Wednesday, April 20

See below activities from invited speakers scheduled for Wednesday, April 20 during Translational Science 2022 in Chicago. All activities take place in the Central Daylight Time Zone (CST) unless otherwise specified.

Select scientific sessions to be live streamed each day for those registered as a virtual attendee. These select sessions will only be available to watch live virtually during the scheduled session day/time. No sessions will be offered on-demand for any registration type at this time. Live stream sessions to be announced soon. Visit the Registration page for more details about the Translational Science 2022 virtual component.

Scientific Session Track Legend

Community Engagement     Core Activities     CR Forum     DEI     Translational Workforce Development + Education     Valued Approaches

Sessions noted as (Virtual + In Person) will be presented in person and available to watch in the meeting app for virtual only attendees.


9:00 - 10:30 AM
  • Plenary Presentation, CR Forum Top 10, and Award Presentations (Virtual + In Person)

    Presenter: Sonja Rasmussen, MD, MS

    Sonja Rasmussen, MD, MS is a professor in the Departments of Pediatrics and Epidemiology at the University of Florida (UF) College of Medicine and College of Public Health and Health Profession. More details to be announced soon.

10:45 - 11:45 AM
  • Advocacy Training*

    Presenters: Dale Dirks and Dane Christiansen

    Core Activities | Join established and young investigators for a one-hour panel discussion on the contemporary policy and funding issues impacting the community, and learn how to work with advocates from your state to connect with the offices of your senators and representatives to advance the community’s legislative agenda. Please note, this year’s training session will not include coordinated congressional meetings but will instead focus on how to conduct outreach virtually.

    *This session requires pre-registration.

  • Working Together For A Common Purpose: Collaborations to Boost Research Education Expereinces (Virtual + In Person)

    Presenters: Brenda Eakin MS; Vicki Ellingrod PharmD; Shokoufeh Khalatbari MS; Catherine Spino ScD; Adisa Kalkan, MA

    Translational Workforce Development + Education | Successful training programs need to develop engaging, experiential training to promote professional development of the next generation of translational researchers. CTSA hubs provide unique training and are encouraged to collaborate and share best practices to strengthen education and broaden scholar and trainee professional networks. In this session, you will learn about the e approaches from four hubs — Michigan Institute for Clinical and Translational Research, University of Minnesota Clinical and Translational Sciences Institute, Clinical and Translational Science Institute at Washington University in St. Louis, and Oregon Health and Science University — working towards workforce training collaborations.

  • In Their Own Words: Diversity-related Bias Impacts Trainees Experience in Clinical and Translational Science (Virtual + In Person)

    Presenters: Felicity T. Enders, PhD, MPH; Joyce Balls-Berry, PhD, FACE; Minerva Orellana, MS; Corey Jacinto Ariangela Kozik, PhD; Patricia Vega-Fernandez, MD, MSc, RhMSUS; David Bradford

    DEI | Diversity-related bias can be challenging and discouraging, especially as perceived bias can almost never be proved and is rarely discussed. Even when there is no malicious intent, it can still have  important impacts on trainees’ learning experiences. In this session, two Black faculty will bring  together diverse trainees at multiple career stages (undergraduate through junior faculty, including TL1 and KL2 trainees) to  share experiences perceived as diversity-related bias and extra-institutional challenges. To maintain anonymity, trainees will exchange first-person stories within and beyond this group. All stories will be first-hand accounts by trainees from under-represented populations (Black, Indigenous, and Hispanic/Latinx). Presenters will also explore ideas to mitigate negative experiences for current and future trainees. While the bulk of the session will be devoted to hearing from the trainees, you will have the opportunity to engage in an  interactive poll to empower reflection, response, and suggestions from session attendees.  Please bring a smartphone or other web-enabled device to participate in interactive polling.

  • Multidisciplinary Translation of Qualitative Research Findings to Address the Treatment of Patients with Opioid Use Disorder in U.S. Emergency Departments

    Ali Raja MD, MBA, MPH; Philip Cola, PhD

    Valued Approaches | Although Emergency Departments (EDs) are often the only sites of care for patients with opioid use disorder (OUD), a proven medication, buprenorphine, is underutilized by emergency physicians. In this session, you will learn about Ali Raja MD, MBA, MPH and Philip Cola, PhD  work to discover the underlying reasons for underutilization of ED buprenorphine at community Emergency Departments using an inductive grounded theory approach and conducted semi-structured interviews to identify emergent factors from experiential accounts of physicians. In this panel discussion, the presenters will describe not only their findings, but also the potential interventions that will target these factors, allowing for clinical translation of their findings using  examples to educate session attendees on  the benefits of multidisciplinary collaborations (in this case, between business and medical schools) in solving complex public health issues.

  • Making Research Accessible Through Community Media: Chicago Community, Media & Research Partnership

    Presenters: Jhmira Alexander, MPH; Jen Brown, MPH; Jess Del Toro; Maudlyne Ihejirika

    Community Engagement | Currently, there are unacceptable health inequities for Black, Latinx, & other marginalized communities. Research findings are not effectively reaching these communities. Researchers often operate in an echo chamber, mostly sharing and talking with other researchers. When research does progress  beyond academic circles, it’s often to mass media. The Chicago Community, Media & Research Partnership brought together community stakeholders, community media, and researchers to work together to figure out how to make health research findings more accessible and impactful to underserved (but often over-researched) communities in Chicagoland through media they trust and use. “Community media”  referring to community or independent media outlets that serve specific community areas, or regional African American, Latinx, Asian, Arab, Native American, LGBTQ or immigrant populations. Led by Public Narrative, the Alliance for Research in Chicagoland Communities at Northwestern University, and a Task Force of stakeholders, the Partnership held three listening sessions with a wider group of community and patient stakeholders, community media, and community-academic research partnerships. Learnings include: 1) research partnerships have little to no experience or relationships with community media and most community media do not have a  deep knowledge of or connections with research or researchers; 2) media and  research share challenges related to trustworthiness and representation of diverse communities; and 3) stakeholders drew a clear distinction between disseminating research findings and sharing actionable health info. COVID-19 also had a huge impact on community media and broadened their understanding of health as a community issue. In this session, presenters will share more learnings from the Taskforce and listening sessions, a framework developed to support research partnerships to engage community media, and next steps for addressing challenges and structural barriers for communities, community media stakeholders, and research.

12:00 - 1:00 PM
  • Clinical Research Professional Development through Inter-institutional, Peer-led, Competency-based Workshops

    Presenters: Mary-Tara Roth, BSN, MSN, MPH; Kimberly Luebbers, MSHS, RN, BSN; H. Robert Kolb RN; Diana Lee-Chavarria, MA

    Translational Workforce Development + Education | Among the challenges to conducting high-quality translational research is ensuring a well-trained, capable, and confident workforce of clinical research professionals. A robust research workforce pipeline requires intensive, on-going training, both for novice and seasoned personnel. The Joint Task Force for Clinical Trial Competency (JTF) framework establishes essential domains for conducting high quality clinical research to guide the development of the clinical trials workforce enterprise. This session will describe the creation of a novel workforce development program: the Research Professionals Network (RPN) Workshops, providing on-going continuing education opportunities for this important segment of the research workforce. The workshops are multi-institutional, peer-led, based in the JTF competencies, designed to enable participants to practice with the material, and engage with others from the participant institutions in doing so. These workshops are an integral component of the participating institution’s own programs that support clinical research professionals.

    The RPN workshop series provides professional development opportunities for both learners and presenters in a mentored, collaborative environment. Evaluations assessing the role of the workshops in professional development, successful integration of learnings into practice and the value of inter-institutional collaboration demonstrate the impact of this novel workshop series. The presenters will share multi-year data highlighting the important role of the RPN workshops in professional development within the partner institutions and present best practices and lessons learned for developing comparable programs at other sites.

  • Data Safety Monitoring Board (DSMB) Service 101

    Presenters: Heidi Spratt, PhD; Jody D Ciolino, PhD; Manisha Desai, PhD; Katherine Hartmann

    Valued Approaches | Clinical trials are considered the benchmark for concluding causality and are influential to clinical practice, but they carry inherent risk to participants. A common strategy to monitor the safety of participants and to ensure the integrity of the trial is to appoint a Data and Safety Monitoring Board (DSMB). While critical to the protection of human participants, few DSMB members have ever received training. You are interested in serving on a DSMB, but what are your  expected duties? You have been asked to serve on a DSMB but how should you best contribute or weigh in on issues that arise during the trial? If these situations sound familiar, you are not alone. This session will provide an overview of DSMB service and what can be expected from those that serve. Additionally, presenters will share information pertinent to what statistical concepts might be discussed as well as important concepts from a clinician’s perspective. 

  • CR Forum Top 10 Clinical Research Achievement Awards: Exploring Contemporary Research Challenges (Virtual + In Person)

    CR Forum Top 10 Clinical Research Achievement Awards – Session I

    CR Forum | The Top 10 Clinical Research Achievement Awards honor outstanding accomplishments in clinical research. This annual national competition seeks to identify major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens. This session features 5 studies from this year’s Top 10.

    • Behavioural nudges increase COVID-19 vaccinations
      • Daniel M. Croymans, MD, MBA, MS, Medical Director of Quality, Department of Medicine, University of California Los Angeles
    • Bionic Arm Restores Natural Behaviors
      • Paul Marasco, PhD, Associate Staff, Cleveland Clinic
    • Evaluating eligibility criteria of oncology trials using real-world data and AI
      • James Zou, PhD, Assistant Professor of Biomedical Data Science, Stanford University
    • The important role of autoantibodies neutralizing type I IFNs in COVID-19
      • Jean-Laurent Casanova, MD, PhD, Professor and Head of Lab, The Rockefeller University
    • Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media
      • Alejandro Hoberman, MD, Executive Vice Chair of Pediatrics, Vice Chair of Clinical Research; Division Director, General Academic Pediatrics, and Professor of Pediatrics and Clinical and Translational Science; Jack L. Paradise, MD Endowed Professor of Pediatric Research; President, UPMC Children's Community Pediatrics, University of Pittsburgh


  • Rare2Care: Community Engaged Research Model to Address Rare Cancer Health Disparities

    Presenters: Gayathri Devi, MS, PhD; Anh Tran, PhD, MPH; Terry Arnold; Kevin Williams, PhD; Greg Sawin, MD, MPH

    Community Engagement | In this session, presenters will will present a proof of concept model for utilizing community engagement strategies to address rare cancer disparities. Patients with rare cancers and their families face unique strife related to incorrect and often late diagnosis, difficulty accessing clinical skill and proper treatments, lack of confidence in clinical decision-making, possible indifference in developing new drugs, and shortage of accessible cancer registries and tissue banks. These challenges can be further exacerbated if the cancer is more prevalent in a specific minority or underserved community leading to significant health disparity and poor clinical outcomes. Leadership representing an academic medical center,  a historically Black college/university and a patient advocacy organization (Duke Cancer Institute, Duke Family Medicine & Community Health,  North Carolina Central University and The IBC Network Foundation) will share their collective experience building a multi-phase, multi-pronged research consortium addressing Inflammatory Breast Cancer (IBC), a NIH designated rare disease and cancer health disparity as a model for academic-community partnership to alleviate health disparities. In this session, you will learn new strategies to : a) engage primary care providers in our local and statewide communities with a large academic medical center; b) improve primary care provider rare cancer knowledge and practice; c) connect patients with rare cancer resources and advocacy opportunities; and d) promote and entice novel research focused on both the clinical care and health equity aspects of a rare disease.

  • Training to Diversify the Clinical and Translational Research Workforce: A Pathway from Undergraduate Students to Independent Researcher (Virtual + In Person)

    Presenters: Margarita Irizarry-Ramirez, PhD; Kristal M. Delgado Serrano; Melissa M. Cabrera Ruiz; Prof. Moraima Sosa Porrata, MS; Janaina Álves Mazaroto, PhD

    DEI | This session will present a model for enhancing diversity in the clinical and translational research workforce. A brief description of the model will be followed by individual presentations from participants ranging from undergraduate and graduate students with a diverse background in health professions, to new faculty members and independent researchers, also from diverse areas of expertise . Each individual presentation will focus on the impact of the program in their careers and the presentation of the results of the research done while participating in the Clinical and Translational Mentoring Teams ( CTMTs).

1:00 - 2:00 PM JCTS Editors Lunch (Invite Only)
1:00 - 2:30 PM Lunch
1:00 - 2:00 PM
  • TL1 Lunch*


    Core Activities | Register for a networking lunch, hosted from 1:00-2:00 pm on Wednesday, April 20. By registering for this event, you secure a spot as a TL1 trainee, TL1 program faculty, or TL1 staff member. TL1 trainees will be able to network with faculty members and peers across the research spectrum during this working lunch. Take advantage of this opportunity while you are at Translational Science 2022 to make valuable connections!

    *This session requires pre-registration.

2:30 - 3:30 PM
  • Engaging Community Health Workers in Patient Centered Outcomes Research: Community Health Worker and Faculty Training Resources

    Presenters: Jennifer Kraschnewski, MD,MPH; Andrea Murray, MPH

    Translational Workforce Development + Education | Racial and ethnic minorities are disproportionately affected by the COVID-19 pandemic, and these populations have been heavily burdened by the virus in the United States. Community health workers (CHWs) are uniquely poised to help address health problems created or exacerbated by the pandemic, as well as engage racial and ethnic minorities in patient-centered outcomes research (PCOR) related to health disparities such as those caused by COVID-19. However, there remain several barriers preventing CHWs from engaging in PCOR, including lack of PCOR training in CHW certification programs, lack of systems to connect CHWs with investigators interested in community-engaged research, and challenges associated with CHWs shifting to virtual work due to the COVID-19 pandemic. To address these challenges, Jennifer Kraschnewski, MD,MPH and Andrea Murray, MPH developed and implemented an innovative PCOR and remote work training, embedded in a long-standing CHW training program and as continuing education. The team also developed a network to connect community-engaged researchers and CHWs. The overarching objective is to increase the utilization of CHWs in PCOR in the context of the COVID-19 pandemic to contribute to the understanding, and reduction, of health disparities among racial and ethnic populations.

  • Workforce Management to Adapt to Diversified Clinical Trial Designs; Sponsored by Advarra

    Presenters: Denise Snyder, MS, RD, LDN, Associate Dean for Clinical Research; Royce R. Sampson, MSN, RN, CRA, Director of Clinical Research; Wendy Tate, PhD, GStat, Advarra Senior Clinical Research Strategist; Josh Fehrmann, MS, CMTS Director, Biomedical Informatics Program (BMIP) & IT Director for the Clinical and Translational Science Institute (CTSI).

    Translational Workforce Development + Education | With the adoption of decentralized clinical trials, efforts to include more communities in clinical research, and the desire to maximize public health safety, the clinical research industry is seeing a shift in how research is conducted. Advarra recently conducted a survey to gain insight on workforce development in the clinical research space, highlighting where and how the clinical research workforce anticipates performing their jobs in the short-term future. In this session, a panel of leaders from CTSA institutions will consider the findings of this survey and discuss how remote workflows are (or are not) being incorporated, what processes organizations are putting in place to maximize efficiency, and what strategies are they are utilizing to retain and grow their clinical research workforce.

  • CR Forum Top 10 Clinical Research Achievement Awards: Contemporary Research Challenges, Part Two (Virtual + In Person)

    Presenters: E. Albert Reece, MD, PhD, MBA

    CR Forum | The Top 10 Clinical Research Achievement Awards honor outstanding accomplishments in clinical research. This annual national competition seeks to identify major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens. This session features the remaining studies from this year’s Top 10.

    • ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness)
      • William Schuyler Jones, MD, Associate Professor of Medicine, Duke University
    • Association of Dose Tapering With Overdose or Mental Health Crisis Among Patients Prescribed Long-term Opioids
      • Alicia Agnoli, MD, MPH, MHS, Assistant Professor, Regents of the University of California (Davis)
    • Development of Pomalidomide in the Treatment of Chronic Graft-Versus-Host Disease
      • Steven Pavletic, MD, MS, Senior Clinician, National Cancer Institute, Center for Cancer Research
    • Once-Weekly Semaglutide in Adults with Overweight or Obesity
      • Robert F. Kushner, MD, Professor of Medicine (Endocrinology) and Medical Education, Northwestern University Feinberg School of Medicine
    • New 'race-free' equation to estimate kidney function
      • Lesley A. Inker, MD, MS, Director, Kidney and Blood Pressure Center; Associate Professor, Tufts Medical Center; Tufts University School of Medicine
    • Race, Genetic Ancestry, and Estimating Kidney Function in chronic kidney disease
      • Chi-yuan Hsu, MD, MS, Professor and Division Chief, University of California, San Francisco


  • Heart Failure Clinical Trial Enrollment at a Rural Satellite Hospital

    Presenters: Yub Raj Sedhai, MD; Antonio Abbate, MD, PhD

    Valued Approaches | Heart failure (HF) is a clinical condition that notably affects the lives of patients in rural areas. Partnering of a rural satellite hospital with an urban academic medical center may provide geographically underrepresented populations with HF an opportunity to access to controlled clinical trials (CCTs).  In this session, presenters will report on their experience in screening, consenting, and enrolling subjects at the VCU Health Community Memorial Hospital (VCU-CMH) in rural South Hill, Virginia (part of the larger VCU Health network) with the lead institution being VCU Health Medical College of Virginia Hospitals (VCU-MCV) in Richmond, Virginia. Subjects were enrolled in a clinical trial sponsored by the National Institutes of Health ( NCT03797001) and assigned to treatment with an anti-inflammatory drug for HF or placebo. They used the electronic health record and remote guidance and oversight from the VCU-MCV resources using a closed-loop communication network to work with local resources at the facility to perform screening, consenting, and enrollment.  The result? One hundred subjects with recently decompensated HF were screened between January 2019 and August 2021, of these 61 are enrolled to date: 52 (85 %) at VCU-MCV and 9 (15%) at VCU-CMH. Of the subjects enrolled at VCU-CMH, 33% were female, 77% Black, with a mean age of 52±10 years. Conclusion. The use of a combination of virtual/remote monitoring and guidance of local resources in this trial provides an opportunity for decentralization and access of CCTs for potential novel treatment of HF to underrepresented individuals from rural areas.

  • Anti-Racist Community-Engaged Research: Supporting Capacity for Researchers & Research Partnerships (Virtual + In Person)

    Presenter: Jen Brown MPH; Karou Wantanabe; Jen Martinez; Tara Gill, PhD

    DEI | It is important to acknowledge, understand, and address the history and legacy of research and healthcare that contribute to health inequities and the underrepresentation of Black Indigenous People of Color in research participation and leadership. Engaged research that centers leadership of communities most impacted by inequities are key and it’s also necessary to address issues of bias and racism in engaged research and partnerships themselves. Established in 2008, the Alliance for Research in Chicagoland Communities (ARCC) at Northwestern University supports community-engaged research to improve health and equity. Since 2018, ARCC community and academic partners have been working to ensure community research partnerships are more racially equitable in their process, practice, and impact. In 2020-21, ARCC piloted a Community-Academic Anti-Racist Learning Collaborative with 30 community and academic partners engagiing together in questioning, learning, and addressing how racism operates in research institutions, (i.e. policies, culture, structures) and how community-academic partnerships can apply a racial equity lens to their research and partnership process. The three-part program included 1) foundational training in racial equity concepts, 2) 6-month application and activation period with facilitated open dialogues and resources including an Anti-Racist Reflective Practice Tool and Action Planning Guide addressing individual and organizational level change, and 3) closing sessions and resources to support participants next steps and plans for collective learning and advocacy. The Collaborative aimed to go beyond educational knowledge-building workshops to aim for cultural change. This included the introduction and implementation of structural changes in the ARCC Community-Engaged Research Seed Grant Program to prioritize and support an increased focus on racial equity, root causes, and representation, as well as initial development of an advocacy agenda at the levels of school, university, funder, and publisher. ARCC partners and staff will share reflections, lessons learned, and next steps for the Learning Collaborative and other anti-racist initiatives.

3:30 - 3:45 PM Break
3:45 - 4:45 PM
  • Mentorship Toward Tenure and Beyond (Virtual + In Person)

    Presenters: Peter L. Elkin, MD; Karen G. Martinez-Gonzalez, MD, MSc; Doris Rubio, PhD; Heidi Spratt, PhD; Joyce (Joy) Balls-Berry, Ph.D

    Translational Workforce Development + Education | In this session, the presenters will discuss faculty issues for those who have yet to attain tenure. Mentorship of junior and mid-level faculty continues to be uneven. This panel  of outstandingly well-recognized women leaders in their fields will help discuss the challenges and methods for overcoming the challenges that led to their success, including  dealing with your dean, preparing your dossier, and working in a culture that may not be as supportive as it should be all the while dealing with tenure clock pressures. A study which was performed at the University at Buffalo showed the about have of the pay gap for women was due to the lack of their promotion from Associate to Full Professor.  The panel will explore methods to keep your career and advancement on track throughout your career.

  • Engaging Youth, Parents, and Healthcare Providers in the Design of Serious Games for Health

    Presenters: Olufunmilola Abraham PhD, MS, Bpharm

    Community Engagement | Engaging community stakeholders throughout the design process is crucial to the development of effective interventions for influencing health behaviors. By involving youth prior to development of MedSMAT: Adventures in PharmaCity, a serious game on opioid safety, theirteam was able to prioritize specific needs and preferences of the adolescent population throughout game design. Using surveys and focus groups, local youth provided their perspectives on prescription opioid safety education for schools, as well as preferences for a serious game on opioid safety. Following development of a prototype, the game was refined through an iterative process guided by feedback from local and national adolescent participants and our own virtual, nationally representative youth advisory board. Youth identified parents and other family members as important educational sources for medication safety information and suggested the use of MedSMAT in the healthcare or school setting, which led to the development of MedSMAT: Families. MedSMAT: Families engages parents, pharmacists, and youth in development of an intervention using the MedSMAT game and a Family Medication Safety Plan to facilitate medication safety conversations among youth, family members, and pharmacists. Input from pharmacists and parents was used to guide further intervention refinement and identify important considerations for future dissemination and implementation. Obtaining input from key stakeholders who will be involved in implementing the serious game and family medication safety plan is necessary to reduce burden on stakeholders and to ensure buy in and uptake of the intervention. Our team is also currently using a similar approach to design OutSMAT Cancer, a serious game intended to educate youth on cancer basics and prevention. This presentation will use the design process for MedSMAT: Adventures in PharmaCity, MedSMAT: Families, and OutSMAT Cancer to demonstrate how these techniques can be applied to the creation of technology-based interventions through a participatory design approach.

  • Incorporating Teaming Concepts and Team Science Competencies for Clinical Translational Research Teams Across the Life Span

    Presenter: Jennifer Cross, PhD; Wayne T. McCormack, PhD; Carolynn Thomas Jones, DNP, MSPH, RN, FAAN; Dayan Ranwala, PhD; Angela Mendell, MS, CCRP

    DEI | The session will provide an opportunity for defining clinical and translational research team stakeholders and stimulate discussion of team science competencies and teaming concepts. The InSciTS (International Science of Team Science) working group Team Science across the Life Course has sought to define team sciences competencies across the career span of clinical translational research teams. Sub-groups focused on three constituencies; translational investigators and trainees, clinical research professionals, and community members are describing team roles, constituency life span, and outputs related to individual and team competencies for team science. The panel discussion will revolve around  diverse stakeholders that comprise clinical and translational research teams. The importance of incorporating teaming concepts and team science competencies across the life span will be presented and discussed. Defining different teaming behaviors across the lifespan can help inform better curriculum development and assessment criteria for targeted training and career progression. This work can help improve team performance at clinical and translational research hubs to enhance innovation, discovery, and the quality of research.

  • Transforming Expanded Access to Maximize Support and Study

    Presenters: Kevin J Weatherwax, CCRC, CCRA; Misty Gravelin, MPH; Joan Adamo, PhD; Erika Segear, PhD, RAC

    Valued Approaches | The Expanded Access (EA) program of the Food and Drug Administration (FDA) provides an opportunity for patients who either lack therapeutic options or who are ineligible for clinical trials to potentially benefit from the clinical use of experimental drugs, biologics, and medical devices. This process represents one of the most immediate forms of translation because an experimental therapy is administered directly to an individual patient in need. However, the individual nature of EA interventions, the silos of care environments using them, and the lack of standardized reporting have led to the inability to make broader inferences about safety or therapeutic potential. Furthermore, the number and complexity of EA requests have grown substantially in recent years as a result of the increase in novel investigational products, the rise in patient advocacy groups, and the national Right-to-Try movement, which bypasses several oversight entities (including FDA and local Institutional Review Boards [IRBs]) without addressing safety or payment issues. A more coordinated approach to EA that can achieve greater integration and yield more robust information could be transformative for the care of patients with rare or refractory disease. Although the efforts of the FDA address regulatory requirements, much of the impediment to access occurs at an institutional level. The NIH Clinical and Translational Science Awards (CTSA) consortium is the ideal network to develop innovative methods for regulatory navigation and support, oversight, and delivery of investigational products through EA. Transforming Expanded Access to Maximize Support and Study (TEAMSS) was funded in July of 2018 with the long-term goal to advance clinical care and translational research by improving patient access to experimental therapies through a federated, national consortium for EA interventions. The primary goal of TEAMSS is to develop a CTSA-based network that can demonstrate successful multisite integration of EA programs, leading to dissemination of best practices.

  • Public Policy Advocacy: The Importance of Your Voice (Virtual + In Person)

    Presenters: William L. Lowe, Jr., MD, Vice Dean for Academic Affairs, Northwestern University Feinberg School of Medicine; Dane Christiansen, Health and Medicine Counsel of Washington

    CR Forum | This panel session will explore the importance of clinical and translational researchers participating in national science policy and advocacy, and how this participation can make a huge difference.

4:45 - 5:00 PM Break
5:00 - 6:00 PM
  • Academic Translational Research Programs - Bringing Ideas to Impact (Virtual + In Person)

    Presenters: Bradley J. Martin PhD

    Translational Workforce Development + Education | In this session, Bradley J. Martin PhD will explore establishing Innovation and Translational Research programs within academia. Since being established in 2013, Fast Forward Medical Innovation (FFMI) at the University of Michigan Medical School has provided groundbreaking funding programs, dynamic educational offerings, and deep industry connections to help biomedical researchers navigate the road to successful innovation and commercialization, with the ultimate goal of positively impacting human health. They do not seek to change their research faculty into entrepreneurs, but rather provide them with the tools, knowledge, funding and vocabulary to successfully interact with those that can bring their technology to market. They have recently partnered with their CTSA organization at the University of Michigan (MICHR) to offer their commercialization education programming to other CTSA institutions in a 'train-the-trainer' model, with the goal of helping them establish similar programs. In this session, attendees will learn best-practices, challenges, key program topics, and identify a network for future support.

  • BeInvolved: An Academic-Community Partnership to Diversify Participation in Research

    Presenters: Sarah Langdon, MPH, MCHES; Mariana Pardy, MPHl; Keena Moore, MA, CHES; Luke Morales, BA

    Community Engagement | Diversifying participation of underrepresented groups in clinical and behavioral research is critical to addressing health inequities among underserved communities. However, due to historical distrust and lack of culturally-relevant recruitment tools, this remains a challenge for many learning healthcare systems. These issues prompted Wake Forest School of Medicine (WFSM) to develop BeInvolved, a bilingual web-based searchable database that aims to bridge study recruitment needs with community understanding of and access to research. Community feedback on design and ease-of-use were key in BeInvolved development and implementation. Qualitative and quantitative feedback were obtained through focus groups and beta-testing among both English and Spanish-speaking community members through an iterative process over a 7-month period. Feedback was crucial in determining appropriate graphic design, culturally- and educationally-appropriate verbiage, and functionality. Parallel to community feedback, sustainable infrastructure to facilitate ongoing implementation of recruitment best practices was established. Prior to posting, studies undergo initial review by Office of Clinical Research Recruitment Manager; health literacy review by a Certified Health Education Specialist; Spanish translation and revision by certified medical translators; and opportunity for research team review/revision. Since establishment, BeInvolved has hosted 470 studies, of which approximately 250 have concurrent Spanish-language postings. BeInvolved demonstrates an average monthly engagement of 385 unique study inquiries and supports a 24% monthly research enrollment among underrepresented groups at WFSM. In addition, the WFSM Program in Community Engagement ensures ongoing community review of BeInvolved updates and revisions. BeInvolved demonstrates the critical nature of community engagement in the development of tools to increase research participation.

  • Guidance for the Statistical Review of Journal Articles (Virtual + In Person)

    Presenter: Heidi Spratt, PhD; Phillip Schulte, PhD; Lauren Balmert, PhD; Dongmei Li, PhD

    Valued Approaches | The statistical peer-review process for clinical and translational research manuscripts varies greatly from one scientific medical journal to the next, with some journals soliciting specialized review from statistical methodology experts on all manuscripts while other journals rarely seek independent expert methodologist feedback. Further, the process may vary among the reviewer community, each individual potentially setting different standards for methodological rigor, writing and presentation style, and ultimately decision recommendation. This may lead to lack of transparency in journal decisions and unclear or conflicting guidance for manuscript improvements. Prior studies have reported variation in practice across medical journals and common statistical errors in biomedical research studies have been described. A panel of methodologists will discuss statistical peer-review for clinical and translational research journals with a focus on pitfalls to be avoided and proposals for uniform guidance.  Such guidance may make the review process more streamlined, structured, and systematic for the reviewers and more transparent, constructive, and informative to the authors, promoting more robust scientific practices.

  • Innovative Models for Workforce Development and Infrastructure Sustainability and Productivity

    Presenters: Lourdes E. Soto de Laurido Ed.D., MPHE

    DEI | An innovative model of four HiRECA's Awards supports the workforce development of junior and mid-career Hispanic researchers. Recognized as a valuable tool to strengthening research infrastructure, partnerships that encouraged a research culture of sustainability and productivity.

6:00 - 7:30 PM

*Activity and/or session requires pre-registration.


Tuesday, April 19

View the schedule of pre-meeting activities for Tuesday.

Thursday, April 21

View the schedule of activities for Thursday.

Friday, April 22

View the schedule of activities for Friday.

Co-Supported by:

Thank you to our sponsors:

Thank you to our travel sponsor:

Thank you to our 3MT award sponsor: