Published February 19, 2018

Introduction & Welcome

Welcome to CTSInsider, the newsletter of the Clinical & Translational Science Institute of Southeast Wisconsin! In this issue you will find news and announcements, including upcoming opportunities and events, and research trainings, as well as an overview of services available to support you. Happy reading!

CTSI & You

Here at CTSI, we recently submitted our Annual Progress Report (APR) to the National Institutes of Health (NIH) and NCATS.  While the APR is always an undertaking for our staff, faculty and programs, it provides an opportunity to reflect on our goals and progress to-date, areas of focus over the next 12 months, and challenges we have encountered as we work to transform the clinical and translational research enterprise locally, regionally, and nationally.  In 2017, we transitioned to year three of our second, five-year grant, bringing achievement of several key milestones related to our overall strategic aims, including:

• Strengthening and solidifying the collaborative enterprise required for the translation of new discoveries by leveraging our CTSA’s institutional partnerships, locally and nationally. For example, the collaborative efforts of two Wisconsin NIH funded CTSA partnering entities – our CTSI of Southeast Wisconsin and ICTIR (UW-Madison/Marshfield Clinic – CTSA) resulted in a $5,360,832 NIH All of Us Research grant that will benefit communities across the state of Wisconsin and the country. Marshfield Clinic Research Institute, University of Wisconsin School of Medicine and Public Health, and Medical College of Wisconsin partnered with the BloodCenter of Wisconsin and regional Federally Qualified Health Centers (FQHCs) to engage and recruit research participants for this important national agenda. Our CTSA infrastructure (BMI, CTO, and TRU) are actively engaged in supporting the All of Us grant.
• Hosting and supporting successful processes, facilitating translation of discoveries into health, including our second annual Healthcare Innovation Pitch (HIP) and the 19th Annual HHS SBIR/STTR National Conference. These events created synergy and shed a spotlight on the unique opportunities available in our community to support the development of new technologies, diagnostics, and therapeutic techniques. During the last year, multiple teams form Madison, Milwaukee, and Chicago were mentored in strengthening their intellectual property, satisfying regulatory requirements for drug or device development, writing business plans, presenting to investors, and forming a startup venture. Seed funds were provided to 3 Wisconsin startups. CTSI hosted the 19th Annual HHS SBIR Conference was held in downtown Milwaukee at the Hilton on Nov. 7-9th, 2017. CTSI was the first NIH-funded CTSA institution to receive the hosting bid in the conference’s history. Outcomes of the 19th Annual HHS SBIR/STTR Conference were summarized in a formal Post-Conference Report.
• Piloting innovative strategies such as our Real-Time IRB review, a CTSI envisioned initiative, implemented through a collaboration between CTSI and the Office of Research’s HRPP. This process is designed to reduce the time from IRB submission to approval for full board protocols without compromising ethical or regulatory standards. To date, 18 studies have been reviewed under this process, reducing the average time between initial submission and final approval from 63 days to 27.8 days, a reduction of 56%. In 2018, we will continue to refine and highlight this strategy to reduce IRB turnaround time and accelerate the pace of research at our institution.
• Encouraging and supporting CTSI students and scholars to leverage the array of CTSI services to support and advance their research and careers. For example, Meredith Adams, MD, MS, assistant professor of anesthesiology was awarded a four-year, $737,492 Mentored Clinical Scientist Research Development Award (K08) from the National Institute of Biomedical Imaging and Bioengineering. Dr. Adams leveraged our BMI core, CRDW, and mentoring and support through our CRS program. In addition, Dr. Adams applied and was accepted to participate in the NCATS Innovation Lab on Radical Solutions to the Opioid Misuse Epidemic.
• Expanding CTSI’s 500 Stars Initiative. Our 2017 Summer Internship Program received 192 applications, of whom 133 (69%) were underrepresented minorities (URMs). We enrolled 109 participants, including 83 (76%) URMs (84 high school students and 25 college students). A total of 53 Wisconsin high schools and 19 colleges/universities (local and out of state) participated. At the end of the summer program, students created and presented posters of their research as part of the closing ceremony. Learn more about the program via the recent MCW Magazine story.
• Hosting ten Science Cafés from January to October 2017, on topics based on the recommendation of community members, such as hypertension, diabetes, stroke rehabilitation and the opioid epidemic. More than 268 people attending the Science Cafés in 2017, and results from the evaluations show significant differences on all five health and scientific literacy statements, indicating that attending a Café increases attendees’ perceived confidence in health and scientific literacy, which is consistent with previous evaluation findings. Podcasts of past Science Cafes are also available for streaming.
• Promoting interdisciplinary research, converging disciplines and nucleating scientists and community of stakeholders around topics of interest through our Pilot & Translational Studies program. The program offers support in the form of three Funding Paths designed to address distinct phases of pilot research. The program supported 42 active projects (see pilot progress report; REM). In addition, we received 55 LOIs, with 39 (70.9%) submitting applications, compared to the previous year’s submission rate of 54%. Investigative teams are conducting a broad range of clinical and translational research including: racial/ethnic disparities and PTSD; the effects of older red cell units in adults with sickle cell disease; utility of a fMRI-based biomarker for chronic pain; developing technologies for rapid production of individualized models of congenital cardiovascular diseases to facilitate clinical treatment; and much more.
• Providing biomedical informatics tools and related services to support the interconnected systems and facilitate research, such as the Clinical Research Data Warehouse (CRDW), i2b2, Cohort Discovery, de-identified data extractions, identified data extractions (with an approved IRB protocol), image de-identification, REDCap study development and hosting, the faculty collaboration database (FCD), custom registries and application development. BMI was pivotal in implementing the Best Practice Alerts (BPAs) as well as launching TrinetX, a third-party software firm that bridges providers and pharma to promote clinical trials. These key accomplishments are vital to supporting clinical and translational research within and across our CTSI hub.
• New Faculty Leadership Join the CTSI: Leonard Egede, MD, MS joined the CTSI late 2017, as Co-Director of the KL2 program and component lead for our Research Implementation and Participation module. He is currently spearheading a faculty-led research committee focus on optimizing the Translational Research Units. Dr. Egede is general internist, tenured Professor of Medicine, and Chief of the Division of General Internal Medicine at the Medical College of Wisconsin (MCW). He is also the Director of the MCW Center for Patient Care and Outcomes Research (PCOR), and the Associate Director of Cancer Disparities at the MCW Cancer Center. Dr. Egede is a nationally recognized health disparities research, whose research focuses on developing and testing innovative interventions to reduce and/or eliminate health disparities related to race/ethnicity, socioeconomic status, and geographic location for chronic medical and mental health conditions. Dr. Egede is extremely committed to mentorship, providing mentorship opportunities to students, general internal medicine fellows, interns, post-doctoral fellows, and junior faculty members. As such, he will bring a wealth of knowledge and experience to the CTSI Mentored Career Development Program and early-career investigators interested in the program. He will also oversee CTSI education programs.

In addition to the highlighted milestones and accomplishments above, our CTSI infrastructure supported more than 680 investigators/research staff in 2017. Approximately 77% of these individuals were from the Medical College of Wisconsin, with 21% coming from our valued partner institutions. We look forward to an exciting 2018 as we continue to work on achieving together what we cannot achieve alone!

About CTSI

Are you conducting multi-site clinical research? If so, there are opportunities for collaboration with the Trial Innovation Network and its partner the Recruitment Innovation Center. The vision for the Trial Innovation Network is to innovatively address critical roadblocks in clinical research and accelerate the translation of novel interventions into life-saving therapies. This collaborative project includes teams of experts across CTSA Program Hubs including our CTSI.

Click on the image to view a PDF

The hubs Trial Innovation Centers specialize in trial protocol, budgets, centralized IRB, data management, and other technical aspects of study.

The Recruitment Innovation Center is focused on the vast array of recruitment efforts including cohort discovery, community engagement studies, and planning recruitment methods.

The Trial Innovation Network is not only the TICs and RIC, but they work with the CTSA Program Hubs, NCATS, NIH ICs, FDA, PCORI, participants, providers, the public, and industry.

Anyone can benefit from the Trial Innovation Network’s free toolkit resources for investigators and research teams so be sure to explore the resources and opportunities today.

News & Announcements For You

CTSI Events & Programming

CTSI Academy: Current and Upcoming Training Opportunities

Check out the current CTSI Academy offerings today! Current training opportunities include boot camp for clinical research management. Stay tuned for future offerings later this year. Learn more and register for boot camp today!

Real-Time IRB Lunch and Learns

Come and learn about the Real-Time IRB review process from investigators, study staff, and IRB members who have had their research reviewed via this innovative mechanism. Presenters will discuss the Real-Time IRB review process, studies that are best suited for this type of review, and lessons learned from the past year of implementation. Come and get your questions answered!

National News and Announcements

Trial Innovation Network Webinars

Have you attended a TIN webinar? If not, be sure to check out the upcoming offerings, which include Research with Older Adults: Recruitment and Retention Efforts, Accrual Quality Improvement Program (AQuIP), and Patient Navigation: A Strategy to Increase Minority Recruitment and Retention in Clinical Trials to name a few.

Burroughs-Wellcome Career Development Pilot Projects

Mentors, Burroughs-Wellcome offers up to $50,000 for career development program pilot projects. Applications are due March 6. Learn about the opportunity and eligibility requirements today. 

Foundation for the NIH Trailblazer Prize

The Foundation for the NIH Trailblazer Prize offers $10,000 to early career clinician-scientists whose work has lead or has the potential to lead to innovations in patient care. Nominations are due March 30.

Rare Disease Day at NIH – Join the Twitter Chat

March 1 is Rare Disease Day at NIH. Rare Disease Day® takes place worldwide, typically on or near the last day of February each year, to raise awareness among policymakers and the public about rare diseases and their impact on patients’ lives. Each year, NCATS and the NIH Clinical Center sponsor Rare Disease Day at NIH as part of this global observance. This year’s global theme is “Research” continuing from 2017, and the slogan is “Patients are not only subjects but also proactive actors in research.”

CTSI At Your Service: Highlights

CTSI offers more than 20 different services and resources all aimed at supporting you and your clinical and translational research. Here are two you should know about.

CORES Search

Many outstanding core facilities and specialized research laboratories exist at CTSI partner institutions. These facilities provide highly specialized services, equipment, and staff. This database includes information on a variety of cores across our CTSI partner institutions. Learn more.  The MCW Office of Research also has an inventory of facilities and resources available to support you, in addition to hosting the Cores Fair, February 28. Learn more.

Clinical Research Data Warehouse

Do you have enough patients with certain characteristics for your study? The i2b2 Cohort Discovery Tool provides an easy-to-use, self-service method for MCW researchers to query the CTSI’s Clinical Research Data Warehouse (CRDW) to answer that question. Search criteria can include patient demographics, ICD-9 coded diagnoses, CPT and HCPCS coded procedures, laboratory test results, medication orders by class or ingredient, clinical encounter metadata and MCW Tissue Bank biospecimen variables. Learn more.

Investigator’s Corner: You & CTSI Advancing Research & Discovery

TL1 Scholar Spotlight

The current cohort of scholars are well into their first year in the TL1 START program and busy focusing in on a wide variety of research areas. We asked two of them to share what their experiences have been like and what the TL1 program has allowed them to do so far. Enjoy the update!

Jennifer Alexander

I am currently a fourth-year clinical psychology doctoral student at Marquette University and a student mentee in the CTSI Scientific Teams Advancing Research Translations (START) TL1 Mentored Translational Research Training Program. Being a student mentee in the TL1 program has been invaluable, given my desire to have an impactful career that enhances understanding and treatment of obsessive-compulsive spectrum disorders through clinical and translational research. The program has provided me with the opportunity to develop and follow a specialized training plan that will help prepare me for the career I desire. Examples of the training that I am receiving as a result of the funding and protected time allotted by the TL1 program include training in MR technology via courses and focused mentorship, training in fMRI statistical analyses via attendance at the March 2018 NIH AFNI bootcamp, and professional development training via attendance at the April 2018 Association for Clinical and Translational conference. These incredible training opportunities would not have been possible for me without the TL1 program.

Anthony N. Correro II

As a CTSI TL1 scholar, I have been provided with the time and resources to focus on my development as a clinical/translational science researcher. The multi-theoretical training provided by this program has exposed me to innovative techniques that will extend my research program in directions I had never considered. Since science and practice appear to becoming increasingly more interdisciplinary, I believe that the TL1 program has given me the tools necessary to assess and address health care challenges in a bench-to-bedside manner. For example, the CTSI Academy lecture series taught me statistical and methodological approaches to health disparities research. By quantitatively evaluating health problems across diverse populations, scientist-practitioners can target modifiable factors influencing health, like stigma and prejudice.

Pilot Awardee Spotlight

Dr. Zeno Franco

Dr. Zeno Franco, assistant professor in the Department of Family & Community Medicine was recently named a 2017 Health Care Hero by Milwaukee Business News along with 4 other MCW faculty.  The Health Care Heros awards are presented annually by BizTimes Milwaukee to honor the positive health impact being made by these individuals. Dr. Franco was awarded within the Community Service category for his work with Dryhootch Milwaukee. Dr. Franco specializes in the treatment of post-traumatic stress disorder and other mental health concerns. He has partnered with Dryhootch, a nonprofit organization dedicated to assisting veterans with their return home from combat. In addition, Dr. Franco is a recipient of a CTSI pilot award which focused on improving outcomes for veterans across a wide variety of health and mental health outcomes via the development of a mobile App. Congratulations Dr. Franco!

CTSI Staff & Faculty: At Work for You

Each newsletter we will highlight staff and faculty working to support you and your research. Leslie Bojar, BBA is the CTSI Business Operations Coordinator. Her role is crucial in the stability of our department. She manages coordination of financial and business processes including: pre-award, post-award, purchasing, budgeting, and receivables within the CTSI. Leslie also acts as liaison with Human Resources for recruiting processes with some involvement in timecard and onboarding procedures. She’s currently working on FY19 MCW budgets and developing a simplified onboarding checklist. Leslie has been with us for three-and-a-half years and enjoys that it’s never a dull moment. Knowing that our efforts are going towards a greater vision of bettering the health of citizens and providing educational programs and trainings to youth keeps her focused. In Leslie’s spare time she enjoys playing most sports, keeping house, and spending time with her children.