With breakthroughs increasingly hard to come by and patented drugs fiercely protected, the pharmaceutical industry has not traditionally been known for a collaborative approach to drug development. But a new EU-funded programme in development aims to change this dynamic.
The Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) is developing an ambitious idea to create a pan-European research network in which the scientific community – academia, the public sector or industry – can share medical data and biobank samples. The programme's organisers hope that this will lead to a more unified and cooperative approach to research, with better access to international samples and intellectual resources. BBMRI could be operational across Europe as early as the beginning of 2012, according to project coordinator Kurt Zatloukal.
But how will big pharma react to this new paradigm? We talk to Dr David Cox, senior vice-president at Pfizer and a member of BBMRI's scientific advisory board, for his view on the programme and the role that industry could play.
Chris Lo: Could you describe your role in drug development at Pfizer?
David Cox: I run the group of individuals that are using human genetic information to try and identify individuals who are more homogeneous in terms of the biological basis of their disease. So we can identify those people to put into trials as well as be able to come up with novel approaches to therapeutics.
In addition to the genetics, we use quantitative modelling as a way of addressing some of these issues. When you're working with whole organisms, it's more than just the genes, it's working out what all the different physiological parameters are too. This kind of genetics and modelling information in early discovery in pharma hasn't really been that successful in the past. So what we're trying to do is instead of studying things at the basic science level and then throwing it over the wall to the clinicians, we're trying to begin with the unmet clinical needs as the starting point, in using genetics as the link to the kind of biology that you would like to study in order to deal with that unmet need.
CL: How is the pharmaceutical industry connected with BBMRI?
DC: I think everyone focuses, or has focused in the past, on a lot of tissue samples. But tissue samples in the absence of really detailed clinical information, from my point of view, really aren't very valuable. And the difficulty right now is that lots of individuals and different types of companies want to sell the pharmaceutical industry samples. But what we've learned is that samples without good clinical information aren't very useful.
The other thing the pharmaceutical industry has learned is that when you're trying to tie up proprietary intellectual property on very early results before you understand enough biology, it's more effective to just set the money on fire and warm up your hands because it doesn't lead to anything useful. So the pharmaceutical industry now understands that it needs to be actively engaged, not just at the money level but at the intellectual level, of understanding biology better with the public sector. Working with an organisation like BBMRI, where pharma can bring some of its expertise and some of its knowledge to answer specific questions and at the same time have access to this large scale epidemiological data, would be a fantastic thing. Our company is looking at this as pre-competitive research and what we bring to it is intellectual manpower and know-how as well as money, and what we learn from using any samples this way would go back into the public domain so all comers could use the knowledge of the biology gains to come up with new therapies.
CL: What can industry contribute to something like BBMRI and what will it get out of it?
DC: What they can contribute is internal knowledge with respect to certain aspects of this unmet medical need. So, in our own case, there's lots of technical expertise in academics but what we do in genetics is everything we can to complement that. So we're developing new applications of technologies that actually aren't available in the public domain and we make those available. One example of that is that we're using DNA sequencing to be able to characterise the normal human immune system in ways that haven't been done before.
What we get out of it is a better understanding of the biology that allows us to go and make new therapeutics, but it would allow anybody else to do it too. So you ask, "Why give other people that opportunity?" From our point of view, if someone else makes a drug faster than a pharmaceutical company, then shame on us.
CL: BBMRI seems like a step in a more "open source" direction for medical data – is this step compatible with industry, which has traditionally had less of a tendency towards cooperation?
DC: It's not only compatible, it's essential. I think what we've all discovered is that biology is more complicated than was laid out, particularly with respect to a lot of the genetics. Everybody wanted to believe that understanding the genetics was going to be the magic key, so I think that what we've learned a lot with the amazing technologies over the past years, but the most important lesson is that genetics is something that can link the unmet need to the type of biology we need to study, but it's not going to give us the answer by itself.
A lot of people believed there would be low-hanging fruit, and that you wouldn't have to do the hard work. And like most things, that wasn't true. It requires hard work. So the pharmaceutical industry knows this and is embracing it. When you think about the total amount of intellectual horsepower to help understand biology, the majority of it is outside pharma.
On the other hand, you can't just throw that knowledge over the wall and have it turned into a drug. So there needs to be more thought at this pre-competitive level, and particularly pharma can help focus the questions that are in a context of the unmet need in terms of blanket basic biology. The biggest problem in accomplishing this is that it's using public resources and materials that individuals in society give for the public good. So unless it's crystal clear that this information is getting fed back as part of the public good, nobody is going to be allowed to play. I feel strongly about that. The good news is that I think that there is really a way forward in this.
CL: So you're aiming for more of an open collaboration between groups and individuals?
DC: Yes, and between the scientists and the rest of society. I know this sounds sort of pie in the sky, but I frankly think it's the wave of the future. One of the ways BBMRI is considering it, and this is really quite revolutionary, is that instead of shipping the samples, ship the scientists to the samples. So, instead of stripping all the information off so that everyone's completely protected, keep all the information and the people involved more engaged with the scientists so they know what's going on.
CL: Do you think creating an open network like this could encourage greater transparency in medical trials and biobanking? Could it have a positive impact on ethical standards, for example?
DC: Absolutely. The biggest problem we face right now with ethical issues, both in terms of privacy and transmission and integration of science with the medical community, is transparency. Things are not transparent – everybody says how well everything is working, but when you look at reality it's just not so.
CL: What are the main obstacles that still stand in the way of the implementation of something as ambitious as BBMRI?
DC: Well I think that we have to be very thoughtful about the issues of privacy and national sovereignty, and to not get people confused when things are research as opposed to clinical therapies. But I think that all of these can be dealt with as long as we're transparent about what we're trying to do and about the issue of money.
I think that the single biggest thing that keeps this from happening is people being concerned that someone else is going to get rich in an unfair way and they're not. If we are completely transparent about that, and transparent about what the access to the valuable information is going to be, and that none of that information is valuable unless you do something with it subsequently, I think it will be easy to go forward.
CL: There must be complications that are thrown up because of the large geographical area being proposed for the network. Are there likely to be problems with maintaining harmony across the continent?
DC: Much of the process of this is that the governance is through the individual countries. I think that right now, with the concept of the legal entity will be a formation of this ERIC (European Research Infrastructure Consortium) legal structure that will enable commonalities across all the different countries. It provides the framework for countries to have harmony in terms of one standard, but it's not the idea of having everybody do things the same, rather the flexibility to let each country maintain its social, ethical and scientific values, while playing on the international stage. It's very ambitious.
I'll be very transparent with you about this. When I was asked to be on the scientific advisory board with the BBMRI, I did it out of politeness because I thought I would be at one or two meeting since I thought this thing wouldn't have a chance of actually working. Now, over the space of a couple of years, I see that not only does it have a chance, but its a really fantastic chance of being successful. I think it's because this is really a very grassroots thing that pays attention to the minimal amount of central co-ordination necessary that allows the grassroots stuff to be used.
CL: How much of an impact do you think that this programme, if successfully put into practice, could have on medical breakthroughs and epidemiology?
DC: Frankly, I don't know if there's anything that I could say is more important than this. If we don't actually incorporate the knowledge that we have right now of real-life outcomes and real-life human beings and use that to identify people who go into trials and get certain treatments, I just don't know what else could be more important in terms of coming up with new therapies.