NIH CTSA Awards: A Home for Clinical & Translational Science

1. Industry Other Community Institutions Partners NIH CTSA Awards: A Home for Clinical & Translational Science Advanced Degree-Granting Programs Clinical Research Ethics Trial Design CTSA HOME Biomedical Informatics Clinical Resources Participant & Community Involvement Regulatory Support Biostatistics

2. NIH CTSA Awards: A Home for Clinical & Translational Science Background leading to CTSA CTSA Organization CTSA Cores CTSA Implementation

3. Planning Translational Sciences Planning Molecular Sciences Tropical Diseases Planning Structural Biology Planning Bioinformatics/ Proteomics/Genomics WRCEand NBL Designation IHII CTSA CTD/CLO Sealy Center for Molecular Sciences Welch Center in Chemical Biology Sealy Center for Aging Centers Sealy Center for Vaccine Development WHO Center for Tropical Diseases Sealy Center for Cancer NIEHS Center GRIP Planning Membrane Protein Program (HHMI) Center for Biodefense and Emerging Infectious Diseases Sealy Center for Structural Biology Proteomics Center Centers and Cores: UTMB DARPA Program 1992 1996 1998 2000 2002 1994 2004 2006 1990 Protein Chemistry Analytical Ultracentrifugation Computational Biology Membrane Protein Lab BSL4 Facility Protein Purification Molecular Biology Bioinformatics Genomics Core Proteomics/ Mass Spectrometry Drug Design Optical Imaging Organic Synthesis Signal Transduction NMR X-Ray Biophysics Macromolecular Assembly Animal MRI Future - BSL3/4: cryoEM Nanotech Metabonomics Systems Biology Virtual Patients Cell Biology Histopathology Animal Knockout Cores/Programs

4. Centers/Institutes Inst. Clinical & Translational Research Center for Nanotechnology Dell Pediatric Research Inst. Inst. Human Immunity & Infections Sealy Center Molecular Medicine Inst. Computational Engineering Sciences Center Biomedical Engineering (UTMB and UTA) Sealy Center Cancer Welch Center Chemical Biology Imaging Research Center National Biocontainment Lab Microelectronics Center HHMI Membrane Protein Program Sealy Center Vaccine Development Sealy Center Structural Biology Texas Advanced Computer Center Western Regional Center of Excellence Biodefense IC2 Proteomics Center Sealy Center Aging TI-3D Seek Assess Team Translational/Clinical Research Development Products Cores Drug Design Membrane Protein Lab 3T Human MRI Animal Knockout Computational Biology Protein Chemistry Molecular Biology Protein Purification Bioinformatics GenomicsCore Proteomics/ Mass Spectrometry Optical Imaging Metabonomics Systems Biology Signal Transduction NMR X-Ray Animal MRI Organic Synthesis Histopathology Nanotechnology BSL3 cryoEM BSL4 Facility Analytical Ultracentrifugation

5. UTMB Medical School WRCE Biodefense & EID Center Sealy Centers Vaccine Dev. & Structural Biology Galveston National Lab World Leader in Biodefense & EID Biomedical Engineering UTMB Austin Program UT AUSTIN TI-3D Natural Sciences Pharmacy & Toxicology National Center Bioterror Countermeasures Medicinal Chemistry School of Engineering Business School Established Incubator, Business Accelerator TACC Resource Leveraging

6. Major Participants School of Natural Sciences College of Pharmacy School of Social Work College of Engineering LBJ School of Public Policy School of Law College of Education College of Liberal Arts (Psychology) School of Medicine School of Nursing School of Allied Health Graduate School of Biomedical Sciences UTMB Hospitals & Clinics UTMB Austin Regional Campus UT-Houston CTSA Seton Health Network Brackenridge Hospital (Austin) Dell Children’s Hospital (Austin)

7. Principles guiding our approach • Focus on teams • Integrating training • Encouraging mentoring • Engaging underserved populations • Establishing proactive processes • Enhancing partnerships • Continuing evaluation • Integrating ethics

8. CTSA AIMS 1. To transform the research environment at the University of Texas Medical Branch (UTMB) & the University of Texas at Austin (UT Austin) to maximally facilitate clinical and translational research 2. To transform the training environment at UTMB & UT Austin to produce the next generation of leaders in clinical & translational science 3. To partner with other CTSAs, in particular the recently funded UT-Houston and MD Anderson CTSA in collaborative networks to support and conduct clinical and translational research 4. To design administrative processes to support research and education to achieve Aims 1 and 2; and to implement, evaluate and revise them and ultimately to disseminate successful processes to other academic institutions.

9. Deputy Director UTMB Galveston (Goodwin) Deputy Director UTMB Austin (Shomaker) Deputy Director UT Austin (Sage) Core Leaders Organization Provost UT Austin President UTMB CTSA Director (Goodwin)

10. CTSA Organization

11. CTSA-wide Committees & Meetings Organized by Administrative Core

12. Tracking and Evaluation (K. Ottenbacher & K. Wooten) Aim 1. Provide standardized training in program evaluation and assessment to all core leaders, faculty, trainees, and staff; Aim 2. Based on the training provided in Aim 1, implement a consistent protocol for data collection, tracking and assessment of outcomes across all cores and CTSA components; and Aim 3. Conduct a team evaluation of the UTMB and UT Austin research infrastructure to identify fundamental processes that require modification or change in order to create an environment and culture supportive of translational research teams.

13. Context Relationships & Capacity Implementation Quality & Quantity Outcomes Effectiveness, Magnitude & Satisfaction Logic Model Influences Activities Outputs Short-term Outcomes Mid-Term Outcomes Long-term Outcomes Resources Formative Evaluation Summative Evaluation What aspects or situations shape the ability to do the proposed work What was the program intended to accomplish in what environment What is the assessment of what resulted from the proposed activities What was learned about the outcomes and the scope of project impact Relationship of components of formative & summative evaluation

14. Research Education, Training and Career Development Aim 1. Employ a nationally acclaimed framework for constructive learning Aim 2. Reorganize current training programs so that all trainees are placed in active multidisciplinary collaborative translational research clusters. Aim 3. Ensure all trainees are provided mentoring teams Aim 4. Provide a novel educational pipeline mechanism by establishing the Texas Academy of Healthcare Leadership for select undergraduate students, expanding undergraduate research opportunities, and expanding existing programs for talented high school and minority students Aim 5. Revise existing predoctoral, postdoctoral and faculty development programs to increase the number of successful clinical and translational investigators

15. Potentially Relevant Doctoral Programs at UT Austin

16. Biomedical Informatics Create a highly interconnected, web-based data management and analysis infrastructurethat facilitates interoperability in a multidisciplinary, multi-team clinical & translational environment, regardless of where members may be physically located Partnership with UT HSC Houston and MD Anderson CC CTSA Link EMRs with rEMRs

17. Initial meeting with Coordinating Center Assignment of Biostatistician & DB Programmer Grant Writing Grant Awarded 1 Biostatistician: assist study design, testable hypotheses 8 Biostatistician: assist with obtaining sample, data forms (EMR) 2 Database programmer: dev plan for data collection (with BIC/BIC work groups) 9 Database programmer: start making database (BIC) 3 Power analysis and Sample Size Determination 10 Biostatistician: assist in database development 4 Write Statistical Analysis section of grant 11 Biostatistician: statistical analysis and MS preparation 5 Submit Grant 12 Publish Results 6 Review Study Section critique with investigator 13 Begin writing next grant 7 Assist in revising grant Design Biostatistics and Database Management 1. Provide investigators & trainees with biostatisticians and epidemiologists to implement optimal study designs based on state-of-the-art statistical methods 2. Develop and implement new statistical and mathematical modeling techniques for clinical & translational research 3. Provide web-based data collection and study tracking systems for clinical studies

18. Community Engagement & Research Aim 1: Establish Community Research Coordinating Center (CRCC) as a mechanism to represent community interests, provide support to researchers, and coordinate the use of relevant community assets. Aim 2: Develop, maintain, and coordinate Practice-Based Research Network (PBRN) of community health care providers Aim 3: Provide education and development in community-based participatory research Aim 4: Coordinate the community advisement and communications function for the CTSA Aim 5: Engage voluntary health organizations (VHO) in the CTSA Aim 6: Develop and disseminate information to public audiences, policy makers, and community clinicians Texas Clinical Networks

19. Coordinating Core Aim 1. To provide ‘one-stop shopping’ for investigators desiring to participate in CTSA-related research Aim 2. To coordinate multidisciplinary Translational Teams and Research clusters Aim 3. To facilitate clinical and translational research, by identifying project needs, allocating resources, and monitoring progress Aim 4. To increase throughput and efficiency of translational research, by identifying and overcoming rate-limiting resource barriers for CTSA core activities, eliminating possible duplication of effort

20. Resource Core Resource Core Resource Core Resource Core Resource Core Core Interactions Coordinating Core Coordinators Tracking & Evaluation Research Education & Training

21. Multidisciplinary Team Support Aim 1. Provide administrative and mentoring support to form new research clusters and help existing clusters achieve stable external funding Aim 2. Assist in creation, implementation, maintenance and termination of Translational Teams Aim 3. Conduct ongoing evaluation of the processes and outcomes of Translational Teams Aim 4. Conduct education and training in team processes

22. Multidisciplinary Team Support Aim 4. Conduct education and training in team processes

23. Funds to be awarded by Pilot Projects Core

24. Novel Methodologies Aim 1. To create a “Catalysts for Innovation Leadership Council”(CILC) to seek out promising early-stage technologies Aim 2. To sponsor new methodologies that accelerate translational research and product development for Pilot Project Core Funding. • New Core grants to develop novel cores or centers • 1-3 yrs @ $50-125,000/yr • Enabling Technologies planning grants to lay the foundation for Pilot Core grant or extramural grant applications • 1-2 yrs @ $25-50,000/yr Aim 3.To build on UTMB and UT Austin's success in developing academic-industry partnerships to improve the product development pipeline for translational research

25. Novel Methodologies: Enhanced therapeutics pipeline Yellow boxes = possible new NMC cores Green = BIC, TTC Gray = DDC & other CTSA cores

26. Translational Technologies Aim 1. Adopt uniform processes in study design, sample handling and data processing. Aim 2. Support high-throughput genomics to identify disease susceptibility and treatment response. Aim 3. Enable biomarker discovery in proximal fluids of diseased tissues. Aim 4. Serve as a focal point for training in the use of high-throughput post-genomic tools in patient-oriented research.

27. Drug Discovery Aim 1. Establish a coordinating infrastructure between UTMB & UT Austin in synchrony with a newly established administrative structure for the Texas Institute for Drug and Diagnostics Development (TI-3D) Aim 2. Establish ‘cradle-to-clinic’ Drug Discovery Research Teams (DDRTs) to move drugs from the lab into the clinic & marketplace Aim 3. Establish a High Throughput Screening Facility (HTSF) to vastly increase investigators’ ability to identify efficacious compounds for a given disease state or model

28. Pathway of drug discovery processes

29. Participant & Clinical Interactions Resources Aim 1.To transform clinical research at UTMB and UT Austin by creating: a. Central, high intensity clinical research sites in Galveston and Austin, including development of a CRC in Austin b. A network of flexible collaborative disease-associated clinical research sites in the AHCs c. Low intensity research sites for community-based investigations both in Galveston and Austin Aim 2. To establish a participant recruitment resource to provide subjects of all ages, genders and ethnicities for clinical research Aim 3. To develop and implement a sample preparation and repository laboratory Aim 4. To serve as a training facility for clinical research education, and as a “home” for multidisciplinary research support personnel

30. Research Ethics Aim 1. Create a continuum of ethical best practices across the life cycle of translational research Aim 2. Generate new knowledge by conducting hypothesis-driven research into emerging Clinical and Translational Research Ethics issues Aim 3. Proactively engage the diverse CTSA constituencies in a Bioethics Community Dialogue Initiative

31. Regulatory Training & Support Aim 1. To provide comprehensive, “user-friendly” regulatory support services, including Intellectual Property, to CTSA investigators and research subjects Aim 2. To provide both compliance training and continuing education for investigators and the research community about the relationship between the regulatory environment & public policy Aim 3. To promote research and development of better systems for regulatory management, compliance, and education, including barriers to local and national collaboration among translational researchers

32. Next Steps

33. Implementation Phase: Pre-Funding Institutional Leadership. Detailed and specific letters of participation from the chief academic officers of UTMB and UT-Austin, relevant Deans, Center Directors, and Department/Unit Chairs commit recourses, space, and personnel Institute for Clinical and Translational Science Mission: to promote and conduct innovative, interdisciplinary, translational research including basic and clinical scientists as co-investigators Director: James S. Goodwin M.D. • created 9/1/06 • increased visibility & prestige • ability to make faculty appointments ~ 3,600 sq. ft. of contiguous office, conference room, classroom and research space has been designated in the 5th floor of the John Sealy Hospital next to existing General Clinical Research Center (GCRC) UTMB Austin Programs Dean Sam Shomaker, MD, JD (appointed Fall 2006) UT Austin Vice Provost for Health Affairs William Sage, MD, JD (appointed Fall 2006)

34. Industry Other Community Institutions Partners NIH CTSA Awards: A Home for Clinical & Translational Science Advanced Degree-Granting Programs Clinical Research Ethics Trial Design CTSA HOME Biomedical Informatics Clinical Resources Participant & Community Involvement Regulatory Support Biostatistics