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Title: CTSI newsletter
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Creator: Clinical and Translational Science Institute, University of Florida
Publisher: Clinical and Translational Science Institute
Place of Publication: Gainesville, Fla.
Publication Date: June 2009
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From the Director

Participant and
Clinical Interactions
Program
Pilot Project Grants
Awarded

Meet the PCIP
Director


Volume 2, Issue 4 June 2009

Volume 2, Issue 4 June 2009


INSIDE THIS ISSUE I


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700


Some things old, some things new, some things yet-to-be....
Most readers of this newsletter have probably heard of the General Clinical
Research Center (GCRC), located on the third floor of Shands Hospital. Many may
already be veteran investigators of the GCRC as UF's traditional NIH-funded resource
for patient-oriented research (POR). Our Center is one of the oldest in the country, hav-
ing been continuously funded by NIH since 1962, and the vast majority of successful
CTSA applicant organizations have at least one of these institutional resources. Patient-
oriented research and training has and continues to be well-served by the GCRC, which
has leveraged millions of dollars in extramural funds to supplement investigators' own
grants, and the Center has provided resources to conduct POR in diverse disciplines
involving several colleges on campus and has helped launch the careers of innumerable
POR investigators.

Upon the anticipated receipt of a CTSA this year, the budget and management of the
GCRC will be folded into the CTSI. Moreover, as a way to further enhance the oppor-
tunities for POR across campus, the Institute has developed the Clinical and Participant
Interactions Program under the direction of Carl J. Pepine, MD, Professor of Medicine
in the Division of Cardiovascular Medicine and a preeminent POR investigator and
clinical trialist. Under Carl's direction, this new program will help guide eight Clinical
Research Units (CRUs) of which the GCRC will be preeminent in terms of its diversity
and direct funding from the CTSI. As described below, the other CRUs will be focused
on more thematically discrete areas of research. Some of these units already exist, and
our goal is to further enhance their resources for research and training under the aus-
pices of the CTSI; others are still in the planning stages. Thus, the evolution of resourc-
es for patient-oriented research and training at both the Gainesville and Jacksonville
UF campuses is dynamic and holds promise for providing greater opportunities for our
clinical and translational science community.

Read on to find out more about the Participant and Clinical Interactions Program and
what it may offer you.





Peter W. Stacpoole, PhD, MD
Director, General Clinical Research Center
Director Clinical and Translational Science Institute
Associate Dean Clinical Research and Training












Volume 2, Issue 4 June 2009

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PARTICIPANT AND~ CINI CAE L WI INI ~1T6ERACTION~~S I PROGRAM BY CURTI.


UF enjoys a wealth of multi- and interdisciplin-
ary extramurally funded programs engaged
in patient-oriented research (POR). For 46
years many have utilized the resources of the General
Clinical Research Center (GCRC) centered at Shands
Hospital. The GCRC has adapted and changed through
the years, so it's no surprise that recent facility renova-
tions, new resources and an ever-expanding portfolio
of innovative research and training programs have led
to consecutive "outstanding" site visit reviews and five
year renewals for the Center.

In order for UF to continue to be a national leader in
patient-oriented research, the CTSI will coordinate and
implement a unique plan to merge multiple new op-
portunities available within UF's expansive academic
research setting by forging strong partnerships with
the residents of Florida served by statewide healthcare
and health delivery systems. As always, the details
of how the program will increase its effectiveness are
critical. In the case of the GCRC, three goals underlie
and guide the transformation:

Goal 1: Provide outstanding venues for conducting
clinical research and clinical trials in pediatric and
adult populations.

Goal 2: Ensure that consistently high-quality research
is conducted at Clinical Research Units (CRUs).

Goal 3: Establish procedural rules and milestones to
evaluate resource utilization, research productivity and
cost accountability.

Let's look at each goal in turn and see how the CTSI
will meet the challenges of the multiple needs in re-


search....

Goal 1: Provide outstanding venues for
conducting clinical research and clinical
trials in pediatric and adult populations.
During the planning process, UF, Shands and the
Malcom Randall VA Medical Center (MRVAMC)
evaluated the current limitations in their ability to
serve investigators in POR and training. As a result,
the CTSI will transform patient-oriented research at
UF by creating a new network of eight Clinical Re-
search Units (CRUs) that together form the venues of
the PCIP. These sites and their principal activities are
summarized in Table 1.

Shands UF CRU. This traditional GCRC facility will
be transformed into a component of the CTSI and
will continue to serve as a major resource for clini-
cal research on the Gainesville campus. It will also be
the principal venue for small clinical trials involving
gene therapy and rare diseases, and will be the major
venue for mechanism-based research projects involv-
ing pediatric and adult patients whose primary care is
rendered by Shands at UF and the North Florida/South
Georgia Veteran's Health System (NF/SGVHS). Sev-
eral emerging regenerative medicine protocols require
telemetry, and UF and Shands will provide telemetry
monitoring for the first time in the CRU beginning
in early 2009. The transformation from the GCRC
into a CRU network and the renovation of facili-
ties in the Shands at UF CRU are particularly timely
because of the emergence of cell therapy trials from
UF's Program in Stem Cell Biology and Regenerative
Medicine. This program, directed by Edward W. Scott,
PhD, is recognized internationally for the quality and


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PATCIAT NCIICAL INEATOS RGA


breadth of its research. Initial cell therapy trials are
coordinated and led by Carl J. Pepine, MD, in collabo-
ration with John Wingard, MD and Christopher Cogle,
MD, of the Shands Bone Marrow Transplant Unit. The
Shands at UF CRU will be co-directed by Mark Brant-
ly, MD, professor of Medicine, and Desmond Schatz,
MD, professor and vice chairman of pediatrics, both of
whom have been associate GCRC program directors
for approximately 10 years.

Shands Jacksonville CRU. Shands Jacksonville
will be integrated directly into the CTSI's network
of CRUs for POR. To transform its ability to conduct
cutting-edge POR, the College of Medicine in Jack-
sonville has renovated existing hospital space and


constructed a four-bed inpatient CRU and additional
outpatient facilities, with the intention of expanding
this resource in future years as demand grows. This
transformation enables both Gainesville and Jack-
sonville campuses to undertake a true sharing of the
following resources: 1) administrative, regulatory, bio-
statistical, and study design and informatics resources
aligned with the academic home of the CTSI; 2)
on-site research coordinators to assist in CRU studies
and link directly to additional research resources at the
CTSI in Gainesville; 3) complimentary patient popu-
lations relevant to racial, ethnic and socioeconomic
demographics; 4) an increased critical mass of clinical
investigators able to engage in collaborative clinical


Table 1. CTSI Clinical Research Units and Foci
CRU Location Primary Research and Cachement Area and
Training Focus Patient Demographics
Shands UF GCRC, Shands General; rare diseases; gene and International, esp. for rare/genetic diseases
Hospital regenerative therapy trials; pediatric and gene therapy; otherwise Alachua County
and early phase trials; cancer trials for health subject participants and GA-FL
for most other POR protocols
Shands Jacksonville Shands Jacksonville/ Community-based pediatric and Duval County and S.E. Georgia; esp. under-
UF campus maternal-child studies; neurological served populations
diseases and stroke, cardiovascular,
women's health
Center for Clinical Gainesville campus Phase 1-2 clinical trials Regional for studies in healthy subjects;
Trials Research international for studies in patients
Institute on Aging Gainesville campus Observational studies, clinical trials Elderly populations in GA-FL
in aging
Periodontal Disease College of Dentistry Oral hygiene trials GA-FL for early-late phase clinical trials;
Research Center esp. underserved populations
Comprehensive Center College of Dentistry Early-late phase clinical trials Adult populations in GA-FL
for Pain Research
Cancer Hospital Shands UF Cancer trials Regional or national, depending
on specific trial
A.G. Holley Hospital Lantana, FL Multi-drug resistant tuberculosis International, esp. Central, North and South
America


Clinical and Translational Science Institute University of Florida


Gainesville, FL -352.273.8700 3












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PRIIATADCINIA INEACIN PRGA


research and clinical trials; 5) closer affiliation through
the CTSI's electronic and videoconferencing facilities
to link laboratory scientists in Gainesville with clinical
investigators in Jacksonville, thus enhancing opportu-
nities for collaborations; and 6) increasing educational
opportunities for fellows and faculty in Jacksonville
through distance learning capabilities embedded in the
CTSI's academic home and its Training and Career
Development Program.

The Shands Jacksonville CRU will be directed by
Alan Berger, MD, Professor of Neurology and Assis-
tant Dean for Research, College of Medicine-Jackson-
ville. Currently more than 500 clinical trials are un-
derway by College of Medicine faculty located on the
Jacksonville campus. The traditional clinical research
infrastructure on the Jacksonville campus is integrated
into the departments, with many hiring their own staff
of research nurses, coordinator and managers.

The Jacksonville campus draws on its vast commu-
nity-based primary care satellite system that consists
of 18 family practice, internal medicine and Ob-Gyn
practices distributed geographically across Jack-
sonville and South Georgia. This system employs
more than 65 physicians and mid-level providers and
provides primary and specialty care for more than
240,000 patients throughout Jacksonville. Pediatric
POR, particularly as it involves community engage-
ment activities, will be led by Mobeen Rathore, MD,
Professor of Pediatrics and Director of the UF Rain-
bow Center in Jacksonville. This Center is the only
comprehensive and family-focused NIH-AIDS center
in Northeast Florida. Under Dr. Rathore, Jacksonville
pediatric researchers will also collaborate with the
nearby Wolfson Children's Hospital's Community
Research Network, a leader in many community-based


studies in Northeast Florida and Southeast Georgia.
These community-based research activities provide a
strong foundation for late-phase clinical trials, particu-
larly in the pediatric population.

Center for Clinical Trials Research (CCTR) CRU.
The CCTR was founded in 2001 as a site for indus-
try-sponsored, FDA-compliant early phase clinical
trials. The CRU is a 14,000-square-foot, 48-bed unit
for conducting inpatient and outpatient clinical trials,
and is one of the only free-standing Phase 1-2 clini-
cal research sites based in an academic institution in
the U.S. Under the auspices of the CTSI, the CCTR
will be transformed into a new resource for training
and for conducting investigator-initiated trials, while
maintaining an active portfolio of industry-supported
studies. The operations and management are under
the direction of Constance Stone, DMD. A long-term
outcome for faculty participation in the CCTR CRU is
developing scientific leaders who can serve as experts
to consult and help oversee early phase clinical trials
at UF and elsewhere. In turn, using faculty as expert
consultants will improve the integrity of trials con-
ducted at the Center and represents a major advantage
for UF versus proprietary clinical trial units not affili-
ated with an academic health center. Faculty also will
receive publication opportunities that enhance promo-
tion and tenure.

Training opportunities at the CCTR CRU include lec-
ture-based courses and patient-oriented research expe-
riences overseen by CCTR CRU staff that will involve
detailed understanding of investigational new drug
applications (IND)s, good clinical practice (GCP),
adverse event reporting, intellectual property rights
and patent issues, patient and minority recruitment and
retention and early clinical phase study design and


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analysis, including pharmacokinetics and safety trial
design strategies. In this way training involving the
CCTR CRU offers an integrated "clinical trials" path-
way for physicians, PhDs, dentists, pharmacists and
nursing coordinators that will integrate closely with
all aspects of the CTSI's Training and Professional
Development Program and to its distance learning
resources.

Institute on Aging (IOA) CRU. With the advent of
the Claude Pepper Center in 2007, POR in aging at UF
has increased exponentially. The transforming aspect
of the IOA is its full integration into the CRU network
to provide a new venue for investigators interested in
mechanism-based and observational studies on ag-
ing. It will also be the focal point of early- and late-
stage drug and lifestyle interventional clinical trials
to improve quality of life in the elderly population.
Currently geriatricians are conducting studies on the
physiological and biomechanical mechanisms contrib-
uting to changes in walking, and secondary analyses
of randomized clinical trials and observational studies.
The CRU occupies space for outpatient research in the
9,500-square-foot Aging and Rehabilitation Research
Center on the Health Science Center campus at UF.
Inpatient investigations will utilize the Shands at UF
CRU. Marco Pahor, MD, will direct the CRU at the
IOA. The PCIP will provide additional administrative
and informatics support to the CRU and will ensure
the availability of Study Coordinators for protocols
relating to aging research.

UF and Shands Cancer Hospital CRU. The Jerry W.
and Judith S. Davis Cancer Pavilion and the adjacent
Shands Medical Plaza are the locations of several out-
patient clinics for pediatric and adult oncology servic-
es. Oncologists participate in industry- or NIH-spon-


scored clinical trials utilizing these outpatient resources
and, occasionally, the GCRC for Children's Oncology
Group protocols involving rare pediatric solid tumors.
For the most part, however, POR involving cancer
patients has not been well organized at UF.

To address these shortcomings and to meet the grow-
ing need for outstanding clinical resources for the care
of oncology patients, members of the CTSI and UF
and Shands Cancer Hospital are working towards the
development of a CRU for early phase oncology trials
at this new hospital. However, use of the Shands at
UF CRU as a site for cancer clinical research stud-
ies will continue even after the Cancer Hosptial CRU
opens, because of the focused resources at the Shands
UF CRU for undertaking around-the-clock monitoring
and conducting precise pharmacokinetic investiga-
tions. To assist in this effort, the entire nursing staff
of the Shands UF CRU has received certification in
administering cancer chemotherapy.

Periodontal Disease Research Center CRU. The
PDRC directed by Ingvar Magnusson, PhD, DDS, has
been a central venue for industry-sponsored clinical
trials in the College of Dentistry since 1985. Many
protocols have dealt with control of plaque formation
and gingivitis. PDRC staff routinely develop standard
operating procedures concordant with FDA and Eu-
ropean guidelines for good clinical practice and good
laboratory practice standards. Clinical staff of the
PDRC includes two full-time and four part-time regis-
tered dental hygienists as well as a patient coordinator.
The PDRC also has laboratory facilities available for
conducting small-scale pilot studies and/or for deter-
mining the effects of various compounds on oral flora.

The PDRC occupies dedicated clinical research space


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in the College of Dentistry and contains nine fully
equipped dental operatories. Despite this invaluable
resource, the PDRC was not formerly incorporated
fully into the academic environment at UF. Thus, it
has not traditionally served as a venue for conducting
investigator-initiated clinical trials or for facilitating
training in patient-oriented research relating to oral
hygiene. Like the CCTR, the PDRC will transform
into one of the CTSI's CRUs in collaboration with Dr.
Magnusson and the College of Dentistry. Accordingly,
the PDRC CRU will continue to serve as a venue
for industry-driven clinical trials but will expand its
mission to encourage investigator-initiated, extramu-
rally-funded POR. In addition, it will serve as a site
for training dentists and dental hygienists in Phase
1-3 dentistry-oriented clinical trials. The CTSI will
provide enhanced biostatistical, study design, bioeth-
ics and informatics support from its other cores for the
PDRC CRU investigators and trainees.

Comprehensive Center for Pain Research (CCPR)
CRU. The CCPR is a university wide Center directed
by Robert Yezierski, PhD, that represents the scien-
tific home for the extensive translational pain research
community at UF. Utilizing resources within the six
colleges of the Health Science Center (HSC), the
McKnight Brain Institute and the GCRC, this multi-
disciplinary initiative provides pain research, educa-
tion and training programs in a wide range of pre-clin-
ical and clinical disciplines, including molecular and
cell biology, physiology, pharmacology, psychology,
sociology, epidemiology, research theory and design
and clinical pain management. Moreover, the CCPR
is the home for UF's NIH-funded training program in
Integrative and Translational Pain Research.

The CRU, which opened July 2008, under the direc-


tion of Roger Fillingim, PhD, represents the most
recently developed entity within the CCPR. This CRU
will be affiliated with the CTSI's Biobehavioral Core,
given its mission of providing expertise and resources
to support human studies involving pain assessment.
The CCPR's CRU will transform POR at UF by
providing for the first time a centralized venue dedi-
cated to hypothesis-driven research and training in the
causes and treatment of pain.

The CCPR CRU facility includes two private rooms
devoted to quantitative sensory testing (QST), which
are equipped with state-of-the-art psychophysical
testing devices for assessment of sensory responses
to thermal, mechanical, cold, ischemic and electri-
cal stimuli. Also, each room includes cardiovascular
monitors. An additional private room is available for
conducting physical and dental exams. Dr. Fillingim
and other affiliated faculty will be able to provide
expert consultation to CTSI investigators to assist with
implementing optimal pain assessment methods into
their protocols.

A.G. Holley Hospital CRU. A.G. Holley is the only
state tuberculosis (TB) hospital in Florida and one of
only two in the US. Its mission is to provide state-of-
the-art inpatient care for the most challenging cases
of TB in the state. It receives national attention as a
model facility dedicated to curing the most compli-
cated and difficult tuberculosis cases that have failed
treatment in the community. Approximately half of
all patients admitted to A.G. Holley are there by court
order because of non-adherence to therapy. The other
half of patients are hospitalized voluntarily because
they could not be managed adequately in the outpa-
tient setting due to the complexity of their disease,
such as multi-drug resistance or complications


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related to HIV infection. For these patients, the hospi-
tal offers complete medical care with extensive sup-
port services. The Southeastern National Tuberculosis
Center (STNC) is located in Gainesville and its clini-
cal campus is at the A.G. Holley State Tuberculosis
Hospital located in Lantana. Because of the Center's
juxtaposition to both academia and public health, it
can serve as a catalyst for multidisciplinary and inter-
disciplinary translational research.

The SNTC is federally funded through the Centers
for Disease Control and Prevention (CDC) and it is
based at UF and the A.G. Holley State TB Hospital.
It is charged with providing training, education and
expert medical consultation for the TB programs of
the southeastern U.S. and U.S. territories in the Carib-
bean. It is one of four national TB Centers nationwide.
Although funding for these centers specifically ex-
cludes research or clinical activities, guidance from
the CDC encourages developing the Center as the
Center leadership sees fit including seeking additional
outside funding for TB-related research activities.
The SNTC is directed by Michael Lauzardo, M.D.,
MSc, and co-directed by David Ashkin, MD. Both are
full-time employees of the Department of Health with
joint appointments in UF's Division of Pulmonary and
Critical Care Medicine.

One of the most significant aspects of the State of
Florida TB Program incorporated into the SNTC is the
TB Physicians Network. This is a network of pulmo-
nologists that was created nine years ago to provide
medical consultation and programmatic assistance to
the county health departments throughout Florida. The
Network has full access to the TB Information Man-
agement Systems database that contains clinical and
demographic information on more than 15,000 pa-


tients during the last 10 years-a tremendous research
resource that has been underutilized but could provide
a valuable entree to community-based public health
programs.

The SNTC with the TB Physicians Network provides
access to an underserved population, approximately 80
percent of whom are from minority groups. Under the
CTSI, the A.G. Holley Hospital will undertake a trans-
formation of its mission to be included as a 50-bed in-
patient CRU for conducting POR in patients with TB.
The CRU at A.G. Holley would function as both an
inpatient resource for studies of multi-drug resistant or
other complex cases of TB and as a venue for outpa-
tient studies in the community. The hospital's location
300 miles south of the Gainesville UF campus might
be considered a major drawback for linking with the
CRU network. However, disparate sites give CTSI in-
vestigators and trainees access to a diverse population
of mostly underserved individuals from a wide variety
of backgrounds that are not usually represented in
traditional biomedical research. Distance communica-
tions and learning opportunities will be facilitated by
the CTSI's Administrative Core. In turn, A.G. Holley
has recently invested resources to create seven sleep-
ing rooms in the hospital to accommodate researchers
overnight or for extended periods of stay. Dr. Lauzar-
do will serve as program director of the A.G. Holley
CRU with Dr. Ashkin assisting as codirector.

Goal 2: Ensure that consistently high-
quality research is conducted at CRUs.
Accessing PCIP's CRUs. The CTSI will create a
physical and virtual research portal in its academic
home. The portal has been developed by the Biomedi-
cal Informatics Program and will be managed by the
Regulatory Knowledge and Research Support (RKRS)


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Program under the direction of David Nelson to fa-
cilitate project development, review and implementa-
tion. The intent of the Program is to decrease the time
required for a CTS research project to be reviewed
and ultimately approved. The CTSI staff estimate
1-2 months will be required for bringing protocols
from concept to the point of scientific and regulatory
review. This timeline could be shortened consider-
ably depending on how much prior knowledge the
investigator has about the general project development
process and the types of resources available through
the CTSI.

Scientific review of research involving humans and/or
vertebrate animals will be administered by the Sci-
entific Advisory Committee (SAC), chaired by N.
Lawrence Edwards, MD, professor of medicine. The
SAC reflects a broad range of scientific expertise and
representation by faculty from the colleges affiliated
with the CTSI. Protocols submitted to the SAC will
be divided into those involving human research and
animal research.

The RKRS program is working with CRU leadership
to transform the process by which CTSI protocols will
be reviewed. The following changes are being ad-
dressed: First, the meetings of the SAC and IRB will
be coordinated so that they occur separately but on the
same day every other week. Second, all submissions
will be made electronically and reviewers assigned
to specific protocols will be encouraged to address
questions or concerns with applicants prior to formal
committee review. Third, all three review groups will
utilize the same five-page mini-R01 protocol for-
mat employed by the SAC. Fourth, regulatory issues
contained in the IRB Introductory Questionnaires will
be reformatted to include queries relevant to the other


regulatory review boards (e.g. radiation, gene therapy
committees), thus eliminating the need for investiga-
tors to submit separate applications to these groups.
The Introductory Questionnaire, protocol description,
CTSI resource utilization section and the informed
consent form will constitute a single, electronically
submitted research project document available simul-
taneously to the SAC and IRB/IACUC. CTSI staff
estimates this procedure, coupled with the frequency
of reviews, will result in at least a 30 to 50 percent re-
duction in the approximately 28-day time required cur-
rently for combined GCRC/IRB review. Collectively,
the entire process of project development, submission,
review and implementation should average two to
three months or less, depending on the experience of
the applicant and the complexity of the research study.

Integration with Biomedical Informatics. Previous
efforts to integrate clinical data in support of research
have focused on case-by-case extractions of data from
the clinical systems using manual methods. Through
the CTSI's Biomedical Informatics Program the units
will alter their strategy to one of creating persistent
technical interfaces using a variety of approaches as
needed. These approaches include extract-transform-
load, access in place and messaging. Each has been
used successfully in previous work. The clinical inter-
face effort will be focused on EpicCare. Interfaces will
include de-identification and data models optimized
for research database construction and patient eligibil-
ity alerts within EpicCare, supporting the CRUs. The
UF Faculty Group Practice has begun designing these
interfaces. Star schema will be used where appropri-
ate. Data from clinical systems will be made available
on a cost recovery basis using strict access control
technology meeting all applicable regulatory and ethi-
cal restrictions.


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Goal 3: Establish procedural rules and
milestones to evaluate resource utiliza-
tion, research productivity and cost ac-
countability.
Organization and Governance of the PCIP. The
PCIP will be led by Dr. Carl Pepine, who has a long
and distinguished career as a clinical investigator.
He has conducted numerous federally and industry-
funded, multi-center or international clinical trials in
areas of cardiovascular medicine. Dr. Pepine will chair
the advisory committee of the PCIP. The committee
is comprised of the program directors of each of the
Clinical Research Units and Michael Conlon, PhD,
CTSI Associate Director for Biomedical Informatics.
Dr. Pepine and the committee will have the authority
to appoint Rapid Action Teams to define, implement
and ensure best clinical practices and to address par-
ticular areas of opportunity or concern. Dr. Pepine will
report his findings to the Steering and Planning Com-


mittee which will have overall governance of the PCIP
and the other cores and programs of the CTSI. The
SPC will have the authority to recommend and enforce
changes in the organization, governance and activi-
ties of the PCIP, but will work in consultation with the
Translational Science (internal) Advisory Committee
and the External Advisory Committee of the CTSI.

It will be essential for the PCIP to receive feedback
from the individuals participating as research study
subjects in the CRUs and investigators and trainees
who utilize these resources. Anonymized question-
naires will be distributed to subject participants and
investigators through the Institute's Translational Sci-
ence Advisory Committee, which conducts the track-
ing and evaluation of all CTSI functions. This infor-
mation will be used by Dr. Pepine, the CRU program
directors, and the SPC in rendering evaluations of the
effectiveness of the program.


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The March edition of the Newsletter contained an RFA for seed money support through our new Pilot and
Collaborative Projects Program. We received nine proposals by the April 30 deadline for receipt of ap-
plications. The Programs' Executive Committee made the following awards on May 7, 2009 with funding
available by June 1.


CTSI Pilot and Collaborative Project Program Awards (May, 2009).
Category Awardee Academic Title of Project Award
Affiliation
Graduate Student Amber Van College of Liberal Pharmacological Treatment of Repetitive Be- $ 7,508
Matre, MS Arts and Sciences havior: Targeting Adenosine, Dopamine, and
Glutamate Heteromeric Receptor Complexes
Junior Faculty Benjamin G. College of Engineer- Dendritic Cell Arrays for Type I Diabetes $ 15,000
Keselowsky, ing Microparticle-Based Vaccines
PhD
Baharak College of Medicine Comparison of Two Macrolides, Azithro- $ 20,000
Moshiree, MD mycin and Erythromycin, for Symptomatic
Treatment of Gastroparesis
Novel Methods* Michael A. College of Public Development and Initial Validation of a $ 24,720
and Technology Crary, PhD Health and Health Swallow Frequency Meter
Professions
Total $ 67,228
*Multiple co-investigators and/or colleges were represented by these proposals, but only the PIs and their
colleges are listed.


Congratulations to the awardees! Competition was stiff and many meritorious proposals could not be funded.
For those who did not apply or who were unsuccessful this round, we plan to announce the next RFA in the
September, 2009 Newsletter.


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Volume 2, Issue 4 June 2009






Carl J. Pepine, MD, is Eminent Scholar Emeritus and Professor of Medicine, Divi-
sion of Cardiovascular Medicine at the University of Florida College of Medicine.
He is a graduate of the University of Pittsburgh and the College of Medicine of New
Jersey.

When asked about the CTSI, Pepine said that the individual units are running sepa-
rately and successfully now but tending to function entirely separately from one
another. The goal of the CTSI is that they can be brought together in a matrix of
research units sharing information and training opportunities.

How does Pepine see the interaction between units taking shape? He sees two broad areas for obvious
cooperation. He says, "The first [area for cooperation] that I'm proposing is that we simply track projects
in an informational tracking program across the units so each would know what others are doing." For the
benefits of this information sharing he gives the example of a new drug that cardiovascular researchers
have discovered and have in Phase 1 trials might be relevant to sleep researchers if they have access to the
compound and its sponsor so that Phase 2 studies might be done in one of our units. According to Pepine,
"At present there's no knowledge of the trials going on in the various units. You can play out the advan-
tages in any of the units. Just the information and tracking structure will add tremendous value."

The second area for training, Pepine says, is training. Through the coordination of the CTSI, all of the units
are now available for training individuals across the participating schools and organizations. Mentors and
researchers now have access to a host of clinical trial units, so a trainee could select one or several of the
units to do projects in or select a mentor out of any of the units.

Pepine says, "These are the first two things that could be rolled out, and there would be others in subse-
quent areas so we could streamline processing and IRB hurdles that are significant issues here."

Asked about the difference that the CTSI will make for the individual units, Pepine says, "They grew up
in their own little specialized niches, and there was no intent or stimulus on a larger level until just a few
years ago when the NIH put forth the money to stimulate the program." Now the structures will be in place
to help the units look beyond the confines of their own specialty to think of research in a larger context, he
says.

The difference for the units will be echoed in the difference the CTSI will make in Pepine's own work. "It
takes me out of my focused niche in ischemic disease in cardiovascular to take a broader view. It's refresh-


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.273.8700















Volume 2, Issue 4 June 2009





ing for me to look into several of the niches that I hadn't had the opportunity to observe before now."

Pepine is an internationally recognized leader in both the clinical and scientific areas of cardiovascular
medicine. His major interests focus on the pathophysiology of ischemic heart disease and coronary and
systemic vascular hemodynamic mechanisms underlying the disease. He is principal investigator for the
UF center for the National Heart Lung and Blood Institute (NHLBI)-funded Women's Ischemia Syndrome
Evaluation (WISE) and the UF center for the Cardiovascular Cell Therapy Research Network (CCTRN).
He has been or is the PI for many investigator-initiated clinical trials. He is past president of the American
College of Cardiology (ACC), the professional organization for cardiovascular physicians. He currently
serves on the Board of Trustees of the ACC and many committees and task forces and is the founder and
overall Project Chair for the Vascular Biology Working Group (VBWG).

Dr. Pepine's clinical interests include ischemic heart disease, heart disease in women, cardiovascular cell
therapy, preventive cardiology, genetic cardiology and clinical trials in cardiovascular disease.

Mailing Address: 1600 SW Archer Road
Box 100277
Gainesville, FL 32610-0277
Phone: 352-846-3292
Fax: 352-371-0370
E-mail: pepincj@medicine.ufl.edu




Employment
Did you know that there are multiple venues through which both internal and external jobs are posted?

For Job Seekers
https://jobs.ufl.edu University of Florida jobs postings.
http://www.union.ufl.edu/jobs/ Reitz Union student job listings.
http://www.sfa.ufl.edu/programs/workstudy Federal Work-Study Program.
http://www.sfa.ufl.edu/programs/ops.html Other Personnel Services jobs.
http://www.sfa.ufl.edu/programs/oce.html Off-Campus jobs.
http://www.sfa.ufl.edu/programs/vaworkstudy.html Veteran's Affairs Work-Study.


Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700




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