National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH
Accelerating
and enhancing research from basic discovery to improved patIent care
Building a National CTSA Consortium: Goals
and Opportunities
January 8, 2009
Indiana Clinical and Translational Science Institute
First Annual Meeting
Barbara Alving, M.D., MACP
Director
National Center for Research Resources
The Translational Research Gap
Source: Butler D. Translational research: Crossing the valley of death. Nature. 2008;453:840–2.
The Translation Gap
Source: Butler D. Translational research: Crossing the valley of death. Nature. 2008;453:840–2.
U.S. Hispanic Population by County, 1980
1980: Hispanic population concentrated in a few counties, mostly
near Mexican border
Source: Where Latinos Live: Pew Hispanic Center. 2008. Available at http://pewhispanic.org/states/population.
U.S. Hispanic Population by County, 2007
2007: Hispanic population has spread substantially
Source: Where Latinos Live: Pew Hispanic Center. 2008. Available at http://pewhispanic.org/states/population.
National Health Expenditures as a Percent of GDP
20%
Percent of U.S. GDP
18%
16%
14%
12%
10%
8%
Actual
Projected
Clinical and Translational Science Awards (CTSAs)

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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
CTSA – Creating National Partnership Opportunities
Consortium Governance
Advisory: providing guidance
and input to the NCRR Director
Oversight: identifying and
selecting collaborative
opportunities to facilitate
research, coordinating
Consortium-wide approaches to
research, and overseeing topicspecific efforts across the
Consortium
www.ctsaweb.org
Steering: coordinating
institutional topic-specific efforts
with the national CTSA
Consortium; each Steering
Committee has an Operations
subgroup that takes timely action
on emergent topic issues
CTSA National Strategic Plan Priorities
Goal One:
 Enhancing National Clinical and Translational
Research Capability
 Clinical research management
 Research infrastructure
 Phenotyping – human and preclinical models
Goal Two:
 Enhancing Training and Career Development of
Clinical and Translational Investigators
CTSA National Strategic Plan Priorities
Goal Three:
 Enhancing Consortium-Wide Collaborations
 Social networking
 Inventory of resources
 Data sharing
Goal Four:
 Enhancing the Health of Our Communities and the Nation
 Community engagement
 Public health policy
Clinical and Translational Science Awards (CTSA)
Clinical
Research
Ethics
Biomedical
Informatics
Trial Design
Advanced
Degree-Granting
Programs
CTSA
HOME
Clinical
Resources
Biostatistics
NIH & other
government
agencies
Industry
Participant
& Community
Engagement
Regulatory
Support
Each CTSA academic health center will create
a home for clinical and translational science
Healthcare &
community
organizations
CTSA – Providing Local Leveraging Opportunities
Atlanta Clinical and Translational Science Institute (Atlanta-CTSI)
at Emory University
Kaiser Permanente
Georgia
Children’s
Healthcare
of Atlanta
Complex Carbohydrate
Research Center
at U Georgia
Yerkes National Primate
Research Center
CDC
Emory
University
Atlanta VA
Medical Center
Morehouse
School of
Medicine
Georgia
Tech
Georgia
Research Alliance
Georgia Bio
Indiana CTSI – Providing Leveraging Opportunities
Throughout the State
Biocrossroads
Wellpoint,
Inc.
Roudebush VA
Medical Center
Clarian Health
Partners
Indiana
University
Regenstrief
Institute
Eli Lilly
and Company
Purdue
University
Richard M.
Fairbanks
Foundation
Notre Dame
Wishard Health
Services
Cook Group,
Inc
Indiana State
Government
Indiana Health Study
Indianapolis is a health challenged community with some of the highest
rates of obesity, heart disease, smoking, and diabetes in the country.
Indiana Health Study
 Longitudinal study of the population of Indianapolis
and surrounding communities
 Collaboration between Fairbanks Institute,
Biocrossroads, Indiana University School of Medicine,
Regenstrief Institute, and other community health
leaders in Indiana
 Focus is on coronary artery disease
Research Centers in Minority Institutions (RCMI) and
CTSA Partnership Example
Vanderbilt University and Meharry Medical College

Community Engagement and Research program

Promotes educational and research activities that
will enhance translation of basic research into the
clinic and into the community

A “bench to bedside to community” project
RCMI-CTSA Partnership Example
CTSA at Weill Cornell Medical College

Partnership includes Weill Cornell Medical College, other
Cornell University schools and hospitals, and the Hunter
College Center for the Study of Gene Structure and Function

Clinical and Translational Science Center, a unique and diverse
biomedical complex on Manhattan’s Upper East Side

State-of-the-art resources for clinical/translational research

Nurtures minority talent and has an effective electronic network
with minority scientists nationwide
CTSAs – Building a National Consortium
of Academic Health Centers
Currently 38 CTSAs Sites Across the Country
WA
MT
ME
ND
OR
VT
MN
ID
NH
WI
SD
NY
WY
MA
RI
MI
PA
IA
NE
NV
IL
UT
OH
IN
CO
MD
WV
KS
CA
NJ
MO
CT
DE
VA
KY
NC
TN
OK
AZ
AR
NM
SC
MS
TX
AK
AL
GA
LA
FL
HI
Participating Institutions
Members 2006 & 2007
New Members 2008
PR
CTSA – Creating Regional Partnership Opportunities
University of
Washington
Oregon Health &
Science University
University of
California, Davis
University
of Iowa
Mayo Clinic
College of
Medicine
University of Wisconsin
University
of Chicago
University of
Rochester
Yale University
Weill Cornell Medical College
Columbia University
University of
California,
San Francisco
Rockefeller University
Albert Einstein
College of Medicine
Stanford
University
= CTSA Institutions
= East Coast Consortium
The Scripps
Research Institute
= Midwest Consortium
= West Coast Consortium
Washington
University
in St. Louis
Educational Impact of CTSA Program

Doubled the clinical and
translational training workforce
from 2006 - 2008

Increased the number of regional
training interactions among
consortium sites

Awarded a supplement to develop
a National CTSA Educational
Resource Program (NCERP) that
will:

Identify, catalog, and assess
training modules in clinical and
translational research

Enhance and broaden training
opportunities for clinicianscientists across the CTSA
consortium
Educational Impact of CTSA Program
(Based on 2008 Annual Progress Reports from first 24 CTSAs)
Field of Training
Clinical Disciplines (includes 37
subcategories)
Pediatric Disciplines
Public Health
Stats, Res Methods, Informatics
Genetics
Allied Health
Immunology
Nursing
Bioengineering
Neuroscience
Psychology, non-clinical
Physiology
Microbiology and Infect Diseases
Pharmacology
Molecular Biology
Other
Total
# of
Investigators
# of Trainees
and Scholars
3,948
272
516
29
317
50
176
10
134
9
121
16
115
7
110
20
108
10
108
18
93
5
77
5
69
8
61
10
53
7
250
37
______
______
6,256
513
Multiple Principal Investigators
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Traditional single-PI model does not always work
well for multidisciplinary efforts and collaboration
Growing consensus that team science would be
encouraged if more than one PI could be recognized
on individual awards
Overarching goal: maximize the potential of team
science efforts, responsive to the challenges and
opportunities of the 21st century
http://grants2.nih.gov/grants/multi_pi/index.htm
CTSA Consortium – Building Connections at
Columbia University
Irving Institute for Clinical and Translational Research
CTSA Program:

Helped inspire Columbia neurologist Petra Kaufmann, M.D.,
to reach outside her discipline to find a collaborator to build
an apparatus to help children with spinal muscular atrophy
(SMA)
 Partnered with Elisa Konofagou, Ph.D., Assistant Professor
of Biomedical Engineering and Radiology to design the
prototype
 Resulted in a device to help SMA patients use their arms
Support for CTSA Consortium-Wide Projects
Administrative supplements

$2.5 million in FY 2008 to support consortium-wide
projects including:
 Informatics – National web portal for research
volunteers

Education – National CTSA Educational Research
Program (NCERP)

Communications – Exploring web-based methods to
maximize sharing in the CTSA consortium
Encouraging and Enhancing Collaboration
CTSA Consortium – Informatics Pilots
Clinical and Translational Information Exchange Environment
Informatics Pilots

Implementation and development of tools for clinical
investigators to facilitate small and medium sized
research studies
 Enhance the collection and management of data in small
and medium sized studies
 Requirements
 At least three CTSA must collaborate
 Data and software sharing
 Must incorporate institutional database support that is
flexible, secure, and easily accessible on demand
Informatics Pilot Projects Under Development
PhysioMIMI at Case Western Reserve University
 Includes investigators from Marshfield Clinic, University of
Wisconsin and University of Michigan
 Collects, manages, and analyzes diverse data types across
institutions
 Allows secure, safe and regulated transfer of information from
clinical care systems and research databases
Sharing Clinical Data at University of Washington
 Includes investigators from University of California, San Francisco,
University of California, Davis
 Allow researchers to access large shared datasets
 Assist with designing research studies and generating hypotheses
Research Electronic Data Capture (REDCap) at Vanderbilt
 Includes investigators from Oregon Health and Sciences University
and Mayo Clinic
 Provides workflows to develop secure, web-based applications for
collecting, managing and sharing of clinical study data
Informatics Pilots Under Development
University of
Washington
WA
MT
ME
ND
Oregon
OR
Health
& Science
University ID
MN
SD
WY Clinic College of Medicine
Mayo
University of California,
Davis
IA
NE
NV
Mansfield Clinic
University of
WI
Wisconsin–
Madison
University
of
MI
Michigan
IL
UT
CO
University of California,
San Francisco
KS
CA
MO
MD
DE
VanderbiltNC
University
AR
TX
NJ
PA
KY
SC
MS
AK
MA
CT RI
Case Western
ReserveWV
University
VA
OK
NM
NH
NY
OH
IN
TN
AZ
VT
AL
GA
LA
FL
HI
PR
Regenstrief Institute Medical Informatics
The Regenstrief Medical Record System, a dynamic electronic medical record
system, has helped physicians manage health care information for over a
quarter century and provides unique research opportunities to fellows



Led by Director J. Marc Overhage, MD, PhD, Indiana
University Professor of Medicine and Regenstrief
Professor of Medical Informatics
Comprise one of the largest medical informatics physician
brain trusts in the United States
Identified information technology, including medical
informatics, as a priority area of study to improve the
quality of the U.S. health care system
Technology Resource Cores Workshop:
Designs for Efficient Management and Utilization
In collaboration with the CTSA consortium, NCRR is planning
a 2-day conference in July 2009
Topics to address include:
 Academic institutions’ policies
 Sharing experiences of using cores (Mayo Clinic, for example)
 Service contracts
 Equipment
 Demand for core services
 Personnel
 NIH I/C Issues
National Cancer Institute
Translational Research Working Group (TRWG)
TRWG conceptualized translational research
as a set of developmental processes focused
on different goals (ie, developmental pathway
for anticancer agents –drugs or biologics)
The pathways are graphically represented in Clin Cancer Res 14:
5664-5672, September 15, 2008
Public-Private Partnerships (PPP) Example:
The West Coast Licensing Partnership
Oregon CTSA is part of a group of
institutions willing to designate a subset of
their technologies for marketing and
licensing purposes
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Adds value by bundling related technologies
over individual tools and technologies
Strengthens inter-institutional relationships
between member partners
Increases global access to research tools by
promotion of non-exclusive licensing
Provides simple one-stop licensing of
technologies from multiple institutions
Saves time and money from negotiating
multiple license agreements
CTSA Consortium – Building Connections with
Business Schools
CTSA are partnering with business schools to:

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Develop business plans, design, and implement community
surveys
Create innovative cross-educational programs
Develop case studies to pilot programs
Collaborate with international colleagues
Prepare cost analyses
Protect CTSA-developed patents
Form industry partnership programs
CTSA Consortium – Building Connections at
University of California, Davis
Center for Entrepreneurship seminar to explore links
between research and inventions– topics included:
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Dynamics of the commercialization process of new
inventions
Moving along the path of research to market
Purpose of intellectual property in the commercialization
process
When is an idea worth protecting and why
Options for faculty, students, and staff in commercializing
their research
Resources available to navigate the journey from research to
commercialization
Thomas Edison: A Design Thinker
Design Thinking

Methodology imbues the full spectrum of innovation
activities with an understanding of what people want
and need
Edison’s Approach
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Team-based
Multidisciplinary
Good business sense
Nimble budget
Full product launch — light bulb, electric power
system, etc.
Source: Brown T. Design thinking. Harvard Business Review. June 2008.
“Hell, there are no rules here — we’re trying to accomplish something.”
Thomas Edison
Design Thinkers: Personality Profiles
(Harvard Business Review June 2008, Tim Brown)
Empathy
 Look at work from multiple perspectives (colleagues, clients, end users,
and customers)
Integrative thinking
 See salient and contradictory aspects of problem and find novel
solutions
Optimism
 Assume that at least one potential solution is better than the existing
alternatives
Experimentalism
 Pose questions and explore constraints in creative ways that proceed in
entirely new directions
Collaboration
 Have significant experience in more than one discipline (engineers &
marketers; anthropologists & industrial designers; architects &
psychologists)
Taking a Global View of Design Thinking:
Aravind Eye Care System in India
More than an eye hospital Aravind is:
 A social organization committed to the goal of elimination of needless
blindness through comprehensive eye care services
 An international training centre for ophthalmic professionals and trainees
who come from within India and around the world
 An institute for research that contributes to the development of eye care
 An institute to train health-related and managerial personnel in the
development and implementation of efficient and sustainable eye care
programs
 A manufacturer of world class ophthalmic products available at affordable
costs