Business
opinion-forming working parties of industry- respected practitioners to think through and find widely-accepted solutions to resolve issues that inhibit innovation. Part of the modus operandi of the Pistoia Alliance is to encourage the cross-company con- versations that identify the most pernicious exam- ples of resource-wasting replication of pre-com- petitive research activities – and then to launch project teams to address these challenges. At its founding in 2009, The Pistoia Alliance set out a programme of work around the following tech- nology pilots:
Figure 3 Historical trends in storage
prices versus DNA sequencing costs. The blue squares describe the historic cost of disk prices in megabytes per US dollar. The long-term trend (blue line, which is a straight line here because the plot is logarithmic) shows exponential growth in storage per dollar with a doubling time of
roughly 1.5 years. The cost of DNA sequencing, expressed in base pairs per dollar, is shown by the red triangles. It follows an exponential curve (yellow line) with a doubling time slightly slower than disk
storage until 2004, when next generation sequencing (NGS) causes an inflection in the
curve to a doubling time of less than six months (red line). These curves are not
corrected for inflation or for the ‘fully loaded’ cost of sequencing and disk storage,
which would include personnel costs, depreciation and
overhead. Stein. Genome Biology 2010 11:207
doi:10.1186/gb-2010-11-5-207
that those resources are not optimally deployed – indeed are wasted – by R&D organisations. This is caused by companies replicating precompetitive activities rather than pooling their resources to achieve common, shared objectives. Other com- mentary focused on research processes and their information flows not being ‘joined up’. Furthermore, those processes that occur in the reg- ulated domains of the industry – and hence are subject to validation – come under scrutiny. Are the approaches to validation in general, and com- puter systems validation in particular, fit-for-pur- pose in today’s sophisticated technology age? Validation practices could be considered obsolete, very time-consuming, very expensive and as such discouraged adoption of newer and more agile, ‘innovative’, computer systems, such as cloud- based SaaS solutions. Our respondents were frus- trated with pharmaceutical industry senior man- agement being captivated by the allure of serendip- ity or the ‘lucky strike’. Senior management seemed unwilling or unable to get to grips with some of the fundamentals of R&D operations that so urgently need to be re-engineered to enable, rather than hinder, the innovative work of the R&D scientists.
These challenges are tractable; none is insur- mountable. If senior management in pharma R&D were to engage in R&D operational excellence, companies could make rapid progress in overcom- ing these barriers to innovation. One ready-made approach would be for them to directly investment in, and provide active and engaged support for, the work of organisations such as the Pistoia Alliance. For it is these not-for-profit, cross-company organ- isations that are ideally positioned to establish
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l Sequence Services: Defining and documenting an externally hosted service where organisations can securely store and mine both in-house derived gene/sequence information as well as the public domain gene databases. l SESL (Scientifically Enriched Scientific Literature): Exploring the feasibility of an
Amazon.com-like ‘brokering service’ that scientists can use rapidly to gather information on disease- causing genes. l Electronic Lab Notebook (ELN): Defining a common standard that would enable scientists to use the same query across any and multiple ELNs. l VSI (Vocabulary Standards Initiative): Defining and publishing a standard, vocabulary-based methodology for querying the scientific literature and bioinformatics databases such that all hits are found against molecular drug target search criteria rather than a subset.
The Sequence Services Project exemplifies how precompetitive collaboration can produce useful solutions. Life science R&D needs access to both public and proprietary gene sequence data. Historically, each lifescience R&D function has taken a copy of the public domain data and mounted it safely behind the company firewall. In this self-evident security, scientists have used simi- lar or the same software tools to compare and con- trast their corporate-specific gene sequence data with public domain data in order to make scientif- ic decisions. But times have changed. The technol- ogy of gene sequencing has become so advanced that the production, quantity and availability of gene sequence data is outstripping Moore’s Law’s ability to accommodate it (Figure 3)12. As the Red Queen told Alice: “It takes all the running you can do, to keep in the same place”13.
Phase 1 of the Sequence Services project brought together bioinformaticians from several pharma companies under the aegis of the Pistoia Alliance to
Drug Discovery World Summer 2011
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