Multidisciplinary Core Services

Transcription

1 Multidisciplinary Core Services A functionally integrated resource of expertise, instrumentation and technology designed to support investigators in the pursuit of their research interests University Town Center 6525 Belcrest Rd., Suite 700 Hyattsville, MD PHONE

2 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 Lab The core preclinical lab consists of two major sections: The large model section performs preclinical studies to develop data for regulatory approval prior to clinical studies The small model core lab performs a 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: Identifying genetic and molecular mechanisms of disease Preclinical feasibility testing Preclinical trials testing therapeutic interventions Providing data for regulatory approvals Large model section: Small model section: Stephen E. Epstein, MD Mary Susan Burnett-Miller, MD Large model section: David Hellinga, MSC david.g.hellinga@medstar.net Small model section: Mary Susan Burnett-Miller, MD mary.s.burnett-miller@medstar.net

3 Cardiovascular Core Imaging Center Purpose: Assists researchers in using imaging as a clinical trial endpoint across multiple purposes: Development of new imaging techniques in comparative effectiveness studies Use of imaging endpoints as primary or surrogate measures in clinical outcome trials Quantitative assessment of a diverse array of patient-based radiographic and ultrasonographic imaging techniques, including: o Quantitative coronary angiography o Intravascular ultrasound o Echocardiography o Carotid intima-media thickness evaluation o Cardiac computed tomography o Cardiovascular magnetic resonance imaging Allen Taylor, MD Neil Weissman, MD Allen Taylor, MD allen.taylor@gunet.georgetown.edu Cardiac, Vascular and Tissue Pathology Core Purpose: Through a collaboration with CV Path Institute, Gaithersburg, Maryland, the Cardiac and Vascular Pathology Laboratory 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). Renu Virmanir, MD Frank Kolodgie, MD fkolodgie@cvpath.org Core Platelet Center Purpose: 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

4 patients to determine variability of intrinsic platelet activity and variability in response to antiplatelet 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 ron.waksman@medstar.net David Hellinga david.g.hellinga@medstar.net Clinical Research Organization (CRO)/ Clinical Trials Core Purpose: Facilitates and conducts investigator- and industry-sponsored clinical trials in compliance with ICH and GCP guidelines. Together, both sections will greatly assist in: Formulating and developing protocols Preparing regulatory submissions, including IRB and FDA Managing multi-center clinical trials and registries Overseeing independent adjudication committees, e.g. clinical event committees and data safety monitoring committees Arranging independent clinical site monitoring Preparing reports and manuscripts for regulatory and peer review journal submission Providing database construction and biostatistical support for investigatorand industry-sponsors ron.waksman@medstar.net Rebecca Torguson, MPH rebecca.torguson@medstar.net Bio-repository, Biochemistry and Biomarker Core Purpose: Collects, processes, stores and disseminates samples of biological material, such as urine, blood tissue, cells, DNA, RNA and protein for research. It includes both preclinical and human samples

5 Provides assay development and validation, quality control services and expertise to clinical and translational investigators Performs more routine manual and automated clinical and biochemical determinations with quality control procedures and standards more stringent than are available in (hospital) clinical environments. Key techniques include multiplexed X-MAP immunoassays, RIA, ELISA and HPLC, as well as enzymatic, colorimetric and turbidimetric assays Accreditations The core laboratory is accredited by the Center for Medicare Services Clinical Laboratory Improvement Amendments (CLIA) and certified by the College of American Pathologists (CAP) The core also maintains level one certification from the National Glycohemoglobin Standardization Program (NGSP) and certification from the Northwest Lipid Research Laboratories Reference Lipoprotein Analysis Basic Survey (ReLABS) program (for lipoprotein determinations) Jason Umans, MD Jason Umans, MD Laboratory Facilities and Equipment The Core Laboratory is a component of the MedStar Health Research Institute located at 6525 Belcrest Rd., Hyattsville, MD 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 C freezers Monitored refrigerators Vitros 5 FS Chemistry System Hitachi 717 auto analyzer TOSOH G7 glycohemoglobin analyzer ECI immunoanalyzer Bio-Plex (X-MAPR) system ELISA reader Gamma counter Beckman centrifuges The laboratory has two freezer storage sites one at MedStar Washington Hospital Center in Washington, D.C., and one in Hyattsville, Maryland

6 (approximately 5.5 miles and 12 minutes apart by car). Both sites are supported by freezer monitoring 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 (utilizing the EMC Networker 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. Jason Umans, MD Jason Umans, MD jason.g.umans@medstar.net Biostatistics and Epidemiology Core Purpose: Provides high-quality epidemiological, statistical and data management services for investigator-initiated studies and commercial projects. The core is experienced in designing studies, developing questionnaires, writing proposals, and managing and analyzing data. Study designs include longterm, prospective cohort studies, case-control studies using stored samples, cross-sectional surveys, randomized clinical trials and chart reviews. Statistical services include conducting sample size and power calculations, developing data analysis and data quality assurance plans, performing statistical analyses, and preparing abstracts and manuscripts. Outcomes services include consulting 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.

7 Nawar Shara, PhD Nawar Shara, PhD Research Pharmacy Purpose: This full-service research pharmacy provides investigators and sponsors with a broad range of services, including: Protocol review and development, secure storage of pharmaceutical and biological materials, preparation and dispensing of study medications (including gene therapy products), patient randomization and drug accountability documentation Experience with multi-center, national and international clinical trials Claude Nogay, RPh claude.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 Core Scientific Advisory Panel, Stephen E. Epstein, MD, at stephen.epstein@medstar.net or Biostatistics and Epidemiology Core Epidemiological, statistical and data management 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 CV Core Imaging Center CT; MRI; IMT; ECHO IVUS; Angio Core Platelet Center Functional assays for platelet reactivity and responsiveness Flow cytometry Cardiac, Vascular and Tissue Pathology Core Gross pathology; Histopathology; scanning/transmission EM; confocal microscopy; laser capture micro-dissection SCIENTIFIC Multidisciplinary Core Services ADVISORY PANEL Biochemistry and Biomarker Core Lab support for population studies and clinical trials Novel assays and assay development Genetic/Genomic/Proteomics Core GWAS analysis Targeted re-sequencing Genetic variants for disease susceptibility Pharmacogenetics mrna analysis and quantitation Protein identification and quantitation Bio-Repository Core Storage of tissue specimens Core Pre-Clinical Lab (small and large models) Preclinical feasibility testing Data for regulatory approvals

8 MedStar Franklin Square Medical Center MedStar Georgetown University Hospital MedStar Good Samaritan Hospital MedStar Harbor Hospital MedStar Montgomery Medical Center MedStar National Rehabilitation Network MedStar St. Mary s Hospital MedStar Union Memorial Hospital MedStar Washington Hospital Center MedStar Family Choice MedStar Health Centers MedStar Visiting Nurse Association MedStar Institute for Innovation MedStar Health Research Institute medstarresearch.org University Town Center 6525 Belcrest Rd., Suite 700 Hyattsville, MD PHONE research@medstar.net MHRI