Assistant Vice Chancellor for Clinical and Translational Science  CCTSI CU-CSU Summit #5 Microbiome Research – from Methodology to Collaboration Ronald J. Sokol, MD Director and PI, CCTSI Assistant Vice Chancellor for Clinical and Translational Science

Welcome 5th Annual CU/CSU CCTSI Summit Goals: Provide information about CCTSI and Microbiome Resources and Programs at each campus Highlight ongoing Microbiome research Promote new collaborations, scientific exchange, mentor-mentee relationships Four Oral Sessions, Poster Session (lunch), 3x5 abstracts, Concurrent Breakout Sessions – getting started in microbiome research (3 topics, 20 minutes each), Coffee breaks, Evaluation

CTSA Program A national consortium of medical research institutions collaborating to transform how clinical and translational science is conducted nationwide Currently, 58 funded Hubs, many of which include multiple universities and hospitals. CTSAs provide many local resources, facilities, research personnel, pilot funding, regulatory and informatics support, research units and education & training programs Grants originate from NCATS at NIH

Vision of CCTSI Accelerate and catalyze the translation of innovative science into improved health and patient care

History of UC Denver CTSA CCTSI initiated on June 1, 2008 Funded by NIH Clinical and Translational Science Award (CTSA) Grant awarded in 2008 with substantial local Institutional support 5 year grant renewed in 2013 ($52 million) One of 62 CTSA Hubs in the nation

UC Health CTSA Consort

CCTSI Monthly Membership Growth 4,477

CCTSI 2013-18 Education & Training Translational Pilot Program Academic Home Education & Training Translational Pilot Program Enhanced Research Environ-ment CTR Resources & Services Translational Informatics

CCTSI Key Functions Education, Training and Career Development Clinical Research Resources & Facilities (CTRCs) Community Engagement & Research Child & Maternal Health Research Biostatistics, Epidemiology and Research Design Translational Informatics Research Bioethics Regulatory Knowledge and Support Pilot Grants and New Methods grants Translational Technologies Dissemination and Implementation Research I-Corps@CCTSI Evaluation & Tracking

CCTSI Website cctsi.ucdenver.edu or Google CCTSI Portal of entry Information, applications, links to services, RFAs, training, announcements, etc. Membership online Need Help? Ask a Navigator Colorado Profiles Cite the Grant WEBSITE: 4 - 6,000 visits per month 20,000 - 25,000 page-views COLORADO PROFILES: >8,000 visits per month >20,000 page-views 10

Clinical Translational Research Centers UCH, CHCO, NJH, CU-B and Perinatal Inpatient and outpatient facilities Research Nursing – inpatient, outpatient, mobile teams (NICU, PICU, ED, etc.) Bionutrition and body composition Vascular Ultrasonography Core Laboratories & specimen processing SARC review of protocols All CTRCs: 420 Projects per year 100-150 New Projects per year 15,000 OP Visits per year 1,000 IP Admits per year

Pilot Grant Awards 6 Pilot Grant programs – CO-Pilot, CMH, Community Engagement, Ctr for NeuroScience, New Methods, CU-CSU Collab. $1.2 million available $20,000, 30,000, $60,000 levels Letter of Intent in August Deadline September (end) Peer Review in November Start-up in January-April

Education, Training and Career Development (ETCD) Summer Undergraduate Minority Mentoring in Translational Science (SUMMiT) TL1 (T32) Pre-doctoral PhD training program Clinical Sciences Graduate Program (PhD, Masters) KL2 (K12) Research Scholar program K-Club and Nuts and Bolts Clinical Faculty Scholars Program

Education, Training and Career Development (ETCD) 7. Clinical Trials Training for Investigators and Coordinators 8. Leadership in Innovative Team Science (LITeS) 9. K to R Transition Grant Review 10. Colorado Mentor Training Program 11. Pre-K Grant Review

Pre-K Grant Review Program Help junior faculty and their mentors write successful career development awards 5 criteria (candidate, career development, mentors, environment, and research plan) Mock grant reviews: 3 times a year Applicants and mentors attend K24 awardees, K12 directors, biostats, other K awardees are reviewers Format: reviewers and then panel discusses, followed by Q&A Lecture series relevant to K applicants Spin off of our KtR program 6 first time, 12 this time

K to R Transition Program Pre-grant submission mock grant review process Faculty with K-level awards who are submitting first R-level grant award Submit grant proposal for internal review about 4-6 weeks before submission to funding agency Deadline for Letter of Intent Mock study section and written reviews PI and mentor - attend mock study section 3 cycles – NIH grant application deadlines Maggie Wierman, MD 303-724-3952

Pragmatic Trials and Dissemination/ Implementation Research Unit To foster a learning community Offer local high-quality educational training workshops, conferences and learning seminars. Leverage and partner with existing local expertise and resources to support educational content creation and course delivery. Disseminate locally (and nationally) training resources via on-line platforms. To catalyze and centrally support researchers Help researchers navigate available resources. Leverage, and partner with, other CCTSI resources to address gaps.

I-Corps@CCTSI Program New Train-the-Trainer pilot program started in 2015 (NCATS) Training of teams in market assessment of feasibility for a new product Beginnings of a new Innovation and Entrepreneurship Core in CCTSI Elaine Morrato, DrPH, MPH

2017 Grant Renewal Renewal submitted: May 25, 2017 Major changes in RFA: Budget (Direct Costs) = 2.5% NIH funding (2016; $230M) Rent for space – not allowed; research nurses, tests and procedures (CTRCs) – limited amount on U54 budget No Translational Technologies supported Allocate Support to RIC and TIC liaisons (TIN) BERD limited to grant and project writing/planning Pilots – no basic discovery, emphasize science of translation More focus on Methods Development Optional functions (n = 2) Grant to be reviewed on Sept. 26, 2017

CCTSI is here to support you! http://cctsi.ucdenver.edu Become a Member (quick, free, powerful) Become familiar with the website Cite our Grant Number

Questions?