Life Science Leader Magazine

SEP 2013

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Exclusive Life Science Feature study. "Because of our involvement, AstraZeneca's investigational compounds are now the subject of three separate proposals that will receive funding via NCATS and allow our scientists to work together with some of the top academic research institutions in the United States." AstraZeneca and MedImmune have multiple iMeds (Innovative Medicines units) that conduct small-molecule and biologics discovery and early development together covering all of the therapeutic areas, with each iMed dedicated to a specific therapy area. Separate from the iMeds, an early clinical development function reports to Pangalos and is accountable for conducting the early clinical trial work on candidate drugs from the iMeds; it also provides a key link between the individual iMeds and late-stage clinical development. A small "emerging innovations" group of scientists and clinicians focus on repositioning AstraZeneca and MedImmune molecules into alternate indications, particularly those outside the core therapy areas, and open innovation opportunities around the world. The group initiated the collaborative drug repurposing efforts with NCATS and the UK-based Medical Research Council. A NEURAL NETWORK FOR NEUROSCIENCE Beyond AZ's "core" therapeutic areas in R&D;, where it sees the most immediate opportunities, the company has chosen to persist in other areas of "high risk" but potentially with high rewards. For CNS, perhaps the riskiest of spaces historically, the company has adopted an externally based model — closing internal programs and turning to a network of outside partners. The Neuroscience iMed will presumably deal with the risk as independent life sciences companies do — responsible to AZ as its chief "investor," but otherwise operating entrepreneurially and autonomously. "CNS is high risk because disease understanding is somewhat more limited, trials are particularly expensive and long, and clinical endpoints in some areas are challenging and quite subjective," explains Pangalos. "But research in neuroscience is actually moving rapidly these days, and some high quality academic and biotech groups are working in this space. So we wanted to work in the space in a more collaborative way." The iMed employs 40 experienced neuroscientists with expertise in biology, chemistry, clinical, toxicology, and all other aspects of neuroscience R&D.; In addition to coordinating external partnerships, the unit has access to AZ resources such as its high throughput screening, protein crystallography, and drug safety. It is charged with running research and clinical development of a portfolio using academic, biotech, and CRO networks. "What we want them to do is spend our CNS dollars on projects and innovative science, not bricks, mortar, and infrastructure." (See also "AZ's Neuroscience iMed — Virtual Model for a High-Risk Area.") EXCITEMENT & EXPECTATION FOR THE EARLY PIPELINE Even as this article was in preparation, more headlines arrived to AZ'S NEUROSCIENCE iMED — VIRTUAL MODEL FOR A HIGH-RISK AREA To gain further insights on AstraZeneca's new Neuroscience Innovative Medicines (iMed) unit, we spoke with John Dunlop, vice president, responsible for the unit's discovery and preclinical portfolio. additional programs. HOW IS RUNNING A VIRTUAL RESEARCH GROUP DIFFERENT FROM OPERATING A SIMILAR UNIT INSIDE THE COMPANY? By externalizing research into a collaborative model, we don't have access to our own neuroscience labs, though we can access other resources within AstraZeneca to help us move our portfolio. We are also free to look for the best opportunities and collaborations that we might find in the outside world. We spent a lot of time developing tools and infrastructure, including IT, that allow us to manage and oversee an external "workshop" of people on our projects. WHAT IS AN EXAMPLE OF NEW AREAS THAT THE EXTERNAL APPROACH HAS OPENED UP FOR YOU TO THIS POINT? We took an asset that was sitting in our portfolio and pursued historically for Alzheimer's disease and found a new indication for it. We looked at the whole totality of the data and found the compound was strongly implicated as a potential target for the treatment of complications of dopamine treatment in Parkinson's disease. So following where the science took us, we moved into an area that traditionally has not been an area of focus for AstraZeneca. Also, as an example of collaboration with the patient community, we are researching this compound in Parkinson's disease via a grant from the Michael J. Fox Foundation. WHEN YOU GO FROM AN INTERNAL TO AN EXTERNAL MODEL, WHAT HAPPENS TO THE LEGACY THAT YOU HAD FROM THE INTERNAL MODEL? We built the foundation of the group on a set of projects that came from the legacy organizations in both AstraZeneca and MedImmune. We spent a lot of time with knowledge transfer, and half of our current team came from those organizations. But it was important early on to make sure that we transferred the resources and capabilities of those projects to the now large network of external CRO and academic partners. Then we could supplement the portfolio by both seeking opportunities on the outside as well as thinking about starting HOW DOES BEING AN EXTERNAL GROUP AFFECT YOUR WORKING RELATIONSHIP WITH CORPORATE MANAGEMENT? We have been given quite a significant amount of autonomy, especially in the early-stage portfolio. We have an allocated budget for our group, and we make decisions without too much need to check in with the larger organization on how we allocate those resources. We tend to have a much closer alignment with the larger organization as molecules advance closer to our clinical development, especially in oversight for patient safety. We must also think about how our programs will fit strategically with AstraZeneca. 34 LifeScienceLeader.com September 2013

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