Regulatory Matters: The Year Ahead in Life Sciences

As I began to write this article to prognosticate on the year ahead, I recalled a Ladies’ Home Journal article from 1900, where an engineer named John Elfreth Watkins, Jr. predicted what life would be like in the year 2000. Surprisingly, many of his predictions, such as the use of cell phones, had actually become reality by 2000. Luckily, government regulations ensure a somewhat predictable rate of change making my job somewhat easier than Mr. Watkins’. But first, let’s take a quick look back at 2014…

bigdata_in_life_sciences

2014 was a great year for life sciences, particularly the pharmaceutical industry. Forty-four drugs were approved by the FDA, an 18-year high. When compared to the dismal 27 approvals in 2013, there seems to be some much needed innovation occuring, especially considering the estimated $100 billion loss in patent protection this year. In 2015, the biggest challenge will remain to innovate and launch products faster while maintaining the highest degree of patient safety amidst increasing global regulatory scrutiny. The industry is poised to meet this challenge head on. In fact, seven drugs have already launched for 14 indications in January.

At the heart of this challenge is to solve the dual Big Data and Quality problems. Every year, exabytes of data are being created within our industry. Digital technologies, such as remote monitoring and wearable devices, are only increasing the data points. However,
data quality is a critical issue. Corporate data warehouses are rapidly becoming akin to landfills with ever growing piles of digital garbage obscuring the nuggets of information which can have a truly transformative effect on the business.

I predict that, this year, much effort will be placed on developing and refining methodologies and technologies to make sense of the massive amounts of data generated by our industry. Improved statistical tools, real-time analytics and information exchange will yield important correlations and allow life science companies to discern which data and which process improvements enhance the business. In effect, quality processes and metrics will be applied to functions beyond manufactuing in building better models for everything from drug safety and efficacy to supply chain operations.

For those companies with ECM and BPM platforms, incorporating new digital technologies into their workflows will dramatically improve their business but only if aligned with a solid EIM strategy based on industry best practice. For those companies without an EIM strategy, the time to move forward is now.

Come hear how OpenText is helping global organizations to utilize information to transform their businesses at one of the Innovation Tour events near you.

Keep innovating!

About Jaleel Shujath

Jaleel Shujath
Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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