Panel Discussion (2014) - Academia and Industry – Exploring the Collaborative Landscapes of the Future; Panelists Beutler, Goldman, Gøtzsche, Gomes, Malik, Wang

Adam Smith. Good afternoon and welcome everybody. Thank you for coming. So this is a discussion session on the topic of the future landscapes for collaboration between academia and industry. And it seems to be a very appropriate topic because all of you, whether you end up in an academic research stream or an industrial research stream, are more than likely to find yourselves working with the other side of the fence and indeed many of you probably are already involved in such collaborations. So it seems a perfect topic to discuss. I’m joined on stage by an amazingly august panel. So let me briefly introduce them. Kemal Malik is a member of the board of management of Bayer and was for 10 years prior to that head of global drug development for Bayer. Peter Gøtzsche is a researcher with a great interest in clinical trials who is director of the Nordic Cochrane Centre based in Copenhagen. Renata Gomes is one of the young researchers on the panel and she is Portuguese but based in London and Oxford and researching cardiovascular regeneration. Bruce Beutler is now known to you all I’m sure but was awarded the Nobel Prize for his work discovering the root of innate immunity. Stan Wang is the other young researcher on our panel. He is American doing an MD PhD but is currently based in Cambridge in John Gurdon’s lab looking at stem cell reprogramming. And Michel Goldman is the director of the Innovative Medicines Initiative based in Brussels. The IMI as it’s called is the largest public/private partnership funding organisation in the health care space. And to my mind is the most interesting experiment in academic industrial collaboration going on in the world anywhere at the moment. It’s been running for 5 years and they’ve just been funded for a further 5 years. So the idea for this panel is that we will have discussion among the panellists and also discussion with and from you. I’ll come out to the audience requesting questions and comments and thoughts several times during the panel. If you want to ask a question, you need to be down here. Apparently we can’t take questions from the gallery. I suppose we could if you came to the front and shouted but that might not work. So I think if at any point you want to ask a question, please come down to the bottom level and find yourself a microphone. There are people wandering around with microphones. That’s it. So let’s start. I thought we might impose some vague order on this discussion by, because there’s so many places to go, by following broadly the track of drug discovery and development. So we might start by asking about the nature of collaboration and thinking about collaborations in the research stage of biomedical research when basic biology meets, in industrial terms, things like target identification. And then later on move into the development phase of the drug pipeline, talking more about clinical trials and data sharing and things like that. But I’m pretty sure that you and you will disrupt that order. So we’ll see where we go. Let me begin by asking Bruce what he looks for in a collaborative partner. Bruce Beutler. Well, there are several things actually. The most important one overall is that a collaboration should be organically grown. And by that I mean it has to develop naturally from a sincere interest on the part of both parties. It really can’t be forced. It often doesn’t work well if people plan for collaboration the way they do when they sit down to write a PO1 grant and think: “Whom should we invite? This person, that person, the other person?” Usually these things grow out of a sincere need if they’re to work. Of course it goes without saying also that you have to trust your collaborator. It should be a quality scientist. And also some kind of personal chemistry definitely helps. Not absolutely essential but best if you each have a need, usually a skill that the other lacks and you both are interested in the same question. Adam Smith. That sounds like it would work if you already know your collaborator. But if you’re looking for collaborators who you might not yet know, how do you begin to assess whether they might be the right collaborator? Bruce Beutler. I get to know them as well as I can. That’s all I can say by way of advice. Adam Smith. Michel, in your organisation you bring together these vast networks of collaborators from the academic and the industrial sides. And you’ve observed many of these collaborations form and get under way. What have you learned about what makes a good collaboration? Michel Goldman. I would start by telling you what it should not be. So if money is really the main driver from both sides, it will not work. And sometimes this happens. You know obviously industries want to reduce their costs in R&D and they can do this by externalising their research. And as you know on the academic side we are always looking for additional funding. So this is not a good incentive for successful collaboration. First you need a common vision of the scientific objective. You must be excited and passionate together to reach the same goal. And to do this... First it’s true what Bruce said. Trust is essential. But trust also means that you see what will be the rewards for each party. And the rewards are different. Industry and academia are looking for different things. And one of the important conclusions of what IMI did is that working in academia... And that’s very important for the young scientists here to know that. To collaborate with industry if anything might actually increase the impact of your publications. And that’s something that we really establish scientifically with Thomson Reuters, an in-depth analysis of Thomson Reuters. And finally I see it’s essential that from the start each party realises indeed the added value to join forces. I would say these are the main conditions. Adam Smith. Very connected with what Bruce said. Kemal, from the Bayer’s point of view, from pharma’s point of view what do you think you look for in a collaborator? Kemal Malik. I think it fits in what the previous speakers have said. So it does work on a mutual understanding of what both parties are looking for. If I look at Bayer, we have a range of activities in terms of partnerships from advisory activities, from academia to single project collaborations right through to strategic partnerships. If we look at strategic partnerships, I think it’s really important to understand why we work together. Let’s just say to find a novel treatment for cancer. Then it’s an eye level discussion. It's joint decision making, joint projects. You have complementary expertise. Usually the academics are bringing the biology, finding the target. The industry is good at chemistry, screening and then drug development. It’s good if there’s clear and agreed governance up front. You agree on who is going to share the intellectual property. And what we found works really well is an exchange of personnel. People from our labs going to work in the partner’s labs and vice versa. Those are the arrangements we have for instance with the DKFZ which is the German cancer research institute with the Broad Institute at Harvard. And we just announced with Oxford -press release today with Andrew Hamilton who is a vice chancellor at Oxford in gynaecology. So that’s on one side, strategic partnerships. Completely opposite is very hands off what we call open innovation platforms which are web based. Grants for targets, grants for leads where academics can apply for a grant. They have got an idea that there’s a new target and a new indication. They can apply for a grant. We don’t have any of the IP. All resides with them. We’ve had about... We launched this about 3 or 4 years ago and we’ve had 1,000 applicants. We’ve awarded 130 grants. And the IP lies solely with the researchers. We kind of hope perhaps that something comes of it and they’ll come back to us because of the relationship but they don’t have to. They could go to Novartis or whoever. So there is a gamut of true strategic partnerships right through to open innovation platforms and crowd sourcing. And we run all of them. It’s about modelling what you’re trying to answer and tailoring it for that need. Adam Smith. Thank you very much. Ok, you’ve raised all sorts of topics that we’d actually like to cover if we can on the panel. This idea of open innovation, a move towards, I suppose, just a more open sharing of information across the boundaries, Bruce, do you have any such collaborations with industry at the moment where you basically just look for biological processes without any particular drug in mind at the time? Bruce Beutler. No interestingly I have never had a collaboration quite like that. And after a target is established there may be interest on the part of pharma in looking at it more closely but although that might be of interest to me, probably it wouldn’t be exactly for the right reason. Because I agree very much with what Michel said. It isn’t really good to have money as the motivation for what you're doing. Now of course it’s what I’m doing anyway. But I wouldn’t particularly like to be encumbered in that way. Adam Smith. Encumbered? Bruce Beutler. Well one can apply for a grant. One can try something. One can do a screen. But there aren’t necessarily hard expectations as to what it’s going to produce. And there aren’t going to be people who are terribly disappointed if it doesn’t turn out the way you hope for. And I just don’t feel very comfortable doing work for hire if it’s not in my area of interest. Let’s say it’s a novel screen. Something that we’re not doing already. That would make me uneasy. Adam Smith. Michel, yes. Michel Goldman. I think that we should make a distinction here between bilateral agreement, between a single company and a single university where the expectation might indeed be the one just described. I think that there has been a very interesting movement over the last 5 years or so, both in Europe and now in the US with the new accelerating medicine partnership for pre-competitive research. What it means is that there are projects of this type where collaboration involves first, collaboration between the big pharmas themselves. So they are strong competitors on the market but they realise that to address some major challenges -let’s take Alzheimer- they have to work together. And they realise this because of recent major failures of course. And they also realise that they should do some of the work together. But that would even be not sufficient. They need, you know, collaboration with academia, with small biotechs. And in this type of research I think that there is less concern of the one you describe. I think that each party can probably in a more comfortable way also keep to some extent his autonomy and that the creativity, the imagination which is so important in academia, in this type of environment... the industry is indeed ready to let the academic scientists really be creative and not so much driven by very specific objectives. So there are 2 different types of collaboration there. Kemal Malik. I think for particularly intractable diseases and particularly where there have been high profile failures in drug development like Alzheimer’s I think consortia between industry, between companies and between industry and academia are probably going to be the way to go. The challenge with Alzheimer’s of course is the lack of validated drug targets which means that you end up doing incredibly expensive drug development programs which fail. The danger of course is that industry will say we’ll not going to do anymore. Fortunately there are enough people in the industry who will say: “Look this is an area of huge medical need and we need to do something about it.” And you can see consortia developing across companies saying in a pre-competitive way: So I can see more and more of that happening for intractable diseases. Adam Smith. At the root of this open innovation concept. And the idea of this pre-competitive information sharing is that you’re researching... not so much trying to find the drug targets but really trying to find the basic mechanisms of disease. And then I suppose, then the commonality of interest comes with academia. But then I remember a conversation that, Bruce, you had with some pharma researchers when we were visiting the US together and that you had 2 panels. One was on immunology and one was on oncology. And it seemed to me that there was a missing... It was an open innovation platform if you like. We were sitting around a table talking about these broad scientific areas. And questions were coming: “Is this a good drug target?” And you kept answering: We need to know more basic biology.” And it seemed that the commonality of interest was there in the basic area but the level of addressing the question was rather different. But presumably there is a deep interest in basic biology within industry which meets the deep interest of academia. Bruce Beutler. I think occasionally there is, quite often there is and that may have been sort of an exception. I remember very well what you’re talking about. There is one collaboration that we have now that’s more along those lines where we found a certain molecule that we think might be a good drug target in lupus. And I am interested in the basic biology of how it works. It’s a target which when mutated prevents plasmacytoid dendritic cells from making an interferon response. And in mouse models it seems like that mutation will suppress lupus. But I don’t have the foggiest idea how it works. And the collaboration has something to do with us working on that aspect and taking the molecule further if warranted. Adam Smith. But is the landscape changing? Are we moving towards a time when there is going to be necessarily more information sharing, more collaboration between academia and industry? Kemal Malik. I think it’s inevitable. I guess we are 7 billion people in the world and Bayer employs 12,000 of them in R+D. So there must be an awful lot of ideas that aren’t there in our R+D. And given that the aim is to try and get some smart ideas and then turn them some way into a molecule that then in some way becomes a drug. I guess we need to get that input from somewhere. And I think companies are realising that there’s an awful lot of knowledge outside their own companies. And if I go back to the time I entered the industry 20 years ago, we were all very insular. Now increasingly we want to talk to other companies in the pre-competitive space. And we actively all work with academia. I don’t think there’s a company out there that hasn’t got some efforts around open innovation. Michel Goldman. I think that the landscape is also changing because the way the new drug targets are identified is changing. Actually we are more and more dependent of rare diseases or right types of diseases. We have some example PCSK9 for hypercholesterolemia remains the last example. It’s really nice to remember how this target was identified, just through a cohort of very rare patients. And if you think about Tocilizumab, the entire L6 receptor for rheumatoid arthritis was first also developed for rare diseases. So it means that companies realise that, you know, they need access to this cohorts of rare patients. Perhaps to get them to develop the best approach for the identification of new targets. And that’s very interesting because it will probably bring to the next part of the discussion where the clinical trials and investigations are important. Adam Smith. Renata, you’ve already been involved in such sharing arrangements? Renata Mota Gomes. As a young scientist at the time as a PhD student I had a brief encounter with big a pharma. It wasn’t the greatest of experiences but you cannot judge a whole industry based on one experience I hope. As a young scientist for me what... And probably I’m still quite idealistic, like Stan and we still are quite young at this... for me the most important thing is complete transparency, is to be able to... that whoever is collaborating with me, shows me everything. And I show them everything with no fears. But I get a little bit apprehensive about because I get worried that that’s not always the case. And perhaps things need to change a bit there. And another thing that probably you can answer for me is something that’s always puzzled me with these academic industry collaborations. Let’s just put it this way. I do a collaboration with you. Negative or positive data, I get a paper out, that’s what I need for my career progression. But you invested all this money on my idea and my project and then at the end there’s no product for you. So I get a paper. Whether it’s positive or negative data I try to push it out. I get something. The product fails. So if the product fails what do you get out of it? Because industry is really not based on knowledge. It’s mostly about application. It’s more about metrics. Where are we (the) kind of the silly idealists? Kemal Malik. First of all, I’m sad that you did have a bad experience. I mean I can’t speak for the entire pharmaceutical industry unfortunately. Adam Smith. It was with your company. Kemal Malik. No, it wasn’t. Behave yourself. Was it? No. Kemal Malik. If you look at the drug development process in the industry, it’s a model that’s based on failure. If you take 100 compounds into preclinical testing, only one of them is going to get to the market. They fail for safety reasons. They fail for efficacy reasons, whatever. So it is a model that’s inherently based on failure. So whilst I’m sure we would be unhappy if we partner with someone on a project and it fails, it’s not as if that isn’t the first time it’s happened because most of the... And this is what... I’m from drug development. I’m a physician, I’m from the other side. I always look at the researchers and then always in awe because the majority of them can spend their entire careers on something and it never sees the light of day in terms of getting to the market. I think: “What inspires you?” And they say.. They’re pretty altruistic most of them. And they kind of say: “You know, we want to change the way diseases are.” And you can spent 30 or 40 years working on something, retire and nothing you’ve ever worked on has ever got through to the market. It’s a lot easier when you’re in drug development because you’re kind of taking the ones that have kind of got past that process and doing clinical trials. So what’s in it for us? Well, eventually we will get one that works. But quite frankly 100 projects that go into preclinical testing only 1 will get to the market. Renata Mota Gomes. So, if my idea just failed you, what would make you... keep you collaborating with me, considering that this one just failed? What about the next one? Kemal Malik. Well, we may think that Renata has a great idea and she’s a great person, a world authority in X. We think X has a valid principle and we want to keep on working with her. And you know what? The first one may have failed but the next one might work. That would be the reason. Michel Goldman. I think that your story, Renata, demonstrates the importance to have a real balance in these partnerships. Industry will not change. We know the driver of industry. So in your story I would like to know, you know, how your academic mentor behaved because for me there is an important responsibility of your mentor, your supervisor on the academic public side to be sure that the partnership remains balanced. And this starts at the very beginning coming back to your very first question. And I think that it’s really very important that, you know, again in this partnership, the public side or the academic side indeed takes full consideration of the public interest and in this case of your interest as a PhD or a postdoc. Adam Smith. Stan, I’d like you to come in now. I’m guessing you might have a different view. You’ve already launched 2 companies. So you are, I assume, keen to work with industry. Stan Wang. My perspective has, I guess, been more positive through my experiences. But that being said I think I probably have 2 primary concerns in terms of academic-industry collaborations. And one of those is rooted in a conversation I had recently with someone that I quite look up to as a mentor. And his name is Roy Vagelos. And for those of you in the pharmaceutical industry you’ll be familiar with him. He was one of the... He was the CEO and chairman of Merck and led it through the heydays of his expansion, grew into one of the top pharmaceutical companies in the world. And what probably not too many people know about Roy is that he had spent time in academia beforehand. He was a professor, he ran a very active research group. And as a result this is someone that has had both sides, has experienced both sides and has seen the positives and the negatives of all sides of the continuum and spectrum. And what he said to me was very profound I think. It’s that he is very concerned with the move in public funding towards translational research by national agencies in the US where this push towards translational research could really harm the industry in the long term because at the end of the day industry is not interested in basic science research. And if scientists on the academic side don’t do basic science research, then the pipeline of true discovery will dry out in the long term. So that’s one concern. And then the second side of it that I’ll just mention briefly before we go off is that as a young scientist, you know, just starting out, coming into the field, coming into the profession, we see these limitations in funding coming down. We’re concerned by the shift towards focus away from basic science towards transitional research. But at the same time are there things that we can do as young researchers to build these collaborations to augment our funding? So that’s another question that I’m sure a lot of people in the audience are thinking about. Adam Smith. Can I just get... Kemal, what is industry’s view, if you can speak on behalf of industry, of the shift towards translational research funding? Kemal Malik. I think what Stan said is actually very important. Inevitably within companies we’ve got to do translational research. I mean that’s what we’re about. There needs to be a balance then in the world where... I’m sorry there’s a lady on the phone there which is very odd (laugh). There needs to be a balance between what we do in industry which is inevitably translational and academia which needs to allow and be allowed to do… Peter Gøtzsche Could I please ask the lady who talks on the telephone to leave the room? Kemal Malik. I’m sorry, it’s very distracting. There needs to be the opportunity for academia to do basic research. If you look at bodies like the NIH etc., I think it’s important beholding that they give research grants for basic research. Because in essence we need a balance across society. Translational research as well as basic research would be my perspective. Adam Smith. Thank you. Let’s go to the audience. Please go ahead. Question. I’m Kaya, I’m from Poland and I’m a scientist but also I own a company. Like Stan I launched a company. And I have a general comment. On the one hand the scientists, as you said already, need to trust to collaborate with companies. And I can see that scientists are still afraid and really do not trust companies to for example pay for some outsourced analysis. But on the other hand I have like a general question. What do you think about scientists launching companies, like joining together like the companies that are from the universities? Adam Smith. Well, Stan, you’ve done it. Stan Wang. So I would say that it’s not something to be afraid of. I did it personally as a means of essentially learning because at the end of the day what I care most about is science benefiting mankind, going out there and making some type of tangible difference in individual people’s lives. With that kind of attitude I started in my various ventures trying to find ways of taking the work that we’ve done in various different realms and having it get out there and affect people’s lives. Whether or not it’s something that’s a model that everyone can do, it depends on your personal tolerance for risk. I mean that’s one thing that it really comes down to. What are your priorities? What do you want out of the experience that you’re trying to do? And I would love to talk to you at some point and hear more about the work that you’ve done since I think it’s up to us, the younger generation, to try and not only, you know, walk in the footsteps of those that have come before us but try and find new models, new ways of pushing forth innovation. Adam Smith. Bruce, have you ever been tempted to start a company? Bruce Beutler. I’ve thought about it from time to time. I think Stan’s motivation sounds very pure and very good. Maybe in many cases people start a company from academia thinking they’re going to run a second lab and it’s going to be a second academic operation but lavishly funded. And of course that never works. And from my own part I have thought about it from time to time: Wouldn’t it be interesting to carry this forward in a company? But frankly I’ve always just been completely busy with my lab and I’ve never gone that far. Kemal Malik. It’s an interesting one. It’s a big difference I see between Europe and the United States. When you go to the US and you speak to leading academics and say: “Have you ever been involved in start-ups?” I was with the head of the Charité which is one of the leading medical institutions in Germany in Berlin. It’s a big difference between the US and Europe in the willingness for academics to have start-ups. We have tried to do something there. We offer space in our facility in Berlin to start-ups. It’s collaborator. They come, there’s no IP from us. They use our facilities. We’re like a landlord. They don’t have to pay anything. We opened our facilities up in Berlin and in San Francisco to start-up companies to use the site and we allowed them to use our infrastructure to an extent free as well. And we don’t want anything from them. There needs to be a bit more of a move in Europe for start-ups because I believe it’s quite fun. The ones who do it. But Americans are much more tuned to doing it than Europeans. Renata Mota Gomes. In a way I totally understand why Stan started his own biotech and the lady as well. It’s because... I think it’s mostly because we are at a stage in our lives that we are still young and we have nothing to lose really. And we won’t be employing anyone in a start-up really. We’ll just be getting friends to help us and it’s a learning curve for everyone. And that’s why we... I think we are very much growing up in the philosophy of why not. But it’s because we don’t have dependents and we have the freedom to do it. And this is why start-ups and biotechs are coming up so easily these days. And maybe in Europe it’s still a bit conservative because when we talk about start-ups in Europe it gets a bit iffy. Bruce Beutler. I would just make the point, the additional point that demotivates me from starting a company. And that is that as an academic you really do have complete freedom. You are your own boss. You come into the lab. You decide what will be done that day, that week, that year. Of course eventually you have to convince somebody that it’s worthwhile but it should be worthwhile or I guess you shouldn’t be doing it. On the other hand you have to have a completely different motivation when you have a company and eventually you’re not your own boss anymore. Always you’re responsible to someone who wants the work to go in a certain direction. And when it came to thoughts of being in pharma, I was always heartbroken to look at stories where people had done really good science over a period of years and then it was cut off because of some upper management decision. No fault of the science. Now of course that can happen in academia too. You get a bad review on your grant and everything is over at least for the moment. But we like to think it’s sort of a meritocracy there. Or that you have some control over it. Adam Smith. Another question please. Question. Thank you, I’m Kathleen Raven from New York. I’m part of the Lindau blogging team. And I have a question for you, Peter. Only about 3% of the population are involved in clinical trials. And I wondered what you envision happening. Collaborations between academia and industry, what clinical trials will look like in the next 5 years? Will there be a new model? Adam Smith. Ok, thank you. So we’ve jumped into the development section with that question which is good timing. Peter. Peter Gøtzsche Well, first of all it’s difficult to know whether 3% is too much or too little. I have analysed drug trials for many years and in my opinion most of them are marketing disguised as science. They shouldn’t be done. So a lot of patients contribute to trials that are pure marketing exercises. So I actually think that there are too many trials in the world and that the trials that we should be making should be trials that are made in the public interest and in which patients have a major saying about what are their problems, what would they like to get relieved and so on. So we could do trials in a very different way from what we do today. And I actually feel that randomised trials should be done by publicly employed people like doctors. The drug industry could still pay for them but they shouldn’t do them because they have a tremendous conflict of interest when it comes to the results. Another thing I wanted to say is that I still see trial protocols where it is written in the back that the data are owned by the drug company. And it’s very rare that the doctors that contribute to these trials can get access to all the data. It is improving these years and it’s badly needed because science ceases to exist when only people with financial conflicts of interest have access to the data. That’s not science. So we need a whole new paradigm for clinical trials of drugs. So that’s what I’m trying to work on. So never sign an agreement with the industry that says that it owns all the data. You need a copy of all the data as well and full freedom to publish. And according to the European ombudsman it’s the legal misconception that a drug company can own data that the patients have created. They are public, they belong to every one of us. Adam Smith. And, Peter, there is an increasing move towards access to clinical trial data. Peter Gøtzsche: Yes. Adam Smith: Around the world, right? Peter Gøtzsche: Yes. Adam Smith. So, Kemal, you were head of global drug developing for 10 years. I guess this one is yours. Kemal Malik. I guess. 2 things. I’ll talk about drug development and then I’ll talk about data transparency. If you look at the drug development model that we have, it’s incredibly antiquated. In essence it’s the same model we’ve had for about 20 or 30 years. And I would agree with Peter, it’s time it changed. If you look at AIDS, I think it’s an interesting experience. I saw my first AIDS patient as a medical student in 1984. And 1984 was a time when the virus was identified as well, categorically positive as being HIV. The first drug got to the market in 1987, 3 years later, AZT. And that was done because there was a lot of collaborations between academia and the NIH played an important role, patient groups, an amazingly organised patient lobby group and the industry and biotech. My first job was actually at Bristol Myers. And we worked closely with the AIDS patient groups who were coming in and designing the clinical trials and telling us: The FDA were very collaborative, mainly because of pressure from congress and the US government. And we actually got the first drug to the market in 1987. So I think the model does need to change. It’s an incredibly antiquated model. And these clinical trials which are, to be honest, artificial in terms of their design and set up we need to come to a new model of how we get drugs to the market. In terms of data transparency I think it’s important that we are transparent. I can only speak on behalf of Bayer. We’ve signed up to a consortium of companies, GSK, Roche, Boehringer, Sanofi, Novartis and Lilly where we’re going to publish the raw data from all our clinical trials on the web. They can be downloaded in SAS format by researchers and they can do their own analysis on the data. We also have the analysis plan on the web as well as the final study report. To be honest there’s not a lot more you could put out there. So people will have access to the raw data. Not just the people in the studies, who run the studies, but any researcher can get access to the raw data and do the analysis. Adam Smith. What do you think of Peter’s suggestion that clinical trials should be run by public institutions? Kemal Malik. I actually think there should be a different model for clinical trials. I haven’t got a problem with the industry not running clinical trials. We employ thousands of people running clinical trials. And you think: Does this really make sense? I haven’t got a problem. Back when I was at Bristol I worked in oncology. A lot of the studies we ran were run by collaborative groups like the EORTC etc. So they weren’t run by the company. And we’ve got drugs approved. Taxol was approved by studies that were run by the EORTC. I have absolutely no problem with the industry not running trials. It would make, to be honest, my life easier as well. Well, I don’t do the development job anymore but my successor. So I’ve got no problem with that at all. Michel Goldman. I think it’s quite clear that the industry in one way or another is losing its monopoly on all the drug development processes including the clinical trial. And I really think that industry realises this as we speak. So that’s why indeed new schemes are developed. If you take antibiotics for example. Terrible situation, no new antibiotics for 20 years. And each year you have 25 European citizens dying form antibiotic resistant infections. So something must happen. Industry will say: “We’ll not invest there because our return on investment is not there for a number of reasons that I will not elaborate on.” Then you need a partnership because for public health you need these new antibiotics, you need industry to develop and market those antibiotics. So there is no other way than to join forces and to provide the industry the incentive they need to reinvest. But again it’s a question of balance between the public interest and the private interest. Now coming to the new type of clinical trials, I’m thinking for example to the adaptive trial design which will become so important. And in cancer, for example in breast cancer, it has been shown possible to indeed develop the clinical trial in much cleverer and flexible manner so that indeed the access to patients is accelerated. We have now to do these outside cancer. And by the definition this indeed requires a real involvement of patients, patient organisations and regulators. And I would like to insist on this point. Because I think that regulators, FDA and EMA in Europe, have a critical role to play and I think that the landscape there is also changing. Until recently they were considered, you know, as the safeguard against, you know, what could happen in terms of drug safety and things like that. It’s still important but they have really to look at benefit-risk assessment in a more objective manner taking into consideration what matters to patients. And I think that one of the keys there is really in the hands of the regulators because, as you know, at the end of the day the clinical trials to be relevant have to be approved and recognised by the regulators. And I think that also for the young scientists and the academics I would recommend if you’re working on biomedical science, to look at the new science, the regulatory science. Looking at benefit-risk assessment of innovative drugs. There are really exciting careers there I think. Kemal Malik. The biggest resisters to a change in the drug development model are the regulatory authorities, the EMA and the FDA. I’m not wedded to running huge clinical trials because they’re not massively efficient. They are a slightly artificial setting. You preselect patients and, and, and. I’d love to change to a new model. But the biggest resister are the regulatory authorities where you say: They’re wedded to a very traditional model. And that’s why it needs the collaboration between the industry, academia and the regulators to change this. Peter Gøtzsche Yes, I agree. I have battled with regulatory authorities for quite some years. And we obtained access to unpublished data reports at the European agency in 2010 after having complained to the European ombudsman. And I agree that the model we use needs to be changed. But first of all what we read in these unpublished data reports is very different from what the same companies have published. So doctors cannot practice evidence based medicine today unless we get access to all the data on every trial that has been conducted. And this process is now going in the right direction. But what I would comment on about clinical trials is that the model is that to show that something works you give half of the patient’s placebo. And then you have some funny scale like a depression scale. And you can see ok people get better on the depression scale so it works and then it gets approved. But guess what. All drugs have side effects. So these drugs are not effectively blinded. If you study depression, these drugs they give dry mouth, they may destroy your sex life, they may do lots of things. So a lot of people know whether they got a drug or placebo. And many years ago trials were done with an active placebo. It wasn’t active, they just put something in the placebo that gave side effects namely atropine which gives you a dry mouth like antidepressant drugs. And when atropine placebos were compared to tricyclic antidepressants the effect was gone. There was none. So I believe a lot of the drugs we have on the market today they are totally ineffective. What doctors have measured is only that they have broken the blinding. And the patients have broken the blinding and then they have subjective outcomes. And then they feel: “Oh yes I get something. So I’m probably a little better, a little less depressed and have a little more lust for sex and sleep a little better.” And whatever it is. So there you have it. A lot of what we see is pure bias. And this is why my research area is bias. Adam Smith. So there was me 2 minutes ago thinking we’d reached a point of agreement. Adam Smith. Michel, did you want to comment on that before we go to the next question? On the placebo? Michel Goldman. Yeah, on placebo. That’s exactly what adaptive trial designs are for, to reduce the number of patients on placebo to be able to adapt the design when you get the first results. So you do interim analysis. So you increase the number of patients which are on board of hopefully active compounds. So I think that you are right. We have to change the way clinical trials are designed. And for this we need the input of patients. We need the input of regulators. But I can tell you I am not working in industry. But I can tell you that industry realises that indeed this must change. It’s in their own interest actually. Kemal Malik. The best determinant is to run a study versus standard of care. So Bayer brought forward a new anticoagulant recently. The comparative arm wasn’t a placebo; it was Warfarin which was a reasonable thing to do because that was a standard of care. The FDA for many, many years insisted on placebo controlled trials which is why the industry ran them. I don’t know a lot about psychiatry so I can’t comment on psychiatry. But in the cardiovascular area which is my background increasingly we use active comparators as the comparison. So, you know, we use heart failure drugs, we use ACE inhibitors, anti-thrombotic, you use Warfarin. The FDA was the biggest resister because it kept on insisting on placebo controlled studies. Often you couldn’t run a study because it would have been unethical to give a patient who is at high risk placebo. You have to give them a standard of care. Adam Smith. Last word on this, Peter. Peter Gøtzsche Yes. I wasn’t arguing for getting away with placebos because we need some proof that a new principle really works. So we need placebos. But we need to put something in them so that people get side effects so that they cannot break the blinding. I mean psychiatry is like this: That you can give psychiatric patients almost anything and they will think it works as long as it gives you side effects. It’s true. Adam Smith. Ok, last word. Michel Goldman. Of course you need placebos. But if you are the father of, you know, a child with I don’t know which type of disease, you would like to reduce the chance or the risk that your child will receive a placebo, right? So that’s the reason why we need new trial designs. Question. Hi there, my name is Jonathan Fuller from the University of Toronto and I work on the philosophy of medical research and I’m also a future physician. So my question is on trust. Earlier we talked about the necessity of trust between academics and industry with whom they are partnering. There’s also an important place for trust between the public and also medicine, medical practitioners and the entire industry funded health research sector. And we have reason to believe that the trust placed in the sector by physicians and by the public has been greatly abused over many years. So we heard earlier about the fact that many trial data are withheld from not only the public but also the regulatory agencies who demand that data slowing down the process for many years. Also industry funded drug trials that show positive results are many, many times more likely to be published than those that show negative results. And this association is much greater than what you see in non-industry funded drug research. But there are also many ways not mentioned so far which I think the entire system of industry funded research has abused the public’s trust. So pharmaceutical companies have ghost written research articles and shopped around for academics who are willing to put their name on the paper. They have contractually gagged academics who were involved in running trials and who might want to report important results to the public or to their patients but who have been stopped from doing so and often smeared afterwards when they have come forward honestly and tried to protect the public and their patients. So my question is: Should medicine and the public trust the current industry funded research system including all the players that are involved, the regulators, the academics who are involved in these collaborations, the companies themselves? And what can be done to restore the trustworthiness of this system? Adam Smith. Let me go to several people. Peter, you can go first please. Peter Gøtzsche As you just said yourself, trust is misplaced. We need control and we need access to all the data ourselves so that we can control what happens. There is so much money to be earned by being less than honest that it’s almost natural that you cannot trust what the drug industry does with its clinical trials. And that’s why I argue they should be a public enterprise. But before they become that, we should just ensure that we get access to all the raw data ourselves. That is the way forward. Adam Smith. Michel, do you want to. Michel Goldman. Yeah, I would say that indeed trust is never granted. You have really... You need like a neutral trusted third party, an honest broker to make this partnership really working. So to be sure that each partner realises that what they do is indeed under scrutiny. And I think you are right. There is still a lot of work to be done there. Now just a word about data sharing. I fully agree with what you said. But when we talk about data and data sharing, we should have in mind why do we want to share data. We want to share data to learn from failures and to learn from successes. Just 2 examples to learn from success: By pooling data for 10,000 patients and realising in 11 different trials by 5 different companies this was schizophrenia. It was possible to show that you can reduce the number of patients to be enrolled by 40%. And this analysis was indeed, you are right, done not by the industry itself but by a neutral party. Actually it was an academic institution. Now learning by failure. You know the elementary theory of Alzheimer disease. It has been estimated that about €10 billion were spent so far in the public, in academia to develop these drugs targeting beta amyloid. And as you know still so far all the 3 trials failed. So what can we learn from these failures? Probably a lot. The problem is that the way the data were recorded are different. So I would like also to insist that when we go for data sharing, we should do whatever we can to be sure that data indeed can be analysed together. We need to use data standard. And I think that there are several organisations. For example CDISC in the US which are working on this. And this is another message for the young scientist. This doesn’t look so exciting to develop standards to record data but when it comes to clinical trials, this is really essential so that we can take full advantage of data sharing. Bruce Beutler. When it comes to the issue of trust. Do we trust all academic research for that matter? Do we trust a paper that’s been published in Nature just because it’s been published in Nature and peer reviewed? And do we consider it sacrosanct and no one can criticise it? The answer is of course not. Everything is subject to distrust and should be scrutinised closely. And probably commercial research, research commercially driven is less trustable than the other. But they’re both things that one should be sceptical about, always. Kemal Malik. Clearly there is an issue of trust with the industry. I can only speak on behalf of Bayer. All clinical trials that Bayer runs are posted on clinicaltrials.gov. And as I said earlier we’re making all the real data available from our clinical trials in SAS format to be downloaded. But if you look at the recent addition of circulation which is the journal of the American Heart Association, there’s actually a call for academia now to be as transparent as we’re being taken to as an industry. So I think there is actually a call for academia now to step up to the plate and share all of their data as well. The industry, screaming and kicking, and people like Peter have been talking about that are now being very transparent. The raw data is out there. The call from this author in circulation was: “Come on, academia, now you step up to the plate.” And I would join that call. Adam Smith. Another question. Question. My name is Rachel, I’m a graduate student at Stanford. I find it interesting that we jumped from research to development without really talking about the transition between those. I spent some time in big pharma and I noticed a clear trend towards development and they’re dropping their research programmes which is in fact why I am a graduate student now. I wondered if you could comment on who should carry the risk in the process and for how long. And what does the ideal transition between academics and industry look like? Because I think that the bar is being raised for academics to show more pre-clinical data, toxicology data even phase zero studies before industry will consider the projects. Adam Smith. So, Kemal, you can go for that. Kemal Malik. There is a move in the industry from going from research and development to search and development. By that industry, and Bayer actually isn’t one of them, is actually reducing the size of its research activities and saying: “You know what? This is an inherently risky business. We may not be as good at it as other companies.” If you look at the success rate of biotech. It’s much higher than large pharma. And as large pharma gets bigger and bigger and bigger they become less and less and less productive in research. So companies are saying: “You know what? We’re quite good at drug development but we’re not so good at research. We should just reduce our research, access innovation externally from academia and then do the bit that we think we’re good at which is drug development.” I think that would be a shame. As I said it’s not where Bayer is. But there is a trend in the industry. And a big trend. Particularly on some of the big large pharmas, much bigger than Bayer, to become search and development companies. Adam Smith. So, Michel, you witness this within IMI? Michel Goldman. Yeah, but I think this is a very important comment and that’s why you know we will not solve everything by the partnership we are talking about. I think that what has been said is just a demonstration that we still need to increase and to support public funding for basic non-orientated, non-driven research. That’s essential. And so that’s one point. Second point in terms of the transition. How do we manage this, at least the early phases of the transition? This was your question. And part of the answer might be what you described. It’s indeed to develop entrepreneurship in academia. So that when you create your company, you do it not by default because you cannot continue your academic career. You do it because you pursue your objective. You had an idea, you did some demonstration in academia. You want to move forward. If you are in the medical science you want... at the end your goal, your dream is to reach the patient. And for that indeed you might consider to become an entrepreneur at some point. And you are fully right. This is the type of thing we see much more often in the US than in Europe. And we have really to work on that. So there is a question of funding, access to capital. For example at IMI we recently organised a big event with venture capitalists and, you know, small medium size enterprise and people from academia trying indeed to change the situation. And one interesting point is that we should not oppose necessarily big pharma to you know small businesses starting. And it was very interesting to realise that VC’s were very much interested in even small and just starting companies if they realise that they were part of consortia where the large pharmaceutical companies were involved as well. So I think that we have to think. But there is indeed a need to develop also new instrument to indeed help you to move forward before the big pharma will become interested because I think this was just confirmed by what you said, search and development. So we have to organise something in between. Adam Smith. I imagine it’s something you see quite a lot of is as this, as more emphasis is placed on academic role in bringing the molecule to the chain, there needs to be a much greater sophistication on academia’s part in understanding IP and how to approach such collaborations with large organisations which really know what they’re doing in this sphere. And I imagine that you don’t... that you’re actually seeing that there’s a lack of sophistication at the moment. Michel Goldman. That’s really a problem. You know, science becomes more and more complex. So even if you do you know just lab research, it becomes more and more difficult. But it’s true that if you are interested in drug development, you have... at the same time you must be acquainted with IP, with other business. But I guess this is what you did. Right? Stan Wang. One of the interesting things working from the student perspective is learning how to navigate this crazy landscape of a lot of things that you don’t normally learn in your education as a PhD student. It’s not something they teach in grad school. And I think for those of us in our generation the onus has been so far on us to go out, find the resources, find the mentors, find the funding to bring it forward. But I really like what Michel is talking about: Looking at more ways that we can bridge that gap and find, you know, more official supportive mechanisms to allow young researchers to be entrepreneurial, to take their ideas further, to find the IP support that they need within the universities, outside of universities and build what they need to take their ideas forward. Adam Smith. Peter, did you want to comment? Peter Gøtzsche Yeah. You touched on a very important subject. Studies have shown that most breakthroughs in health care actually come from publically funded research. Not even biotech companies but publically funded research. And yet out politicians go in the wrong direction. They think that they can steer research by all these program type of money. That now dementia is common and osteoarthritis is common so we set aside some billions for this. Or cancer? How many billions haven’t we used on cancer without moving too much? And what politicians should do is the opposite. Give really good people a load of money that they can play with without using all their weekends on searching for grants which is driving Americans crazy to the extent that they immigrate to Australia and elsewhere. I have examples of that. So drop all this nonsense about competition and writing grants all the weekends and holidays. Give people some money so that they can play around with them. And then we will have more breakthroughs that can benefit everyone of us including the drug industry. That’s what we need. What do you say about that? Bruce Beutler: Who would be giving the money to us? Peter Gøtzsche: The best of us. Bruce Beutler: No, who will be giving it to the best of us? Peter Gøtzsche: Our governments. Bruce Beutler: The government will? Peter Gøtzsche Our governments, instead of saying that we should compete with each other and write grants and, oh, and according to some silly ideas they have dreamt up themselves. Bruce Beutler: And who will decide who is the best, aside from all of us here? Peter Gøtzsche: Oh, that can be done, you know, this can be done, this can be done. We just need to want it. Adam Smith. Bruce would you like to comment on the move towards directed research programs especially in the US. Bruce Beutler. Well I’ve had some exposure to that. And I think they can be well done or badly done probably. The program I was most familiar with I saw during the time I was at Scripps. There were global agreements with Scripps first from Johnson and Johnson, then Novartis, then later Pfizer. And they were all similar in some ways. The usual way of interacting was that investigators at Scripps could write grants to pharma if they were interested. Then a collaboration could be started whereby some money would be provided for research. And I’ve heard also, never participated in, sorts of arrangements where people come with targets to pharma and they vet them internally. And they decide whether collaboration is warranted. And I think these suffer always from the problems we’ve talked about at the very beginning. The problems of trust. You don’t know quite what you’re getting into. It’s not clear that it really is an organic collaboration and that it’s really going to help. Adam Smith. But what about the wider funding scenario where a government declares a war on cancer or a war on this or that and then puts a lot of money into saying go solve that problem? Bruce Beutler. Well, certainly a lot of money gets wasted when there’s a huge surfeit of money. We saw this with the stimulus program. I don’t know where most of that money went but probably a lot of it went down the drain. Now there does have to be some oversight and some review. And people do get complacent if they’re simply given a lot of money with no particular plan in mind. That’s my feeling. Adam Smith. Did you want to speak, Renata? Renata Mota Gomes. I agree with you saying that maybe we should start pushing governments to actually invest in science because maybe the USA the government declares war on cancer and actually invests in it. But where I come from the government will declare war on cancer and will get cancer research UK to go and get the funds and sponsor the people. So there is this push that although I know nothing about business and economy, we all push to understand that there is this push for socioeconomic benefits of science. And the government, whether it does not have the money to sponsor it or the will, I don’t know, pushes the industry to justify their ethics and get us together. And they basically just, I think... Well, probably this is not going to look good for me, but maybe in terms of the UK maybe they need to start getting a bit more guts and actually put the money where their mouth is. It’s not trying to push, you know, a giant and a child together and get the solution from there. That’s what I think. That’s what we’re trying to do with industry and academia. Adam Smith. I think we have 3 people wanting to answer you. Bruce, do you want to say something? And then Peter and then Kemal. Bruce Beutler. Can I return to the issue of funding and of how it could be made better? I do think that the peer reviews system for grants is terrible now in the US. I think nobody would disagree with that. Used to be a great honour to be on a study section and there were really distinguished scientists there. And now the usual situation is I don’t recognise any of the names. And you can read about these people who are on your study section and you’ll find they’ve published almost not at all. Don’t have grants themselves. Lately I’ve been a participant in some grants, grant reviews, that are done entirely over the internet, no face to face discussion at all. Just let’s say an hour for a quick presentation and comments from everyone by a website. And then another hour or so during which you can read over the other grants. Now I think this is just terrible. It’s almost like no review at all. It really is almost random who gets grants. There isn’t really good oversight. That could be greatly improved very easily. One could make it an honour again to be on the study section. One could get a grant for it for example. And then things might go better. Adam Smith. Michel, did you want to talk to that point or? Michel Goldman. Yeah, in terms of funding obviously governments are important for public funding. We should not forget about another important source of, I would say, non profit funding which is obviously the charities, the philanthropists. Obviously the Bill Gates Foundation is a prototype of this. I think that there are more and more interesting organisations. For example in diabetes we are working with the Juvenile Diabetes Research Foundation. And actually they bring more than money. They bring the perspective of the patient when you assess the project. And very often they indeed succeed to bring the right experts around the table. Renata Mota Gomes. But is it right to rely on charities to fund national research? That’s what worries me because if charities in the UK stop finding money to fund research 90% of us will be out of a job. Michael Goldman. It depends how it is organised. But I think that you know you have charities which indeed can really provide significant help. I don’t know specifically the situation in the UK. We can discuss this after if you want. Peter Gøtzsche Just a little thing to you. What I was talking about was not, maybe I expressed myself a bit awkward. I wasn’t talking about a big chunk of money. What I was talking about is that good research groups should have some core funding. And it need not be very much. For example I just have 5 million Danish Krones. That’s less than €1 million a year. But the most important research I have done has been completely unfunded. And I’m not the only one. But many of my colleagues have experienced that these peer reviewers at funding agencies they just didn’t understand how important this funding was. And they didn’t give you the grants you needed. And then it’s wonderful. You have a little core funding so that you can go home and say: “Ok people don’t understand it. I’m going to do it anyhow because I have a little money.” And then you do it. And then people understand it. So, you know, there must be some core funding for researchers. Some of my best, brilliant American colleagues they have zero core funding and they give up now. They just don’t want to go on. And I understand that, this is wrong. Question. I’m from Newcastle in the UK. My question is around pre-clinical optimisation. So about who bears the risk in the processes of choosing which potential targets are taken through into clinical trials. So, Kemal, you already mentioned earlier about the number of potential targets which get as far as the clinic. But then there’s another drop off between those going into clinical trials and those which actually make a benefit for the patient. And in the UK there’s a drive towards, instead of monitoring outputs from funding in terms of for example papers published but in the number of targets which are produced. And so there seems to be a dichotomy between a drive to develop targets and yet an ultimate aim which is to get 1 or 2 successful targets. So how do we make sure that the process going from target identification to really effective treatment, not just going into clinical trials but effective output from a clinical trial is optimal? Kemal Malik. Well, I think if you look at where the most attrition occurs in the process it is from target identification, well, lead identification and optimisation through to getting through that early clinical testing. So pre-clinical and translational discovery. So first in man studies, proof of concept and pre-clinical. That is probably the most sensitive area. It’s the area that most pharmaceutical companies are trying to optimise is pre-clinical testing and that proof of concept translational research area. I don’t have the answer to it. But what I do know is that probably if you polled 20 heads of R+D in the industry and say for them: What is the most critical part of their R+D spectrum? They’d say that translational medicine area, which is taking candidates from pre-clinical testing, first in man and that initial testing. It’s where the greatest attrition but also the greatest opportunity is to profile drugs. And most companies have moved to things called proof of concept designs, optimising that area. So it is an area of high attrition, I couldn’t agree with you more. But no one actually has quite sussed it out. Michel Goldman. Yeah, I would say that this is an area where I think academics can really develop interesting projects and programmes. Let’s take drug safety. Let’s look at how now we try to predict side effects. This is not very efficient. We use very old methods, you know, animal studies which at the end are not very predictive. And there is a range of new approaches. For example in silico approach to predict toxicity which I think should be first developed in academia and which might be quite exciting to work on. So I think that it’s interesting that you raised the question. Then the next step is: What can we do in academia to develop the innovative tools that will indeed increase the efficiency of predicting, not only you know that the target is right in terms of drug efficiency but also try to reduce, you know, the risk of side effects at the end killing the drug at the late stage which for industry is the worst case scenario? Adam Smith. You still have the microphone I think. Do you want to make any further comment? Question. I just wonder whether there’s any clarity on what’s going wrong at that initial... at the pre first in man stage because we really have to get that right. It’s unethical to put a drug into a man if we’re not sure A that its safe and B that it’s got a reasonable chance of being effective. And the attrition says that we’ve got something wrong. Kemal Malik. You’re right. I mean clearly we don’t want to take things into man where we don’t think they’re going to work or we don’t think they’re going to be safe. So industry has an enormous amount of attrition. And several of the IMI projects are looking at that space. And once again that’s an opportunity for the best of the industry to work in collaboration with academia under the IMI umbrella. To say what are we not really understanding about that pre-clinical period? You know that 100 compounds that ends up with one. But you still only take about 10 into clinical testing. So you’re losing about 80 or 90 of them in that space. And that’s where IMI I think is useful. Bruce Beutler. I’ve a kind of related question that maybe the other panellists could answer better than I can and that has to do with the risk adverse nature of regulatory agencies like the FDA. How much of an impediment is that? I’m told that the reason no new adjuvants have been introduced or are not likely to be introduced is that fact that while not necessarily that great of an adjuvant, is very safe. And if vaccines are to be given to very large numbers of people then you don’t want to have even one bad response. Even though good adjuvants might open the door to vaccinating against things we can’t vaccinate against now. So how much is it a problem that regulatory agencies just tolerate no risk because that would be very bad for them? Adam Smith. Who wants to answer? Michel Goldman. Well, I think that there perhaps Europe has some advantage. I think that there is. That the approach at least at EMA... I know better EMA than FDA. But I think that if you hear for example senior medical officer of EMA, he will tell you clearly that you have to look at the risk-benefit ratio. And actually in IMI we develop new tools to assess the risk-benefit. I mean zero risk doesn’t exist as you know. So it’s really again a question of balance and of assessing objectively. That’s very important, you know, what’s the ratio. Just to give you one example. In IMI we are looking retrospectively at the history of natalizumab which is this drug against multiple sclerosis which was withdrawn from the market because of very rare side complications. You know, this progressive multifocal leukeoncephalopathy. And at the end the patient said: “Ok, it’s very rare. We are ready to take the risk because for us the benefit is so high.” And at the end the regulators accepted to introduce the drug on the market. So I think that we have really to build new approaches so that indeed regulators have in their hands tools which allow them to assess and to put metric which is not easy on this risk-benefit ratio. And at least in Europe we are putting a lot of efforts in that. Adam Smith. And it emphasises the role of the patient group in mitigating risk. Please another question. Question. My name is Genevieve Foster, I’m from Colorado State University. And my question may be a little bit off topic. So if that’s true please move on. But I wonder if we’re at a place now, I feel like we’ve identified some insurmountable opportunities perhaps. But moving forward supposing that we have established positive collaborations, are we at a place now where we can maybe look forward far enough and start to see what potential downfalls there will be with these collaborations? And will the discussions we can start having now to prevent the problems that will inevitably come with any system regardless of how fantastic it is now? Adam Smith. Nice question. Michel, you see many collaborations blossoming and they have long lives, they last for 5 years or more. What do you think the most common potential downside of those collaborations might be? Michel Goldman. Yeah, that’s a very good question. It’s not out of... you are really at the core of the question. I think that the most difficult aspect now is that everyone including companies recognise, and we heard this today, that collaboration is really needed. It’s probably the way forward. The problem is that you have many consorcia appearing everywhere in the world, not only in Europe, in the US, in Asia. But companies are global. So, you know, in a company like yours you have you know one department dealing with neuroscience. How can they engage seriously and efficiently in, I don’t know, 5 or 6 or 7 different consorcia on Alzheimer? And there can be some internal pressure in the companies to really work with these different partners around the world. So for me there is really... And that’s really in the hands of the companies. There must be a reflection how global companies can indeed deal with different collaborative approaches. And I think that there is really a need now thinking to the future to go to the next level. This is what we do for Alzheimer. There is the G8 and the OACD initiative. We’re trying to bridge and to establish links between the different collaborations which are ongoing. Otherwise we are really a risk. There is a name for the risk, this is the consortium fatigue. Which is now, you know, apparently a potential threat. Kemal Malik. One of the consultancy companies it was either BCG or McKinsey, I can’t remember which one, published recently an analysis of where industry/academia fails. They would look back at case histories of why they didn’t work and worked with industry and academia on this. Everybody was terribly excited about getting something going. So they didn’t actually establish clearly enough what both parties really were doing this for and why they wanted to and then agree that. So the most common reason to avoid that is actually... And it’s boring and its tedious and all of those things but spend time from both sides working out why you really want to go into this collaboration because then you can avoid some of the pitfalls downstream. Adam Smith. Ok, we have just 5 minutes left. Another question. Question. I work at the Max Planck Institute of Colloids and Interfaces in the field of drug discovery. And I have a couple of questions actually. One going back to your views about academia sharing their data. It’s great if we all share our negative data too, what went wrong, so we can then improve? But my career is not going to get far if I share my negative results. And I’m probably not going to find a job after that if I don’t have at least one nice paper even if it’s in E-Life. So that’s one comment/question and I’m asking about your opinion about it. And then the other trend I’ve been noticing. You, Kemal, said that companies see that they’re not productive in their R&D. But why do you keep getting bigger all the time? Why do you keep eating smaller companies? I mean not just you but why are there so many mergers on the market? Thank you very much. Adam Smith. Who wants to answer the one about negative data? Peter, go. Peter Gøtzsche If we talk about patient data we just have to share them. Patients run an unknown risk altruistically by contributing to trials. Out of respect for them we must share our data. There is no way backwards from now on. And it’s great to hear that Bayer and other companies will provide their raw data but I have a question to, Kemal, because what I have heard so far is that it is not freely available. There are obstacles. These companies have established committees so your project needs to get approved by committees established by that company. So what if I would like to study if a block buster actually kills people, would I get access to the raw data? We will wait and see what happens. So in my opinion this raw data should be made available to everyone without any obstacles. That’s the idea. Kemal Malik. Ok, I’ll answer that very quickly. Currently the consortium of companies I’ve talked about have an independent scientific review committee. We’re going to announce within the next month or so that that is going to be handed over to an independent charity totally separate from the companies, one of the world’s largest... I can’t mention it because they need to mention it. It’s one of the world’s largest medical charities. And let’s face it. There aren’t that many of them so you can probably work out which 2 or 3 it is. And they will administer it. It will be totally independent of the pharmaceutical companies. Why do companies take over other companies is because their R&D is failing. Companies that have poor R+D need to actually maintain their top line growth. The way they do it is they acquire other companies. It’s actually paradoxical because then they get larger and have even worse R+D. So they take over other companies and get even bigger. It’s an odd model. Adam Smith. Anything to be done about it. Kemal Malik. No, it’s capitalism. Adam Smith. Last question. Question. So talking about capitalism. We have been talking the whole session about how do you get the idea of developing a drug and how you get a drug that you can sell. But my concern is that for example we have been talking that the drugs are for the good of humanity. And I come for example from Columbia. And there I think in Columbia the medicines are the most expensive ones in the whole of South America. And you can only get that drug if you really pay for it or you show that you can pay for it. So at the end I think it’s really sad if we make all this effort of getting the drugs but at the end they are not fairly distributed among the whole humanity. And I don’t know if this is a concern for the pharmaceutical companies or for the funding agencies. Adam Smith. Or for both. Kemal Malik. Ok, very quickly. Most companies now are moving to something called tier pricing. So there’ll be one price charged in the United States and there’ll be a completely different price charged in developing countries. I’ll give you an example from a competitor which is in the public domain. The drug for hepatitis C, from Gilead which is costing like, I don’t know, a thousand bucks a pill in the United States. Its 1% of that in the developing world. There’s a bit of an issue for Americans because their taxes are paying for it in the United States. But in the developing world their price is 1% cheaper than it is in the United States. So tiered pricing is the way forward for the industry. Michel Goldman. Yeah, I think it is a very important point. That’s why in IMI when we are talking of access, it’s indeed access to market but also access to patients. And I think that for that we indeed need new models. And we need also new research on these models. And that’s why we have for example in our initiative new programmes where we put together health economists and scientists to reflect on this upfront. That’s a critical point and believe me this is true in your country today. It will become true in our countries tomorrow if we don’t change the system. Adam Smith. That’s a good point. Any closing remarks. We’re out of time. No, everyone happy. It’s an extremely important and far ranging topic we’ve been investigating. And we’ve scratched the surface a little. Thank you all for helping us explore it. And I’d like to thank you the audience and the panellists. Applause.

Panel Discussion (2014)

Academia and Industry – Exploring the Collaborative Landscapes of the Future; Panelists Beutler, Goldman, Gøtzsche, Gomes, Malik, Wang

Panel Discussion (2014)

Academia and Industry – Exploring the Collaborative Landscapes of the Future; Panelists Beutler, Goldman, Gøtzsche, Gomes, Malik, Wang

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