José Szapocznik , PhD, Principal Investigator, Director

1. Proposal for the Miami Clinical &TranslationalScience InstituteCulturalized Health Sciences for a healthier South Florida! José Szapocznik , PhD, Principal Investigator, Director

2. Proposal to Miller School Council • Formally establish a multidisciplinary research institute to advance culturalized health science and research translation • Partners • University of Miami • Jackson Health System • Miami VA Healthcare System • Closely aligned with Miller Office of Research and Innovative Medicine, proposed CTSI will work to fashion new research infrastructure, research training and career development programs

3. CTSI Background • Prestigious NIH consortium of 60 research-intensive institutions transforming how biomedical research is conducted across the nation • Miami CTSI funded $20M by NCATS & NIMHD • Only CTSA dedicated to diversity, disparities, training minorities in research • Only minority PI devoted to research with ethnic/racial minorities and their communities

4. CTSI Mission • Culturalized Health Sciences for the health of South Florida! • Transform research infrastructure to: • Promote excellence in interdisciplinary clinical and translational research meaningful to our region’s diverse populations • Expedite scientific discovery, translation into evidence-based practice and community health

5. CTSI Master Plan • Culturalized health sciences • Interdisciplinarity/team science • Integration, consolidation, harmonization in service/resource platforms • Breaking down research barriers

6. CTSI Overall Strategy Three-pronged approach: • Reengineer research environment • Overcome process impediments to research • Translational science training, education, career development • Institutionalsupport for research collaboration/translation • Consolidated service/resource platforms • Research education, training, and mentorship • Collaborative & pilot studies funding • Investigator-focused support/consultation • Protocol development, research design, & biostatistics • Regulatory knowledge & support • Research safety/quality improvement

7. Miami CTSI Organizational Chart President Shalala Provost LeBlanc Dean Goldschmidt Key Green: Line of Authority Orange: Advisory Pink: Independent Advocate Blue: Evaluation Functions Research Subject Advocate Wright Tracking & Evaluation Czaja, Byrne Internal Advisory Dean Goldschmidt, V Provost Bixby Research Dean Velazquez Deans Anderson, Avissar, Bachas, Peragallo, Plater-Zyberk, Prilleltensky, Shepherd, Tien, White Senate Chair, Community Advisory Board representative External Advisory Committee Executive Committee Szapocznik, PI & Director Wright, Co-I & Associate Director Co-I Schneiderman Co-I Sacco Research Vice Provost Bixby Research Sr. Exec Dean Velazquez Executive Operations Director, Van Der Put Scientific Advisory Committee Lippman & Wahlestedt, Chairs Community Advisory Board Shalala & Losa, Chairs Institutional Research Resource Council TBA & Tien, Chairs Community Engagement & Cultural DiversityCarrasquillo, Nicolas, Kobetz EthicsGoodman, Braunschweiger Novel Clinical & Translational Methods, Technologies, & Resources Kenyon, Vance, Cheung Pilot & Collaborative Translational & Clinical Studies Antoni, Lokeshwar Study Design & Biostatistics Brown, Messinger, Rao Regulatory Knowledge & Support Wright, Fischl ¡Alianza! Miami Center for Research Participation & Partnership Wolf, Miller, Potter Education, Training, & Career Development Schneiderman, Scott Biomedical Informatics Seo, Tsinoremas Research Operations Leadership BioResource Cote, Vance, Chen, Gomez, Seo, McCauley

8. CTSI Operational Components • Novel Translational Methods, Technologies: platform to speed discoveries to application; foster scientific innovation, new lines of investigation • BioResource: resources to procure & manage human samples, annotations, data • Biomedical Informatics: manage information/communication through secured regulatory-compliant IT research environment • Pilot & Collaborative Translational & Clinical Studies: foster research start-ups/collaboration across departments, clinical operations, community settings

9. CTSI Operational Components, cont. • Research Design & Biostatistics: research design & biostatistics innovation, training, and investigator support • Research Ethics: research ethics training & consultation; CITI platform for study-specific DSMPs, survey research • Regulatory Knowledge & Support: assisting investigators in regulatory procedures; assuring regulatory adherence, participant safety in studies • Community Engagement & Cultural Diversity: culturalizing health sciences; teaming academia, clinical practice, community in research/research translation

10. CTSI Operational Components, cont. • Centerfor Research Participation & Partnership: networking clinical research facilities to harmonize SOPs/best practices; increase synergy, efficiency, and quality in clinical research activities • Network of Clinical Research Professionals: clinical research professionals working together to improve service quality, expand research support services; building career ladders; offering educational programs to support the advancement of research professionals