OBJECTIVES/GOALS: Maternal health and exposures during pregnancy play a major role in shaping the neurodevelopment of our offspring—one influence is maternal immune activation (MIA). Here we explore the association of MIA during pregnancy and the developing human connectome through analysis of 46 markers of activation. METHODS/STUDY POPULATION: 74 healthy women with singleton pregnancies underwent blood draws between 34-37 weeks gestation. 46 markers of maternal immune activation, both adaptive (e.g., IgG) and innate (e.g., cytokines and acute phase reactants), were collected. In addition, for preliminary analyses of MIA in relation to the newborn brain, we utilized 30 participants with MRIs between the ages of 0-6 months. RESULTS/ANTICIPATED RESULTS: Principal component analysis (PCA) identified the first 5 PCs explains ~68% of the variance and the first 10 explains ~83% (top PC is 42.1%). Using the top PC each edge in the connectome was correlated with the immune profiles. Several regions trended towards significance–one survived correction and included 359 edges, showing. The highest number of edges was observed in the inferior parietal lobe of the left hemisphere–a region associated with functions from basic attention toa social cognition, suggesting that deviations in fetal exposure to MIA can longitudinally impact offspring behavior in areas essential for human interaction. DISCUSSION/SIGNIFICANCE: This is the first study in understanding how interruptions (i.e., MIA) influence later development. Identification of alterations, and long-term outcomes could lead to the development of mechanism-based healthcare, facilitate timely referral for appropriate interventions and provide family support.

OBJECTIVES/GOALS: To evaluate the clinical trial designs of stimulant medications approved for the treatment of adult Attention-Deficit/Hyperactivity Disorder (ADHD) and identify discrepancies between safety and efficacy outcome measure criteria. METHODS/STUDY POPULATION: There are 24 stimulants currently approved and marketed for the treatment of adult ADHD: 12 amphetamine (AMP)-based and 12 methylphenidate (MPH)-based formulations. A mixed methods review of clinical trials that have evaluated the safety and efficacy of these drugs will be performed using qualitative and quantitative data, including inclusion and exclusion criteria, primary and secondary outcome measures, manufacturer recommendations, and package inserts, as well as FDA recommendations for industry. After compiling a list of clinical trials for each of the 24 drugs, this information will be analyzed for themes and trends in the assessment of safety and efficacy with particular attention paid to differing criteria between individual drugs and/or the two subclasses of prescription stimulants. RESULTS/ANTICIPATED RESULTS: The FDA has published recommendations for ADHD medication clinical trial design, including suggested outcome measures utilizing validated assessment tools. However, the FDA notes that these assessments may be altered to fit study populations and indicate that other primary and secondary endpoint measures may be acceptable. As such, efficacy assessments for these drugs may vary greatly, and the specific criterion selected for each drug’s study population and outcome measures may suggest more specific indications and usage conditions for optimal efficacy. DISCUSSION/SIGNIFICANCE: Regulatory officials consider AMP- and MPH-based stimulants equivalent therapeutic options for the treatment of ADHD. A study of clinical trial criteria reveals that differing mechanisms have been used to evaluate safety and efficacy. This discrepancy may have implications that affect clinical decision-making and patient experiences.

OBJECTIVES/GOALS: To examine the prevalence of new indications for existing drugs conducted by non-originator companies from 2015 to 2021 and determine how many could qualify for 505(b)(2) under the Food, Drug, and Cosmetics Act. METHODS/STUDY POPULATION: A search within Clinicaltrials.gov was conducted to identify phase 3 drug interventional studies completed from 2015 to 2021. Results were categorized by funding source and industry sponsored studies were further separated into originator- and non-originator companies using dailymed.com. An in-depth review of 2018 was conducted to understand the nature of the studies including indication, dosage form, and route of administration. RESULTS/ANTICIPATED RESULTS: According to clinicaltrials.gov, a total of 7148 phase 3 studies were conducted between 2015 and 2021. Most of these studies were funded by industry (4447, 66.21%), followed by other (2428, 33.97%), NIH (266, 3.72%), and government (62, 0.87%). In-depth examination of the studies completed in 2018 (n=1077) revealed similar pattern in that most were funded by industry (674, 62.58%) followed by other (356, 33.05%), NIH (43, 3.99%), and government (10, 0.93%). Some studies were funded by more than one type. Of the industry-sponsored studies, 623 were funded by originator companies and 51 by non-originator companies. A total of 49/674 of the industry sponsored studies were for new indications, with 42 studies conducted by originator companies and 7 conducted by non-originator companies. DISCUSSION/SIGNIFICANCE: The 505(b)(2) is a way for manufacturers to add new indications to drugs by non-originator companies. In 2018, 49/674 studies were conducted to pursue new indications with few, 7/49, conducted by non-originator companies. The product development landscape reveals few opportunities for entities pursuing the 505(b)(2) pathway for new indications.

OBJECTIVES/GOALS: Despite expanded interest in translational research, barriers in funding, infrastructure, staffing, training opportunities, and interdisciplinary collaboration still remain. Our goal was to interview basic science researchers to identify research barriers and potential areas for improvement. METHODS/STUDY POPULATION: After receiving an IRB determination for a quality improvement study, 15 New Jersey-based principal investigators (PIs) from various departments and at various stages of their careers were virtually interviewed one-on-one by a trained medical student and asked a series of standardized questions about their subjective experiences with their institutions’ research processes, training and mentoring, interdisciplinary collaboration, and intellectual property. The interview was then transcribed to complete an anonymous, standardized REDCap form. Qualitative data analysis was performed to identify common themes, barriers, and gaps in conducting translational research as reported by the PIs. RESULTS/ANTICIPATED RESULTS: Of the 15 PIs, 4 (27%) were assistant professors, 6 (40%) associate professors, and 5 (33%) professors. 5 (33%) joined the institution less than 5 years ago. The most common barrier was translational research funding. Time needed to navigate administrative and regulatory processes and access to clinical collaborators were other common barriers. One PI noted leaving the institution due to difficulty accessing clinicians and patient samples. PIs with extensive training or who reported successfully conducting translational research noted fewer barriers. Suggested solutions included programs and grants to link basic scientists with clinicians, a streamlined IRB process, and better staffing to support research. DISCUSSION/SIGNIFICANCE: The findings suggest a need to increase grant funding for translational research. Improving support staffing and minimizing administrative barriers would also be helpful. Improving the dissemination of available resources, grants, and guidance on administrative processes may further decrease barriers.

OBJECTIVES/GOALS: To identify factors enabling growing underage consumption of disposable Electronic Nicotine Delivery Systems (ENDS) by understanding young adults’perceptions and patterns of use of disposable ENDS through surveying college students. METHODS/STUDY POPULATION: Disposable ENDS are all-in-one devices with pre-filled nicotine liquid and a built-in battery. Recent data shows increased sales as users, including youth, are switching from pod-based to disposable ENDS. Gaps were identified via a literature review of current survey data revealing unknown information about disposable ENDS. Based on these data gaps, an anonymous survey was developed to gain insight into youth disposable ENDS use. The survey was distributed to college students via social media, university email chains, and flyers with QR codes. Responses were analyzed to identify trends and correlations in disposable ENDS use among college students. The survey was approved by USC IRB, Study ID: UP-22-00023. RESULTS/ANTICIPATED RESULTS: Between March 6 and October 28, 2022, 166 completed survey responses were collected; 158 were students. 80.4% (127/158) of surveys were eligible for analysis with the following criteria: 18-20 years old, under the US legal age to use ENDS. Of respondents aged 18-20, 57.5% (73/127) reported using ENDS at least once. 79.5% (58/73) of underage respondents used disposable ENDS and 72.9% (51/70) reported disposable ENDS as their usual device. 93.0% (53/57) of underage users reported using a flavored product, 56.1% (32/57) reported Flum®as their usual brand, 48.2% (27/56) reported convenience of use as the most attractive aspect of disposable ENDS, and 46.4% (26/56) obtained disposable ENDS from a convenience store. Of all disposable ENDS-using respondents, 98.7% (75/76) used for the first time while under the age of 21. DISCUSSION/SIGNIFICANCE: The survey continues to be open for data collection, with the goal of obtaining additional data. The goal with the additional data will be to create a comprehensive list of identified risk factors influencing underage disposable ENDS use and to suggest specific regulatory and policy reform to better address underage nicotine addiction.

OBJECTIVES/GOALS: To understand the current landscape of clinical trials involving the homeless population by examining opioid or alcohol use disorders and the challenges in clinical trial recruitment. METHODS/STUDY POPULATION: Clinicaltrials.gov was searched with the keywords homeless or unhoused. The search was limited to studies conducted in the United States that were recruiting, not yet recruiting, active and not recruiting, completed, and enrolling. The search findings were further characterized and categorized by the definitions that were used for homelessness. Next, the trials were grouped based on the inclusion of alcohol or opioid use: (A) had no relevant mention, (B) included alcohol or opioid use as a secondary or other outcome measure, or (C) alcohol or opioid were the primary focus of the trial. Lastly, patterns and trends were identified for these trials. RESULTS/ANTICIPATED RESULTS: Out of 161 trials, 77 trials that met search criteria were identified then grouped based on how they classified homelessness: McKinney-Vento (n=5, 6%), DHHS (n=4, 5%), HUD (n=2, 3%), HEARTH Act (n=3, 4%), Custom (trials that specified parameters for homelessness, n=12, 16%), Not Specified (trials that provided no parameters for homelessness, n=26, 34%), and Other/Ambiguous (trials that used enrollment in an independent program as parameters or had unclear parameters, n=25, 32%). Of the 77 clinical trials that targeted homeless populations, 65% did not include alcohol use and 100% did not include opioid use in any outcome measure, 22% included alcohol use in a non-primary outcome measure, and 13% included alcohol use as the primary outcome measure of the study. DISCUSSION/SIGNIFICANCE: The number of clinical trials targeting homeless populations has increased over time, yet there is still no universal definition for classifying an individual as homeless. This lack of harmonization poses a challenge when coupled with the findings that there is a lack of clinical trials targeting opioid or alcohol use disorders.

OBJECTIVES/GOALS: To understand the implications of minimal HIV generic drug availability on long-term HIV disease management, including anti-competitive agreements and patent strategies that hinder (ART) competition and ART medication safety and efficacy improvement. METHODS/STUDY POPULATION: Individuals living with Human Immunodeficiency Virus (HIV) require sustained ART treatment. Despite excessive ART costs, the treatments use active ingredients known to be toxic, causing bone and renal impairments. A review of pharmaceutical legal cases examined the role of strategic patenting–product hopping–and anti-competitive agreements, which prevent generic competition and contribute to minimal ART improvement. A literature review explored the long-term safety effects of ART medications on HIV patients and disease management. A cost analysis of HIV disease management assessed the implications of using treatments with known toxins and their contribution to comorbidities and their effect on the cost of overall HIV disease management. RESULTS/ANTICIPATED RESULTS: Ongoing lawsuits of major ART medication manufacturers demonstrate the intentional agreements made to hinder generic competition, which is an inherently anti-competitive strategy. Thus, prices for ART medications remained high, causing treatment costs to be a significant barrier to treatment access. Further, the entry of a new ART, Tenofovir Alafenamide Fumarate (TAF), was delayed despite knowing the key active ingredient in Tenofovir Disoproxil Fumarate (TDF) was toxic to patients long-term. As a result, patients were more likely to experience comorbidities, significantly increasing the cost of HIV care. The average cost of HIV care without comorbidities is $30,312. However, HIV care is $46,000 for two comorbidities and about $219,000 for people with 11 or more. DISCUSSION/SIGNIFICANCE: Abuse of patent rights prevents more effective HIV medication and generic option development. Thus, HIV disease management is inhibited. The only method of HIV disease management is patient adherence to ARTs. Patients taking less effective medications increase the development of comorbidities from toxic treatments, magnifying the cost of HIV care.

OBJECTIVES/GOALS: Food and Drug Administration (FDA) warning letters regarding misbranding of products intended to treat, prevent, or diagnose COVID-19 were used as a proxy for assessing misinformation on social media. The FDA database of Warning Letters was used to identify the largest misinformation contributor. METHODS/STUDY POPULATION: On November 9, 2022, the full dataset of warning letters dating back to January 1, 2018 was extracted from the FDA website. Separate datasets were also extracted using the search terms: Facebook’, Twitter’, YouTube’, and Instagram’. The data entries were organized by issuing office and subject. The subjects were then filtered to only include letters related to misbranding of products for COVID-19. Letters regarding medical devices, manufacturing practices, and adulterated products were excluded from the analysis. Cumulative totals were collected for the number of letters issued for each search term. These totals were stratified by year and scaled by platform size for relative comparison. RESULTS/ANTICIPATED RESULTS: The FDA’s Center for Drug Evaluation and Research issued the most letters related to misbranding of COVID-19 products, 153 out of the 2798 entries in the complete dataset. Analysis of the datasets by search term show: 53, 18, 24, and 17 letters were related to Facebook, Twitter, YouTube, and Instagram respectively. Forty-one letters were related to other non-social media sources. Facebook had the most letters issued, however when scaled to account for the size of each respective platform’s approximate user base, Twitter had the largest proportional amount of misinformation regarding agents for the management of COVID-19, followed by Facebook, then Instagram. Most letters were issued in 2020. DISCUSSION/SIGNIFICANCE: In light of COVID-19, many social media sites adopted policies to limit inaccurate information. The success of these efforts have been variable. Although Facebook is the largest absolute contributor assessed, greater attention should be given to the policies of other platforms utilized by the industry.

OBJECTIVES/GOALS: To understand how energy drinks are marketed and regulated and the effects of these policies on adolescent consumption and perceptions of the product. METHODS/STUDY POPULATION: A review of research studies using the PubMed database (PubMed.gov); clinical trials (clinicaltrials.gov); FDA Recall, Market Withdrawals, and Safety Alerts (FDA.gov); and emergency department (ED) visits from reports from the Drug Abuse Warning Network (DAWN) were conducted. A survey is being designed and will be sent to undergraduate and graduate university students through advertised QR codes and university email chains sent out to student organizations and courses. The survey will determine the percentage of respondents who consume caffeine, the frequency in which individuals consume caffeine, and reasons for consuming caffeine. The survey also seeks to understand perceptions and thoughts on energy drinks and caffeine regulation and consumption. RESULTS/ANTICIPATED RESULTS: From January 1st, 2000, to August 5th, 2022, 112 research studies investigated the physiological impact of energy drinks on adolescents, and 13 clinical trials from the age group of 0-17 were conducted. No FDA recalls have been observed for energy drinks or the top 4 brands within the US (by sales; Red Bull, Monster, Bang Energy, Rockstar), though some recalls regarding container manufacturing were made outside the US. ED visits from energy drinks doubled from 2007 to 2011 with 1/10 of them resulting in hospitalization. 58% of the total ED visits were exclusively related to energy drinks. It is anticipated that survey results will indicate trends of frequent caffeine/energy drink consumption among college students for studying, but students will not have a clear understanding of recommended caffeine intake. DISCUSSION/SIGNIFICANCE: Due to the lack of regulations and studies surrounding energy drinks, the dangers (as seen from ER visits) to public health are concerning. Regulatory agencies should invest in developing new protocols or regulations regarding the content of energy drinks as well as find ways to monitor the marketing strategies more closely behind them.

OBJECTIVES/GOALS: To identify, categorize, and streamline the wide range of commonly encountered barriers in translational research that prevent studies from progressing along the translational research spectrum through a comprehensive needs assessment survey. Results will be utilized to institute potential solutions to overcome these identified barriers. METHODS/STUDY POPULATION: The comprehensive survey consisted of three sections, Demographics and Background, Self-Reporting of Barriers, and Comments and Feedback. An extensive literature review was conducted to develop and compile questions and barrier categories for the survey. The survey content was derived from primary literature sources and supplemented with the NCATS Translational Science course material. The target population for the survey included all researchers engaged in translational research at the NJ ACTS CTSA hub. The hub includes Rutgers, Princeton, and NJIT and all of their affiliated institutions and partnered healthcare systems, such as Robert Wood Johnson Barnabas Health and University Hospital. Results will be analyzed according to the type of research conducted and stage of translation research (T0-T4). RESULTS/ANTICIPATED RESULTS: Examples of the survey barrier categories being analyzed include Regulatory/IRB, Funding, Collaborations and Networking, and Training. Initial analysis (N=106) consisted of these top barriers in the NJ ACTS CTSA hub: obtaining timely IRB approval, inadequate staffing for the research team, and lack of holistic institutional support. After completion of data collection, the survey results will be further analyzed to determine common barriers and patterns in barrier type across the different institutions, schools, positions/roles in research, and translational research stages. Given that the Comments and Feedback section of the survey entailed ranking the top three barriers across the entire survey as a whole, the results will also indicate the relative prevalence of specific barriers and categories. DISCUSSION/SIGNIFICANCE: The impact of the survey and its results is to develop feasible institutional solutions to overcome the prevalent barriers and improve efficiency in all parts of the research process. Possible solutions encompass accessible resources for researchers, longitudinal training programs, consultative services, and workshops for investigators.

OBJECTIVES/GOALS: Suicide is the second leading cause of death in teens. Substance misuse, including opioids, is a risk factor for suicidal thoughts and behaviors among teens. School-based approaches are promising, yet they lack evidence on their effectiveness. To fill this gap, we created supportED, a digital game to prevent suicide in youth who misuse substances. METHODS/STUDY POPULATION: We conducted focus groups and interviews to inform the development of the digital game and discuss approaches to enhance user experiences, acceptability, and feasibility of the intervention. A semi-structured focus group/interview guide was developed, pilot tested, and used in focus groups/interviews. The guides aligned with constructs from a safety planning intervention, a well-recognized, evidence-based suicide prevention intervention, to identify potential warning signs of emotional distress, coping strategies, and resources for seeking help to prevent suicidal thoughts and behaviors. Focus groups/interviews were led by a facilitator, who is also a certified school counselor and licensed professional counselor, and a co-facilitator who took field notes and provided debrief summaries. RESULTS/ANTICIPATED RESULTS: A total of 35 participants, including 10 high-school-aged teens [aged 16-19], 10 college-aged youth [aged 18-22], 10 school-based providers, and five interviews with adults who had experience with opioids in their youth informed the development stage. Of the focus group participants, 25.7% identify as female (n=23), 71.4% identify as male (n=6), and 2.9% do not identify as male or female (n=1); 60% identify as White (n=18), 20% identify as multi-racial (n=6), 10% identify as Black (n=3), 3.3% identify as Asian (n=1), and 6.7% identify as race unknown (n=2); and, 37.1% (n=13) identify as Hispanic/Latinx. Salient themes that emerged focused on opioids, substance misuse, mental health, bullying, grief, family, identity, and stigma to create six distinct narratives in the digital game. DISCUSSION/SIGNIFICANCE: Findings informed the development of a digital game to prevent suicide among adolescents who misuse substances. The digital game is currently being evaluated in a pilot RCT to assess the preliminary efficacy of the intervention, user experience, usability, and feasibility of delivering the intervention and protocols among 60 youth.

OBJECTIVES/GOALS: Lack of diversity within clinical trials is well known, but there is little data on the use of investigational products through other pathways, such as expanded access. This project sought to determine the demographic diversity of patients benefiting from expanded access at Michigan Medicine. METHODS/STUDY POPULATION: Previous quality improvement reviews provided the list of 271 patients for whom a single-patient, expanded access request had been approved by the FDA and University of Michigan IRBMED between 2005 and 2021. Demographic information was collected through the EMERSE tool, including age, legal sex, race, ethnicity, and zip code. These data were cross-referenced with available regulatory documentation on product requested, treatment area, and date of request. Descriptive statistics were performed using Excel. RESULTS/ANTICIPATED RESULTS: Patients who were approved to use an investigational product through expanded access at Michigan Medicine showed a wide geographic distribution, including 48 Michigan counties, 20 states, and 1 province. All age groups were served, with those between 30-49 underrepresented and those under 10 and over 60 overrepresented. Race data generally followed the proportions of the Michigan state census, including 76% white and 14% black or African American (expected: 79% and 14%) and 48% female (expected: 50%). On further breakdown, populations differed by specialty and county. DISCUSSION/SIGNIFICANCE: The distribution of Michigan Medicine patients with approved expanded access requests was similar to the population of Michigan with respect to age, sex, and race. Further research is needed to determine if this reflects equitable use or if these results are generalizable to other institutions.

OBJECTIVES/GOALS: The purpose of the project was to create a Tableau dashboard to track metrics on requests for research data at Atrium Health Wake Forest Baptist. The objectives included: 1) define and identify request fulfillment metrics, 2) build a dashboard to capture metrics, and 3) integrate the dashboard into metrics tracking and reporting activities. METHODS/STUDY POPULATION: Project managers and team leaders in the Office of Informatics collaborated to determine which measures would be most relevant and impactful to report on. Metrics that were collected included: total count of tickets fulfilled over time, number of tickets currently open, sum of outstanding quoted hours, quoted hours vs. actual hours needed to fulfill ticket, and hours billed. Tableau's direct connection feature was used to extract the Trac ticket data from its Postgres database and the dashboard was published to Tableau Server. After the initial draft was created, several rounds of revisions were made as new data insights were discovered through further investigation of the data. RESULTS/ANTICIPATED RESULTS: Each morning, Tableau Server runs an automatic refresh of the data. On the dashboard homepage, users can see a quick view of all available metrics; to minimize noise, only the current statuses, active tickets, and stats for the most recent monitoring periods are displayed. Many of the charts give the user the option to link out to a page with related supplemental information (historic data, ticket status history, etc.). With the help of the dashboard, project managers and team leaders can now monitor how long tickets are in each status, increase quote accuracy using the hours quoted and hours billed charts, and examine ticket complexity over time. DISCUSSION/SIGNIFICANCE: Prior to dashboard creation, metrics were sparse and difficult to assemble. By providing information on the quantity, size, and complexity of data requests, the dashboard enables the Office of Informatics to monitor how the process is functioning overall, make informed decisions about resource allocation, and provide quick interventions.

OBJECTIVES/GOALS: The goal of the CTSA consortium is to move scientific discoveries to clinical application. Translational science (TS) focuses on the process by which this happens, and NCATS supports pilot projects that propose TS questions. We are developing a rubric to guide program managers’ability to discriminate between TS and translational research (TR). METHODS/STUDY POPULATION: The CTSA External Review Exchange Consortium (CEREC) and CEREC II are reciprocal review collaborations between CTSA hubs that identify reviewers for each other’s pilot grant applications. CEREC and CEREC II partners developed a 31-item rubric, based on NIH’s Translational Science Principles, for discriminating pilot TS grant applications from those proposing TR. The hubs contributed proposals pre-selected as either TS or TR projects. Then, experienced reviewers and/or program administrators from the hubs used the rubric to score each of the proposals. Reliability of the rubric will be assessed using inter-rater reliability (% agreement and kappa). To identify which of the items in the rubric best discriminate between TS and TR, Item Response Theory analysis will be employed. RESULTS/ANTICIPATED RESULTS: Ten CEREC participating hubs submitted 30 applications: 20 TS proposals and 10 TR proposals. Twenty-two reviewers from 12 CEREC hubs evaluated the applications by using the scoring rubric; at least two reviewers evaluated each proposal. The results of the analyses will describe the reliability of the rubric and identify which of the seven TS Principles are most useful for distinguishing between TS and TR pilot grant proposals. Ultimately, this work will yield a scoring rubric that will be disseminated throughout the CTSA network to facilitate the screening of TS applications. DISCUSSION/SIGNIFICANCE: Optimizing research processes is critical to ensure that scientific discoveries are integrated into clinical practice and public health policy as rapidly, efficiently, and equitably as possible. By appropriately identifying and funding TS projects, CTSA hubs can accelerate the impact of clinical and translational research.

OBJECTIVES/GOALS: CTSA Program hubs provide a wide range of research support services (funding, training, consultations, etc.) to individuals and teams. The CTSA Program hub at Columbia University seeks to identify best practices across CTSA hubs in how they facilitate researchers to identify, navigate, and access services at complex academic medical centers. METHODS/STUDY POPULATION: o A landscape analysis across CTSA Program hub websites was conducted during December 2021-February 2022, with the goal of assessing the availability of research navigation services and the ease of accessing and requesting research support services at each hub. Websites of 66 CTSA hubs were accessed and browsed for the following: 1) if a research navigation or concierge service was available; 2) how to request and apply to use common services such as pilot funding, biostatistics, clinical research services; 3) if there was a contact form and/or email address for general inquiries. Binary coding (1=Yes, 2=No) was used to track and summarize if these features were available, and then further classification and observations were noted into the full data set. RESULTS/ANTICIPATED RESULTS: The landscape analysis determined that 68% of CTSA hubs offer a form of research navigation including consultative models (personalized guidance, studios) and web-based models (self-service web portals, graphics, toolkits). Consultative models could be classified into three levels of support ranging from general information sharing to providing scientific expertise to convening more intensive studio sessions. 92% of CTSA hubs have at least 1 system in place for researchers to request services with a majority of hubs using a mix of tools and systems. In addition, 36% of hubs have additional general contact forms and 75% have general email addresses to assist researchers in obtaining more information. DISCUSSION/SIGNIFICANCE: There is a relative lack of data and information on the effectiveness of different research navigation models across the CTSA network, and barriers for researchers to identify services remain (Elworth et al). Our team is planning additional evaluations including interviews with leaders at other CTSA hubs and researchers and trainees at Columbia.

OBJECTIVES/GOALS: The Learning Health System (LHS) framework at Columbia University Irving Medical Center (CUIMC) aims to optimize health system performance through enhancing the patient and care team experience, reducing inequities, costs and improving population health outcomes, through a collaborative, interdisciplinary and data driven approach. METHODS/STUDY POPULATION: In alignment with the Quintuple Aim, the LHS program at CUIMC is composed of five critical components: data integration (particularly using Epic EHR and real-time informatics data), utilization of evidence-based practices, a methodology for continuous improvement, and leadership commitment. Our methodology incorporates an iterative process improvement project cycle into an integrated infrastructure and governance of an academic medical center and its hospital partners to fulfill rapid project design and implementation. The LHS at CUIMC aims to bring a cultural shift through stakeholder engagement, symposia, training, accelerated pilot award opportunities, and building external partnership engagement. RESULTS/ANTICIPATED RESULTS: At CUIMC, our definition of a successful integration of a LHS framework is a cultural shift in thinking, method, and continuous improvement. The LHS program has developed multidisciplinary teams that are involved in defining and sharing data, design, and project management resources. In 2021, the first annual symposium was launched and brought together over 200 stakeholders from across the organization to support continuous education, training, and scaling of the framework. As a result of this foundation, two pilot initiatives have been funded and launched, the innovation accelerator model developed and is supporting over ten unique innovative and transformative clinical and operational programs, and several research grant applications have been submitted citing learning health system methodologies. DISCUSSION/SIGNIFICANCE: Our LHS framework has broken down silos and institutional barriers, creating a network of stakeholder groups. Our interdisciplinary approach has enabled us to create sustainable processes, resources and training on rapid, rigorous design, evaluation and implementation of interventions using real-time informatics data and digital health tools.

OBJECTIVES/GOALS: The goal of this project is to develop a strategy to collect and extract published evidence in real time and to house and model these data for efficient downstream application to Program activities such as targeted reviews, grant evaluation and partner engagement. METHODS/STUDY POPULATION: We created the World Trade Center Health Effects Library in 2016. Today, this living review is ongoing and is fueled by daily systematic searches of online publication databases. Each day we screen new references for health effects of 9/11. The publication must include measurements, reports, or discussion of 9/11 health effects. If a publication meets these criteria, it is categorized by outcome and funding category. Primary outcome category data, reference metadata, and funding data are then made immediately available for programmatic analysis. All reference data are entered into a data pipeline and modelled for targeted reviews. RESULTS/ANTICIPATED RESULTS: The WTC Health Effects Library curates 1932 references and adds an average of 60 new references each year on a wide range of study populations, exposures, and conditions. The completeness of the library has been verified by comprehensive literature searches for 9/11 health outcomes conducted externally and by CDC Library staff. As a result, the curated library is a proven alternative to a lengthy literature search and allows the Program and stakeholders to explore the data and engage immediately in targeted reviews on curated topics. The data that are collected in the screening and categorization process are merged with publication metadata and funding data to inform a data pipeline that supports outputs such as interactive visuals, charts, reports, and curated bibliographies for structured review. DISCUSSION/SIGNIFICANCE: This living review allows the Program to rapidly conduct focused reviews, to evaluate grants, and to communicate accurate data to partners. By using the curated data, we have reduced the time required to perform mandated evidence reviews by weeks, have conducted two structured reviews, and defined gaps in research maturity and health equity.

OBJECTIVES/GOALS: Obesity is associated with increased incidence of breast cancer (BC), yet is not included in many lifetime-risk calculators. Obesity may impact breast cancer screening sensitivity. Retrospective studies show that bariatric surgery is associated with a lower risk of BC, but the effects of surgical weight loss on breast tissue are poorly understood. METHODS/STUDY POPULATION: We proposed a mixed-methods before and after study design to investigate the effects of surgical weight loss on breast tissue via pre- and post-weight loss breast tissue biopsies and imaging. In addition, we aimed to better understand barriers to BC screening for patients with obesity by conducting qualitative interviews. With institutional review board approval, we have begun recruiting 14 cisgender women who plan to undergo Roux-en-Y gastric bypass or sleeve gastrectomy. Participants must be at least 40 years old, with no prior history of breast biopsies or breast cancer and will undergo comprehensive breast cancer screening including mammography with quantitative density assessment, breast MRI, as well as breast core biopsies. RESULTS/ANTICIPATED RESULTS: We hypothesize that obesity and its associated metabolic changes lead to altered breast stroma, including increased inflammation, and tissue stiffness, with subsequent risk of carcinogenesis. If true, we expect to find obese women will have measurably increased inflammatory markers in their breast tissue, which are reduced after bariatric surgery. We expect that change in mammographic density may correlate with fibroglandular volume change on MRI; there are little data on change in background parenchymal enhancement in the setting of obesity and weight change and quantifying this will provide preliminary data for future work. Last, we expect that undergoing BC screening will be easier for patients after weight loss due to constraints of imaging equipment and potential bias in the screening process. DISCUSSION/SIGNIFICANCE: Screening for BC is paramount to improving outcomes yet people with obesity are screened less with worse outcomes. Studying the effects of weight loss on the breast may improve interpretation of breast imaging in the setting of obesity and identify markers of risk. Understanding barriers to screening may help us develop strategies to improve screening.

OBJECTIVES/GOALS: The SC CTSI Quality by Design (QbD) program aims to improve the execution of clinical research studies identifying and addressing possible issues before implementation. The program’s overall goal is to optimize operational design to achieve an 80% on-time completion rate. METHODS/STUDY POPULATION: Adapted from the Clinical Trials Transformation Initiative, our QbD program applies principles of quality management, project management, and team science to SC CTSI-funded studies. The process begins with a Design Studio for systematic review of critical-to-quality factors and a discussion of risks and mitigation plans. Studio attendees generally include the research team, SC CTSI faculty, and at least one community member. Outcomes include mitigation plans, a study project plan, and continued support from the project-tailored advisory board. We will iteratively evaluate satisfaction, quality improvement, and study completion rates. RESULTS/ANTICIPATED RESULTS: In an evaluation of the pilot phase, QbD participants responded that careful planning and expert input added value to their studies. The QbD process improved the quality of their studies, and all participants plan to apply QbD tools and resources to future studies. Beyond quality improvement, other anticipated outcomes include higher on-time study completion rates and uptake of QbD resources by other research teams. We also plan to assess the comparative benefit of QbD by study type. DISCUSSION/SIGNIFICANCE: Broader application of the CTSI QbD program has the potential for widespread benefit on research processes and outcomes. Studies implemented with minimal avoidable errors are more likely to complete on time, helping ensure efficient use of valuable resources and participant time.

OBJECTIVES/GOALS: To increase public awareness and access to research opportunities at the University of Minnesota (UMN) utilizing StudyFinder, a public-facing website that features actively enrolling UMN research studies and directly connects website visitors with study teams. METHODS/STUDY POPULATION: Promote the University of Minnesota CTSI’s StudyFinder website to the public via social media ad campaigns and community outreach. Upon completion of the latest StudyFinder enhancement project in 2021, CTSI focused 2022 efforts on marketing and promotion of the site. CTSI created three StudyFinder social media ad campaigns in January, June, and October. CTSI also planned outreach events during the week of Clinical Trials Day, the Minnesota State Fair (1.8M attendees over 12 days), and the UMN’s Urban Research and Outreach-Engagement Center Community Day. RESULTS/ANTICIPATED RESULTS: Website traffic data from Google Analytics indicated a 72.76% increase in StudyFinder sessions from 2021 (Jan 1, 2021 to Nov 1, 2021) to 2022 (Jan 1, 2022 to Nov 1, 2022), with 16,262 sessions to 28,094 sessions, respectively. Direct emails from potential participants to study teams increased 89% in that same timeframe, from 3,082 emails to 5,819 emails. Targeted marketing campaigns and attending community events can improve the visibility of an institution’s research and connections of potential research participants to research teams. DISCUSSION/SIGNIFICANCE: Recruitment remains a main challenge in clinical and translational research. StudyFinder is an important patient-facing tool to connect individuals to specific studies. Future directions include expanding marketing efforts, events, and public feedback.