There are medicines & then there is Haute Apothicaire
From what’s written on the wall, 2015 could well be the year when good old medicine finally goes designer chic. Even if not for the masses just yet, a privileged few could soon have their meds custom made to match their genes - well, just as soon as the fitting trials are done & the master says aye!
For those who didn't quite get my pun, I am indeed talking about personalized medicine going mainstream in 2015 - From Novartis making the first move to bring protocol to patient through its series of #SIGNATURE trials & JnJ opening up its clinical data vaults to Yale for open research to #Google #Calico aiming to tackleageing through big data & bigger collaborations, it's clear there's this huge trend of big pharma going all guns blazing after the alluring promise of personalized medicine.
This alliance with big data is in some way an existential manoeuvre by big pharma poised precariously on the patent-cliff & thus most initial approvals of designer drugs would be those that have been pulled up from the gorges of failed/failing PII/ PIII trials. Either which way, there is no doubt that the best use of cutting-edge drug design capability is only when it is coupled with the invaluable human genomic & proteomic data decoded in the past decade and using the #bigdata analytics to throw up the statistically best therapeutic match for an individual patient.
If one goes by the regularity with which FDA has been approving companion diagnostics and genetic tests over past few years; the apparent merit they see in the label of an approved drug referencing the genomic biomarker(s) & the pragmatic use of conditional approvals such as the recent one for Translarna by the EMA, it appears the regulators too are in sync with this new reality & have been gearing upto deal with the potential multitudes of personalized therapeutic applications & evolve an approval mechanism that's applicable despite the indication not being orphan enough.
Even as connoisseurs may not quite like it, high fashion attains scale only when it goes mainstream & by analogy the designer drugs too would find their way to the masses eventually, I only hope sooner & safer.