CTSA Program Webinar Wednesday, February 27, 2019 2:00 PM – 3:00 PM ET
Agenda Time Topic Presenter Welcome 2:00 - 2:05 NCATS and CTSA Program Clare Schmitt Updates 2:05 - 2:25 DTF/WG Function & Structure 2.0: Kathleen Brady & Building on the DTF Successes Clare Schmitt 2:25 - 2:30 Common Metrics and Spring CTSA Martin Zand & Program Group Meetings - Updates Deborah Ossip A New CTSA Initiative: Drug 2:30 - 2:55 Repurposing Screening Nikki Rogers Alvarez Collaborations 2:55 - 3:00 Adjourn 2
NCATS and CTSA Program Updates Clare Schmitt
Welcome NCATS Deputy Director Dr. Joni Rutter
Research Efforts to Address Rural Health Disparities Congress embedded language within our FY19 appropriations to encourage the CTSA Program to expand translational research efforts that address rural health disparities as well as the significant burden of conditions that disproportionately affect minority and special populations. Recent CTSA Program Enhancements: • NCATS Notice of Information (NOT-TR-19-015) emphasizes the CTSA Program’s interest in improving rural health outcome and reducing health disparities. CTSA Program investigators and investigators supported by Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR) awards are encouraged to work together to address translational science barriers. • January’s CTSA Program Webinar highlighted the IDeA-CTRs and described some of the partnerships in place with CTSAs • NOT-TR-19-016 – Notice for the Collaborative Innovation Award U01 (PAR-19-099): • An application must involve investigators who are supported by CTSA Program hub institutions from at least three different and currently funded CTSA Program hubs as of the due date of the application or alternatively, an application may involve investigators from at least two different and currently funded CTSA Program hubs (of which one must be the contact PI on the application) and one or more currently funded NIH Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR) participating institution , as of the due date of the application. 5
Un-Meeting on Rural Health and Health Equity • This event will focus on catalyzing new collaborations to bridge the translational science, cooperative extension and other sectors to improve rural health and achieve health equity. Discussion topics will be identified and prioritized by attendees in real time, but examples of potential topics of interest include food insecurity, the opioid epidemic, geographic disparities in life expectancy, experiential learning opportunities, social determinants of health, healthy environments, rural diversity and cultural identity, access to health care, occupational health, bridging silos across sectors and disciplines, and opportunities for regional collaboration. • Hosted by: University of Florida Clinical and Translational Science Institute and the University of Florida Institute of Food and Agricultural Sciences • Support from: Center for Leading Innovation and Collaboration (CLIC) • Date: April 7-8, 2019 • More Info: https://www.ctsi.ufl.edu/an-un-meeting-on-rural- health-and-health-equity/
Collaboration & Engagement DTF Health Disparities WG • Leads: • Co-Lead: Lloyd Michener (Duke University) • Co-Lead: Sergio Aguilar-Gaxiola (University of California, Davis) • Co-Lead: Katrina Kubicek (University of Southern California) • C/E DTF Lead Team Liaison: Laurene Tumiel-Berhalter (University of Buffalo) • Goals: • Make recommendations to CTSA Consortium about opportunities for partnership and collaboration on assessing and reducing health disparities o Strengthen and leverage capabilities and assets of CTSAs nationwide o Contribute understanding of and solutions of health disparities translational research o Objectives: • Compile comprehensive list of current community and state partnerships on reducing health disparities • Map this list to CTSA hubs to find opportunities to collaborate • Facilitate these partnerships with tools and guidance The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA) Program, funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), Grant U24TR002260.
Notice to CTSA Program FOA PA-18-940 (NOT-TR-19-014) Updates in Overall Core: • Updated info in the Letters of Support: • “The application must include a letter of support from an authorized institutional official stating that the institution is willing to comply with the NIH single IRB policy for multi-site research and in particular is willing to sign or is a current signatory to the CTSA Program SMART IRB Reliance Agreement , is willing to use master subcontract agreements/trial agreements (see for example https://www.ott.nih.gov/resources#MCRDA) and is willing to work under a transparent cost structure for per patient cost. Updates in NRSA Training Core: • Clarified that the core does not provide support for personnel • Clarified that in Other Direct Costs: Trainee Travel: Enter the total costs for Trainee Travel (up to $1,500 per year per trainee) NCATS website updated with this information: https://ncats.nih.gov/ctsa/funding/par-information Questions? CTSAFOAQuestions@mail.nih.gov 8
NCATS / Eli Lilly Externship Update Objective • Promote experiential rotation opportunities for CTSA investigators and trainees in “real world”, private sector setting Program Characteristics • Embedded in functional teams, mentoring by Eli Lilly scientists • 6 months, based in Indianapolis at Eli Lilly • Shared funding between NCATS and Eli Lilly Examples of Projects worked on at Eli Lilly (2016-2018 cohorts) • Mechanistic Modeling of the Tau Pathway in Alzheimer’s disease • Translational pharmacology of diabetes • FDA approval process for a new oncology drug Featured above: Christopher P. Austin, M.D., Director, NCATS; Joan Nagel, M.D., M.P.H., Medical Officer, Program enhancements coming, 2020… Division of Clinical Innovation, NCATS; Danise Subramaniam, Ph.D., Senior Director, Global Regulatory Affairs-NA Eli Lilly and Company; Josephine Taverna, 2019 Cycle, expect to announce by mid-March 2019 M.D., NCATS Eli Lilly Scholar; Anticipated start date: July 2019 Michael Kurilla, M.D., Ph.D., Director, Division of Clinical Innovation, NCATS https://ncats.nih.gov/ctsa/training/resources/lilly-externship (live video vignette of Dr. Taverna now on NCATS website) Contact: Joan Nagel, M.D., M.P.H. joandav@mail.nih.gov
Notice of Intent to Publish a Funding Opportunity Announcement for Administrative Supplements for Research on Bioethical Issues (NOT-OD-19-045) • Purpose: • The National Institutes of Health (NIH) Office of Science Policy within the NIH Office of the Director (OD) intends to publish a Funding Opportunity Announcement for administrative supplements to support research on bioethical issues to inform future policy directions or embed bioethics within NIH- supported research. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus. • Funding Information: • Estimated Total Funding: TBD • Expected Number of Awards: 5-15 • Estimated Award Ceiling: Up to $100,000 direct costs for 1 year • Inquiries: • Jennifer Plank-Bazinet, PhD, NIH Office of Science Policy; Email: jennifer.bazinet@nih.gov 10
DTF/WG Function & Structure 2.0: Building on the DTF Successes Kathleen Brady & Clare Schmitt
History • Original purpose of the Domain Task Forces: Execute the NCATS Advisory Council Working Group (ACWG) recommendations. o Provide NCATS/CTSA with input from all stakeholders to set direction and priorities for CTSA projects o Focus on short and long term needs with the goal to enable translational science and provide patients with access to treatment more quickly o Provide a structure where high priority issues (that relate to ACWG and CTSA goals) can be studied o Inclusive process where all Hubs can participate and have access o Foster communication and collaboration at all levels o Discrete objectives, timelines and deliverables for every activity • These activities continue to be central to a robust CTSA Program 12
Background • November 2014 DTFs Created • April 2018 Steering Committee F2F Meeting o Reviewed Domain Task Force Packet/Updates Included Suggested Enhancements for the DTFs o Convened a Steering Committee Work Group on Enhancing the DTFs CLIC Coordination: • Kate Fetherston • Scott McIntosh • Debbie Ossip o July 2018 Launched DTF Survey 13
DTF Survey – Key Responses (n=275; July 2018) • Generally Supportive • Overall DTF Structure o Well-Informed about DTF Activities: 11% YES* o Addressing Important Issues: 43% YES o Valuable: Scale of 1-10 6-10 = 50% (5-10 = 73%) o “Right” Structure: 50% YES * Yes includes only agree/strongly agree responses • Issues Identified Communications o Provide Resources for DTFs; Unfunded Mandate o DTFs Too Broad; Need Focus, Timelines, Deliverables o Strengthen Collaborative Efforts o Change DTF Name to Avoid a Problematic Acronym and Better Reflect o Function 14
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