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).