ABSTRACT

We are living in an era of mass marketing and big business-a

strategy that favors retail giants such as Walmart R©, Costco R©, and Best Buy R© in attempts to satisfy the insatiable commercial needs of a growing population. Current economic drivers instinctively

motivate fiscally conscious consumers to flock to warehouse-style

retailers to purchase mass-produced generic products; rather than

paying a premium at privately owned and operated boutique shops

that sell unique goods marketed toward specific subgroups of

customers. Unfortunately, this trend superficially appears to have

been adopted with vigor by large pharmaceutical companies, “Big

Pharma” as they are commonly referred to, as they develop and

market blockbuster drugs to treat the masses. As a result, an

individual patient’s clinical needs have been blurred in efforts to

accommodate entire populations of patients. But beforewe lumpBig

Pharma into the likes of retail giants that mass-produce products

to lower costs and boost margins, one must understand the harsh

realities of drug development. On average, it is estimated that

a single new drug compound costs over $1 billion and 10-15

years to develop [1]. And shockingly, only one out of five new

drug compounds actually generates revenue equal or greater to

its inherent developmental costs [1]! It is obvious that to disrupt

this drug development trend, a “perfect storm” of novel emerging

technologies, nonconventional regulatory approaches, Big Pharma

support, and health insurance reform must converge to initiate the

shift toward developing personalized therapies (Fig. 1.1).