Overall Component

10. Facilities & Other Resources:

S C I E N T IFIC E N V I R O N M E N T Overview: The Washington University Institute of Clinical and Translational Sciences (ICTS), has been funded by the Clinical and Translational Science Awards (CTSA) program of the National Center for Advancing Translational Sciences (NCATS) since 2007. ICTS is a transformative partnership between the School of Medicine and four other Washington University in St. Louis Schools, the College of Arts & Sciences, the George Warren Brown School of Social Work, and Schools of Engineering and Law; and BJC HealthCare, a large, nationally recognized, nonprofit health and integrated care delivery organization comprising Barnes-Jewish Hospital, the Goldfarb School of Nursing, and St. Louis Children’s Hospital. Since inception, partnership has included St. Louis College of Pharmacy and Saint Louis University, which are embedded within or located adjacent to the Washington University Medical School campus, easily accessed via the MetroLink light rail system. In 2015, a formal partnership was established with the University of Missouri-Columbia (MU), incorporating the School of Medicine, School of Journalism, Sinclair School of Nursing, and the Colleges of Engineering and Veterinary Medicine into our CTSA relationship. The ICTS is a catalyst for intra- and inter-institutional cooperation and through these collaborative relationships works to support the overarching goals of the national CTSA consortium and the ICTS mission.

Was h in g ton U ni v ers i ty in S t . L o u is ( W U ) , founded in 1853, is a medium-sized, private research university with approximately 12,000 full-time students, half of whom are enrolled in graduate and professional programs, and nearly 2,100 part-time students. The diverse student body represents all 50 states, the District of Columbia, Guam, Puerto Rico, the Virgin Islands and more than 100 countries around the world, with approximately ninety percent of undergraduates derived from outside the state. With 30,000 applicants for 1,600 places in the freshman Class of 2016, the university’s undergraduate program was the 7th most selective in the nation, and the most recent U.S. News & World Report ranks WU 14th among national universities. For 2016, WU undergraduate and graduate programs in entrepreneurship have been recognized as among the top 25 in the United States by The Princeton Review and Entrepreneur magazine survey of more than 300 schools. This strength in entrepreneurial studies complements recent St. Louis recognition as among the best startup cities in the nation, evidenced in the CORTEX Innovation District (detailed below in Resources) and their 20 partners. The CORTEX Innovation District, bisected by MetroLink, is bounded by Saint Louis University to the east, and WU and St. Louis College of Pharmacy on the western border.

W a sh i n gton U n i v ersity S c ho o l o f M e d i c i n e (WUSM) creates a world class scientific environment that brings strengths, efficiencies, and unique opportunities to the CTSA research community as a nexus to perform clinical and translational studies founded on established successes in research, education, and patient care. Since its founding in 1891, WUSM has trained nearly 9,000 physicians and has contributed groundbreaking discoveries in many areas of medical research. WUSM is internationally known for research in neuroscience, genetics, diabetes, cardiovascular diseases, oncology, immunology, diagnostic imaging, and many other specialty areas, which are supported through the ICTS infrastructure. WUSM was ranked #6 in 2015 by U.S. News & World Report among the nation’s research-oriented medical schools and currently has 1,983 full-time faculty members. In fiscal year 2014, WUSM received more than $353 million in grants from the National Institutes of Health (NIH), ranking as one of the top 5 academic institutions for NIH funding. WUSM has a longstanding commitment and track record in the training of investigators in basic sciences and clinical sciences extending to their pre-doctoral Medical Scientist Training Program (MSTP; MD/PhD) that accepts up to 20 of the nation’s most promising students per year.

The WUSM Faculty Practice Plan (FFP) is one of the largest integrated academic medical practices in the US with over 1360 physicians representing 76 specialties and subspecialties. WUSM physicians treat more than a million patients per year at Barnes-Jewish Hospital (BJH), St. Louis Children’s Hospital (SLCH), and The Rehabilitation Institute of St. Louis (detailed below). WUSM physicians also provide hospital-based care throughout the St. Louis metropolitan area at several off-campus facilities, including Barnes-Jewish West County Hospital, Barnes-Jewish St. Peter’s Hospital, Shriner’s Hospital, Missouri Baptist Medical Center, and Christian Hospital. All WUSM clinical practice sites participate in research, clinical trials, and training.

BJC HealthCare (BJC) system includes 13 community hospitals in Missouri and southern Illinois with 3,479 staffed beds, and is one of the largest academically-based health care systems in the country. The system serves regional residents through hospitals, seven nursing facilities, and includes The Rehabilitation Institute of St. Louis, a 96-bed inpatient rehabilitation hospital that offers comprehensive inpatient and outpatient rehabilitation services that are designed to return patients to leading active and independent lives. Barnes-Jewish Hospital (BJH) and St. Louis Children’s Hospital (SLCH) (detailed below) constitute the academic core of BJC. BJC is recognized for its ability to integrate health services in a cost-efficient manner, while providing an innovative medical data and imaging repository to enhance physicians’ access to patient data. BJC has more than 100 sites in the St. Louis metropolitan area for medical care and services, and is the dominant health care provider in the region with a 34 percent market share – more than double that of the next largest system. BJC is the first health care system in the nation to integrate an academic medical center with suburban, rural, and metropolitan-based health care facilities. Both BJH and SLCH are on the WUSM campus and serve as regional, national, and international referral centers, offering comprehensive care and providing a full range of health services and research for complex populations across the lifespan. The Goldfarb School of Nursing is set in an academic, clinical environment that includes two top 10, Magnet-status hospitals. Master of Science in Nursing degree programs prepare graduates to assume complex professional roles in advanced nursing practice, nursing education, or management and leadership. The Doctor of Nursing Practice/Doctor of Philosophy in Nursing (DNP/PhD) integrates practice and research aspects from both degrees through dynamic, integrated online coursework developed in collaboration with the Center for Lifelong Learning at the BJC Learning Institute. This program prepares graduates to become “practice scientists” and is the only program of its kind nationally. Goldfarb Hall, a 105,000 SF building on the Medical School Campus, is home to a Clinical Simulation Institute, and dedicated space for on-site faculty research.

B arn e s-J e w i sh H o s p it a l ( B J H ) is a 1,252-bed non-profit teaching hospital – the largest in Missouri. With a premier reputation in patient care, medical education, and community service, the hospital has been ranked among an elite group of the nation’s best academic hospitals on the U.S. News and World Report Honor Roll since 1993. BJH was ranked tenth in the 2015 U.S. News and World Report list of best hospitals; has a National Cancer Institute (NCI)-designated comprehensive cancer center, the Alvin J. Siteman Cancer Center (SCC) (detailed below) which received an “exceptional" rating in its 2015 renewal; and carries Magnet designation, the highest honor for excellence in nursing. The 1,800 member medical staff includes full-time faculty of WUSM, as well as private physicians. The medical staff is supported by a house staff of more than 900 residents and fellows, in addition to professional nurses and technicians, and service and support personnel. BJH is fully accredited by the Joint Commission on Accreditation of Healthcare Organizations and by the American College of Surgeons Commission on Cancer.

The Alvin J. Siteman Cancer Center (SCC) is an NCI-designated comprehensive cancer center housed in the Center for Advanced Medicine (CAM), a single-site, outpatient ambulatory care facility. SCC brings together over 350 WUSM, BJH, and SLCH physicians and researchers to comprise one of the nation’s leading medical research, teaching, and patient-care centers. SCC is the only NCI-designated cancer center in the state of Missouri, and the only NCI-designated cancer center within a 240-mile radius. Integration of all cancer-related activities under the authority of the SCC provides an effective administrative structure to promote novel interactive approaches to cancer research. SCC members hold approximately $130 million in cancer research funding, and WUSM physicians treat nearly 7,000 new cancer patients and follow more than 32,000 patients annually.

The SCC supports eight research programs in 1) prevention and control, 2) clinical and translational research, 3) genetics, 4) cellular proliferation, 5) developmental biology, 6) immunology, 7) stem cell biology and 8) imaging and ten resources shared with the ICTS and other entities.

The SCC comprises 107,422 SF and houses a 61-chair/bed infusion center, investigational pharmacy, clinical trials office, and multidisciplinary outpatient practices. All adult outpatients being treated for cancer are seen in this central facility, and the oncology inpatient floors are immediately adjacent to the outpatient floors dedicated for the SCC.

The Kling Center for Proton Therapy, launched in 2009, is the first implementation of a single vault proton therapy center and one of only six proton therapy centers in the U.S.

The SCC maintains a 2,615 SF FDA registered modern pharmaceutical cleanroom facility dedicated to the manufacture of custom biologics and drugs under current Good Manufacturing Practices (cGMP) conditions through the Biologic Therapeutics Center. This facility houses six (6) independent

manufacturing suites (ISO Class 7, Class 10,000) with positive pressure to adjacent areas, equipped with biological safety cabinets and incubators, pass-through both sides, seamless cove base, intermediate entry rooms (Iso Class 8), separate gowning rooms (G1, G2), unidirectional traffic flow for personnel and materials and validated dual-door autoclave.

The SCC also provides patients with educational resources and support through a street-level Health and Cancer Information Center. The CAM has been designed to be a building within a building, having its own unique identity, lobby elevators and waiting areas and is located on the northern edge of the Medical School Campus.

The SCC supports one of only three NCI Specialized Programs of Research Excellence (SPORE) grants in the US that focus on leukemias and myelodysplastic syndromes. The SPORE is the cornerstone program of the National Cancer Institute’s effort to promote collaborative, interdisciplinary translational cancer research. The SCC SPORE also supports a Career Development Program to recruit and mentor new investigators in translational leukemia research and a Developmental Research Program to support innovative translational concepts.

St. Louis Children’s Hospital (SLCH) forms the focus of child health research, training, and education within the Medical School Campus. This 264-bed Pediatric hospital serves as the primary pediatric referral institution for individuals in the greater St. Louis population (~15,000 admissions/year; including over ~52,000 emergency unit visits/year). As part of a Campus Renewal Project concluding in 2016 (visualized left from Forest Park), SLCH will undergo a 100 bed expansion to consolidate and modernize the Women and Infants program and place labor and delivery close to the Neonatal Intensive Care Unit (NICU) , while providing leading-edge diagnostics and outpatient clinical space. As the largest pediatric hospital in Missouri, SLCH hospital currently maintains a 70-bed level III NICU, a 36-bed Pediatric Intensive Care Unit (PICU), and a 12 bed Cardiac Intensive Care Unit (CICU). All surgical subspecialties are represented, including pediatric cardiothoracic surgeons with special emphasis in lung transplantation. SLCH has been consistently ranked among the top Children’s Hospitals in the United States by U.S. News & World Report.

Saint Louis University (SLU), the first university founded west of the Mississippi River in 1818, has been an engaged CTSA partner since 2007. As a private institution, it has served as a major catalyst for urban renewal in St. Louis on its 271 acre campus located east of the Medical School Campus (adjacent to the CORTEX Innovation District). The SLU College for Public Health and Social Justice, Doisy College of Health Sciences, offering health care education at the baccalaureate, master’s, doctoral, and professional levels; Schools of Medicine and Nursing and the Albert Gnaegi Center for Health Care Ethics are ICTS partners for public health, health services, epidemiology, and health care ethics. The College for Public Health and Social Justice is a leader in community-based clinical research. U.S. News and World Report ranked the Master of Health Administration (MHA) program # 7, and the College for Public Health and Social Justice earned the # 23 spot in the 2016 Best Schools of Public Health rankings. Master of Public Health (MPH) and PhD degrees are offered in 6 concentration areas, with 60 faculty members involved in research projects covering a wide range of topics.

The Center for Vaccine Development at SLU Medical Center is a multi-disciplinary research center designed to conduct basic and clinical research on new vaccines and biologics. The Center occupies ~20,600 SF on the first floor of the Edward A. Doisy Research Center on the SLU Medical campus, completed in 2007 at a cost $82 million. The Vaccine Center aims to provide volunteer education to promote health and infectious disease prevention, and engage with the community to conduct trials in accordance with good clinical practices that will lead to decreases in health care costs through primary prevention of infectious disease. Nearly a dozen vaccine trials have been conducted or are currently active, several involving pediatric populations or older adults. The Center ranks among an elite group of nine Vaccine and Treatment Evaluation Units (VTEUs) eligible to bid on up to nearly $1 billion in NIH projects that will study protecting people from infectious diseases, including emerging threats. The SLU VTEU was recently awarded a five-year, $5.8 million contract from the NIH and the unit was designated as one of two in the country that have been designated by the National Institute of Allergy and

Infectious Diseases to conduct -omics assessments on multiple potential vaccines to protect against infectious diseases.

The Center for World Health and Medicine (CWHM) was founded by a multidisciplinary team of former pharmaceutical company scientists at SLU in 2010 as a not-for-profit research center dedicated to the discovery and development of medicines to treat diseases that predominantly affect the world’s poor and underserved patient populations. CWHM partners with researchers at SLU and other collaborators around the world to overcome translational gaps in the pathway from early compound leads to true drug candidates. The CWHM is housed in the new Doisy Research Center in over 2,500 SF of laboratory space equipped with many former Pfizer research instruments.

Founded in 1864, St. Louis College of Pharmacy (STLCOP) is the 10th-largest college of pharmacy in the US. STLCOP is located on nine acres in the heart of one of the world’s finest biomedical and patient-care centers, immediately east of the Medical School Campus, where it forges active partnerships with nearby institutions such as WUSM, SLU, and Goldfarb School of Nursing. STLCOP stresses global prominence in pharmacy and health care education, interprofessional patient-centered care, and collaborative research.

STLCOP co-founded the Center for Interprofessional Education with Goldfarb School of Nursing and WUSM to jointly educate students in the health professions to provide evidence-based, patient-centered interprofessional care.

In a unique partnership announced in 2015, STLCOP and WUSM collaborated to create the Center for Clinical Pharmacology (CCP), designed to uncover better, safer, and more effective ways to use prescription medications to improve health. The CCP has five purpose-built laboratories occupying 12,000 SF in STLCOP’s new Academic and Research Building, located at Taylor and Duncan Avenues on the Medical School Campus.

The University of Missouri-Columbia (MU), founded in 1839 in Columbia, MO, is the flagship campus of the University of Missouri System. MU offers more than 280 degree programs among its 17 colleges and professional schools, and has a total enrollment of more than 32,000 students. MU is designated “Highest Research Activity” by the Carnegie Classification of Institutions of Higher Education, and is a member of the prestigious American Association of Universities (AAU). MU is a public institution that is one of only six universities nationwide with schools of medicine, veterinary medicine, law, engineering, agriculture, and a university hospital all on the same campus, and is one of only 13 universities with both an accredited school of medicine and an accredited college of veterinary medicine. As the first public university west of the Mississippi River, Columbia, midway between St. Louis and Kansas City, is a growing community with a population of more than 102,000. ICTS is partnering with five Schools and Colleges: the School of Medicine (SOM), School of Journalism, the Sinclair School of Nursing (SSON), and the Colleges of Engineering and Veterinary Medicine.

The School of Medicine (SOM) is a pioneer in the problem-based learning style of medical education that emphasizes problem solving, self-directed learning, and early clinical experience. In addition, the SOM Family Medicine Program ranked #7 in the U.S. News and World Report in 2015 and the Pre-Admissions Program and the Rural Track Program offered through the school give students an opportunity to gain education and experience practicing medicine in a rural area. A faculty of 100 basic scientists and 513 clinicians oversee the education and professional development of 392 medical students, 427 residents and fellows in 23 specialty programs, and 342 PhD and master’s degree candidates. Since 2000, more than 100,000 SF of medical laboratory space has been created at the Life Sciences Center and in labs for medical research through construction and renovation at the SOM, Truman Veterans Hospital and Dalton Cardiovascular Research Center. New buildings supporting medical research were completed in 2015 include MU's Biochemistry Complex, International Institute of Nano and Molecular Medicine, and Regional Biocontainment Laboratory. Radiopharmaceutical sciences is a signature program through the SOM, which supports biomolecular imaging and, through the MU-Research Reactor, provides the most powerful university research reactor and the largest producer of radioisotopes for biomedical and medical applications in the nation.

In 2007, the MU Institute for Clinical and Translational Science (iCATS) was established to provide an infrastructure for clinical and translational research, and bridge the gap between clinical and basic scientists. MU-iCATS is a campus-wide institute supported by twelve schools and colleges that is housed on the fifth floor of the Medical Science Building and aims to foster translational research by expanding the reach of basic science into clinical medicine. Under the authority of the MU Vice

Chancellor for Research, MU-iCATS includes a state-of-the-art Clinical Research Center (CRC) that opened in 2012, as well as several support cores and services. iCATS is the focal point of MU's efforts to develop clinical and translational science programs that improve health through better research, education, and public service. By encouraging collaboration and sharing of resources through partnership with the WU Institute of Clinical and Translational Sciences (ICTS), these programs also improve innovation, productivity, and efficiency of our region.

The MU School of Journalism, formed in 1908, was the first school of professionalism journalism established in the world. Providing practical hands-on training in real-world news media and strategic communication agencies, the Journalism School aims to communicate the benefits of clinical and translational research to health care providers, policy makers, and communities through the Health Communication Research Center (HCRC). Supporting Health Literacy Missouri, the HCRC adopted evidence-based practices to create tailored stories with data and information specific for interests in each community with a media outlet (newspaper, radio or television station) that could be augmented with standard public relations practices to enhance local messaging within the community. In over two years of this targeted program, disseminated news stories were picked up more than 600 times by 123 different newspapers covering 86 Missouri counties, with nearly 90% of the features covered in rural areas.

The Sinclair School of Nursing (SSON) was rated as the top nursing school program in the country by CollegeAtlas.org in 2014, offering degree opportunities such as a bachelor’s degree, an online RN to BSN option, an accelerated BSN program, a master’s program, a Doctor of Nursing Practice (DNP), and a PhD degree. The DNP at SSOM received a 2015 Central Region Excellence Award for its on-line course programming, joining nine additional specialist nursing programs in distance learning initiatives offered by MU. The SSOM has been in the top 20 percent of nursing research institutions receiving NIH grant funding in three of the past four years. Since 2012, the SSON has held a $14.8 million grant from the U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) to reduce avoidable re-hospitalizations among nursing home residents and created the vision for TigerPlace (detailed below in Resources), a facility partnered with Americare and the College of Engineering that combines cutting-edge technology and current research to enable older adults to continue living longer in an assisted-living environment, a practice called Aging in Place (AIP).

Research programs in the MU College of Veterinary Medicine (MU-CVM) contribute to the advancement of science and significantly enhance the quality of professional education, including statewide leadership on the One Health initiative, a worldwide strategy for expanding interdisciplinary collaboration, education and communication in all aspects of health care that converge on animal and human health in the context of the environment. The Clinical Translational Science Award One Health Alliance (COHA) is comprised of veterinary schools partnered with medical and other colleagues through a NIH CTSA, aiming to advance understanding of diseases shared by humans and animals. The MU-CVM complex is made up of five buildings on the southeast corner of the MU campus: Connaway Hall, the Veterinary Diagnostic Laboratory, the Veterinary Medicine Building, the Veterinary Health Center (Clydesdale Hall), and the Veterinary Medical Science Building. The MU-CVM supports clinical trials through the Veterinary Health Center, which provides first access to proposed new treatments and studies to improve diagnosis or monitor disease in internal medicine, orthopaedics, neurology, and oncology medical services. The Companion Animal Clinic boasts one of the few veterinary medical cancer treatment programs in the country, mimicking the same cancer-fighting techniques and technology as in human hospitals. Cancer diagnosis is aided by use of a Spiral CT scanner and one of the few linear accelerators in the world dedicated to animal use.

The BJC Institute of Health (BJC-IH)/BioMed 21 The largest building ever constructed on the WUSM campus is the home base for BioMed 21 — the University's innovative research initiative designed to speed scientific discovery and apply breakthroughs to patient care rapidly. The BJC-IH building, supported by a $30 million gift from BJC, provides laboratory space for five newly created Interdisciplinary Research Centers of BioMed 21 and two academic departments at WUSM. The five Interdisciplinary Research Centers, which comprise WUSM researchers and ICTS members from a wide variety of fields, are devoted to cancer, cardiovascular disease, neurodegeneration, infectious diseases, and membrane excitability disorders, which encompass neural, cardiac, and other conditions. The High Throughput Screening Shared Resource, eligible for JIT funding, is located in BJC-IH.

The Institute for Public Health (IPH) is a university-wide initiative designed to transform our approach to public health and partnership with the community. Formed in 2008, the IPH brings together many disciplines and diverse partners to address the complex health issues facing the St. Louis region and the world. The IPH serves as a connector to public health at WU to amplify, improve, and support efforts across campus, within the local community, and around the world. The IPH is also a convener, bringing together faculty and students from diverse disciplines to share ideas, form community partnerships, and turn ideas into action. The vision for public health at WU is to improve community and international health through the creation of new knowledge, the application and translation of science, and the training of advanced academic and practice leaders in public health. The IPH includes diverse research centers with interests relevant to CTSA, Academy of Medicine (formerly IOM), and Agency for Healthcare Research and Quality (AHRQ) priority areas and vulnerable populations. IPH/ICTS faculty members have expertise in several relevant to the ICTS programs including communication science, health behavior, community-based research, health disparities, health policy, systems approaches, and implementation science supported through the following centers:

The Center for Community Health Partnerships and Research (CCHPR) (detailed below in Resources) was formed by merging the IPH Center for Community Health Partnerships and the ICTS Center for Community Engaged Research.

Center for Global Health and Infectious Disease (CGHID) was initiated in 2012 through support of the Departments of Medicine, Molecular Microbiology, and Pathology and Immunology. It serves as the hub for numerous initiatives related to global infectious diseases, built on a broad infectious diseases research portfolio that focuses on disease pathogenesis, immunology, pathogen genomics, as well as diagnosis and treatment. The CGHID aims to be recognized as an international authority in global infectious diseases by fostering a transdisciplinary program in education, research, and service that will make significant contributions to prevention and treatment of global infectious diseases, thereby improving the health and well-being of people throughout the world.

Harvey A. Friedman Center for Aging (detailed below in Resources) aims toward a global society where all older adults have maximum opportunity for health, security, and engagement. as described in the main Resources section.

Public Health Data and Training Center (detailed below in Resources) aims to put public health data into action by promoting its effective use in research, practice, and policy.

The Center for Health Economics and Policy (CHEP) encourages the development of evidence-based research focused on improving the health and dissemination of work to policymakers and other stakeholders. The CHEP provides seminar series charting impact evidence for Medicaid expansion under the Affordable Care Act and improving care for patients at high risk of hospitalization in a reforming health care system. Access to analytic tools that that support research in health economics and policy is provided in a succinct, accessible style, such as workshops on using restricted use Medical Expenditure Panel Survey (MEPS), a set of large-scale surveys of families and individuals, their medical providers, (doctors, hospitals, pharmacies, etc.), and employers across the United States.

The Center for Dissemination and Implementation seeks to ensure that the most effective services are delivered in health and public health settings, and provides support for the WU Network for Dissemination and Implementation Research (WUNDIR) (detailed separately in Resources) and two funding programs designed to support innovative projects focused on improving the dissemination and implementation of health interventions.

A major thrust of the Institute is event organization and programming focused on public health bringing together hundreds of students, faculty, staff, and St. Louis community members, and coordination of curriculum and program development and support to help strengthen public health education and research. Specific funding initiatives that ICTS-IPH investigators can access include the Public Health Cubed (PH 3 ) program, a rapid seed funding mechanism designed to nurture novel ideas in public health research or education. Each faculty scholar contributes a virtual credit of $5,000 which can be cashed in with combined credits with a minimum of two other investigators to receive $15,000 funding. The PH3 program runs three cycles annually.

RESOURCES AVAILABE TO THE INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCES (ICTS)

WUSM was awarded a CTSA grant in 2007 (renewed in 2011) that enabled development of the Institute of Clinical and Translational Science (ICTS). The ICTS integrates pre- and post-doctoral training in clinical and translational research (detailed in the K and T submission) and research services throughout WU and

partnering institutions. Forged through the merger of previous grants, the current award (UL1 TR000448) facilitates regional partnerships with academic, healthcare, community and scientific institutions and key research core resources to stimulate and facilitate the performance of safe and ethical interdisciplinary clinical and translational research and to provide an environment to train the next cadre of clinical and translational investigators. In concert with the National CTSA Consortium goals, the ICTS provides infrastructure (services, personnel, space, equipment), strategic funding and training in order to reduce the time it takes for laboratory discoveries to become treatments for patients.

Investigators are able to draw upon ICTS Cores and services for assistance during all phases of a clinical and translational research study, from protocol development to dissemination and implementation of results. Biostatistical, ethical and regulatory consultations and reviews are available to assist in early planning and protocol development. Pilot funding, participant recruitment services, access to specialized clinical research units, biospecimen banking and biomedical informatics expertise facilitate study implementation. Other ICTS programs are designed to assist in the publication of findings and/or connection to community and commercial partners. Cross-disciplinary clinical research training and career development for pre-doctoral students, house- staff, postdoctoral fellows and faculty, including specialized expertise to conduct studies in children, is also fundamental to the ICTS. Key resources are summarized below alphabetically.

The ICTS Administrative Core provides support for programmatic initiatives, including the Barnes-Jewish Hospital Foundation (BJHF) BJHF/ICTS Clinical and Translational Pilot Program, Just-In-Time (JIT) voucher program, Sharing Partnership for Innovative Research in Translation (SPIRiT) and Strategic Pharma-Academic Research Consortium (SPARC) initiatives, the Research Forum (RF) Program, and coordinates the structure that supports day-to-day operations to achieve the overall goals of the ICTS. The Administrative Core provides budgetary oversight for the CTSA program and coordinates institutional funds allocated to the ICTS; manages tracking procedures and processes for internal monitoring and NCATS required reporting, and provides marketing and communication between WUSM and the NCATS, ICTS partner institutions and internally with other WU centers and institutes. The Administrative Core has dedicated space (1,500 SF), near the Clinical Research Training Center (CRTC) in the Wohl Complex and staff to support these functions. Small and mid-size conference rooms that accommodate between 8-15 participants are contiguous with this space.

The Biostatistics Epidemiology and Research Design( BERD) group offers expertise in the statistical and computational aspects of conducting clinical research. Support from this core includes the determination of overall experimental designs, hypothesis generation, interim analysis, data management, quality control of research data and final statistical analysis. The BERD team also assists investigators in exploring new approaches and methods of research design in order to better understand outcomes of laboratory experiments, new treatments, and the significance of interventions when exploring preventive measures for disease. Main BERD activities are housed within the Division of Biostatistics, a WUSM-wide facility that engages in research, biostatistical consultation, teaching and training. A multi-disciplinary graduate program in biostatistics, launched in 2011 with a Master of Science (MS) degree in Biostatistics (MSIBS), provides training in biostatistics, genetic epidemiology, statistical genetics, and bioinformatics. The division leads a post-doctoral training program in genetic epidemiology and a PRIDE summer institute program (Program to Increase Diversity among Individuals Engaged in Health-Related Research).

The BERD group provides regular consultation office hours to ICTS investigators and scholars for research design advice through their Biostats Clinic (Tuesdays 9am-12pm, Thursdays 1-4pm). The clinic has full computer and software resources in a dedicated conference room within the hospital setting and is staffed by faculty- and staff-level biostatisticians that will assess the needs of the investigator and refer to appropriate personnel as necessary. BERD also maintains an Methodologist Database of ~50 experts drawn from our CTSA in a range of research design areas (clinical trials, adaptive designs, observational studies, epidemiology, econometrics, patient reported outcomes, qualitative research, and statistical genetics). These individuals are available for consultation and discussions segue into formal collaborations.

The WUBIOS Computing Resource is an organized activity within the Division of Biostatistics that provides computing and networking services for BERD and ICTS members. The resource is organized around 100 multiprocessor Intel and AMD architecture servers running Linux. Compute servers provide access to statistical

analysis resources like SAS, R and S+, as well as specialized genetic epidemiology software. Web servers provide access to both static content web pages and dynamic resources. These are utilized for the display of information contained within databases and for the web-based data entry systems. REDCap runs within this environment in order to provide investigators with a mechanism for building and manipulating study data. REDCap, supported through BERD, now services almost 800 projects, representing a 33% increase compared to YR8, and provides resource guidance for over 5,000 users. Notably, nearly 2,000 users are drawn from outside of the medical center representing the strong use of REDCap to support multi-institutional studies.

The Biotechnology and Life Science Advising (BALSA) Group is a non-profit organization founded and led by WU graduate students and post-doctoral fellows. The BALSA group provides short-term consulting services to companies ranging from small start-ups to large corporations and to the ICTS during the scientific and commercialization merit review of proposals the BJHF/ICTS Clinical and Translational Pilot Program. The goals of the BALSA group are to 1) facilitate closer collaboration between the local business community and WU researchers and students, 2) assist local biotechnology firms in overcoming obstacles, exploring opportunities, achieving growth and maximizing profits and 3) provide opportunities for group members to obtain real. Although the St. Louis biotechnology and life science community is vibrant and growing, many early stage companies lack the human and financial resources needed to develop their ideas into viable commercial products at the invention/entrepreneur interface, so the BALSA group addresses this challenge, and provides education and insight to apply diverse, analytical skills to facilitate the translation of science within the local biotech marketplace. These opportunities allow students to gain practical experience and make valuable interdisciplinary connections, on and off campus.

The Bernard Becker Medical Library serves WUSM, BJH, and SLCH on the Medical School Campus. The mission of the Becker Medical Library is to provide information resources and technology in support of the educational, research, and patient care objectives of WUSM. The eight-level, 114,000 SF structure has capacity for more than 300,000 volumes. The Research Pod is located on the main floor of the library and contains customized iMacs and PCs equipped with a core set of statistical, research, and presentation software packages. The current biomedical resource collection includes 33 subscribed databases, 4,615 full-text electronic journals, and 42,000 electronic books. The Library is organized into several departments which play unique roles in serving the WUSM community, including: Archives and Rare Books, Collection Management Services, Health Information Resources (Reference), and Translational Research Support. Dedicated scholarly publishing specialists provide services, education, and resources to assist faculty, investigators and students on public access policies for publication and evaluation needs. An early Becker Medical Library Model for Assessment of Research Impact provided a list of key indicators to document evidence of biomedical research impact, including pathways such as advancement of knowledge, clinical implementation, community benefit, legislation and policy and economic benefit. Through additional resources, the Library offers the Communicating for Health program, a service that provides customizable presentations, tailored trainings, and consultations in the areas of health information, health literacy, and health communication. The Library has a staff of 50, including librarians and information technology specialists and two specialist-librarians serve as members of the ICTS Tracking and Evaluation (T&E) Team and support evaluation and continuous improvement for the CTSA.

Center for Administrative Data for Research (CADR): CADR assists ICTS investigators interested in using existing administrative data for clinical epidemiologic, health services, and comparative effectiveness research. Led by researchers with a background in medicine, epidemiology and health policy, CADR assists ICTS members with study design and selection of appropriate administrative databases; storing data securely and in accordance with data use agreements; using the data; and providing collaboration tools, programs and resources.

The CADR repository currently holds 12 types of databases including Medicare, Medicaid, Truven Health Analytics MarketScan® Commercial Claims and Encounters database, Claritas, American Hospital Association Annual Survey data, Health Resources and Service Administration (HRSA) Area Resource File (ARF) and multiple sources of billing data from the AHRQ Healthcare Cost and Utilization Project (HCUP). The HCUP data sources cover inpatient, emergency department, and some ambulatory surgery services. The Medicare, Medicaid and MarketScan data also include outpatient (provider and facility) and pharmacy services. CADR has published data access and services rates: dedicated Linex server fees ($40/GB/yr), statistical software ($600-850/user); data use ($200-$2000/year, depending on selected database) and programing and analysis consultation (hourly faculty or programmer rates), and many projects are supported through the JIT voucher scheme. On an

annual basis, 50 investigators receive CADR services. Through CADR, a database of information for approximately 4 million veterans is available through the

Clinical Epidemiology Center (CEC) at the Saint Louis VA Health Care System. Established in July 2013, the CEC serves as a core resource available to VA investigators to support the growth of clinical epidemiology research through weekly seminar programs and lectures on novel concepts in biostatistics, epidemiology, data visualization, presentations of current research results, and hands-on seminars in statistics, grant writing, and proposal preparation. The CEC provides support to investigators in study design, data management, statistical analyses, preparation of grant proposals, and preparation of manuscripts, posters and scholarly presentations.

CADR houses and maintains numerous large administrative datasets, and provides data management expertise to users in the ICTS community and provides training to program scholars in the use of health services administrative data in clinical epidemiologic, health services and outcomes research. The table below outlines the data sets that can be used by the ICTS investigators and Clinical Research Training Center (CRTC) scholars and trainees:

Database Setting/Types of Files Years PopulationNCI Surveillance Epidemiology and End Results (SEER) – Medicare (breast CA )

MEDPAR, Outpt, Carrier Claims, Home Health, Hospice, DME

1995-2002 (SEER) /1995-2004 (Medicare claims files)

76,199 breast cancer Medicare patients

CMS Medicaid eXtract (MAX) files – MO, IL, CA, FL, GA, TX

Inpt, Other Therapy, Personal summary, Prescription Drug 1999-2005 ~2.2-3.0 Medicaid enrollees

CMS Chronic Condition WarehouseInpt, Outpt, Carrier Claims, SNF, DME, Beneficiary Summary, Chronic Condition

1999-2010 3.9 million Medicare enrollees

CMS Medicare 100% Inpatient SAF Inpatient 2003 38.2 million Medicare patientsAHRQ HCUP Nationwide Inpatient Sample (NIS) Inpatient 1998-2011 ~7.1-8.2M (unweighted); ~34.8-39.5M

(weighted) hospital dischargesAHRQ HCUP Nationwide Emergency Department Sample (NEDS) Emergency department 2006-2010 ~25.7-28.6M (unweighted); ~120-

129M (weighted) ED visitsAHRQ HCUP Kids’ Inpatient Database (KIDS) Inpatient 1997, 2000, 2003,

2006, 2009~1.9M-3.4M (unweighted); ~6.3-6.6M (weighted) hospital discharges

AHRQ HCUP State Inpatient Databases (SID) – AZ, AR, CA, CO, FL, HI, IA, KY, MD, MA, MI, NE, NJ, NM, NY, NC, SC, UT, VT, WA, WI

Inpatient Varies by state;~2000-2011

129K-3.9M hospital discharges per year per state

AHRQ HCUP State Emergency Department Databases (SEDD) – AZ, CA, FL, HI, IA, MD, MA, NE, NJ, NY, NC, UT, VT

Emergency department Varies by state;~2000-2011 223K-9.9M ED visits per year per state

AHRQ HCUP State Ambulatory Surgery Databases (SASD) – CA, FL, MD, MI, NE, NJ, NY, NC

Ambulatory surgery Varies by state;~2003-2011

180K-3.0M ambulatory surgery visits per year per state

American Hospital Association (AHA) Annual Survey Database Hospital facility 2000, 2004, 2006,

2008, 2009, 2010 n/a

Nielson Claritas Demographic data 2004, 2005, 2006, 2008 n/a

Truven Health Analytics MarketScan® Commercial Claims Database Inpatient, outpatient, outpatient drugs 2006-2010 ~31-49 million enrollees/year

The Clinical and Translational Research Unit (CTRU), supports Participant and Clinical Interaction (PCI) activities, which will be unified with Clinical and Translational Imaging Unit (CTIU) (currently Human Imaging Unit, described separately in Resources) resources as described in the Hub Research Capacity Component narrative. The CTRU manages several distinct but interactive research units, the Adult Clinical Research Unit (ACRU), Clinical Trials Unit (CTU) and Pediatric Clinical Research Unit (PCRU) for both inpatient and outpatient research activities, as well as a research kitchen, a Core Laboratory for Clinical Studies (CLCS) for routine metabolite assays and body-composition analyses. CTRU currently supports 556 protocols (127 ACRU, 78 PCRU and 351 CTU) from 189 investigators. Overall, there is an increase in the use of the units and in the performance of more sophisticated and complex studies, including 48 protocols that use multiple units simultaneously. As described below, the ACRU, the PCRU, and the CTU are currently established in three different locations, approximately a 5-minute walk apart on the WUSM campus. Under this CTSA submission, three research units (ACRU, PCRU, CTU) and the Lifestyle Intervention Research Core (LIRC) will be colocated in newly renovated space specifically designed for maximal function in the Center for Outpatient Health (COH), with occupancy expected early in 2017.

The ACRU is primarily used for conducting inpatient and outpatient intensive research studies in adults and is located within ~7,500 SF of dedicated in-patient and outpatient space on the 4th and 5th floors of Barnard Hospital. This space includes a 12 bed semi–private inpatient unit, a 2 bed and 4 chair/bed outpatient area, waiting room, nurses’ station, Lab Processing/Storage facility, space for body composition analyses housing a dual energy x-ray absorptiometer (iDXA), BOD Pod and Pea Pod, Metabolic Kitchen, and a Conference Room. The ACRU provides research beds, research nursing and technician support, and routine supplies. Skilled nursing staff is needed to provide expert clinical care of study subjects, while ensuring the integrity of study protocol and data collection. ACRU nurses have a range of special skills and knowledge to implement and execute a large number of diverse and complex study protocols. For example, they have been trained to support investigators in specialized procedures, including placing arterial catheters, obtaining tissue biopsies, and performing hyperinsulinemic-euglycemic clamps.

The CTU is a 5,500 SF outpatient facility located in the CAM. This site is within a 5-minute walk from the ACRU and PCRU. The CTU has 6 exam rooms, a phlebotomy room, a consultation room, 2 long-term procedure rooms, laboratory specimen processing/packaging area, temporary workspaces for investigators and coordinators, and 2 conference rooms for meetings and visits by study monitors. The CTU offers dedicated research space, equipment, and nursing support for low-intensity clinical studies, particularly multi-center clinical trials. These studies include single-center and multi-center clinical trials funded by the NIH, medical and charitable foundations, and industry. However, the CTU space is also used for outpatient studies that require complex sampling procedures, intravenous infusions and pharmacokinetics. The CTU staff is comprised primarily of medical technologists and phlebotomists; a small number of registered nurses provide oversight and nursing support.

The Pediatric Clinical Research Unit (PCRU) provides space, nursing, and bionutritional support for clinical research projects conducted with children at WUSM. The PCRU provides critical resources to a broad range of clinical and translational studies in infants, children and adolescents (<18 years old). The PCRU has skilled nursing and technical staff to conduct complex, intense or lengthy research procedures (as would be performed in the ACRU) and less intense, single-visit, cross-sectional or longitudinal clinical trials research (as would be performed in the CTU). A suite of 6 private exam rooms, long-term treatment areas, and two cognitive rooms are currently available in the 2,400 SF unit on the 11th floor of SLCH. In addition to research space, the unit provides phlebotomy, research nursing, specimen processing and short term sample storage, and bio-nutrition services. In the most recent grant year, the PCRU provided support for 32 investigators from 6 departments and 7 divisions of the Department of Pediatrics implementing 65 protocols with 1,854 unique research visits totaling 4,564 hours. These visits vary from short 1-2 hour visits for data and/or sample collection and processing to extended visits up to 8-10 hour for complex infusion or pharmacokinetic studies or glucose clamps in children and adolescents. As described in this application, the PCRU will be co-located in early 2017 in the COH, with the ACRU, CTU, and LIRC in purpose-built space. This new space will enhance efficiency of services and use of unit personnel and will help to develop the PCRU, which currently is an exclusively outpatient unit, into a comprehensive research resource for the broadest scope of pediatric investigators.

The Lifestyle Intervention Research Core (LIRC), established through an NIH CTSA American Recovery and Reinvestment Act of 2009 Administrative Supplement, helps ICTS investigators implement an effective lifestyle intervention program into their research studies. LIRC supports: 1) Specialized nutrition services, including nutrition assessment, education, and counseling; recipe development; nutrient analysis; and development of menus/formulas for diet intervention, 2) Behavioral assessment and therapy for diet and activity lifestyle changes, 3) Training in sensory evaluation techniques and lifestyle behavior-change therapy, and 4) Image processing and analysis services to monitor the effects of lifestyle intervention on body composition.

The Core Laboratory for Clinical Studies (CLCS) occupies 4400 SF on the 6th floor of the Wohl Clinic Building and 688 SF on the 5th floor of the connected Wohl Hospital Building at WUSM. CLCS, a CLIA certified facility, has a proprietary laboratory information system known as CLAS, the Core Laboratory Access System which is focused on research testing (rather than a typical hospital laboratory) and allows CLCS to adapt to the special requirements of clinical researchers. CLAS runs on a virtual server located in the WUSM Computing Facility. Data are backed up nightly and a policy is in place for data handling during computer downtime. Computer services are HIPAA compliant and part of the WU intranet. Analytical instruments are interfaced directly with CLAS. The CLCS has all common

types of clinical chemistry analyzers, including a digital single molecule counting immunoanalyzer and instrumentation for radioimmunoassays and plate based ELISA tests.

The Center for Biomedical Informatics (CBMI) provides essential data management/analysis, tools, and comprehensive training resources to promote collaborative studies and facilitate the identification of diagnostic and prognostic biomarkers and the subsequent development of personalized therapies. Along with the BJC Center for Clinical Excellence (CCE) (described separately in Resources), the biomedical informatics within the CBMI is supported through under the direction of the new Institute for Informatics (described separately in Resources).

The CBMI handles medical records, clinical studies, biospecimen, and microarray data management services to support clinical and translational research broadly at WU as well as all the primary and processed clinical genomic data for Genomics and Pathology Service. Specific equipment, security, and disaster recovery is described under Equipment.

CBMI occupies approximately 5,295 SF of modern research biomedical informatics space in the CORTEX Innovation District. This includes 27 cubicles, and 15 offices of which five are capable of being occupied by up to three programmer analysts. In addition, all servers are housed in an environmentally controlled, redundantly powered, redundantly networked, state of the art, monitored and managed data center. There are also four conference rooms where face-to-face, voice, web and video conferences take place. All personnel have workstations and/or laptops with dual monitors and appropriate programming environments (e.g. Eclipse for Java) and software to develop the tools described in this application. 

The CBMI provides near real-time, point of care recruitment to trials is supported through the Clinical Investigation & Data Exploration Repository (CIDER), which exploits the WUSM/BJH clinical research data warehouse. CIDER contains EHR records on over 5 million patients across 12 hospitals and multiple WUSM clinics. Together with continued involvement with the three Patient-Centered Outcomes Research Institute (PCORI)-funded Clinical Research Data Networks (PEDSNet: A Pediatric Learning Health System, SCILHS-A Scalable Collaborative Infrastructure for a Learning Health System; and the Great Plains Collaborative, described separately in Resources), the CBMI supports application of the Informatics for Integrating Biology & the Bedside (i2b2) (described separately in Resources) platform to allow cohort discovery across institutions.

The BJC Center for Clinical Excellence (CCE) was founded in 1995, and provides leadership in quality assessment and health services research throughout BJC. The CCE’s nearly 100 clinicians, epidemiologists, analysts, programmers, industrial engineers, facilitators, project managers, and supporting personnel promote quality improvement and research. The center exists to improve clinical quality and patient safety, contribute to medical education and research, and enhance workforce development. The CCE maintains three core functional areas: (1) Healthcare informatics, (2) Clinical Excellence Consulting, and (3) Transformation Support. CCE manages BJC’s Preventable Harm Initiative, the BJC Excellence in Patient Care Committee, the Infection Prevention and Epidemiology Consortium, the BJC Patient Safety Program, and the Medical Informatics Laboratory (MIL). CCE resources will be used to ensure optimal methods and processes to improve efficiency of research and research training. With the Center for Biomedical Informatics (CBMI), the CCE is supported under the new organizational umbrella of the Institute for Informatics (described separately in Resources).

The Medical Informatics Laboratory (MIL) at WUSM and BJC comprises ten computer scientist programmer/analysts, a clinical pharmacist, and its physician director. MIL operates state-of-the-art computing hardware and develops cutting edge clinical software. This group's core competencies include integration of data from disparate sources, automated expert system programming, use of databases for discovery, and automated notification technology. Strong working partnerships exists with BJC pharmacists and BJC’s IS Department. Specific equipment is described under Equipment.

The Clinical Data Repository (CDR) was developed by BJC to facilitate integration of data from disparate sources. This repository is used for system-wide patient care, decision support, and research. Most of the data in the repository are acquired from source systems in real time via HL7 interfaces, and incoming data are encoded to standard vocabularies wherever possible. A group within BJC IS maintains a Medical Entity Dictionary that maps inbound facility-specific concepts to an enterprise code. This allows most applications, queries, and reports to work across all facilities with little or no changes. All observations within the CDR are associated with a registration number assigned by the facility where the observation occurred. A separate team in the BJC IS department

maintains a Master Patient Index (MPI) database that maps all registration (encounter) numbers to an enterprise-wide patient identifier. The database also stores times associated with each observation. Together with the MPI number, registration number, and facility, the date and time information allows single patients to be tracked across multiple facilities and the sequence of observations within one or more registrations to be analyzed. The repository started with registration, medication, and microbiology data from a single hospital in 1993. Subsequently, new hospitals and data sources were added, as summarized in the table below. Using the MPI as the patient indexing backbone, the CDR has acquired information for 4.6 million persons. The CDR contains over 34.5 million patient encounters and nearly 270 million results, events, and documents. The CDR accepts data from over 140 different BJC Clinical Applications as sources of data with a yearly average of 94 million messages.

The Center for Cardiovascular Research (CCR) supports basic research laboratories that focus on understanding the biologic processes that are responsible for cardiovascular disease. A major objective of the CCR is to establish novel interfaces among cardiovascular researchers in diverse scientific disciplines, including molecular and cellular biology, physiology, biophysics, and bioorganic chemistry. Accordingly, the CCR provides a unique research environment for scientists with distinct backgrounds who have common interests in diseases of the heart and vasculature. A key facet is facilitation of interactions between CCR basic scientists and clinical researchers engaged in patient-oriented research. Research faculty, fellows, and students meet twice weekly through highly interactive CCR trainee and faculty (internal and Visiting Professor) seminars

The Center for Community Health Partnerships and Research (CCHPR) is a transformative initiative supported jointly through the ICTS and the Institute for Public Health (IPH) that fosters collaborative research partnerships between and among the community at large, community organizations, ICTS academic institutions, community-based health providers, and researchers. The CCHPR was formed by merging the ICTS Center for Community Engaged Research (CCER) with programming within the IPH and resides in dedicated suites on the WUSM and WU Danforth campuses. The CCHPR enhances and expands the Practice-Based Research Networks (PBRN) of community practitioners affiliated with WU by establishing core support functions to 1) Actively engage community practitioners in clinical and translational research, 2) Implement strategies developed collaboratively with our partners to train students and investigators to properly conduct community-based participatory research in culturally diverse populations, and 3) Facilitate the participation of underrepresented populations in research by reducing barriers to participation, by increasing public trust, and by making research opportunities more accessible. The CCHPR also works with community practitioners, provider organizations, health agencies, policy makers, and trainees to assess community needs for services and perceptions about research, to translate those needs into clinical research, and to speed the application of these results to practice, and link the community to appropriate services (social, educational, and medical).

The St. Louis region is diverse in its ethnic/racial and socio-economic makeup. African-Americans are the predominant minority group; however, 38.6% of African Americans in St. Louis City live in poverty (U.S. Census Bureau, 2013) and are rarely represented in research. The Research Engagement to Advance Community Health (REACH) (described separately in Resources) initiative focuses on increasing research participation among underrepresented groups by using a “boots on the ground” approach where the CCHPR engages subjects in their own communities – grocery stores, community centers, food pantries, etc. The REACH initiative (and its predecessor, HealthStreet), has been very successful in supporting collaborative research partnerships between community members and university investigators, and more importantly in increasing public trust since its inception in 2009. In addition, there is an active Community Advisory Board that provides consultations on community – university research project design and implementation, and an active PBRN focused on community pediatricians. The CCHPR REACH initiative has dedicated office space (~200 SF) in conjunction with the IPH in the Taylor Avenue Building on the Medical School Campus to house personnel, supplies and secure maintenance of data relating to CCHPR/REACH activities. There is access to a group of 10 multipurpose, state of the art conference rooms that can accommodate 4 - 30 occupants. The bulk of patient engagement occurs in the community by utilizing public spaces. Access to these spaces is gained through our relationships with community partners and stakeholders in an effort to facilitate bidirectional communication in an environment familiar and comfortable to the stakeholder.

The CCHPR developed and maintains the Community Based Organization (CBO) Database, a tool developed from an earlier ICTS landscape survey on community academic research partnerships to help identify mutual research interests that promote collaborations between research investigators and community based organizations.

The Center for Clinical Research Ethics (CCRE), established through a partnership between our CTSA and the Center for Health Care Ethics at SLU, provides a comprehensive consultation network that assists ICTS investigators and programs in addressing clinical research ethics within clinical research protocols and policies. In addition, the faculty provides the Responsible Conduct of Research (RCR) courses and seminars and develops programming responsive to specific needs. The CCRE provides a range of resources including the Program for Ethical and Responsible Conduct in Science and Scholarship (PERCSS), offering ethics workshops and online RCR learning modules as well as didactic course working in ethical and legal issues in clinical research, enabling investigators to critically evaluate ethical and regulatory issues in clinical research. The CCRE maintains a library of research case studies; developed the Interdisciplinary Bioethics Network (IBN) to foster scholarly collaborations and promote clinical bioethics, research ethics and general bioethics; and provides professional development education for investigators who have engaged in wrongdoing or unprofessional behavior through the Professional Integrity (PI) program.

Linked to the CCRE is the Professional and Social Issues Lab (PSI Lab), which works to understand professional and social issues in research and develop ethics and professionalism training programs based on the best available social science methods and scientific evidence. PSI Lab faculty have conducted significant research projects identifying factors that support or impede research integrity, factors that enhance the effectiveness of RCR training, and best practices for research involving vulnerable participants. The PSI Lab’s unique features and services are supported by 3 full-time staff (a Clinical Coordinator, Program Coordinator, and Senior Research Technician) and 4 part-time graduate student research assistants. As the RCR and PI program needs increase with future growth in multicenter clinical trial activities, the capacity to expand is supported by departmental and institutional commitments to maintain the necessary faculty and staff. The CCRE and the PSI Lab will provide two services for the WU Trial Innovations Unit (TIU); (1) Informed Consent Enhancement, and (2) Regulatory and Ethical Issues Survey.

The Informed Consent Enhancement Core (ICEC) aims to enhance the quality of the informed consent process by providing education, resources, and consultation services to investigators and research staff that facilitate the use of best practices. Issues with the informed consent process are the most common concerns that require investigators to revise protocols, thus, creating delays in study approval. Hence, the ICEC also aims to reduce regulatory burden on investigators and increase the efficiency of IRB review by helping investigators to develop consent processes that respect participants and satisfy IRB requirements for complex clinical trials. The ICEC will focus its efforts to help expedite clinical trials that are neither exempted nor expedited—that is, on greater than minimal risk studies that require IRB full board review.

The PSI Lab resources will provide survey and assessment services (SAS) focused on regulatory and ethical issues. Assessment will take place across the lifespan of the change process in the immediate and mid-term, and it will continue throughout the long-term. Metrics will be defined across each change dimension—people, process, and technology. SAS faculty have specific expertise related to organizational psychology, psychological assessment, and the conduct of Delphi consensus panel surveys, and will advise on the content and process for assessment related to people at the internal and external levels and work to align assessments across the TIU. SAS will offer the following services: 1) Delphi consensus panel surveys of diverse stakeholder groups to establish a consensus on priorities for the TIU’s regulatory and clinical research ethics services; 2) Quality assurance surveys among users of TIU’s regulatory and clinical ethics services; and 3) Consultation on matters of clinical research ethics to other programs within the TIU that are engaged in establishing TIU goals or providing quality assurance services for the TIU.

The Center for Diabetes Translation Research (WU-CDTR) aims to eliminate disparities in Type 2 diabetes by translating evidence-based interventions to high-risk populations. The NIH-funded research center is a collaboration between the WU George Warren Brown School of Social Work (Brown School) and WUSM and was formed to address health literacy and health communication; dissemination and implementation; health economics and health policy; and community-based participatory research and cultural competency.

The WU-CDTR is a regional and national resource to investigators committed to translating interventions that have demonstrated efficacy into healthcare settings, communities, and populations at-risk. The WU-CDTR supports studies around two interacting scientific themes: the root causes of diabetes and disparities; and the prevention of obesity as a major contributing cause of Type 2 diabetes. WU-CDTR provides access to core services in support of real-world translation research and funds a pilot and feasibility program and enrichment program to support team science and transformative diabetes research.

The Center for Drug Discovery (CDD) at WUSM, aligned closely with the Center for Research Innovation in Biotechnology (CRIB) (described separately in Resources), aims to identify and advance promising drug candidates from the community with emphasis on four sets of activities: 1) identification and prioritization of promising projects; 2) education and project strategy; 3) implementation and project management; and 4) facilitation of external partnering. Projects are identified through established WU centers, including the ICTS, the Skandalaris Center for Interdisciplinary Innovation and Entrepreneurship (SCIIE) (described separately under Resources) and the SCC. Assay development is supported through automated, high throughput screening for both small molecular and siRNA screening through the High Throughput Screening Core (HTSC) (described separately under Resources). CRIB and CDD faculty participate on the Entrepreneurship and Drug Discovery KL2 Multidisciplinary Research Team, and support specialized didactic courses leading to the entrepreneurship thesis in the Master’s Degree of Science in Clinical Investigation degree.

The Clinical Data Research Networks (CDRNs) supported by the Patient-Centered Outcomes Research Institute (PCORI) connect many different types of health systems who are partnering to conduct research as a network with the intent to build capacity for conducting both randomized trials and observational comparative effectiveness studies using data from their practices and patient populations. Through the ICTS, investigators can access three PCORI-supported CDRNs:

The Scalable Collaborative Infrastructure for a Learning Health System (SCILHS) supports an open data platform across 13 healthcare centers, including BJC, as established through collaboration with the Department of Biomedical Informatics at Harvard Medical School. Supported by PCORI, this CDRN facilitates clinical research by sharing EHR data between academic medical centers using Informatics for Integrating Biology and Bedside (i2b2). SCILHS provides support for the development and establishment of an i2b2 instance at WUSM and BJC to build two local network nodes. The deployment of i2b2 for both pediatric and adult clinical data will provide the ICTS researchers with the necessary discovery tools to identify patient cohorts for clinical research studies. This network covers a broad array of populations, including underserved, rural, urban, rare disorders, children, geriatric, minority, disabled, and other vulnerable groups.

PEDSnet is a community of patients, families, clinicians, scientists, and health system leaders who are building a national, pediatric learning health system dedicated to discovering and implementing new ways of providing the best care and ensuring the best outcomes for children. It is producing reusable and expandable governance, logistical, informatics, regulatory, scientific, and training resources, organized as a Pediatric Research Commons that will help the pediatric patient-centered outcome research process become faster and more efficient. PEDSnet has created connections with disease-specific Patient-Powered Research Networks (PPRNs), CTSAs, health plans, and other national pediatric research initiatives with the intent of forming a sustainable pediatric clinical research infrastructure and is implementing a flexible dual data architecture that incorporates two widely used data models and national terminology standards to support multi-institutional data integration, cohort discovery, and advanced analytics that enable rapid learning. A consortium consisting of PEDSnet includes eight academic medical centers (Boston Children’s Hospital, Children’s Hospital of Philadelphia, Cincinnati Children’s Hospital Medical Center, Children’s Hospital Colorado, Nationwide Children’s Hospital, Nemours Children’s Health System, Seattle Children’s Hospital and SLCH), existing disease-specific networks (inflammatory bowel disease, hypoplastic left heart syndrome, childhood obesity, and two national data partners (ExpressScripts and IMS Health) forms the initial partners in the National Pediatric Learning Health System (NPLHS). Areas of expansion are the development of new relationships with pediatric PPRNs, NIH-funded centers for translational research, CDRNs, HealthCore (BC/BS health plan data), and with local health plan partners of PEDSnet sites.

The Greater Plains Collaborative (GPC) is a network of 12 leading medical centers in 8 states, including MU, who have implemented i2b2 as the common platform for developing a federated PCORI

CDRN. The goal is to improve healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination. Now in Phase II, the GPC will offer broadened network leadership and productive partnerships across CDRNs and five patient-powered research networks. Enhanced data resources to support observational/interventional research will be created by adding record linkage and duplication analysis capabilities with new data partners, and deploying free text note de-identification and processing to support advanced computable phenotyping at a vast scale across PCORNet data warehouses. This network serves a broad array of populations, including underserved, rural, urban, rare disorders, children, geriatric, minority, disabled, and other vulnerable groups.

The Center for Genome Sciences & Systems Biology (CGS_SB) studies the role of genes in human health, including the influence of the millions of microbes that live in and on humans. The CGS_SB also fosters development and application of new analytic methods for studying the disease families embraced by BioMed 21. The CGS_SB strives to develop new ways to address global health problems, including childhood malnutrition, obesity and antibiotic resistance; to discover new technologies for understanding how genetic variations impact health worldwide; and to create innovative programs to prepare the next generation of scientists.

The Center for Human Immunology and Immunotherapy Programs (CHiiPs), established in 2014, aims to become a leader in the field of human immunology by establishing an environment where basic, translational and clinical aspects of human immunology and immunotherapy research are seamlessly integrated. These objectives are achieved through 1) facilitation of basic research in the new and rapidly evolving areas of human immunology; 2) application of the insights that emerge from this research to achieve a better understanding of human disease; and 3) creation and support of an environment that encourages and supports the clinical translation of these insights into novel therapies for autoimmunity, cancer, immunodeficiency and infectious diseases. The CHiiPs houses a state-of-the-art instrumentation, including a time-of-flight CyTOF2 mass cytometer that simultaneously can detect more than 50 different structures either on the cell surface or inside the cell. And instrumentation for tetramer production and flow cytometry. Immunoassay support is provided through BioTek synergy H1 plate reader, Immunospot (ELISPOT) universal analyzer and Quickplex meso-scale discovery instrumentation. Bi-monthly CHiiPs translational seminars which explore topics in pediatric translational immunology, infectious diseases, autimmunity, neuroimmunology and tumor immunology and monthly CyTOF interest group meetings provide educational and practical exposure for trainees and scholars.

The Center for Neuroimmunology and Neuroinfectious Diseases (CNND) provides additional structure and support for the established neuroimmunology and neuroinfectious diseases interdisciplinary community at WUSM. The CNND increases their synergy and enrichment for individual and collaborative translational and basic science research programs. The CNND, comprised of researchers and clinicians from Internal Medicine, Neurology and Radiology, is the first such multidepartmental endeavor focused on the pathogenesis of central nervous system inflammatory and infectious diseases. The mission of the CNND will be to promote outstanding patient care and research for immunological and infectious disorders of the nervous system via the training of clinician consultants and basic science researchers, the development of novel diagnostic approaches and treatments, and by providing the WUSM scientific community with access to facilities and expertise in neuroimmune interactions and neurotropism. To further the goal of increasing scientific interactions, the CNND hosts an annual symposium to introduce the intersecting fields of neuroimmunology, neuroinfectious diseases and neuroimaging and to foster interactions between WUSM researchers working within these scientific disciplines.

The Center for Public Health Systems Sciences (CPHSS) at the WU Brown School aims to create sustainable solutions to public health problems by connecting research and evaluation. Downstream effects lead to better integration of theory and practice; greater understanding of whole systems; improved health policies; and rapid adoption of evidence-based policies and practices. Originally formed in 2001 and focused on tobacco policy research, the Center was rebranded to reflect growth into new directions in research and evaluation. The CPHSS is part of the ICTS T&E Team, leading a collaborative program comprised of partners from CPHSS, WUSM, the Becker Medical Library, and members of the ICTS Administrative Core. This is a large-scale institutional and scientific evaluation designed to utilize evidence-based and innovative evaluation methods to provide information necessary to ICTS leadership to make effective decisions leading to organizational change. The evaluation is also designed to demonstrate the

impact of ICTS support on scientific outcomes that result in clinical applications and meaningful community health results. The CPHSS is located in 2,100 SF of dedicated space in Goldfarb Hall on the Danforth Campus of WU. With the Bernard Becker Library and the Evaluation Center at the WU Brown School, the CPHSS drives evaluation and continuous improvement within the CTSA.

The Center for Regenerative Medicine aims to advance regenerative medicine through excellence in education and collaborative research. Housed in state-of-the art facilities in the 4515 McKinley Scott Research building, the Center embraces a broad understanding of regenerative medicine, including embryonic and adult tissue stem cells, cell reprogramming, cell and tissue engineering, and development, degeneration, and aging. The Center aims to facilitate and enhance research in regenerative medicine, as well as educate the public on the vast potential that regenerative medicine holds for human health. Four working groups including 1) Development and Regenerative Biology; 2) Developmental and regenerative biology in aging; 3) Chromatin and Epigenetics and 4) Stem cell, provide seminars and training. Just-In-Time awards to use core resources, seed grants, and graduate fellowships are available. Joint challenge funding opportunities, such as the hPSC Kidney Organoid Challenge supported by the Center and the Division of Nephrology, are open to faculty and postdoctoral fellows.

The Center for Research Innovation in Biotechnology (CRIB) aims to blend understanding of the science, business and regulation of biotechnology to ensure continued improvements in the delivery of medical innovations. The CRIB was established in the @4240 Building adjacent to the Office of Technology Management (OTM) in the CORTEX Innovation District by WU in 2014 to develop further knowledge about FDA-approved medicines by expanding this knowledge to include other FDA-approved biomedical products, including vaccines and medical devices. CRIB investigators are also deepening an understanding of the scientific, medical and commercial evolution of FDA-approved products. The Skandalaris Center for Interdisciplinary Innovation and Entrepreneurship (SCIIE)(described separately in Resources) and CRIB have collaborated with the Clinical Research Training Center (CRTC) (described separately in Resources)on two entrepreneurial biomedical training options: 1) an Entrepreneurial Master’s Degree of Science in Clinical Investigation (MSCI) Thesis Option with opportunities to develop a business plan through an externship with an experienced entrepreneur at SCIIE or conduct an historical analysis of a medical device or drug class through mentorship with the CRIB; and 2) a TL1 Postdoctoral Fellowship in Accelerated Innovation which provides options in Entrepreneurship or Research Innovation/Technology Transfer tracks. Through these programs trainees will learn commercialization strategies and approaches for establishing milestones, costs and timelines for new translational discoveries.

The Children’s Discovery Institute (CDI) is a world-class center for pediatric research and innovation created to fund the work of creative scientists and clinicians in collaborative, multi-disciplinary research aimed at some of the most devastating childhood diseases and disorders. The CDI acts to accelerate the realization of better treatments, cures, and preventions. This partnership established in 2006 between SLCH and WUSM is uniquely positioned to leverage the abilities of clinicians, investigators, trainees, and professional staff throughout the University’s academic and medical community. Since the CDI’s inception in 2006, the CDI has awarded more than 43 million in scientific grants. The CDI supports broad, interdisciplinary research initiatives within four specific centers:

McDonnell Pediatric Cancer Center : focuses on the etiology and treatment of pediatric cancers. Center for Metabolism and Immunity : focuses on musculoskeletal, kidney and gastrointestinal disorders

including the microbiome, disorders of metabolism and diseases related to the immune system. Center for Pediatric Pulmonary Disease : focuses on the biology of the pulmonary system and genetic

and acquired causes of pediatric lung disease. Congenital Heart Disease Center : focuses on the environmental and genetic etiology of congenital

heart and vascular disease, related birth defects, and other heart disorders.

The Clinical Genomics Research Unit is a full service state-of-the art research facility with CLIA and CAP accreditation, equipped with modern imaging stations, laboratory information system, chromosomal microarray facility and automated metaphase scanning. The Unit, located in a 2nd floor suite in the CORTEX Innovation District, provides support for clinical trials/studies for which a CLIA/CAP environment is required as well as conventional metaphase karyotyping and a comprehensive menu of molecular cytogenetic methods (FISH, Chromosomal Microarrays) for human and mouse tissues.

The Clinical Research Training Center (CRTC) is the umbrella program which oversees the KL2 Career Development Award, the Paul Calabresi K12 in Clinical Oncology, the TL1 Pre-doctoral Program, the Postdoctoral Mentored Training Program in Clinical Research (MTPCI), the Cancer Genomics and Outcomes Research STRENGTH R25 Program, the BJHF Patient Safety and Quality Fellowship, and the Advanced Summer Program for Investigation and Research Education (ASPIRE). The CRTC provides didactic curricula leading to a Certificate or a Master’s Degree of Science in Clinical Investigation (MSCI) or Applied Health Behavior Research (AHBR) Degree and has a wealth of experience in developing innovative curriculum for scholars and scholars at all stages of their medical careers. The CRTC has dedicated space (4,400 SF) and staff to support the clinical and translational research training programs at WUSM and its regional CTSA partners. Housed within the hospital setting, the CRTC has dedicated classrooms, educational software to digitally record and archive training programs, technology to provide distance learning and online tools and databases to facilitate scholar selection, and evaluate faculty mentors, scholars and training programs. The CRTC infrastructure will be leveraged to create new curricula, classes, and mentored training for the program scholars.

The CRTC supports and coordinates a large number of courses, certificate and degree programs that serve to support development of a workforce competent and confident in diverse skills necessary for the advancement of clinical and translational science.

Summary of Translational Workforce Development Resources within the ICTS

Program

Target Group(s)

DescriptionPre-doc

Post-doc,

Junior Faculty

Mid / Late-

CareerStaff

Degree / Certificate ProgramsMS in Clinical Investigation X X 33-credit degree with thesis that includes rigorous training in T1-T4 translational research

methods with 3 tracks: Clinical Investigation, Genetics/Genomics & Translational MedicineCertificate in CI X X 16 credits of training in the fundamentals of clinical research methodologyMS in Applied Health Behavior Research (AHBR) X 33-credit degree focused on developing the applied skills needed to manage health

behavior & clinical research programs in academic, clinical, & community settingsCertificate in AHBR X 16-credit program for research administrators committed to careers in clinical researchMaster of Population Health Sciences (MPHS) X X Hands-on experience in leading, designing, conducting & moving clinical research findings

to applications that will improve patient care & treatment

MS in Biostatistics (MSiBS) X X 18-month, 42-credit master’s program is designed to prepare students for careers in Biostatistics & Statistical Genetics

Master of Public Health (MPH) X X 52-credit degree, the curriculum includes outstanding research opportunities, real-world learning experiences through practicum, & unique classes & course packages

Master of Engineering in Biomedical Innovation X 30-credit degree to train engineers in the specific skills of innovation, design &

entrepreneurship in the biomedical and clinical research fieldsMS in Clinical Research Management X 30-unit degree teaching updated skills, strategies, & resources for developing & managing

products, treatment protocols, & other clinical research and patient care processesCareer Development Programs (CDP)

Clinical Scientist Training & Research (CSTAR) X Integrated translational research training for Internal Medicine residents pursuing a career

in academic medicine focused on clinical or outcomes researchMentored Training Program in Clinical Investigation (MTPCI) X 2-3 year program that provides mentored, multidisciplinary clinical & translational research

training to promote the career development of postdoctoral fellows & junior faculty

TL1 Predoctoral Program X Training for predoctoral students (MD, MD/PhD, PhD, OTD, AuD, DPT, PharmD) for a summer term or 1-3 year appointment with dual & joint degree options

TL1 Postdoctoral Fellowship in Accelerated Innovation X New program with 3 tracks: Dissemination & Implementation, Entrepreneurship, and

Technology TransferKL2 Career Development Awards X Multidisciplinary 2-5 year program for junior faculty with a health-professional doctoral

degree, or its equivalent, and a commitment to a career in academic medicineCancer Genomics & Outcomes Research STRENGTH Program

X R25 education program that utilizes online learning opportunities to educate postdoctoral researchers in the emerging disciplines of cancer genomics & outcome research

K12 Paul Calabresi Award for Clinical Oncology X Career development award which supports patient-oriented cancer research training,

curricula, & mentored projectsResearch Career Development Program X Monthly sessions which provide a forum to share best practices related to conducting

research & networking opportunities for researchDoris Duke Fund to Retain Clinical Scientists Program X Provides innovative institutional solutions to reduce faculty attrition by assisting junior

faculty facing extraprofessional demandsCommunity Research Fellows Training Program (CRFT) X Training program in public health and research methods for community members from

underrepresented populations to empower members to actively partner in researchCoulter Translational Partnership (TP) X X Program that pairs physicians & engineers to increase the capacity and pace of biomedical

innovation that ultimately benefits patients and society by addressing unmet clinical needs.

Workforce Development Activities/Resources

Program

Target Group(s)

DescriptionPre-doc

Post-doc, Junior Faculty

Mid / Late-

CareerStaff

CTRC Curriculum Committee X X X X Our courses & degree programs use competencies, have mapped competencies into courses, & use Comprehensive Competency Review to assess competencies

Good Clinical Practice (GCP) On-line Training Program X X X X An online program based on the Assoc. of Clinical Research Professionals GCP training

modules. The WU Learning Management System houses the modules & tracks completionResearch Career Development Program X Monthly sessions which provide a forum to share best practices related to conducting

research & networking opportunities for research staff.Evidence-Based Entrepreneurship Workshop X X X X Workshop series that covers information on how to identify viable new venture concepts,

build plans for a sustainable & scalable enterprise, & get ventures off the ground

Genomics in Medicine X X Seminar series that introduces the principles of genomics in medicine as they apply to clinical research & provides a practical background in molecular biology & genetics

Professionalism & Integrity in Research (PI) Program X X Program that uses a career-coaching model, offers personalized assessments, group

workshops & post-workshop coaching calls to help researchers operate professionally

Team Science X X X Develop an 8-course certificate program in Team Science & Collaboration (see section C6b).

Mentor Training X X Training series for mentors and scholars transitioning to a mentor role provided through in-person and on-line through didactic lectures and small group discussions.

indicates a New or Enhanced Program (see text)

The CORTEX Innovation District is a vibrant 200-acre innovation hub and technology district integrated into St. Louis’ historic Central West End and Forest Park Southeast residential neighborhoods, and adjacent to the Medical Center campus. CORTEX is a tax exempt 501(c)3 formed in 2002 by WU, BJC, University of Missouri – St. Louis (UMSL), SLU, and the Missouri Botanical Garden to capture the commercial benefits of university and regional corporate research for St. Louis, and is home to the CRIB, as well as ICTS cores such as CBMI and GTAC. The mile-wide square district, comprised of dilapidated and deserted factory buildings was transformed through this partnership into the fastest growing technology hub in the world. The 1,200% growth rate of the St. Louis technology hub is almost double that of its closest follower (Munich, Germany). St. Louis is host to more than 100 different pharmaceutical and biotechnology companies, many of which (approximately 80%) were founded by WU faculty, staff and alumni. The impressive growth of St. Louis technology has been facilitated by the Skandalaris Center for Interdisciplinary Innovation and Entrepreneurship (SCIIE) (described separately in Resources) and by the creation of novel entities such as the WU-supported non-profit, BioGenerator, which provides laboratory space, expertise from current and former entrepreneurs and biopharmaceutical executives as well as novel sources of investment funding. In addition, WU, aided by the ICTS, was instrumental in recruiting the Cambridge Innovation Center, the entrepreneurial hub that gave rise to Kendall Square in Boston, to conduct its first expansion outside the Boston metropolitan region. Most recently, the CORTEX Innovation District witnessed the expansion of Tech Shop, a creative community that provides access to 3D printing and design to support the creation of novel medical devices and other state-of-the-art technologies. 

Since inception, the CORTEX Innovation District has completed or has under construction 1 million square feet of new and rehabilitated space totaling $350 million of investment and generating 2,500 technology-related jobs. When fully implemented, the CORTEX Innovation District master plan projects $2.1 billion of construction, over 4.5 million square feet of mixed-use development (research, office, clinical, residential, hotel, and retail), a new MetroLink light-rail station and 13,000 permanent technology-related jobs.

The Diabetic Cardiovascular Disease Center (DCDC) is dedicated to finding better methods for diagnosing, treating and preventing cardiovascular disease in people with diabetes. Because roughly two-thirds of the 25 million Americans who have diabetes will die of heart or vascular disease, the DCDC's work holds tremendous implications for improving human health. The DCDC brings together physicians and scientists from cardiology, endocrinology, nutrition, molecular biology, chemistry, radiology, physics and other areas of biomedicine. They focus on studying the roots of the diabetes, particularly understanding why cardiovascular disease is more prevalent and more aggressive in people with diabetes compared with non-diabetics. DCDC's major goal is to find ways to identify heart and vascular disease in diabetes very early, when it is still most treatable, devise better treatments, and ultimately, develop effective methods to prevent disease altogether.

The Diabetes Research Center (DRC) aims to support and enhance research in diabetes and related metabolic diseases through expert Biomedical Research Cores, a vibrant Pilot & Feasibility Program, and a

dynamic Enrichment Program, all of which address the evolving needs of diabetes investigators. The WUMS DRC Research Base is organized in three Focus Groups: Metabolic Regulation, Complications, and Islet Biology & Immunology. Investigators from each of these groups participate in DRC programs that address two central, interacting scientific themes—a) Approaches Across the Translational Spectrum, and b) Prevention of Diabetes Complications

The Division of Biology and Biomedical Sciences (DBBS) provides a successful model of interdisciplinary research training and source of postdoctoral candidates for this program. The DBBS is a graduate educational consortium that includes faculty affiliated with basic science departments in the Medical School and College of Arts and Sciences, organized into twelve graduate programs. These programs emphasize a broad, interdisciplinary approach to the investigation of the most important questions in biology. More than 500 students are currently pursuing PhD degrees through the DBBS. Graduate study is highly individualized, with the unique feature that each graduate student is free to choose any of over 300 faculty members for her/his dissertation research. WU's Graduate School of Arts and Sciences grants the degree and each of the 12 programs within DBBS establishes its own requirements for earning the PhD degree. A listing of the course work requirements for the individual programs can be obtained at the DBBS web site. The DBBS and WUSM also support the largest Medical Scientist Training Program (MSTP) in the country. The 194 trainees in the MSTP are young physician scientists uniquely positioned for future clinical research careers.

The Dissemination and Implementation Research Core (DIRC) provides methodological expertise to advance translational (T3) research to inform and move efficacious health practices from clinical knowledge into routine, real-world use. DIRC works with ICTS scientists to move forward scientific agenda and grant writing related to dissemination and implementation (D&I) of health care discoveries. DIRC provides access to the Implementation Outcomes Collection, which includes measurement tools for implementation outcomes (distinct from services and clinical outcomes); the Strategies Collection, an abstracted set of definitions and evidence about D&I and quality improvement strategies from a variety of fields, providing a menu of strategies interventions which ICTS investigators can test in their own D&I studies; and design expertise unique to T3 and T4 research, notably multiple levels of measurement and analysis, randomization challenges, contamination, and power. Examples are: development of an implementation guideline toolkit and two websites, including (1) the Dissemination and Implementation Models in Health Research and Practice, supporting professionals through review, selection, and adaptation to integrate D&I models into their study or practice contexts; and (2) the Instrument Review Project from the Society for Implementation Research Collaboration.

The ICTS and the IPH jointly offer a Speaker Series through DIRC that brings field leaders to campus throughout the academic year to offer talks on a variety of relevant topics and meet for one-on-one consultation with investigators. Funding programs from DIRC were created with ICTS administrative guidance (process, review, grant awards and tracking) that provided NIH-style study section review and investigator feedback to support innovative projects focused on improving the dissemination and implementation of health interventions. These large ($30,000) and small ($5,000) DANDI annual grant schemes support a broad range of dissemination and implementation studies and are available to IPH/ICTS investigators. With reviewer critiques in hand, investigators can access the April “Next Steps Proposal Writing Bootcamp”, a unique event that brings together proposal development resources along with national and local experts in D&I research for consultation with WUSM researchers developing grant proposals responsive to D&I research in health.

The Evaluation Center at the WU Brown School is committed to maximizing impact through evaluation science – an “understanding of the work, and why it matters”. The Center, located on the Danforth Campus in ~500 SF of dedicated space in Goldfarb Hall, adopts a collaborative and integrated approach to evaluation through planning (logic models, continuous quality improvement process), data needs and management, communication and utilization of findings, and training and technical assistance. The Center uses best practices to operate under the American Evaluation Association Guiding Principles For Evaluators. The Evaluation Center joins other units to contribute to evaluation and continuous improvement within the CTSA.

The Harvey A. Friedman Center for Aging (Friedman Center) at IPH aims to provide multi-disciplinary support for investigators and organization to conduct innovative aging research and ensure its translation into practice, expand education on issues relevant to individual and population aging, and support aging initiatives throughout St. Louis and around the world. Monthly seminars present current research and perspectives on

aging for experts drawn from medicine, social work, psychology and law. The Friedman Center is an active partner in the I-70 Corridor Network on Aging, which aims to facilitate the creation of interdisciplinary research teams from universities and industrial partners along the I-70 corridor in Missouri and Kansas. These research teams work to address significant questions about aging, successfully compete for the funding of research that might not otherwise be fundable, and share in the advancement of teaching gerontology through cooperative exchanges among the I-70 participants. In addition to WUSM, founding institutions include the University of Kansas, Lawrence, the University of Kansas Medical Center, Kansas City, Kansas State University, Washburn University of Topeka, the University of Missouri - Kansas City, Rockhurst University, MU, UMSL, and SLU. Senior housing partners include TigerPlace (described separately in Resources), a state-academic-private project to revolutionize traditional long-term care, and three care institutions in Lawrence Kansas.

The Gephardt Institute for Civic and Community Engagement serves to catalyze community and civic engagement among students, staff, faculty and alumni stakeholders by community-based teaching and scholarship. The Institute was founded by retired US Congressman Dick Gephardt as the Gephardt Institute for Public Service in 2005. The Community-Based Teaching and Learning (CBTL) program is embraced by all seven WU schools and offers nearly 75 courses that enable students of all disciplines to provide service to the community while applying their learning in a real life context.

The goal of the Genome Engineering and Induced Pluripotent Stem Cell Center (GEiC) is to speed scientific discovery through the rapid and precise modification of genomes. GEiC was formed by the consolidation of two pre-existing cores, the Genome Engineering Center (GEC), which uses engineered endonucleases to create targeted modifications of mammalian genomes in order to speed scientific discovery, validate therapeutic targets, and increase scientific productivity; and the Induced Pluripotent Stem Cell Core (iPSC), which facilitates functional genomic studies through the use of patient-derived cells. (The GEC and the iPSC Core are described separately in Resources)

The Genome Engineering Center (GEC) is a core facility offering a variety of custom genome editing services. The GEC supports the following:

Custom and Validated TALEN or CRISPR Vectors: The GEC designs, assembles, and validates transcription activator-like effector nucleases (TALENs), and clustered regularly spaced palindromic repeats (CRISPR) vectors for each user-defined modification. Activity of each endonuclease in a cell line from the species of interest is validated for targets in the human, mouse, or rat genome.

Custom Knockout Cell Lines: The GEC will work with investigators to create targeted knockout cell lines.

Custom Knockin Cell Lines: The GEC will work with investigators to create targeted knockin cell lines. These modifications include, but are not limited to, point mutations, codon modifications, targeted insertions or deletions, and gene tagging.

The Genome Technology Access Center (GTAC), a component of the ICTS Genomic Medicine Program, was established by the WUSM Department of Genetics to provide cutting-edge and cost effective sequencing and analysis technologies to local colleagues and external investigators. The GTAC offers fee-for-service sample preparation, data generation, bioinformatics analysis, and intellectual support for microarray, PCR, and high-throughput sequencing studies. Clinical sequencing, microarrays and PCR are done in CAP/CLIA certified laboratories, providing test validation and direct translation of research observation to clinical genetics analysis. GTAC provides leading-edge detection of disease-specific mutations and gene expression patterns in patient samples using conventional and laboratory-developed assays, and can provide a seamless conduit from the Tissue Procurement Core (TPC) so that samples can be accessed, processed and analyzed in an organized fashion. GTAC is a WUSM shared resource including SCC and the CTSA. The GTAC laboratories are located on the 2nd and 3rd floors of the CORTEX Innovation District, which are proximal to the Center for Biomedical Informatics (CBMI). Laboratories and facilities consist of approximately 5,000 sq. ft. of space in total. GTAC is currently staffed by 23 scientists.Services and Technologies

NGS (Next Generation Sequencing) – The GTAC is involved in every step of sequencing research, including experimental design, DNA/RNA QC, library construction, sequencing, and analysis of NGS data. Numerous NGS technologies are available including whole genome, whole exome, custom

capture, amplicon sequencing, RNA-Seq, ChIP-Seq, and methylation sequencing. For each case, multiple library preparation methods are in production. For example, RNA-Seq libraries can be prepared from polyA selection, ribosomal depletion, or multiple cDNA amplification approaches for low input samples.

Microarray – The microarray facility involves itself in every step of microarray research, including custom array design, DNA/RNA QC, amplification, labeling, hybridization, scanning, statistical analysis and submission of data. The facility is equipped to run all microarray formats, including Illumina, Affymetrix, and Agilent.

PCR – The PCR facility provides researchers with several options for gene expression, copy number variation, SNP genotyping, custom amplicon generation for sequencing, and single-cell expression. Both high and medium-to-low throughput options are available.

Bioinformatics – In addition to providing raw data (sequencing, microarray, PCR) the GTAC also gives investigators access to comprehensive bioinformatic analysis using extensively validated workflows for all of its data generation services. Pipelines for alignments, variant calling, expression, differential expression, PCA, clustering, tumor/germline subtraction, and allelic expression (among others) are in production.

CAP/CLIA – In addition to research services, the GTAC also supplies CAP/CLIA services for NGS, Microarray, and PCR as part of the Genomics & Pathology Services (GPS) organization. The GTAC is responsible for the development and running of both patient care tests such as the Comprehensive Cancer Panel as well as custom tests for clinical trials.

The Genomics and Pathology Services (GPS@WUSTL) Core is a collaborative initiative between the Department of Pathology & Immunology and the Department of Genetics, is a clinical genomics laboratory at Washington University School of Medicine in St. Louis. Located in the state of the art Cortex building in the Cortex Innovation District, GPS delivers clinically validated testing in CAP-accredited, CLIA certified laboratories that are supported by extensive clinical and genomic experience and advanced technologies. Clinical genomic tests offered through GPS improve patient care by enabling a personalized approach to medicine, founded on next-generation sequencing tests that return actionable genomic intelligence across 24 multiple key disease-relevant gene sets. Sequencing results are interpreted by board-certified pathologists and clinical geneticists. Variants are categorized by medical significance in a concise clinical report. These results help ordering physicians stratify disease subtypes and identify optimal patient treatment strategies. GPS provides customized assay development in support of clinical trials and research, as well as clinical genomics fellowships that provide career development tracks for MD or doctoral level, biomedical professionals. GPS capabilities include Next-Gen sequencing, Sanger Sequencing, microarray for CNV analysis and SNP genotyping, quantitative digital PCTS, as well as a wide range of cytogenetic tests and clinical bioinformatics.

Working jointly with the CBMI, the GPS bioinformatics unit has been responsible for remarkable innovation in the area of clinical genomics, building the Clinical Genomicist Workstation (CGW) to manage all aspects of clinical next-generation sequencing-based testing. CGW offers a HIPAA-compliant cloud-based bioinformatics solution that tracks and analyzes patient specimens from the time of accessioning through DNA isolation and sequencing, genomic alignment of sequence results and clinical interpretations based on a custom clinical annotation database. The CGW software application was recently licensed and is now available through its Washington University-sponsored distributing entity, PierianDX.

Human Connectome Project (HCP) and the New Aging Connectome - The Human Connectome Project (HCP) consortium led by WUSM, University of Minnesota, and Oxford University, is comprehensively mapping human brain circuitry in 1,200 healthy adults using cutting-edge methods of noninvasive neuroimaging. Starting with the first quarterly data release March, 2013, HCP datasets are freely available to the scientific community. Four imaging modalities are used to acquire data with unprecedented resolution in space and time. In 2016, a new Aging Connectome consortium will launch through five sites (Massachusetts General Hospital, University of California at Los Angeles, University of Minnesota, WUSM, and Oxford University), bringing together extensive complementary expertise in human brain imaging and aging to provide an unprecedented opportunity to advance understanding of the normative changes in human brain connectivity with aging. Protocols for studying the very old (80+ years) will be developed and high quality neuroimaging, behavioral, and other datasets on 1200 individuals in the age range of 36 – 100+ years will be collected.

Through the WU Brown School, ICTS investigators can access the Health Communication Research Laboratory (HCRL) which seeks to eliminate health disparities by increasing the reach and effectiveness of health information to low-income and minority populations. Research through the HCRL innovative and community-based programs finds new ways to reach disadvantaged populations affected most by health disparities, working to develop and deliver effective health interventions designed specifically for these populations and using technology and partnerships to connect people to health services in their community. Areas of expertise include developing tailored and general print communication programs and health and behavioral surveys, designing and conducting health communication research trials, and conducting formative research to evaluate effectiveness among target populations, including pre-testing, focus group interviews, and cognitive response testing. The HCRL physical facility includes a focus group room with an observation area. This room can accommodate 12 focus group participants, and has video, computer, Internet and teleconferencing capabilities. The adjacent observation area can accommodate six staff members who can observe the focus group unobtrusively and listen to the conversation with a monitoring system.

The Hope Center for Neurological Disorders was formed by a collaborative alliance between WUSM and Hope Happens, a St. Louis-based non-profit formerly known as ALS Hope. The Hope Center improves the lives of people living with neurological disorders, through collaborative research that aims to discover fundamental mechanisms of neurodegeneration and repair, and translate that new understanding into cures and treatments. The Hope Center brings together world-leading scientists and clinician scientists to collectively focus on mechanisms of neurodegeneration and neural repair, accelerating the translational research process through three key aims: 1) establishing state-of-the-art core resources and technical expertise, so that basic science discoveries can be rapidly tested in relevant and validated animal models; 2) providing funding for innovative disease-focused research, without the multi-year delays that can be typical for other sources of grant funds and 3) developing a research infrastructure that promotes collaboration across disciplines and institutions, trains the next generation of scientists, and speeds dissemination of information. The Hope Center offers diverse opportunities to exchange ideas and learn the latest information in translational neuroscience through noon seminars, annual retreats, and didactic coursework, including the ‘Neurobiology of Disease’ course and lectures.

The current Human Imaging Unit (HIU) will evolve into the Clinical and Translational Imaging Unit (CTIU) as described in the Hub Research Capacity Component. The HIU is a research-dedicated, comprehensive imaging center that resides in the Center for Clinical Imaging Research (CCIR), a state-of-the-art biomedical imaging facility located on the 10th floor of the West Pavilion of BJH. The CCIR provides the latest in advanced imaging technology, equipment and expertise to support basic and translational inpatient and outpatient clinical research. HIU on-site staff include nurses, imaging technologists, research coordinators, data analysts, programmers, and managers to monitor, advise, and coordinate all aspects of the imaging resources for research studies. Patient care areas via the HIU include outpatient waiting areas, an inpatient holding zone, a nurse’s station, and monitoring equipment integrated into the existing hospital system. The design includes seven private holding rooms with flexible configuration to accommodate the consent process, interviews, physical examination, or any of a variety of other procedures. Equipment includes six state-of-the-art imaging scanners in computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), combined PET/CT and ultrasound (US). Single photon emission computed tomography (SPECT) imaging cameras also can be accessed from the Center. The CCIR was one of the first three centers in North America to acquire a simultaneous acquisition whole body PET-MRI scanner (Biograph mMR, Siemens). In 2015, 90 investigators performing 197 distinct trials or studies use the CCIR. Over 70% of investigators using CCIR services are non-radiologists and often are not imagers by training. Investigators using the CCIR come from throughout WUSM as well as from Arts and Sciences (Psychology and Physics) and the School of Engineering and Applied Sciences (SEAS).

The Human Research Protection Office (HRPO) is responsible for safe and ethical conduct of research at WU, BJH, SLCH, and other sites for which HRPO is the IRB-of-record. HRPO is a group of professional staff dedicated to the 1) protection of human subjects, 2) administration and support of the Institutional Review Boards (IRBs), 3) support of researchers and the conduct of ethical research compliant with local, state, and federal requirements and 4) education of the research community.

HRPO has built an infrastructure to support the use of Central IRBs (CIRBs) that are becoming the “norm” for NIH-funded multi-center trials with one dedicated FTE for CIRB studies and expansion of other positions to provide further support. HRPO has experience with a range of IRB-reliance models from full reliance, such as NeuroNext, the National Cancer Institute CIRB, and research conducted through the Sharing Partnership for Innovative Research in Translation (SPIRiT) Consortium (a consortium of six CTSA hubs), to shared IRB reliance through participation in IRBshare and the three PCORI CDRNs in which our Hub institutions participate. All ICTS partner institutions have agreed to some degree of reliance on one another's IRBs, and HRPO is actively investigating opportunities for broader reliance among local partners. WU currently serves as the IRB of Record for 180 institutions and 195 non-WU study team members or community partners.

Within HRPO, the Human Research Protection Program (HRPP) at WU was accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in 2004 and re-accredited in September 2015. This process occurs every five years and affirms the institution’s capacity, compliance, and commitment to the protection of human subjects and support for the ethical conduct of research. HRPO leadership is very active in human research protections at a national level. The Associate Dean for Human Studies and Executive Chair of the Institutional Review Board was recently appointed to the Secretary’s Advisory Committee on Human Research Protections within Department of Health & Human Services. The HRPO Executive Director serves as an AAHRPP site visitor and sits on the AAHRPP Council on Accreditation.

Central to HRPO’s success is a staffing and meeting structure that supports efficient and effective reviews. HRPO supports six IRB meetings per week, which has brought current turnaround times from IRB submission to approval to an average of 46 days for new full board studies; Phase III Clinical Trials are reviewed and approved in an average of 48 calendar days (26 days with HRPO and 22 days with the PI). New expedited studies are approved, on average, in nine days. HRPO processed a total of 15,244 submissions in 2014 (12,076 Expedited, 2,136 Full Board). In an average month, the myIRB system supports 2,304 unique users who access the system 19,636 times/month and view 60,7979 different pages/month. In 2014, WU had enrolled a total of 29,192,547 research subjects (including retrospective use of data or specimens) in a total of 5,532 open studies.

HRPO provides education through the Study Initiation Program (protocol-specific visits in concert with quality assurance representatives to provide compliance guidance and best practices); on-call and office service hours through the SWAT (Staff With Answers Today) program; dedicated conferences, ongoing series, and specialized workshops extending beyond the WU community; open access publication of HRPP-oriented tools, research guidance, and media through the HRPO Digital Commons; hands-on myIRB training workshops; educational events tailored to departmental/investigator and student or team needs; flexible CITI training for WU faculty, staff and community partners; and guidance on local community-engaged research.

HRPO has detailed information regarding community engaged research to address the needs of CTSA investigators engaged in research collaborations or affiliations with community partners, and to ensure regulatory compliance for investigators and their research affiliates. The Community-Engaged Research (CEnR) program includes information on getting started (from plan, funding, assurances, and approvals, and maintains a checklist for community partnership while providing information on education and assurance requirements CBO or community partners. CITI training is not available on-line for community partner human subjects training, but options for providing approved training to community partners are available, as well as guidance for compliance with research for non-exempt human subjects through Federal Wide Assurance (FWA). IRB community members play a crucial role in the successful ethical review of research involving human subjects. In 2014, over 30 community members committed their time and expertise to fill this important role at IRB meetings.

HRPO organizes quarterly meetings of the St. Louis IRB Consortium, with partners from key institutions in the region including all ICTS partner institutions as well as MO Baptist Hospital, St. Luke’s Hospital, Mercy Hospital and SSM Healthcare, Logan College of Chiropractic,

and Lindenwood University. Key conversation topics have included IRB review and submission processes, how to manage incidental findings, as well as a focus on current events in research ethics.

The High Throughput Screening Core (HTSC) specializes in small molecule screens to identify agonists/antagonist of biologically/pathologically interesting proteins, and sub- or genome-wide siRNA screens in live cell functional assays. A wide variety of siRNA (including Human Phosphatase, Kinase, Druggable Genome, and Whole Genome) and chemical compound libraries, molecular imaging platforms, and expertise with assay development and data analysis is available. The clean-room environment and an on-line humidified, CO2 incubator provide ideal conditions for performing cell-based assays, while the rail system and random access ensures the uniform treatment of every well across the entire screen.

IdeaBounce® is the flagship program of the Skandalaris Center for Interdisciplinary Innovation and Entrepreneurship (SCIIE) and the gateway to many other opportunities, including funding. Anyone in the world can post ideas on the IdeaBounce® website and the network of creators, inventors, investors, business people, service providers, customers, mentors and others can begin to connect to transform ideas into reality, create value and bring inventions to market. IdeaBounce® is a very quick first step where bouncers receive feedback about their idea and find out what potential customers think about the concept – with follow-up through virtual connections on the website as well as in-person free, fun, fast-paced IdeaBounce® events. Events start with 2-minute ‘elevator’ pitches from pre-selected bouncers, followed by an “open mic” segment for audience members to pitch concepts that were not picked. Winners receive $100 plus an invitation to an exclusive event the following week with the judges for a private mentoring sessions. IdeaBounce® is the essential first step for all SCIIE competitions including the BearCub, Skandalaris Center Cup, Global Impact Award and Social Enterprise and Innovation Competitions.

The Induced Pluripotent Stem Cell (iPSC) Core facilitates the use of induced pluripotent stem cell technology to enable investigators to leverage our institutionally diverse patient population to study and potentially treat human disease in a novel way.

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.

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.

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.

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.

The Institute for Health Systems Innovation (IHSI) is a joint initiative between Center for Biomedical Informatics (CBMI) faculty and BJC focused on improving healthcare through the development of a sustainable platform for population and patient-centered improvements. The IHSI was created with a $20M commitment from BJC to enhance capacity for innovation and discovery and to facilitate progress in bedside-to-community research. At the heart of IHSI are its integrated data assets that include clinical, operational, and third-party administrative and public health data. IHSI also facilitates advanced analytics to improve individual and public healthcare in innovative ways. Specifically, IHSI is dedicated to: (1) developing and maintaining the electronic infrastructure facilitating an expeditious clinical and translational research; (2) promoting the use of electronic resources maximizing the safety and quality of patient care; and (3) developing comprehensive training programs in biomedical informatics. Through resource pooling, data request processes are expedited, thus erasing the inefficiencies of prior established practices.

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).

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.

The Intellectual and Developmental Disability Research Center (IDDRC) partnered with SLCH to become one of a network of 15 NICHD-funded Centers of Excellence for research in mental retardation and developmental disabilities which are linked to existing CTSA programs. The IDDRC aims to implement cutting-edge innovations in science for the discovery of new higher impact interventions for individuals with developmental disabilities and incorporate vigorous interchange with scientists in other institutions, clinical providers and the local community. Currently, the IDDRC comprises over 45 active programs of research in intellectual and developmental disability conducted by its 70 participating investigators, including active research in clinical trials for new interventions. 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).

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.

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.

The Charles F. and Joanne Knight Alzheimer's Disease Research Center (Knight ADRC) in the Department of Neurology, at WUSM, is funded in part by the National Institute on Aging. The Knight ADRC facilitates research on clinical, genetic, neuropathological, neuroanatomical, biomedical, psychosocial, and neuropsychological aspects of Alzheimer's disease (AD) and related brain disorders. This center is at the forefront of a worldwide effort to uncover key causal factors in the development of AD, with a goal of developing more effective treatments and an eventual cure. The Knight ADRC is located in a WUSM-owned medical office building at 4488 Forest Park on the Medical School campus. This space is ideally suited for research participants with ample and convenient parking and full accessibility. Imaging at the Knight ADRC occurs at the Center for Clinical Imaging Research (CCIR) which houses the latest hybrid imaging technology, whole-body PET/MR imaging via the Siemens Biograph mMR scanner. This scanner combines two well-established human imaging techniques, PET and MRI. The Knight ADRC Biomarker Core is located in the new state-of-the art Barnes-Jewish-Christian Institute of Health (BJCIH) research facility at WUSM. The facility includes approximately 245,000 SF of laboratory, vivarium and support space. These laboratory spaces (~2000 SF) are constructed as an open floor plan with laboratory space for Knight ADRC-affiliated investigators. An important focus of the Knight ADRC is the differentiation of mild dementia of the Alzheimer type (DAT) from normal aging, through the African American Outreach Satellite. The activities of the Satellite are designed to support this focus by ensuring that the participant pool for the Knight ADRC is appropriately diverse. The Satellite seeks to identify and resolve barriers to research participation for African Americans, particularly those in the mildest stages of DAT. In addition, the Satellite works to provide new information about attitudes, perceptions, and beliefs regarding specific research activities (clinical trials, blood collection for genetic analysis, neuroimaging studies, lumbar puncture for collection of cerebrospinal fluid, autopsy) to enhance understanding and promote committed research participation.

Mallinckrodt Institute of Radiology (MIR) : The MIR provides a full range of diagnostic radiology procedures, including conventional radiography, ultrasonography, computed tomography, and magnetic resonance imaging. In addition, MIR provides nuclear medicine examinations (including positron emission tomography) and interventional radiology procedures. The MIR faculty consists of 73 full-time academic physicians who are board certified in radiology and/or nuclear medicine, as well as 45 PhD scientists, including physicists, chemists, and computer scientists. MIR is organized into three divisions: Diagnostic Radiology, Nuclear Medicine, and Radiological Sciences.

The Mallinckrodt Institute of Radiology (MIR) provides all diagnostic and therapeutic radiology services for the WUSM and BJH, and supplies Centralized Regulatory Services (CRS) to support ICTS investigators seeking to conduct early-phase, FDA-monitored studies. The CRS is a central core of unique Radiology research professionals with years of regulatory experience in pre-clinical and clinical studies of a variety of disciplines. The goal is to help facilitate continuity and efficiency of regulatory submissions in order to improve study

timelines from initiation to final approval, accelerate study start-up, and reduce PI time spent on non-revenue generating activities. MIR’s CRS can provide comprehensive support for regulatory requirements including FDA submissions for Sponsor-Investigator Investigational New Drug (IND) applications including first-in-man exploratory IND applications and Institutional Review Board (IRB) submissions, as well as other university regulatory governing bodies, including the Radioactive Drug Research Committee (RDRC).

Approximately 618,000 diagnostic imaging examinations, 39,000 nuclear medicine studies, and 31,000 interventional radiology procedures are performed annually at MIR’s facilities at BJH north and south campuses, SLCH, Barnes-Jewish West County Hospital and Barnes-Jewish St. Peters HospitalCenter for High Performance Computing (CHPC) : The CHPC provides the resources and expertise to tackle any computationally-intense research project undertaken by the WUSM research community. Located in the McDonnell Genome Institute's 16,000 SF Tier 4 data center at the Medical School Campus, the CHPC offers users access to ~1,800 computing cores, 10TB of memory and 19TFLOP/s of computing power as well as high-speed networking, bulk storage and technical support. Service is free to members of contributing departments at the Medical School and Danforth Campuses. Since inception in 2010, over 3.8 million research jobs have been processed, specifically covering ~20 million processors' hours of work. This would take a single PC-core approximately 2,300 years to accomplish.

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.

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.

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.

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

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.

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.

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.

As a world leader in the fast-paced, constantly changing field of genomics, the McDonnell Genome Institute (MGI) is one of only three NIH funded large-scale sequencing centers in the United States. The MGI brings strengths and efficiencies to the CTSA research community and has the capacity to perform large MCTs. Since its inception in 1993, the institute has played a vital role in the field of genome sequencing, receiving over $800 million in funding. The MGI began as a key player in the HGP – an international effort to decode our genetic blueprint – ultimately contributing 25 percent of the finished project.

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.

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.

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 10th 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.

The Musculoskeletal Research Center (MRS), formed in 2012 by Division of Bone and Mineral Diseases with the Departments of Orthopaedic Surgery and Internal Medicine, aims to enhance the productivity of established musculoskeletal scientists, to support young investigators in the field of musculoskeletal research and clinical care, and to facilitate collaboration between established skeletal scientists and those bringing non-traditional questions and strategies to the discipline. Just-In-Time funding is available to support investigators in obtaining data for developing a clinical/translational proposal for extramural submission or to develop new research directions. The MRS offers a small grants program, with funds available to support team building and grant planning activities for Teams in Translational Musculoskeletal Research. An active seminar and journal club series continues throughout the year, including a summer educational series exploring topics in 2016 such as bioinformatics in high throughput sequencing, epigenetic analyses, and the design of complex animal experiments. A Skeletal Biology and Pathophysiology Mini-Course is offered weekly along with a half-day symposium featuring poster sessions, latest laboratory updates and a featured speaker.

The MU Center for Health Policy (MU-CHP) supports health policy and collaborative health equity work at the communities levels through health systems, academia, advocacy groups, community based organizations, public health officials and policymakers. In partnership with the MU Office of Social and Economic Data Analysis (OSEDA) and MO HealthNet, Missouri’s Medicaid Program, CHP houses the MO HealthNet Data Project, which facilitates the utilization of Medicaid claims data by researchers and policy analysts concerned with population health, evaluation, quality improvement and cost savings across health care systems. Datasets, technical assistance and data analysis are available to data requesters through an established process with MO HealthNet.

The MU Coulter Translational Partnership Program (MU-Coulter TPP) was initiated in 2012 as a joint initiative between the University of Missouri-Columbia and the Wallace H. Coulter Foundation, a Charitable Remainder Trust established to provide leading scientific and medical societies the resources necessary to develop distinctive educational programs designed to improve the quality of care in resource-limited areas. The MU-TPP is a university-based translational research grant program providing seed (~$25,000) or full bridge (~$100,000) funding designed to establish a business-like process to accelerate academic innovations to the marketplace. Since program inception, 18 projects have received funding support through an annual vetting process that includes staged project development monitored by a program oversight committee with membership drawn from biomedical engineering faculty, clinical specialists, Office of Technology Management representatives, venture capitalists, entrepreneurs and industry representatives. The MU-TPP MU is in elite company as one of just 16 schools to host a Coulter program, which fosters groundbreaking, collaborative research with practical business plans to turn ideas into tangible products.

The MU Informatics Institute (MUII) is a partnership with the MU SOM and other stakeholders such as the SSON and the MU-CVM. The three major emphasis areas include Bioinformatics (sequence analysis,

structural biology, plant phenotypes, animal sciences), Health Informatics (EMR/HER, Neuroscience and imaging informatics, text mining, nursing informatics, mHealth) and Geospatial Informatics (epidemiology, public health, intelligence, agriculture, ecology and environmental studies).

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.

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.

The Nutrition and Obesity Research Center (NORC) works to enhance understanding of the basic and clinical aspects of nutrition in the prevention, etiology, pathophysiology and therapy of nutrition-related diseases. Since its inception in 1999, the NORC has served as a nucleus for the growth and development of nutrition and obesity research through four core facilities: Adipocyte Biology Molecular Nutrition Core (ABMN), Animal Model Research Core (AMR), Biomolecular Analysis Core (BMA), and Clinical Science Research Core (CSR). Overall, the NORC aims to 1) stimulate new and innovative nutrition and obesity research and to support collaborative research among investigators from different disciplines; 2) attract new investigators to the field of nutrition and obesity and enhance their development as independent and creative investigators through access to specialized hands-on training, core laboratory resources, shared facilities, and training and educational programs; 3) improve the training and education of students, house staff, postdoctoral research fellows, physician faculty, and allied health personnel in clinical nutrition, clinical obesity and nutrition/obesity research; 4) improve nutritional aspects of patient care by enhancing clinical nutrition services and by improving physician and health care provider nutrition knowledge; and 5) coordinate and promote community education and research to promote health and reduce obesity in the greater St. Louis Metropolitan area.

The Office of Technology Management (OTM) assists members of WU in the management of a wide variety of intellectual properties arising from research programs throughout the university, ranging from patents, copyrights, know-how, and proprietary materials to assisting faculty with consulting agreements. The current portfolio contains active and pending patents in areas of technology ranging from gene therapies to magnetics. In 2015, OTM supported 4 start-up companies, 149 invention disclosures and 146 US patents/PCT, as well as

>750 Materials Transfer Agreements (690 Academic; 62 Industrial). Using OTM resources, nearly $31M licensing revenues were realized in 2015, representing a 3.4-fold growth from the previous year.

OTM is located in first floor office space (~20,000 SF) in 4240 Duncan, the Phase II project of the growing CORTEX Innovation District. The Quick Start License is a new initiative provided through OTM to foster the formation of new startup companies based on new WU technologies via a simplified process (no upfront fees or performance payments) that will allow faculty to focus on the development and commercialization of products, streamline the contract negotiation process, and enhance the attraction to potential investors. The Women in Innovation and Entrepreneurship (WIE) initiative, sponsored by OTM, seeks to increase gender diversity by navigating female faculty through the WU invention and commercialization process by providing educational seminars, workshops, and a network of internal and external individuals involved in commercialization. 

A range of educational and training opportunities are offered through the OTM including: 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.

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. 

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. 

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.

Activities related to translational workforce development are supported through the WU Office of the Vice Chancellor for Research (OVCR), which regularly collates information on educational opportunities , the ICTS CRTC, and various student-led or center-supported programs. Many clinical research education and training modules provided through the OVCR can be taken on-line and are supported through the Learn-At-Work Program.

Summary of Translational Workforce Development Resources through OVCR

Program

Target Group(s) DescriptionAdmin Clin.

Research Coord.

PI or researcher

Clinical Research Education and Training

Billing Matrix Training X

Billing Matrix system houses information on clinical trials and the participants that are enrolled in them to help WU bill correctly for clinical items and services provided in the context of a clinical research project. Individuals must complete an online training session to obtain access to the Billing Matrix. [On-line]

Research Career Development Program X X

The Research Career Development Program is designed to offer training and continuing education opportunities for clinical and behavioral research professionals. These are monthly sessions which offer a series of modules and individual sections based on research related topics. [Seminar recorded with on-line access]

CITI Human Subjects Training [Online Modules] X

The CITI modules are designed around the type of research being conducted (biomedical or social-behavioral) and the research setting. These modules will meet the requirements of the Human Research Education Policy . This policy defines educational requirements for anyone undertaking human research at Washington University.

ACRP Good Clinical Practice Certification X X

The Good Clinical Practice Certification is designed to give the researcher a basic understanding of the regulations and requirements for research using investigational (not approved by FDA) drugs or devices. This Certification is valid for three years, and can be earned by successfully completing a Test-Out Challenge or by taking an online course with content specific for PIs and CRCs.

HRPO Educational Programs X X X

HRPO offers many programs related to human subjects research, such as New Submitter's Orientation, the HRPO Ethics Series, and Question and Answer Sessions on various human research topics. Visit the HRPO Education website for more information.

Necessary Elements in the Fundamentals of Human Subjects Research

X X X

Three-day introductory course to the conduct of human subjects research at WU which delivers an overview of research ethics and the research process from study origination through project close-out. Visit the Necessary Elements webpage for more information.

Responsible Conduct of Research (RCR) Education and Training

Identified RCR Education X X

OVCR offers listings of educational opportunities for researchers interested in learning more about ethics and responsible conduct in research. Includes coursework, calendars to seminar programming (faculty, post-docs, graduate students) and on-line training videos to educate clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct.

Program for Ethical and Responsible Conduct in Science and Scholarship (PERCSS)

X X

Washington University provides education in ethics and responsible conduct in research via PERCSS, which provides WU-specific online learning modules and regular face-to-face ethics workshops. Web-based learning modules are: Introduction to Ethical and Responsible Research Authorship and Publication Collaborative Research Conflict of Interest Data Ownership, Acquisition, Sharing, and Management Mentor-Trainee Relationships Peer Review Research Integrity

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).

The ICTS Proteomics and Mass Spectrometry Program (PMSP) offers next generation mass spectrometry and data analysis tools for global and targeted protein quantification in biological fluids and tissues. Consultation on experimental design, selection of analytical platforms and sample preparation are provided. PMSP offers integrated proteomic workflows for discovery and verification of protein targets in biological fluids and tissues. Procurement and sample preparation methods; access to software tools for global and targeted

quantitative proteomics; support for customized database construction for high-specificity analysis of post-translational modifications; and a centralized data structure for access, storage, backup and retrieval of raw and processed MS data are provided through the proteomics program core. The PMSP laboratory includes instrumentation for automated, microscale preparation of biological fluids and tissue, supported by three robotic liquid handling devices for the solid phase extraction of peptides, the enrichment of proteins using immobilized tips and the processing of multi-well plates for ELISA assays. This facility, an NCI-designated Proteome Characterization Center, is housed in a 3,500 SF customized proteomics laboratory on the 7th floor of the Southwest Tower at the Medical School Campus.

The Public Health Data and Training Center at the IPH aims to put public health data into action by promoting its effective use in research, practice and policy and provides additional informatics resources. The key strategies are to: 1) Build the capacity of students, faculty and community partners to use and interpret data; 2) Stimulate transdisciplinary collaboration to address specific public health issues; 3) Provide centralized access to diverse public health datasets; 4) Attract and train the next generation of public health researchers; and 5) Create opportunities to share important public health information with the community. The Center offers 90-minute, tailored “crash course data workshops” which covers a range of topics, including how to open and use the software, data import/export and management, programming syntax, graphs, and basic statistics for training and professional development. A SAS® users-group was created in 2015 as a forum to network and share knowledge.

Leveraged community and collaboration resources at WU are available through the Program for the Elimination of Cancer Disparities (PECaD) within the SCC, emphasizing prevention and control. The PECaD program aims to create a national model for eliminating disparities in cancer through community-based partnerships. PECaD encompasses SCC efforts to address pervasive issues of disparities of cancer diagnosis, treatment, prevention and control and education. PECaD works through community partnerships, research, and education to foster healthy communities and break down barriers to quality cancer care. The PECaD Clinical Trials Outreach Program has established a successful multi-year program for increasing participation in cancer trials that has extended the catchment area to seven Missouri and five Illinois counties over its twelve years of operation.

The Recruitment Enhancement Core (REC) , is a portion of the Recruitment Innovation Unit (RIU), helping ICTS investigators establish and meet study recruitment targets (including adequate participation by women and underrepresented minorities) while ensuring regulatory compliance and the highest ethical standards in participant recruitment. The REC is comprised of dedicated recruitment specialists for developing and implementing participant recruitment plans across all studies. The REC supports eMHR searches and research data repository queries (consistent with IRB and HIPAA rules), and provides assistance with creating targeted, comprehensive approaches to participant recruitment (to include creative solutions to existing and potential recruitment challenges), which will maximize recruitment efforts for clinical trials. The REC augments these activities with advertising assistance, by print or electronic media, both in development of materials and strategic placement. The REC creates a communication bridge between all members of the study team to optimize each entities value in the process. The proof of concept pilot for these recruitment related strategies has yielded a 2 fold increase in enrollment accrual. REC provides access to: 1) the Research Participant Registry (RPR) database, 2) the REACH (Research Engagement to Advance Community Health - the recruitment and retention arm of the CCHPR), and 3) the Emergency Care Research Core (ECRC) which provides consultation and recruitment services for studies involving clinical research in acute illness and injury. Each of these approaches can be used to enhance recruitment by passing a steady stream of qualified participants to the investigator and study coordination team.

1) 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.

2) 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: Community flyer distribution and engagement to facilitate participation screening Database targeted recruitment based on study inclusion/exclusion criteria Community pre-screening recruitment from the field 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

REACH also provides active services for community members and organizations, by: Maintaining an active presence in the community at engagement sites on a monthly basis Extending engagement sites to provide on-going or single event support for underrepresented

populations in research Presenting to organizations regarding REACH services and/or the research process to staff or

community members.3) 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:

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.

The Participant Advocacy and Ombudsman Core provides the key components of the Research Subject Advocate (RSA) program, including the development, maintenance & training on ICTS Site SOP’s as well as on-going training & orientation programs for clinical research coordinators and nursing staff. The core monitors studies . to promote adherence to human subject protection regulations and adoption of operational best practices

The Recruitment Enhancement Core (REC) delivers systematic, data-driven, and strategic support to optimally recruit and retain eligible research participants, as detailed separately in Resources.

The Saint Louis University Center for Health Outcomes Research (SLUCOR) supplements programs available through SLU on health information management (Doisy College of Health Sciences), health management and policy (College of Public Health and Social Justice). Within SLUCOR, work is organized in three sets of activities to inform health care in the translation from patient to policy: education and training, independent research, and consulting. Unique sample data sets include integrated USRDS, Medicare and commercial claims data for US solid organ transplantation, Symphony Health data comprising 10 years of national integrated claims data for ~34M Americans with diabetes, and information from the Missouri Health Initiative, comprising integrated commercial state data (from MO, Southern IL, and KS), PBMs, and Medicare for 6 years. SLUCOR offers a Master’s program in health data science that includes a substantive experience through a capstone project.

The Siteman Biostatistics Shared Resource (SBSR) facility is a shared resource supporting consultation on biostatistics and epidemiology. The core supports cancer research conducted through experimental designs, study monitoring, and data analyses. The faculty and staff utilize efficient methods that reflect ‘best practices’ in biostatistics and epidemiology. Examples of core work include: NIH-funded peer reviewed cancer grants, and pilot and small-scale studies to become part of successful applications for peer-reviewed funding. SBSR offices are located in the Taylor Avenue Building on the east edge of the WUSM campus within the Division of Population Health Sciences, established in 2010. Building on relationships with the SCC and the IPH, the division is a major component of the population health initiative embraced by WUSM leadership. The division also provides a home for the Master of Population Health Sciences (MPHS), a degree program for clinicians who seek training in population-based clinical outcomes research methods. The division also cosponsors the Cell to Society Pathway doctoral training program with the Division of Biology and Biomedical Sciences (DBBS), which provides rigorous training in biology, genomics, epidemiology and biostatistics together to establish new leaders in biological and quantitative population sciences.

The Skandalaris Center for Entrepreneurial Studies was established in 2002 to convey the fundamentals of entrepreneurship to undergraduate and graduate students. In the Fall of 2014, under the direction of the new Managing Director, Emre Toker, the Skandalaris Center changed its name to Skandalaris Center for Interdisciplinary Innovation and Entrepreneurship (SCIIE) and expanded its focus to offer a variety of co-curricular workshops, activities, and competitions to complement the range of classroom education at the individual WU schools. In 2015, the SCIIE Director partnered with the CRTC to offer a 10-hour series of seminars and workshops on I&E thinking on the medical campus to keep up with the student and faculty appetite for additional training. This series was attended by over a hundred participants and, based on extremely positive participant feedback, has been repeated each semester.

The SCIIE offers co-curricular programs to draw students and faculty into the funnel of entrepreneurial activity which provide real-world, practical training opportunities including: pitching ideas at an IdeaBounce® to get feedback and test the market; participating in a three-day intensive Pre-orientation program (for first-year students); working through IDEA LabsTM with Medical School clinicians to develop solutions to every-day problems they experience in practice; attending a series of non-credit workshops that lead from idea generation to business plan development; and taking classes such as The Hatchery, a popular course offered in both the fall and spring semesters through Olin Business School. IdeaBounce® and IDEA LabsTM and described separated under Resources.

The SCIIE hosts several business plan competitions that award funding to support social and commercial new ventures. The innovation and entrepreneurial pathway in these competitions begins with a concept posting to

IdeaBounce to provide connection to available resources to prepare the application and identify subsequent deliverables for the competition. The Bear Cub Competition, offering $250,000 awards in three annual cycles, is open to WU faculty, post-docs and graduate students who have previously submitted an invention disclosure to the OTM or who submit an invention disclosure concurrently with their Bear Cub application. Since 2005, the Social Enterprise and Innovation Competition (SEIC) has expanded opportunities for collaboration, innovation and learning supporting SCIIE goals of engaging students and faculty, providing practical training, and funding for the most promising ventures. In its first ten years, the competition has awarded over $1.2 million in cash and in-kind prizes to nearly 50 different mission-based organizations.

The SCIIE coordinates more than 50 entrepreneurship courses across campus, including a capstone course — the Hatchery and the Skandalaris Student Venture Fund (SSVF), an MBA student-run, advisor-guided investment fund. Cocurricular programs include IdeaBounce®, Coffee with the Experts, the Olin Cup, the YouthBridge Social Enterprise and Innovation Competition, the Skandalaris Seminar Series, and the Skandalaris Center Internship Program. Through partnership with the Center for Experiential Learning (CEL) in the Olin Business School, the SCIIE supports the CEL Entrepreneurial Consulting Team (CELect) which delivers impact to the St. Louis start-up community. During fall 2014 through spring 2015, 42 students worked with 12 entrepreneurial organizations, including Arch Grants, Hatchbuck, Prosper Women Entrepreneurs, and Sparo Labs.

Since 2009, the Social System Design Lab (SSDL), supported through the WU Brown School, develops and implements systems dynamics and simulation approaches for the improvement of health and human services. The Lab supports an aggressive scientific research agenda with the expectation that it become a place where students, post-graduates, human service professionals, and researchers can engage in collaborations that bridge the divide between disciplines and government, university, and private sectors to accelerate the research and development of organizational innovations. The SSDL provides a unique role in the fields of systems dynamics, social work, and health and human services by unifying and advancing this approach to research, quality improvement, policy, and evaluation. One of the Lab three main objectives is to promote the application of systems dynamics approaches for the improvement of services and policy through collaborations between professionals, communities, governmental, and nongovernmental organizations. Use of these services over the past six years has established bidirectional communication with community groups. In conjunction with the St. Louis City Department of Health, SSDL services helped to identify barriers to initiating breast cancer treatment among lower socioeconomic status women who receive a suspicious diagnosis of breast cancer in community health centers and federally qualified health centers (FQHCs).

The Statistical Genetic Analysis Core (SGAC) capitalizes on existing WU infrastructure in genetics, including the McDonnell Genome Institute (see below), and the Division of Statistical Genomics to provide comprehensive resources to support investigators engaged in genomics research. The SGAC assists investigators by providing statistical genetics input in experimental design, analysis and interpretation through general services such as protocol design, database development, and statistical analytics.

The StL Biogenerator is an evergreen investor that creates, grows, and invests in promising companies and entrepreneurs in the St. Louis region. BioGenerator identifies and de-risks commercially promising innovations and services; advises innovators and entrepreneurs; recruits and supports entrepreneurial talent; makes staged investments grounded in rigorous due diligence; and offers access to lab space and capital equipment. The Biogenerator positions companies to navigate the unique challenges of early-stage bioscience company development. Facility use agreements for WU and SLU have been developed. Externship programs for trainees are available as well as an Entrepreneur in Residence EIR program to support the growth of entrepreneurial talent by identification of experienced professionals with strong backgrounds including management, operating, and scientific expertise.

TigerPlace is an innovative independent living environment built and operated by Americare of Sikeston, MO, in affiliation with the MU Sinclair School of Nursing. TigerPlace provides a unique opportunity in which to develop and evaluate technology in a collaborative setting with researchers drawn from nursing schools, electrical and computer engineering programs, health management and informatics, as well as schools of social work and medicine to improve the quality of life and care of seniors. This unique setting offers an unparalleled environment combining an aging subject population, research infrastructure, and clinical and

translational science resources; TigerPlace residents who choose to participate in research projects enjoy helping to develop new technologies to help other seniors “age in place.” Key concerns of TigerPlace residents mirror those expressed by other seniors in Missouri and the United States; they are concerned about maintaining independence and dignity, have at least one chronic illness and some limitations in activities of daily living; their average age is 85. Located near the MU campus, TigerPlace is a 54-unit apartment complex specially planned to promote the independence of older adults. Nurses, physical therapists, occupational therapists, and specialists in environmental design contributed and participated in the building plan. A 23-unit expansion was opened in 2009.

The Tissue Procurement Core (TPC) facilitates the collection, processing, storage, and molecular analysis of biospecimens from participants enrolled in clinical and translational research studies. ICTS investigators may utilize the core to assist in the prospective collection and processing of human blood and tissue specimens associated with clinical trials, and may also search for and request previously collected biospecimens for translational and correlative research studies.

TPC maintains the WUSM Biospecimen Navigator (WBN), a comprehensive catalog of research biospecimens collected across the WUSM scientific community. The TPC also assists investigators in designing and executing studies focused on genomic and molecular (e.g. proteomic and lipidomic) analyses of study participant biospecimens. Through close alignment with the CBMI, researchers can have highly integrated access to clinical, pathology, and molecular data associated with each study participant biospecimen(s).

The TPC occupies 3,000 SF of newly constructed laboratory space on the fifth floor of the BJCIH and an additional 2,800 SF of newly renovated space for off-site biospecimen storage, 3 blocks east of the main laboratory. The BJCIH facility consists of 2300 SF of laboratory space, and 400 sq. ft. of temperature monitored storage space for ultralow mechanical freezers (-80°C), refrigerated storage (4°C) and liquid nitrogen (LN2) vapor storage (-196°C), as well as 300 SF office space. The off-site biospecimen storage facility houses temperature monitored refrigerated, ultralow mechanical freezer, and LN2 vapor storage that is supplied by a bulk-feed LN2 and manifold system. Both facilities are monitored with restricted access limited to TPC Staff and institutional security. The TPC is also located down the hall from the Pathology and Immunology Digital Imaging Center (DIC). Through this combined clinical and research shared resource, whole slide imaging, file storage, and image sharing is available for investigators on a fee for service basis using the Aperio ScanScope XT scanner and Imagescope and Spectrum data management and image analysis software. The main laboratory is equipped with standard instrumentation for blood processing, histology, and nucleic acid isolation and quality assurance.

The Translational Cardiovascular Biobank and Repository (TCBR) was established for the acquisition, utilization and storage of integrated human cardiovascular tissues and clinical data for detailed phenotypic and genotypic analyses. Specimens are obtained using standardized, validated procedures and clinical data can be referenced along with electrophysiological, structural and biochemical for genomic, epigenetic and somatic analyses. Consultation services provided by the TCBR include study form creation, generalized procedures for the creation of tissue biobanks or data repositories, and detailed services for investigators planning to utilize human cardiac tissue and/or clinical data in their research projects. Pediatric cardiovascular tissues facilitate discovery into genetic and epigenetic mechanisms underlying congenital heart and vascular defects, through support provided by the CDI. Experimental data, integrated with clinical information in an accessible database, enables collaborative efforts among basic, translational and clinical researchers to facilitate the timely application of novel research findings to the clinic.

The Undiagnosed Mendelian Disorders Clinic at St. Louis Children’s Hospital (SLCH) specializes in the evaluation of children and adults with severe and complex medical conditions for which a diagnosis has not been made by traditional testing methods (physical exam, imaging studies, metabolic evaluation, single gene testing or chromosomal microarray analysis). Following evaluation, testing recommendations are discussed with the family with counseling regarding the benefits and risks of the test. Clinical exome sequencing, offered through the Division of Medical Genetics and Genomic Medicine of SLCH, examines the majority of coding regions simultaneously to provide a diagnosis. The Clinic provides precision medicine resources to determine diagnosis and subsequent treatment options for affected individuals and their families.

An array of –Omics resources are available through the Saint Louis University Vaccine Trial and Innovation Unit (VTEU) within their central facilities in support of clinical studies and trials. SLU Omics Core investigators will provide expert consultation on 1) timing of sample collection, 2) methods of sample collection, 3) optimal sample storage and shipping conditions, 4) optimal experimental platforms for generation of Omics data, 5) cost-effectiveness of different Omics platforms, and 6) any other issues that arise regarding the planning, preparation or analysis of Omics data. Omics resources available to ICTS members include:

Lipidomics: comprehensive analysis and quantitation of the structure and function of lipids and their interactions with other lipids, proteins and metabolites within the cell or organism at the membrane or mediator level. This unit offers a range of GC equipment for detection, including electron impact and chemical ionization sources for mass spectrometry and two Thermo Electron Surveyor LC and Quantum Ultra triple quadrupole electrospray ionization mass spectrometers for lipidomic studies.

Metabolomics: in depth analysis of complex mixtures of small molecular metabolites as a molecular snapshot of cell or organismal physiology in response to pathological processes or genetic modification. This unit offers separation as well as detection methodology.

Proteomics: comprehensive analysis of the entire complement of proteins, including modification, produced by the organism from a variety of clinical specimens to understand abundance, protein variations and their interacting partners in a network to understand cellular processes in health and disease. This unit uses MALDI-QIT-TOF MS/MS for protein identification and LC-MS/MS on Agilent 6550 Q-TOF to identify signature peptides.

Transcriptomics: examines the expression level of mRNASs within a given cell or population through expression profiling to determine the type and concentration of mRNA moieties. The unit assays quality through Agilent BioAnalysis for defined QC parameters and uses a combination of DNA microarrays and RNA-Seq approaches for transcriptome profiling. An Ion Torrent Proton sequencer is available, using AmpliseqTM technology (Life Technologies).

The Women and Infants Health Specimen Consortium (WIHSC) assists researchers with the collection of high-quality data and biospecimens related to pregnancy and health of women and infants. A core facility within WUSM, the WIHSC was created in 2008 to advance excellence in the study of women’s and infants health. WIHSC obtains patient consent; collects, processes and stores specimens; and helps researchers select and obtain previously banked specimens based on a comprehensive database of outcomes metrics. The consortium now provides specimens to many academic departments at WUSM, including Pediatrics, Microbiology, Obstetrics and Gynecology, Pathology, Internal Medicine and Developmental Biology. Many sub-studies using WIHSC specimens and data involve multidisciplinary collaboration from the departments involved in WIHSC.

WIHSC enrolls subjects from several clinics at the Medical School Campus, including BJH and is a major provider of obstetrical services to underserved populations in the City of St. Louis, as well as the sole provider of perinatal (high risk obstetrics) and prenatal diagnosis services within the city. WIHSC also enrolls from the Assisted Reproductive Technologies (ART) program offered in the Division of Reproductive Endocrinology and Infertility. ART performs the largest number of in vitro fertilization cycles in the St. Louis area. Patients represent a broad range of socioeconomic groups since roughly half are from Illinois and have mandated fertility/in vitro fertilization (IVF) insurance coverage, and the other half, from Missouri, are often self-pay patients. WIHSC serves as a partner and honest broker, distributing biospecimens and data to researchers focused on women and infant health, disease, fertility and pregnancy. With the ability to consent patients and collect specimens throughout pregnancy – and 24/7 on labor and delivery – WIHSC helps researchers overcome barriers to accessing the tissue, fluid and other samples necessary for women and infants health research.

In 2010 and under the auspices of the Institute of Public Health, the Washington University Network for Dissemination and Implementation Research (WUNDIR) was formed as an informal network of researchers with a common interest in dissemination and implementation science in a variety of different settings and sectors (mental health services, public health, diabetes, acute care, emergency medicine, obesity, cancer, tobacco). Over 80 WUNDIR members attend six half day meetings throughout the year, alternating between the Danforth and Medical School campuses. Meetings provide updated D&I resources, collaborative options for trans-disciplinary research, and a forum to provide peer critique of papers and grant proposals (from concept to full submission).

Washington University Pediatric and Adolescent Ambulatory Research Consortium (WU PAARC) is a practice-based research network of community pediatricians in St. Louis and surrounding areas that initiates and conducts research studies and collaborates with other investigators to design and implement studies in the community setting. Community practitioners provide input to identify study questions and ensure that network studies are relevant to clinical practice and feasible to complete in the office setting. The network was established in 2002 with an infrastructure development grant from the Agency of Healthcare Research and Quality (R21 HS13530-01), and is affiliated with WUSM Department of Pediatrics. Currently WU PAARC includes about 78 pediatricians and 6 pediatric nurse practitioners (PNPs) from 36 practices (see map). These providers care for about 160,000 children who are demographically diverse and representative of the local community. WU PAARC is part of the CCHPR, a core of the ICTS that is supported in part by a NIH CTSA. The director and staff are located in the Patient Oriented Research Unit, comprising 22,100 SF on the 10th floor of the Northwest Tower.