Personalised Medicine
Early patient stratification is critical to enable effective and personalised drug discovery and development
With the current chances of an efficacious outcome in Phase II for novel mechanisms being in the region of 1 in 5, we argue the need for personalised drug discovery and development to be executed at the beginning of the process and that the pharmaceutical industry’s future successes will likely depend upon effectively enacting this paradigm.
I
t is well known that the drug discovery and development process is lengthy, expensive and prone to failure1-3. This high failure rate is a significant factor in the pharmaceutical industry’s productivity problems, subsequent mergers and downsizing4. Starting from the selection of a novel target in Discovery, through the multiple steps to regulatory approval, the overall probability of success is less than 1%1. Given the time and resources needed to investi- gate a novel biological mechanism, ie one that has not been tested in humans before, success rates as low as these yield an unsustainable busi- ness model. In the face of a negative return-on- investment for new chemical entity drug discov- ery and development (DDD)2 and constricted healthcare budgets that demand improved drugs to warrant reimbursement, an alternative approach must be identified to provide patients with new and better therapies as well as sustain the industry. The central tenet of this paper is
Drug Discovery World Summer 2011
that the data-driven matching of patients to the appropriate investigational therapy in early drug development is critical to the industry’s success, overall cost reductions in healthcare spending and to the delivery of effective, personalised and innovative medications to patients.
Phase II challenge
Of the multiple hurdles in DDD that must be over- come, successfully establishing efficacy in Phase II is one of the most significant. For novel mecha- nisms, the likelihood of an efficacious outcome in Phase II is approximately 20%5. One of the major challenges in DDD is to understand why this suc- cess rate is so low, as the selection of the biological mechanisms and the identification and develop- ment of agents to manipulate those mechanisms are most often based on state-of-the-art science. As an industry, we need to better understand why some investigational agents are successful in Phase II and most others are not.
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By Dr David A Fryburg, Dr Diane H Song and Dr David de Graaf
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