NIH CTSA Awards: NIH CTSA Awards: A Home for Clinical & Translational A Home for Clinical & Translational

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NIH CTSA Awards: NIH CTSA Awards: A Home for Clinical & Translational A Home for Clinical & Translational

ScienceScience

Background leading to CTSABackground leading to CTSA

CTSA OrganizationCTSA Organization

CTSA CoresCTSA Cores

CTSA ImplementationCTSA Implementation

Centers and Cores: UTMBCenters and Cores: UTMB

1990 1992 1994 1996 1998 2000 2002

CentersCenters

Cores/ProgramsCores/Programs

Protein Chemistry

Molecular Biology

Membrane Protein Lab

Bioinformatics Genomics CoreProteomics/Mass SpectrometryDrug Design Optical Imaging

Analytical Ultracentrifugation

Cell BiologyHistopathology

Animal Knockout

ComputationalBiology

Protein Purification

Organic SynthesisSignal Transduction

NMR

X-Ray

Biophysics

Macromolecular Assembly

Animal MRI

BSL4 Facility

Planning Molecular SciencesTropical Diseases

Sealy Center for Molecular Sciences

Planning Bioinformatics/Proteomics/Genomics

Planning Membrane Protein Program

(HHMI)

Center for Biodefense and Emerging Infectious Diseases

Sealy Center for Aging

Planning Structural Biology

Sealy Center for Structural Biology

DARPA Program

WHO Center for Tropical DiseasesSealy Center for CancerNIEHS Center GRIP

Sealy Center for Vaccine Development

Welch Center in ChemicalBiology

Proteomics Center

2004

WRCEand NBL

Designation

IHII

CTSA

CTD/CLO

Future -BSL3/4: cryoEM NanotechMetabonomicsSystems BiologyVirtual Patients

Planning Translational Sciences

2006

Drug Design

Protein Chemistry

Molecular Biology

Membrane Protein Lab

Bioinformatics Genomics CoreProteomics/Mass Spectrometry

Optical ImagingMetabonomicsSystems Biology

Analytical Ultracentrifugation

Histopathology

Nanotechnology

Animal Knockout ComputationalBiology Protein Purification

Organic Synthesis

Signal Transduction

NMR

X-Ray

Animal MRI

BSL4 Facility

Sealy Center Molecular Medicine

HHMI Membrane Protein Program

Inst. Human Immunity & Infections

Sealy Center Aging

Sealy Center Structural BiologySealy Center Vaccine

Development

Welch Center ChemicalBiology

Proteomics Center

BSL3 cryoEM

Assess Team Translational/ClinicalSeekResearch Development Products

TI-3D

Sealy Center CancerCenter BiomedicalEngineering

(UTMB and UTA)

Center for Nanotechnology

3T HumanMRI

Inst. ComputationalEngineering Sciences

Texas AdvancedComputer Center

Inst. Clinical & Translational Research

Dell PediatricResearch Inst.

Western Regional Center of

Excellence Biodefense

National BiocontainmentLab

Microelectronics Center

IC2

Imaging ResearchCenter

Centers/Institutes

Cores

Resource LeveragingResource Leveraging

UTMBUTMB• Medical SchoolMedical School• WRCEWRCE• Biodefense & EID CenterBiodefense & EID Center• Sealy Centers Vaccine Sealy Centers Vaccine

Dev. & Structural BiologyDev. & Structural Biology• Galveston National LabGalveston National Lab• World Leader in World Leader in

Biodefense & EIDBiodefense & EID• Biomedical EngineeringBiomedical Engineering• UTMB Austin ProgramUTMB Austin Program

UT AUSTINUT AUSTIN• TI-3DTI-3D• Natural Sciences Natural Sciences • Pharmacy & ToxicologyPharmacy & Toxicology• National Center Bioterror National Center Bioterror

CountermeasuresCountermeasures• Medicinal ChemistryMedicinal Chemistry• School of EngineeringSchool of Engineering• Business SchoolBusiness School• Established Incubator, Established Incubator,

Business AcceleratorBusiness Accelerator• TACCTACC

Major ParticipantsMajor Participants

School of MedicineSchool of Medicine

School of NursingSchool of Nursing

School of Allied HealthSchool of Allied Health

Graduate School of Biomedical Graduate School of Biomedical SciencesSciences

UTMB Hospitals & ClinicsUTMB Hospitals & Clinics

UTMB Austin Regional CampusUTMB Austin Regional Campus

School of Natural School of Natural SciencesSciences

College of PharmacyCollege of Pharmacy

School of Social WorkSchool of Social Work

College of EngineeringCollege of Engineering

LBJ School of Public LBJ School of Public PolicyPolicy

School of LawSchool of Law

College of EducationCollege of Education

College of Liberal Arts College of Liberal Arts (Psychology)(Psychology)

UT-Houston CTSAUT-Houston CTSA

Seton Health NetworkSeton Health Network

Brackenridge Hospital (Austin)Brackenridge Hospital (Austin)

Dell Children’s Hospital (Austin)Dell Children’s Hospital (Austin)

Principles Principles guidingguiding our approach our approach

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

CTSA AIMSCTSA 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.

OrganizationOrganization

PresidentPresident

UTMBUTMB

ProvostProvost

UT AustinUT Austin

CTSA DirectorCTSA Director

(Goodwin)(Goodwin)

Core LeadersCore Leaders

Deputy DirectorDeputy Director

UT AustinUT Austin

(Sage)(Sage)

Deputy DirectorDeputy Director

UTMB GalvestonUTMB Galveston

(Goodwin)(Goodwin)

Deputy DirectorDeputy Director

UTMB AustinUTMB Austin

(Shomaker)(Shomaker)

CTSA OrganizationCTSA OrganizationAdministration (J. Goodwin, W. Sage & S. Shomaker)

Tracking and Evaluation (K. Ottenbacher & K. Wooten)

Research Education, Training and Career Development (K. Anderson & L. Abraham)

Biomedical Informatics (B. Luxon & E. Marcotte)

Design Biostatistics and Database Management (D. Freeman & L. Meyers)

Community Engagement and Research (S. Shelton & M. Velasquez)

Coordinating (W. Calhoun & B. Iverson)

Pilot Projects (E. Volpi & K. Diller)

Novel Methodologies (D. Gorenstein & S. Stavchansky)

Multidisciplinary Team Support (C. Soto & R. Helmrich)

Translational Technologies (A. Brasier & J. McDevitt)

Drug Discovery (B. Iverson & S. Gilbertson)

Participant and Clinical Interaction Resources (D. Powell & T. Erlinger)

Research Ethics (H. Brody & J. Robertson)

Regulatory Knowledge & Support (L. Stanberry & W. Sage)

CTSA-wide Committees & Meetings Organized by Administrative Core

Meetings Attendees Frequency Length Purpose

Steering Comm. See Table 5 Weekly 60 min. See Section 5.b.3.

External Advisory Comm.

Ext. Ad. Comm. plus CTSA members as needed

Twice yearly One day in fall; 4 hours in spring

Review of all activities

Internal Advisory Comm.

See Table 6 Monthly 60 min See Section 5.b.5

Investigators governance meetings

All CTSA investigators, trainees, & staff

Monthly 60 min. Information on activities, input on directions.

Translational Research meetings

All CTSA investigators, trainees, & staff

Monthly 60 min. Presentations of research in progress

Seminar Series in Translational Research

All CTSA investigators, trainees, & staff, and academic communities

Monthly 60 min. Topics in translational research from basic and clinical perspective

Scientific Review Committee

Members listed in Pilot Projects Core

Six times yearly at CTSA retreat

Variable Evaluate and rank proposals to PPC, NMC, PCIR, and Education Core

Catalysts for Innovation Leadership Contract

Members listed in Novel Methodologies Core

Six times yearly at CTSA retreat

120 min. Brainstorm/develop ideas for applications of novel technologies

Tracking and Evaluation (K. Ottenbacher & K. Wooten)

Aim 1.Aim 1. Provide standardized training in program evaluation Provide standardized training in program evaluation and assessment to all core leaders, faculty, trainees, and and assessment to all core leaders, faculty, trainees, and staff;staff;

Aim 2.Aim 2. Based on the training provided in Aim 1, implement a Based on the training provided in Aim 1, implement a consistent protocol for data collection, tracking and consistent protocol for data collection, tracking and assessment of outcomes across all cores and CTSA assessment of outcomes across all cores and CTSA components; andcomponents; and

Aim 3.Aim 3. Conduct a team evaluation of the UTMB and UT Conduct a team evaluation of the UTMB and UT Austin research infrastructure to identify fundamental Austin research infrastructure to identify fundamental processes that require modification or change in order to processes that require modification or change in order to create an environment and culture supportive of create an environment and culture supportive of translational research teams.translational research teams.

Relationship of components of formative & summative evaluation

Influences

Resources Activities Outputs

Short-termOutcomes

Mid-TermOutcomes

Long-termOutcomes

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

Logic Model

Context

Relationships

& Capacity

Implementation

Quality

& Quantity

Outcomes

Effectiveness, Magnitude & Satisfaction

Research Education, Training and Career Development

Aim 1.Aim 1. Employ a nationally acclaimed framework for Employ a nationally acclaimed framework for constructive learning constructive learning

Aim 2.Aim 2. Reorganize current training programs so that all trainees Reorganize current training programs so that all trainees are placed in active multidisciplinary collaborative translational are placed in active multidisciplinary collaborative translational research clusters.research clusters.

Aim 3.Aim 3. Ensure all trainees are provided mentoring teams Ensure all trainees are provided mentoring teams

Aim 4.Aim 4. Provide a novel educational pipeline mechanism by Provide a novel educational pipeline mechanism by establishing the Texas Academy of Healthcare Leadership for establishing the Texas Academy of Healthcare Leadership for select undergraduate students, expanding undergraduate select undergraduate students, expanding undergraduate research opportunities, and expanding existing programs for research opportunities, and expanding existing programs for talented high school and minority studentstalented high school and minority students

Aim 5.Aim 5. Revise existing predoctoral, postdoctoral and faculty Revise existing predoctoral, postdoctoral and faculty development programs to increase the number of successful development programs to increase the number of successful clinical and translational investigatorsclinical and translational investigators

Potentially Relevant Doctoral Programs at UT AustinPotentially Relevant Doctoral Programs at UT Austin

Aerospace EngineeringAnthropologyBiochemistryBiological SciencesBiomedical EngineeringCell & Molecular BiologyChemical EngineeringChemistryCivil EngineeringCommunication Sciences & DisordersComputational & Applied MathematicsComputer SciencesCurriculum & InstructionEcology, Evolution, & BehaviorEducational PsychologyElectrical & Computer EngineeringElectrical EngineeringEngineering MechanicsHealth Education

Human Development & Family SciencesJurisprudenceLinguisticsMarine ScienceMaterials Science & EngineeringMechanical EngineeringMicrobiologyMolecular BiologyNeuroscienceNutritional SciencesNursing SciencePharmacyPhysical EducationPlant BiologyPsychologyPublic PolicyScienceScience EducationSocial WorkSpecial Education

Biomedical InformaticsBiomedical Informatics

Create a highly interconnected, Create a highly interconnected, web-based data management web-based data management and analysis infrastructureand analysis infrastructure that facilitates interoperability in that facilitates interoperability in a multidisciplinary, multi-team a multidisciplinary, multi-team clinical & translational clinical & translational environment, regardless of environment, regardless of where members may be where members may be physically locatedphysically located

Partnership with UT HSC Houston Partnership with UT HSC Houston and MD Anderson CC CTSAand MD Anderson CC CTSA

Link EMRs with rEMRsLink EMRs with rEMRs

Design Biostatistics and Database Management

1. Provide investigators & 1. Provide investigators & trainees with trainees with biostatisticians and biostatisticians and epidemiologists to epidemiologists to implement optimal implement optimal study designs based on study designs based on state-of-the-art state-of-the-art statistical methodsstatistical methods

2. Develop and implement 2. Develop and implement new statistical and new statistical and mathematical modeling mathematical modeling techniques for clinical & techniques for clinical & translational research translational research

3. Provide web-based data 3. Provide web-based data collection and study collection and study tracking systems for tracking systems for clinical studiesclinical studies

Initial meeting with Coordinating Center

Assignment of Biostatistician & DB Programmer Grant AwardedGrant Writing

1 Biostatistician: assist study design, testable hypotheses

7 Assist in revising grant

3 Power analysis and Sample Size Determination

4 Write Statistical Analysis section of grant

5 Submit Grant

6 Review Study Section critique with investigator

11 Biostatistician: statistical analysis and MS preparation

13 Begin writing next grant

12 Publish Results

8 Biostatistician: assist with obtaining sample, data forms

(EMR)

10 Biostatistician: assist in database development

2 Database programmer: dev plan for data collection (with BIC/BIC

work groups)

9 Database programmer: start making database (BIC)

Community Engagement & ResearchCommunity Engagement & Research

Aim 1:Aim 1: Establish Community Research Establish Community Research Coordinating Center (CRCC) as a Coordinating Center (CRCC) as a mechanism to represent community mechanism to represent community interests, provide support to interests, provide support to researchers, and coordinate the use of researchers, and coordinate the use of relevant community assets. relevant community assets.

Aim 2:Aim 2: Develop, maintain, and coordinate Develop, maintain, and coordinate Practice-Based Research Network Practice-Based Research Network (PBRN) of community health care (PBRN) of community health care providers providers Aim 3:Aim 3: Provide education Provide education and development in community-based and development in community-based participatory research participatory research

Aim 4:Aim 4: Coordinate the community Coordinate the community advisement and communications advisement and communications function for the CTSAfunction for the CTSA

Aim 5:Aim 5: Engage voluntary health Engage voluntary health organizations (VHO) in the CTSAorganizations (VHO) in the CTSA

Aim 6Aim 6: Develop and disseminate information : Develop and disseminate information to public audiences, policy makers, to public audiences, policy makers, and community cliniciansand community clinicians

Texas Clinical Networks

Coordinating CoreCoordinating 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

Core InteractionsCore Interactions

Reso

urce C

ore

Reso

urce C

ore

Reso

urce C

ore

Reso

urce C

ore

Reso

urce C

ore

Coordinating Core CoordinatorsCoordinating Core Coordinators

Tracking & EvaluationTracking & Evaluation

Research Education & TrainingResearch Education & Training

Multidisciplinary Team Support

Aim 1.Aim 1. Provide administrative and mentoring support to Provide administrative and mentoring support to form new research clusters and help existing clusters form new research clusters and help existing clusters achieve stable external funding achieve stable external funding

Aim 2.Aim 2. Assist in creation, implementation, maintenance and Assist in creation, implementation, maintenance and termination of Translational Teamstermination of Translational Teams

Aim 3.Aim 3. Conduct ongoing evaluation of the processes and Conduct ongoing evaluation of the processes and outcomes of Translational Teams outcomes of Translational Teams

Aim 4.Aim 4. Conduct education and training in team processes Conduct education and training in team processes

Multidisciplinary Team SupportAim 4. Conduct education and training in team processesAim 4. Conduct education and training in team processes

Module Topic Module Content

Effective Team Processes Types of teams, Models of Team effectiveness, Team assessment procedures, Team followership versus leadership, Stages of development/evolution, Development of team culture and norms, Use of Creativity

Meeting Facilitation/Management

Developing agendas, Contextual and constituent planning, Stakeholder analysis, Facilitation skills and techniques, Identifying roles and tasks, Dealing with disruptive behavior, Time management, Meeting techniques and procedures, Feedback and documentation.

Interpersonal Communication Models of interpersonal communication, Models of effective interpersonal communication, Non verbal communication, Styles of communication, Influencing individuals, Influencing teams, Listening skills, Communicating across genders, ethnic orientations, and generational lines

Conflict Resolution/Negotiation

Types of conflict, Origins and diagnosis of conflict cycles, Steps and skills to reduce conflict, Negotiation planning, Negotiation strategies, Managing strategic relationships

Project Management Supervision, Legal and institutional considerations, Team membership, setting goals, identifying resources

Funds to be awarded by Pilot Projects Core# /yr Amt Term $$ /yr Deadline

Pilots awarded with CTSA and institutional funds

Research Grants 2-4 50-100 K 1-2 yr 200 K August

Novel Technologies Awards 4-6 25-125 K 1-2 yr 400 K December

Seed Money 10-15 5-30 K 2-12 mo

150 K April, August, December

Trainee Awards 8-15 5-30 K 1 yr 125 K April, August, December

Support for symposia 1-2 5-10 K < 1 yr 15 K April

Other support awarded with CTSA funds

Grantsmanship support 10 0.5 K 1 mo 5 K April, August, December

Other support awarded with institutional funds only

Translational research faculty leave 4 50 K 6 mo 200 K April

Bridging Grants 2-4 50-100 K 1 yr 400 K August

Support for CTSA resource utilization with CTSA and institutional funds

Analytical support 15-50 < 30 K 1 yr 200 K April, August, December

Novel MethodologiesNovel Methodologies

Aim 1.Aim 1. To create a “Catalysts for Innovation Leadership To create a “Catalysts for Innovation Leadership Council”(CILC) to seek out promising early-stage Council”(CILC) to seek out promising early-stage technologiestechnologies

Aim 2.Aim 2. To sponsor new methodologies that accelerate To sponsor new methodologies that accelerate translational research and product development for translational research and product development for Pilot Project Core Funding.Pilot Project Core Funding.

– New Core grantsNew Core grants to develop novel cores or centers to develop novel cores or centers

• 1-3 yrs @ $50-125,000/yr1-3 yrs @ $50-125,000/yr

– Enabling Technologies planning grantsEnabling Technologies planning grants to lay the to lay the foundation for Pilot Core grant or extramural grant foundation for Pilot Core grant or extramural grant applications applications

• 1-2 yrs @ $25-50,000/yr1-2 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

Novel Methodologies: Enhanced Novel Methodologies: Enhanced therapeutics pipelinetherapeutics pipeline

Yellow boxes = Yellow boxes = possible new possible new NMC cores NMC cores

Green = BIC, TTCGreen = BIC, TTC

Gray = DDC & Gray = DDC & other CTSA other CTSA corescores

Translational TechnologiesTranslational TechnologiesAim 1.Aim 1. Adopt uniform processes in Adopt uniform processes in

study design, sample handling study design, sample handling and data processing.and data processing.

Aim 2.Aim 2. Support high-throughput Support high-throughput

genomics to identify disease genomics to identify disease susceptibility and treatment susceptibility and treatment response.response.

Aim 3.Aim 3. Enable biomarker discovery in Enable biomarker discovery in

proximal fluids of diseased proximal fluids of diseased tissues. tissues.

Aim 4.Aim 4. Serve as a focal point for Serve as a focal point for training in the use of high-training in the use of high-throughput post-genomic tools in throughput post-genomic tools in patient-oriented research.patient-oriented research.

Drug DiscoveryDrug Discovery

Aim 1.Aim 1. Establish a coordinating infrastructure between Establish a coordinating infrastructure between UTMB & UT Austin in synchrony with a newly UTMB & UT Austin in synchrony with a newly established administrative structure for the Texas established administrative structure for the Texas Institute for Drug and Diagnostics Development (TI-Institute for Drug and Diagnostics Development (TI-3D) 3D)

Aim 2.Aim 2. Establish ‘cradle-to-clinic’ Drug Discovery Establish ‘cradle-to-clinic’ Drug Discovery Research Teams (DDRTs) to move drugs from the Research Teams (DDRTs) to move drugs from the lab into the clinic & marketplace lab into the clinic & marketplace

Aim 3.Aim 3. Establish a High Throughput Screening Facility Establish a High Throughput Screening Facility (HTSF) to vastly increase investigators’ ability to (HTSF) to vastly increase investigators’ ability to identify efficacious compounds for a given disease identify efficacious compounds for a given disease state or modelstate or model

Pathway of drug Pathway of drug discovery discovery processesprocesses

Figure 1

Participant & Clinical Interactions ResourcesParticipant & 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

Research EthicsAim 1.Aim 1. Create a continuum of ethical best Create a continuum of ethical best

practices across the life cycle of practices across the life cycle of translational research translational research

Aim 2. Generate new knowledge by Aim 2. Generate new knowledge by conducting hypothesis-driven conducting hypothesis-driven research into emerging Clinical and research into emerging Clinical and Translational Research Ethics Translational Research Ethics issuesissues

Aim 3. Proactively engage the diverse Aim 3. Proactively engage the diverse CTSA constituencies in a Bioethics CTSA constituencies in a Bioethics Community Dialogue InitiativeCommunity Dialogue Initiative

Regulatory Training & SupportRegulatory 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

Next StepsNext Steps

Implementation Phase: Pre-FundingImplementation 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-investigatorsDirector: 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 DeanSam Shomaker, MD, JD (appointed Fall 2006)

UT Austin Vice Provost for Health AffairsWilliam Sage, MD, JD (appointed Fall 2006)

NIH CTSA Awards: NIH CTSA Awards: A Home for Clinical & Translational A Home for Clinical & Translational

ScienceScience

Trial Trial DesignDesign

Advanced Advanced Degree-Granting Degree-Granting

ProgramsPrograms

Participant Participant & Community & Community InvolvementInvolvement

Regulatory Regulatory SupportSupport

BiostatisticsBiostatistics

Clinical Clinical ResourcesResources

Biomedical Biomedical InformaticsInformatics

Clinical Research Clinical Research EthicsEthics

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