Business
Figure 1
l Regulatory authority ‘rituals’ with regard to preclinical and clinical testing procedures that may, or may not, have basis in empirical evidence. l Differences in perception of risk among differ- ent stakeholders. l Uncertainty about the timing and level of reim- bursement decisions leading to uncertainty among stakeholders. l General business uncertainties in drug develop- ment. l Potential increases in the cost of doing business due to intellectual property concerns.
Regulatory agencies have also taken on a key role in advising pharma on how best to solve its inno- vation challenges – an interesting development given that regulators are ultimately responsible for the approval (or lack thereof) of marketing autho- risation for new medical therapies. The FDA pub- lished its report ‘Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products’6 (more commonly known as the Critical Path Initiative) in March 2004. Not to be outdone, ‘The European Medicines Agency Road Map to 2010 – Preparing the Ground for the Future’ was published by the EMEA at the same time with the promise to “help to stimulate innova- tion, research and development in the European Union (EU)”. The World Health Organisation also entered this advisory vogue with its ‘Priority Medicines for Europe and the World’7 which refer- ences “innovation” and “barriers to innovation” a multiplicity of times. Also in 2004, EFPIA and the
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EU created the Innovative Medicines Initiative, to which the European Commission’s Seventh Framework Programme will contribute €1 billion and member companies of the EFPIA will provide at least another €1 billion in matching, in-kind con- tributions8. The IMI’s Strategic Research Agenda9 states in section 1.5: “It is important to appreciate that IMI will not – and is not expected to – deliver new medicines per se. However, it is expected to deliver powerful new multi-disciplinary tools to improve the innovation process and thus establish a new drug development paradigm.” One of these tools is knowledge management and indeed all these above referenced seminal texts point to the importance of IT or knowledge management in the delivery of these innovation initiatives. The Pistoia Alliance (http://www.pistoiaal-
liance.org) originated in this rapidly developing, pharmaceutical industry-wide imperative to enable and enhance innovation. During a meeting in Pistoia, Italy in 2007, a group of senior pharma- ceutical industry R&D IT directors concluded that many of the activities carried out by researchers in bioscience organisations were remarkably similar. For example, the activities to determine a gene sequence, identify a signal transduction pathway, search a chemical repository or keep abreast of the scientific literature were all of course necessary, but remarkably common. They identified that much replication of effort by their respective R&D IT organisations might be minimised if they shared thinking about, defined and then documented the best practices for these precompetitive research activities. This would enable expert, third-party organisations to build and deliver such services to many companies. The money saved by sharing the costs of provision of precompetitive scientific serv- ices could be redeployed for company-specific, strategic, transformational, innovative initiatives. Precompetitive alliances such as the Pistoia Alliance expose a disconnect in the industry between the pursuit of innovation and actually achieving it. Recent conversations on the Pistoia Alliance website (
http://www.pistoiaalliance.org/ blog/2011/05/whats-strangling-pharma-innova- tion) and at the Pistoia Alliance’s inaugural confer- ence in Boston, MA, in April 2011 reveal several opinions from technology vendors, academics and consultants about what is hindering innovation. Richard Resnick, CEO of GenomeQuest, places the blame on:
l Top-down corporate strategies that fail to recognise the innovation happening at the lower levels of the company.
Drug Discovery World Summer 2011
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