“From bench to bed-side”. The motto sums up the goal of translational research: to apply knowledge derived from basic research to the prevention and treatment of problems detected in clinical medicine. Clearly, closing the gap between laboratory results and patient care will contribute to improving people’s health. It will also increase the sustainability of the system, as resources invested in research will be recovered in the form of economic and medical benefits. The August Pi i Sunyer Biomedical Research Institute (IDIBAPS) is a leading centre that participates in numerous national and international research projects. Its director, Ramon Gomis, is Professor of Medicine at the University of Barcelona. He is a specialist in endocrinology and nutrition, and has worked for almost thirty years at the Hospital Clínic de Barcelona. He has been a member of the Government of Catalonia’s Committee for the Catalan Agreement on Research and Innovation (PNRI), the Confederation of Scientific Associations of Spain (COSCE) for the Law of Science, and the innovation think tank organized by the Spanish Ministry of Science and Innovation.
What is translational research?
Translational research appears when we realize that clinical and basic research cannot function independently, because clinical research needs the collaboration of basic research, and basic research requires a more immediate object of application in health. In translational research, we consider that questions arising at a patient’s bedside may have answers in the laboratory. Likewise, laboratory findings may be quickly transferred to clinical practice. The concept of translational research emerges from this symbiosis.
In other words, it’s a two-way journey?
It’s a two-way journey, but the idea is not to answer specific questions about a patient’s health. This is the main difference between clinical and basic research, which focuses on studying a scientific problem. In no case is the aim to resolve a specific problem that affects someone at that time.
We could say that basic research and clinical practice advance at different paces, as knowledge of biological processes has not led to the corresponding increase in new drugs and treatments. What is the reason for this time lag?
«If penicillin had been tested with the degree of rigour that we apply to some drugs today, it would probably not exist»
To date, clinical research has been based on epidemiology and physiopathology. It should be able to go further with molecular and genetic markers, among other factors. But it needs to ask questions in the laboratory with cells and animals; this is where translational research plays a role. The problem with medicines is different: today any drug, whether it was discovered by academia or the pharmaceutical industry, is subject to complex regulation. We know that drugs have adverse effects, so we have to be very careful. The effects and efficacy of drugs designed to alleviate chronic diseases must be investigated thoroughly. If penicillin had been tested with the degree of rigour that we apply to some drugs today, it would probably not exist. What’s more, taking an idea to the health market is very risky. It’s a long process, which requires a lot of time and money, and this is what leads to the delay in knowledge transfer.
Exceptions are made for drugs that could be critical to life. For example, with Ebola, drugs are being used experimentally, even serum from Ebola survivors, without a great deal of evidence, because peoples’ lives are in the balance. However, what we do normally is make acute diseases chronic: we have made AIDS and diabetes chronic diseases and we are doing the same with cancer. To achieve this, we need very complex strategies. However, I would say that translational research goes beyond bringing a drug to the market. It is about applying the most basic knowledge to medicine. Before biomedicine was a matter for doctors alone. Now things are different: professionals from diverse fields are researching the area.
You have mentioned two obstacles to knowledge transfer. One is related to funding, as drug development requires large investments, and the other is related to the rigour of the regulations that apply. Is the solution to make the approval and marketing process more flexible?
No. The regulations are in place and we should be clear that they protect people’s health. Let’s not forget thalidomide. If we produce a drug without all the guarantees, we are putting people’s lives at risk. So we have to be very careful. How can we improve? Perhaps pharmacogenetics will help us to find out why a drug is effective in one population group and not another. We also have the option of pre-clinical studies, which give us an increasing number of guarantees of what will then happen in clinical practice. For example, the fact that we are now in a position to obtain humanized cells from pig cells or from cells from other animals means that we can carry out studies on human cells and anticipate in some way what the response will be. The solution will not come from reducing the regulations, but from our capacity to do much more powerful translational research. And this is within our reach.
Is this the aim at the centre you direct, the August Pi i Sunyer Biomedical Research Institute?
IDIBAPS was founded to bring together clinical researchers from the hospital and basic researchers from the university and from the Spanish National Research Council under the umbrella of the Government of Catalonia. These are people with motivation and a capacity for research. They are also motivated and skilled in teaching or healthcare, but their background is more focused on research. They come together to find answers; and to a certain extent, what we do is create a suitable environment so that they can strengthen this research.
Ultimately, the main aim of translational research is to benefit people. Does the patients’ proximity due to the location of IDIBAPS in a hospital environment help to achieve this?
It’s fundamental. In general, translational research groups are situated close to hospitals. In fact, part of the research revolves around patients and samples taken from them, such as tissues. There wouldn’t be much sense in locating an institution like this far from a hospital environment. So IDIBAPS was designed to be housed on the Casanova Campus, next to Hospital Clínic.
Is collaboration with industry essential to achieve the goal of transferring scientific knowledge to the production sector? Is private investment needed to develop new drugs, therapies or devices?
Companies are important because they form part of the existing system: to efficiently transfer all kinds of products to society, we need industry’s participation. To date, we have not invented anything better than this market that has existed since the earliest times, since the agricultural revolution. Clearly, companies have always had close relationships with universities. Biomedical companies are probably obtaining a lot of answers from academia. I think it’s essential for companies, particularly leading ones, to understand that knowledge emerging from an institution like IDIBAPS is useful, because it provides know how. This doesn’t necessarily have to be in the form of patents and licences: it may involve advice, training, discussion, perhaps an advisory board. Institutes and hospitals are also capable of promoting what we know as clinical guidelines. That is, pathways.
It is important that companies know the clinical decisions in order to adapt to them. If industry designs a tool, but the clinical decision does not support it because it makes the patient uncomfortable or hurts or for whatever reason, it will have to be changed. Companies should be close to us, not only in expectation of a patent or a licence or to take over a spin off, but also for the information that we generate.
What are your predictions for the future of public health?
Investment in health is a business because, in western societies, resources are allocated to looking after health. Of course this may also change. People in the future may invest more in prevention than in disease; maybe they will take responsibility for their health. At some point, this responsibility was given to the state, but there will probably be a cultural change in this area. We also need to have a major debate about the ageing process: what is ageing and what is illness? With good prevention, there are more opportunities to reach old age with fewer diseases; but there is a final period of our lives that is critical and that we will pass through. Some ailments are associated with ageing, but other problems can be avoided with prevention. In a 75 year old man, the risk of a heart attack will vary very little if he takes five pills a day or ten. But slipping in the shower or tripping on the curb will probably be the cause of higher mortality. Therefore the risk of falling is more serious than cardiovascular risk.
«With elderly people, the age-related problems are considered illnesses»
We need to think carefully about what we do with elderly people. We know what to do with infants, we know they lack some skills, they are incontinent; they have a lot of problems. But we accept that these are age-related. But with elderly people, the age-related problems are considered illnesses. We shoulder the burden of children because this is an investment in the future, but we find it harder to accept the burden of the elderly, because we only associate it with the present. We need a major debate on ageing. And it must cover health and social issues, because there are social solutions that could definitely improve people’s health.
You predict that we’ll have to take more responsibility for our health in the future, and this will probably make us focus on prevention. Is this true for the system as well? In other words, is prevention more economical in the long-run?
The last five years of our lives will always be expensive. We need to know the level of solidarity that our society is willing to accept, because some people will be more expensive than others. To put it bluntly, a man who dies then and there from a stroke will be cheap while a man in the terminal stage of cancer will be very expensive. We already know this. But one of the factors that distinguish man from other animals is the network established between members of the species. This solidarity needs to survive in the future. Just like education. Now, I would say that prevention is important for individual well-being: reducing the risk of a heart attack through nutritional measures and exercise is beneficial to the individual.
We should not only consider health in economic terms. The costs are what they are. The idea is that prevention is quite easy to achieve and will reduce the rate of disease. Clearly, reducing the rate of disease could cut social costs; but even if they do not, I don’t think that this would be the main problem. Social costs are a decision related to the kind of society we want: whether we want a society that seeks to achieve people’s well-being, or whether we want another that collects tools and objects. I don’t know if a lot of prevention saves a lot of money. But I would not want to promote prevention as a saving, but as a sure benefit at individual and group level.