1. Collaborative Innovation Awards Paula K. Shireman, MD Professor of Surgery Vice Dean for Team Science Co-PI Institute for Integration of Medicine & Science TRCC Meeting San Antonio, March 29, 2016

2. Collaborative Innovation Program Purpose  Address IOM report  Encourage all CTSA hubs to collaboratively conceptualize, develop, and implement multi-site innovative experimental approaches that overcome translational barriers in science, operations, and training

3. CTSA Collaborative Innovation Award Summary  At least 3 CTSA hubs anticipated to promote new initiative  Up to 5-year projects $500K annual directs (non-clinical) $1M annual directs (clinical) $9M total in the program for FY16  Approximately 5-10 awarded first round  Multiple applications from the same organization allowed  Pre-application process  Encouraged, not required  Pre-applications externally reviewed  Multiple application opportunities  3x a year through July 2018

4. Specific Objectives Innovative collaborative investigations / experimental translational research projects: 1.Develop new technology, methods, and approaches to address translation roadblocks 2.Demonstrate accelerated translation across multiple CTSA hubs 3.Advance collaboration to increase the likelihood of a successful hand-off to the private sector 4.Define and measure what constitutes success of the proposed project

5. Collaborative Innovation Examples Some examples of such opportunities include, but are not limited to: 1)Innovative community engagement methods and technologies aimed at improving health outcomes  Engaging minorities or other understudied populations in translational research 1)Improving the consent process  Simplifying and reducing the length of consent forms without sacrificing information to ensure cultural sensitivity

6. Collaborative Innovation Examples Page 2 3)Educate / train a translational research workforce via collaboration across CTSA hubs:  Use innovative features - online resources  Focusing on competencies of individuals  Training in multi-disciplinary team science, regulatory science, entrepreneurship and experiential learning experiences 4)Identify and fast-track promising translational research  Reduce time required for intervention development or demonstration of unfeasibility 5)Adapt successful technology and methodology from other domains to address challenges in clinical and translational research

7. Collaborative Innovation Examples Page 3 6)Utilize multi-disciplinary teams to solve clinical and translational research problems. 7)Use mobile technology and web- or phone-based communications to obtain information 8)Use adaptive designs, serial “n of 1” designs or other small population approaches to overcome intervention evaluation challenges 9)Innovative approaches to the implementation of precision medicine 10)Methodologies that address translational research roadblocks specific to pediatric, geriatric, or other populations throughout the lifespan

8. Status of CIA X02 and U01  3 application dates/year for X02 and U01 (March, July & November)  Three cycles of X02 applications  6/24/15, 11/10/15, 3/8/16  Next application date: 7/6/16  One cycle of U01  2/3/16  Next application date: 7/7/16

9. Brainstorming Next Steps!