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BU\u2019s Clinical & Translational Science Institute<\/a> (CTSI) has been awarded a $23.4 million, four-year National Institutes of Health (NIH) renewal grant<\/a> to train and support scientists across both campuses in conducting cutting-edge clinical research and turning their discoveries into treatments, diagnostics, and improved public health.<\/p>\n CTSI is part of a national network of translational science institutes at some 60 medical research universities that have been established by the NIH\u2019s Clinical and Translational Science Awards (CTSA). NIH created the program in 2006 to speed the translation of biomedical advances into better health care. All members of the CTSA network\u2014among them Harvard, Tufts, and the University of Massachusetts\u2014share research tools and innovations.<\/p>\n \u201cBy providing our researchers with resources, infrastructure, and funding, BU\u2019s Clinical & Translational Science Institute supports innovation and discovery that may improve health, diagnosis, or treatment,\u201d\u00a0says Karen Antman, provost of the Medical Campus and dean of the School of Medicine.\u00a0\u201cWe\u00a0are delighted to be awarded this grant from the\u00a0National Center for Advancing Translational Sciences<\/a>\u00a0at the NIH to support BU\u2019s outstanding investigators and increase cross-fertilization between bedside and bench.\u201d<\/p>\n While CTSI is based on the Medical Campus, its resources, including pilot grants funded by the award, are available to investigators across the University. \u201cOne of the great advantages we have at BU is exceptionally strong faculty in the life sciences and biomedical engineering who have the potential to collaborate with both clinical and basic science faculty in the medical school,\u201d says Gloria Waters, BU vice president and associate provost for research. \u201cBU CTSI, along with other initiatives we are embarking upon, provides much needed resources and infrastructure to help our faculty make connections across our two campuses. The collaborations and the infrastructure that are developed as a result of this grant will have a very real impact on our ability to facilitate translation of biomedical advances into improved care for patients.\u201d<\/p>\n Under the leadership of CTSI director David Center<\/a> (MED\u201972), associate provost for translational research, BU has received two NIH clinical translational research awards since 2008. \u201cThese were meant to be, and still are, grants that build the infrastructure of the University to help scientists do science better\u2014and do better science,\u201d says Center, the Gordon and Ruth Snider Professor of Pulmonary Medicine at MED and chief of pulmonary, allergy, sleep, and critical care medicine at Boston Medical Center<\/a>\u00a0(BMC). Center says the awards have been the foundation for a number of BU investigators\u2014especially those in the early stages of their careers\u2014to successfully apply for other types of federal funding.<\/p>\n The renewal awards also enable CTSI to provide research support for core facilities for clinical trials, biomedical informatics, pilot funding, help in navigating the regulatory system, and biostatistics, epidemiology, and research design. Center says the awards can help CTSI connect researchers with BMC patients, a large percentage of whom are underserved minorities at risk of multiple chronic diseases. The NIH considers these patients, and their health, integral to the mission of translational research.<\/p>\n \u201cTranslation can occur on multiple levels, not just from the bench to the bedside, but from the bedside to patients, from patients to the community\u2014and it all flows back and forth,\u201d says CTSI associate\u00a0director David Felson<\/a> (SPH\u201984), a MED professor of medicine and epidemiology, and section chief of the BMC clinical epidemiology research and training unit. \u201cIt also occurs from knowing something works that\u2019s been tested in trials and actually getting it into the community where it\u2019s given to people.\u201d<\/p>\n Additionally, the award will help advance regenerative medicine at BU. Under the supervision of Darrell Kotton<\/a>, a founding director of the University\u2019s Center for Regenerative Medicine<\/a> (CReM), the award will provide for six predoctoral students and four postdocs to receive advanced training in any University laboratory\u2014it could be pediatrics, orthopedic surgery, hematology, or any number of other medical fields, Center says\u2014that is engaged in stem cell research and regenerative medicine.<\/p>\n \u201cThis training program will prepare the next generation of scientists and physician-scientists to work with stem cells to advance this new technology toward clinical application,\u201d says Kotton, a MED professor of medicine and pathology and a BMC attending physician in pulmonary and critical care medicine.<\/p>\n Most important, says Kotton, whose lab studies cystic fibrosis, emphysema, and other pulmonary diseases, the award \u201cwill help support open-source sharing of Boston University\u2019s expansive bank of pluripotent stem cell lines generated from patients who have the diseases that we and other BU CTSI partners across the country study.<\/p>\n \u201cWe hope this stem cell bank and our capacity to make new stem cell lines for national sharing will provide the tools to better understand and treat these diseases in the years ahead,\u201d he adds. \u201cIn this way, the award stands to benefit many universities across the country that participate in our shared mission of improving human health.\u201d<\/p>\n A key part of the CTSI mission is fostering collaboration across many disciplines and across both campuses, says Center, \u201cwhether those collaborations are spurred by money in the form of pilot awards or new grants or by an individual who identifies someone in any other department doing work that might be applicable to their own.\u201d<\/p>\n \u201cWe\u2019re free to give our money as an investment to anyone across the University,\u201d Center says. \u201cBU CTSI\u2019s idea is for creating unencumbered money that would be multidisciplinary and cross schools and departments. It doesn\u2019t mean money is given without review or without strings attached. But with us, if you\u2019ve got a good translation idea\u2014fine. We support junior and senior investigators.\u201d<\/p>\n Collaboration is one of the cornerstones of the CTSI training program, which educates young physician-scientists and other junior faculty across the University in cutting-edge, multidisciplinary translational research methods. Researchers today should be \u201cconversant and capable in thinking about a broad range of methodologies and to be able to communicate and interact in an interdisciplinary fashion,\u201d says Felson.<\/p>\n One way CTSI training encourages this sort of creativity is by holding seminars where physician-scientists and other investigators from a broad range of disciplines\u2014cardiologists, pulmonary physicians, epidemiologists, biomedical engineers, and others\u2014share their research findings. \u201cThey\u2019ll be sitting in their own research world\u2014in their own little silo\u2014and they listen to someone doing something vastly different from them,\u201d Felson says. \u201cThey realize, this isn\u2019t my question that I\u2019m pursuing, but their approach has great relevance to me.<\/p>\n \u201cThe future is multidisciplinary\u2014familiarity with a lot of different research methods and an open mind about how to bring in and work with collaborators,\u201d he says.<\/p>\n CTSI training also focuses on the more practical aspects of succeeding as a researcher: how to write a paper, how to write a grant, how to connect with and communicate with your mentor.<\/p>\n For CTSI, a major part of the NIH award will be targeted at more quickly and efficiently launching and conducting clinical trials. \u201cWe are charged to grease the wheels of a very slow and cumbersome national clinical trials network,\u201d Center says. \u201cWe aim to shorten the Institutional Review Board [IRB] process and to assist in the efficient enrollment and retention of subjects in trials and in all the steps along the way, from identification of the need for the trial to data analysis.\u201d As part of this, CTSI \u00a0supports researchers by providing free consultation services on clinical research study design; facilities, skilled nursing, and help in enrolling subjects for clinical trials; biostatistics and bioinformatics; and hands-on assistance in navigating the obstacles that come with the often cumbersome but necessary regulatory system that oversees clinical trials.<\/p>\n \u201cThe overall goal is to provide resources for sharing research discoveries and tools to train researchers to translate their basic discoveries into treatments and diagnostics,\u201d Center says. \u201cWe are in constant search of ways to expedite processes involved in clinical trials. We don\u2019t want scientists to have to do everything themselves or reinvent the translational research wheels over and over.\u201d<\/p>\n Part of complying with the necessary regulations, which are intended to protect human subjects as well as investigators, means obtaining IRB approval to run clinical trials. \u201cBU\u2019s process is similar to other universities, but the levels of expertise in running clinical trials and navigating the regulatory systems of our clinical researchers vary widely,\u201d Center says. \u201cThe BU CTSI aims to help inexperienced researchers get through that process as efficiently as possible.<\/p>\n \u201cWe give advice to researchers so they don\u2019t make mistakes when they write the protocol,\u201d he says. \u201cWe help them with the consent form. We make sure it\u2019s translated into Spanish if that\u2019s appropriate and they\u2019re enrolling people who don\u2019t speak English. We give them advice on how to respond to the IRB\u2019s concerns. But we don\u2019t manage or influence the IRB. It is an independent body, and it should be.<\/p>\n \u201cWhat we aim to do,\u201d Center says, \u201cis to simplify the complexities of translational research\u2014that is, research involving human beings\u2014make it more efficient, and make the science better.\u201d<\/p>\n