The Role of the Indiana CTSI:
Impacting the Life Sciences Sector,
Translating Science Into Therapies
November 12, 2015
Chris Eckerle,
Project Director, BioCrossroads
Thank You
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The Role of the Indiana CTSI:
Impacting the Life Sciences Sector,
Translating Science Into Therapies
November 12, 2015
Indiana’s Position in the Past, Present & Future
November 12, 2015
Evolution of the Translational Science at NIH
1960
1970
2004
National Institutes of Health (NIH) develops vision to foster patient-oriented research (POR) and
creates 5-year renewable competitive grants for the establishment of General Clinical Research
Centers (GCRCs). 5 funded sites.
NIH awarded equal number of research project grants to MD, MD-PhD and PhD
scientists. By 2005: 7000 grants to PhDs; 3000 to MD and MD PhDs combined.
GCRCs described by Congress as “critical” infrastructure for POR. GCRCs expected to be a driving
force behind future biomedical research. 80 GCRCs.
2005
Implementation of the NIH Roadmap and efforts to revitalize clinical and translational research
lead to phasing out of GCRC program.
Funding consolidated and redirected to launch CTSA program.
2006
Following the first round of awards, NIH added between 5-14 new sites each year until the
program reached level of 62 sites nationwide in 31 states and the District of Columbia.
2012
NCRR dissolved,
and National Center for Advancing Translational Science (NCATS) founded.
Evolution of NIH CTSA
2004: The NIH
Roadmap
2005: Conceiving
the Program
2007: Anticipating
the New Era
CTSA Today
NCATS Mission
To catalyze the generation of innovative methods and technologies
that will enhance the development, testing and implementation of
diagnostics and therapeutics across a wide range of human
diseases and conditions.
Some of the scientific translational
problems on NCATS’ to-do list
► Predictive
toxicology
► Predictive efficacy
► Derisking undruggable
targets/untreatable diseases
► Data interoperability
► Biomarker qualification process
► Clinical trial networks
► Patient recruitment
► Electronic Health Records for
research
► Harmonized IRBs
► Clinical
diagnostic criteria
► Clinical outcome criteria
(e.g., PROs)
► Adaptive clinical trial designs
► Shortening time of
intervention adoption
► Adherence
► Methods to better measure impact
on health…
Some of the organizational translational
problems on NCATS’ to-do list…
►Data
transparency/release
►IP management
►Integration of project management
►Incentives/credit for team science
►Incentives/credit for health improvements
►Education/Training (scientific and cultural)
►Collaborative structures
►
Public-private partnership models
Recent Developments
 In its 2013 report, the Institute of Medicine (IOM) recommended the
creation of a Working Group within NCATS.
 In 2014, the Working Group set forth measurable goals for the
CTSA program including:
 Workforce development
 Collaboration and engagement of stakeholder communities
 Integration of translational science across lifespan
 Method and process improvement to enable hubs to
function individually and collectively
 The 2014 CTSA RFP was revised to emphasize patient and
community engagement, and collaboration between CTSA hubs
CTSA 2015
 The 2015 CTSA RFP is expected to be refashioned even more
significantly in response to IOM and Working Group
recommendations, and feedback over the last year
 Anticipated changes include:
 A focus on funding program priorities
 Expanding to fund more sites using smaller grants
 Emphasis on interdisciplinary team science
 Recognizing the value of non-traditional contributions of CTSA
hubs to the national platform
 Creating new models for POR
 It is clear that CTSA remains a priority for the Administration
 President Obama’s FY2016 budget request asked for 72% of
total NCATS funding to be allocated to CTSA
Evolving the CTSA Program to
Transform Clinical Translational Science
CTSA Hubs
RIC:
TIC:
Recruitment Innovation
Centers
Trial Innovation Centers
Central IRB
Contracting
Budgeting
Other support PRN
Feasibility Assessment
Recruitment Plan and
Implementation
Multi-site Study funded by NIH IC
or others
Clinical
Lead
Stats/Data
Management
No need to
re-build trial
components
each time
Domain Task Forces
The Indiana CTSI
Indiana’s CTSI: Report Methodology
1.
2.
3.
4.
Several metrics were developed to measure CTSA site performance.
Data collection methods included:
a) Literature review
b) Interview with site leaders
c) Publicly-reported data
d) Insights from key opinion-leaders
Six candidate CTSA hubs were selected to inform the report based on eight
key measures: Three “comparable” hubs were chosen with similar funding
levels to Indiana University’s, and two “outlier” hubs were chosen with
much higher levels of NIH funding than Indiana University
Three key areas of CTSA activity were identified:
a)
Translational Science
b)
Community engagement and impact
c)
Education and workforce development
Measurable variables and qualitative data were used to generate individual
site reports, summaries, and key comparisons
Selected CTSA Hubs
Institution
Funding Level for
CTSA PIs (FY14)
Total NIH Funding
(FY14)
Total Bioscience
Industry Employment
Population of the
Region
School of
Public
Health
Health
System
Health
Ranking*
Indiana University
$6,715,523
$147,332,684
57,644
1,953,961
Yes
Yes
41
Albert Einstein
College of Medicine
$5,217,637
$157,391,499
76,070
19,949,502
No
Yes
15
Emory
$6,229,144
$265,282,296
27,667
5,522,942
Yes
Yes
38
University of Texas
$6,451,913
$156,565,936
80,792
6,810,913
No
Yes
36
Washington
University
$10,722,640
$371,946,949
28,109
2,801,056
No
Yes
39
Stanford
$10,497,336
$384,340,065
235,864
1,919,641
No
Yes
21
* America's Health Rankings: http://www.americashealthrankings.org/about/annual
Key Findings Across Hubs



Positive shift in relationships within universities
 Increased collaboration and interaction within the
university, as well as with university leadership
Blurring the lines between research program and clinical care
 The extent to which the CTSA hubs are informing and
partnering with local responses to health care reform
pressures is striking
Concern about the future direction of CTSA program
 The use of a new CTSA hub funding formula tied to the
host institution’s overall NIH funding level
 Rising emphasis on standardizing processes around
translation and especially in the conduct of clinical trials
Key Findings Across Hubs



Incentivizing Team Science
 Program has maintained emphasis on enabling
multi-disciplinary and multi-organizational approaches to
research and development
 However, while there was a consistent acknowledgement of the need for this
strategic shift, the traditional mechanisms for professional promotion and
recognition at the hubs remain largely intact
Industry Remains Substantially at Arm’s Length
 For the majority of sites contacted for this report, external industry
relationships do not play a central role in the CTSA hub
Community Engagement
 All hub leaders were quick to acknowledge the importance of
community engagement
 But, it is more difficult to plan and execute in a rigorous manner as both the
nature and degree of CTSA program expectations are in flux
Summary of the Indiana CTSI Structure
Key Findings – Indiana CTSI

The Indiana CTSI is a leading CTSA program hub when compared to peers across the nation.

Very few comparable mechanisms exist in the region with the skills, flexibility, and mission to
bridge the academic, industry, and clinical components of the sector:
Key Findings - Indiana CTSI
Where does Indiana’s comparative strength come from?




A founding principal investigator who is uniformly recognized as
a translational science thought leader
Industry commitment at the highest levels
Multitude of organizations that are co-invested with the Indiana
CTSI across translation, commercialization, and health impact
Perhaps most importantly, a supportive regional life sciences
sector that increasingly values and rewards collaboration among
its participants with the Indiana CTSI
CTSA Future Challenges
Congress & the Public: What are we getting for our nation’s investment in the NIH?
Challenges
►
People are unhealthier and funders of biomedical research enterprise
(private and public) are impatient
►
The number of new drugs approved by the FDA per billion dollars spent on R&D
has halved every year since 1950
CTSA Future Opportunities
Opportunities
– We are entering a pivotal stage of development
for the program as it grows from a definitional
phase to maturity
– Expectations for the CTSA program to deliver will
continue to mount and continue to place
pressure on the NIH and recipient institutions
– The question will remain: Is the CTSA bringing
more innovation into clinical practice and
improving health outcomes for Americans to
make it worth the investment?
– If hubs continue to rise to the challenge as
Indiana has, then the answer is yes
The CTSI as the translational HUB in Indiana
Accelerating Clinical and Translational Research
SPARC
Indiana CTSI launches
multi-state consortium to
spark translational
medicine collaborations
@BioCrossroads
#CTSI
#INlifesciences
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