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Integration

Collective project

Researchers, physicians, businesspeople and users come together to speed up medical research applications

Justin Ide / Harvard UniversityAkiko Yabuuchi works with stem cells at the Harvard Medical SchoolJustin Ide / Harvard University

In 2009, the National Center for Research Resources (NCRR), part of the National Institutes of Health (NIH), based in Bethesda, Maryland, announced that eight groups of universities in the United States are to be given US$171 million over the next five years to further their clinical and translational science research project infrastructure. This would be a commonplace occurrence, were it not for the intentions and difficulties involved: these institutions will be required to transform scientific findings into new drugs, diagnoses or services that can be widely used. The difficulty consists of mobilizing researchers, academics, physicians and other healthcare professionals, enterprises and communities of users, who will have to work together to achieve their shared objectives.

These medical research centers, based in the states of New York, Illinois, Arkansas, Texas, South Carolina and Florida, are the newest members of the Clinical and Translational Science Awards (CTSA) program, which currently encompasses 11 thousand people – experts from academia, hospitals, professional associations, businesses and local community organizations – from 46 medical research centers in 26 of the 50 American states. CTSA is one of the NIH’s newest efforts to promote so-called translational research, defined as the integrated work of all the interested parties – from the inventors to the end users – in the conveyance or transfer of scientific discoveries through first human use to clinical practice.

One of the results of this program, which started in 2006, is a system for the pressurized release of medication directly from the nose to the brain, which avoids the side effects of the high concentration of orally administered drugs. The graduate students who created the device at the DNA Sequencing and Gene Analysis Center at the University of Washington got US$50 thousand from the university’s innovation fund, licensed the technology and opened a company to develop the nasal applicator for drugs. Other results achieved are more subtle, such as slashing the lead-time required to obtain approval for new clinical drug trials from six months to 30 or 45 days, “provided that everybody works together from the start,” comments Heng Xie, NCRR’s medical supervisor. “The toughest challenge is encouraging scientists to collaborate rather than to compete amongst themselves,” says Anthony Hayward, director of the NCRR division of clinical research resources. However, how can one make the scientists collaborate with each other? “By providing them with substantial funding, like US$ 4 million, sometimes US$10 million a year, showing them that scientists can go further if they work together, and by supporting their objectives.”

Defined as the joint construction of solutions to problems that affect different groups of people, translational medical research depends on collective development, and not merely on the transfer of technologies that make it easier to treat or to prevent commonplace or rare diseases. The more diverse the group of participants, the better, because problems can be foreseen and solved jointly, before they become more serious. The participation of community leaders and healthcare professionals from local hospitals, to which academic groups are linked, has been enhanced as a means of identifying the medical care people need and fostering faster research progress. “Rather than saying ‘We want something from you,’ we went to the community asking, “What can we do for you?” “, acknowledges Steven Reis, a professor of medicine at the University of Pittsburg, in a recent issue of the magazine NCRR Reporter. In order to get a survey about heart diseases to move forward, he contacted the director of the Urban League of Greater Pittsburg, an NGO that serves the region’s inhabitants. They decided to start with simple blood and blood pressure tests, which is what the inhabitants most required. This contact helped Reis to attract the participants needed for his study.

The CTSA coordinators encourage the visibility of the researchers and of the work in which they take part. “Can you see Dr. Hayward’s computer video camera?” Xie asks, looking behind him, during the interview that led to this article. “He uses it a lot to connect with people,” he says. “If people really want to work together, distance is not a major problem.” Another tool to overcome institutional barriers, which is one of the CTSA objectives, is Building Connections, one of the parts of the CTSA website (www.ctsaweb.org) that fosters interaction among research groups, business schools, enterprises, communities and the general public.

Yet another CTSA feature is that the research project coordinators can get financing from pharmaceutical companies at the same time. “There has been a huge division between enterprises and academic medical centers, but they have to work more closely with each other, because of the regulating agencies’ requirements, which are increasingly complicated,” observes Hayward, the director of NCRR’s clinical research resources division. Another reason for such partnering is the cost of developing new drugs or medical products, which are increasing. According to Hayward, “the academic centers are unable to foot the bill.” There are constant meetings with businesspeople and community representatives. The most recent one, held in February, was the CTSA Industry Forum, designed to facilitate the collaboration of government, companies, universities and NGOs in order to speed up the discovery and development of medication, medical devices and medical diagnoses and to exploit new partnership opportunities. “We have interfaces, obviously avoiding conflicts of interest among academia, government and industry,” says Hayward. “Companies want successful products, but we cannot disregard the need for medication to be safe, nor do we want the government to favor one company over another. We maintain academic independence. The agreements set high ethical standards.”

Dan Davenport/ University of CincinnatiFrank McCormack, from the University of Cincinnati, takes part in a collaborative project to facilitate the treatment of rare lung diseasesDan Davenport/ University of Cincinnati

The desire to transform great laboratory findings into commercial products also mobilizes researchers in Brazil and inspires events such the “A. C. Camargo Global Meeting of Translational Science” course, to be held from April 19 to 30, in São Paulo, under the coordination of Ricardo Brentani and Emmanuel Dias. Esper Cavalheiro, a professor of neurology at the Federal University of São Paulo (Unifesp), recalls: “The divide between what is basic and what is clinical was already bothering me a lot when we instituted postgraduate studies in neurology at Unifesp, reserved for those physicians that hold the title of neurologist specialists.” Transforming anguish into action, in the late 1980’s he managed to get permission from Capes (the Coordinating Office for the Training of Personnel with Higher Education) for the course to also accept people who were not physicians, who would have a doctor of neuroscience degree, as opposed to the physicians, who would have a doctor of neurology degree. “Many followed our lead, so that today adding professionals from other areas is no longer an impediment in Brazilian post-graduate studies.”

According to him, his research group, even though it did not employ the term “”translational,” always tried to see how the knowledge derived from its experiments with animals might help to improve the treatment of epilepsy among humans. “This is a typical case of a two-way path. Besides discussing everything jointly, the clinicians who examine patients more closely come up with new questions,” he says. “And we went even further when we created, back in the 1980’s, the Brazilian Epilepsy Association, for epileptics, their relatives and professionals interested in the subject, when in monthly meetings, we transferred to society the advances in the field that might be of direct interest.” Just a few years ago, when the group came up with the idea of a National Institute of Translational Neuroscience, which he has been coordinating since its inception, “the entire group of researchers involved was already taking into account, in one way or another, this translational aspect.”

“Science and technology always go hand-in-hand, yet they aren’t really integrated with each other,” he reminds us. “Just as in certain fields of knowledge, the basic biological sciences, for a range of historical reasons, were never particularly concerned about the practical use of the results of their work.” Terms such as “interdisciplinary” or “multidisciplinary” tried to bring together the two universes during the 1980’s and 1990’s. “However, for quite some time, just goodwill or new words have ceased to do the job. The very research stimulus policy didn’t help much. The pure pursuit of applications for scientific results didn’t yield much in the way of academic prestige. It was necessary do something more outstanding, to pursue knowledge and truth; this was the true role of the academic.”

In his opinion, the National Innovation Initiatives, of which his institute is part, promote the integration of experts from different fields so that, jointly, they may produce and apply new knowledge, giving rise not only to academic benefits, but to social and economic ones as well. “We had to move beyond the association of basic and clinical healthcare areas, because new medical equipment calls for software scientists and engineers; for new medication, we need chemists and physicists; for populational health studies, mathematicians and statisticians; and for the social impact of the so-called new diseases, human and social scientists,” comments Cavalheiro.

He tells us that he took part in some planning meetings for one of the NIH translational research programs. “Over there, with more money, the project was very clear and targeted all the academic healthcare groups, with or without any interaction with companies. They even created a NIH branch just to look after the program. There’s highly suitable management, so that one can monitor achievements very clearly.” Over here, according to him, what predominates is interdisciplinary or multidisciplinary research, in which each researcher has his or her own ideas and knocks on the door of another researcher to ask for help. “It’s no use calling upon another person to help you with your problem,” warns Cavalheiro, who proposes a convergent view, with all participants embracing the same question (see “The reconstruction of man,” Pesquisa Fapesp, issue 136). “The problem must belong to everyone.”

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