Roche: Shafique Virani. Focusing on areas of great unmet clinical need in Neuroscience and Metabolism




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Video title: Roche: Shafique Virani. Focusing on areas of great unmet clinical need in Neuroscience and Metabolism
Released on: December 12, 2012. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BioEurope 2012 in Hamburg, Germany, Fintan Walton talks to Shafique Virani, the Global Head Neuroscience Cardiovascular and Metabolism Partnering at Roche
Roche's focus on three major therapeutic areas
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioEurope in Hamburg, in 2012. On this show I have Shafique Virani, who is Global Head for Neuroscience Cardiovascular and Metabolism Partnering at Roche, welcome.
Shafique Virani:
Thank you Fintan, it's a pleasure to be here today.
Fintan Walton:
We want to learn a little bit more about the partnering strategy for Roche in these three areas that you have responsibility for, neuroscience, cardiovascular and metabolism are large therapeutic areas, very important therapeutic areas, so with that in your remit, as part of your objectives, what are you looking for?
Shafique Virani:
So thank you, so both neuroscience, cardiovascular and metabolism are our key areas in our ex-oncology portfolio. As we all know Roche has had a very strong heritage and legacy in oncology with Genentech, but moving forward these two areas are absolutely key pillars to drive our growth in the future. So both portfolios are maturing quite nicely in the development stage, especially neuroscience portfolio, and we essentially have two key areas of focus within neuroscience and they go along the traditional pillars of neurology and neuropsychiatry. And when we delve into this further we've had a huge commitment to Alzheimer's disease and neurodegeneration in general, both disease modifying approaches, and also the quest for looking for improved symptomatic therapies, the unmet need remains huge in this area, and you know Alzheimer's disease has gone at a lot of press attention both in terms of the epidemiology, but also in terms of some of the high profile drug candidates that have made it to Phase III and perhaps have not managed to demonstrate benefit to patients. So it's an area that's of deep focus to us, and in that portfolio I think we have a ground breaking program with our antibody for Abeta which is the first large molecule being tried out in the prodromal Alzheimer's patient, and perhaps just to qualify prodromal disease is quite a new notion and really the essence is to try and capture the disease as early as possible. So here we are looking for very early stage clinical science coupled with a pathological biomarkers signature in the CSF. So we are very excited about that trial and we truly believe that intervening at this early stage will give us perhaps the best avenue to demonstrate benefit to patients with Alzheimer's disease.
Fintan Walton:
Sure.
Shafique Virani:
Going further we have an inherent interest Parkinson's disease as well along with Huntington's disease, ALS those are our key areas of focus within neurology. We also have a late stage program in multiple sclerosis with ocrelizumab, which is a CD20 corrected therapy, and that's currently in large Phase III trials. So that's our neurology portfolio in its entirety, and then in neuropsychiatric the focus is very much on again on unmet need and coupling that with evolving science and biomarkers. So here we are looking at refractory states of diseases, treatment-resistant depression is an area of focus for us, two Phase IIb programs in that particular arena, and then a Phase III program a very exciting program with the glycine inhibitor for negative symptoms in schizophrenia.
Novel therapeutic researches of Roche
Fintan Walton:
So those are the programs that you are pursuing, but in terms of looking for new products, what's the, are you looking for complimentary products?
Shafique Virani:
We are to an extent, you know there was another new franchise that was created called neurodevelopmental disorders, which is looking at behavioral disorders in children primarily, so this was doing by our quest to try and make a difference in autism spectrum disorder. Now this is an incredibly complex condition, very complex heterogeneous phenotype, and we are learning as science is evolving as to you know what pathways may be involved here and we currently have a few active programs in mid-stage development, but in this particular area we remain very open across the value chain all the way from promising approaches in early research but also programs that have shown some signal in related conditions such as fragile X syndrome that would give us clues as to what it would take to make a difference in autism spectrum disorder.
Fintan Walton:
Right, so these are really novel areas of research?
Shafique Virani:
Absolutely.
Fintan Walton:
A breakthrough potentially?
Shafique Virani:
Yes break through, and as most of our peer pharma's are exiting neuroscience, our investment in neuroscience is actually increasing, because we truly believe that one the science is evolving, and two the unmet need remains incredibly high in this area. So those are the two adding principles for most of our approaches at Roche.
Main focus of Roche in cardiovascular area
Fintan Walton:
Okay, now the cardiovascular area is obviously another huge area, how do you distinguish the areas that you want to focus on?
Shafique Virani:
Yes so for cardiovascular and metabolism the needs are different, this is a portfolio we are building at the moment. Our key sort of talents of focus in this area are around type II diabetes in cardiovascular risk, we are also very keen to understand end stage organ failure in diabetes, so this includes kidney so diabetic nephropathy, the eye diabetic retinopathy and also then looking at sort of ophthalmology in its own right with various forms of macular degenerations, so those are areas of focus for us within cardiovascularmetabolism.
Fintan Walton:
Right.
Shafique Virani:
In addition to that there also is an unmet need as far as specialty care of cardiovascular medicine is concerned. So here again we are looking for improved therapies, perhaps more in the hospital stroke acute setting on that, but as I mentioned we are in the mode for building this franchise and the need perhaps compared to neuroscience is more acute in terms of needing promising approaches, molecules especially within the late stage research Phase II space, so we remain very active from a business development standpoint in that respect.
Roche's competition in pharma industry
Fintan Walton:
Right, now obviously you are out there competing with other pharmaceutical companies who are interested in the same space?
Shafique Virani:
Sure.
Fintan Walton:
So how are you differentiating yourselves in that respect?
Shafique Virani:
One of the core capabilities that Roche brings to the table is its strength in translational medicine, I mean I think if you look at our portfolio of mid to late stage compounds really almost 80% of those successes to date can be attributed to strengths in translational medicine, this could be appropriate dose selection, receptor occupancy, imaging, biochemical analysis and this is really very much in keeping with the structure at Roche where we are in a fantastic position to have the largest diagnostic organization out there that's coupled with pharma and what we've done very judiciously over the past four to five-years is really create this bridging structure in the middle which is clinical research and exploratory developments stroke translational medicine. So from a very early stage we start looking for companion diagnostics for our therapeutic programs, we start, we make a very strong endeavour to try and understand how we can understand more about surrogate end points, biomarkers to help us stratify clinical trial populations really with the ultimate quest to find that medicine that's going to make a difference. And in neurosciences this is particularly important, because we all hear about the placebo effect, up to 30, 40% of the patients show a placebo effect, so the more targeted we can be towards finding the patient who will respond to therapy I think that will serve medicine well in general going forward.
Complications in recent deals
Fintan Walton:
And does that mean that the types of deals you are doing now are more complicated than they were in the past?
Shafique Virani:
Certainly the deals we've been doing in the past, sort of two to three-years have been, perhaps construed as complex but really I think the point here is that we are very keen to tap into external innovation, we are very keen to ensure that there is a win, win scenario for ourselves and the partner, because ultimately we are doing deals to leverage expertise from our partners and it's very important that they get to remain nimble and operationally capable to really realize that value they are bringing to the table. So depending on the needs in our portfolios all the way from looking for mid-stage programs to fill in the clinical portfolio to perhaps other needs that are considered more in terms of keeping the portfolio sustainable over a 10, 15-year period, so here we are looking at early stage discovery deals, we are looking at deals where we partner with academia and bringing new targets and then some more complex deals, for example the Inception deal [PharmaDeals ID = 49943] we've signed recently where we are really trying to marry parties who have an interest in early stage research and development, so we bring in the venture side of things here to share the risk and to really enable that key technology that sits in academia.
Fintan Walton:
I mean when you say the venture side you mean venture capital themselves or rather than just Roche ventures?
Shafique Virani:
Venture Capital, absolutely, yes this is primarily with venture capital outside.
Fintan Walton:
Yes, sure. So people have to be a little more creative in the way they think about deals?
Shafique Virani:
They do indeed.
Fintan Walton:
And so does that creativity assist you in making sure that you are doing the deal in the end?
Shafique Virani:
It's hugely enabling we feel, because at the end of the day I think R&D productivity has been a key issue that large pharma has been faced with, we have to get more sort of creative and apply out of the box thinking in terms of how do we, now do one of two things you know ensure that we are getting a pipeline of the best innovation that sits externally within the company, but also within perhaps a fixed cost budget structure also enable those dollars to go as far as possible, so here we are bringing the context of bringing in investors to risk share with us, but also construct deals that give us an avenue to make an early stage commitment and then perhaps to think about exits at predefined terms as opposed to market prices down the road.
Fintan Walton:
Right, and is that partly driven because funding is less available for some of these biotechnology companies, I mean you are focusing on these areas of great unmet clinical need?
Shafique Virani:
That's right.
Fintan Walton:
Which is, and of course they carry quite a high risk so they are less likely to potentially get the funding from venture capital, is that correct?
Shafique Virani:
That is very correct and this is what we are seeing out in the external environment. VC's now that make investments into very early stage research that 10-year return cycle is getting, that's few and far between as far as VC's are concerned, so I think big pharma has a large role to play here either in terms of forming direct partnership with academics but also then making investments with venture capital into some of these areas where, and again with advances in translational medicine I think the period of return can be shortened, so for example again coming back to the Inception deal [PharmaDeals ID = 49943] we just signed, not so long ago, the exit, the first sort of exit is within the sort of five, six year time frame on that. So that's very much different from the traditional 10-years cycle that the VC's have been accustomed to as far as early investments are concerned.
Fintan Walton:
Okay. Shafique, thank you very much indeed for coming on the show.
Shafique Virani:
Pleasure to be here.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Shafique Virani
Global Head Neuroscience Cardiovascular and Metabolism Partnering
At the time of this PTV interview Shafique Virani serves as Global Head Neuroscience Cardiovascular and Metabolism Partnering at Roche. As Head of CNS Partnering, Shafique Virani leads Roche's search for external innovation in the Central Nervous System disease area. His team is responsible for driving forward the CNS deals that hold the most promise for patients and their careers coping with devastating diseases such as Alzheimer's, Parkinson's and schizophrenia. Having been Director of Global Business Development for CNS in Nutley since 2006, Shafiquehas played a leading role in many CNS partnering evaluations, including platform technologies, research agreements, as well as product licensing and M&As. Shafiquejoined RocheWelwyn in 2004 and worked as Senior Medical Advisor for the hepatitis franchise, where he was recognized with several awards for his contribution to the business in the UK. His commercial career began in 2002 at PPD Development in Cambridge, UK, where he was a consultant for neuroscience development. Prior to that Shafique's medical experience was in neurosurgery, which was gained from 1994 at Addenbrooke's Hospital, University of Cambridge, UK, and Massachusetts General Hospital, Harvard Medical School, USA. He has a medical degree from the University of Nottingham Medical School, UK, and is a Fellow of the Royal College of Surgeons in England.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialization.
Roche
As a research-focused healthcare company, Roche discovers, develops and provides innovative diagnostic and therapeutic products and services that deliver significant benefits to patients and healthcare professionals " from early detection and prevention of diseases to diagnosis, treatment, and treatment monitoring. Roche was founded on October 1st, 1896. The founder, Fritz Hoffmann-La Roche, was among the first to recognize that the industrial manufacture of standardized medicines would be a major advance in the fight against disease. From the very beginning, Roche's visionary founder focused his company on innovation and on establishing an international presence. This multinational presence reinforces our ability to offer our healthcare solutions and to anticipate needs in all regions of the world. Today, Roche employs over 80,000 people and sells its products in over 150 countries. Today Roche ranks among the world's leading healthcare companies and has two strong core businesses: diagnostics and pharmaceuticals. Roche's prime objective is to identify and meet the patient's and customers' needs. This implies solving their problems and anticipating their future needs by maintaining close contact with them and listening to what they say. Roche focus resources on two research intensive businesses: pharmaceuticals and diagnostics and aim is to develop new and improved drugs, diagnostic tests and services offering significant benefits over existing options.