Multidisciplinary Core ServicesA functionally integrated resource of expertise, instrumentation and technology designed to support investigators in the pursuit of their research interests

University Town Center6525 Belcrest Rd., Suite 700Hyattsville, MD 20782-2031301-560-7300 PHONE

MedStar Health Research Institute Multidisciplinary Core Services

MedStar Health Research Institute provides access to core support services for investigators conducting research across the MedStar Health system.

Each core service offers a depth of knowledge and expertise in their area of specialty.

Core Preclinical LabThe core preclinical lab consists of two major sections:

• Thelargemodelsectionperformspreclinical studies to develop data for regulatory approval prior to clinical studies

• Thesmallmodelcorelabperformsa broad array of studies, including testing the effects of altered genetics on disease phenotype, the effects of various therapeutic interventions and the development of models of disease, including ischemia and atherosclerosis

Together, both sections will greatly assist in:

• Identifyinggeneticandmolecularmechanisms of disease

• Preclinicalfeasibilitytesting

• Preclinicaltrialstestingtherapeuticinterventions

• Providingdataforregulatoryapprovals

Core LeadersLarge model section: Ron Waksman, MD

Small model section: Stephen E. Epstein, MD Mary Susan Burnett-Miller, MD

ContactsLarge model section: David Hellinga, MSC202-877-5013david.g.hellinga@medstar.net

Small model section: Mary Susan Burnett-Miller, MD 202-877-8360mary.s.burnett-miller@medstar.net

Cardiovascular Core Imaging Center PurPOsE: Assists researchers in using imaging as a clinical trial endpoint across multiple purposes:

• Developmentofnewimagingtechniques in comparative effectiveness studies

• Useofimagingendpointsasprimaryor surrogate measures in clinical outcome trials

• Quantitativeassessmentofadiversearray of patient-based radiographic and ultrasonographic imaging techniques, including:

oQuantitativecoronaryangiography

o Intravascular ultrasound

o Echocardiography

o Carotid intima-media thickness evaluation

o Cardiac computed tomography

o Cardiovascular magnetic resonance imaging

Core LeadersAllen Taylor, MDNeil Weissman, MD

ContactsAllen Taylor, MD202-444-0382allen.taylor@gunet.georgetown.edu

Cardiac, Vascular and Tissue Pathology CorePurPOsE: Through a collaborationwithCVPathInstitute,Gaithersburg, Maryland, the CardiacandVascularPathologyLaboratory has state-of-the-art technology to perform an array of histology services, including paraffin, resin embedding/sectioning, cryotomy, section grinding, immuno-histochemistry (double staining) and microscopic imaging (high-quality digital image capture, scanning and transmission electron microscopy, and confocal laser scanning microscoy).

Core LeadersRenu Virmanir, MD

ContactsFrank Kolodgie, MD301-208-2481fkolodgie@cvpath.org

Core Platelet CenterPurPOsE: Assesses platelet reactivity and responsiveness via an array of assays consistent with current practice in this important and growing field. This core will have the capacity to use multiple assays to assess platelet function and thereby facilitate investigations of large cohorts of individual

patients to determine variability of intrinsic platelet activity and variability in response to anti-platelet drugs. Its assays will provide mechanistic insight into thrombotic events, such as stent thrombosis or bleeding.

This technology not only provides information relating to platelet phenotype and function, but also may be used for a broad array of experimental purposes.

Core LeadersRon Waksman, MD

ContactsRon Waksman, MD202-877-2812ron.waksman@medstar.net

David Hellinga202-877-5013david.g.hellinga@medstar.net

Clinical Research Organization (CRO)/Clinical Trials Core PurPOsE: Facilitates and conducts investigator- and industry-sponsored clinical trials incompliancewithICHandGCPguidelines.

Together, both sections will greatly assist in:

• Formulatinganddevelopingprotocols

• Preparingregulatorysubmissions,including IRB and FDA

• Managingmulti-centerclinicaltrialsand registries

• Overseeingindependentadjudication committees, e.g. clinical event committees and data safety monitoring committees

• Arrangingindependentclinicalsitemonitoring

• Preparingreportsandmanuscriptsfor regulatory and peer review journal submission

• Providingdatabaseconstructionandbiostatistical support for investigator- and industry-sponsors

Core LeadersRon Waksman, MD

ContactsRon Waksman, MD202-877-2812ron.waksman@medstar.net

RebeccaTorguson,MPH202-877-2194rebecca.torguson@medstar.net

Bio-repository, Biochemistry and Biomarker Core PurPOsE:

• Collects,processes,storesanddisseminates samples of biological material, such as urine, blood tissue, cells, DNA, RNA and protein for research. It includes both preclinical and human samples

• Providesassaydevelopmentandvalidation, quality control services and expertise to clinical and translational investigators

• Performsmoreroutinemanualandautomated clinical and biochemical determinations with quality control procedures and standards more stringent than are available in (hospital) clinical environments. Key techniques include multiplexed X-MAPimmunoassays,RIA,ELISAandHPLC,aswellasenzymatic,colorimetric and turbidimetric assays

Accreditations• Thecorelaboratoryisaccredited

by the Center for Medicare Services Clinical Laboratory Improvement Amendments (CLIA) and certified by the College of American Pathologists(CAP)

• Thecorealsomaintainslevelonecertification from the National GlycohemoglobinStandardizationProgram(NGSP)andcertificationfrom the Northwest Lipid Research Laboratories Reference Lipoprotein Analysis Basic Survey (ReLABS) program (for lipoprotein determinations)

Core LeadersJasonUmans,MD

ContactsJasonUmans,MD301-560-2959jason.g.umans@medstar.net

Laboratory Facilities and EquipmentThe Core Laboratory is a component of the MedStar Health Research Institute located at 6525 Belcrest Rd., Hyattsville, MD 20782. The laboratory occupies 6,000 square feet of newly constructed space with all necessary equipment to perform chemistry, molecular and immunologic assays.

Major equipment includes:

• -80°Cfreezers

• Monitoredrefrigerators

• Vitros5

• FSChemistrySystem

• Hitachi717autoanalyzer

• TOSOHG7glycohemoglobinanalyzer

• ECIimmunoanalyzer

• Bio-Plex(X-MAPR)system

• ELISAreader

• Gammacounter

• Beckmancentrifuges

Thelaboratoryhastwofreezerstorage sites—one at MedStar Washington Hospital Center in Washington, D.C., and one in Hyattsville, Maryland

(approximately 5.5 miles and 12 minutes apart by car). Both sitesaresupportedbyfreezermonitoring systems. This arrangement meets National Institutes of Health requirements that critical sample repositories be split between two remote sites in order to protect their integrity in case of fire or (natural) disaster.

The laboratory currently uses a remotely hosted software package called CernerWorks. CernerWorks allows dissemination of individual and group data reports. Lab data are stored off-site at Cerner Corporation, Kansas City. CernerWorks provides a highly available, redundant environment capable of withstanding a single component failure with no (or minimal) disruption to a contracted service. CernerWorks system backups are conducted in compliance with the CTC backup procedure or enterprise backup procedure(utilizingtheEMCNetworker solution) to provide a method to restore a system in case of a disaster. Data output via electronic means in ASCII or other universal format is currently being coded into CernerWorks by MedStar Laboratory Information Systems.

Core LeadersJasonUmans,MD

ContactsJasonUmans,MD301-560-2959jason.g.umans@medstar.net

Biostatistics and Epidemiology CorePurPOsE:Provideshigh-qualityepidemiological, statistical and data management services for investigator-initiated studies and commercial projects.

The core is experienced in designing studies, developing questionnaires, writing proposals, andmanagingandanalyzingdata.

Study designs include long-term, prospective cohort studies, case-control studies using stored samples, cross-sectional surveys, randomizedclinicaltrialsandchart reviews.

Statistical services include conductingsamplesizeandpower calculations, developing data analysis and data quality assurance plans, performing statistical analyses, and preparing abstracts and manuscripts.

Outcomesservicesincludeconsulting on model application and cost effectiveness.

Data management services include creating data entry and management systems, archiving data for long-term storage, and performing quality control for data collection and management.

Core LeadersNawarShara,PhD

ContactsNawarShara,PhD301-560-7314nawar.shara@medstar.net

Research PharmacyPurPOsE: This full-service research pharmacy provides investigators and sponsors with a broad range of services, including:

• Protocolreviewanddevelopment,secure storage of pharmaceutical and biological materials, preparation and dispensing of study medications (including gene therapy products), patientrandomizationanddrugaccountability documentation

• Experiencewithmulti-center,nationaland international clinical trials

ContactsClaudeNogay,RPh202-877-6645claude.w.nogay@medstar.net

For more information about potential collaborations or use of core resources and expertise, contact the individual cores. If investigators would like to discuss the potential use of multiple cores or are uncertain as to which core would be most relevant to their needs, they can contact the chairman of the Multidisciplinary CoreScientificAdvisoryPanel,Stephen E. Epstein, MD, at stephen.epstein@medstar.net or 202-877-5977.

SCIENTIFICSCIENTIFIC

ADVISORY PANELADVISORY PANEL

MultidisciplinaryCore Services

MultidisciplinaryCore Services

CRO/Clinical Trials Core • Coordination of all aspects of clinical trials

• Clinical trial design, management and quality control • Management of regulatory and

monitoring functions • Data management and analysis

Cardiac, Vascular and Tissue Pathology Core

Gross pathology; Histopathology; scanning/transmission EM;

confocal microscopy; laser capture micro-dissection

Bio-Repository Core • Storage of tissue specimens

Core Pre-Clinical Lab (small and large models)

• Preclinical feasibility testing • Data for regulatory approvals

Biochemistry and Biomarker Core • Lab support for population studies and clinical trials

• Novel assays and assay development

Core Platelet Center • Functional assays for platelet

reactivity and responsiveness • Flow cytometry

CV Core Imaging CenterCT; MRI; IMT; ECHO

IVUS; Angio

Genetic/Genomic/Proteomics Core• GWAS analysis

• Targeted re-sequencing• Genetic variants for disease susceptibility

• Pharmacogenetics• mRNA analysis and quantitation

• Protein identification andquantitation

Biostatistics and Epidemiology Core • Epidemiological, statistical and

data management services

University Town Center6525 Belcrest Rd., Suite 700Hyattsville, MD 20782-2031301-560-7300 PHONE

research@medstar.net EMAIL

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MHRI-1371-12.022012