NIH CTSA Awards: A Home for Clinical

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NIH CTSA Awards A Home for Clinical
Translational Science
Advanced Degree-Granting Programs
Clinical Research Ethics
Trial Design
CTSA HOME
Biomedical Informatics
Participant Community Involvement
Clinical Resources
Regulatory Support
Biostatistics
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NIH CTSA Awards A Home for Clinical
Translational Science

• Background leading to CTSA
• CTSA Organization
• CTSA Cores
• CTSA Implementation

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Centers and Cores UTMB
Planning Translational Sciences
Planning Molecular Sciences Tropical Diseases
Planning Bioinformatics/ Proteomics/Genomics
Planning Structural Biology
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
DARPA Program
1992
1996
1998
2000
2002
1990
1994
2004
2006
Protein Chemistry
Membrane Protein Lab
Analytical Ultracentrifugation
Computational Biology
BSL4 Facility
Protein Purification
Molecular Biology
Bioinformatics Genomics Core Proteomics/ Mass
Spectrometry Drug Design Optical Imaging
Organic Synthesis
Signal Transduction NMR X-Ray Biophysics Macromole
cular Assembly Animal MRI
Future - BSL3/4 cryoEM Nanotech Metabonomics
Systems Biology Virtual Patients
Cell Biology Histopathology
Animal Knockout
Cores/Programs
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Centers/Institutes
Inst. Clinical Translational Research
Center for Nanotechnology
Inst. Human Immunity Infections
Dell Pediatric Research Inst.
Sealy Center Molecular Medicine
Inst. Computational Engineering Sciences
Sealy Center Cancer
Center Biomedical Engineering (UTMB and UTA)
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
Assess
Team
Translational/Clinical
Seek
Research
Development Products
Drug Design
Cores
Membrane Protein Lab
3T Human MRI
Animal Knockout
Computational Biology
Protein Chemistry
Molecular Biology
Protein Purification
Bioinformatics Genomics Core Proteomics/ Mass
Spectrometry Optical Imaging Metabonomics Systems
Biology
Signal Transduction NMR X-Ray Animal MRI
Histopathology Nanotechnology
Organic Synthesis
BSL3 cryoEM
BSL4 Facility
Analytical Ultracentrifugation
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Resource Leveraging

• 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

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Major Participants

• School of Medicine
• School of Nursing
• School of Allied Health
• Graduate School of Biomedical Sciences
• UTMB Hospitals Clinics
• UTMB Austin Regional Campus

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)
UT-Houston CTSA Seton Health Network Brackenridge
Hospital (Austin) Dell Childrens Hospital
(Austin)
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Principles guiding our approach

• Focus on teams
• Integrating training
• Encouraging mentoring
• Engaging underserved populations
• Establishing proactive processes
• Enhancing partnerships
• Continuing evaluation
• Integrating ethics

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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.
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Organization

• President
• UTMB

Provost UT Austin
CTSA Director (Goodwin)
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CTSA Organization
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CTSA-wide Committees Meetings Organized by
Administrative Core
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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.

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Relationship of components of formative
summative evaluation
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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

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Potentially Relevant Doctoral Programs at UT
Austin
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Biomedical Informatics

• Create a highly interconnected, web-based data
  management and analysis infrastructure that
  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

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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

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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
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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

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Core Interactions
Coordinating Core Coordinators
Tracking Evaluation
Research Education Training
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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

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Multidisciplinary Team Support

• Aim 4. Conduct education and training in team
  processes

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Funds to be awarded by Pilot Projects Core
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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 _at_ 50-125,000/yr
• Enabling Technologies planning grants to lay the
  foundation for Pilot Core grant or extramural
  grant applications
• 1-2 yrs _at_ 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

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Novel Methodologies Enhanced therapeutics
pipeline

• Yellow boxes possible new NMC cores
• Green BIC, TTC
• Gray DDC other CTSA cores

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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.

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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

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Pathway of drug discovery processes
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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

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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

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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

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Next Steps
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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)

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NIH CTSA Awards A Home for Clinical
Translational Science
Advanced Degree-Granting Programs
Clinical Research Ethics
Trial Design
CTSA HOME
Biomedical Informatics
Participant Community Involvement
Clinical Resources
Regulatory Support
Biostatistics