What’s New in Research at the What’s New in Research at the

Anschutz Medical Campus:Anschutz Medical Campus:

Colorado Clinical Translational Colorado Clinical Translational

Sciences InstituteSciences Institute

Ronald J. Sokol, MDRonald J. Sokol, MD

DirectorDirector

Colorado Clinical and Translational Sciences Colorado Clinical and Translational Sciences InstituteInstitute

Professor and Vice ChairProfessor and Vice Chair

Department of Pediatrics, SOMDepartment of Pediatrics, SOM Oct., 2007

CTSA Objectives: Speed Discoveries to CTSA Objectives: Speed Discoveries to Improved Patient CareImproved Patient Care

• Develop a Develop a distinct disciplinedistinct discipline for clinical and translational for clinical and translational science at institutions science at institutions

• Provide opportunities and resources for Provide opportunities and resources for original research on original research on novel methodsnovel methods

• Develop Develop translational technologiestranslational technologies and a knowledge base for and a knowledge base for the full spectrum of the full spectrum of clinical and translational scienceclinical and translational science

• Synergize partnershipsSynergize partnerships with industry, foundations, and with industry, foundations, and community physicianscommunity physicians

• Train the interdisciplinary teamsTrain the interdisciplinary teams who will conduct the clinical who will conduct the clinical and translational research of the futureand translational research of the future

BasicBasicResearchResearch

Clinical Clinical InvestigationInvestigation

Clinical TrialsClinical Trials

PracticePracticeIn the In the

CommunityCommunityT1T1

BenchBench BedsideBedside TrenchTrench

Bidirectional Translational ResearchBidirectional Translational Research

Molecules & Cells, Molecules & Cells, Animal ModelsAnimal Models

PatientsPatients Community & PopulationCommunity & Population

T2T2

NIH CTSA Awards: NIH CTSA Awards: A Home for Clinical and Translational ScienceA Home for Clinical and Translational Science

Trial DesignTrial Design

AdvancedAdvanced Degree-GrantingDegree-Granting

ProgramsPrograms

ParticipantParticipant& Community& CommunityInvolvementInvolvement

RegulatoryRegulatorySupportSupport

Biostatistics

ClinicalResources

BiomedicalInformatics

ClinicalClinicalResearchResearch

EthicsEthics

CTSACTSAHOMEHOMECTSACTSAHOMEHOME

IndustryIndustry

Other Other Institutions

Institutions

Housed in a Department, Center or InstituteHoused in a Department, Center or Institute

CSTA – Reorganizes Current CSTA – Reorganizes Current UCDHSC InfrastructureUCDHSC Infrastructure

• CTSA will subsume GCRC grants CTSA will subsume GCRC grants (M01), K30 grant – will end in 2010-11(M01), K30 grant – will end in 2010-11

• These programs will be integrated into These programs will be integrated into CTSACTSA

• Must develop a K12 programMust develop a K12 program• Optional – new predoctoral T32 Optional – new predoctoral T32

programprogram

• Adds many new programsAdds many new programs

• NIH to award 60 CTSA grants by 2011NIH to award 60 CTSA grants by 2011

Ten CTSA Key FunctionsTen CTSA Key Functions(New Organization - NIH)(New Organization - NIH)

• New translational and clinical methods New translational and clinical methods

developmentdevelopment

• Regulatory knowledge and supportRegulatory knowledge and support

• Design, biostatistics and clinical Design, biostatistics and clinical

research ethicsresearch ethics

• Translational technologies and Translational technologies and

resourcesresources

Ten CTSA Key FunctionsTen CTSA Key Functions

• Pilot and collaborative translational and Pilot and collaborative translational and clinical studiesclinical studies

• Participant and Clinical InteractionsParticipant and Clinical Interactions

• Translational informaticsTranslational informatics

• Community EngagementCommunity Engagement

• Research Education, Training and Career Research Education, Training and Career Development Development

• Evaluation and TrackingEvaluation and Tracking

Why a Colorado CTSA?Why a Colorado CTSA?

• MustMust be part of CTSA national program to be part of CTSA national program to have a voice in CTS research, shape national have a voice in CTS research, shape national programsprograms

• Ability to attract and retain outstanding Ability to attract and retain outstanding faculty, trainees and physicians at all faculty, trainees and physicians at all affiliated institutions and campusesaffiliated institutions and campuses

• Provision of essential infrastructure, support Provision of essential infrastructure, support and improved trainingand improved training

• Be eligible for special NIH funding (RFAs)Be eligible for special NIH funding (RFAs)

Current CTS Research and Training Current CTS Research and Training Strengths at UCDHSC and CUStrengths at UCDHSC and CU

• Many successful collaborative Translational Many successful collaborative Translational research efforts across campuses research efforts across campuses

• Outstanding clinical research facilities (two Outstanding clinical research facilities (two General Clinical Research Centers and two General Clinical Research Centers and two satellites) and core resourcessatellites) and core resources

• Excellent community research programs Excellent community research programs (including Native American Health)(including Native American Health)

• One of first Clinical Science PhD and Masters One of first Clinical Science PhD and Masters programs in U.S.programs in U.S.

• Strong Child Health Research ProgramsStrong Child Health Research Programs

Progress toward CTSA Progress toward CTSA ApplicationApplication

1. CTSA Planning Grant awarded in 20061. CTSA Planning Grant awarded in 2006• Funded – Funded – $150,000 direct costs $150,000 direct costs

$231,000 total costs$231,000 total costs

• Major critiques: Major critiques: – Expand scope to Expand scope to include more collaboration with include more collaboration with

CU BoulderCU Boulder – Physiology, – Physiology, bioengineeringbioengineering, etc., etc.– Evaluation process to assess outcomes resulting Evaluation process to assess outcomes resulting

from infrastructure changesfrom infrastructure changes

2. New2. New Colorado CST Institute (CCTSI) Colorado CST Institute (CCTSI)

approved by Regents in Aug. 2007approved by Regents in Aug. 2007

3. Grant application – Nov. 7, 2007 deadline3. Grant application – Nov. 7, 2007 deadline

Vision of CCTSIVision of CCTSI

Transform the current clinical and Transform the current clinical and

translational research and training efforts of translational research and training efforts of

all Schools at UCDHSC and affiliated all Schools at UCDHSC and affiliated

institutions into an innovative, institutions into an innovative,

interdisciplinary, collaborative campus-wide interdisciplinary, collaborative campus-wide

academic home for clinical and translational academic home for clinical and translational

sciences, scientists and traineessciences, scientists and trainees

Mission of CCTSIMission of CCTSI

Improve the health of the population of Improve the health of the population of

Colorado by catalyzing the translation Colorado by catalyzing the translation

of biomedical discoveries into of biomedical discoveries into

prevention and intervention strategies prevention and intervention strategies

in the community, and by reducing in the community, and by reducing

health care disparitieshealth care disparities

Goals of Colorado CTSIGoals of Colorado CTSI

1.1. Transformation of the InstitutioTransformation of the Institution: n: UCDHSC will create the CCTSI as a UCDHSC will create the CCTSI as a visible, integrated and interdisciplinary visible, integrated and interdisciplinary statewide academic home for the statewide academic home for the disciplines of clinical and translational disciplines of clinical and translational sciences and research that will remove sciences and research that will remove barriers and obstacles and promote barriers and obstacles and promote successful careers successful careers

Goals of Colorado CTSIGoals of Colorado CTSI

2. Transformation of the Clinical and 2. Transformation of the Clinical and Translational Scientist:Translational Scientist:

The CCTSI will enhance, integrate and The CCTSI will enhance, integrate and transform training of translational transform training of translational scientists to develop a new generation scientists to develop a new generation of investigators with advanced of investigators with advanced degrees, interdisciplinary and degrees, interdisciplinary and collaborative skills and a team collaborative skills and a team approach to scientific investigation approach to scientific investigation

Goals of CCTSIGoals of CCTSI

3. 3. Transformation of Discovery Translational Transformation of Discovery Translational Research:Research:

The CCTSI will transform the performance of The CCTSI will transform the performance of discovery translational research (bench-to-discovery translational research (bench-to-beside research) by providing new resources beside research) by providing new resources and infrastructure, integrating current and and infrastructure, integrating current and developing new innovative research tools developing new innovative research tools and methodologies, catalyzing new and methodologies, catalyzing new interdisciplinary research programs and interdisciplinary research programs and removing barriers to efficiencyremoving barriers to efficiency

Goals of CCTSIGoals of CCTSI

4. Transformation of Community Translational 4. Transformation of Community Translational Research and PracticeResearch and Practice. .

The CCTSI will transform community and The CCTSI will transform community and population-based research by enhancing, population-based research by enhancing, extending and integrating community-based extending and integrating community-based participatory research into programs that will participatory research into programs that will engage community participation and develop engage community participation and develop novel methodologies for translation of novel methodologies for translation of scientific discoveries into clinical practicescientific discoveries into clinical practice

Basic and Engineering

Sciences

CommunityAnd Population

Sciences

PatientOriented Research

ClinicalTrials

DisadvantagedPopulations

CollaborativeInvestigative

Teams

InterdisciplinaryResearch Programs

New Generationof Trainees

Academic HomeMulti-Institutional

Collaboration BiomedicalBiomedicalDiscoveriesDiscoveriesBiomedicalBiomedicalDiscoveriesDiscoveries

ResearchTeams andLeaders of The Future

ResearchTeams andLeaders of The Future

Colorado CTSI

Discovery Translation

CommunityTranslation

Education, TrainingCareer Development

Child andMaternal Health

EvaluationAnd Improvement

Graduate DegreePrograms

ImprovedCommunity

Health

ImprovedCommunity

Health

CommunityPhysicianOutreach

Novel Methods& Technology

CCTSI Institutional MembersCCTSI Institutional Members

• UCDHSC Schools of Medicine, Nursing, UCDHSC Schools of Medicine, Nursing,

Dental, Pharmacy, Graduate School, Public Dental, Pharmacy, Graduate School, Public

HealthHealth

• CU Boulder, UCDHSC Denver Campus CU Boulder, UCDHSC Denver Campus

(e.g. Bioengineering), (e.g. Bioengineering),

• Affiliated hospitals - UCH, TCH, DH, NJMRC, Affiliated hospitals - UCH, TCH, DH, NJMRC,

VAH, Kaiser PermanenteVAH, Kaiser Permanente

• Graduate Training ProgramsGraduate Training Programs

Chancellor of Chancellor of UCDHSCUCDHSC

Vice ChancellorVice Chancellor of Researchof Research

DirectorDirectorCCTSICCTSI

Executive Committee:Executive Committee:Director, 5 Co-Directors,Director, 5 Co-Directors,

CFO, Chair of IACCFO, Chair of IAC

ExternalExternalAdvisory Advisory CommitteeCommittee

Internal Internal AdvisoryAdvisory

CommitteeCommittee

CFOCFO

Vice ChancellorVice Chancellor of Health Affairsof Health Affairs

CCTSICCTSIAdvisoryAdvisoryCouncilCouncil

CCTSI Organizational Structure and GovernanceCCTSI Organizational Structure and Governance

Chancellor of Chancellor of UCDHSCUCDHSC

Vice ChancellorVice Chancellor of Researchof Research

Director CCTSIDirector CCTSISokolSokol

Executive CommitteeExecutive Committee

CFOCFO

Vice ChancellorVice Chancellor of Health Affairsof Health Affairs

Training andTraining andEducationEducation

DiscoveryDiscoveryTranslationTranslation

CommunityCommunityTranslationTranslation

Novel MethodsNovel Methods& Technology& Technology

Child & Child & MaternalMaternalResearchResearch

SteinerSteiner EckelEckel KramerKramer GeraciGeraciHayHay

FIVE PROGRAMSFIVE PROGRAMS

Training andTraining andEducationEducation

DiscoveryDiscoveryTranslationTranslation

CommunityCommunityTranslationTranslation

Novel MethodsNovel Methods& Technology& Technology

Child & Child & MaternalMaternalResearchResearch

SteinerSteiner EckelEckel KramerKramer GeraciGeraci HayHay

DirectorDirectorSokolSokol

PredoctoralPost-docJr. FacultyCareer Development

K30, T32, K12

CTRCsCTRCsClinical TrialsClinical TrialsCPCCPCPharmaceutical Pharmaceutical developmentdevelopment

Design, Biostatistics, Design, Biostatistics, Research EthicsResearch Ethics

RegulatoryRegulatory

Community Community Engagement & Engagement & ResearchResearch

InformaticsInformatics

Novel Methods Novel Methods DevelopmentDevelopment

Pilot ProjectsPilot Projects

Translational Technology Translational Technology CoresCores

Integrate Integrate Programs Programs ThroughoutThroughoutTCH and otherTCH and otherFacilitiesFacilities

ACADEMIC HOMEACADEMIC HOME

TimetableTimetable

• Working Groups for each key function for Working Groups for each key function for

past 10 monthspast 10 months

• External Advisory Committee meeting External Advisory Committee meeting

July 23, 2007July 23, 2007

• Working Groups – final drafts submittedWorking Groups – final drafts submitted

• Executive Committee finalizing and Executive Committee finalizing and

editingediting

• Application Deadline: November 7, 2007Application Deadline: November 7, 2007

SummarySummary

• CTSA application is a exceptional opportunity to CTSA application is a exceptional opportunity to

transform andcatalyze clinical and translational transform andcatalyze clinical and translational

research and training across campuses of research and training across campuses of

University of Colorado, Affiliated Hospitals and University of Colorado, Affiliated Hospitals and

OrganizationsOrganizations

• Will take a University-wide and Hospital-wide Will take a University-wide and Hospital-wide

partnerships partnerships

• Will require broad faculty and institutional Will require broad faculty and institutional

commitmentscommitments

ContactContact

• Sokol.ronald@tchden.orgSokol.ronald@tchden.org

• Phone:Phone: 720 777-6669 720 777-6669

• Pager: 303-890-7744Pager: 303-890-7744

• http://ctsa1.uchsc.eduhttp://ctsa1.uchsc.edu