The National Center for Advancing
Translational Sciences
The Clinical and Translational Science Award
Program in the Division of Clinical Innovation
CHRISTOPHER AUSTIN, M.D.
DIRECTOR, NCATS
PETRA KAUFMANN, M.D.
DIRECTOR, NCATS Division of Clinical Innovation
CTSA PRINCIPAL INVESTIGATOR MEETING
FEBRUARY 3-4, 2015
NCATS FY 2015 Budget
Update
• In December, the President signed the CRomnibus


It is a combination of a CR for the Department of
Homeland Security (through February 27, 2015),
And an omnibus covering funding for the rest of the
government (through September 30, 2015)
• It includes funding for NCATS at approximately the
same level as last year ($635 million, 0.3% increase)
2
Congressional Briefings
• NCATS is still new (3 yrs 2 mos) and the CTSA
program is important to us so we brief Congress
frequently on our activities
• Over the past year we (Pamela, Petra, other senior
scientists and I) have had meetings with numerous
congressional representatives and staffers, both on
the Hill and at NCATS
• Some highlights include:



21st Century Cures Initiative roundtables and briefings
Meetings with appropriations staff
Visits with Congressmen to their districts
3
4
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.
5
NCATS “3D’s”
evelop
emonstrate
isseminate
6
The Big Picture
• The opportunities for translation are unprecedented.
• The need is enormous.
• Given its local, regional, and national strengths, the
CTSA program is a critical – indeed, unique - player
in the national translational research enterprise.
• Our goal is to bring more treatments to more
patients more quickly through advances in
translational science and operation.
• We need laser-focus on what will get us to this goal.
• We direct research and training towards that goal.
• Patients, current and soon-to-be, are waiting.
7
NCATS Division of Clinical Innovation
Strategic Goals
1. Train, develop and cultivate future leaders in translational science
2. Innovate in translational science
1.
2.
3.
4.
Engage patients and communities in every phase of the translational process
Promote the integration of special and underserved populations in translational
research across the lifespan
Innovate processes to increase the quality and efficiency of translational
research, particularly of multi-site trials
Advance the use of modern informatics in translation
3. Communicate effectively with internal and external audiences using
clear, timely, and consistent messages
4. Measure success of the CTSA program through a set of common
metrics
5. Partner effectively with NIH and other stakeholders
8
Clinical Innovation
From IOM to Implementation
• Based on the IOM report and Advisory Council WG
recommendations, created new CTSA Steering
Committee
• Steering Committee and CTSA PIs identified critical
needs and opportunities
• Four demonstration projects initiated in mid-2014
to pilot solutions prior to implementation via new
FOAs
9
Ongoing consortia demonstration projects
1. Transforming Multi-Site Trials: Central IRBs for the CTSA
Program
2. Innovating Research Participant Recruitment
3. Enhancing Clinical Research Professionals’ Training and
Qualification
4. Innovating Scientific Review for the CTSA Program
10
Austin Visits to CTSA Hubs
• Outstanding scientific advances
• Transformation of local and regional culture that is advancing translation
• Many local success stories
• Lots of great discoveries, less network-wide dissemination
Enhancing Communication about the
CTSA program
• Our goal: to show our stakeholders and the public that the CTSA
program is making transformational contributions to advancing
translational science
• We need your help in bringing successes into the spotlight
• Examples of advances in translational science that follow the 3Ds




What was the general translational roadblock being addressed?
What was the accomplishment and how did it advance a translational project
and/or create a new technology/paradigm that overcomes the translational
roadblock?
How will what was learned be applied to future translational projects locally,
CTSA-wide, and systemically?
Must have clear and substantial contribution from the CTSA program
• I hear about many such success stories every time I visit a CTSA hub
• Let’s trumpet them!
• Cindy McConnell, NCATS Communications Director,
[email protected]
• Terry LaMotte, DCI communications project lead,
[email protected]
Focusing training on translation
“The health needs of the nation call for a generation of scientists trained in
‘interdisciplinary, transformative translational research’ and in the leadership and
team skills to engage in effective collaborative partnerships.” [IOM Report, page 105]
• We aim to increase the translational impact of training by
focusing on

21st century competencies such as
 Team science
 Entrepreneurship
 Regulatory science


Making translation a viable career path
Innovative training methods including externships: “study abroad”
• Many CTSA hubs have outstanding training programs derived
from local strengths but those are not available at other hubs

Enormous benefit to trainees of aggregate hub capacities being
available
• We recognize that some CTSA hubs will need more time than
others to transition to this new focus
Partnering with key stakeholders
“Translation is a team sport.”
“Much is known, but unfortunately in different heads.”
• Given its local, regional, and national strengths, the CTSA program
is a critical – indeed, unique - player in the national translational
research enterprise
• The CTSA program is increasingly developing innovative and
comprehensive solutions to key challenges in translation
• However, it is only a small part of a larger ecosystem (1.6% of NIH,
0.5% of total) and needs to partner with key stakeholders, to


Leverage its resources
Ensure relevance and applicability of solutions
 “Translation” = to “carry across”
• NCATS is actively engaged in information exchange and
partnerships with






NIH Institutes and Centers
FDA
PCORI
Global players in translational research
Biotech and pharma
Patient advocacy groups
Innovation and continuity
• Capacity to innovate requires a solid base
• The CTSA program has an increasingly strong
set of tools and methods – locally and nationally
• What we have accomplished in 2014 represents a fantastic
start toward the NCATS (and IOM) goals
• We look forward to more creativity, innovation,
unconventional thinking, and experimentation


Translational science encompasses some of the most difficult
problems in science today
Difficult scientific problems require diversity of approaches,
experimentation, expectation of reiterative cycles of learning
 The only thing that is constant is change ― Heraclitus, d. 474 BC
 The higher your structure is to be, the deeper must be its
foundation ― Augustine, d. 430 AD

In the CTSA “Sundae”, keep the delicious and diverse ice cream
flavors, enable innovative toppings and creative cherries on top
In Models in Paleobiology, Schopf, TJM (ed). Freeman,
Cooper & Co, San Francisco, 1972, pp. 82-115
16
And now… over to Petra