The development of targeted therapies is rapidly changing the very nature of healthcare. Known as ‘personalised medicine’ by some, or ‘precision medicine’ by others (putting emphasis on the molecular-level information involved), it is reshaping the traditional pharmaceutical sector. As a result, all those involved – from clinics, diagnostic labs, clinical trial companies, contract manufacturers, research companies to drug manufacturers – are facing change and challenges at a pace not experienced before.
According to the US FDA,1 since the approval of Herceptin, the development of targeted therapies has grown rapidly. The FDA’s Center for Drug Evaluation and Research (CDER) has approved 30 targeted therapies since 2012. In 2014 alone, eight of the 41 novel drugs approved were ‘targeted’. They are: Lynparza (olaparib), Blincyto (blinatumomab), Harvoni (ledipasvir and sofosbuvir), Viekira Pak (ombitasvir, paritaprevir, dasabuvir and ritonavir), Cardelga (eliglustat), Beleodaq (belinostat), Zykadia (ceritinib) and Vimizim (elosulfase alpha).
The move towards precision medicine has created new fields of science – genotyping, molecular diagnostics, pharmacogenetics, pharmacogenomics, pharmacoproteomics, metabolomics – as well as a raft of new industries in the making, including next generation sequencing (NGS), biomarkers, companion diagnostics, bioinformatics and databank curators, and biobanks.
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