Title: CTSI newsletter
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Title: CTSI newsletter
Series Title: CTSI newsletter
Physical Description: Serial
Language: English
Creator: Clinical and Translational Science Institute, University of Florida
Publisher: Clinical and Translational Science Institute, University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: July 2008
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Volume ID: VID00001
Source Institution: University of Florida
Holding Location: University of Florida
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Volume 1, Issue 1 July 2008


From The Director 1

CTSINews 4

Seed Money Available 6

Biomedical
Informatics Program 7


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909


FROMito goal. I
Welcome to the first edition of the CTSI
News! With great help from one of our
partners, the College of Journalism and
Communications, UF's new Clinical and Transla-
tional Science Institute goes "live" today. In this first
edition of our newsletter we'll try to explain who
we are, how we came into being and what we intend
to accomplish, which is nothing less than a cultural
sea-change at UF in the way it conducts clinical and
translational research and training. And I used the
word "partners" deliberately to emphasize the absolute interdependency
of every academic and intellectual element of the Institute in realizing this
ambitious goal.

Whenever you make significant changes to an organization, it can become
an occasion for both excitement and anxiety. As we look forward to the
evolution of the CTSI, I wanted to write about the goals of the Institute and
some of the concrete organizational steps we will take to meet those goals.
Everything that you'll read about the Clinical and Translational Science
Institute will be aimed a furthering its essential mission: to encourage and
improve the path of discoveries from basic science to clinical research to the
practice of medicine and back again.

More than a generation has passed since the term "bench-bedside inter-
face" was first used to describe the diffusion of information between basic
research laboratories and the clinical arena required to translate scientific
discoveries into practical advances in the diagnosis, prevention, treatment
and cure of human diseases. The explosion over the last decade of new
scientific methodologies and technologies, such as the "omics" (genomics,
proteomics, metabolomics), stem cell, structural and computational biology,
gene transfer and imaging, have transcended individual disciplines and have
become powerful incentives for their integration. It's also become obvious
that the transfer of new knowledge isn't unidirectional, i.e., from the bench
to the bedside, but, at its best, is highly iterative and dynamic. This is par-
ticularly so at the initial interface between discovery and development and
at the bi-directional interface between the scientific and lay communities.

The University of Florida's General Clinical Research Center (GCRC) has














Volume 1, Issue 1 July 2008

FRM TH DIRETO
COTNE


been, since 1962, charged with assisting scientists
who want to conduct research in a clinical setting.
Established by Congress and funded by the NIH,
UF's GCRC (one of about 78 such centers in the
U.S.) has provided many types of assistance to the
research communities at UF. The CTSI will build
on, and vastly expand, the mission of the GCRC.

There are four basic goals that the institute will
strive to meet. They are: creating the proper envi-
ronment for fruitful research, training the individu-
als who will form research teams, making better
technology more available for conducting research
and applying the results, and increasing the oppor-
tunities for individuals and teams at all stages of
research and application to work together to im-
prove health and healthcare throughout the state, the
country and the world.

The CTSI will create a better environment for
research and practice by helping to eliminate bar-
riers between teams working at different stages of
basic research and clinical practice. Through a vari-
ety of means, ranging from administrative support to
information dispersion, the Institute will help foster
inter-team cooperation and the resulting translation of
discoveries into products and practices.

Such "team science" is enhanced when all members
have access to the training required to improve their
job skills and stay abreast of the latest developments
in their field. The CTSI will offer a level of training
that will not only help individuals become better in
their positions, but will enable them to become leaders
in their clinical and scientific fields.

Infrastructure is critical to cutting-edge research, and
the CTSI will provide superior technology and leader-


Fig 1. Collaborating Partners in the CTSI

ship in making new discoveries and removing institu-
tional barriers to their translation into clinical research
and practice. Whether the technology involves in-
strumentation for research or systems for information
retrieval and dissemination, the CTSI will act in a
critical infrastructure support role.

Information that flows readily between members of the
scientific and clinical communities can foster new top-
ics of research and create opportunities for coopera-
tion and collaboration. The CTSI will engage in active
outreach to all members of the research and healthcare
communities to encourage information exchange and
professional collaboration. A Community Advisory
Council will help involve community members in the
process of improving healthcare for Florida's citizens.
Special attention will be given to the needs of children
and under-represented minorities.


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909














Volume 1, Issue 1 July 2008

FRM TH DIRETO
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In order to fulfill the goals of the CTSI, a new orga-
nizational structure will be created and housed on
campus. The Administrative Core of the institute will
provide administration and support for the investiga-
tors who are at the heart of the CTSI. Together, they
will deliver the major functional components of the
CTSI (FIG. 1), which are:

* Research Design and Analysis
* Translational Technologies and Resources
* Comprehensive Drug Development
* Patient-Oriented Research Venues
* Community Engagement and Research
* Pilot and Collaborative Projects
* Training and Professional Development
* Biomedical Informatics
* Regulatory Knowledge and Research Support
* Clinical and Research Ethics

The programs to support these functions and their
staffs will constitute the CTSI Commons. These open
forums will bring together all members of the CTSI
community through programs such as:

* The CTSI Newsletter, which will include both a
regular publication and electronic chat rooms.
* CTS Grand Rounds, modeled on grand rounds of
clinical departments, which will include both a talk
and a discussion based on the work of a CTS com-
munity member or outside investigator.
* The CTSI Visiting Scientist Program, which will
building on the successful GCRC Visiting
Scientist Program.
* Out-of-the Box Lunches, for informal meeting
and discussion of creative ideas.


* Annual Research Symposium, an annual retreat
for members of the community to discuss the
on-going state of the CTSI.

Obviously, this list isn't exhaustive. It is, however,
intended to give an idea of the breadth of programs
the CTSI will offer, and the expansive vision that will
guide its operation. Governance of the Institute is the
charge of a 16-member Steering and Planning Com-
mittee made up of representatives of UF's biomedical,
healthcare, and other affiliated colleges and communi-
ties. The SPC's broad range of collective experience
and individual expertise will be taped to establish
principles, strategies, and policies that will make the
CTSI an effective instrument for enriching clinical and
translational research and training at UF.

Stay tuned for much more to come!

Peter W. Stacpoole, Ph.D., M.D.
Director, CTSI
Director, GCRC
Professor of Medicine, Biochemistry and
Molecular Biology
Associate Dean for Clinical Research and Training,
College of Medicine


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909













Volume 1, Issue 1 July 2008





Communities Brought Together
he University of Florida, through the CTSI, will bring together the skills, training and experience of a
dozen colleges, two campuses, two regional healthcare systems and all 67 Florida counties (FIG. 2).
The colleges involved include Agriculture and Life Sciences, Dentistry, Engineering, Fine Arts, Health
and Human Performance, Liberal Arts and Sciences, Journalism and Communications, Medicine, Nursing,
Pharmacy, Public Health and Health Professions, and Veterinary Medicine. Both Shands and the North Florida/
South Georgia VA Health Systems will be involved in the CTSI, as will the Institute for Food and Agricultural
Science's Extension program. It's a huge group of individuals and organizations, but what will the CTSI hope to
accomplish by this partnership? Simply stated, the CTSI will work to overcome institutional and cultural bar-
riers to communication and collaboration between scientists and professionals in diverse disciplines to aid in
preventing, diagnosing, treating and curing disease. The end result should be nothing short of a transformation
of Florida's clinical and translational research enterprise.


Figure 2.
Major Components
of the CTSI


University of Florida Colleges
Agricultural and Life Sciences, Dentistry, Engineering, Fine Arts, Health and Human
Performance, Journalism and Communications, Liberal Arts and Sciences, Medicine,
Nursing, Pharmacy, Public Health and Health Professions, and Veterinary Medicine


/


IFAS Extension
Advisory Council


- H-- Healthcaie Systems -s
Shands, North Florida, South
Georgia VA Hospital


The university is not simply waiting for funding from the NIH to begin the transition to the CTSI. UF has al-
ready committed thousands of feet of newly-renovated space and millions of dollars in funding to the creation
of the new Institute. The Institute will also make seed money available this year to members of the CTSI com-
munity who want to develop pilot projects that will lead to new extramural grant applications. More information
on these funding opportunities will appear shortly in the next issue of the CTSI News.
Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909


I


I














Volume 1, Issue 1 July 2008


Communities of Practice

One of the core issues addressed by the CTSI
is that scientists and healthcare professionals
tend to spend their time concentrating on the
area of their immediate concern. It's widely accepted
that members of the research and healthcare communi-
ties could learn from one another if given the chance,
but, as noted earlier, the infrastructure to facilitate that
communication has not been optimal. The CTSI will
provide the venues and mechanisms for communica-
tion within "communities of practice", assisting in the
development of both institutional and cultural means
for sharing information. If scientists, healthcare pro-
fessionals, and the public can be encouraged to share
information more broadly, the hope is that new ways
of solving problems, new ideas for research topics, and
new opportunities for moving scientific discoveries
down the path toward new treatments will be found.

This year the CTSI will occupy renovated space in
the Health Science Center campus to establish its
new academic home that will provide the leadership,
infrastructure and resources to oversee and guide the
transformation of CTS at UF. It will house offices for
the Administrative Core of the Institute and for many
of the faculty and staff associated with the component
programs identified in FIG. 2 that will be discussed in
subsequent issues. The plans for the CTSI recognize
that working in cross-disciplinary teams may require
training that most laboratory- based scientists and
healthcare professionals have never received. That's
why funding for new training programs is included
within the CTSI. This funding recognizes the impor-
tance of training future leaders in the communication,
management and research skills that will allow them to
make use of the practices and processes embodied
in CTS.


An Aggressive Timeline

The transition to the CTSI will begin this year
in tangible ways with the inauguration of pilot
project grants this fall; a Visiting Scientist Lec-
ture series (Jeremy Nicholson and Elaine Holmes from
the U.K. speaking on July 24 about the new field of
Metabolomics); development of new technology cores
in Metabolomics and Biobehavior; the beginnings of
a major initiative in Biomedical Informatics; opening
within the next few months of the Institute's Office of
Regulatory Affairs for assistance in circumnavigating
local and federal regulations in areas such as investi-
gational drugs and devices; and a centralized Research
Portal (both physical and electronic) through the
Administrative Core for CTSI protocol development.
Mechanisms for tracking the milestones and outcomes
of each new program will come on line within the next
year and will continue through the Institute's five-year
planning window.

The objectives are aggressive and ambitious. However,
they speak to the critical need to integrate UF's rich
environment of distinguished colleges, state-of-the-art
research facilities and statewide health education and
health delivery systems in a manner that will place
our institution at the forefront of the new discipline of
Clinical and Translational Science.


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909














Volume 1, Issue 1 July 2008


No Longer Lost in Translation: the New
Discipline of CTS and the Transfer
of Information

To improve the process by which scientific
discoveries become tools for healthcare profes-
sionals and to enhance communications be-
tween members of the scientific and healthcare com-
munities, the National Institutes of Health launched a
new initiative in 2005 called the Clinical and Trans-
lational Science Award (CTSA) program. CTSAs are
designed to incorporate and expand upon the funding
provided General Clinical Research Centers (GCRCs)
that for almost 50 years have been the principle venues
at academic health centers in which hypothesis-driven
research using human subjects is carried out. UF's
GCRC, located in Shands hospital, began in 1962 and
is one of the country's oldest continuously federally
funded Centers.

When one four-letter acronym becomes another, it's
tempting to think that nothing but the letters are chang-
ing. In the case of our GCRC's transition to the CTSI,
the name is the least of the changes involved. Indeed,
on a national level the move to CTSAs will be accom-
panied by consolidation, as approximately 78 GCRCs
become 60 CTSIs. The shift to the CTSI model is in-
tended to build on the success of the traditional GCRC
program while improving key areas in process and
communications among the various communities that
make up the CTSI. In particular, the Institute is struc-
tured to target what NIH defines as the two "nodes"
of translational science: the translation of laboratory
discoveries to "first-in-human" clinical trials and the
translation of clinical research to community prac-
tice, through new treatments, healthcare policies and
healthcare delivery.


he CTSI benefits are about to begin. A pool of
seed money for grants under the CTSI is being
made available by the university, with initial
grants for graduate students and faculty anticipated
by the end of September 2008. Be watching for the
next issue of the newsletter for details on the proposal
process and more information on the precise amounts
available. The time-line is short, so start thinking about
the projects that you would like to see funded under
these initial CTSI pilot project grants.






General Information
Peter W. Stacpoole (stacpool@ufl.edu)
Christopher D. Batich (cbati@ufl.edu)

Office of Regulatory Affairs and Licensing
Waj eeh Bajwa (waj eeh@bajwa.net)

Office of Budget Development and Negotiations
Candy Caputo (candy.caputo@medicine.ufl.edu)

Clinical and Research Ethics
H. Robert Kolb (kolbb@gcrc.ufl.edu)

Translational Technologies and Resources (Cores)
Jesse F. Gregory (jfgy@ufl.edu)

Community Engagement and Research
Elizabeth A. Shenkman (eas@ichp.ufl.edu)

Research and Design Analysis
Keith E. Muller (keith.muller@biostat.ufl.edu)

Biomedical Informatics
Mike Conlon (mconlon@ufl.edu)


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909














Volume 1, Issue 1 July 2008


n the not too distant past, clini-
cians and researchers felt they
didn't have enough data at their
fingertips to find answers to many
of the deepest questions they had
about diseases and the best ways to
treat them in their patients.

That problem of too little data has
disappeared, replaced by perhaps
an even weightier issue: How to
adequately sort out and pull togeth-
er the appropriate strands of data
from among the heaps being created
these days so they can be used to
translate basic research studies into
new and better disease treatments
more quickly and improve the care
that patients receive in
the meantime.

Those who know the problem most
intimately say these are lofty goals,
but that endeavors to accomplish
them at a time when data issues
have become extremely compli-
cated will be significantly enhanced
by establishing a biomedical infor-
matics program at UF's proposed
Clinical and Translational Science
Institute to assist researchers and
clinicians from across campus do
just that.

Particularly in the two decades
since the invention of the personal
computer, collection of data of all
kinds is ubiquitous. Technology-


enabled machine production of data
has also exploded with the capabili-
ties to sequence genes, automate
patient monitoring in hospitals and
clinics, and create immense digital
images. Consider as an example the
seven terabytes of data generated
by a single genetics-based phar-
macy study at UF. Seven terabytes
is equivalent to about 200 laptops
worth of data, about 3.5 million
pages of text, or enough books to
line the home team sideline of more
than three Gator football fields.

"It's very easy to make data these
days," said Michael Conlon, Ph.D.,
UF's director of data infrastructure
and interim director of biomedical
informatics. "It's not very easy to
use it, and biomedical informatics is
about using it."

And it's about using it in two
important ways, according to
Conlon. The first is to assemble all
the appropriate components from
what are now disparate basic sci-
ence research studies in a variety of
disciplines so that, as a whole, the
information can improve the under-
standing of diseases and translate
that knowledge sooner into new and
better disease treatments.

Second, biomedical informatics
works to bring together all the exist-
ing data about each patient so that


his or her clinician, and the patient
as well, will have it all available in
one place information, for exam-
ple, from various doctors, clinics,
hospitals, pharmacies, imaging cen-
ters, and even genetic sequencing
- in order to ensure the best pos-
sible treatment and care decisions.

"Data about you is everywhere, and
bringing it together in some reason-
able way is important to you and
it's important to your caregivers,"
Conlon said. "We're looking at a
very holistic view."

Not only does BMI hold promise
for significantly improving research
and patient care, but it has potential
for creating a more efficient health
care system in which clinicians
would know the genetic makeup
of their patients and could use that
information to determine specifi-
cally which therapies would work
for each person.

"But you can't do any of this with-
out informatics because you've got
to hook all this stuff up, otherwise
it's just data in a drawer it's data
in a drawer, data in a hard drive
somewhere it's not a part of the
environment that you can use to do
this work," Conlon said.


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909














Volume 1, Issue 1 July 2008


BMI is a complex field in
which informaticians like
Conlon often think in terms of
"stacks" of data-related work
segmented by layers. The
stack's top layer contains the
lofty goals of improving scien-
tific research and patient care.
The bottom layer consists of
infrastructure or hardware all
the networks, computers, stor-
age devices and other compo-
nents where data is held.

Sandwiched in between are two
giant but often overlooked
- layers in which biomedical
informaticians are working to
figure out how to make the data
useful. The layer directly above
the infrastructure is data man-
agement. It involves all of the ef-
fort, engineering, utility and think-
ing that go into efficiently storing
the information in ways that allow
it to be easily accessed for later use.
The next layer up, falling just below
the lofty goals, comes the challenge
of finding ways to display the thou-
sands or even millions of pieces of
data so it can be analyzed.

"We used to display 100 data
points, now we've got 5 million,"
Conlon said. "So we have to have
visualization techniques that are
optimized for handling massive
amounts of data, and those tech-


niques cannot obscure any impor- now commonplace in research and
tant scientific features of the data." patient care, Conlon said. "We're
now creating the capability that we
The use of biomedical informatics need now and forever to address the
is in its earliest stages at UF and ever-increasing complexity of data
worldwide, but it underpins the in the modern science world."
university's large-scale research
initiatives, Conlon said. He foresees
a program that will one day become
a distinct academic department with
as many as 30 biomedical informa-
ticians involved in scientific re-
search across all disciplines at UF.

Previously the problems being
investigated at UF did not require
the kind of complex data that are


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.8909




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