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The Rockefeller University Center for Clinical and Translational Science
Minutes of the Advisory Committee on Clinical and Translational Science (ACCTS)
September 30, 2009
Voting Members Present: James Krueger - Acting Chair, Ed Barbour, Jon Blumenfeld, Gila
Budescu, Edgar Charles, Barry Coller, Lynn Dustin, Emil Gotschlich, Lisa Hudgins, Rhonda Kost,
Michelle Lowes, Maija Neville, Melissa Offenhartz, Barbara O’Sullivan, Sarah Schlesinger, Terry
Solomon, Mayte Suaraz-Farinas, Knut Wittkowski
Invited: Donna Brassil, Angela Slattery, Neil Renwick
______________________________________________________________________________
The meeting was called to order at 2:35pm
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1. Approve minutes from the July 15, 2009 ACCTS meeting
2. INITIAL REVIEWS
Jean-Laurent Casanova
JCA-0678: Molluscum Contagiosum in Childhood:
A Novel Primary Immunodeficiency
[Reviewer: Emil C Gotschlich]
Haiteng Deng
Crosstalk Among Oral and Gastrointestinal Soluble
Innate Factors, HIV, and Microbes
[Reviewer: Edgar Charles]
Paul Greengard
Expression Analysis of gSAP in Post-Mortal Brains
of Alzheimer’s Patients
[Reviewer: Edgar Charles]
Rhonda Kost
RKO-0679: Research Participant Perception of
Care Project, Part II: Fielding and Validation of the
Research Participant Perception Survey Derived
from Focus Group-Identified Key Dimensions of the
Research Participant Experience
[Reviewer: Lynn Dustin]
James Krueger
Screening for entry into skin disease studies
[Reviewer: Emil C Gotschlich]
Andreas Mauer
AMA-0674: Establishment of the Rockefeller
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University Bleeding History Phenotyping System
Repository (RUBHPSR)
[Reviewer: Lynn Dustin]
Mina Pastagia
Antibiotic Prescribing Behavior and Post Hospital
Discharge Outcomes in MRSA Infection
[Reviewer: Emil C Gotschlich]
Mina Pastagia
MPA-0677: Eradication of Staphylococcus Aureus
from Skin Lesions Through the Use of a Newly
Developed Lytic Enzyme Called ClyS
[Reviewer: Michelle Lowes]
Manish Ponda
The Effect of Vitamin D3 Repletion on Small LDL
Particle Number in Subjects at Elevated
Cardiovascular Risk
[Reviewer: Edgar Charles]
Jeffrey Ravetch
Specificity of Anti-CCP (Cyclic Citrullinated Peptide)
Autoantibodies in Rheumatoid Arthritis
[Reviewer: Emil C Gotschlich]
Neil Renwick
Characterizing RNA Regulation in Disease
[Reviewer: Lynn Dustin]
Sohail Tavazoie
The Discovery of microRNAs that Predict
Chemotherapeutic Responsiveness of Cancer
[Reviewer: Peter Holt]
Sohail Tavazoie
Discovery of Molecules that Regulate the miR-335
Metastasis Suppressor MicroRNA
[Reviewer: Peter Holt]
Leslie Vosshall
Genetic Basis of Odor Discrimination
[Reviewer: Lynn Dustin]
Shen-Ying Zhang
Mendelian Genetic Predisposition to Herpes
Simplex Encephalitis in Childhood
[Reviewer: Michelle Lowes]
3. CONTINUING REVIEWS
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Jon Blumenfeld
JBL-0496: Autosomal Dominant Polycystic Kidney
Disease Repository
[Reviewer: Barry Coller]
Donna Brassil
DBR-0668 A comparison of hemolysis rates and
laboratory values using intravenous catheters
versus venipuncture for obtaining venous blood
samples
[Reviewer: Emil C Gotschlich]
Jean-Laurent Casanova
JCA-0640: Human Genetics of Infectious Diseases
[Reviewer: Edgar Charles]
Emmanuelle Jouanguy
EJO-0650 Predisposition to Severe Fibrosis in HCV
Chronic Hepatitis
[Reviewer: Michelle Lowes]
Martin Markowitz
MMA-0645: A Multicenter, Randomized, OpenLabel, Active-Controlled Pilot Study to Evaluate the
Safety and Antiretroviral Activity of Unboosted
Atazanavir BID Plus Raltegravir BID and Boosted
Atazanavir QD in Combination with
Tenofovir/Emtricitabine QD in Treatment Naïve
HIV-Infected Subjects (BMS-AI-424-376)
[Reviewer: Edgar Charles]
4. AMENDMENTS
Edgar Charles
ECH-0675: Pilot Study to Assess Gut Mucosal B
Cells in Individuals Co-Infected with HCV and HIV
[Reviewer: Michelle Lowes]
Michel Nussenzweig
MNU-0625: Identification and Characterization of
Human Auto-Reactive B Cells in Autoimmune
Diseases, HIV Infection and Healthy Volunteers
[Reviewer: Sarah Schlesinger]
Swaroop Pendyala
SWP-0660 Monocyte Intracellular Cytokine
Production in Healthy Volunteers
[Reviewer: Barry Coller]
5. CHAIR EXPEDITED
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Jan Breslow
JBR-0583: Exploratory Feasibility Study: High
fat/protein diet in the treatment of obesity
Charles Gilbert
CGI-0573: Processing Mechanisms of Visual
Cortex
Charles Gilbert
CGI-0121: Processing Mechanisms in Visual
Cortex
Rhonda Kost
RKO-0648: Research volunteer screening/
recruitment data repository
James Krueger
JKR-0671: A Randomized, Double-blind, Placebocontrolled, Ascending Dose Study to Assess the
Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of CNTO 1959 following a
Single Intravenous or a Single Subcutaneous
Administration in Healthy Subjects and in Subjects
with Moderate to Severe Psoriasis
(Correspondence dated 8/28/09 and 8/20/09)
James Krueger
JKR-0642: Effect of UVB Exposure on 15Prostglandin Dehydrogenase in Skin
James Krueger
JKR-0641: A Study to Document The Natural
History of Atopic Dermatitis Before, During, and
After Treatment with Conventional Therapies
James Krueger
JKR-0622: The Natural History of Pigmented Skin
Lesions
James Krueger
JKR-0663 A study to evaluate reversal of the
pathological epidermal phenotype in severe AD
with suppression of immune activation during
cyclosporine A therapy
James Krueger
JKR-0638: Effects of narrowband UVB
phototherapy on melanocyte proliferation in
patients with vitiligo (No participant accrual- only
open for data analysis)
James Krueger
JKR-0653: Safety, Tolerability, Pharmacokinetics
and Pharmacodynamics Study of Single Rising,
Open-Label Doses of AbGn-168 (1 mcg/kg, 5
mcg/kg, 25 mcg/kg, 125 mcg/kg, 625 mcg/kg, 3
mg/kg, or 10 mg) Administered by Intravenous
Infusion to Patients with Chronic-Plaque Psoriasis
(BI Trial No.: 1240-1)
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Michelle Lowes
MIL-0644 Effects of Cigarette Smoke on
Inflammatory Cells and Markers in Oral Mucosa
Michelle Lowes
MIL-0646 Characterization of the Skin in NeonatalOnset Multisystem Inflammatory Disease
Maria Patricia Maningat
PAM-0655: Quality of Life and Metabolic
Alterations in Patients with Statin-Associated
Myopathy
Martin Markowitz
MMA-0577: A Randomized Phase II Study of
Therapeutic Immunization and Treatment
Interruption Among Subjects Who Began Potent
Antiretroviral Therapy Within 16 Days of Diagnosis
of Acute or Recent HIV Infection (AIN504)
Martin Markowitz
MMA-0591: HIV Elite Controller Study
Martin Markowitz
MMA-0639: Acute HIV-1 Infection Prospective
Cohort Study (CHAVI-001)
Martin Markowitz
MMA-0643: A Phase III Multicenter, Double-Blind,
Randomized, Active Comparator Controlled Clinical
Trial to Study the Safety and Efficacy of Once Daily
Raltegravir (MK-0518) versus Twice Daily
Raltegravir, Each In Combination with TRUVADA,
in Treatment-Naive HIV Infected Patients (MK0518-071)
Martin Markowitz
MMA-0448: Viral and Host Factors in the
Transmission and Pathogenesis of HIV
Martin Markowitz
MMA-0592: The Transmission and Fitness of Drug
Resistant HIV-1 (NIH Grant #2R01-AI-47033-06)
Martin Markowitz
MMA-0666: An Interdisciplinary Approach to HIV
and Other Infectious Diseases of Drug Users
Martin Markowitz
MMA-0610 A Phase II, Randomized Trial of OpenLabel Truvada with Darunavir/ritonavir versus Multiclass Therapy with Truvada, Darunavir/ritonavir,
Maraviroc and Raltegravir in Acutely HIV-1 Infected
Antiretroviral-Naïve Subjects (ADARC 2007-01)
Martin Markowitz
MMA-0607: A Pilot Study of the New York HIV
Transmissions Study: Project HITS-NY, Illicit Drug
Use and Social Network Effects Among at Risk and
Recently/Acutely HIV-1 Infected MSM
Andreas Mauer
AMA-0637: Assessment of Bleeding Symptoms in
Normal Individuals Using a Comprehensive
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Bleeding History Phenotyping Instrument
Jurg Ott
JOT-0587: Genetic Modifiers for 22q11 Deletion
Syndrome
Swaroop Pendyala
SWP-0620: Obesity associated Colorectal
inflammation; the effects of weight loss
Charles Rice
CRI-0636: Isolation and culture of circulating
hepatoma cells from blood
Sarah Schlesinger
SSC-0630: Vaccination of a Patient with
Pancreatic Cancer with Dendritic Cells Generated
From Monocytes by Culturing with GM-CSF and
INF Alpha, Loaded with a Mixture of Synthetic
Peptides and Activated with LPS and CD40 Ligand
Ralph Steinman
RST-0094: Human Lymphocyte Activation: Role of
Dendritic Cells
Leslie Vosshall
LVO -0619: Physiological Effects of
Androstadienone Exposure
John Zabriskie
JZA-0540: Natural History of Rheumatic Fever at
Rockefeller University Hospital (8/6/09)
Barry Coller
BCO-0417: Studies of the interactions among
normal and abnormal blood cells and between
normal and abnormal blood cells and the vessel
wall, and Studies of genetics and functional basis of
inherited platelet, white blood cell, red blood cell
and coagulation disorders
[Reviewer: Emil C Gotschlich]
6. Reports of Director and Co-Director
Dr. Coller reported that the Center was awarded 4 NIH/NCRR ARRA supplemental grants. The
first quarterly reports are due October 10. The four supplements approved for funding are:
1.
Administrative Supplement for Enhancing NCRR Pilot Project Mechanism, $132,450
direct cost requested year 1, $132,450 direct cost requested year – Knut Wittkowski(secondary PI)- Pilot Project aimed at using the NCBI CASP data base of Genotypes and
Phenotypes (dbGAP) (1) to empirically validate a methodology by comparing its results to those
from traditional approaches (2) to conduct a proof of principle analysis to explore a recent
finding from ongoing research under the parent CTSA award which suggest that genetic factors
may determine why psoriasis affects primarily the skin in some patients, while others develop
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psoriatic arthritis, and (3) to accelerate sharing of technology through rapid dissemination of the
results, Web-based documentation of the analyses as case studies for the use of the novel
technology and development of training material in collaboration with neighboring CTSA
institutions in the NYC area.
2.
Administrative Supplement to Advance Translational (T1 & T2) Research, $211,154 direct
cost requested year 1, $211,210 direct cost requested year – Agata Smogorzewksa Using the
Bleeding History Phenotyping System as a prototype of a comprehensive patient phenotyping
instrument, this submission proposed the creation of a comprehensive, ontology-driven
phenotyping system and database for Fanconi anemia (FA). Work stemming from this proposal
will create a uniform phenotyping ontology based on a comprehensive Fanconi Anemia
Phenotyping Questionnaire (FAPQ) that will be designed and peer-reviewed by experts in the
field. Information will be used to generate a Fanconi anemia phenotyping database (FAPD),
which will be accessible to physicians and researchers worldwide through a secure Web-based
interface.
3.
Administrative Supplement to Advance Translational (T1 & T2) Research, $254,661 direct
cost requested year 1, $ 254,661 direct cost requested year 1, $96,200 direct cost
requested year 2.- Knut Wittkowski- To Advance Translational (T1 & T2) Research by
increasing accuracy and accelerating analyses and dissemination of results, two critical
enhancements with long-term implications for the use of µStat and WISDOM as resources for
clinical and translational research will be made: (1) We will partner with industry to move
WISDOM another step towards it becoming a comprehensive support system for clinical and
translational scientists by making the meta data base already used for the REDCap link a
resource shared with a graphical user interface to assist and provide help with specifying
statistical analyses to be performed on the µStat Web server. (2) A full time software engineer
will be hired to provide technical assistance to clinical and translational researchers while
enhancing the capacity, stability, and functionality of the grid, in general, and automating the
iterative resubmission of interim results as the number of factors analyzed increases.
After the 2-year period, WISDOM will facilitate clinical and translational research as a coherent
user inter-face with intelligent, knowledge-based help for both REDCap as a data entry system
and a µ-stat as a innovative statistics server. To accelerate further development, it will have
been ported to the industry standard Java and have an innovative and easily expandable help
system to facilitate training and dissemination.
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4.
Administrative Supplement for Research Workforce Development and Dissemination,
$140,477direct cost requested year 1, $144,943 direct cost requested year 2.-Edward
Barbour- This supplement proposes to create a comprehensive course in the area of Applied
Bioinformatics for the further education of clinical researchers. The field of bioinformatics, which
applies information technology to molecular biology data, is being elevated to a prominent role
as newer equipment for DNA, RNA, and protein sequencing is generating vast amounts of data
from scientific experiments. Therefore, it is of great value to the researchers responsible for
such experiments to understand the tools and techniques that are available to analyze this vital
data. As in many areas of rapidly advancing technology, many educational programs are not
able to keep up with the advanced pace of this educational need. This submission will fill that
gap by creating a web based course that will contain numerous examples and exercises, giving
the researcher the full advantage of knowing what it takes to draw valid scientific conclusions
from such data. This course will look at the subcategories of bioinformatics including genomics,
protein structure and interaction networks, metabolomics, natural language processing, and
simulation using complex systems. The course will also expose the researcher to currently
available bioinformatics tools including open source and leading third party tools, as well as, the
low level components used to build such tools.
Dr. Coller reported that the competitive renewal application information was recently published.
Senior staff of the hospital and the CCTS have reviewed the RFA and are in the process of
drafting key components for review and feedback. The RFA will be due June 1, 2010. Dr. Coller
announced that NIH has informed the RUCCTS that the maximum it will be allowed to request
will be $2.4 million less than our current CTSA award.
Dr. Coller reported that the CCTS is actively writing and researching additional funding
opportunities in preparation of the budget cuts to our CTSA award. Recently an R01 was
submitted to provide additional Bioinformatics support to the University.
Dr. Krueger announced that 35 Pilot Projects were submitted this year, of which 27 were
recommended for funding by the Pilot Project subcommittee. The funded pilot projects will be
award from October 5, 2009-June 30, 2010. The ACCTS committee approved the funding of the
27 recommended projects.
7. Reports of Subcommittees
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a) Informatics [Ed Barbour]
Ed Barbour Introduced Ross Gillamn the new Project Manager in Informatics. Ross will be
responsible for iRIS implementation and support.
b) Research Education, Training, and Career Development [Sarah Schlesinger]
Dr. Schlesinger reported that the dean’s office has approved providing credit for participants
who complete the Certificate Program. Currently 14 MD PhD students have expressed interest
in participating in the next Certificate Program, which is scheduled to begin in the fall of 2010.
8. Review of Center Metrics and Resource Utilization
None to report
9. Assessment of Underutilization, Inappropriate Use, and Low Productivity
None to report
10. Review of Budget
M. Neville reported that our financial status report for our CTSA award has been submitted for Year
03.
11. Strategic Planning Issues
None to report
The meeting was adjourned at 4:40pm
Respectfully submitted,
_________________________________
Maija Neville
ACCTS Administrator
_________________________________
Robert B. Darnell, MD, PhD
Chair
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