Business
l A systemic desire by informaticians to build precompetitive tools on their own, rather than investing their effort in developing tools that will provide competitive advantage. l An enterprise-wide culture of letting ‘perfect’ get in the way of ‘good enough’. l An inability to understand the fully-loaded costs of research. l An inability to measure the ROI of partner- ships and customer-vendor relationships. l A lack of empowerment of innovative depart- ments with sufficient budget to be nimble, even if it means duplication of effort across the enterprise.
Hedley Rees, a consultant and author with expertise in the pharmaceutical industry supply chain, noted that in his experience, “senior man- agement boards still believe drug discovery and development is about a ‘lucky strike’ followed by a race to the clinic to get an approval; anything else is off their radar screen”. They do not afford suffi- cient time in the critical early stages of drug devel- opment to ‘stress-test’ the robustness of their com- pounds destined for market. The net result is that only one in 250 survives the journey from develop- ment candidate to regulatory approval10. If that is the case, one could conclude that sever- al key elements are ‘off the radar screen’ of senior management. Work in the research laboratory, for one. As Niggi Graber, a lab automation specialist in Pharma, observed: “Innovation happens in research labs and is heavily dependent on the avail- ability of appropriate IT support as well as on a flexible use of equipment in the lab. Legacy data architecture and IT structures are major obstacles in providing required information across the com- pany. On the other side rearrangement, replace- ment of existing equipment and an easy and rapid adoption of new equipment based on new tech- nologies have to be realised faster and faster. It is the aim of SiLA11 to remedy this situation by establishing globally, provider-independent, open standards for device integration and for data inter- facing. This enables pharma and biotech R&D to focus on its main business by reducing equipment connectivity efforts to a minimum.
Also ‘off the senior management radar screen’ is ambitious and effective management of IT in phar- ma. As another correspondent remarked: “Consider the general case of IT organisations in pharma. IT reports into the CIO who, in turn, reports into the CFO and CFOs tend to regard IT as an expense rather than an urgently needed opportunity. And that brings us to the question of why pharma CIOs seem to understand little of the
Drug Discovery World Summer 2011 19
end-to-end information flows in the companies they serve. Rather they focus on attempting to drive out cost, running internet auctions for sever- al thousand desktop computers or struggling with implementing SAP. None of which contributes in any way to innovation.”
Another respondent complained about trying to use technology innovatively in the regulated domains of the industry. “QA departments which regarded themselves – not the business owners – to be the arbiters as to whether or not a validated system could be released into production – and the QA departments which agonise over Computer Systems Validation templates or demanding thou- sands of pages of documentation to be produced (that no-one will ever read again) when validating a common, best-of-breed, off-the-shelf-commer- cial product. And then the QA departments which still struggle to implement a risk-based validation methodology to include the opportunity of phar- ma using cloud-based services.”
Other contributors were frustrated by the repli- cation of research activities in pre-competitive areas. Such unimaginative effort, said one, “sounds like a serious waste of money”!
Smart innovation: going far by going together
What does this admittedly small sample of responses indicate about barriers to innovation in the pharmaceutical industry? There seems to be only a little concern about a fundamental shortage of resources for R&D. However, there is concern
Further reading Williams, Michael. Productivity Shortfalls in Drug Discovery: Contributions from the Preclinical Sciences? Journal of Pharmacology and Experimental Therapeutics, Vol. 336, No. 1. (1 January 2011), pp. 3-8. Grasela, TH, Slusser, R. Improving Productivity With Model-Based Drug Development: An Enterprise Perspective. Clinical Pharmacology & Therapeutics, Vol. 88, No. 2. (30 June 2010), pp. 263-268.
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