Clinical and Translational Clinical and Translational Science AwardScience Award

University of ColoradoUniversity of Colorado

Ronald J. Sokol, MDRonald J. Sokol, MD

Program DirectorProgram Director

CU Program for Clinical and Translational CU Program for Clinical and Translational SciencesSciences

April, 2007

Who I am?Who I am?

• Pediatric GastroenterologistPediatric Gastroenterologist

• Professor and Vice Chair of Clinical Professor and Vice Chair of Clinical Research – Dept. of Pediatrics, School of Research – Dept. of Pediatrics, School of MedicineMedicine

• Program Director – Pediatric CTRC (GCRC)Program Director – Pediatric CTRC (GCRC)

• Section Chief – Pediatric GI, Hepatology and Section Chief – Pediatric GI, Hepatology and Nutrition, CU SOMNutrition, CU SOM

• Liver cell injury and death, cholestasis, Liver cell injury and death, cholestasis, mitochondrial pathways, oxidative stress, mitochondrial pathways, oxidative stress, National Clinical Research NetworksNational Clinical Research Networks

NIH RoadmapNIH Roadmap

• In 2002, Dr. Zerhouni charted a new In 2002, Dr. Zerhouni charted a new “Roadmap” for Medical Research“Roadmap” for Medical Research

Three objectives:Three objectives:

1. 1. New pathways to discoveryNew pathways to discovery

2. 2. Research Teams of the FutureResearch Teams of the Future

3. 3. Re-engineering the Clinical Research Re-engineering the Clinical Research EnterpriseEnterprise

• In 2005 the In 2005 the Clinical and Translational Science Clinical and Translational Science AwardAward (CTSA)(CTSA) program was developed program was developed

BasicBasicResearchResearch

Clinical Clinical InvestigationInvestigation

Clinical TrialsClinical Trials

PracticePracticeIn the In the

CommunityCommunityT1T1

BenchBench BedsideBedside TrenchTrench

Bidirectional Translational ResearchBidirectional Translational Research

Molecules & CellsMolecules & Cells PatientsPatients Community & PopulationCommunity & Population

T2T2

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

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

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

OtherOtherInstitutions

Institutions

CTSA EligibilityCTSA Eligibility Domestic institutions, universities, academic health Domestic institutions, universities, academic health

centers, or other organizationscenters, or other organizations

A graduate school accredited to award higher degrees in A graduate school accredited to award higher degrees in clinical research clinical research must bemust be included included

Partnerships with independent and other research Partnerships with independent and other research institutions are strongly encouragedinstitutions are strongly encouraged

Institutions can only submit, or be part of, a single Institutions can only submit, or be part of, a single applicationapplication

Evidence of significant institutional commitmentEvidence of significant institutional commitment

CTSA Funding CTSA Funding

• 60 awards by 2012, costing in aggregate up to 60 awards by 2012, costing in aggregate up to $500 M$500 M

• Budget = Combine certain current NIH grants Budget = Combine certain current NIH grants + additional funds:+ additional funds:

– NCRR: K12, NCRR: K12, K30K30, , M01 (GCRC x 2)M01 (GCRC x 2)

– Roadmap: T32 and K12Roadmap: T32 and K12

+ up to + up to $6 million$6 million in total costs per year in total costs per year

• Length of awards: 5 yearsLength of awards: 5 years

• GCRC program, K30 program, etc. GCRC program, K30 program, etc. will bewill be phased out by 2011phased out by 2011

FY2006 CTSA Funding OpportunitiesFY2006 CTSA Funding Opportunities

• RM-06-002RM-06-002: Institutional Clinical and : Institutional Clinical and Translational Science Award (CTSA) RFATranslational Science Award (CTSA) RFA

• RM-06-001RM-06-001:: Planning Grant RFA for Institutional Planning Grant RFA for Institutional CTSAsCTSAs

– Allows more time to prepare a CTSA Allows more time to prepare a CTSA applicationapplication

– One time solicitation for one-year awardOne time solicitation for one-year award– ~50 awards, $150K direct costs; $11.5 M total~50 awards, $150K direct costs; $11.5 M total

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

• Many successful collaborative Many successful collaborative translational research efforts across translational research efforts across campusescampuses

• Outstanding clinical research facilities Outstanding clinical research facilities (two General Clinical Research Centers (two General Clinical Research Centers and two satellites) and translational and two satellites) and translational resourcesresources

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

UCDHSC CTSA Planning GrantUCDHSC CTSA Planning Grant

• Submitted - Jan., 2006 Submitted - Jan., 2006 • Reviewed in July, 2006Reviewed in July, 2006• Mark Geraci, MD – Principal InvestigatorMark Geraci, MD – Principal Investigator• 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 include more collaboration with Expand scope to include more collaboration with CU Boulder – Physiology, bioengineering, etc.CU Boulder – Physiology, bioengineering, etc.

– Evaluation process to assess outcomes resulting Evaluation process to assess outcomes resulting from infrastructure changesfrom infrastructure changes

Why a UCDHSC CTSA?Why a UCDHSC 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 institutionsaffiliated institutions

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

• Be eligible for special RFAs and NIH fundingBe eligible for special RFAs and NIH funding

First CTSA Specific RFAFirst CTSA Specific RFA

• RFA-RM-07-006RFA-RM-07-006• Release Date: November 28, 2006 Release Date: November 28, 2006 • Limited Competition for Limited Competition for Supplements to CTSAsSupplements to CTSAs to to

plan for pilot projects to apply the national clinical plan for pilot projects to apply the national clinical research associates model in their community research associates model in their community engagement activities (UL1) engagement activities (UL1)

• Concept of establishing cadres of community-based Concept of establishing cadres of community-based health practitioners trained to conduct clinical health practitioners trained to conduct clinical research as part of the Community Engagement research as part of the Community Engagement component of their grants.   component of their grants.  

Roadmap FundingRoadmap Funding(dollars in millions)(dollars in millions)

FY04FY04 FY05FY05 FY06FY06 FY07FY07 FY08FY08 FY09FY09 TotalTotal

Pathways to Pathways to DiscoveryDiscovery

6565 135135 169169 182182 209209 188188 948948

Research Research TeamsTeams

2828 4343 4444 9292 9696 9393 396396

Clinical Clinical ResearchResearch

3939 6161 120120 174174 214214 227227 835835

TotalTotal 132132 239239 333333 448448 520520 507507 2,1792,179Roadmap Initiative ~ 1% of NIH budget

Totals on table may not add due to rounding9/27/2005

Roadmap FundingRoadmap Funding(dollars in millions)(dollars in millions)

FY04FY04 FY05FY05 FY06FY06 FY07FY07 FY08FY08 FY09FY09 TotalTotal

Pathways to Pathways to DiscoveryDiscovery

6565 135135 169169 182182 209209 188188 948948

Research Research TeamsTeams

2828 4343 4444 9292 9696 9393 396396

Clinical Clinical ResearchResearch

3939 6161 120120 174174 214214 227227 835835

TotalTotal 132132 239239 333333 448448 520520 507507 2,1792,179Roadmap Initiative ~ 1% of NIH budget

Totals on table may not add due to rounding9/27/2005

12 Funded CTSAs - 200612 Funded CTSAs - 2006

Columbia University Health Sciences (New York, NY)

Duke University (Durham, NC)

Mayo Clinic College of Medicine (Rochester, MN)

Oregon Health & Science University (Portland, OR)

Rockefeller University (New York, NY)

University of California, Davis (Davis, CA)

University of California, San Francisco (San Francisco, CA)

University of Pennsylvania (Philadelphia, PA)

University of Pittsburgh (Pittsburgh, PA)

University of Rochester (Rochester, NY)

University of Texas Health Science Center at Houston (Houston, TX)

Yale University (New Haven, CT)

UCDHSC CTSA StructureUCDHSC CTSA Structure

• Schools of Medicine, Nursing, Dental, Schools of Medicine, Nursing, Dental,

Pharmacy, Graduate School (Public Pharmacy, Graduate School (Public

Health)Health)

• UCDHSC, CU Boulder, CU DenverUCDHSC, CU Boulder, CU Denver

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

NJMRC, VAH, Kaiser PermanenteNJMRC, VAH, Kaiser Permanente

• Graduate Training ProgramsGraduate Training Programs

CTSA PlanningCTSA Planning

• Executive Steering Committee (ESC)Executive Steering Committee (ESC)

– Deans and Hospital Presidents, Paul Deans and Hospital Presidents, Paul

Bunn, othersBunn, others

1.1. Oversight Oversight

2.2. Decision about Center/InstituteDecision about Center/Institute

3.3. AppointmentsAppointments

Working GroupsWorking Groups

• 11 groups – integrated PhDs and MDs11 groups – integrated PhDs and MDs• Each focuses on one of the 9 components Each focuses on one of the 9 components

required by CTSA RFA + Evaluation + Child required by CTSA RFA + Evaluation + Child Health ResearchHealth Research

• Organized into 5 major Resource Programs Organized into 5 major Resource Programs (Divisions):(Divisions):– Discovery translation (bench to bedside research)Discovery translation (bench to bedside research)– Community translation (bedside to trench)Community translation (bedside to trench)– Education and career developmentEducation and career development– Methods Development and BiotechnologyMethods Development and Biotechnology– Child and Maternal Health ResearchChild and Maternal Health Research

Nine CTSA Components Nine CTSA Components (mandated by NIH)(mandated by 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

resources – resources – -omics, biobanking, etc.-omics, biobanking, etc.

Nine CTSA Components - 2Nine CTSA Components - 2

• 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 Research Education, Training and Career Development Career Development

ResearchResearch trainingtraining

and educationand educationJohn Steiner

DiscoveryDiscoveryTranslationTranslation

Robert Eckel

CommunityCommunityTranslationTranslation

Andrew Kramer

Methods Methods DevelopmentDevelopment

And And BiotechnologyBiotechnology

Mark Geraci

Child and Child and MaternalMaternalHealthHealth

ResearchResearchWilliam Hay

K30K30MPHMPHK12K12T32T32PhDsPhDs

Adult and Adult and Pediatric GCRCsPediatric GCRCs and satellitesand satellitesCTOCTOCPCCPCDrug DiscoveryDrug Discovery

Public HealthPublic HealthCare DeliveryCare DeliveryResearch Research networksnetworksImplementationImplementationCommunityCommunity engagementengagement

Methods developmentMethods developmentPilot projectsPilot projectsTechnology CoresTechnology Cores

IntegratingIntegratingResearchResearchprogramsprograms

BiostatisticsBiostatistics InformaticsInformatics RegulatoryRegulatory EthicsEthics

CTSI or CCTSI or C

Program DirectorsProgram Directors

Board of GovernorsBoard of Governors

EvaluationEvaluation

GovernanceGovernance

• CTS Institute or CenterCTS Institute or Center

• Board of GovernorsBoard of Governors

• External Advisory CommitteeExternal Advisory Committee

• Internal Advisory Committee (CTRAC)Internal Advisory Committee (CTRAC)

• Director and 5 Co-Directors (for each major Director and 5 Co-Directors (for each major

resource function)resource function)

• Assistant Directors for components (Cores)Assistant Directors for components (Cores)

• Hospital and Campus CTSA officesHospital and Campus CTSA offices

• Faculty membership – appointmentsFaculty membership – appointments

2006-2007 Planning Phase2006-2007 Planning Phase

• Working groupsWorking groups for each component for each component

• Each with representation from all 5 Schools at Each with representation from all 5 Schools at

UCDHSC, Boulder and Denver Campuses and as UCDHSC, Boulder and Denver Campuses and as

many Hospitals as possiblemany Hospitals as possible

– develop Specific Aims, Background and current develop Specific Aims, Background and current

strengths, Areas for improvement, Methods to strengths, Areas for improvement, Methods to

achieve aims, Integration and innovation, achieve aims, Integration and innovation,

Timeline, Tracking and evaluationTimeline, Tracking and evaluation

• Draft first draft for grant (15 pages each) by mid-MayDraft first draft for grant (15 pages each) by mid-May

• Co-PDs to edit and blendCo-PDs to edit and blend

TimetableTimetable

• Co-Directors Co-Directors

– meeting biweekly meeting biweekly

– each Co-Director supervising 2-4 WGseach Co-Director supervising 2-4 WGs

• WGs to develop first draft by May, 2007WGs to develop first draft by May, 2007

• External Advisory Committee meeting External Advisory Committee meeting

end of May, 2007end of May, 2007

• Application Deadline: October 24, 2007Application Deadline: October 24, 2007

How participating Faculty will benefit How participating Faculty will benefit from a successful applicationfrom a successful application

• New bridges across translational research New bridges across translational research barriers, across campusesbarriers, across campuses

• Core resources (e.g., biobanking) and Core resources (e.g., biobanking) and expertiseexpertise

• Regulatory Support and StreamliningRegulatory Support and Streamlining• Benefits of modern clinical research facilities Benefits of modern clinical research facilities

and research nursing, nutrition, etc. and research nursing, nutrition, etc. • New Biostatistics, Informatics and Research New Biostatistics, Informatics and Research

Ethics UCDHSC CoresEthics UCDHSC Cores• New opportunities for traineesNew opportunities for trainees• Eligibility for new NIH RFAs – CTSA-specificEligibility for new NIH RFAs – CTSA-specific

How participating Institutions will benefit How participating Institutions will benefit from a successful applicationfrom a successful application

• Benefits of being part of a new alignment of Benefits of being part of a new alignment of regional/community assetsregional/community assets– Savings due to new efficiencies – training, Savings due to new efficiencies – training,

informatics, regulatory, repositoriesinformatics, regulatory, repositories– Predictable enhanced competitiveness for every Predictable enhanced competitiveness for every

institution due to new translational research institution due to new translational research architecturearchitecture

– Community visibility, PR, and collaborative Community visibility, PR, and collaborative fundraising opportunitiesfundraising opportunities

• Benefits of being a part of the broader NIH Benefits of being a part of the broader NIH CTSA CollaborativeCTSA Collaborative

• Benefits of sharing in CTSA award – e.g., Benefits of sharing in CTSA award – e.g., institutional FTEs, core facilities, institutional FTEs, core facilities,

SummarySummary

• CTSA application is tremendous CTSA application is tremendous

opportunity to reshape clinical and opportunity to reshape clinical and

translational research and training across translational research and training across

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

and Organizationsand Organizations

• Will take a University-wide combined effort Will take a University-wide combined effort

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

commitmentscommitments

ContactContact

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

• Phone:Phone: 303-861-6669303-861-6669

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