IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
The Indiana Clinical Translational
Science Institute (I-CTSI)
Institute Director:
Anantha Shekhar, MD, PhD
Bloomington director:
William P. Hetrick, PhD
Purdue director:
Connie Weaver, PhD
Notre Dame director:
Gregory Crawford
Crawford, PhD
IndianaCTSI
IU Health Information and Translational
Sciences Building, Indianapolis
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
What is clinical translational science?
• Science aimed at:
– translating discoveries in basic science to the understanding,
treatment and prevention of human disorders (T1)
treatment,
• translating discoveries generated during research in the laboratory,
and in preclinical studies, to studies in humans and the development
of human trials
– developing and implementing evidence-based standards of
practice and public health policy (T2)
• enhancing the adoption of best practices in the community
• enhancing cost-effectiveness of prevention and treatment strategies
• More than simply
p y interdisciplinary
p
y
Conventional Model:
g g
systems
y
of research & training
g
Segregated
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Mental or
Physical Health
Genetics
Neuroscience Cognitive
Social
•Behavioral
•Neuroimaging
•Systems
•Cellular
•Molecular
•Animal models
Health policy
Psychopathology
Clinical practice
•Classification
•Diagnosis
•Phenomenology
•Etiology
gy
•Case management
•Psychotherapy
•Neurophysiology
•Pharmacology
gy
Conventional Model:
g g
systems
y
of research & training
g
Segregated
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Mental or
Physical Health
Genetics
Neuroscience Cognitive
Social
Psychopathology
Clinical practice
Health policy
Clinical Translational Science Model:
Integrated systems of research & training
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Best
Practices
&
Policy
The Problem Area
(e.g., schizophrenia)
Patient
Bedside
Genetics
Neuroscience Cognitive
Social
Psychopathology
Clinical practice
Problem focused
research & training
that facilitates translation
Health policy
Laboratory
L
b t
Bench
Clinical Translational Science:
A subdiscipline to add to the landscape
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Mental &/or
Physical Health
Translational
Science
Genetics
Health policy
Clinical practice
Neuroscience
Cognitive
Social
Psychopathology
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Statement of justification
•
“At no other time has the need for a robust, bidirectional information flow
between basic and translational scientists been so necessary. Advances in
our understanding of biologic systems and the development of powerful new
t l that
tools
th t can be
b applied
li d att b
both
th th
the b
bench
h and
d th
the b
bedside...offer
d id
ff
unprecedented prospects for advancing knowledge of human disorders in a
translational context... Today, there is good reason to believe that the
scope of knowledge and expertise needed to be an effective translational or
clinical scientist can no longer be acquired "on
on the job,
job " as was done in the
past. Although we have made every effort to provide the support functions
for translational and clinical research, there is a call for training in a wider
range of skill sets that span the biomedical and behavioral sciences and
make use of far more advanced and more complex resources and methods
than
h ever b
before.
f
W
We may have
h
ffailed
il d to recognize
i that
h clinical
li i l and
d
translational science is an emerging discipline that encompasses both the
acquisition of new knowledge about health and disease prevention,
preemption, and treatment and the methodologic research necessary to
develop or improve research tools
tools.” — Elias A
A. Zerhouni (2005)
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Agenda
1
1.
Q i k overview
Quick
i
off the
th Indiana
I di
CTSI
a.
b.
c.
2.
What is clinical translational science?
a.
b.
c.
d.
3.
NIH’s impetus
Strategic goals the CTSAs
Key functions
Who has a CTSA?
Indiana CTSI research & training programs
a.
b.
c.
4.
What it is?
Who funds it?
Who are its partners and users?
Research grants
Education & career development
p
Infrastructure and resources
Translational research & training on the Bloomington campus
a.
b.
b
c.
d.
e.
What is its role?
How
o do we
ep
promote
o o e it a
at IUB?
U
How do we increased IUB participation in the I-CTSI?
How can IUB strengthen the I-CTIS?
Annual Bloomington InCTSI retreat
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Providing Leveraging Opportunities Throughout the State
Biocrossroads
Wellpoint,
Inc.
Indiana
University
Roudebush VA
Medical Center
IndianaCTSI
Clarian Health
Partners
Regenstrief
Institute
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Eli Lilly
and Company
Purdue
University
Richard M.
Fairbanks
Foundation
Notre Dame
Wishard Health
Services
Cook Group,
Inc
Indiana State
Government
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Agenda
1
1.
Q i k overview
Quick
i
off the
th Indiana
I di
CTSI
a.
b.
c.
2.
What is clinical translational science?
a.
b.
c.
d.
3.
NIH’s impetus
Strategic goals the CTSAs
Key functions
Who has a CTSA?
Indiana CTSI research & training programs
a.
b.
c.
4.
What it is?
Who funds it?
Who are its partners and users?
Research grants
Education & career development
p
Infrustructure and resources
Translational research & training on the Bloomington campus
a.
b.
b
c.
d.
e.
What is its role?
How
o do we
ep
promote
o o e it a
at IUB?
U
How do we increased IUB participation in the II-CTSI?
How can IUB strengthen the II--CTIS?
Fall 2010 meeting in Bloomington
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
The Translational Research Gap
Source: Butler D. Translational research: Crossing the valley of death. Nature. 2008;453:840–2.
Impetus for the CTSA Program
Integrative



Across health disciplines p
Between scientific areas
Into the community  engagement/participation
Translational

Laboratory to Clinic to Community to Laboratory
Educational



Scientists
Health care providers
Health care providers
Community
Provides resource infrastructure



NIH funded research
Non‐NIH funded research
Public‐private partnership
CTSA Strategic Goals
(1) Enhancing National Clinical and Translational Research Capability
• Clinical research management
• Research
R
h iinfrastructure
f t t
• Phenotyping – human and preclinical models
(2) Enhancing the Training and Career Development of Clinical and
Translational Scientists
(3) Enhancing Consortium-Wide
Consortium Wide Collaborations
• Social networking
• Inventory of resources
• Data sharing
g
(4) Enhancing the Health of Our Communities and the Nation
• National Model for Community Engagement
• Inform Public Health Policy Through Research
Re--engineering Clinical Research
Re
T1 Translation
B
Bench
h
T2 Translation
B d id
Bedside
Building
B
ildi Blocks
Bl k and
d Pathways
P h
• Molecular Libraries
• Bioinformatics
Translational
• Computational Biology
R
Research
h
• Nanomedicine
Initiatives
•
•
•
•
C
Community
it
Practice
Integrated Research Networks
Clinical Research Informatics
NIH Clinical Research Associates
Clinical Outcomes
Cross-cutting: Harmonization, Training
Clinical and Translational Science Awards (CTSAs)






Educate the next generation of clinical
researchers
Improve clinical research management
Build diversity in leadership
Assemble interdisciplinary teams
Enhance public trust
Forge partnerships with private and public
health care organizations
CTSAWeb.org
Key Functions
NIH & other government
government agencies
Cli i l R
hI
i
Clinical Clinical Research Innovation
Education and Research
Career Development
Ethics
Translational
Biomedical
Informatics
Community
Engagement
CTSA
Academic Center
Clinical
Resources
Industry
Communications
Evaluation
Public Private Partnerships
Public Private Partnerships
Comparative Effectiveness
Healthcare organizations
Regulatory Support
Biostatistics
Building a National CTSA Consortium
Case Western Reserve
University of Illinois at Chicago
Northwestern
University of Washington
g
Albert Einstein
OSU
University of Michigan
University of Pittsburgh
University of Rochester
WA
MT
ND
OHSU
OR
ID
WY
Univ. of Utah
UC, Davis
NV
Univ. of Colorado
UCSF
UT
CO
Stanford
MN
WI
Mayo Clinic
SD
University of Wisconsin
y
IA
University of Iowa
NE
University of Chicago
Washington University, St. Louis
KS
CA
VT
Columbia
Scripps
IL
MO
OK
UT Southwestern AR
NM
UT MB
LA
NJ
PA
TN
NH
MA
Duke
UNC
UT San Antonio
University of Cincinnati
University of Florida
UT, Houston
HI
Since 2006
Since 2007
Since 2008
Since 2009
NYU
VA
SC
Medical University of SC
Emory
GA
AL
MS Univ of Alabama at Birmingham
Participating Institutions
Yale
Weill Cornell Mt. Sinai School of Med. Rockefeller
University of Pennsylvania TX
AK
Harvard
Boston University
Tufts University
Johns Hopkins
IN
Indiana University
OH
WV
KY
Vanderbilt University of Arkansas
AZ
NY
MI
ME
FL
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Agenda
1
1.
Q i k overview
Quick
i
off the
th Indiana
I di
CTSI
a.
b.
c.
2.
What is clinical translational science?
a.
b.
c.
d.
3.
NIH’s impetus
Strategic goals the CTSAs
Key functions
Who has a CTSA?
Indiana CTSI research & training programs
a.
b.
c.
4.
What it is?
Who funds it?
Who are its partners and users?
Research grants
p
Education & career development
Infrustructure and resources
Translational research & training on the Bloomington campus
a.
b.
b
c.
d.
e.
What is its role?
How
o do we
ep
promote
o o e it a
at IUB?
U
How do we increased IUB participation in the II-CTSI?
How can IUB strengthen the II--CTIS?
Fall 2010 meeting in Bloomington
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
I. Translational research acceleration programs:
A Research awards
A.
1.
2.
3.
4.
Collaboration in Translational Research Pilot Grant Program (CTR)
•
Goal: Foster collaborations between investigators at IUB, Purdue,
ND, IUSM, and IUPUI in translational research p
projects
j
with strong
g
potential to develop into externally funded programs or IP.
Project Development Team (PDT) Pilot Funding
•
Goal: Provides funding to support development of preliminary data
for external grant submissions.
submissions
Pilot Core Funding
•
Promotes use of CTSI cores across CTSI partner institutions and
supports science with a high potential for external funding or IP.
Research Inventions and Scientific Commercialization (RISC)
•
Pilot program to support potential gaps in research that leads to IP
generation at IU in collaboration with IURTC.
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
I. Translational research acceleration programs:
B Education & career development awards
B.
1.
2.
3.
4.
5.
T Trainee awards
•
The T32 focuses on pre-doctoral training in translational research.
K Clinical Scholar awards
•
The K12 program focuses on junior faculty pursuing clinical or
translational research.
K Basic Science Scholar awards
•
The K12 program focuses on junior faculty pursuing Basic Science
research.
Notre Dame Innovation Postdoc (ND only)
•
Post-doc funding to facilitate movement of research
inventions/concepts to commercialization.
Purdue’s Trask Venture Fund (Purdue only)
•
Goal: To assist faculty to further clinical commercial potential of IP
disclosed to the Office of Technology Commercialization
Commercialization.
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
I-CTSI p
programs
g
that facilitate research:
•
•
•
•
•
•
•
•
•
•
•
•
Novel Translational Methodologies and Pilot Studies Program,
Project Development Teams (PDTs)
g
Biomedical Informatics Program
Design and Biostatistics Program (DBP)
Regulatory Knowledge and Support (RKS)
Clinical Research Resource Center (CRRC)
Community Health Engagement Program (CHEP)
Translational Technologies and Resources (TTR) Cores
Program
Research Education,
Education Training and Career Development
Bioethics and Subject Advocacy Program (BSAP)
Disease and Therapeutic Modeling Program
Biomedical Engineering and Bionanotechnology Program
Indiana CTSI HUB (http://www.indianactsi.org)
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Project Development Teams:
• Purpose:
– “one-stop
p shop”
p for study
y development
p
by
y
providing investigators access to
multidisciplinary research expertise, biostatistics,
IRB/regulatory services,
services nursing support
support, and
pilot funds
– Comprised of experienced researchers who
discuss ideas and concepts with investigators to
assist in developing high quality, feasible,
f d bl clinical/translational
fundable
li i l/t
l ti
l research
h projects.
j t
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Project Development Teams:
•
Eight PDTs address a broad spectrum of research focuses
1. Preclinical PDT (TRAC1) focuses on translational studies in animal and cellular
models.
models
2. Pediatric PDT (PRAT) facilitates research in children with emphasis on interactions
with basic scientists to design and implement bench-to-bedside studies.
3. Adult PDT (TRAC2) focuses on early translational studies related to adult medicine.
4 Behavioral/Population Science PDT (BEHV) helps investigators design and
4.
implement epidemiological and behavioral research.
5. Purdue PDT has particular strengths in assisting investigators with a special emphasis
on bioengineering, nutritional, and veterinary medicine.
6. Translating Research into Practice PDT (TRIP) focuses on projects that evaluate
and
d iimplement
l
t evidence-based
id
b
d practice
ti and
d other
th h
health
lth services
i
research.
h
7. Notre Dame PDT provides access to broad biomedical expertise particularly in basic
research.
8. Imaging PDT provides expertise in the application of anatomical, functional, and
molecular imaging methodologies and technologies
technologies.
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
PDT projects - portfolio by stage
BEDSIDE
BENCH
Basic Science Research
Preclinical Studies
Animal Research
Proof of
Concept
Model
Dev
Drug
Dev
TRAC1
4 14 1 3 6 7 11
2 10
9 16
20 12 17 18 5 23 8 13
15 21 24
19 25
22
TRAC2
46 49 54
44
PRAT
73 81
63
53
Beh/Pop 97
TRIP
PRACTICE
Clinical Practice
Delivery of Care
Identification of New Clinical
Questions and Gaps in Care
26 27 29 31 33 35 37 39 41 43 45 48105123
51 28 30 32 34 36 38 40 42 47
50 52
65 66 68 70 79 82
55 57 59 61 64 69 72 75 77
56 58 60 62 67 71 74 76 78
84 86 88 90 92 94 96
83 85 87 89 91 93 95 98
106
99 101103104
100 102
Imaging
Purdue
Human Clinical Research
Controlled Observational Studies
Phase 3 Clinical Trials
T1
Case Series
Phase 1 and 2
Clinical Trials
T2
Guideline Development
Meta‐analyses
Systematic Reviews
T3
Dissemination & Implementation Research
Health Systems Redesign
Applied Health IT
108
109 113114 110117
122
107
111
112
116 119 121
115 118 120
Notre Dame
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Agenda
1
1.
Q i k overview
Quick
i
off the
th Indiana
I di
CTSI
a.
b.
c.
2.
What is clinical translational science?
a.
b.
c.
d.
3.
NIH’s impetus
Strategic goals the CTSAs
Key functions
Who has a CTSA?
Indiana CTSI research & training programs
a.
b.
c.
4.
What it is?
Who funds it?
Who are its partners and users?
Research grants
Education & career development
p
Infrustructure and resources
Translational research & training on the Bloomington campus
a.
b.
b
c.
d.
e.
What is its role?
How
o do we
ep
promote
o o e it a
at IUB?
U
How do we increased IUB participation in the I-CTSI?
How can IUB strengthen the I-CTIS?
Annual Bloomington InCTSI retreat
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Questions?
Q
estions?
Suggestions?
gg
Future directions?