Challenges to the development of personalised medicine

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Published: 22 Oct 2012
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Prof Alexander Eggermont – President of the European Academy of Cancer Sciences; Prof Franҫoise Meunier – Director General, EORTC

Prof Alexander Eggermont and Prof Francoise Meunier discuss the challenges associated with the development of personalised medicine, including difficulties raising sufficient funds for European cancer trials, the way this can be addressed by collaborations with academia and the steps that must be taken to overcome the differences in the agendas of academia and industry.

RS: Professor Franҫoise Meunier from the EORTC, the Director General, and Professor Lex Eggermont, Director of the Institut Gustave Roussy, a very warm welcome. Oncopolicy Forum 2012 of ECCO, there’s a huge amount of activity going on in the room next to us but we’re here today to talk about what you think are the key issues around cancer policy in research and in clinical practice for personalised medicine. So let me start with the big one which is, from your perspective, translating research into clinical practice. Where are the big stumbling blocks in terms of policy at the moment? Is it about funding, is it about regulation, is it about reimbursement and pricing? What’s your perspective, Lex?
AE: I think it’s about all the three above but I think there’s a particular challenge in translating the evolutionary stages that we are in in exploring personalised cancer medicine and bring it to the reality of clinical practice under the guidance of a number of academic trials that probably will need to be put in place for which traditionally we already lack funding. But in this particular case I think we, in particular, lack funding because it’s not the straightforward new drug type of development system but it’s a development system that requires a lot of diagnostic interventions before you get anywhere. These diagnostic interventions are very much academic or are outsourced in very expensive models, neither of which are truly supported at this point in time by sufficient funding. I think if we want to make the bridge from a concept to identify the niches where it will be firstly applied in clinical practice, that bridge needs to be defined and that’s, to a large extent, an academic clinical trial bridge that needs to be looked at and needs to be integrated. So this is a major policy issue.
RS: Right, so Franҫoise on this, you’ve had a lot of experience of raising funds for academic trials and, of course, we’ve seen this being squeezed and squeezed and squeezed through a combination of just less funding because of the economic situation countries find themselves in, the impact of regulations etc. So from a funding policies perspective over the next few years in delivering personalised medicine, as Lex said, we’re going to need more and more academic trials to bridge across. What would you like to see happen at European and national level? What do you think are the key policy changes?
FM: Yes indeed, we need additional funding for independent evaluation but what I really think is the main challenge is that it’s not only the academic world who will succeed and it’s all together. We have to identify a new model of collaboration: academics do not own molecules, pharma is in a difficult situation as well when you look at the attrition rate and so on. So I really believe we need independent evaluation, a more integrated comprehensive approach but interfering with key players which are part of the play for the moment and for the last fifty years – insurance, healthcare providers, the payers, all of those need really to put their acts together and identify new models to assess where to allocate the budget when you see the cost of all of those tremendous breakthroughs.
RS: So the issue here, of course, is we have, as you say, multiple players here. We’re talking about money and we’re talking about a lot of money in some cases in terms of the costs of research, and then, of course, the returns on investment for particular medicines or new technologies. Do you think, though, that policies are taking into account the fact that some of this could be a bit of a zero sum game in order for industry to win on certain areas academia must lose or vice versa. Do you think we can have a situation where it’s a win-win?
AE: Well, I think we were accepting at this point in time a model where there would be a biomarker, there would be a companion test together with a targeted drug and that the coupling of these two things would lead to a targeted registration. The point of this model is already completely bypassed, it’s a thing of the past. We thought eight years ago we had found a solution to accommodate what’s happening; what’s happening goes beyond.  All these companion tests will go out of the window because we will need a much more comprehensive analysis of the tumour to identify not this one little thing but to identify a whole number of things that can be addressed, either successively or concomitantly by one or combinations of agents or therapeutic strategies. So that means that you cannot really do this without the academic arena and by investing into the heaviness of the structures that you need to go with this approach. Therefore personalised cancer medicine poses really different questions now and requires a different infrastructure compared to what we were used to.
RS: So you’ve both also got long histories of working in collaboration with the pharmaceutical industry and of course we use the word industry to cover, actually, a multitude of different companies, set-ups and differing visions, actually, of where the future is going to be. Do you think there is either a neutral or a collaborative space between academia and industry where personalised cancer medicine can genuinely be delivered or do you think we’re still in a situation where the policies that drive industry and the issues you’ve just articulated around academic development are still sitting in two different camps?
FM: Of course the agendas are different, the agenda of the pharma industry and academia is different but the end result is we, European citizens and researchers, what do we want for society? One attempt is IMI, the Innovative Medicine Initiative, where we tried to mix the agenda of pharmaceutical industry and academic research and to do precompetitive collaboration between industry and academia. It’s an experiment, we will see, but I am highly positive about this experiment.
AE: It will be a big give and take, actually, mainly on the part of pharma to break away from the old paradigms because you cannot patent a molecular portrait of a patient, meaning that we are beyond all the past models. We are not only going to work with incidental biomarkers but we will look at a full portrait. That full portrait will be too individualised, actually, to be able to cope with all the old systems. So there will be a lot of re-positioning for pharma to be done to make these collaborative events and identify within the collaborative events what is the economic model behind it. If we don’t do that we will be unable to move forward.
RS: Just taking that forward, you’re both clinicians at the coal face, you know what it’s like, the clinical reality of practising cancer medicine day in, day out. Siren voices outside our grouping here saying, ‘Hang on a minute, cancer is still social. You’re talking about a paradigm and a model within personalised cancer medicine which is focused on pharmaceuticals and, if you like this is what I would call the biogenomic area.’ What would your reaction be to that? Do you think that’s correct or do you think we should have a wider vision of what personalised cancer medicine or personalised cancer should be.
AE: I think the term personalised cancer medicine either should be identifying only one type of the whole individualised care model. So individualised care we’ve done for a long time already in surgery and radiation therapy, in social psychological companionment  and all this. But personalised cancer medicine was really the term to be used only to replace the term molecular medicine and a reflection of the molecular biology approach, molecularly defined targets, and basically therefore was a term to describe nowadays systemic therapies with molecularly targeted agents. Now, if we have a problem with that then we just replace personalised cancer medicine by molecular cancer medicine, so instead of PCM use MCM. I’m fine with that. But it only confuses the discussion now that everybody says, ‘Yes, but I’m doing personalised stuff.’ That was not the original intent to only deal with systemic therapy for metastatic disease with targeted agents, that’s what it’s supposed to mean.
RS: That’s the importance about the policy perspective here as being very clear on what your definitions are like upfront.
AE: Exactly.
RS: Franҫoise,  EORTC has funded and conducted studies across the breadth of cancer medicine over the last ten, twenty years. Where do you see the future going in terms of the perspective from ECCO and for the Oncopolicy Forum? What would you like to see European cancer organisations doing now in terms of the policy arena? At both European and national levels because we forget, of course, a lot of the research is heavily influenced by national policies.
FM: Yes, well to put in light the need for better co-operation and also to make sure that national authorities and ethics boards and ethics committees understand the challenge and try to promote pan-European co-operation. I think, as I always say, we have to try to keep Europe on the map. We have been pioneers, we have been experts, we have a lot of breadth of skills and knowledge but sometimes we feel that oncopolicy could help us to make sure that we are all on the same page and that we do not fragment more due to national aspects.
RS: Right. And Lex, you’re on the global arena, do you think this is about Fortress Europe developing personalised cancer medicines or are we now this is Europe as part of a global activity?
AE: Well absolutely and one of the reasons is that the genetic background also must be taken into account. So not all tumours were created equally but fortunately all people were created equally but with genetic differences as a background that actually identifies, for instance, the host immunologic background and identifies, or defines, I should say, the host metabolic background etc. etc. We know that there are large differences, for instance, between European populations, Caucasian populations and Chinese and Japanese populations in terms of how they metabolise drugs and that will not only be true for chemotherapeutics it will be true for targeted agents as well. So this whole personalised medicine business therefore needs to be also tailored to the genetic background that is very heterogeneous, of course, across the globe. So this is going to be a global development system.
RS: Lex, Franҫoise, thank you very much indeed for your time today. A real pleasure, thank you.