November 19, 2018

Cultural Resistance… Who are the Real Enablers?

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Advanced analytics technologies in the pharmaceutical industry are accessible now more than ever and regulators have slowly become more accepting to these kinds of advances.  The introduction of machine learning, artificial intelligence, and big data technologies are disrupting our industry, and it’s time we change our mindset.  People are the real enablers of the paradigm shift and if we continue this pattern of cultural resistance, pharmaceutical companies cannot continue accelerating and will not remain competitive in the growing pharmaceutical market.

Technology in place

From the processing of big data to the kinds of cloud computing architectures (serverless and SaaS), the industry is evolving.  Technology has made it possible for most companies to afford remote computing power akin to NASA’s servers.  Additionally, tools running artificial intelligence (AI) models are becoming much more accessible.  Companies continue gaining access to these kinds of technologies and it is time they start leveraging them.  Why are companies still using basic statistics and only working with a few process variables?

Regulators are becoming more open minded

Up to now, the fear of regulatory exposure was used as an excuse for companies to stay conservative and away from implementing new technologies.  But as the industry continues to shift, this is coming to end. There has been a real mindset shift in how agencies incorporate new technologies into their standards and guidelines. A recent example is from the European Pharmacopoeia, where they established artificial neural networks and support vector machines as chemometric methods applied to analytical data.

Also, the MHRA (Medicines and Healthcare products Regulatory Agency) established a GxP Data Integrity Guidance for cloud providers including Software-as-a-Service, Platform-as-a-Service, and Infrastructure-as-a-Service.

And the FDA (Food and Drugs Administration) has incorporated a cloud technology into their Emerging Technology Team recognizing that it will influence how quality systems will be assessed by FDA.

The need for change

There is a clear trend in the decrease in margins while regulatory pressures continue to increase. Additionally, there are no more blockbusters and the increase in personalized medicine will require more flexible production requirements. Taking into consideration all of these factors, most companies are not using 70% of their manufacturing data.  It’s clear that there is huge room for improvement.

There is also an increasing number of FDA Warning Letters for data integrity issues that reflect a clear lack of process knowledge and data management skills.

People, People, and People

There are several factors important in enabling Pharma 4.0 but one of the most crucial components in the paradigm shift is the people.  The workforce is used to working in such regulated and protected markets surviving in their comfort zone.  Nowadays, technologies allow us to work with big data in the cloud while ensuring data integrity and cloud technologies.

At this point, we know the reason for changing, we have the technologies and tools in place and regulators aligned.  So why is the pharma industry so slow to adopt these new technologies? Because of the mindset of people. Pharma 4.0 will continue to stay as an industry hype in the marketing departments until we have a real mindset shift.