Boston University’s Clinical & Translational Science Institute (BU CTSI) has been awarded a prestigious $23.4 million, four-year National Institutes of Health (NIH) renewal grant 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.
BU CTSI is part of a national network of translational science institutes at some 60 medical research universities that have been established by the NIH’s 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—including Harvard, Tufts, and the University of Massachusetts—share research tools and innovations.
“By providing our researchers with resources, infrastructure, and funding, BU’s Clinical & Translational Science Institute supports innovation and discovery that may improve health, diagnosis, or treatment,” says Karen Antman, provost of BU’s Medical Campus and dean of the School of Medicine (MED). “We are delighted to be awarded this grant from the National Center for Advancing Translational Sciences at the NIH to support BU’s outstanding investigators and increase cross-fertilization between bedside and bench.”
While BU CTSI is based on the Medical Campus, its resources, including pilot grants funded by the award, are available to investigators across the University. “One 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,” says Gloria Waters, BU vice president and associate provost for research. “BU 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.”
Under the leadership of David Center (MED’72), associate provost for translational research and CTSI director, BU has received two NIH clinical translational research awards since 2008. “These were meant to be, and still are, grants that build the infrastructure of the University to help scientists do science better—and do better science,” says Center, who is the Gordon and Ruth Snider Professor of Pulmonary Medicine and chief of pulmonary, allergy, sleep, and critical care medicine at BU and Boston Medical Center (BMC). Center says the awards have been the foundation for a number of BU investigators—especially those in the early stages of their careers—to successfully apply for other types of federal funding.
The renewal awards also enable BU 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.
“Translation can occur on multiple levels, not just from the bench to the bedside, but from the bedside to patients, from patients to the community—and it all flows back and forth,” says David Felson (SPH’84), associate BU CTSI director, professor of medicine and epidemiology, and section chief of the clinical epidemiology research and training unit. “It also occurs from knowing something works that’s been tested in trials and actually getting it into the community where it’s given to people.”
Additionally, the award will help advance regenerative medicine at BU. Under the supervision of Darrell Kotton, a founding director of the University’s Center for Regenerative Medicine (CReM), the award will provide for six pre-doctoral students and four postdocs to receive advanced training in any University laboratory—it could be pediatrics, orthopedic surgery, hematology, or any number of other medical fields, Center says—that is engaged in stem cell research and regenerative medicine.
“This 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,” says Kotton, a MED professor of medicine and pathology and an attending physician in pulmonary and critical care medicine at BMC.
Most importantly, the award “will help support open-source sharing of Boston University’s 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,” says Kotton, whose lab studies cystic fibrosis, emphysema, and other pulmonary diseases.
“We 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,” he adds. “In this way, the award stands to benefit many universities across the country that participate in our shared mission of improving human health.”
A key part of the BU CTSI mission is fostering collaboration across many disciplines, and across both campuses, says Center, “whether 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.”
“We’re free to give our money as an investment to anyone across the University,” Center says. “BU CTSI’s idea is for creating unencumbered money that would be multidisciplinary and cross schools and departments. It doesn’t mean money is given without review or without strings attached. But with us, if you’ve got a good translation idea—fine. We support junior and senior investigators.”
Collaboration is one of the cornerstones of the BU 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 “conversant and capable in thinking about a broad range of methodologies and to be able to communicate and interact in an interdisciplinary fashion,” says Felson.
One way BU CTSI training encourages this sort of creativity is by holding seminars at which physician-scientists and other investigators from a broad range of disciplines—cardiologists, pulmonary physicians, epidemiologists, biomedical engineers, and others—share their research findings. “They’ll be sitting in their own research world—in their own little silo—and they listen to someone doing something vastly different from them,” Felson says. “They realize: ‘This isn’t my question that I’m pursuing, but their approach has great relevance to me.’ ”
“The future is multidisciplinary—scientists will need familiarity with a lot of different research methods and an open mind about how to bring in and work with collaborators,” he says.
BU 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 and communicate with your mentor.
For BU CTSI, a major part of the NIH award will be targeted at more quickly and efficiently launching and conducting clinical trials. “We are charged to grease the wheels of a very slow and cumbersome national clinical trials network,” Center says. “We 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.” As part of this, CTSI supports 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.
“The overall goal is to provide resources for sharing research discoveries and tools to train researchers to translate their basic discoveries into treatments and diagnostics,” Center says. “We are in constant search of ways to expedite processes involved in clinical trials. We don’t want scientists to have to do everything themselves nor reinvent the translational research wheels over and over.”
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. “BU’s 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,” Center says. “The BU CTSI aims to help inexperienced researchers get through that process as efficiently as possible.”
“We give advice to researchers so they don’t make mistakes when they write the protocol,” he says. “We help them with the consent form. We make sure it’s translated into Spanish if that’s appropriate and they’re enrolling people who don’t speak English. We give them advice on how to respond to the IRB’s concerns. But we don’t manage nor influence the IRB. It is an independent body and it should be.”
“What we aim to do,” Center adds, “is to simplify the complexities of translational research—that is, research involving human beings—make it more efficient, and make the science better.”