OBJECTIVES/SPECIFIC AIMS: Translating conventional and regenerative medicine strategies from the research laboratory into the clinic is a complex process that can delay bringing novel therapies to the patient. Navigating the increasingly complex regulation surrounding cell-based and combination product technologies is a major challenge for the translational biomedical scientist. To this end, Mayo Clinic created a new position, the “Translational Integrator,” as part of the cGMP Biomaterials Facility in the Center for Regenerative Medicine. METHODS/STUDY POPULATION: The Translational Integrator educates investigators about FDA standards and regulatory pathways; determines where the product is on the translational spectrum; works to understand the science behind the product; determines what additional studies may be needed; supports investigators in preparing for FDA communications and submissions; and educates researchers about institutional resources and funding mechanisms needed to move their product into manufacturing and trials. A primary objective is to meet investigators at an early stage in product development to avoid conducting potentially redundant work to meet regulatory requirements. RESULTS/ANTICIPATED RESULTS: Robust training in clinical and translational research methodology enables the integrator to facilitate the collaboration necessary between investigators, clinicians, institutional resources, regulators and funders to move products towards FDA IND/IDE approval and first-in-human trials. It is an iterative process using technology/translational readiness criteria, project management and review by subject matter experts that is highly interactive and customized to each project. Current projects include topics in orthopedic surgery and ENT. In creating and refining this position, several key lessons have been learned. DISCUSSION/SIGNIFICANCE OF IMPACT: First, the Translational Integrator must undergo constant reflection and assessment of investigator needs, which requires flexibility and understanding that their role may change in the context of each product. Second, the support that the Translational Integrator provides can shift the mindset of the investigator from being averse to engaging in the translational process to eager to move their product forward. Finally, for the investigator who does not personally want to move their work into first-in-human trials, establishing connections to intellectual property generation and licensing may support movement of their findings into patients.

OBJECTIVES/GOALS: Micronutrient deficiencies contribute to poor health and childhood development outcomes. The objective of this study was to examine the independent and combined effects of responsive parenting and multiple micronutrient supplementation interventions on preschooler hemoglobin and ferritin concentrations in southwestern Guatemala. METHODS/STUDY POPULATION: We enrolled 387 preschoolers (36-52 months) at nutritional risk (height-for-age z-score < -1) (51% male; 17% indigenous ethnicity) in a double blind, 2 x 2, cluster randomized controlled trial. Participants in the parenting intervention received culturally tailored responsive parenting or nutrition education (control) curriculum, delivered over 6 home visits. Participants in the nutrition supplementation group received daily supplementation with a maize-soy product fortified with 21 micronutrients for 6 months or a control product fortified with vitamin B2 only. Linear mixed models were used to estimate changes in hemoglobin and ferritin from baseline (2015) to endline (2017) in a subsample with blood specimens (n = 218). RESULTS/ANTICIPATED RESULTS: At baseline, 14% of preschoolers were iron deficient and 11% were anemic. Preschooler ferritin significantly increased over time in most arms, with the largest increase in the combined responsive parenting + multiple micronutrient supplementation arm (ferritin = 95.6 (95% CI 46.4, 144.74); rates of change did not differ between study arms (p = 0.16). Preschooler hemoglobin did not change over time. Further analysis will examine the moderation of intervention effects by pre-specified child and household factors. DISCUSSION/SIGNIFICANCE: Increases in preschooler ferritin did not differ between intervention and control arms. There was no effect of the intervention on hemoglobin. Future analyses will examine intervention effects on pre-specified subgroups including baseline micronutrient deficiencies.

Objectives/Goals: The objective of this project is to develop a tool for evaluating clinical trial (CT) eligibility criteria for demonstrated “gender literacy,” defined as the recognition that biologically assigned “sex” is distinct from personally defined “gender identity,” as a way to quantify the inclusion of gender minority populations. Methods/Study Population: The study is validating an assessment scale that evaluates gender literacy based on CT eligibility criteria (EC). Two health professionals will serve as “coders,” tasked with grading 15 CTs. EC for all CTs will be exported from clinicaltrials.gov. Once trained with using the scale, each coder will give a score for each trial. After this first scoring period, coders will share their scores and experiences using the scale. Coders will be tasked again with grading 15 new CTs. This second scoring period will yield final scores to calculate the inter-rater reliability (IRR), or the extent to which qualitative measurements are consistent and not due to random chance. IRR will be quantified by Cohen’s kappa to validate the scale. Results/Anticipated Results: Cohen’s kappa is on a continuous interval from 0 to 1, where 0 means no agreement and 1 means perfect agreement. It is expected that the Cohen’s kappa for this assessment scale will exceed 0.80. Such validation is necessary to ensure the scale is robust and dynamic for multiple use-cases and consistent across any coder. By having a discussion after the initial scoring period, we can identify confusions or challenges with the scale early on and correct them before the secondary scoring period. In comparing these two coders’ performance, it is expected that the second scores will be more similar, thus a kappa closer to 1. However, if the kappa is low, this may be because gender literacy is a learned skill, through the internalized recognition that gender is truly different from sex. Discussion/Significance of Impact: Systemic barriers and exclusionary language have excluded gender minorities from CT spaces for too long. Tools such as these, paired with standardized language for sex and gender eligibility criteria, will greatly bolster the representation of this population and spark change for a more inclusive future.

OBJECTIVES/GOALS: To comprehensively understand the training needs of clinical research professionals (CRPs) employed across various roles in team science. The purpose is to identify areas for competency development and determine the modality of training desired to enhance their skills further. METHODS/STUDY POPULATION: This study targets Clinical Research Professionals (CRPs) across various roles in Academic Health Centers via an online survey. From novices to experts, participants are often trained on the job covering some clinical research competencies, but team science aspects like communication and leadership are usually overlooked. The survey will assess current skills, identify training gaps, and explore preferred learning methods and topics. Participants will be recruited through the CTSA hub research network. Additionally, they'll share experiences of team cohesion, dynamics, conflict, and their contributions to the team through participation in focus group sessions.The focus groups will be held via Zoom with volunteer participants from the survey (6 per session, 3 sessions, N=18). RESULTS/ANTICIPATED RESULTS: The recently developed leveled CRP team science competencies based on Lotrechianno (2022) will be the basis of the survey items. Demographic characteristics of the participants by role will be presented. Moreover, perceptions of team science applications, learning needs and training preferences will be described. Results will be compared across CRP roles. Finally, three recorded and transcribed focus groups (n=18) will contribute to knowledge gained through this research allowing for a deeper understanding of training needs. Qualitative analyzes of recorded focus-group discussions will present key themes. Qualitative data will be coded by more than two people for interrater reliability. DISCUSSION/SIGNIFICANCE: This study offers the first needs assessment on academic medical center CRP team science learning requirements, utilizing newly established CRP individual and team competencies. Findings will guide the creation of tailored training and research initiatives.

OBJECTIVES/GOALS: The purpose of this study was to assess if the Mentoring Competency Assessment (MCA) could be used to capture mentee gains in mentorship skills and how the mentorship competencies may vary structurally for mentees compared to mentors, while the original MCA was shown to be a validated measure to assess mentor skills. METHODS/STUDY POPULATION: The mentee training survey data were collected nationally from 2015 to 2022. The survey data set included 401 respondents who consented to participate after 59 mentee training events hosted by 34 institutions/organizations who participated in face-to-face and online training as well as completed the Mentoring Competency Assessment (MCA) in their surveys. We conducted principal component analysis (PCA) with varimax rotation to investigate the internal structure of the MCA and Hatcher’s criteria were applied. After a team of mentoring experts independently interpreted the PCA results and reached a consensus on the interpretations of the components, factor analysis and internal consistency reliability analysis were applied to assess the construct validity and the reliability. RESULTS/ANTICIPATED RESULTS: There were significant component loadings of the eight components with varimax rotation and 22 of the total 26 items were loaded into components. Four items, (5) pursuing strategies to improve communication, (6) coordinating with other mentors, (11) developing strategies to meet goals, and (23) setting career goals, were excluded from the factor analysis and Cronbach’s alpha analysis since these items were not significantly loaded into any components. The eight-component structure was validated (χ2=313.209, p<.001, RMSEA=.083, CFI=.907, TLI=.881, SRMR=.073) and the hypothesized model of the eight components resulted in an acceptable fit to the data with standardized factor loadings ranging from 0.58 to 0.93. The alpha coefficient is from 0.58 to 0.90, suggesting the items have high internal consistency. DISCUSSION/SIGNIFICANCE: Based upon the findings we recommend that the full revised MCA for mentees is used to capture mentees’ mentorship skill gains even if not all of the competency modules are used in the training. The development and validation of measures such as the MCA are important as we move toward the use of common measures across programs such as the CTSAs.

ABSTRACT IMPACT: The purpose of the T1-T4 in 3 Minutes program is to improve trainees’ capacity for communication of complex to a non-scientific audience as well as to ensure that our community stakeholders have access to, and understanding of, ongoing clinical and translation research OBJECTIVES/GOALS: The T1-T4 in 3 Program: ο Increases knowledge of research across institution; ο Increases capacity of trainees to convey complex science to lay audiences, funders, colleagues, and the media; ο Increases health and scientific literacy; ο Bridges gaps between trainees and potential entrepreneurial mentors METHODS/STUDY POPULATION: T1-T4 in 3 (Minutes) is an adaptation of the University of Queensland’s Three Minute Thesis competition in which PhD students present their thesis in 3 minutes or less to a lay audience. The competition enables them to cogently communicate their ideas and research findings to a non-specialist audience. Our adapted version, T1-T4 in 3, requires a presentation in three minutes or less to a lay audience, but rather than a thesis, the topics are on trainees’ research, and in this particular case, an idea for a commercial venture. The competition provides awards for the first- and second-best projects as determined by a panel of judges, and a ‘people’s choice’ award determined by a lay audience. RESULTS/ANTICIPATED RESULTS: This exercise is anticipated to improve trainees’ capacity for communications as well as ensure that community stakeholders and research and business community partners have access to, and understanding of, ongoing clinical and translation research with potential commercial applications. Further, the increased ability of our faculty and trainees to effectively communicate complex science to the public and other audiences’‘ including potential funders’‘ supports additional stakeholder dissemination mechanisms by increasing their confidence in their abilities to converse with non-specialists about their research, thus increasing the likelihood of participation in other community-based activities. DISCUSSION/SIGNIFICANCE OF FINDINGS: To increase ITS commercialization efforts, we envision involving numerous external partners to educate, fund, and support new ventures. T1-T4 in 3 judges will include commercialization scholars from regional and national institutions as well as pharmaceutical entities and regional angel investors.

OBJECTIVES/GOALS: To facilitate the development of innovative injection products by providing translational researchers with a regulatory and manufacturing road map for producing small batch sterile products for Phase 1 research use. To leverage recent AMC investments in facility improvements and pharmacy training in the areas of sterile product production, testing, and environmental controls, that can be used to support production of phase 1 clinical trial supplies METHODS/STUDY POPULATION: Searching and organizing relevant data and information from web portals and databases in the following: areas: FDA, EMA, USP regulations, regulatory science, pharmaceutical formulation and analytics, supply vendors, analytical testing laboratories, and product testing laboratories. Present the information using a user friendly format including flow charts and development timelines, taking the perspective of the translational investigator. RESULTS/ANTICIPATED RESULTS:

• Choosing AMC resources vs outside consultants and vendors, leveraging local resources where possible

• Qualifying and monitoring suppliers, testing laboratories, in-house departments, and Contract Drug Manufacturing Organizations (CDMO)

• Bringing together the deliverables for the IND CMC section

• Where and how to leverage available products and science to simplify safe and reliable production

DISCUSSION/SIGNIFICANCE OF IMPACT: Use and utility of injectable drug products, both small molecule and biologics, is growing rapidly, and is projected to continue to escalate well into the next decade. This is due not only to advances in medicine, but also to improvements in AMC-based sterile product production, and a better understanding of small batch manufacturing methods. All three trends align in academic medical centers (AMC) and can be utilized by translational researchers, if they can understand the potential and regulatory requirements.

OBJECTIVES/SPECIFIC AIMS: To improve the quality of evidence synthesis projects, including systematic reviews and other comparative effectiveness reviews, at the University of Utah. METHODS/STUDY POPULATION: Systematic reviews and other types of evidence syntheses are best when collaborative teams with expertise in multiple disciplines participate, including content experts, librarians and information specialists, systematic review methodologists, and statisticians. The Center for Clinical & Translational Science (CCTS), due to its interdisciplinary nature, connectivity to clinical experts, and existing Cores of methodologists, presented an opportune location for a Systematic Review Core. We designed the Systematic Review Core to focus on 2 primary aspects of evidence synthesis support: overall systematic review methodology guidance and in-depth information retrieval planning and execution. After establishing a conceptual partnership, a new position, Evidence Retrieval and Synthesis Librarian, was created to build capacity within the Core. RESULTS/ANTICIPATED RESULTS: Close connections with the CCTS’s Population Health Research Foundation have led to better interdisciplinary coverage of systematic reviews and other evidence syntheses produced by the University of Utah. We are able to partner with statisticians and clinical experts from formulating the question to completing the final manuscript. Hourly rates charged through a cost recovery model have enabled us to grow our staff able to work on the Core, as well as offset costs for major databases and resources these bibliographic data-heavy research methods require. After 1 year of existence, the Core is already at maximum capacity, with no sign of slowing. Projects have ranged from brief consultations to highly intense interactions for the duration of the research spectrum. We have also been added as key personnel to grants with systematic review components. DISCUSSION/SIGNIFICANCE OF IMPACT: Systematic reviews and other evidence syntheses are a labor-intense, interdisciplinary team effort that fit well within the scope of CTSA’s. They are a key component of the translation of science to practice, and can be used at all stages of the translational science spectrum. Quality of systematic reviews remains poor, particularly surrounding protocol development, sensitive search strategy design and reporting, and overall reporting. Librarians and information specialist involvement has been shown to positively correlate to the search strategy design and reporting aspects of systematic reviews, and librarians and information specialists increasingly act as systematic review methodologists. By including librarians and information specialists as part of the CTSA’s official Core structure, these systematic review methodologists are able to connect with statisticians, other methodologists, and clinical experts in a nexus of interdisciplinarity. At the University of Utah, the visibility and structure provided by the CCTS helps the Systematic Review Core with promotion, creating connections and opportunities for collaboration across the campus. This partnership has already led to increased uptake in services, and over time, we believe it will increase the quality of the science produced. CTSA’s have a natural partner with their health science library colleagues in translational science, as shown by this model.

OBJECTIVES/SPECIFIC AIMS: The aims of this project are to: (1) examine placebo effects on subjective and objective outcome measures, (2) determine if an increase in the placebo is associated with changes in benefit, (3) evaluate if the trauma related insomnia placebo group in our study has different side effect reports compared with insomnia placebo participants in previous suvorexant trials, and (4) (Exploratory) examine associations between the placebo group’s characteristics (e.g., trauma/PTSD severity, demographics) and placebo effects. METHODS/STUDY POPULATION: The parent study is a randomized double-blind placebo-controlled clinical trial (clinicaltrials.gov ID: NCT02704754) of suvorexant for treatment of adults (age 18–55) with insomnia that started or worsened after trauma exposure. Suvorexant is a first in class orexin antagonist and is approved by the FDA for the indication of insomnia. In this 6-week trial, all participants initially take 10 mg of suvorexant/placebo, and the dose will be increased to 20 mg if participants continue to experience clinically significant insomnia symptoms 1 week after starting the medication. Sleep outcomes will be measured by polysomnography, daily sleep diary, and the Insomnia Severity Index. RESULTS/ANTICIPATED RESULTS: We hypothesize that (1) within the placebo group data both subjectively and objectively measured outcomes will similarly show improvement in insomnia symptoms, (2) the increase of the placebo medication dose will result in an increased benefit, (3) the trauma-related insomnia placebo group will have the same type and similar rate of side effects reported in previous suvorexant trials. DISCUSSION/SIGNIFICANCE OF IMPACT: Most previous studies examining placebo effects focused on pain and depression. Information obtained from this project will complement our current understanding of placebo effects by characterizing placebo effects on trauma-related insomnia. This study will inform the development of novel strategies to maximize utility of placebos in future clinical trials.

OBJECTIVES/GOALS: Community-based primary care autism diagnostic models are one promising solution to delays in autism diagnosis. Our objective is to describe the development and report on outcomes related to primary care professional (PCP) training and sustained engagement in a longitudinal learning collaborative across a statewide network for autism diagnosis. METHODS/STUDY POPULATION: We developed ADAPT (i.e., Accelerating the Diagnosis of Autism with Primary care Training), a training program to prepare PCPs to develop independent competency in evaluation of autism in children ages 14-48 months. ADAPT includes didactic and case-based modules and expert practice-based coaching delivered by a diagnostic specialist; following training PCPs participate in a longitudinal learning collaborative. Aligned with competency-based medical education standards, measures of autism evaluation knowledge and diagnostic competency are collected. RESULTS/ANTICIPATED RESULTS: To date, 13 PCPs have completed ADAPT didactic and practicum training reaching competency in independent autism evaluation. Clinicians demonstrated significant improvement in total autism knowledge following didactic training (p=.02). There was an overall trend toward increased scoring agreement on an autism observational assessment over case observations and practicum evaluations. Similarly, PCPs demonstrated improved evaluation competence, moving on average from Advanced Beginner to Competent Performer as rated by expert trainers. Following training, PCPs attended 57% of monthly learning collaborative sessions. DISCUSSION/SIGNIFICANCE: Training PCPs to deliver autism evaluations as part of community-based models of care is a promising solution to address access and waitlist challenges. ADAPT is an intensive, standard PCP training model which results in achievement of independent competency and sustained engagement in in autism evaluation.

OBJECTIVES/GOALS: Use the World Trade Center (WTC) Health Program Health Effects Library to identify the breadth and depth of research on the health effects of youth due to exposures from the events of September 11, 2001, to track the research trajectories by study population, and to identify gaps and define needs for future research. METHODS/STUDY POPULATION: We selected references from the WTC Health Effects Library. This curated library includes research publications that measure, report, or discuss health effects of 9/11 at the three disaster sites. Articles included had to evaluate people under 18 years old on 9/11/2001, including those in-utero. Of the 1,813 references considered, 195 were included in our study. Data from each reference was extracted using DistillerSR software and organized in four topics: overview, methods, conditions, and results. Each publication was abstracted independently by a team of two health scientists and conflicts were resolved by the four-person team. All data was then exported from DistillerSR into Microsoft Excel for analysis. RESULTS/ANTICIPATED RESULTS: The 195 articles included were published between 2002 through 2021, of which 29 were funded by the WTC Health Program. The study population represented ranged from in-utero to 18 years old. Research trajectories will be developed by assessing chronological research by outcome groups (physical, mental and behavioral, interventions, and biomarkers), study population categories, as well as exposure location and mechanism. Demographic data extracted will be used to assess whether there are disparities in the research conducted to date for this population and if so, in what areas. Research recommendations and clinical implication extracted from references will be used to assess whether more recent research has addressed research from the early post 9/11 years. DISCUSSION/SIGNIFICANCE: WTC research strengthens our understanding of 9/11 health effects and provides a way to improve healthcare for the people afflicted from 9/11 exposures. The anticipated results from this scoping review can lead us to identify past research challenges and current knowledge gaps that the Program can address in future research grants.

OBJECTIVES/SPECIFIC AIMS: The goal of this study is to measure speech fluency and brain activity before and after 5 days of behavioral speech fluency training alone (sham group) or speech training plus stimulation (active group). A 1-month follow up will also be completed. The first primary outcome measure is changes in brain activation in speech motor control/timing network. The second primary outcome measure is changes in percentage of stuttered syllables during speech sample (speech fluency). The secondary outcome measure is changes from baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES), a detailed subject rating of how stuttering affects their lives. METHODS/STUDY POPULATION: This study is a between subjects, counterbalanced, sham-controlled, double-blind design. Participants will be 40 adults who stutter who will be randomized (using minimization) into either the active or sham stimulation group, with all other study procedures being the same in both groups. Participants will completed 2 days of baseline testing, 5 consecutive days of brain stimulation during speech training, 2 days of post-testing, and a 1-month follow up. All outcome measures will be completed immediately before and after the 5 days of brain stimulation, as well as at follow-up. as of submission, 10 subjects have completed the study. Data collection is ongoing. RESULTS/ANTICIPATED RESULTS: Expected results. Questions this study aims to answer: 1) Does a more intensive training period lead to decreased stuttering? We expect that both groups will show improvements in speech fluency immediately after training. We expect that those in the active group will continue to exhibit improved speech fluency at 1 month follow up. 2) Does a more intensive training period lead to changes in brain activity? We expect that both groups will exhibit increased activity in auditory/motor regions immediately after training. We expect that the active group will continue to exhibit an increase in activity in these regions at 1 month follow up. DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first RCT study involving brain stimulation in adults who stutter. We expect to provide preliminary evidence for the effectiveness of tDCS as an augmentative agent for increased speech fluency in adults who stutter during a brief, intensive training paradigm. We also expect to be able to provide information on the effects of tDCS on brain activity in speech and auditory-motor regions of the brain. The findings will add to the growing body of literature suggesting that developmental stuttering is a neurodevelopmental disorder with roots in timing and rhythmic aspects of speech motor control and auditory-motor integration.

Translational science is, by definition, groundbreaking; however, without an emphasis on quality and efficiency, some innovations in healthcare may translate into unnecessary risk, suboptimal solutions, and potentially loss of well-being and even lives. The COVID-19 pandemic and the Clinical and Translational Sciences Award Consortium’s response created an opportunity for quality and efficiency to be better defined, expediently and thoughtfully addressed, and further studied as central foundations in the translational science mission. This paper presents findings of an environmental scan of adaptive capacity and preparedness to illuminate the assets, institutional environment, knowledge, and forward-looking decision-making needed to optimize and sustain research quality and efficiency.

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/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/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.