services provided by the Center for Clinical and Translational Science (CCTS), home for CTSA program in the School of Medicine at the University of Utah. METHODS/STUDY POPULATION: We will apply a longitudinal database of research and tenure track faculty (n>600) in the School of Medicine at the University of Utah from 2006 to 2016 to estimate the effect of initial usage of the biostatistics and clinical services cores of the University of Utah CCTS on the probability of (a) ≥1 peer reviewed publication, (b) external grant funding, and (c) academic promotion within 1, 2, and 3 years after the initial contact. We will apply a “new users” design (Hernan et al., Epidemiology, 2008; 19: 766–779) to compare the outcomes of faculty initiating use of the 2 CCTS cores Versus faculty without prior use of these cores in a series of cohorts defined by the calendar year of initial contract with the 2 cores, with covariate adjustment performed within each cohort to account for measured confounders. Separate outcome models will be specified for each cohort, but the statistical models will be fit to stacked augmented data sets which include the data from each cohort. Using the stacked data set, results will be pooled across each of the cohorts to increase statistical power. Robust sandwich estimates of standard errors will be used to account for the inclusion of multiple assessments for each faculty member. RESULTS/ANTICIPATED RESULTS: Estimates of the effect of initiation of new CTSA usage on academic productivity outcomes will be obtained, and provided in conjunction with sensitivity analyses to address the potential impact of uncontrolled confounding. DISCUSSION/SIGNIFICANCE OF IMPACT: The proposed evaluation strategy should overcome some of the biases inherent in typical metrics for effectiveness of CTSA programs, and will be applied to evaluate success of future initiatives.

ABSTRACT IMPACT: This work aims to identify best practices for university-based asset development programs to improve commercialization throughput, which in turn will drive innovation in the biomedical space and directly contribute to improved human health. OBJECTIVES/GOALS: University technology transfer exhibits a high rate of failure, often due to a lack of researcher experience or early-stage financial capital. The LEAP program at Washington University (WUSTL) was created to address these needs. The goal of this study is to assess the performance of LEAP against similar gap funds and further improve program operations. METHODS/STUDY POPULATION: The goals of LEAP are achieved by providing university inventors with individualized consulting and feedback from industry experts, as well as awarding funding to the most promising projects. To determine whether these activities are impactful, we distributed an awardee report form to collect data on all funded LEAP projects, and then combined the results with project registration information. We also collected records Office of Technology Management, including invention disclosures, licenses, and startup creations. The resulting dataset was used to calculate program metrics and then evaluated against comparable gap funds. Sentiment data from participant surveys were also analyzed to assess perceived program value and knowledge transfer. RESULTS/ANTICIPATED RESULTS: As of the Sp2020 cycle, LEAP has funded 76 projects. Resubmitted projects had a funding rate of 52%, vs. 34% for new projects. Of the startups founded off of WUSTL intellectual property since 2016, nearly two-thirds had previously participated in LEAP. Funded LEAP projects also had a 29% licensing rate, which is comparable to similar gap funds. Lastly, participants self-reported an increase in knowledge across a range of commercialization areas. DISCUSSION/SIGNIFICANCE OF FINDINGS: The increased repeat funding rate and self-reported knowledge suggest that LEAP is impactful in building commercialization proficiency. The licensing rate and prevalence of LEAP projects in WUSTL startups also indicate that LEAP is indeed promoting tech transfer. Together, these results suggest that LEAP could be a model for other institutions.

OBJECTIVES/GOALS: - Illuminate processes and findings of a translational science case study of impactful research with incarcerated pregnant women and mothers; - Improve our understanding of the translational mechanisms by sharing translational challenges, facilitators, an METHODS/STUDY POPULATION: Utilized the following evaluation methods and tools: - The Retrospective Translational Science Case Study protocol to examine translational path from innovation to policy and practice, barriers and facilitators for that translational movement. - Translational Science Benefits Model (TSBM) Checklist for translational/research impact analysis Triangulated diverse data sources: - Primary data: semi-structured interviews with research partners - Secondary data: researchers’ grant applications, reports, and publications; public stories/news related to their research; scientific publications; organizational/policy documents; and over 50 interviews with 30 stakeholders featured in published sources. RESULTS/ANTICIPATED RESULTS: The research contributed to community and public health, policy/legislative, clinical/medical, and economic benefits, social/institutional change, health equity advocacy, catalyzing research (consequent research studies) and public awareness. Translational research challenges: cultural differences between research and prison system; politics of translating research to policy change; issues of capacity, power, privilege, and opportunity when doing community-engaged research; and science vs. social justice criticism. Facilitators of translation: CTSA support; stakeholder engagement; authentic collaboration; researchers as translation catalysts; and engagement in legislative activities. DISCUSSION/SIGNIFICANCE: The evaluation case study provides useful knowledge about translational impact, challenges, and facilitators of community-based research that moved along the translational continuum and contributed to transformational, systemic changes on the legal, clinical, organizational, and interpersonal levels.

OBJECTIVES/GOALS:

1. 1. Examine the associations among BMI and markers of cardiometabolic risk, including blood pressure, lipids and blood glucose.

2. 2. Assess prevalence of kidney function deterioration, identified as hyperfiltration and moderately increased albuminuria (MIA), in obese compared to normal weight adolescents.

METHODS/STUDY POPULATION: De-identified electronic health records (EHR) data were extracted for female adolescents, aged 12-21 years, and their offspring through 24 months, who received health care services (Jan 2012 to Dec 2016) in NYC from 12 academic health centers and community health centers that are part of PCORnet NYC Clinical Data Research Network (NYC-CDRN). Data were analyzed using SAS (version 3.2.5). Patient characteristics overall and for study subgroups were examined using standard summary statistics. Trends in cardio-renal variables were examined by BMI groups coded according to NHANES as underweight, normal weight, overweight or obese. Multiple linear regression analyses will control for covariates. RESULTS/ANTICIPATED RESULTS: Data from 651,066 adolescent females ages 12-21 were retrieved. Analysis was performed on a subset of 202,214 unique patients (26% white, 15% black, 12.9% Latina) for whom there was complete data for BMI and blood pressure. Distribution of BMI was 6% underweight, 59% normal weight, 19% overweight, and 17% obese. There were significant differences in mean systolic (SBP, mean±SD mmHg: 102±12, 108±11, 112±12, 116±12) and diastolic blood pressure (DBP, mean±SD mmHg: 62±10, 66±8, 68±8.9, 70±9) across the four BMI groups with an increasing trend (p-values<0.0001). We will examine renal function trends, and whether these cardio-renal differences persist when controlling for age, race and ethnicity. DISCUSSION/SIGNIFICANCE OF IMPACT: Although SBP/DBP means were within normal limits across BMI groups, significant increasing trends suggest that women in higher BMI groups may be at increased risk for hypertension and potentially for renal dysfunction. We will examine contributions of race/ ethnicity and age to these associations.