Health Communication Research Laboratory (HCRL)

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  Skin Biopsy Processing: The iPSC Core Facility has developed an efficient protocol for the generation of dermal fibroblast cultures from skin punch biopsies to generate patient-specific fibroblast lines and their subsequent reprogramming to yield induced pluripotent stem cells.
  
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  iPSC Generation and Characterization: The iPSC Core Facility offers multiple reprogramming techniques for the generation of induced pluripotent stem cells from dermal fibroblast cultures, provide characterization of iPSC lines generated within the facility, as well as those obtained from external sources.
  
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  Training: The iPSC Core Facility offers training in various techniques related to iPSC maintenance, differentiation, and cryopreservation, as well as fibroblast reprogramming for the generation of induced pluripotent stem cells. Additionally, the facility serves as a repository for protocols related to iPSC maintenance and differentiation.
  
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  Cryopreservation: The iPSC Core Facility provides cryopreservation services for all dermal fibroblast and iPSCs generated within the facility.
  

The Innovation, Design and Engineering in Action Laboratories (IDEA Labs^TM), founded in 2013 at WU, was designed to bring together students, faculty, staff, and local entrepreneurs to tackle unmet needs in healthcare delivery and clinical medicine. IDEA Labs aims to make medical entrepreneurship attainable for students; to teach engineering, medical, and business students the skills and process need to invent and implement new biomedical technologies; and to develop novel devices and software applications targeting unmet clinical needs. Through the guidance of a clinician mentor and technical advisors, student teams drawn from engineering, medicine, business and other disciplines obtain a deep understanding of clinical problems by shadowing in local clinics and academic medical centers and work collectively to devise milestones that develop design implementations on paper or through software that are then prototyped, tested and redesigned in a series of increasingly realistic models and prototypes. As impact in 2014-15, 11 startups were formed out of the program with 12 provisional patents vetted and 19 proof-of-concept prototypes developed in the annual competition. Outside investments or awards raised ~$2 Million, garnering nationwide expansion of the IDEA Labs concept through a unique collaboration with the American Medical Association to help inspire and support cutting-edge medical technology development from the next generation of young entrepreneurs studying at WU, Harvard University, Massachusetts Institute of Technology, University of Pennsylvania, and University of Minnesota.

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  The Public Health Dashboard is a collaborative project of IHSI and the Center for Public Health Data and Training at the IPH. The Dashboard will create a portal to integrate shared public health and community relevant data obtained from a broad array of third-party administrative and public health resources across collaborating partners and link this data to internal patient data from WUSM and BJC. The Dashboard will provide baseline data gathered from the ‘For the Sake of All’ Project and will combine health data with concepts derived from Federal Research Economic Data (FRED).
  
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  The IHSI maintains a core faculty of investigators to support comparative effectiveness, patient-centered outcomes, healthcare research, clinical informatics, data mining and analytics, epidemiology, behavioral science, dissemination and implementation science, and quality improvements. IHSI also maintains support personnel and tools that help investigators at BJC, WU, and affiliated academic and healthcare institutions to pursue novel solutions for relevant healthcare problems. This framework facilitates rich assets for fertile analytics over the pooled data assets. Finally, IHSI supports investigator training by providing data access, analytical support, and faculty mentors. Governance is provided by a partnership between BJC and WU.
  

The Institute for Informatics was formed by joining the existing Center for Biomedical Informatics (CBMI) and BJC informatics within the BJC Center for Clinical Excellence (CCE) (described separately as Resources). The Institute is led by a group of active and experienced bioinformatics experts and integrates elements of Medical Informatics, Bioinformatics and Computational Sciences. It offers industry-standard, enterprise-class infrastructure and software tools to store, integrate, query, analyze, and visualize complex clinical and molecular data sets.

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  The IDDRC Clinical-Translational Core promotes excellence and accelerates progress in the design and implementation of comprehensive, integrative, multidisciplinary, translational research with infants and children to enhance the prevention, diagnosis and treatment of developmental disabilities. This Core provides crucial infrastructure, professional expertise and assessment services that are essential to thoroughly characterize the phenotypes (cognitive, behavioral, social and emotional domains of development) and genotypes of children with developmental disabilities. The Core also utilizes ICTS world-class facilities for genomic research, including the Genome Technology Access Center (GTAC) for genomic sequencing and the Genomic Engineering and iPSC Center (GEiC) (described in H.1- Translational and Applied Genomics resources).
  
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  The IDDRC Developmental Neuroimaging Core supports high-quality basic and applied magnetic resonance (MR) imaging research relevant to understanding and preventing the causes of intellectual and developmental disabilities. This Core works closely with the ICTS Human Imaging Core (HIU) to foster translational research by enriching interdisciplinary collaboration across basic and clinical services using imaging as a research tool.
  
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  The Model Systems Core provides expertise in the generation of new animal and neuronal cell models capitalizing upon state-of-the-art genetic engineering techniques available through the Genomic Engineering and iPSC Center (GEiC). This core assists in the development of strategies based on prenatal therapies as well as gene and stem cell therapy and promotes a better understanding of genetic modification in disease processes in intellectual and developmental disabilities.
  

A series of programs developed for pediatric residents, fellows, junior faculty and practicing physicians coalesced to form the Interdisciplinary Career Development and Translational Research in Pediatrics Program to enhance and expand the clinical pediatric research opportunities available at WU and to foster career development for pediatric investigators. These programs ensure rigorous training in clinical research programs, and hands-on research experiences that take into consideration the special needs of children and families. Although there are many collaborations between investigators in pediatrics and investigators working with adults, this program provides an institution-wide mechanism to help integrate research in children into broader institutional research programs. This institutional support includes training and resources for issues related to informed consent, recruitment, ethics, vulnerable patient populations, sample size issues for rare diseases and conditions, increased participant risks, and greater difficulty performing procedures and obtaining specimens.

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  Central Neuroimaging Data Archive (CNDA): The CNDA is a resource for managing study data collected by the WUSM neuroimaging community. It includes a secure database, automated pipelines for processing managed data, and tools for exploring and accessing the data. The archive currently stores over 25,000 individual scans from all major modalities. It also manages an extensible set of non-imaging data, including neuropsychological, clinical, biomarker, genetic, and behavioral data. The CNDA is hosted by the Neuroinformatics Research Group (NRG) and is the site of the NRG flagship installation of the Extensible Neuroimaging Archive Toolkit or XNAT, an open-source software package for managing neuroimaging and related data. Researchers who use the CNDA also have the capability to create their own custom pipelines to handle specific image-processing tasks central to their research. As the most heavily used instance of XNAT, the CNDA’s user group provides invaluable feedback toward the ongoing development and improvement of the XNAT system.
  
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  Clinical Research Lab (CRL): The CRL, described previously under Regulatory Knowledge and Support, provides coordination services to support the basic and clinical research of WU investigators needing advanced imaging and information technology systems. The CRL provides training, design, execution, and analysis of imaging to support basic and translational science.
  
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  Cyclotron Facility: The Cyclotron Facility provides PET isotopes, radiochemicals, radiotracers, and radiopharmaceuticals to the research and medical communities for use in research and clinical practice. The Cyclotron Facility underwent a $12 million expansion, completed in August of 2014. This expansion added a fourth cyclotron to the facility (TR 19/9 – the highest performing radioisotope production cyclotron available) along with space for an equivalent cyclotron for future expansion, an ISO Class 7 Good manufacturing practice (GMP) production area, GMP quality control lab, GMP reagent lab, two solid target processing labs and shipping and receiving areas to support operations. The goal with this expansion was to develop a facility to generate and support the production of first-in-human and other novel radiotracers that could undergo phase 0, phase I and subsequent phase assessment in the HIU. The first such radiotracer – a WU developed receptor targeted nanoparticle radiotracer for atherosclerosis assessment – received FDA IND approval for research with assistance from the Cyclotron Facility infrastructure and then completed phase 0 testing in the HIU in 2015. Phase I assessment in patients with carotid artery disease began this past Fall. An updated, state-of-the art shielded pneumatic tube system was installed 2014 which allows transport of radiotracers from the Cyclotron Facility to the HIU in under 27 seconds.
  
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  MRI Facility: This imaging facility has an 1 MRI scanner dedicated exclusively to both clinical and non-clinical research involving outpatients and healthy control subjects. Researchers with MR certified personnel can operate the scanner or an MRI Technologist is available upon request. The facility supports both human and animal research with a strong emphasis on brain imaging
  
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  Neuroimaging Informatics Analysis Center (NIAC): The NIAC provides data management, processing and analysis, computing, and consulting to WUSM’s neuroimaging community. Our services enable the university's researchers to study virtually every aspect of the brain in normal and diseased states, including Alzheimer's Diseases, autism, stroke, depression, traumatic brain injury, schizophrenia and many other disorders.
  
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  Pre-Clinical PET/CT Imaging Facility: This facility is a core within the Department of Radiology for small and large animal PET and CT imaging studies. Animal models of disease such as in mice and rats have become an indispensable part of research for the development of new imaging probes and validation of novel therapy drugs. To support this research endeavor, the facility provides investigators with the tools and expertise to gather reliable and reproducible data. Located in proximity of the Cyclotron Facility, the Pre-Clinical PET/CT Imaging Facility has easy access to wide array or radio-pharmaceuticals on demand to maximize close collaboration. The services include PET, CT, and Cerenkov Imaging in small animals as well as radiopharmaceutical biodistribution studies in addition to various animal surgical procedures. This facility constitutes the Nuclear Medicine Imaging component of the BJH and WU SCC Small Animal Cancer Imaging Core.
  
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  Small-Animal Magnetic Resonance Facility located within the Biomedical Magnetic Resonance Laboratory (BMRL) has state-of-the-art facilities and equipment found at few laboratories in the world. The Facility houses 4.7-T and 11.74-T MRI systems with magnetic field strengths substantially higher than generally encountered in clinical systems. These offer improved spatial or temporal resolution for imaging and improved accuracy of resonance amplitude and frequency estimates for spectroscopy. Peripheral resources include animal holding and procedure rooms, a wet chemistry lab, an electronics lab and a climate-controlled room holding computer server and data archival devices. Experienced BMRL scientists provide a full range of research services, from initial planning and implementation to data collection and analysis. The Small-Animal Magnetic Resonance Facility is a cost-effective way to include preclinical MRI and spectroscopy in research.
  

The March of Dimes Prematurity Research Center (MOD Center) was established in 2014 to improve the health of babies by preventing birth defects, premature birth, and infant mortality specifically by addressing the crisis of preterm birth. In partnership with SLCH, the MOD Center became the third prematurity research center supported by the March of Dimes aimed exclusively at finding the unknown causes of preterm birth. Causes of preterm birth likely involve highly interactive biologic and environmental factors that will not be uncovered by singular studies from isolated disciplines. The MOD Center examines 1) cervical remodeling; 2) 3-dimensional electrophysiology of the uterus; and 3) chronodisruption as a risk for preterm birth, and is establishing a cohort of 1,000 women to be followed through pregnancy with individual level data collected about demographic, environmental, physiology, genetic and outcomes (the delivery and the offspring). Since this cohort will be derived from the women presenting to the BJH Obstetrics Service, it will be enriched for underrepresented minorities and those of lower SES, and it is anticipated that about one-third will deliver prematurely. In addition, the outcomes of these pregnancies (that is, the offspring) will create a new inception cohort of well-characterized infants who can be followed to explore developmental and disease outcomes.

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  The MGI also has the potential to affect populations around the world by studying variation in our genomes, in the communities of microbes living in and around us and by decoding the genomes of many other important organisms and food sources. The mission is to improve the human condition by producing, studying and interpreting high-quality genome-based data that drive biological discoveries ranging from the bench to the hospital bedside. While biomedical research areas such as cancer, other chronic and infectious diseases and human genetics are at the heart of activities, the MGI was also part of a $150 million NIH Roadmap project to sequence and understand the human microbiome – the complement of microbes that colonize the human body.
  
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  The MGI is located at 4444 Forest Park Ave., on the northeast corner of the Medical School Campus. Currently, MGI occupies 56,660 square feet of space for laboratory and administrative personnel in purpose-designed space to accommodate production sequencing activities and includes specialized equipment to maintain strict power and temperature requirements. A 900 square-foot technology development laboratory is available for testing prototype equipment and developing new hardware and biochemistry. A large cold room and walk-in freezer are available on the floor.
  
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  The CLIA licensed environment (CLE) occupies 2,412 SF of space. The data center is housed in a distinct 15,600 sq. ft. state-of-the-art facility that contains fully redundant power and cooling systems capable of housing over 100 racks of high-density network, server and storage systems in its 3,100 SF raised floor computer room. The computational cluster has 517 servers, 5,926 cores, and 1.1 petabytes of RAM, and runs on average 2.5 million individual computational jobs per month equal to 131 years wall clock time. A 1 Gigabit external network link protected by a modern firewall and a 10 Gigabit link on the Internet 2 research network, which is protected by a central WU router with a whitelist of collaborating institutions such as CGHub and NCBI sequence data repositories. To insure continuity of services in the case of a disaster, defined service level agreements and nightly backups of critical data, which are stored monthly are maintained and retained for one year at an off-site location.
  

The ICTS Metabolomics Core is a CLIA-certified laboratory providing targeted metabolomics analysis, support for pharmacokinetics (PK) and Pharmacodynamics (PD) studies, bioanalytical method development and validation, and pre-clinical and clinical sample analysis. The Metabolomics Core Facility was established by the Diabetic Cardiovascular Disease Center (DCDC) and the Center for Women's Infectious Disease Research (cWIDR), and is a resource available through the ICTS JIT voucher program. The Core Facility is a 1,500 SF mass spectrometry-based resource in the 10^th floor of the BJCIH building that has been designed for analysis of small molecule metabolites in blood or body fluids to identify biomarkers for detection and treatment of human diseases.

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  Several major research initiatives that cover large-scaled biomedical data analysis in ‘big data’ formats, complex morphoproteomics and applying information to individualized cased through ‘precision medicine’ approaches, and One Health partnerships aimed at minimal animal and clinical data to address complex research questions are supported institutionally. The interdisciplinary MS degree in Data Science and Analytics is offered through MU, building on 19 credits in core competencies in database and analytics, data and information ethics and big data security, data mining and information retrieval through nine credits in emphasis areas such as biotechnology, high performance computing, socio-technical data analytics and culminating in a capstone experience on big data analytics (6 credits). MUII supports training programs that cover i2b2 introductory material, various REDCap resources, HealthFacts (providing HIPAA-compliant de-identified patient data from 90 institutions including MU Healthcare) analytics and weekly informatics walk-in clinics.
  
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  The MUII has grown since its inception in 2000, and currently enrolls 34 doctoral students training under 43 core faculty members from 17 departments and 8 colleges. The Institute offers informatics students the chance to participate in campus-wide labs and research centers. MUII is managed by the Interdisciplinary Degree Programs Office under the MU provost to ensure its autonomy from individual colleges and schools. MUII is a highly successful interdisciplinary degree programs, graduating 19 PhDs to date with a 100% placement rate. In addition to ranked faculty positions (UNC-Chapel Hill, Mississippi State University, University of Minnesota, University of Nebraska-Omaha, and MU) and post-doctoral appointments (Virginia Tech), MUII graduates have become senior scientists at federal research labs (Sandia National Lab), data scientists in industry (Microsoft), and founders of startups across the country.
  

ICTS investigators have access to the University of Missouri Research Data Center (MU-RDC), a joint project between the US Census Bureau and the University of Missouri. The MU RDC is a satellite branch of the Kansas City RDC that is located at the Federal Reserve Bank of Kansas City. The facility, located in Ellis Library at the MU Campus, provides a secure environment where researchers with approved projects can access restricted-use datasets. The MU RDC gives researchers access to hundreds of federal datasets that will support research in economics, sociology, and public health. Generally, there are four categories of data on which qualified researchers may perform statistical analysis inside the secure MU RDC: demographic data, economic data, linked business and household data through the Longitudinal Employer-Household Dynamics (LEHD) data, and health (non-census) data.

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  FastTrac^® TechVentures™ is a business planning and development course designed specifically for technology-based entrepreneurs by the Kauffman Foundation. This course is offered periodically through the OTM in conjunction with the Small Business Development Center of Missouri. Outside Guest Lecturers include: Intellectual Property Professionals, Attorneys, Venture Capitalists, Angel Investors, Technology Transfer Specialists, SBIR/STTR Experts, Marketing Professionals, Public Relations, Human Resource Professionals, and WU Faculty Founders.
  
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  Faculty Seminar Series, The OTM offers a series of seminars targeted specifically to faculty interests. Each seminar pairs an external industry expert with an experienced member of the WU faculty to explore topics in intellectual property, industry relationship building, commercialization, and other subject matter that relate to technology transfer. 
  
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  Technology Transfer Workshop, The OTM has developed a workshop to provide WU community members with an introduction to technology transfer and an understanding of how technology transfer intersects various efforts in intellectual property (IP) and commercialization within WU. The workshop is also designed to provide concrete examples and best practices in technology transfer as it directly relates to laboratory researchers in their everyday roles. Participants are exposed to intellectual property, technology transfer and commercialization topics through sessions and case studies taught by OTM and individuals from the greater St. Louis commercialization community. 
  
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  OTM Trainee Program. This unique trainee program exposes the individual to a broad range of technology transfer related activities, allowing the acquisition of skills and experience in the commercial development of research discoveries. This is a three phase training program involving: I) trainee shadowing a Business Development Director (BDD), 2) project-driven trainee and project oversight by BDD, and 3) final skills demonstration.
  

The Office of Training Grants, co-located with the Clinical Research Training Center (CRTC) Administrative Core, directly supports the ICTS Council of NIH-funded Training Programs designed to develop strategies to optimize recruitment of the most talented trainees, create strategies to improve recruitment of women and under-represented minorities as trainees/scholars, optimize joint approaches to meet curricular requirements that span various training programs. This forum provides an annual opportunity to share best practices, including educational resources/materials, curriculum content, evaluation and competency materials, and methods to foster successful long-term tracking of trainees and mentors; and brainstorm on strategies to smooth the transition from trainee to junior faculty status. The OTG hosts Mock Study Sections twice a year, which are designed to simulate an actual NIH study section. In this process, NIH clinical and translational R, K, and F series grant applications will be reviewed, critiqued, and scored by three internal faculty members as well as other study section members and the feedback will be distributed to applicants prior to the NIH grant deadline. The OTG has developed a Grants Library to serve as a centralized resource for grant writers and investigators at various career stages.

The Patient-Oriented Research Unit (PORU) is the academic and administrative infrastructure for patient- oriented investigators in the Department of Pediatrics. The PORU has dedicated space located in 22,000 square feet on the 10th floor of the Northwest Tower. This area comprises office space for 22 investigators and additional workspaces for support and research staff. There are locked NIH computer rooms and storerooms for study medications and supplies, conference rooms, and work areas with copy machine/FAX/printers. The PORU administrative group includes administrative and financial support as well as a regulatory (IRB) specialist who assist clinical investigators in the Department. In FY 2015, the PORU staff assisted 87 investigators with projects totaling $17,764,009 (direct costs).

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   The Research Participant Registry (RPR) database, powered by the Volunteer for Health program, provides individuals the opportunity to participate in clinical studies and play a vital role in improving health care. The RPR helps researchers find people who are interested in any of the more than 1000 WUSM clinical studies begin every year to evaluate new experimental therapies or devices and who meet study qualifications. The RPR database, holds information on over 15,000 potential participants and can be queried by study inclusion and exclusion criterion. People who are healthy and those who have medical conditions are needed, from every ethnic and age group. The RPR provides a conduit to connect individuals with studies at other institutions who partner with WUSM in clinical research. Research participants may benefit in many ways, such as making a difference in future medical care, receiving experimental drugs or devices not widely available, receiving compensation for time and effort, receiving research related medical care at no cost, ultimately taking a more active role in their own health care.
   
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   REACH aims to increase research understanding and participation among underrepresented populations in order to make research more representative. REACH Community Health Workers engage with community members at locations throughout the St. Louis region, including grocery stores, libraries, employment agencies, health fairs, and food pantries. Services provided for investigators include:
   

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  Community flyer distribution and engagement to facilitate participation screening
  
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  Database targeted recruitment based on study inclusion/exclusion criteria
  
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  Community pre-screening recruitment from the field
  
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  Education regarding benefits of participation in clinical research by debunking common myths and misconceptions, and helping community members become more comfortable with the research process
  

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  Maintaining an active presence in the community at engagement sites on a monthly basis
  
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  Extending engagement sites to provide on-going or single event support for underrepresented populations in research
  
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  Presenting to organizations regarding REACH services and/or the research process to staff or community members.
  

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   The Emergency Care Research Core (ECRC) provides a mechanism to conduct research in adult populations under acute illness and injury conditions by providing consultation for study design and access to subjects based on study inclusion/exclusion criteria. The Charles F. Knight Emergency and Trauma Center is a Level 1 trauma center that handles 95.600 adult and approximately 50,000 pediatric ED visits annually. The ECRC fosters interdisciplinary collaboration for research focused on emergency care. Currently the ECRC has 27 primary investigators using some aspect of ECRC resources ranging from IT resources including case review to full ECRC coordinator screening and enrollment of patients. Almost 50% of these primary investigators have primary appointments outside the Division of Emergency Medicine, including cardiology, urology, pulmonary, hematology, neurosurgery, and physical therapy. Computer Assisted Screening and Enrollment in the Emergency Department (CASE-ED) is a proprietary program developed and maintained by Emergency Medicine to aid in automated, comprehensive screening of potential subjects for the purpose of patient-oriented clinical research in the BJH ED. The CASE-ED database receives all information entered into the electronic medical record of ED patients and updates every 15 minutes. The ECRC provides RN research coordinators who are experienced with the ED environment and electronic medical record and can work with research teams to provide consent and enrollment services such as specimen collection, ECG, vital signs, assessments, or interventions as necessary for the study in the ED.
   

The Regulatory Support Center (RSC), supported jointly by the Center for Clinical Studies (CCS) and the ICTS, which coordinates activities for Regulatory Knowledge and Support (RKS). which facilitates clinical research of the highest quality – supporting the effective evaluation of pharmaceuticals, medical devices, and treatment outcomes – by providing the research community with administrative and clinical research services that move trials efficiently from initial proposal through study close-out. Through the RSC, the CCS supports budget development, negotiation, and feasibility assessment for clinical research studies supported by federal/foundation grants and industry contracts, including strong support for investigator-initiated studies. The RSC provides ICTS investigators with guidance and assistance with protocol development, IRB applications, support for FDA IND/IDE requests, developing clinical trial budgets, expert study coordination, dedicated research space and quality improvement initiatives while providing recruitment support services that establish and meet study targets (including adequate participation by women and underrepresented minorities). Three core services span the regulatory process to facilitate regulatory compliance and operational best practices:

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  The Regulatory Core of the RSC provides regulatory services to ICTS investigators, designed to overcome organizational barriers to the conduct of clinical research. This group has extensive regulatory experience, including preparation of IRB and related regulatory submissions, maintenance of approvals, adverse event reporting, protocol amendments and required annual renewals. The interactive process between the PI, sponsor, reviewing committee, coordinator and the regulatory specialist is designed to optimally facilitate approvals.
  
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