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Transcript of BioCentury This Week TV Episode 139
Dr. Ruxandra DRAGHIA, Director, Health Research, European Commission
PRODUCTS, COMPANIES, INSTITUTIONS AND PEOPLE MENTIONED
Innovative Medicines Institute (IMI)
Steve Usdin, Senior Editor
STEVE USDIN: Health research as industrial policy -- Europe's increasing investments in health research are aimed at advancing medicine and boosting industry. The woman in charge describes Europe's approach to health research. I'm Steve Usdin. Welcome to BioCentury This Week.
NARRATOR: Your trusted source for biotechnology information and analysis, BioCentury This Week.
STEVE USDIN: As Europe continues to slog through bleak economic times, the front pages are dominated by arguments over austerity. So it may be news to some that the European Commission is set to boost its budget for research and innovation by nearly 60% over the next seven years. After budgeting about 51 billion euros for 2007 to 2013, the EC now is proposing to spend 80 billion from 2014 to 2020. The Horizon 2020 plan would boost biomedical research spending nearly 40% to 8.5 billion euros or about $11 billion. While that doesn't come close to matching NIH, the European investment isn't limited to basic science. The goal is to build an innovation ecosystem involving academics, industry, and government players. The EC calls its innovative medicines initiative the world's largest public, private partnership, one that now aims to affect the entire innovation cycle from the bench to the patient bedside.
Today, we talk to the head of health research in Europe, Dr. Ruxandra Draghia. We'll find out how Europe is setting its medical research priorities, where Europe thinks it can build competitive advantages in science and innovation and why small innovator biotechs are part of the plan. I'm pleased to be joined by Ruxandra Draghia.
STEVE USDIN: Dr. Draghia, I wanted to start out by asking you -- the investment in Europe for public research is far less than it is in the United States, both on absolute basis and on a percentage basis.
One, do you have any idea why that is? And two, is the gap growing or shrinking?
RUXANDRA DRAGHIA: In the last framework program for research and innovation, health research was allocated a total of 6.1 billion euros. But one needs to remember that the funding at the level of the European Commission represents only 5% to 10% of the total investment in medical research in Europe, most of the funding being located at the level of the member states. But it is true that both in absolute and relative terms, in Europe there is less investment in this area compared to the United States.
And thus is the value of collaborative research, which is what we do promote in Europe. The main difference with the National Institutes of Health is in the area of collaborative research. We do find consortia of academics, small, medium enterprises, industry, patient organization, regulators. So a complex set of stakeholders are working together in order to tackle the problems that can be very fundamental or very applied.
STEVE USDIN: And that brings up something else I think is very interesting and a difference between Europe and the United States. Your website materials that describe what you're doing very explicitly talk about an economic development component to what you're doing. How does that work? And what are you doing to try to merge public health research to make it into an economic development engine?
RUXANDRA DRAGHIA: I think that the question is twofold. One relates to the economic benefits -- the creation of jobs, the creation of the ecosystem of innovation that is linked to the public funding. And in an interim evaluation of what happened under the framework program six and seven, we have determined that approximately 100,000 new jobs have been created, in particular, the highly skilled jobs -- academic investigators, investigators involved in research, and small enterprises and so forth.
If you're looking at what is the value of that innovation and how it's going to be implemented at the level of public health, I think that involving those stakeholders from the very beginning in the research fosters this translation to the patient and to the implementation. Things are not always very easy, because, of course, while research is done either at the national level or at the European level, the implementation part is always done at the member state level.
And there you have to go through the national processes. Nevertheless, being able to develop this ecosystem and the transmission of information occurs much more readily between and among the member states. I think that this implementation is fostered by the European program.
STEVE USDIN: So one of the other things you're dealing with in Europe right now, obviously, is very, very tough economic times. You've got very difficult times for example in Greece, where their children who are going to school are going hungry because their parents don't have enough food and things like that. How are you going to be able to justify continued investment research in Europe? Is there going to continue to be enthusiasm for it?
RUXANDRA DRAGHIA: I think that enthusiasm for research and innovation is still there in Europe. It's not that we are not realistic about the financial crisis and about the problems that all of us are facing in Europe. But I think that one, while taking care of the problems of the moment and obviously investing massively in trying to resolve some of these problems immediately, we have to also look at the future and the health of the European population.
The European population is aging. And with that, there will be an increase in chronic diseases. There will be an increasing in the demand for health care. And the estimates, in fact, are pointing down to the fact that only about 25 years from now, 25%, 30% of the European population will be over 65. So we really need to start investing now, taking into account the drug development, the intervention development, the times, which is this area of medical research are excessively long -- 10, 15 years -- in order to be able to respond to the changes in the future.
STEVE USDIN: Thanks very much. We'll be right back with Dr. Ruxandra Draghia.
NARRATOR: You're watching BioCentury This Week.
STEVE USDIN: We're back with Dr. Ruxandra Draghia. Dr. Draghia, we talked about the smaller scale of public research in Europe and the United States. But one area which has actually been quite impressive in scale is something called the Innovative Medicines Initiative. Where the European governments have put in a billion euros and industry has put in another billion euros.
Can you talk about first, what is the IMI, Innovative Medicines Initiative? And what have you gotten from it so far?
RUXANDRA DRAGHIA: IMI is the Innovative Medicines Initiative, is the biggest public-private partnership in life sciences. And as you correctly pointed out, the European Union put in a billion euros in cash contribution. That goes to academic investigators, to small, medium enterprises, to regulators, or to patient organization participating in the consortia. While the European Federation of Pharmaceutical Industries and Associations, so the pharma industry, is matching that contribution with another billion euros in in-kind contribution.
And I would like to make two points: first that the pharmaceutical industry in this partnership does not receive any of the union funding. That goes to the publicly funded entities. Secondly, that their contribution being in-kind prompts the academic investigators, SME investigators, to work with the investigators for --
STEVE USDIN: SME is small, medium enterprises in European speak.
RUXANDRA DRAGHIA: Exactly, small, medium enterprises -- to work with the industrial investigators to tackle problems that initially were considered as bottlenecks in drug development.
STEVE USDIN: So that's an interesting point. It makes it different from anything, I think, that's happening in the United States. Because industry is in the driver's seat. It's picking the problems that are being solved by the IMI.
How has that worked out? And are there any results yet that have made a difference?
RUXANDRA DRAGHIA: So the original strategic research agenda had evolved. And while most of the work of IMI at the beginning was to the pre-clinical and to the early stages of drug development, throughout the life of IMI, it moved towards the entire innovation cycle. And if you're asking for example of very successful projects, yes, they are.
And they range from creating new models that can be used in drug development -- for instance, it's the first human beta cell line that could be used for development of new drugs for diabetes -- to reducing unnecessary animal models. For instance, for pain where a specific project had succeeded to take all the animal models that the investigators from academia, from industry were using -- about 25 of them -- and be able to validate four. But now, those four models are going to be used throughout the entire community, bringing really the results and the possibility of being immediately validated.
On the other hand, many of the projects are dealing with data polling, knowledge management, and how patients can be stratified, and therapies better targeted. A good example would be a project called NEWMEDS, which is looking at data for more than 23,000 patients that suffer from schizophrenia. Those patients had been enrolled in 67 different trials, getting about 13 different medications. And now, they are looked at on criteria of success and failure for their therapy in order to much better target the therapies.
That particular project, on the top of it, if you wish, a side effect, that looking at all these data, one determined that, for instance, patients have to be enrolled in the clinical trials for a lesser period of time for the same type of data that is coming out. And not only that, but they can be less number of patients. So that project is working with the regulators at looking if that could be translated in the future in new guidelines. And I think that that has a dramatic impact, not only on the cost of the clinical trials but also on the speed on which these interventions can arrive to the patients.
STEVE USDIN: Very quickly, what are the prospects for an IMI-2, for another investment? And will it be in the same kind of scale as the first one?
RUXANDRA DRAGHIA: So we do hope that we will have an IMI-2. And we do hope that our industrial partners would be committed for even much more than what IMI-1 had, in fact, delivered up to now. It is very encouraging. And our proposal for IMI-2, that industrial partnership would be enlarged. So there would be an opportunity for other industrial sectors, for instance, medical devices, or animal health, or the emerging epidemics, or medical imaging to participate on the industrial side.
STEVE USDIN: One of the issues that's really kind of difficult, very difficult anywhere -- in the United States, I know the NIH is grappling with it -- is how do you measure the success of investments in research? How do you go about doing that in Europe? What are the things that you think about?
RUXANDRA DRAGHIA: Key performance indicators for research and innovation programs are by definition very difficult to set and look forward. And they range all the way from the number of publications and patents, small, medium enterprises that have been created, to how many products actually have been brought to the market, based on investment that had at least started in the framework programs.
But I think that as you were pointing in one of your initial questions, we do have an impetus in creating jobs and developing this ecosystem where academia can talk to the industrial partners, where ideas can find their way easier throughout the innovation cycle. And I know that that is very hard to be captured in a single indicator. But we do consider this creation of a new innovation ecosystem as one of the most successful indicators with successful programs.
STEVE USDIN: So it's interesting that you bring up this idea of an innovation ecosystem. What do you think are the components, worldwide, of this ecosystem that are kind of endangered or that need help?
RUXANDRA DRAGHIA: One would be the spread. I think that while in the medical research the problems are global, solutions may sometimes be local. And the implementation part of the ecosystem will have to take into account the local factors. I think that if we were just trying to transplant from a location to another, that ecosystem is not going to work.
Secondly, I think that we do have a lot of collaboration. We have a lot of exchanges. Sometimes though, the various specialities are tending to sink in a silo. So I think that one of the biggest challenges is the challenge of multi-disciplinarity, which is needed.
STEVE USDIN: We'll be right back with Dr. Ruxandra Draghia.
NARRATOR: Now, back to BioCentury This Week.
STEVE USDIN: We're back with Dr. Ruxandra Draghia. Dr. Draghia. When you ended there, you were saying that you imagined, are hoping that the industry portion of IMI-2 will be bigger than the $1 billion of in kind contributions for the first one. Does that also imply that the European Union contribution will also be bigger?
RUXANDRA DRAGHIA: So, in fact, the Union contribution is matching the contribution from the various industrial partners. Obviously, our missions are big. They are related to what the IMI-1 had already delivered, but they will be a function of the total budget that would be allocated for Horizon 2020, which is our next research and innovation program.
STEVE USDIN: So, let's go there. What is Horizon 2020? What do you hope to achieve there?
RUXANDRA DRAGHIA: So, the proposal from the European Commission for Horizon 2020, which was set in November of the previous year, not 2012, but 2011, was for an investment of €80 billion euros in the future program for research and innovation. And I'm talking about all fields of activity, not necessarily for health.
Out of that, Horizon 2020 is three pillars. One dedicated to excellence in science, a second one dedicated to industrial leadership, and the third pillar dedicated to tackling societal challenges. The Health Demographic Change and Wellbeing challenge is part of these societal challenges. And the proposal was for approximately 8.5 billion euros to be dedicated --
STEVE USDIN: Over what period of time?
RUXANDRA DRAGHIA: Over the period of 2014 to 2020 to be dedicated for medical research. And obviously some of our partnerships that, in fact, are being able to leverage further investment into this area will be also part of our proposal for this particular societal challenge.
STEVE USDIN: So, one of the things that characterizes research in Europe, and you mentioned at the beginning of our conversation, is that it's fragmented. You have a certain amount of if that's at a Europe-wide level, then you've got a great deal of it that's going on in the individual member countries.
One of the proposals that I've heard discussed is the idea of creating a European Institute of Health, essentially a counterpart for NIH. Is that realistic? Is that something that you're talking about?
RUXANDRA DRAGHIA: I think that very many discussions have taken place related to better coordination medical research in Europe. This is one of them. It's not the only one. And I think that all our ideas, in particular in this part of societal challenges are for better coordination.
But we have proven the value of working in partnership across the different member states and across the different type of stakeholders. And I think that it is a moment to capitalize, in particular now that science has evolved enormously in particular in the biomedical area with the boom in the findings of omics with a strive to go towards stratified and personalized medicine.
And as a consequence, one cannot work anymore in a silo. This idea of exchanges of partnership is, in fact, what we would like to promote for the future. A very simple example, one of the proposals for Horizon 2020 for our challenge is to come up with a novel classification of diseases.
So, taking it from the current situation today, which is more or less a phenotypic definition of diseases to a molecular definition of diseases. That is a type of endeavor where the various stakeholders across nations have to work together.
STEVE USDIN: Because obviously you can't have 27 different definitions of diseases.
RUXANDRA DRAGHIA: Absolutely.
STEVE USDIN: Thanks. We're going to be back in just a moment with some final thoughts with Dr. Ruxandria Draghia.
We're back with Dr. Ruxandra Draghia. Dr. Draghia, There's a sense, I think that kind of the center of biotech and biomedical research has moved to some extent, to the United States. Obviously you're trying to get at least some of it to move back to Europe. What are the competitive advantages that Europe has over the United States in that kind of competitive environment?
RUXANDRA DRAGHIA: We have discussed about the public-private partnerships, and IMI. And I think that is one. Also, there is a lot of research in very specific areas, which are a global problem, but where Europe takes the lead. And I would give the example of antimicrobial resistance, where very comprehensive programs have been put forward, both in in cooperative research and in our partnerships with the pharmaceutical industry in the area of rare diseases.
In Europe, we have about 30 million patients affected by one or another of the rare diseases, and a lot of investment will go into that area, also because that is one of the ways of capitalizing on this personalized medicine. But most importantly, we are diverse enough to make interesting, the trans-national clinical trials.
And one of the focus in our future programs are the clinical trials for various applications, from comparative effectiveness to very novel, advanced therapies, and everything in between. And I think that the possibility, in fact, to conduct these multinational clinical trials, it's quite an important advantage.
STEVE USDIN: And that's very interesting, because I think if you look anywhere, if you look in Europe, if you look in the United States for an area where government intervention can actually spur innovation, it's in trying to facilitate clinical trials, and to set up new infrastructures for clinical trials. What's the direction that you're going in in Europe? You mentioned the idea of being able to have trials more easily to go across European countries?
RUXANDRA DRAGHIA: Yes. So it's a multifaceted approach. It is based both on improved regulation, and new clinical trial regulation has been proposed, and is now in discussion with the European counsel and the European Parliament. It is the network of clinical trials in an area or another that we're trying to develop, which we do actively fund.
And there are our collaborative research programs, which have moved from maybe 10 years ago, funding some 5% to 7% of the total budget for clinical trials, to now about 30% of the entire investments in medical research going to clinical trials. And I think that that shift, it's parallel with our impetus to foster innovation, but also to bring these products closer to the patients in the most rapid and efficacious manner.
STEVE USDIN: So you're talking about, and you're talking about the European investment, then, it's interesting, it's in research. You're also talking about an economic development component, and a very explicit translational component.
RUXANDRA DRAGHIA: Absolutely.
STEVE USDIN: Well, thanks very much. Thank you, Dr. Ruxandra Draghia, and thank you for watching. I'll see you next week.