Published May 8, 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

Adult Translational Research Unit News

From February through March, we conducted three town hall meetings to generate investigator and coordinator feedback and collaboratively optimize restructuring of the Adult Translational Research Unit (ATRU) to best serve the needs of the research communities across the CTSI partnering institutions. ATRU is a valuable resource for research and a key ingredient in supporting an academic research center. In 2017, the ATRU supported 134 projects and 73 PIs from 21 different departments and 5 different institutions. Of those projects, more than 36% were new research protocols for the ATRU and 44% of them are industry-funded. These studies are exploring a range of diseases and health conditions, including PTSD, the impacts of concussions, epilepsy research, Alzheimer’s disease, breast cancer, and epigenetic research.

We look forward to engaging the research community in the restructuring efforts and would like to thank those who attended the town hall meetings early this year and provided us with valuable feedback. As a follow up to the town hall meetings, we are surveying PIs, Co-Is, and research coordinators who have had an active research protocol in the past two years. This voluntary survey was sent out May 7th and takes 10- 15 minutes to complete. Through the survey, we hope to gather additional feedback on current and potential future services, staffing models, hours of operations and learn more about the research community’s needs for clinical and basic research infrastructure. After collection and analysis of these data, the CTSI will share a comprehensive restructuring plan with our research community in the coming months.

About CTSI

The CTSI community has come together once again to work in partnership in interdisciplinary research teams to advance research discoveries that lead to improved health. The CTSI Pilot Translational and Clinical Studies Program advocates, facilitates, and fosters the continuum of research from bench to bedside and from bedside to community practice. The studies will explore the multidisciplinary and clinical potential of promising mechanistic findings that have the potential to be translated into improvements to clinical practice and community health.

This year CTSI is funding 14 new traditional pilot research projects, supporting 23 principal investigators from 4 different institutions and an additional 31 co-investigators, representing all the CTSI partner institutions. Investigative teams are conducting a broad range of clinical and translational research including factors that contribute to cancer disparities, novel therapies, and interventions for patients with congenital heart disease, and new approaches to treating children with IBS. Congratulations to this year’s awardees and their investigative teams. We look forward to following their progress. Read more about this year’s awardees here.

News & Announcements For You

Opioid Overdose Prevention Research – CTSI Nucleating Workshop  – May 29 2018

The CTSI along with the Milwaukee Community Opioid Prevention Effort (COPE), the Neuroscience Research Center, and the Comprehensive Injury Center at the Medical College of Wisconsin are pleased to host a nucleating workshop to develop and facilitate multi-disciplinary team research collaborations targeting opioid overdose prevention strategies that will develop research proposals that will be competitive for local and federal funding. This nucleating workshop will provide those individuals and organizations working on addressing the opioid crisis the opportunity to come together to identify knowledge gaps and develop collaborative research partnerships to fill the identified gaps. Learn more and register here.

CTSI Funding Opportunities Currently Available

We currently have several funding opportunities available.

Traditional Pilot Awards: Special Emphasis on Opioid Prevention Strategies. The total available funding CTSI is offering for the 2019 Traditional Pilot Award cycle is $50,000 each for up to 12 meritorious projects. Due to the importance of supporting research to address the opioid epidemic in alignment with the NIH HEAL Initiative, the CTSI has set aside funding for up to 3 meritorious opioid-related pilot studies for the 2019 cycle. This does not preclude the funding of additional pilot proposals that are opioid-related and demonstrate merit.

Proposals should describe a clear link to future funding opportunities, such as specific NIH program announcements or other federal or private funding opportunities (e.g., NIDA, CDC). Applications in this area may include but are not limited to:

1. Prevention modalities for patients around opioid misuse and abuse
2. Personal and social factors impacting risk for opioid addiction
3. Provider practices and structure of the healthcare system as contributing to opioid misuse and abuse
4. The intersection between pain conditions and opioid use disorder
5. The neurobiology of pain as related to efficacy of opioids vs. non-addictive analgesics
6. Innovative treatment modalities, including non-addictive analgesics and non-pharmacologic approaches

Start-up Awards: Start-up awards are designed to prepare fully-developed Traditional Pilot proposals. Six start-up awards are available for up to $12,500 each.

CTSI 500 Stars Internship Preceptors Needed

The CTSI 500 Stars Initiative is looking for preceptors/supervisors interested in hosting summer internship participants. The preceptor/supervisor is responsible for providing education and research experience in his/her respected career focus. The program provides participants with a broad range of opportunities in a health science setting.

Preceptor Time Commitment (Durations, Frequency):
A minimum of 20 hours (Mon.-Thurs.) of contact time with students from June 11, 2018 through August 3, 2018 is required. Preceptors and/or their qualified designee may fulfill the time commitment. Students are required to attend the career enrichment sessions held every Friday from 9 a.m. to 4 p.m. at MCW.

If you are interested in hosting a student please complete the preceptor request form at https://redcap.mcw.edu/surveys/?s=3EKLEARRR9 or contact the CTSI 500 Stars Initiative at ctsi500stars@mcw.edu for additional information. We appreciate your willingness to serve!

Discovery Radio explores the Past, Present & Future of Precision Medicine

Learn about Precision Medicine’s past, present, and future from Dr. Raul Urrutia, inside this edition of CTSI Discovery Radio! He calls it the last revolution in medicine, and he ought to know. He’s new to SE Wisconsin, but through his years of expertise, he’s leading researchers and clinicians in using the human genome to better understand disease, improve diagnoses, and advance patient care in our community and beyond! Listen today!

Marquette Exercise Translational Unit

The CTSI encourages researchers to explore the Marquette Exercise TRU, which provides infrastructural support for the conduct of clinical and translational research projects by providing access to space, resources, and the expertise of research support personnel.

Housed in and coordinated through the Human Performance Assessment Core (HPAC) in Marquette’s Program in Exercise Science in the College of Health Sciences, the MU EXSC TRU provides an environment for investigators to conduct comprehensive human studies in health and fitness. It is designed to support a wide range of research techniques and protocols in an easy to navigate location with ancillary labs and expertise available to accommodate physiology, body composition, biomechanics, engineering, blood sampling, strength, and power assessments.

For additional details on the MU EXSC TRU including available services, equipment, hours of operation, fees and more, please visit the MU TRU page.

Pediatric Translational Research Unit Moves – Request a tour today!

The Children’s Pediatric Translational Research Unit moved to a new location in December. The PTRU is now located on C4S of Children’s Hospital (Center Tower – 4th Floor) and encourages those interested in using the space for the conduct of their research, to contact them for a tour. For more information call the team at 414-266-6515.

Leadership Positions Available at CTSI

The Clinical & Translational Science Institute of Southeast Wisconsin (CTSI) is seeking applications for a Medical Director (20%) and an Associate Medical Director (10%) of its Adult-Translational Research Unit (ATRU). The responsibilities for these individuals include the following:

• Committed day-to-day on-site supervision of the ATRU
• Ability to manage a busy research infrastructure and supervise personally the conduct studies in support of all phases of clinical trials
• Overall responsibility for quality and safety of research performed at ATRU
• Leading the processes for providing services in the ATRU

CTSI is seeking MCW faculty with the following qualifications:

• MD with research training
• MCW faculty at the rank of assistant professor or higher

Willingness to commit the time necessary is essential. In addition, approval from the department chair is required. Interested faculty, please send your CVs to Dr. Leonard Egede and Dr. Tom Aufderheide.

CTSI Boot Camp – Clinical Research Coordination Seminar

The CTSI Academy and the CTSI Clinical Trials Office (CTO) is excited to offer an upcoming Boot Camp training program. This program has a strong focus on the practical conduct of clinical research at MCW and its partner institutions. This program is made possible by contributions from experts at the CTSI, MCW Office of Research, MCW and Children’s Hospital of Wisconsin IRBs, the departments of Medicine and Pediatrics, the Cancer Center CTO and the Clement J. Zablocki VA Medical Center Research Office. Learn more and register here.

National News and Announcements

Writing a K-grant?

Check out this blogpost where three K awardees (K01, K08, K23) share the advice they wish they’d received before preparing career development awards at a recent seminar. Read more from the Edge for Scholars.

ACTS Conference Recap

CTSI leaders and scholars recently returned from attending the Association for Clinical and Translational Science 2018 Conference in Washington D.C. where they networked with colleagues, researchers, scholars, industry leaders, and NCATS program officers, and attended exciting and innovative sessions on topics related to Clinical and Transnational Science.

Several of our TL1 Scholars participated in the ‘Hill Day Advocacy Training’ and had the chance to advocate on Capitol Hill. We also presented on the CTSI 500 Stars Initiative and Real-Time IRB efforts. Read more. 

Un-Meeting: Addressing the Opioid Crisis through Translational Research

The National Institutes of Health (NIH) recently announced an initiative pledging resources and efforts to combat the opioid epidemic. On the heels of that announcement, the Center for Leading Innovation and Collaboration (CLIC) will host an “Un-Meeting” on Saturday, June 2, 2018 at the University of Rochester Medical Center to discuss how to best address opioid misuse and abuse through translational science.

Register by May 23rd as space is limited. Event admission is free of charge, but interested parties must fund their own travel and accommodations.

Science of Team Science (SciTS) 2018 Conference

The Science of Team Science (SciTS) field is building the evidence base for how to conduct, manage, and support effective and efficient team-based research and ultimately enhance the science it produces.

The SciTS conference is the annual international forum dedicated to SciTS, bringing together thought leaders from a broad range of disciplines and fields, including: communications, management, social and behavioral sciences, information technology, systems science, and translational research. This year’s conference will be hosted by the University of Texas Medical Branch in Galveston, Texas May 21-24. Learn more and register here. 

New CTSA Program Informatics Center to Create a Nationwide Data Ecosystem

Making data more meaningful, open, and accessible is a key goal in NCATS’ efforts to improve translational science. Read more about the creation of a nationwide data ecosystem through the National Center for Data to Health (CD2H) in a new featured news item from NCATS. We invite investigators at our CTSI institutions to get involved with the CD2H.

Alex Bruss, CCRC

Clinical Research Coordinator

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.

IND/IDE Services

Applications for IND are often complex and multi-step processes that require expert navigation through ambiguous FDA guidelines and regulations. The process involves both local and federal authorities, determination of exemption status, creation of coherent application packets, request to FDA for meetings and/or consultations, and management of any ancillary requirements. Once an IND is obtained, there are federal requirements for annual updates, data quality and safety reporting guidelines and eventually, publishing of results.

The CTSI CTO recognized a need to fill a gap in this area for MCW and now offers full support for IND applications. CTO’s regulatory specialist – Alexandra Bruss, CCRC has years of experience with IND applications and has recently attended an advanced training course. Ms. Bruss will assist with each of these steps, meet with PIs and necessary regulatory authorities as required. You may find additional information on our website or by contacting Ms. Bruss directly or 414-805-7128.

Ayman Isahaku

CTSI 500 Star

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

Each newsletter we will highlight researchers, scholars, and students engaging in research across the CTSI.  Ayman Isahaku participated in CTSI’s 500 Stars Initiative, a ten-year, comprehensive, multi-institutional, and community-focused, education and workforce diversity plan, with the overarching objective of replenishing, while increasing diversity in the translational science workforce. Ayman shared his experiences from participating in our 500 Stars Summer Internship program.

CTSI 500 Star Ayman Isahaku

My involvement in the CTSI 500 Stars program has provided me with an outstanding foundation for my scientific career. I have always been very passionate about science, however only after participating in this program and taking advantage of the state of the art resources and professional experience it offers did I truly begin to dive into the world of biomedical research. Using the extensive research experience that I gained last summer, I started my own independent research project entitled “Metformin as a Novel Neurogenic Method of Methylmercury Neurotoxicity Symptom Mitigation in Danio rerio as a Model for Human Fetuses”. I drew upon recommendations from people that I had worked with at the Medical College during the 500 Stars program to gain access to a lab to conduct my research in. The project was long and intensive, however the connections that I made while participating in the internship never failed to help me out when I needed it. My project won the regional science fair and qualified me for the state competition. At state, I won the top prize among many other awards. As a result, I will be competing at the Intel International Science and Engineering Fair (ISEF) this May, along with attending prestigious research conferences in New York, Arizona, and North Carolina throughout the summer. My project and the invaluable experience I gained last summer have also enabled me to receive a full-ride scholarship to continue my work in college at The Ohio State University next fall. I am immensely grateful for the 500 Stars program as it has undoubtedly changed my life forever. Not only did it inspire me to reach for my dreams and equip me with the tools to do so, but it also introduced me to a group of amazing lifelong friends, and colleagues. I wouldn’t trade my involvement in this program for the world as it truly has changed my life.

Ryan Spellecy, PhD

Associate Professor

CTSI Staff & Faculty: At Work for You

Each newsletter we will highlight staff and faculty working to support you and your research.

Ryan Spellecy, PhD is an Associate Professor of Bioethics and Medical Humanities in the Center for Bioethics and Medical Humanities, in the Institute for Health Equity at the Medical College of Wisconsin. Dr. Spellecy leads CTSI’s Clinical Research Scholars program, a program designed to support and mentor junior faculty committed to pursuing careers in academic medicine as independently funded, clinical and translational investigators. In addition, he serves as a faculty advisor for the CTSI’s Regulatory and Support group, which aims to facilitate regulatory knowledge and compliance related to clinical and translational research across CTSI partner organizations. Dr. Spellecy has authored and co-authored numerous peer-reviewed articles in the area of research ethics, informed consent, ethical issues in psychiatry, and community involvement in research. He has advised the Patient Centered Outcomes Research Institute regarding engaging patients in the peer review process, the Association of American Medical Colleges on IRBs and community based research, and testified before the National Committee on Vital and Health Statistics regarding the use of clinical data for research, and served on the Association of American Medical Colleges working group on IRBs and community based research. He currently chairs an Institutional Review Board at the Medical College of Wisconsin, and recently completed an NIH funded national study evaluating a novel, easier to read informed consent form for BMT trials. He also works on character for the Kern Institute for the Transformation of Medical Education. Outside of work, Dr. Spellecy enjoys spending time with his family, fly fishing, and cycling.