Pharmaceutical InnovationsOctober 23, 2020
Indeed, reports Steven M Paul et al3, to get each dollar lost in decreasing product earnings due to patent expirations by 2012, it’s been estimated that big cap pharmaceutical businesses will simply be able to replace an average 26 pennies with new merchandise revenues. The industry’s answers to the pressure are multi. Some businesses have increased expenditure on R&D others have engaged in improved merger and acquisition, so several have reinforced their product in licensing capacities, all appear to be reorganising and just a few haven’t instituted significant staff cutbacks. To produce another generation of advanced medical treatments, pharma desperately needs better, faster and more affordable drug discovery and development processes.
None of those business alterations has caused significant progress. What’s keeping pharma from innovating? Cynics might argue that the barriers lie in the processes of R&D itself and the relationships between scientists and their supporting corporate functions such as information technology, intellectual property, legal, procurement and quality assurance. Nevertheless, regardless of what the counter revolutionary influences of these functions may or might not be, the fundamental barriers to innovation more correctly reside from the industry’s inability to allow intra- and inter business organizations to swap information securely and within an unequivocal and comprehensible way. This paper provides some insights, gleaned from the Pistoia Alliance community, into what is impeding innovation in pharma and provides examples of how precompetitive collaboration can identify common use cases and from them, derive appropriate and useful information standards that improve the interoperability of R&D business processes.
Identifying obstacles to invention – Many commentators have identified obstacles to invention in pharma, including Warren Kaplan, that gathered the following list in 2004 5: l Inadequate comprehension of fundamental science for specific diseases and the identification of goals amenable to manipulation. L Regulatory authority rituals with respect to preclinical and clinical testing procedures that might, or might not, have basis in empirical evidence. L Differences within perception of risk among different stakeholders. L Uncertainty about the timing and level of reimbursement decisions leading to uncertainty among stakeholders. L General business uncertainties in drug development. L Potential increases in the cost of conducting business due to IP concerns. Regulatory agencies have also taken on a key role within advising pharma on how best to solve its invention challenges, an intriguing development given that regulators are ultimately accountable for the approval of marketing authorisation for new medical treatments. The FDA published its report Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products6 in March 2004. Not to be outdone, The European Medicines Agency Road Map to 2010 Preparing the Ground to get the Future was published by the EMEA at the same time with the promise of helping to stimulate innovation, development and research in the European Union .