Business


The apocalyptic horsemen of drug discovery and development


The pharmaceutical industry should consider an ‘evolutionary disease management’ approach based on homeostasis, irreversibility, biological alinearity, ‘‘pseudo-N-of-1’ health and disease states’ and narrative medicine best practices in order to help secure a successful drug development future


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he issues discussed in this article have defined the success, and failure, of phar- maceutical research and development, and disease management more widely. Each area con- tributes individually to the low success rates across R&D, but they need to be addressed in aggregate if long-term changes are to be brought about. Because most biological systems are based on the characteristics described and they are not readily amenable to external forces, a new R&D paradigm is likely required. While the primary areas of focus are discussed in philosophical terms in the current perspective, concrete steps can be initiated in order to address them and processes altered to embrace them, helping to make the areas discussed the means to improve novel drug development and improve clinical outcomes. The points here are also paralleled within organisations, and can be used to help improve not just what is done within compa- nies and research labs, but how. Research and clin- ical entities should consider how they operate as ‘living organisms’ with similar constraints (resis- tance to change, etc) of the individual employees, patients, departments and processes. Embracing an ‘evolutionary organisational management’ para- digm would be expected to maximise individual employee development, and help secure a place for them, and their employers, in the ever-changing future environment.


Background


Discussions by those involved in pharmaceutical research and development (R&D), as well as the


Drug Discovery World Winter 2011/12


beneficiaries of the collective work, often include asking what processes need to be further refined in order to improve the success rates and decrease the timelines behind the delivery of vitally-needed novel medications. Perhaps appropriate to the sci- entific foundation of the industry, many have sup- ported the contention that similar scientific approaches would highlight high priority areas and guide process improvement activities. This approach has solid footing in that reductionistic sciences to understand the human body have led to dramatic understandings of how the individual parts work. By certain metrics the combination of traditional scientific-based ‘trial and error’ approaches and lean sigma/process improvement approaches have led to significant improvements in pharmaceutical R&D1-4. These activities, however, have failed to produce dramatic improvements in the key metric for the industry: the continued delivery of novel new med- ications to patients5,6. Perhaps the well-intentioned questions that have been asked, and multiple analy- ses subsequently conducted, represent subsets of higher-level issues deserving attention. Perhaps the reductionistic approach to R&D process analysis, ie continued dissection of the parts into the smallest fractions describable to our work, has provided minute details that must now be woven back into the overall tapestry of the industry’s fabric. Perhaps it is an appropriate time to add higher-level debates and to begin revisiting the ‘basics’ of biology that may have been forgotten among the significant sci- entific and technological advances in the past few


By Dr Gary J. Keil


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