Business
References 1 Spotlight on Drug Innovation: An ongoing update of FDA’s novel new drug approvals of 2011. 2 Pharma 2020: Which path will you take? PwC report – November 2009. 3 Paul, Steven M, Mytelka, Daniel S, Dunwiddie, Christopher T et al. How to improve R&D productivity: the pharmaceutical industry’s grand challenge. Nature Reviews Drug Discovery, Vol. 9, No. 3. (19 February 2010), pp. 203-214. 4
http://www.fiercepharma. com/story/2010-pharma-job- cuts-cross-50k-mark/2010-12- 01. 5 Kaplan, Warren. Benefit, Risk and Innovation in Pharmaceutical Research and Development: Opportunities and Issues – JD, MPH 7 October 2004. 6
www.fda.gov/CriticalPath. 7
http://apps.who.int/
medicinedocs/documents/s142 08e/s14208e.pdf. 8 European Federation of Pharmaceutical Industries and Associations. 9 The Innovative Medicines Initiative (IMI) Strategic Research Agenda. 10 US Government Accountability Office (GAO), New Drug Development, Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts.
http://www.gao.gov/new.items/ d0749.pdf. 11 Standardization in Lab Automation,
http://www.sila.coop. 12 Stein, Lincoln D. The case for cloud computing in genome informatics.
http://genomebiology.com/201 0/11/5/207. 13 Thornber, S, Kallesøe, CS, Wise, JCM. The Pistoia Alliance –The Sequence Services Project. G.I.T. Laboratory Journal Europe, Issue 1-2/2011. 14 http://www.pistoiaalliance. org/workinggroups/sequence-
services.html.
formulate the business, scientific and functional requirements for a common, shared, externally- hosted sequence service. Performance, availability and security capabilities were all considered. Four technology vendor companies or consortia were then selected to build functional and testable sequence service installations14: Constellation Technologies and Microsoft, Eagle Genomics and Cognizant, Infosys and Thomson Reuters. The working group then checked the security robust- ness of these systems through an independent ‘eth- ical hack’ carried out by AT&T. The resulting proofs of concept are publicly available from the vendors for evaluation.
Phase 2 of the project will supplement these already demonstrable businesses and scientific capabilities with an enhanced, cross-company, commonly-defined scientific toolkit including open source codes as well as workflow. These requirements will be published as an RFP in mid- 2011 and the vendor community will have the opportunity to display its technical and business prowess in meeting these requirements cost-effec- tively and securely.
The benefits of such precompetitive work are clear to all the stakeholders. The larger lifescience R&D companies are looking to reduce their cost of sequence services by at least 50% thereby liberat- ing resources for innovative, transformational projects. Some of the smaller lifescience R&D companies – who so far have been unable to afford the technology to perform these sequence services – envisage a future where they too will have access to this fundamental, non-discretionary, scientific toolkit through the cloud. The Sequence Service providers see the opportunity to generate revenue.
Conclusion
The pharmaceutical industry certainly pays lip service to ‘innovation’, but is it really committed to achieving it? What is evident is that there is no clear strategy of how innovation should be encour- aged. At a high level, innovation is undoubtedly a complex function of patients’ needs, providers’ capabilities, appropriate funding, regulatory frameworks, incentive mechanisms and intellectual property rights. Nearer the research bench, though, innovation may have more to do with sen- ior management getting actively engaged in some of the detail of R&D operations. How does the CIO think he is supporting R&D? What are the reasons why legal will not let R&D information be stored in the cloud – and can those reasons be addressed? Pharma in general and pharma R&D in particular is a high-risk business in dire need of
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innovation; critical service functions, eg IT, legal, procurement and QA should partner with R&D to understand this need and cut through red tape to create a true innovation culture.
The Pistoia Alliance is firmly committed to sup- porting R&D at the research bench. Its project teams identify common use cases, establish best practices, define user requirements, create proof- of-concept implementations, signpost standards, and offer thought-leading perspectives on how pre- competitive collaboration can lower barriers to innovation. Our members are committed to encouraging expert, external, systems suppliers to provide hosted, secure, shared resources to support R&D processes in the precompetitive domains of the life science R&D industries.
The Pistoia Alliance is particularly keen to receive readers’ ideas about innovation and the barriers to innovation; please leave comments on our blog: (
http://www.pistoiaalliance.org/blog/2011/05/whats- strangling-pharma-innovation)
DDW
The Pistoia Alliance was established as a members’ organisation in 2009. Today, it includes more than 45 member organisations encompassing life sci- ence companies, academic groups, informatics ven- dors and publishers. Together, Pistoia Alliance members aim to lower barriers to innovation by improving the interoperability of R&D business processes through precompetitive collaboration. The organisation focuses on bringing stakeholders to the table to define common, conceptual steps of the life science R&D workflow.
Drug Discovery World Summer 2011
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