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Resources & Scientific Environment Office of Research Development

Facilities & Resources

Scientific Environment August 2012

Early Stage Investigators

Biohazards

The Medical University of South Carolina Office of Office of Research Development Research Develop August 2012 ment has compile d institutional information about the Medical University of South Carolina, primarily to assist faculty, staff, and trainees in preparing the resources section for proposals. Formerly known as the "institutional boilerplate", the newly named Resources and

Resources & Scientific Environment

August 2012

RESOURCES AND SCIENTIFIC ENVIRONMENT

The Office of Research Development has compiled institutional information about the Medical University of South Carolina, primarily to assist faculty, staff, and trainees in preparing the resources section for proposals. Formerly known as the "institutional boilerplate", the newly named resources and scientific environment provides brief descriptions of major elements and initiatives to serve as a guide for faculty as they develop the resources and facilities portion of their proposal. To update your core, facility or provide suggestions, please contact the Office of Research Development at 843.792.5828 or email (research@musc.edu).

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RESOURCES AND SCIENTIFIC ENVIRONMENT Quick Reference Facilities and Resources Laboratory Clinical Animal Computer Office Other Resources Cores & Facilities

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Scientific Environment MUSC Overview Research at MUSC Research Training Research Development & Administration Foundation for Research Development Support Services

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Early Stage Investigators Biohazards

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FACILITIES AND RESOURCES Laboratory Laboratory research buildings at MUSC include the Thurmond Biomedical Research Building. This building contains the Gazes Cardiac Research Institute as well as MUSC and VA research labs and shared facilities. The Basic Science Building is a complex that houses the basic science departments as well as the Darby Children's Research Institute. The Institute is fully integrated with the Basic Science Building, providing labs for researchers in 14 multidisciplinary programs. The Walton Research Building houses the Pathology & Laboratory Medicine as well as research laboratories for Otolaryngology-Head & Neck Surgery and Pharmaceutical Sciences. Additional campus buildings that include significant laboratory space as well as clinical facilities include: the Storm Eye Institute, housing the Vision Research Center; the Institute of Psychiatry, basic science laboratories for substance use disorders research; and the Hollings Cancer Center which includes dedicated to laboratory-based research. Two new research buildings opened in fall 2011. Connected to the Basic Science Building via a pedestrian skybridge, the Drug Discovery and Bioengineering Buildings were designed for translational research, research training and in vivo experimentation. All research laboratories at MUSC have access to shared equipment and resources such as ultra-low freezers, centrifuges, scintillation counters, and cold, warm, light-controlled and tissue culture rooms. Appropriate glassware and sterilization facilities are provided. All laboratory investigators have well equipped modern laboratories with suitable space for trainees and students.

Clinical MUSC Medical Center The MUSC Medical Center currently has 709 licensed beds in four inpatient facilities—Medical University Hospital (MUH), Ashley River Tower, MUSC Children's Hospital, and the Institute of Psychiatry. The MUSC Medical Center is fully licensed by the South Carolina Department of Health and Environmental Control and has JCAHO accreditation with the “Gold Seal of Approval.” The Gold Seal of Approval™ attests that the accredited organization has demonstrated compliance to the most stringent standards of performance. MUSC is the #1 hospital in South Carolina according to the U.S. News & World Report released on July 17, 2012. In addition, four adult and two pediatric specialty programs at MUSC are ranked among the top 50 in the nation. To be nationally ranked, a specialty program must not only have a good reputation but show that it can handle a high volume of the toughest cases and objectively document the highest-quality care and good outcomes (survival rates, patient safety), often with data available from the federal government. The four nationally ranked adult specialties are cardiology & heart surgery (#47); ear, nose & throat (#30); gastroenterology (#49) and nephrology (#44). Nine other adult specialties at MUSC are designated as “highperforming,” meaning that they are among the top 25% of programs nationally: cancer, diabetes & endocrinology, geriatrics, gynecology, neurology & neurosurgery, orthopedics, pulmonology, rheumatology and urology. Overall, MUSC was recognized for excellence in 13 of the 16 adult specialty programs assessed. MUSC has been recognized for excellence by US News & World Report for more than 15 consecutive years. MUSC Children’s Hospital ranked in the top 20 hospitals for children’s heart programs in U.S. News Media Group's 2011 edition of America’s Best Children’s Hospitals. MUSC is the only medical center in the state that offers transplant programs for heart, pancreas, kidney-pancreas, small bowel and liver (including living donor procedures for liver transplantation), and has the only comprehensive eye center in the state. Medical Center data for the year ending June 30, 2011 include: 4

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Number of Licensed Beds

709

plus 50 Neonatal Special Care

Average Daily Census Rate Annual Admissions Number of Births Number of Outpatient Visits Number of Inpatient Surgical Procedures Number of Outpatient Surgical Procedures

581 34,295 2,623 951,118 17,152 7,927

Medical Center Research Mission. The Medical Center mission is to provide excellence in patient care, teaching, and research in an environment that is respectful of others, adaptive to change, and accountable for outcomes. The Medical Center advances biomedical knowledge by serving as a setting for clinical and translational research, providing resources to conduct research, and offering opportunities for patients to participate appropriately in research and treatment protocols. Hospital Accreditation. The most recent Joint Commission on Accreditation of Healthcare Organizations (JCAHO) survey in September 2006 resulted in full re-accreditation. MUSC Medical Center is fully licensed by the South Carolina Department of Health and Environmental Control (SC DHEC). Access to Patients. The MUSC Medical Center has managed care contracts with all major commercial payers in its area. The tri-county Charleston area is the state’s fastest growing region with a population of 665,000 in the primary area and another ~500,000 in the secondary market. A quarter of the state’s senior population lives in these catchment areas. As South Carolina's premier health care center, MUSC receives statewide and regional referrals through consortium hospitals, satellite clinics, and an extensive network of referring physicians. Data regarding inpatient and outpatient activity are provided above. Clinical Trials. SCresearch.org is the South Carolina Research Studies Directory, which enables South Carolinians to participate in research opportunities and novel treatment options available at MUSC as well as many of the other state’s hospitals. Participation in these treatment options (i.e., clinical trials) allows individuals to play an active role in their own health care and access new treatments before they become widely available. It also allows individuals to help others that may benefit in the future from their contribution to medical research.

Computerized Clinical Data Management System MUSC's electronic medical record system has three primary components: a clinical data repository from Telus Health Solutions (Oacis), an inpatient electronic medical record system from McKesson (Horizon Clinicals), and an ambulatory electronic medical record system from Epic. Both the inpatient and ambulatory electronic medical record systems include computerized physician order entry, nursing clinical documentation and medication administration. MUSC also utilizes McKesson's Horizon Patient Folder document imaging system. Clinical information and results are integrated in Oacis from McKesson Horizon Clinicals and Horizon Patient Folder, as well as numerous other sources such as general laboratory, microbiology, pathology, radiology, respiratory therapy and multiple sources of transcription. Additional interfaces to other data sources continue to be developed. The Oacis system is designed on a service-based model as a longitudinal patient record for both inpatient and outpatient information. The collection of data in the Oacis system at MUSC started in June 1993. With authorization, professional staff can access detailed data on a given patient or a group of patients. All data in the Oacis clinical data repository has also been replicated into the Enterprise Data Warehouse (EDW). EDW is accessible from using business intelligence tools either in a patient identifiable mode or a patient de-identified mode. Both the EDW and the Oacis system supports clinical decision-making and serves as repositories for data associated with clinical, health services, and outcomes research. MUSC has also implemented the Picis 5

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Corporation system to automate MUSC's Operating Room and Anesthesia clinical documentation.

Ashley River Tower 
 
 MUSC’s Ashley River Tower facility opened for patient care in February 2008. It is the first phase of a longterm initiative to construct an entirely new comprehensive teaching and referral hospital on the west side of campus. This facility continues MUSC’s long history of providing excellence in patient care. Focusing on Heart & Vascular Disease and Digestive Disease, Ashley River Tower offers the latest technologies and top physicians to address the increased incidence of cardiovascular and digestive diseases among the growing population of South Carolina and the region. This state-of-the-art building has 156 licensed beds, an intensive care unit, operating rooms, laboratories, interventional radiology and endoscopy suites, and a specialized chest pain center. The hospital is designed to accommodate the most modern medical equipment available and to offer patients and their families the highest quality of care in a safe, comfortable and healing environment. Charleston Memorial Hospital Charleston Memorial Hospital (CMH) is a short-term inpatient facility licensed for 20 beds, providing emergency room services, ancillary department support, and limited inpatient services. MUSC Medical Center purchased CMH from Charleston County in July 2001. This facility provides support for a number of academic, clinical, research, and facility support initiatives at MUSC. MUSC Children's Hospital MUSC Children's Hospital is the largest and most comprehensive pediatric medical center in South Carolina. Our health system covers the state with an extensive network of physicians, health care professionals and services – all dedicated to children. MUSC Children’s Hospital was again ranked in the top 20 hospitals for children’s heart programs in U.S. News Media Group's 2012-2013 edition of America’s Best Children’s Hospitals, along with a first-time top 50 ranking for the pediatric gastroenterology program. The MUSC Children’s Hospital is dedicated to enhancing the health of children throughout South Carolina and to providing an environment that supports excellence in pediatric patient care, teaching, and research. The Children’s Hospital offers a full range of age-specific care. It is South Carolina’s largest and most comprehensive pediatric healthcare center, offering the only Level III neonatal intensive care unit in the region and the only Children’s Emergency Department in South Carolina. MUSC Children’s Hospital consistently earns high rankings from American Health Magazine and Best Doctors of America. The health system consists of a comprehensive network of primary care physicians, specialists, surgeons, and service providers who provide a variety of services and programs, including the Child Life Program, Community Outreach, Emergency and Transport Services, Pediatric Burn Center, Prenatal Wellness Center, Transplant Programs, and Trident Area SAFE KIDS, as well as specialty care in more than two dozen medical, surgical and psychiatric areas. Darby Children's Research Institute The Darby Children's Research Institute is the largest and most comprehensive pediatric research facility in the Carolinas. It is one of 15 buildings in the country dedicated to children's research. Located next to the Basic Sciences building on Ashley Avenue, the seven-story institute houses 150 state-of-the-art laboratory modules, 11 research programs, and approximately 150 investigators and staff. Researchers work non-stop to discover the causes of and cures for ailments that continue to afflict our children, including cancer and blood disorders, congenital heart disease, multiple sclerosis, AIDS and other immunological diseases, Genetic disorders, mental 6

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retardation and learning disabilities, pneumonia and respiratory syncytial virus, and diabetes, which afflicts more than 311,000 children and adults in South Carolina. The work being performed in these areas raises the level of care not only at MUSC Children's Hospital, but also throughout the entire Medical University. Research conducted at the Institute could potentially assist children throughout the world. Ralph H. Johnson Veteran's Administration Medical Center The Ralph H. Johnson VA Medical Center (VAMC) in Charleston, SC offers primary, secondary, and tertiary care facility and operates approximately 145 inpatient beds. The facility provides primary and specialized outpatient services in southeastern South Carolina and Chatham County, GA. The VAMC also supports Veterans Centers in North Charleston, SC and Savannah, GA and operates outpatient clinics in Savannah, GA and Myrtle Beach, SC. Over the past year, the total number of inpatients treated was approximately 4,500 and the total number of outpatient visits was more than 500,000. The Charleston VAMC is closely affiliated with the Medical University of South Carolina. For FY2009-FY2010, the VAMC supported an average of 80 House Staff positions. Residents from MUSC rotate through all major clinical services, as do student trainees and trainees from nursing, pharmacy, social work, and other allied health positions. The Research Service at the Ralph H. Johnson VA Medical Center is broad-based with more than 262 active research protocols being conducted by 98 investigators. A unique partnership between the VAMC and MUSC maintains the nation’s only mutually supported research facility, housing collaborative biomedical research with an FY11 VA and non-VA funding level of about $18 million ($15.7 million from the National Institutes of Health and the remainder from other sponsors) and over $10 million in funding from the VA. VA investigators have wet bench laboratories totaling more than 46,000 square feet in the Thurmond Biomedical Research Facility as well as an AAALAC accredited Veterinary Medical Unit directed by a board-certified veterinarian. Major research areas include hypertension, diabetes mellitus, heart failure, stem cell biology, immunology, cancer biology, renal diseases, signal transduction, mental health, substance abuse, and aging. The Ralph H. Johnson center has 1 of 13 national VA Health Services R&D Research Enhancement Award Programs (REAP); research focuses on disease prevention and health interventions for diverse populations. Outpatient clinical/translational research activities are housed in a dedicated 2,800 square foot Clinical Research Unit (CRU) on the 2nd floor of the VAMC. The CRU has 10 examination rooms, a 4-station transfusion room, a 3-station physician workroom, a waiting room and a general laboratory with a –80ºF freezer, centrifuge, several refrigerators, and a microscope. The CRU also includes a sterile specimen storage facility, staff offices, and break- and workrooms. Construction for a new mental health research building that will be attached to the VAMC is soon to break ground. The Charleston VAMC was one of the first research programs in the country to successfully achieve accreditation for its Human Subjects Protection Program. Re-accreditation was accomplished in December 2011 for a five year duration. The research program has also obtained and maintained accreditation of their animal program through the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC), with reaccreditation accomplished in 2011. Protection of Human Subjects Participation of human subjects in research is under the jurisdiction of federal regulations (45 CFR 46 and 21 CFR 50 and 56). MUSC investigators are granted the privilege of working with human subjects under normal assurance to the government that such research complies with regulations protecting human subjects. The university has a federal-wide assurance for research with human subjects (FWA 00001888, expires 08/25/2016), and is in compliance with federal policy governing use of human subjects. Individuals involved in human subject 7

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research at MUSC are required to complete the Collaborative IRB Training Initiative (CITI) offered on-line by the University of Miami. All human subject protocols are reviewed through an academic Institutional Review Board (IRB) process that has been accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP). The MUSC Office of Research Integrity coordinates the activities of three IRB committees, involving faculty members as well as representatives of the business, legal, ethical, religious, and civic communities. These committees are registered at: http://ohrp.cit.nih.gov/search/search.aspx. The MUSC IRB serves as the university affiliate for the Ralph H. Johnson VA Medical Center, which is accredited by the National Committee for Quality Assurance. Compliance The MUSC University Compliance Program is a proactive program designed to promote full compliance with all applicable policies, procedures, laws and regulations. This involves a confidential Compliance Helpline to encourage all members of the MUSC community to ask questions or voice concerns about laws and regulations on such topics as coding and billing, research integrity, professional ethics, human subject/animal research, biological safety, conflict of interests, and patient/subject confidentiality. The Compliance Office proactively trains employees, monitors high-risk activities, and facilitates discovery of concerns, followed by appropriate investigation and corrective action where appropriate. This program directly assists MUSC’s management at all levels in maintaining and enhancing an environment where ethics are paramount considerations in strategic and operational decisions throughout the organization.

Animal Care and Use of Vertebrate Animals in Research The Division of Laboratory Animal Resources (DLAR) centrally manages the University’s animal care program. The Institutional Animal Care and Use Committee (IACUC) is independently chartered and appointed by the President and is fully independent of DLAR. The IACUC reports to the Vice President for Academic Affairs & Provost. Committee functions are staffed by the Office of Research Integrity under the direction of the Associate Provost for Research. The IACUC is responsible for review of all proposals using lab animals at the university as well as oversight of the programs and policies associated with animal use. The committee meets monthly to review and approve animal protocols and address other issues. It performs semiannual inspections and review of the DLAR programs and facilities for compliance with PHS, USDA and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) regulations. To help the IACUC in monitoring the conduct of animal-based research and proactively assist investigators in establishing and maintaining good practices, MUSC also has a program for Post-Approval Monitoring of Animal Use (PAMA). A designated Animal Research Compliance Liaison works with the MUSC investigators and the individuals who handle animals in their laboratories to ensure that the highest level of animal care is maintained and that all research involving animals is conducted with appropriate IACUC review and approval. MUSC has been fully accredited by the AAALAC International since 1987, with an unbroken record of compliance with regulatory inspections by the U.S. Department of Agriculture (USDA). MUSC’s Animal Welfare Assurance number is A3428-01 (expires 04/30/16).

Computer Office of the Chief Information Officer – Information Services (OCIO-IS) Information Services, a division of the Office of the Chief Information Officer (OCIO), manages MUSC’s campus-wide data and voice communication network as well as other core infrastructure systems and applications. The campus data network provides Gigabit Ethernet connections to the desktop and Gig throughputs in the core. There are currently 50000 network ports with 35000 active devices. The campus wireless network has 8

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1000 access points with 3500 wireless users daily. Campus data switches utilize a fiber optic backbone to the core switches/routers and fiber optic and copper cables connecting the access layer switches. Gig connections are provided for users with a need for higher bandwidth requirements. Individual campus sub-networks are administered as an Internet Class B Network. Cisco routers provide high-speed connections between internal subnets and the Internet. Metro Ethernet and cable modems are used to extend the campus network to remote or rural office locations. The campus voice communications network has more than 15,000 telephones and a voice mail system with more than 6000 active mailboxes. Information Services also provides support for main infrastructure systems, including Microsoft Exchange email, file storage (Homeroom), Web servers, calendar, network identification and account maintenance, network time protocol, domain name system, and directory services. Core applications supported by Information Services in the area of Academic and Research Computing include the MUSC library system, OVID, WebCT, SYBYL (molecular modeling), and GCG (gene sequence research). Core campus-wide financial and administrative applications are also supported through Information Services, such as GL, AP, financial reporting, purchasing, payroll, and human resources. Infrastructure services and key applications are accessible to authorized users from any Windows, Macintosh, or Unix workstation with access to the campus network. The MUSC Web servers provide a convenient campus-wide search and retrieval system for information. MUSC accesses the supercomputer at the University of South Carolina in Columbia, SC, and co-sponsors the Beowulf cluster at the College of Charleston. The OCIO office provides free encryption service for laptops, personal or institutionally owned. Encryption is important for computers containing Personal Health Information (PHI) or sensitive data of any kind. South Carolina Light Rail South Carolina Light Rail (SCLR) is a collaborative project among Clemson University, the Medical University of South Carolina, and the University of South Carolina to support and enhance economic development, research, education and healthcare in South Carolina. SCLR is envisioned as a public-private partnership to provide a broadband, high-speed optical network that will extend throughout the state and link to regional and national networks such as Southern Light Rail (SLR), National Lambda Rail (NLR), Internet2, and SURAgrid and TeraGrid. The SCLR can be used for high definition, full motion video conferencing as well as rapid massive file transfers, uploads and downloads and remote computational resources. The SCLR is configured for telemedicine and telehealth applications, providing secure transmissions to protect Private Health Information (PHI) and other sensitive data. Computational Biology Resource Center The Computational Biology Resource Center (CBRC) is a state-of-the-art computational infrastructure for scientists to apply advanced computer algorithms to biological problems. Toward reaching this goal, the CBRC has purchased and maintains a 16 node 132 CPU computing cluster combined with multi terabit storage capacity. The cluster is a LINUX-based system aimed at supporting a host of biodatabases as well as applications in drug discovery, NMR, x-ray crystallography, DNA microarray analysis, bioinformatics, image analysis and molecular modeling.

Office Office areas at MUSC are well lighted ventilated and appointed for scholarly activities, paperwork, and modes of communication (voice, data, analog, digital, etc.) that are common and appropriate at a contemporary health professional university and academic medical center. Competent support staff and all standard office services and software are readily available to facilitate the academic and scientific activities of faculty, trainees, and technical staff. 9

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OTHER RESOURCES Cores & Facilities Biomedical research requires the application of new and diverse technologies that are often difficult to obtain within the resources of a single laboratory or department. Access to routine instrumentation and services that are costly to duplicate, to facilities that a single laboratory cannot support, and to evolving technologies at the forefront of research are essential for research viability. At MUSC, University Research Resource Facilities (URRF) was established with support and oversight from the Vice President for Academic Affairs & Provost. In addition to these facilities, many other research cores and facilities are sustained by colleges, departments and/or centers to enhance the university research profile. Cores and facilities include the following:                   

Antibody Facility Biomedical Imaging Biorepository & Research Pathology Services Biostatistics & Epidemiology Collaborative Unit Biostatistics Shared Resource (HCC) Cell and Molecular Imaging Shared Resource Cellular Therapy Clinical Trials Office Computational Biology Resource Center Data Coordination Unit Drug Design and Synthesis Core Drug Discovery Shared Resource Drug Metabolism and Clinical Pharmacology Flow Cytometry Facility Flow Cytometry and Cell Sorting Facility Fluorescence Imaging Plate Reader Facility Gene Targeting and Knockout Mouse Facility Gnotobiotic Animal Research Facility Irradiator Facility

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Laser Capture Microdissection Facility Lipidomics Shared Resources Mass Spectrometry Facility Metabolomics Core Facility Mineralized Tissue Facility Molecular Morphology and Imaging Nephrology Proteomics Laboratory Nuclear Magnetic Resonance Facility Nucleic Acid Analysis Facility Oral Preclinical Research Facility Protein Production Laboratory ProteoGenomics Facility Seahorse Bioscience Academic Core Facility Small Animal Imaging Core State Office of Research and Statistics Transgenic Mouse Core Facility Translational Research Shared Resource X-Ray Crystallography Resource Xenograft Facility

Antibody Facility The MUSC Antibody Facility provides monoclonal antibodies to proteins or peptide. Depending on the desire of the requester, the sera, cell line, cell culture supernatants, ascites, purified immunoglobulins or all of the above are provided. Monoclonal antibodies are derived from mice immunized with a particular immunogen or derived from autoimmune mice spontaneously producing antibodies to the antigen of interest. In specific instances of a polyclonal antibody that has been difficult to derive, the facility will aid in this process. Technical assistance in selecting the antigen for injection is also offered. We also provide services to generate phage display libraries for selection of antibodies.

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Biomedical Imaging The Medical University of South Carolina (MUSC) has recently established the Center for Biomedical Imaging (CBI). The CBI provides state-of-the-art imaging resources to support clinical and research activities, provide opportunities to advance the imaging field, disseminate new technologies and approaches to the larger community, and train and mentor young investigators interested in developing and applying biomedical imaging to clinical and research problems. The mission of the CBI is to maximize the impact of imaging at MUSC by providing leadership and infrastructure that enables the university to address local and national priorities and developing regional and national collaborations that strengthen capabilities and enhance the university’s image. The CBI also provides opportunities for basic and clinical scientists to collaborate and discover new ways to study diseases and disease processes, to develop and apply this knowledge to clinically relevant research, and to translate advances to the community. The CBI includes approximately 4500 square feet of space at 30 Bee Street, as well as approximately 9000 square feet in the new Bioengineering Building. Space at 30 Bee Street is the main facility for human imaging research and houses a Siemens 3T TIM Trio MRI scanner equipped with integrated fMRI paradigm presentation equipment. The scanner operates with a 100% mandate for research use and is covered by a master research agreement with Siemens Medical. The site also contains an image analysis laboratory and bioengineering facility along with subject interview and changing rooms. Researchers also have access to clinical Siemens 1.5T and 3T Verio MR scanners, located within the Radiology Department in the Clinical Sciences Building. The space at the Bioengineering Building house offices, wet and dry labs, classrooms, an auditorium, a Bruker 7T/30 animal MRI system, a bioluminescence imager, and a Siemens micro PET/CT scanner. There is also an animal quarantine room within the imaging center itself dedicated to holding animals that have been imaged. Biorepository & Research Pathology Services Shared Resource The Biorepository & Research Pathology Services Shared Resource at the Medical University of South Carolina and the Hollings Cancer Center provides investigators with a centralized infrastructure that promotes biomedical research involving the use and study of human biospecimens. The shared resource is comprised of four integrated components: Biospecimens and data bank, Laser Capture Microdissection, Tissue Microarray, and Research Pathology Services. These components, along with extensive staff expertise, offer a comprehensive means by which researchers can utilize valuable human biospecimens and cutting edge technology to support basic, translational and clinical research. Biostatistics & Epidemiology Collaborative Unit The primary mission of the Collaborative Unit, a Provost-sponsored University Research Resource Facility (URRF), is to provide expert grant development assistance in biostatistics, bioinformatics and epidemiology. The Collaborative Unit is housed within and includes the entire faculty of the Department of Biostatistics, Bioinformatics and Epidemiology (DBBE). Faculty activities include assistance in design of observational studies and experiments, selection of data collection instruments and data management systems, and preparation of the statistical narratives, with appropriate budget and justification, associated with grant applications. The Collaborative Unit is the single point of access for MUSC researchers conducting translational research. To complement the research mission of the university, the Collaborative Unit offers general research seminars to departments upon request. These seminars present fundamental research topics and are appropriate to investigators at all stages of development. The Collaborative Unit also provides practical educational experiences for selected departmental doctoral students interested in developing skills in applying the quantitative tools.

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Biostatistics Shared Resource (Hollings Cancer Center) The Biostatistics Shared Resource provides biostatistical support to cancer center investigators. Our primary responsibilities include study design and statistical analysis. Biostatistical support is essential for cancer researchers to develop rigorous study designs to efficiently manage data, and to make maximum use of data collected for informed conclusion. Early statistical input into the design of experiments increases the efficiency of investigations and improves the quality of research. Our services span all types of cancer research including cancer clinical trials, cancer prevention studies, epidemiologic studies, animal studies, and other laboratory studies. Hollings Cancer Center members are encouraged to utilize Biostatistics Core resources for development of cancer related grants and protocols (to be submitted to federal as well as private agencies), and help in answering the biostatistical related questions and suggestions of the external reviewers. Cell and Molecular Imaging Shared Resource The Cell and Molecular Imaging Shared Resource provides technical services and training in confocal microscopy to MUSC investigators. The Cell and Molecular Imaging Shared Resource is also a part of the Center for Cell Death, Injury and Regeneration. Services include data acquisition/capture at the cellular and/or tissue levels, data analysis and software packages. The latter services are provided on a separate computer station. In addition to providing state of the art microscopes, the Imaging Shared Resource strives to identify specific user needs for future purchases. This may include non-destructive, low energy imaging of live and fixed cells, FRET (fluorescence resonance energy transfer) and multiphoton imaging applications. During the initial training session users will be instructed regarding the safety precautions of lasers, proper handling of microscope and high cost objectives, and general overview of the image acquisition software. The Cell and Molecular Imaging Shared Resource Facility supports five confocal laser-scanning microscopes.  Zeiss LSM 510 NLO Laser Scanning Confocal Microscope with Multiphoton Excitation  Olympus FV10i Laser Scanning Confocal Microscope  BD Biosciences CARV II for Video Rate Confocal Imaging  Zeiss 510 META Laser Scanning Confocal Microscope  Leica TCS SP2 AOBS Laser Scanning Confocal Microscope

Cellular Therapy Shared Resource The Cellular Therapy Shared Resource is an interdepartmental initiative to facilitate a variety of cell-based therapies requiring cell and tissue processing in a clean room environment. It will be a cell processing facility in accordance with Good Manufacturing Practice (cGMP) and Good Tissue Practice (cGTP) standards in order to support multiple investigator-initiated (IND), industry-sponsored Investigational New Drug/Investigations Device Exemption (IDE) and standard clinical care protocols to include:        

Processing autologous and allogeneic pancreatic islet cells for transplantation Processing and isolating hepatocytes Generation of Dendritic cells for cancer vaccines Hematopoietic stem cell expansion protocols Gene transduction into dendritic or stem cell populations Tumor cell and T-cell purging protocols using human hematopoietic stems cells Cell-based immune therapy protocols involving plasmid/viral transduced human cells Cell processing to facilitate the fabrication of engineered tissues.

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Clinical Trials Office The Hollings Cancer Center (HCC) Clinical Trials Office (CTO) provides a centralized office for the conduct of cancer clinical trials at the Medical University of South Carolina (MUSC). The purpose of the HCC CTO is to provide an effective and efficient clinical research infrastructure to support investigators and clinicians in developing and implementing clinical research studies.

Computational Biology Resource Center The Computational Biology Resource Center (CBRC) The CBRC is a state-of-the-art computational infrastructure for scientists to apply advanced computer algorithms to biological problems. Toward reaching this goal, the CBRC has purchased and maintains a 16 node 132 CPU computing cluster combined with multi terabit storage capacity. The cluster is a LINUX-based system aimed at supporting a host of biodatabases as well as applications in drug discovery, NMR, x-ray crystallography, DNA microarray analysis, bioinformatics, image analysis and molecular modeling. Data Coordination Unit (DCU) The Data Coordination Unit (DCU) is highly experienced with all aspects of multicenter clinical trials and offers full service statistical consulting ranging from protocol development to final analysis and report writing. DCU services include study design/protocol development, central registration and randomization, data management, reporting and publications and web-based database system development. The DCU, housed within the Division of Biostatistics and Epidemiology in the Department of Medicine at the Medical University of South Carolina, specializes in providing assistance with the design of clinical trials and analysis of their data and in establishing, implementing and maintaining data and project management systems for multicenter clinical trials. The Unit is experienced with the design and conduct of Phase I through III trials in a variety of therapeutic areas including neurology, digestive diseases, psychiatry, and diabetes, as well as trials conducted under FDA Investigational New Drug applications. The director is Dr. Valerie Durkalski, Associate Professor of Biostatistics and Epidemiology. The DCU is involved with several clinical research studies, most of which are NIH-funded, multicenter clinical trials involving over 100 academic institutions (including MUSC) in North America as well as international institutions. All data management activities for these studies are conducted using the DCU’s internally developed and validated Clinical Trials Management System (CTMS) referred to as the WebDCU™ system. The WebDCU™ offers a full collection of web-enabled modules for randomization, protocol and site management (e.g., drug accounting and shipping, automated SAE reporting, regulatory document tracking), study monitoring, data entry and validation, and report generation. The system provides a web-based collaborative environment for study team members across all participating clinical sites and provides all the required tools for site coordination and data management in one efficient and easy to use system. Drug Design and Synthesis Core The Drug Design and Synthesis Core provides access for researchers to infrastructure, expertise, and capabilities in obtaining small organic molecules and peptides and also synthetically introduces labels into bimolecular and/or biological probes.

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Drug Discovery Shared Resource The Drug Discovery Shared Resource at MUSC provides a mechanism for faculty, postdocs and students to discover chemical agents that affect targets that they hypothesize to be involved in human diseases. The Drug Discovery Shared Resource provides the following resources: expertise for assay development; chemical libraries; instrumentation for high-throughput screening, including robotic liquid-handling and state-of-the-art cell imaging, and technical support for screening. The compounds can then be used as biochemical probes of the functions of the target proteins, and/or developed into new therapeutic agents. This provides opportunities for new research funding, patents and technology commercialization. Drug Metabolism and Clinical Pharmacology The Drug Metabolism and Clinical Pharmacology shared resource maintains multifunctional Molecular Devices Spectramax M5 and PerkinElmer Envision microplate readers that are capable of quantifying absorbance, luminescence, fluorescence intensity, time-resolved fluorescence and fluorescence polarization. These are robotically coupled to a Caliper SciClone 3000 ALH automated liquid-handling workstation and a Molecular Devices AquaMax microplate washer. A GE InCell Analyzer 1000 with liquid handling and the OptiGrid Structure Light Module is used for cell imaging-based assays. The Drug Metabolism and Clinical Pharmacology Shared Resource is equipped with the latest instrumentation and software necessary to support collaborative interactions between basic scientists and clinicians in the preclinical and clinical (Phase I and II) investigation of new drugs. The core offers broad, comprehensive pharmacology support in the areas of sample handling, pharmacokinetics, drug-drug interaction, pharmacodynamics, metabolite identification and human safety pharmacology. The Drug Metabolism and Clinical Pharmacology Shared Resource offers the following services:      

Preclinical / clinical trial design and analysis Drug Metabolite identification: (in vivo, in vitro and ex vivo) Quantify drug levels in serum/plasma, tissue or cell/media Pharmacokinetic and pharmacodynamic studies Evaluation of human safety pharmacology using normal target cells from dose-limiting tissues, including hepato-, nephro- and myelo- toxicity Education and training

The facility is equipped with the latest HPLC and UPLC-MS instrumentation and software necessary in Phase I and II clinical trials. Available capabilities include chromatography (HPLC), spectroscopy (UV, FL, electrochemical), and electrophoresis as well as LC/MS/MS. Our LC-MS/MS facilities include a 96-well plate automated liquid-handling system and a triple quad LC-MS/MS from Waters Corporation (Micromass Quattro Premier XE) with ES and APCI ionization. The Quatro Premier UPLC/MS/MS System is an enhanced highperformance triple quadrupole mass spectrometer system with applications in protein and peptide analysis, small molecule analysis in drug metabolism and pharmacokinetic studies. The entire system is controlled by MassLynx software. Hematologic and toxicology parameters can be assayed on an Abaxis VetScan and Beckman Coulter DU800 spectrophotometer. Flow Cytometry Facility Flow Cytometry Facility serves to provide information and encourage individual researchers to bring their expertise in cell proliferation, extracellular signaling, intracellular signaling, cell adhesion, cell migration, or gene regulation to bear on studying the biological properties of stem cells. This facility offers technical information and training to guide investigators in using stem cells to enhance their individual research interests or scientific expertise. Through this facility, investigators can arrange training and tutorials in procedures to isolate, clone, store, and culture stem cells from adult bone marrow, cord blood, or established cell lines.

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Equipment available to the facility includes: Becton Dickinson FACSVantage flow cytometers with five fluorescent detectors for use in complex cell sorting; tissue culture hoods and incubators; a Cryomed Programmatic Cell Freezing system with an MVE Cryogenic Liquid Nitrogen Freezer for keeping cells longterm; and computer workstations for visiting faculty and students. Flow Cytometry & Cell Sorting Shared Resource Facility The Flow Cytometry & Cell Sorting (FCCS) Shared Resource Facility is co-sponsored as a Hollings Cancer Center (HCC) Core Facility and a University Research Resources Facility. Equipped with state-of-the-art instruments and staffed by experts, the goal of the FCCS Shared Resource is to provide comprehensive analytic flow cytometry and high-speed cell sorting services in a cost-effective manner to HCC members. The facility staff have considerable expertise in high-speed sorting of rare populations of cells including stem/progenitor cells and epitope-specific T cells and are continually expanding the repertoire of available techniques to meet the needs of the innovative research within the HCC. This shared resource offers a wide range of services from access to routine flow cytometric analysis to expertise in high-speed cell sorting to the development of novel assays. Examples of assays available include, but are not limited to: immunophenotyping, cell cycle analysis, DNA ploidy analysis, apoptosis, cell proliferation (BrdU incorporation), intracellular antigen/protein and membrane potential measurement, as well as cytokine detection (bead assay). High-speed cell sorting based on cell surface marker immunostaining and/or side-population staining is also available. FCCS Shared Resource Facility supports the following equipment:  Becton Dickinson FACSAria IIU Cell Sorter  Beckman Coulter MoFlo XDP High-Speed Cell Sorter  Becton Dickinson FACSCalibur Analytical Flow Cytometer  Becton Dickinson LSRFortessa  Becton Dickinson FACSVerse Fluorescence Imaging Plate Reader Facility - (FLIPRTETRA®, Molecular Devices) The FLIPRTETRA® purchased through a shared instrumentation award obtained from NIH under the American recovery and Reinvestment Act of 2009 (NCRR 1S10RR027777-01) is an industry-renowned instrument for monitoring GPCRs and ion channels. The system provides a reliable and flexible high throughput screening solution for identifying early leads in the drug discovery process. FLIPRTETRA®, features 96, 384 and optional 1536 well configurations, multi-wavelength kinetic readings, LED modules and user configurable excitation and emission filters, and enhanced luminescence sensitivity with the aequorin luminescence camera. With the user configurable LED excitation modules, the FLIPRTETRA® has been used for the following assays: membrane potential, intracellular pH, sodium and calcium, reactive oxygen species, nitric oxide, c-AMP (utilizing GLO-sensor cells; Promega, Inc) and others. The FLIPRTETRA® is optimized for use with both fluorescent and luminescent assays, including aequorin and Molecular Devices' nowash FLIPR® calcium and ion channel assays. The table lists examples of target assays and current available LEDs and emission filters, highlighting (underlined) those currently installed. Experiments must be pre-consulted with Dr. Tom Morinelli, facility manager, to assure that they are feasible and that the proper 15

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dyes are available. All disposables are provided by user (plates, dyes, buffers). Subsequent to initial training session, reservations can be made utilizing the on-line calendar. The FLIPRTETRAŽ facility is located in room 519 Strom Thurmond Biomedical Research Center. The instrument is available for $50 an hour for investigator-initiated funding and $100 an hour for private/commercial funding projects. To request use of the FLIPR tetra Resource Facility use the Online Registration Form. For further information, please contact Dr. Tom Morinelli, facility manager, at 843-792-0071 or morinelt@musc.edu. Gene Targeting and Knockout Mouse Facility The Gene Targeting & Knockout Mouse Facility consists of four facilities: Transgenic, Gene Targeting and Knockout, Xenograft, and Carcinogenesis. Transgenic and Gene Targeting facilities are essential genetic tools for studying mammalian gene functions in vivo, by testing the over-expression and loss-of-function mutations in animal development and in tumor susceptibility, respectively. In addition, transgenic technology can be used in generating tissue-specific expression vehicles that can be utilized in creating conditional knockouts, either by Cre recombinase or by siRNA expression. Xenograft of human cancer cells or tissues into immune deficient mice is an indispensable step in correlating in vitro cell biology studies of cancer biology with tumorigenicity in vivo. The tumor grown in mice can also serve as a realistic test model for new therapeutics. For studying specific cancer types, the Carcinogenesis facility is able to generate several organ-specific cancers in rodents; they are invaluable tools for testing the function and therapeutic values of specific genes and therapies. The Cancer Animal Model Shared Resource combines the existing expertise of these four facilities to form a comprehensive service to assist cancer researchers at HCC. The overall goal of Gene Targeting and Knockout component of the Animal Models Shared Resource is to provide the means by which researchers can learn and apply cutting edge technology to the molecular analysis of mammalian gene function. The specific aim of this facility is to create "knockout mice" through the utilization of DNA-, stem cell-, and embryo-manipulation procedures. Molecular cloning techniques are employed to clone and manipulate DNA sequences. Homologous DNA recombination in cultured embryonic stem (ES) cells is employed to generate "targeted" ES cells (i.e. ES cells carrying the replacement of specific chromosomal DNA sequences with cloned DNA sequences). Embryo manipulation techniques involving the targeted ES cells are employed to generate chimeric mice, which are then used to generate the knockout mice. Gnotobiotic Animal Research Facility MUSC has established a Gnotobiotic Animal Research Facility under the direction of Dr. Edward Balish. The facility is a joint initiative of the College of Dental Medicine, University Research Resource Facilities program, and the Division of Laboratory Animal Resources (DLAR). The facility is located in state-of-the-art DLAR facility in the Darby Children's Research Institute. The MUSC Gnotobiotic Research Resource gives investigators at MUSC a unique opportunity to conduct research with germfree or “gnotobiotic� animal models, in addition to more widely available specific-pathogen-free animal models. Irradiator Facility The Irradiator Facility serves as a shared resource for the MUSC and the Hollings Cancer Center. The facility contains a JL Shepherd Model 143 137 Cesium irradiator. This equipment is designed to irradiate biological samples at variable doses. Adapters allow exposure for both tissue culture samples and small rodents. As of October 3rd, 2007, the irradiator produces an unshielded exposure rate of 235 rads/min (2.35Gy/min).

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Laser Capture Microdissection Facility The state-of-the-art technology of Laser Capture Microdissection (LCM) Facility provides researchers with the ability to accurately analyze DNA, RNA and protein from pure populations of cells, such as tumor cells that are captured from complex heterogeneous tissue samples. Protocols have been developed and optimized for acquisition of high-quality RNA and DNA from both frozen and formalin-fixed, paraffin-embedded tissue. Care is taken to preserve the integrity of the samples at all times, ensuring high quality retrieval of molecular targets. Services provided in the LCM facility include:  Laser Capture Microdissection of pure populations of cells  DNA/RNA/protein extraction and QA/QC from microdissected samples  RNA/cDNA Amplification from microdissected, frozen, and FFPE tissues  Support for grant applications by providing LCM budgets and support letters The establishment of the LCM shared resource is a combined effort of the College of Dental Medicine Center for Oral Health Research and the Hollings Cancer Center Tissue Biorepository. The Center for Oral Health Research provided significant support such as LCM equipment and partial salary support for LCM personnel. The LCM shared resource is housed in the Tissue Biorepository at Hollings Cancer Center, and is equipped with an ArcturusXT LCM system, Agilent Bioanalyzer, Leica CM 1850 Cryostat, and a Microm HM340E Microtome, which are available for a wide range of applications. Viability of the IR laser-enabled LCM technique has been shown for a variety of different cell types. The LCM procedure is remarkably simple and robust. The method is extraordinarily gentle and ideal for microdissection of single cells or small numbers of cells. The LCM system utilizes a laser microbeam that melts a thermoplastic membrane that sticks to the selected cells, which can then be lifted and secured in a microfuge tube containing the appropriate extraction solutions. The transferred tissue on the film retains its original morphology, thereby allowing microscopic verification of the specificity of the captured material. Using this strategy, a single small cluster up to thousands of cells can be procured safely and without contamination. The Agilent 2100 Bioanalyzer and Nanodrop ND1000 monitor the quality and quantity of extracted RNA, DNA, as well as proteins from the LCM sample. Lipidomics Shared Resource The Lipidomics Shared Resource represents a novel scientific service that is unique to the Medical University of South Carolina and the Hollings Cancer Center. The Lipidomics Shared Resource builds on unique expertise at MUSC in sphingolipid biology, chemistry and analysis and their role in signal transduction and cell regulation. Sphingolipid metabolism assumes a key role in the complex mechanisms regulating cellular stress responses to environmental changes. Several sphingolipid metabolites act as bioactive molecules, and their individual contribution to the regulatory pathways that govern cell growth are being established. This offers promises for new molecular insights into tumor growth and metastasis and emphasizes the needs to analyze sphingolipid components, examine sphingolipid chemistry and regulation of sphingolipid metabolic pathways. Monitoring changes in sphingolipid composition in normal and cancer environments will provide one of the missing links in the search for a novel and effective therapy. The Lipidomics Shared Resource includes analytical and synthetic units. Resource personnel provide conceptual and practical training in various aspects of lipidology, qualitative and quantitative analysis of lipid components from different biological materials (cells, tissue, biological fluids), synthetic molecular tools to study lipid metabolism (functionalized and fluorescent ceramides, site-specific radioactive sphingolipids), diversified synthetic lipids and analogs for cellular, in vitro, and in vivo studies (organelle-targeting sphingolipids and organelle-targeting inhibitors of sphingolipid metabolizing enzymes). Resource personnel also assist investigators in experimental design, selection of lipid of interest and interpretation of the analytical results. Analytical approaches are based on High Performance Liquid Chromatography-Tandem Mass Spectrometry (LC/MS) 17

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technology. This sensitive and specific analytical methodology can be applicable to a broad spectrum of diversified chemical compositions of sphingolipids and glycerolipids. This shared resource supports the following equipment:  Three ThermoFisher TSQ Quantum triple-stage quadrupole mass spectrometers with super high pressure HPLC system, ESI and APCI probes came online to assist with increase in demand  1100HP/ThermoFinnigan TSQ 7000TM triple-stage quadrupole mass spectrometer LC/MS system, ESI and APCI probes.  1100HP/SCIEX 2000 Q-Trap triple-stage quadrupole/ion trap combination mass spectrometer LC/MS combo, ESI and APCI probes.  Berger FCM 1200 Supercritical Fluid Chromatograph (SCF) Mass Spectrometry Facility The Mass Spectrometry Facility is housed within the Department of Pharmacology and directed by Pharmacology faculty. It serves as a university research resource facility and as a component of the MUSC Proteomics Center. The aim of the Mass Spectrometry Facility is to provide expertise, services, education, and training to faculty, postdoctoral fellows, and students at MUSC to enhance biomedical research endeavors through proteomics. The MALDI-TOF MS, LC-MS, and LC-MS/MS tandem mass spectrometry analyses are offered for protein analysis. Protein identification services include in-gel or in-solution protease digestion, chromatographic separation and tandem mass spectrometric analysis of the resulting peptides, and interpretation of MS/MS data using Sequest® or Mascot® software. The facility will also assist in the development of customized applications for the isolation, detection and characterization of posttranslationally modified peptides (e.g. phosphorylation, glycosylation, oxidation, glutathionylation, and O-GlcNAc modification). Sites of modification are verified by manual inspection of the data. Please consult facility staff for feasibility and pricing of quantitative proteomic experiments (iTRAQ or SILAC), the implementation of specialized approaches with quantitative proteomics (e.g. phosphoproteomics, O-GlcNAc proteomics), and MALDI-imaging mass spectrometry for tissue imaging experiments. Mass spectrometers and associated proteomic applications available include:      

Thermo LTQ XL Linear Ion Trap MS (CID, PQD, ETD fragmentation) - LC-MS/MS for protein identification and characterization of fragile modifications. Thermo LTQ Linear Ion Trap MS - LC-MS/MS analysis for protein identification and characterization. Applied Biosystems 4800 MALDI-TOF-TOF Proteomics Analyzer - LC-MALDI-MS/MS for protein identification and quantitation of differentially expressed protein using iTRAQ reagents. Bruker Autoflex III MALDI-TOF-TOF MS - MALDI Tissue Imaging. Bruker Autoflex III MALDI-TOF MS - Molecular weight determination of intact proteins and peptides. Associated HPLC systems (5 LC Packings nano-LC systems and 2 Dionex Probot MALDI Spotters for LC-MALDI)

Metabolomics Core Facility The Metabolomics Core Facility provides the technology and expertise for the identification and quantification of low molecular weight metabolites (typically <1500 Da). The Metabolomics Core is under the direction of Dr. Craig Beeson, a bioanalytical and organic chemist with wide ranging experience in fluorescence/NMR spectroscopy and mass spectrometry as applied to metabolic flux analyses. The primary focus of the core facility is the characterization of metabolites related to cellular redox. Because energy metabolism produces both the primary oxidative and reductive species involved in cellular redox reactions, another major focus of the core is on 18

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the characterization of energy metabolism in cells, tissues, and whole animals. The facility provides access to traditional, ‘gold standard’ techniques such as isotopomer, radiometric, and spectroscopic analyses. In addition to a dedicated Thermo-Finnegan HPLC-hyphenated ion trap mass spectrometer used for basic biochemical metabolite quantifications, the facility also provides access to a 700 MHz Bruker Biospin NMR with a flow-through probe and a hyphenated Bruker ion trap mass spectrometer to be used for complete molecular characterization and quantification of complex mixtures of metabolites obtained from biological samples (cell lysates, plasma, urine). The Bruker analytical system is supported with an automated sampler and capillary HPLC. Dr. Mirko Henning in the Department of Biochemistry and the director of the MUSC NMR facility provides additional, technical expertise for the NMR instrumentation. Analyses of reactive oxygen and nitrogen species in tissue samples is made possible using a Bruker ELESYS500 Electron Spin Resonance (ESR) Spectrometer with an aqueous flat cell and tissue slice holder. The ESR spectrometer provides for direct measurement of radical species with moderate lifetimes and post-hoc analyses of short-lived radical species using spin traps. Dr. Andrew Gelasco in the Department of Nephrology provides additional technical support for the ESR spectrometer instrument. Also provided is access and expertise in ‘cutting edge’ techniques that include hyphenated biosensor-based metabolic flux assays and surface plasmon resonance (SPR) imaging of protein arrays. Dr. Beeson’s lab is a development site for Lumera’s innovative SPR Protein Microarray Imaging Instrument. The microarrays consist of immobilized antibodies that can capture specific proteins for which the level of metabolite modification (i.e., carbonylation, sulfenic acids, etc.) can then be quantified with secondary reagents. Dr. Beeson’s lab is also a development site for the Seahorse Biosciences fluorometric biosensor technology used to measure metabolic fluxes (i.e., oxygen consumption, CO2 and lactate extrusion) in real time using multiwell plates. The basic Seahorse applications enable high throughput metabolic measurements with small sample sizes that have been adapted by both academia and industry. Innovative adaptations of the technology developed in the core facility are providing access to real time flux measurements of redox species such as hydrogen peroxide and nitric oxide. Mineralized Tissue Facility The Mineralized Tissue Facility (MTF) within the Center for Oral Health Research is dedicated to providing MUSC researchers with the equipment, techniques, and technical expertise necessary to study mineralized tissues. MTF services are available to researchers investigating mineralized tissue biology and function at MUSC and other institutions. The facility is equipped with state of the art equipment and experienced staff to assist both new and experienced researchers. Services available include: ex vivo microCT imaging and analysis using a Scanco uCT40 scanner and software; digital imaging/slide scanning and pathological scoring using automated software; brightfield and fluorescent imaging; plastic and ground sections of mineralized tissues; and specialized histological stains and analysis for mineralized tissues. Molecular Morphology and Imaging The Morphology, Imaging and Instrumentation Core is to provide space, facilities, supervision, and training for COBRE investigators who use imaging technology to answer specific aims proposed in individual projects. In addition, this facility provides investigators with skilled personnel able to perform highly specialized techniques, such as echocardiography, in situ hybridization, and cell kinetics assays. Specific aims are: (a) to maintain the resources for safe and effective use by properly trained research personnel; (b) to assist the research projects perform state-of-the-art image and data analyses; (c) to help design and perform in situ hybridization analyses; and (d) to implement and maintain an online database of the data generated in this project. Project investigators have access to core facilities to run their own experiments and are assisted by core staff concerning experimental 19

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design; data interpretation and technical information to best utilize facilities and instrumentation. The MUSC facility falls into eight basic components: (1) basic microscopy (light, electron, and video); (2) confocal microscopy; (3) echocardiography; (4) histology (in situ hybridization, and immunohistology); (5) special techniques (laser capture; apoptosis and proliferation assays; optical mapping); (6) morphology, image analysis and statistics; (7) presentation graphics; and (8) data sharing technology. Nephrology Proteomics Laboratory The Nephrology Proteomics Laboratory is a state-of-the-art facility capable of separation and identification of proteins in tissue, cells and body fluids. The major interest of our laboratory is biomarker discovery and pathophysiology of renal diseases. To support this interest we perform liquid chromatography/mass spectrometry, 2D gel electrophoresis and other protein separation techniques. The facility is located in the Strom Thurmond Building at MUSC. The laboratory is a sample repository and analytical lab for the Southern Acute Kidney Injury Network (SAKInet) and the Southeastern Kidney Disease Consortium (SEKDC). The MUSC nephrology proteomics lab has purchased a state-of-the-art mass spectrometer. The ABSciex 5600 Triple ToF mass spectrometer has brought exciting new capabilities to the lab for biomarker identification because of its extremely high mass accuracy and sensitivity. The instrument was purchased with a combination of funds from a VA grant and MUSC contributions. The mass spectrometer has been used to identify novel biomarkers that predict the development and progression of both diabetic nephropathy and acute kidney injury. Nuclear Magnetic Resonance Facility (NMR) The Nuclear Magnetic Resonance Facility contains: a Varian UNITYINOVA- 400 (9.4 T), operating at 400MHz proton. This spectrometer provides a moderately high field multi-nuclear NMR capability to MUSC and the College of Charleston. The UNITYINOVA- 400, a top-of-the-line spectrometer, is capable of running most contemporary homonuclear, heteronuclear one and two-dimensional pulse sequences, using pre-designed software. Pulse sequence programming has been simplified so that additional sequences can be installed. The INOVA spectrometer is equipped with a 5mm pulse field gradient indirect detection probe with a frequency range of 39-161 MHz, which allows for the routine acquisition of 1D and 2D 1H-1H correlations as well as 1D 31P and 2D 1H-31P correlations. Indirectly detected 1H-13C, 1H -15N and 1H-31P spectral correlations are also routinely obtained. Directly detected 13C spectra as well as other nuclei with resonances between 39-161 MHz are also accessible. Gradient versions of some 2-dimensional pulse sequences are present as is a gradient shimming module for accurate and rapid shimming. As presently configured, the spectrometer can generate the less demanding shaped pulses, but the addition of waveform generators can be added if more sophisticated shaped pulsed are required. The availability of shaped pulses allow for very selective excitation of a selected resonance, which results in much improved water suppression in peptide NMR. Because of the magnetic field strength of the INOVA spectrometer, the practical peptide molecular weight limit for meaningful interpretation of 2D spectra is 3-4kDa. If higher field spectra are required, MUSC researchers have access to state-of-the-art Brucker 500 MHz, 700 MHz, and 800 MHz instruments located at the Hollings Marine Lab (HML). The HML point of contact is Dr. Dan Bearden, dan.bearden@noaa.gov, 843-762-8865. Nucleic Acid Analysis Facility Nucleic Acid Analysis Facility a Provost-sponsored University Research Resource Facility (URRF), provides automated DNA sequence analysis of plasmid DNAs and PCR fragments, using an automated fluorescence-based DNA sequencer. Automated DNA sequencing produces longer lengths of read from each priming reaction, a 20

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generally more accurate sequence than from manual sequencing, and the convenience of computerized data. The service includes performing sequencing reactions on investigator-provided DNA templates, followed by sequencing gel analysis, data collection, and data transfer to investigator computer files. Samples are sequenced by thermal cycle sequencing using Taq DNA polymerase and fluorescent dye-labeled terminators. The average length of sequence obtained per priming reaction is 500 to 600 bases, with 99 percent accuracy. Both standard (e.g., M13 -21p, M13 reverse, T7, T7terminator, T3 and SP6) and custom primers can be used for sequencing. The facility also offers heterozygote detection, microsatellite analysis, and SSCP analysis. Phosphor imaging capabilities for analysis of polyacrylamide gels and membrane blots used in Southern, Northern and Western analyses are also available. These imaging techniques enable detection and quantitation of proteins and nucleic acids by fluorescence, chemifluorescence and storage phosphor detection. The facility is equipped with an ABI 377 DNA Sequencer equipped with DNA sequence analysis, GeneScanâ&#x201E;˘ and AutoAssembler software, a Perkin Elmer 9600 thermal cycler, a phosphor imager, and associated small equipment. The facility also provides access to an ABI 3100 Genetic Analyzer as well as capability for non-radioactive dideoxy DNA sequencing using an ABI 373 DNA Sequencing System and Analysis Software. Oral Preclinical Research Facility The Oral Preclinical Research Facility provides services to investigators who studying oral related diseases. We offer several animal models, including a xenograft tumor model, 4NQO oral cancer model, periodontitis model, and oral mucositis model. Services include injection of tumor cells, 4NQO delivery, animal health monitoring, and imaging of tumor progression (in vivo), oral injections, animal irradiation, and animal dissection and tissue collection. Protein Production Laboratory Protein Production Laboratory, which is located in the Basic Sciences Building, has been set up as part of the Center for Structural Biology and the Department of Biochemistry & Molecular Biology. It exists as a service to investigators at MUSC to produce proteins of interest on a large scale and, if desired, to characterize their biophysical properties by circular dichroism and dynamic light scattering. The laboratory is fully equipped for molecular biology, protein expression, protein purification, crystallization and the biophysical characterization of proteins. Instrumentation includes a circular dichroism spectrometer (Aviv Biomedical) that is used to determine the folded state of a protein and its thermal stability, and to measure conformational changes that occur in the protein response to titration of a ligand. A dynamic light scattering instrument (Precision Technologies, Inc) is used to measure the disparity of a protein in solution (i.e., the degree of protein aggregation) and to provide an approximate measure of the oligomeric state of the protein. A full-time technician works within this laboratory to perform protein purifications or provide assistance, expertise and training to investigators who wish to perform these experiments themselves. ProteoGenomics Facility The MUSC ProteoGenomics Facility offers a range of proteomics and genomics services to the MUSC research community as well as to outside academic and corporate researchers. The proteomics component provides investigators with technical assistance and instrumentation resources to use conventional and cutting edge protein biochemistry-based technologies to address questions of protein function. Proteomics related services include: Luminex bead array based cytokine and phosphoprotein analysis (i.e., Bioplex) and surface plasmon resonance based protein interaction analysis (i.e., BIAcore). In addition, the facility provides genomics related services such as Qualitative analysis of RNA (i.e., Agilent Lab-on-a-chip Bioanalyzer), DNA microarray based whole transcriptome and miRNA expression profiling, SNP and ChIP-Chip analysis, Real time PCR, Next generation sequencing (i.e., Ion Torrent PGM) for RNA-seq, resequencing and ChIP-seq 21

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applications, and bioinformatics services for analysis of DNA microarray and next generation sequencing data and web-based archiving of data. Seahorse Biosciences Academic Core Facility The Seahorse Bioscience Academic Core Facility is part of the Center for Cell Death, Injury & Regeneration and provides access to the XF Extracellular Flux Analyzer. This equipment is the industry standard for measuring cellular bioenergetics, simultaneously measuring the two major energy producing pathways of the cell – mitochondrial respiration and glycolysis - in a microplate, in real-time. This fast and sensitive measurement of cellular bioenergetics is label free, enabling time-resolved analysis and the reuse of the cells. XF assays provide increased throughput in a drug discovery format that is superior to its single parameter predecessors. This fast and sensitive measurement of cellular bioenergetics is label free, enabling time-resolved analysis and the reuse of the cells. XF assays provide increased throughput in a drug discovery format that is superior to its single parameter predecessors. Small Animal Imaging Core The Small Animal Imaging Core provides state-of-the-art in vivo imaging capabilities to MUSC researchers. The center's mission is to support the thriving and growing research environment at the Hollings Cancer Center and the university at large. In vivo serial imaging of animal models of disease can provide information not easily obtained by other methods. With tracking of disease process, the number of animals used in an experiment can be reduced by eliminating the need to sacrifice animals at multiple time points. The advent of commercially available imaging devices capable of interrogating small animals are revolutionizing biomedical research and has opened up the field of molecular imaging. Our center provides access to instruments and expertise to aid MUSC researchers in leading the way to advancing biomedicine. The Small Animal Imaging Core supports the following equipment:  Caliper Life Sciences/Xenogen IVIS 200 Bioluminescent/Fluorescent Imaging System  Siemens Inveon micro-CT/PET  Bruker 7T MRI

State Office of Research and Statistics In South Carolina the State Budget and Control Board (SBCB), Office of Research and Statistics manages multiple health-related databases. Databases contain information from both the public and private sector. In the databases personal identifiers are used only for creating unique tracking numbers so that an episode may be followed statistically across settings over time; street address are used only for translating to geographic codes for mapping; identifiers and addresses are never stored on the statistical database. Many summary statistics from the state database are available through the office. While data from the website can provide a useful vehicle for developing an understanding of data sources available through the SBCB and for generation of health-related hypotheses, a researcher generally needs access to individual patient data to pursue a research project. Within the limits of state staffing availability it is possible for some special data files to be generated or tabulations to be run by SBCB staff in response to questions from researchers. Direct access to individual patient data is not currently possible for researchers due to concerns about patient and provider confidentiality. In some cases, MUSC researchers arrange to support a programmer at the state to prepare data sets that can include 22

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linkages across time with ID codes but without patient identifiers. Through a strong collaborative relationship between MUSC’s Department of Biostatistics, Bioinformatics & Epidemiology and the State Office of Research and Statistics, MUSC faculty and trainees can gain invaluable data to advanced health-related research projects. Transgenic Mouse Core Facility The Transgenic Mouse Core Facility is located in a new integrated laboratory animal facility in the Children’s Research Institute (CRI). Facility equipment includes a Defonbrune microforge, a Sutter automated programmable needle puller, color video system for oviduct transfer stereo microscopy, tissue culture incubator, Zeiss inverted research microscope equipped for pronuclear/blastocyst microinjection, Zeiss stereo microscope system for embryo pronuclear evaluation, black and white video system for pronuclear microinjection microscopy, Zeiss stereo microscope system equipped with dual observation for teaching oviduct transfer, Physiotemp warming stage for pronuclear microinjection, and an optical illumination system for the dual observation system. The housing for the animals is located adjacent to the laboratory in the CRI. Housing is in isolator cubicles, each with its own environmental controls. This is a pathogen free-facility that is designed to keep the mice free of naturally occurring rodent pathogens.

Translational Research Shared Resource The Hollings Cancer Center of Medical University of South Carolina established the Translational Research Shared Resource in 2008. The need for this resource was made evident by both clinicians participating in early phase drug development clinical trials, as well as basic scientists with an interest in exploring the clinical relevance of their research projects. The Translational Research Shared Resource offers the following services:  Consultation services including experimental and clinical protocol design, tissue procurement, assay development and IRB issues in conjunction with the Hollings Cancer Center Clinical Trials Office.  Generation of preclinical data to support the development of phase I or phase II clinical trials.  Drug mechanism of action and target validation studies  Biomarker analyses in tumors and blood  Laser capture micro-dissection of tumors  Immuno-magnetic cell isolation  Solid tumor dissaggregation and nucleic acids isolation  Western blotting  Reverse transcriptase PCR and real time PCR  Immunohistochemistry  Liquid nitrogen storage of cells and tissue specimens X-Ray Crystallography Resource MUSC has excellent facilities for X-Ray Crystallography to enable researchers at MUSC to engage in highresolution structural studies of biological macromolecules. The facility, which operates as a University Shared Research Resource, is located in the Department of Biochemistry & Molecular Biology in the Basic Sciences Building. The facility is supported by an X-ray Manager, who is responsible for maintaining the diffraction equipment and assisting users with X-ray data collection and structure determinations, and a Systems Manager for the computing resources. It includes three components: X-ray diffraction, crystallization and molecular graphics. X-ray diffraction is a purpose-designed diffraction laboratory containing an RU-H3RHB rotating anode generator fitted with Osmic Blue Confocal Optics, a Raxis-IV++ imaging plate system, and an X-Stream cryostat (Rigaku-MSC). In an adjoining room, the crystallization facility contains two large incubators and a stereomicroscope for setting up and monitoring crystallization experiments. Another adjoining room contains four small-scale incubators to test a wide range of temperatures in crystallization. 23

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Adjacent to the diffraction lab, the molecular graphics suite contains a cluster of Unix/Linux workstations for molecular graphics and crystallographic computing. One of these is configured for remote access to the SER-CAT beamline (see below) at the Advanced Photon Source (APS) of Argonne National Lab, allowing synchrotron data to be collected at the home lab. Cluster computing in the form of a 16 node dual-quad core system will be available in Fall 2007. Standard crystallography and modeling software are running on these systems including HKL2000, d*Trek, CCP4, CNS, O, Shake’n’Bake, SHARP, SOLVE, and SYBYL, as well as high-throughput phasing software. Data are stored on a 2.5 TB RAID system, which is backed weekly by tape. An additional 2.5TB of file storage is available on the University’s SAN. Xenograft Facility Xenograft of human cancer cells or tissues into immune deficient mice is an indispensable step in correlating in vitro cancer cell biology studies with tumorigenicity in vivo. The Xenograft component of the Cancer Animal Models Shared Resource:   

Offers immunodeficient SCID mice at reduced rates to MUSC investigators and provides pathogen-free working area for in vivo experiments. Provides appropriate housing and maintenance for these animals, as well as technical expertise to facilitate in vivo experiments. Provides technical personnel to instruct or assist investigators with their mouse experiments, and perform optional services such as engrafting tumor samples or survival surgery.

The Xenograft Facility uses the strain, commonly referred to as SCID, NOD.CB17-Prkdcscid/J Mice homozygous for the severe combined immune deficiency spontaneous mutation. Prkdcscid are characterized by the absence of functional T cells and B cells, lymphopenia, hypogammaglobulinemia, and a normal hematopoietic microenvironment. Normal antigenpresenting cell, myeloid, and NK cell functions are strain dependent. SCID mice carry a DNA repair defect and a defect in the rearrangement of genes that code for antigen-specific receptors on lymphocytes. Most homozygotes have no detectable IgM, IgG1, IgG2a, IgG2b, IgG3, or IgA. Thymus, lymph nodes, and splenic follicles are virtually devoid of lymphocytes. SCID mice accept allogeneic and xenogeneic grafts making them an ideal model for cell transfer experiments. Some SCID mice will spontaneously develop partial immune reactivity. SCID mice that have serum Ig levels greater than 1 ug/ml are considered “leaky.” SCID leakiness is highly strain dependent, increases with age, and is higher in mice housed under non-pathogen-free conditions. In general, SCID leakiness is high on the C57BL/6J and BALB/cBy genetic backgrounds, low on the C3H/HeJ background, and even lower on the NOD/LtSz background. However, there is a high incidence of thymic lymphomas in this congenic stock limiting the mean lifespan to only 8.5 months under specific pathogenfree conditions. The strain used in this facility is of low leakiness and is widely used in tumor Xenograft experiments.

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SCIENTIFIC ENVIRONMENT MUSC Overview Founded in 1824 as the first school of medicine in the southeastern U.S., the Medical University of South Carolina (MUSC) is now the core of the state’s largest medical complex and the largest employer in the metropolitan Charleston area with more than 11,000 employees. A freestanding academic health center, MUSC is the only tertiary/quaternary care referral center in South Carolina for a statewide population of about 4.7 million people. MUSC is a state-assisted institution. The South Carolina General Assembly and Governor appoint the Board of Trustees, who appoint the President. The Vice President for Academic Affairs serves as Provost and Chief Academic Officer. The Dean of the College of Medicine serves as Vice President for Medical Affairs. The Chief Executive Officer of the Medical Center serves as Vice President for Clinical Operations. These dual appointments ensure that strategic planning, implementation and oversight are closely and continuously coordinated to provide excellent education, research and patient care in a first-rate academic health center. Although MUSC is a public institution, it receives less than 7% of its total annual budget from the State of South Carolina. The majority of financial resources are generated through patient care fees, tuition, federal grants and contracts, and private contributions. The university has been at its present site on the Charleston peninsula since 1913, currently occupying 76 acres and 89 buildings. Major construction and renovation in recent years include the 122,000 ft2 Darby Children’s Research Institute (2004); a major renovation of the Hollings Cancer Center (2006) that expanded the cancer center to >200,000 ft2; an education and research complex for the College of Health Professions involving renovation of a 40,000 ft2 historic building adjoining a newly constructed building of similar size (2006); the Ashley River Tower as the first phase of a long-term initiative to construct an entirely new comprehensive teaching and referral hospital on the west side of campus (2008); a 120,500 ft2 home for the James B. Edwards College of Dental Medicine (2009); and the new Drug Discovery and Bioengineering Buildings (2011). As key components of the James C. Clyburn Research Center at MUSC, these two newest buildings add ~220,000 ft 2 for translational research and research training to generate molecular targets, lead compounds, tissue engineering constructs, novel devices and genomic technologies. MUSC is a partner with the City of Charleston and the South Carolina Research Authority in the SCRA MUSC Innovation Center ~1 mile from the center of campus, providing research incubator and laboratory space to advance the commercialization of knowledge-based based on research discoveries and advances in health care. MUSC’s major components are the MUSC Medical Center and six colleges: Medicine, Pharmacy, Nursing, Graduate Studies, Health Professions, and Dental Medicine. The Medical University of South Carolina is fully accredited by the Southern Association of Colleges and Schools (SACS) to award bachelor, master, doctoral and professional degrees. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and numerous national, professional and specialized accrediting bodies provide additional accreditations. The teaching faculty on campus consists of ~1,200 full-time and >200 part-time members. MUSC offers professional education at undergraduate, graduate and postgraduate levels appropriate to the health care disciplines, awarding ~900 degrees annually with enrollment of >2,500 degree-seeking students. In addition, the university coordinates the training of approximately 80 interns, 400 medical/surgical residents and 100 specialty fellows in ACGMEapproved programs and dozens of dental and pharmacy residents MUSC leads the South Carolina Area Health Education Consortium (AHEC), linking the academic health sciences center in Charleston to community-based health care centers statewide with an emphasis on health disparities, rural health issues and access to health care. South Carolina was among the first 11 states to receive federal funding to establish a model statewide AHEC program in 1972. South Carolina AHEC received the prestigious Eugene S. Mayer Award in 2006, presented every two years to the best model statewide AHEC 25

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system in the nation. MUSC has received national recognition from the Association of American Medical Colleges and other professional associations for outstanding community service and leadership in innovative health services delivery, outreach, and emergency preparedness. MUSC is the leading biomedical research institution in Health Sciences South Carolina (HSSC), a statewide consortium to facilitate and accelerate the development, testing and dissemination of new, more effective health interventions and therapies to improve the health and well-being of all residents of the state. Through HSSC, the state’s three research universities and four largest healthcare systems have created a statewide integration of scientists, clinicians and data systems. HSSC has active working groups on science, clinical care, information technology and data interoperability, a statewide IRB, and an integrated Center for Clinical Safety and Effectiveness that develops and coordinates state-of-the-art patient simulation technologies across the state. In August 2006, The Duke Endowment made a $21 million grant to HSSC to help bring about transformational changes in health sciences/services research, representing the largest single award ever made by The Duke Endowment. A renewal is in negotiation.

Research at MUSC MUSC has a substantial research enterprise with 1282 extramural awards totaling more than $243M in FY2011. The Chronicle of Higher Education's 2011-12 Almanac Issue recognized MUSC as one of the top 10 institutions with the “biggest gains in federal funds for research and development in science and engineering, adjusted for inflation, 1999-2009”. Federal funding constitutes about 71% of extramural support, with the National Institutes of Health as the primary funding agency.  

MUSC's ranking in Federal R&D expenditures at universities and colleges rose from 100th in FY08 to 85th in FY10 (NSF, March 2012) MUSC’s ranking in Total R&D expenditures at universities and colleges rose from 94th in FY08 to 91st in FY 10 (NSF, March 2012)

The South Carolina SmartState™ Program (previously known as the CoEE Program) was created by the South Carolina legislature in 2002 and is funded through South Carolina Education Lottery proceeds. The legislation authorizes the state's three public research institutions, Medical University of South Carolina, Clemson University and the University of South Carolina, to use state funds to create Centers of Economic Excellence in research areas that will advance South Carolina's economy. To date, 49 Centers have been created and 38 SmartState Endowed Chairs have been appointed to lead the centers. The SmartState Program has resulted in more than $400 million dollars in non-state investment into the South Carolina economy and is responsible for the creation of 5,000 jobs. To date, this has resulted in initiating 19 SmartState™ Centers at MUSC, bringing the total of MUSC endowed chairs and named professorships to 42 (20 appointed as of October 2011). In addition to the obvious benefit of providing substantial resources to recruit senior research leadership and entrepreneurship, the program has dramatically raised the profile of university-based research in South Carolina – especially biomedical and clinical/translational research – and stimulated significant philanthropy to meet match requirements. For calendar year 2011, the Medical University received more than $30.5 million in new gifts, pledges and pledge payments.

Research Training MUSC offers an outstanding environment for training. The university ranks in the top tenth percentile of domestic educational institutions in number of NIH grants for research training and education. NIH FY2011 award data include 13 NRSA institutional training grants (T32s, T35s, TL1), 31 NRSA individual fellowships (F30s, F31s, F32s), 5 research education grants (R25s), and 26 individual and 3 institutional career development awards (Ks). MUSC has four dual degree programs: the NIGMS-funded Medical Scientist Training Program (MD/PhD), the NIDCR-funded Dental Scientist Training Program (DMD/PhD), and PharmD/PhD and PharmD/MBA programs, plus a well-subscribed Master of Science in Clinical Research (MSCR) program that was initiated with K30 26

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support. In July 2009, MUSC received an NIH Clinical Translational Science Award (CTSA) award totaling $20 million to support the South Carolina Clinical and Translational Research (SCTR) Institute that provides research infrastructure and additional training opportunities at the intersection of basic, clinical and community health sciences. Four MUSC training programs focus specifically on diversity in the biomedical sciences: an NIGMSfunded Initiative for Maximizing Student Diversity (IMSD) that supports doctoral training for minorities; two NHLBI T35/R25 grants for short-term research training for minority students; and an NIGMS K12 award for postdoctoral research training and teaching in collaboration with Claflin University, a historically black university in Orangeburg, SC.

Research Development and Administration The MUSC research infrastructure includes pre- and post-award functions reporting to the Vice President for Academic Affairs & Provost through the Associate Provost for Research. The Office of Research Development focuses on program and proposal development, identifies funding opportunities, develops proposal concepts, networks faculty members with complementary interests, provides grant-writing consultation and workshops, offers pre-submission critiques, compiles institutional data, and prepares competitive proposals for research resources and research training. The Office of Research and Sponsored Programs (ORSP) handles certifications and assurances, ensures that policies and procedures are followed, helps prepare budgets, negotiates terms and conditions, maintains proposal and awards data, administers the program of intramural research grants, and oversees re-budgeting and close-out activities. ORSP is the institutional interface with Grants.gov and coordinates all aspects of electronic research administration. The Office of Research Integrity provides oversight and staffing for activities focused on compliance with regulations for research involving humans, vertebrate animals, and biohazardous agents. It also coordinates management of conflict of interest, financial disclosure, and scientific integrity issues.

Foundation for Research Development The MUSC Foundation for Research Development (FRD) is an affiliated, not-for-profit, 501(c)(3) corporation, established in 1995 to manage technology transfer and private sector research relationships for MUSC. MUSC investigators present approximately 50 new invention disclosures per year. On behalf of MUSC and its investigators, FRD has filed 173 US patent applications that cover new subject matter, and received 58 US patents since FY 2003. In addition, FRD has negotiated 10 options, 20 exclusive license agreements, and 12 nonexclusive license agreements. FRD has been involved with 13 start-up companies utilizing MUSC intellectual property. These accomplishments illustrate the quality and practical relevance of MUSC expertise and research findings, setting the pace for future progress.

Support Services Health Affairs Library The MUSC Library serves as a database and knowledge center, academic computing support unit, electronic education center, and leader in information planning. Online resources include the full catalog as well as major biomedical databases (e.g., MEDLINE, CINAHL, PsycINFO, SciFinder, and PubMED). Links include online catalogs of other libraries, drug information (MicroMedex, Mosbyâ&#x20AC;&#x2122;s Drug Consult), consumer health (Hands on Health, MEDLINEPLUS, Health Reference Center), clinical decision support systems (eMedicine, UpToDate, InfoPOEMS), Clinical Practice Guidelines and alerts, reviews of clinical trials, evidence-based practice (Cochrane database, INFOPOEMS), government resources (Toxnet, Federal Register, Code of Federal Regulations), electronic books (MD Consult, Harrison's Online, Access Medicine) and e-journal packages with literature search capabilities (ScienceDirect, ejournals@MUSC, Journals@Ovid, American Chemical Society), statewide shared academic databases (Collegiate DISCUS, DISCUS), and other resources that provide a wealth of worldwide information. Service-oriented faculty and staff assist in the use of a variety of informational systems. An active program of individual, class, and group instruction supports teaching, clinical care, research and community outreach. The Library includes the Educational Technology Lab for web-based instruction and curriculum 27

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evaluation, and the Informatics Lab with more than 200 microcomputers and peripheral equipment. In addition to providing access to collections and information remote from its physical facility, the Library maintains a comprehensive collection of books, journals, slides, tapes, and videocassettes (>200,000 volumes), and subscribes to more than 14,000 electronic journals and 250 print journals that are not available electronically. The library serves as a resource library within the National Network of Libraries of Medicine, and is a major health science resource library for the State of South Carolina and the Southeast. The MUSC Library has received several prestigious awards from National Commission on Libraries and Information Science (NCLIS) for excellence in providing health information and promoting health awareness. In May 2006 the NCLIS Health Information Award for Libraries was awarded to MUSCâ&#x20AC;&#x2122;s Racial and Ethnic Approaches to Community Health (REACH) 2010 Diabetes Coalition Library Partnership. Chosen from entries nationwide, the REACH 2010 program was judged as the best library program for encouraging healthy lifestyles and providing health information to citizens. The program is a collaborative effort of a library-communitycampus partnership consisting of the MUSC College of Nursing, MUSC Library, county public libraries and other community-based organizations. In 2004 the Library received the NCLIS Blue Ribbon Consumer Health Information Recognition Award for Libraries recognizing the impact, innovativeness and replicability of its Hands on Health-South Carolina project. The NCLIS, National Commission on Libraries and Information Science, has recognized outstanding libraries in 37 states for their contributions to health awareness and health education. Designed to serve the consumer and community health information needs of South Carolinians, Hands on Health, (www.handsonhealth-sc.org), a public web-site, pays special attention to health issues of particular importance in South Carolina, such as hypertension, heart disease, stroke, diabetes, disabilities, obesity, nutrition, family violence, and cancer. The Office of Media Services and Digital Imaging within the Library provides services for illustration, design, and photography, including posters for scientific presentations and rapid production of slides from computer files. This service is very helpful to researchers when preparing abstracts and presentations for scientific meetings.

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EARLY STAGE INVESTIGATORS MUSC is committed to promoting the development and advancement of Early Stage Investigators. Institutional investments to help ESIs achieve success in their academic careers include the following: SCTR Resources: MUSC’s South Carolina Clinical and Translational Research Institute (SCTR), one of NIH Clinical and Translational Science Award (CTSA) Programs, offers substantial resources for Early Stage Investigators. SCTR’s Society of Clinical Research and Translational Early Scientists (SOCRATES), a mentoring forum for all mentor and mentee faculty, holds monthly meetings where junior investigators present their research proposals‐in‐development and get peer review feedback. Other SCTR resources include: (1) a robust Pilot Project Program that awards >$1 million dollars in seed funds for promising multi‐disciplinary clinical and translational research, enabling ESIs to form interdisciplinary, interactive and sustainable research networks and teams; (2) extensive support of clinical and translational research at MUSC, including biostatistical assistance and training, database management, an enterprise-wide clinical data warehouse (CDW), and biorepository for ready access to de-identified patient data and human samples, subject recruitment and retention, education and outreach activities, and other training and research opportunities; and (3) a voucher program whereby investigators may request research related vouchers at any given time to pay for lab services, participant recruitment, biostatistical and epidemiological consultations, ethics consultations, and other research costs. Institutional Resources: MUSC’s Office of Research Development offers a full array of resources to guide early stage investigators towards research independence. These include: (1) Research Project Grant (RPG) Retreats that are modeled after NIH study section reviews to give individual investigators constructive criticism on a specific research concept or proposal; (2) Grantsmanship Workshops focusing on the NIH organization, peer review system, grantsmanship tips, and the ABCs of an R01 or other NIH grant application; (3) Individual and team consultations with external advisors and consultants; and (4) MyPeerReview, an on-line, searchable database that provides information about MUSC faculty service on study sections and special emphasis panels for the NIH and other federal and non-federal sponsors, as well as service as a manuscript reviewer or editorial board member for scientific journals. Department Mentoring Plan: All academic departments are required to have a faculty mentoring plan based on each department’s unique resources and needs of the faculty, as well as mentoring champion(s) who work under the chair’s direction to implement and ensure the plan’s effectiveness. These plans provide junior faculty with a supportive environment encompassing skills, knowledge, and resources to achieve success and career satisfaction.

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BIOHAZARDS The University Risk Management has an established Biological Safety Policy. This policy establishes responsibility for the proper use of biohazardous agents, including recombinant DNA, infectious agents and biological toxins in research and other educational activities at the Medical University of South Carolina in order to protect students, faculty, staff, the community and the environment. This policy is intended to ensure compliance with all applicable local, state and federal guidelines and regulations for research involving biohazardous materials. MUSCâ&#x20AC;&#x2122;s Institutional Biosafety Committee (IBC) conducts initial and continuing review of all research proposals and projects involving recombinant DNA as outlined in the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (http://oba.od.nih.gov/rdna/nih guidelines oba.html). The IBC also reviews work with infectious agents and biological toxins. The IBC comprises at least five (5) members with experience and expertise in recombinant DNA technology and microorganisms, microbiological techniques and the potential risk to public health or the environment from these materials. At least two (2) members are not affiliated with the institution (apart from their membership on the IBC) and represent the interest of the surrounding Charleston community with respect to health and protection of the environment. The Associate Provost for Research makes all appointments as recommended by the IBC Chairperson/Vice Chairperson. This committee reports to the Associate Provost for Research. All Principal Investigators (PIs) assume primary responsibility for the proper use, handling and disposal of all biohazardous agents in research or other educational activities conducted under their supervision ensuring compliance with the governing documents and MUSC policies applicable to their research. To further protect students, faculty, staff, the community and the environment, the Institutional Biosafety Committee (IBC) and the Biosafety Officer are authorized to review and monitor all research and other educational activities involving biohazardous agents, whether such research is funded or not. Failure to comply with this policy results in a review by the IBC and possible suspension or revocation of approval or privileges by the IBC to work with biohazardous agents.

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Resources and Scientific Environment, August 2012