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Precision Medicine


because they manifest safety, effectiveness or eco- nomic problems. For example from 1994-2015, the USA Food and Drug Administration (FDA) issued 215 ‘Withdrawal of Application’ notices6. During that same time period the FDA actually recalled 26 drugs from the US market predicated primarily on safety concerns7.


ii. Drug effectiveness There is now a significant body of evidence that indicates individual patients diagnosed with the same disease indication respond differently to the same therapeutic drug8. For example Spears and co-workers analysed the effectiveness of a number of different drug classes against major disease indi- cations9. They found that most drugs were 50- 75% effective as determined by patient responses. The lowest patient responders occurred with con- ventional cancer chemotherapy (25%) whereas the highest percentage of patient responders was treat- ed with Cox-2-inhibitors (80%). Therapeutic drugs were reported to be ineffective for Alzheimer’s (70%), arthritis (50%), diabetes (43%), and asthma (40%) patients9.


iii. Pricing Approved drug price points are determined by market forces that include drug safety and efficacy


10


differentiation, market need, patient acceptance, sales and marketing strategy and IP position as well as individual R&D costs10. In many cases, pharmaceutical companies have used rampant R&D costs to maximise prices charged to the patient/consumer. Unfortunately, even in such a favourable economic climate, only 3-in-10 approved drugs generate revenues that are at least equal to or greater than average R&D costs11.


We have argued in the past that the


‘Blockbuster Model’ has inadvertently led to the ‘wagon-of-woe’ for the DDD process12. This model focused on a ‘one drug-one target’ mecha- nism that was potentially safe and effective in a large, but heterogeneous population. We have suggested the use of more efficient technology usage13, decision-making tools13, systems biolo- gy14,15, and personalised/precision medicine16 in order to overcome the limitations of such a model. More recently, we presented the concept of a combined systems biology-personalised/pre- cision medicine approach to the development of more effective and safe therapeutic drugs17, par- ticularly in the treatment of Alzheimer’s Disease18. In this manuscript we introduce the concept of ‘Targeted’ or ‘Precision Medicine Drugs’ which is a logical outflow from a combi-


Drug Discovery World Summer 2018


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