In addition to the core services described above, a number of administrative programs provide critical support and oversight for the research and translational efforts of the SISCB/RM.
Stanford Center for Clinical and Translational Education and Research (SCCTER)
SCCTER is a multidisciplinary organizational unit whose mission is to transform and integrate critical components of clinical and translational research, by converting basic discoveries into practical methods, and training the next generation of research leaders in translational research methods. SCCTER supports clinical trials through five main program functions: Biostatistics and Study Design, Biomedical Informatics, Bioethics, Clinical and Translational Research Unit, and the Clinical and Translational Research Service Portal. SCCTER will have an administrative presence in the SISCB/RM, but the majority of the clinical trials support will be housed in a new facility located 150 yards from the SISCB/RM and the two hospitals. Development of this building, which will be named the Jill and John Freidenrich Center for Clinical and Translational Research, should be completed and available for occupancy in 2010, and will be supported by a generous gift of $25 million from the Freidenrich family.
Research Management Group (RMG)
RMG provides administrative oversight and management of sponsored research projects and ensures compliance with managing sponsored funds. The support provided by RMG to SoM faculty is outstanding. Faculty in the School of Medicine had over $241 million in direct research expenditures from federal grants and contracts in FY06. Based upon the most recent annual Institutional Profile compiled by the Association of American Medical Colleges for which this data is available (2006), the SoM ranks first for research grant income per full-time faculty member, in both basic and clinical science departments ($270,000 compared to the average for all medical schools of $75,000). Finally, RMG has a strong track record with supporting the development of CIRM grants applications. A total of 33 CIRM applications were submitted and Stanford has received 25 awards (1 training, 12 SEED, 7 comprehensive, 4 new faculty and 1 shared laboratory facility).
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Office of Technology Licensing (OTL)
Stanford is one of the most effective academic institutions in the U.S. in translating basic discoveries into tangible improvements in human health. OTL is a critical enabler for translational research. The Stanford OTL is one of the oldest and most active in the country, and the example by which other universities model their technology licensing efforts. Its mission is to transfer Stanford technology to industry as effectively as possible for the benefit of society. In its 37-year history, OTL has evaluated over 6500 inventions, obtained 1600 U.S. patents, entered into 2600 license and option agreements, produced $1 billion in licensing revenue, and taken equity in over 120 start-up companies. In the fiscal years 2003-2005, Stanford executed 300 licenses (highest out of 155 institutions), exceeding the total for the entire University of California system. In FY06 alone, OTL received 518 disclosures of inventions by Stanford employees, $61 million in gross royalties and $3.3 million in liquidated equity from 470 technologies. The most successful application of OTL in the area of human health was the fundamental invention underlying biotechnology – the Cohen-Boyer DNA Cloning Technology – which was non-exclusively licensed to over 440 companies.
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Stanford must prepare its students, postdoctoral fellows, and faculty to address the future challenges of health care through its three-fold mission of research, education, and translation of discoveries into patient care. The goal of the SPARK program is to help investigators overcome the obstacles intrinsic to moving research discoveries from the bench to the bedside by piloting early development of inventions and intellectual property. Given the inherent risk of early-stage commercial ventures, newly discovered therapeutic and diagnostic advances are unlikely to attract the interest or support of the commercial sector until they have been further developed. Similarly, funding from government programs and foundations tends to target early basic research and later clinical stage programs. This lack of support for the applied science stage of discovery creates a significant barrier to the advancement of new medical discoveries. In order to bridge this gap between discovery and clinical application, investigators need access to specialized knowledge regarding drug and diagnostic development, dedicated core laboratory facilities to aid in the discovery of new chemical entities and pharmacodynamic markers, and sources of funding to support these translational efforts. SPARK provides funding, education, access to facilities, expert advice, and mentorship to researchers whose projects show promise as future medical therapies.
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Institutional Review Board (IRB)
Stanford University has seven IRB panels with 120 members (Administrative Panels on Human Subjects in Medical Research) that meet at least once monthly. Each panel has 9-11 voting members, typically including six physicians, a nurse, pharmacist, minister, and graduate student. The protocol submission process is electronic, with a new system brought online in 2005 in order to decrease the review time to less than 30 days. All applications involving human subjects must be approved by the IRB; those that employ stem cells, must also be approved by the Stem Cell Research Oversight Committee (see below).
Stanford Stem Cell Research Oversight Committee (SCRO)
The Stanford SCRO Committee is charged with reviewing all human stem cell research to assure compliance with CIRM, the State of California and National Academies of Sciences guidelines. This committee is chaired by Dr. Theo Palmer and meets monthly to review protocols.
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