Specialized areas of developmentFintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioEurope in Hamburg, in 2012. On this show I have Susan Galbraith, who Heads up Oncology at AstraZeneca together with Tim Herpin, who is Vice President of Strategic Partnering and Business Development Specializing in Oncology at AstraZeneca, welcome to you both.
Susan Galbraith:
Thank you.
Fintan Walton:
Susan, AstraZeneca has a very strong history in oncology, I suppose the burden is on you to make sure it continues to have a strong focus on oncology and excels in oncology, so could you describe to us where AstraZeneca sits in relation to oncology? What type of areas or specialized areas are you developing?
Susan Galbraith:
Sure, so obviously as you said we have a history in particularly in the hormonal therapy of breast and prostate cancer, and in the early development of personalized care for lung cancer patients with the development of Iressa for EGFR mutated lung cancer. Our early development portfolio is designed to build on the strengths of those, we have strengths in the p10 pathway, AKT and dual TAK inhibitors that can help to combine with hormonal therapy in breast and prostate cancer and overcome resistance to those therapies. We have strengths with the acquisition of KuDOS [
PharmaDeals ID = 23004] in DNA damage repair where we are using our compound Olaparib, which is a PARP inhibitor, which is in Phase II developments and we got exciting developments with that compound in both ovarian and breast cancer. And then again in addition we've also got early programs in enhancing apoptosis so building on cell death, and I think really exciting thing is about the opportunities to put some of those compounds together, because anyone area is unlikely to completely overcome the multiple mechanisms of resistance that cancer can have and so understanding which are the right patients to treat with a particular combinations I think will enable us to make that next step forward in the treatments of these diseases.
Strategy and approachFintan Walton:
Sure and obviously we just must make clear that you are responsible for the, from discovery all the way up to Phase II proof of concept basically, you've just described to us there quite a range of approaches, each of those have certain benefits for certain particular types of cancer, so how do you from a strategic point of view decide what's going to you, what you going to keep and what you are not going to keep?
Susan Galbraith:
Well I think there is a mix, it's been clearly there are understanding the disease areas, I think it really starts with understanding the heterogeneity of the patients diseases, so it's focusing on particular disease areas and building platforms of the right kinds of preclinical models so that we can understand those well and then match those to the drugs that we have in the portfolio, so that's one example. So for example in breast cancer and in lymphoma we are building panels of the right kinds of tumor models, understanding the breadth of the cell lines that we've got, building the right kind of in vitro and screening methodology and understanding the molecular phenotypes there, and also then having the right kind of xenograft models with an increasing number of primary explant xenografts so that that replicates better the true heterogeneity of the disease that exists in the patient population and that means that we can test combinations more rationally. So I think it's not just about identifying the right patient for an individual drug it's then about anticipating what combinations are going to emerge and having the strength in the portfolio and in the platform to help put those together.
Fintan Walton:
Right, right and of course we also need to point out that your area of responsibility is largely for small molecules and then for larger molecules in oncology that tends to go to MedImmune?
Susan Galbraith:
Yes, so there is I have an equivalent Ed Bradley, who heads up the large molecule innovative medicines group, and we work closely together obviously, I mean I think one of the exciting areas in lung cancer for example you know building on Iressa experience we've now understand that lung cancer is getting more segmented, different pieces of that disease that can be treated by different targeted therapies, but again ultimately though the patients benefit from those, the survival curve sadly still tend to end at zero, and I think one exciting development is the opportunity to develop immunotherapies in this area. We have seen exciting data with anti"PD-1 and PD-L1 antibodies and the MedImmune portfolio has a number of immune mediated targeted therapies and that are coming forward that I think can combine very well with the range of targeted therapies we have for different segments. So for example we have data that we published with Selumetinib, a MEK inhibitor in lung cancer, ASCO last year and I think it will be interesting to see how EGFR therapies and MEK inhibitors and ALK inhibitors might be combined with immunotherapies to help move that disease forward.
Opportunities and partnership strategyFintan Walton:
Okay, well I will turn to you now Tim, because obviously as Susan just described you've got a quite a broad range of activities already, of course your job and role is to go and out there and make sure that there your, first of all obviously aware of what other new approaches to therapy are taking place, so obviously you two work together, so Tim how would you describe how that works, and how does that set your objectives in terms of what you are looking for when you go out and look for opportunities?
Tim Herpin:
So since the beginning of the year we've had a new way at AstraZeneca to work between business development and R&D. There is a group within Susan 's organization who is dedicated to working with business development to help us identify opportunity and drive the scientific evaluation. So this is a bit of a new model for us, but it really gives us the ability to have scientists that are dedicated to externalization, it gives us a better heads up on what are the hot areas of science and gives us the ability to be a bit better at being proactive in looking in the areas that are promising, it also gives us the ability when we work with an outside partner to have someone clearly within the company that is going to be the scientific champion for the opportunity and that's helping us quite a bit in our relationships with potential partners.
Fintan Walton:
Right, okay so obviously when you go out as you come to here in Hamburg at BioEurope you've got a presumably you've got a shopping list of opportunities that you are trying to look out and you are trying to establish those relationships, so how do you compete then with the other major pharmaceutical companies who are probably looking at the same prizes that you are looking for, how do you do that?
Tim Herpin:
Yes, so as you allude to, the field in oncology is very competitive for quality opportunity, the way we do that is really twofold, on the one hand we really try to be proactive at building relationship and dialogues with company early, when they are in the early stage of developing their science, and then the other way as we mentioned we have people in the R&D organization that are dedicated to working with us and basically it gives us an ability to have an early sense of what are the hot areas, what are the areas that we should go after.
Fintan Walton:
Sure, so that comes back to you Susan I suppose, because once the collaborations are set up with Tim's group with these external biotech companies, may be the universities as well, presumably you are looking at your research and development activities as both internal and external activities?
Susan Galbraith:
Yes absolutely, I mean we've already achieving 40% of the pipeline coming from external partnerships. I think when you have got a field that's large and complex like oncology is the idea that there all the innovation is going to come just from inside the you know your four walls is unrealistic, it's na"ve. So I think it's very important that we look outside and that we partner effectively with people on the outside so that together we are more likely to be successful in terms of moving things forward and people want to know that they are going to partner the compound that they've been working on, on the program that they've been working on, with a company that's going to take it very seriously and going to move it forward as aggressively as they can in the right patients and we are committed to wanting to do that, it's really about what we want to do is get the right drugs to patients and that the range of those options can come from inside AstraZeneca or outside, the two drugs I've mentioned earlier for example are both in-license opportunities.
AstraZeneca's role in personalized medicine areaFintan Walton:
Sure, so I suppose the other element that's come in particularly in the area of oncology is personalized medicine, you've already talked about combination drugs but also combination with diagnostics and so forth, so how does that play at AstraZeneca at the moment?
Susan Galbraith:
So we have a group called personalized healthcare on biomarkers which was set up a couple of years ago to make sure that we've got the dedicated expertise and understanding of what it takes to produce the companion diagnostic, however our strategy is to be a pure play biopharmaceutical company and not to be a diagnostic company, so our idea is we need to understand how to develop our drugs with the right patients and partner effectively with the right diagnostic company to help deliver that through into a you know with a companion diagnostic that's qualified and validated and well ready to meet the regulatory authorities needs.
Opportunities in diagnostics and types of dealsFintan Walton:
Okay, I suppose then Tim for you when you are all out there again looking at opportunities, you are looking at things that include diagnostics, that include underlying technologies, platform technologies as well, tell us a little bit more about the types of deals you are doing in that area?
Tim Herpin:
So let me clarify a little bit the way we handle diagnostic, as Susan mentioned we have the separate group within AstraZeneca that looks after personalized healthcare and that group has a dedicated BD component, so there is actually a small BD group that is actually focused exclusively on these diagnostic opportunities. We tend to, in oncology we tend to work very closely with them because any compound opportunity that we look at has a diagnostic component, so we'd actually proactively as we try to put that deal together work with the diagnostic group to find out who could we partner with to bring in that component as we try to develop the compound.
Importance of Biomarkers in terms of approach to oncologyFintan Walton:
Right, I suppose that feeds into the area of biomarkers and then also obviously clinical endpoints, I mean how important is biomarkers now in terms of approach to oncology?
Susan Galbraith:
Well it's critical, I mean we are measuring the quality of the programs that we've got using a system that we are calling the Five R's, you know it's perhaps the right patient being one of those five R's, so right from the beginning in terms of where we are going from discovery we are trying to work out which are the right patient populations to use. Another one of the five R's is a right tissue and exposure, to show that early on typically in Phase I get confirmation, we've actually hit the target that we've identified hard enough and for long enough that we can be reasonably confident it may translate to a clinical effect on the tumor. So there is two different uses of biomarkers, one is to identify the right patient population, the second is to confirm that you are hitting the target effectively in the tumor tissue and that's a core component of what we do. So in addition to personalized healthcare group that we mentioned earlier we've also got a strong translational science group within the innovative medicines structure to help build both the discovery knowledge about how the science is segmenting, which patients then are grouped to test and the early exploratory developments of biomarkers both for pharmacodynamic assessment as well as for prediction of the patient population that can then evolve into the companion diagnostic.
Relationship with MedImmuneFintan Walton:
Right, I suppose the thing that comes to my mind is that this knowledge has to be shared with MedImmune as well, because obviously there is a complementary activity is going on between the two parts of the organization?
Susan Galbraith:
Yes absolutely, so the personalized healthcare group does serve with MedImmune in the small molecules needs, and the two translational science organizations are speaking to each other all the time about the data that we have in the exchange of the platforms, so yes absolutely it's critical.
Deals with Hutchison Medi Pharma, Regulus, PTC and PeptiDreamFintan Walton:
Okay and Tim just could you give us some examples of some of the deals you've done in the last twelve months?
Tim Herpin:
Sure, so probably the first one we should mention is a deal we did about a year ago with Hutchison Medi Pharma [
PharmaDeals ID = 44597], which is a Chinese company, and this was for a c-Met inhibitor that was about to get into Phase I. What's interesting for us is it was an ability to work with the Chinese company and the way the deal is structured is actually we co-develop with them in China and then we get the rights outside of China, so it gives us the ability to work with a local partner on developing a drug in China.
Tim Herpin:
Yes, so we've also been quite active on the platform technology side, so in oncology we've been interested to get access to technologies that allow us to address targets that are difficult to handle with other small molecules or biologics. So for example this year we did a deal with Regulus [
PharmaDeals ID = 48158] for both cardiovascular and oncology, which is a way to work in the microRNA space, which for us was interesting. Last year we did a deal with PTC [
PharmaDeals ID = 41604] which again gives us access to a technology that allows to identify compounds that modulate the expression of the particular protein, and then early this year we did a deal with PeptiDream [
PharmaDeals ID = 49578] which gives us access to another chemical space which again is another way to address difficult to drug proteins.
Fintan Walton:
Right, and just in terms of the types of deals that you do now, have these deals bit a little more sophisticated than they were in the past or you still doing sort of straight forward licensing deals?
Tim Herpin:
I think the range of deals that we do is broader than what we do in the past, than we were used to do in the past. I think we are becoming much more sensitive to the need of the partner as well as I think the needs of the partner is becoming a bit more complex over the time.
Tim Herpin:
I think we are being a bit better at leveraging our capabilities particularly when it comes to personalized healthcare and so finding the right type, the right time to partner and the right deal structure so that we can actually work with the partner to use our capability in their compound leads us to deal structures that are a bit more complicated and a bit more sophisticated.
Future programs in R&DFintan Walton:
Right, and I suppose Susan just in terms of where you go with your research and development, because obviously this whole area is still, there is lot of breakthroughs happening on a regular basis, how much of a steer would you take, how much of a shift away from your existing research and development would you make if you saw some new breakthroughs coming in an area that you are not actually active at the moment, but may be coming through either at a university level or at a biotech level?
Susan Galbraith:
Yes so I think there is a couple of points that you've made in that, first of all the whole fields of the cancer biology has multiple different specialized pieces within it and so to be really good at all of them is a challenge, so I think we've chosen to focus on some of the areas that I spoke about earlier and what we do in the areas that we think it might be breaking, so cancer metabolism is one, as we've done a deal with Cancer Research Technology [
PharmaDeals ID = 34890] and [
PharmaDeals ID = 25183] where we are sharing some of the resource across that piece in the discovery space and at the time when we have programs coming through that we think are close to that proof of concept it means that we can be more flexible in terms of how we approach that resource, and there is a couple of other examples like that where, I don't think we want to sort of, we want to be able to understand what's happening in that area well enough so that at that time that you get to a tipping point you can move quickly to upsize the level of resource that you put up on that particular area. So that's how we are trying to approach the core areas that we are going to be strong in, and because I still think they are going to have sustainable opportunities for discovery for several years to come, and other areas that may break and may emerge where we will partner often with academia or other collaborations or sometimes with biotech in order to be well positioned in those areas at the time when the technology is breaking.
Fintan Walton:
Susan Galbraith, and Tim Herpin thank you very much indeed for coming on the show.
Susan Galbraith:
Thank you.