It’s Not All in the Medicine: the Human Factor of Drug Development

Blog Post Breakthrough Results

In the pharmaceutical industry, the odds of successfully bringing a drug compound from discovery, through all phases of development, to submission and ultimately approval are daunting.  If drug development was a table game at the casino, you wouldn’t sit down to play unless you were looking to lose all your money – fast!

A study conducted by Tufts CSDD Outlook Report from 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 6 (about 16%), costs more than $1 billion and takes on average more than 7 years.

If ever there was an area of business that was ripe for a breakthrough, drug development is it.

The answer isn’t always clear

Executives in pharmaceutical companies, in an effort to mitigate the numerous risks their development teams face as best they can, spend hundreds of millions of dollars a year supporting these teams as best they know how.  The lions-share of those dollars are spent on the latest technology, state-of-the-art equipment, and technical expertise.

While those aspects of the process are important, there is one key ingredient that is usually grossly undervalued and underfunded – the people themselves.

The real culprit

While companies often focus on what’s missing – be that competencies, skills, and resources – Insigniam’s 20-plus years of experience working in drug development tells us that often it is people’s perceptions, beliefs and mindset about the project that is the difference between business-as-usual and breakthrough results.

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