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Written for Scott Heron, Ph.D.

Pharma 4.0—Quality Management in the Digital Age

By Scott Heron, Ph.D.

Merck Pharmaceuticals

Today’s pharmaceutical companies are replacing the one-drug-fits-all approach with more personalized therapies. According to a survey by the Tufts Center for the Study of Drug Development, 42 percent of drugs in the pipeline today are personalized medicines.  


Specialized drugs that give smaller patient groups the best therapies based on their genetic makeup and other predictive factors are replacing blockbuster mega-drugs designed to treat larger populations. The patents for mega-drugs are slowly dying away.


For example, the one or two drugs used a few years ago to treat high cholesterol have splintered off into many, more focused therapies based on the genetic variables of specific patient populations.

This approach springs from discoveries in genomics—the structure, function and mapping of human genomes—and it’s giving rise not only to targeted therapies, but also to highly specialized diagnostic tools and personalized drug monitoring.


Vast Potential for Targeted Drugs

Due to the enormous potential of these therapies, the White House has requested an initial budget of $215 million for its precision medicine initiative. President Obama believes “the possibilities are boundless” for specialized drugs and his administration aims to collect genetic data from one million Americans so scientists can develop therapies tailored to individual patients.


In response to the shift to targeted drugs, pharmaceutical companies have diversified their product portfolios to include these medicines. A powerful motivation for this change is that that despite increases in R&D spend for mega-drugs, financial returns from them are shrinking.


While specialized therapies can produce better outcomes for patients, they present challenges for manufacturing because of the wide variety of products and small batch sizes.


Small-batch production has the advantage of a lower initial operational investment, but it can be cumbersome because after a product run, equipment must be stopped, reconfigured and tested before the next batch can be produced. This downtime lowers time- and cost-efficiency.  


The Federal Drug Administration (FDA) has addressed batch-to-batch quality requirements for years and plans to provide incentives to companies that raise manufacturing quality and reduce drug shortages.


Change Is Essential

Pharma companies that don’t make changes to stay at the forefront of targeted medicines will struggle. A major part of those changes is revamping operations by implementing “Pharma 4.0.”  

Pharma 4.0 is an operational approach that connects all resources—human, informational and technological—in one virtual network. This connectivity extends from within the company to beyond its walls and combines diverse technologies such as cloud computing and big data analytics.


Pharma 4.0 moves from robust but inflexible mass production processes to more agile, highly automated methods that create specifically tailored products quickly and cost-effectively.   


Many pharmaceutical companies still store and disseminate manufacturing information on paper, which slows down quality-control processes by limiting  efficient sharing of knowledge and collaboration among employees at worldwide company sites.    


Efficient Data Management

The latest cloud-based content management applications allow managers to route quality-control data throughout the entire company using an efficient system for review and approval.


Because all data resides in the same system, workers have the visibility and access they need to monitor key performance indicators, guide the manufacturing process and respond to incoming patient data that triggers the production of  personally tailored medicines.


Pharma 4.0 also aligns with the business world’s migration away from the desktop to the flexibility of mobile devices. Accessing information stored in the cloud, managers can work more efficiently by reviewing and approving quality-control data at any location.   


The trend toward personalized therapies requires nothing short of an operational transformation and such a drastic change can lead to disruption and uncertainty, as least for a time. But the pharmaceutical industry is more capable than most to analyze its critical processes, assess risks and define controls.


By adopting the Pharma 4.0 approach, pharmaceutical companies can successfully make the transformation and safely manufacture high-quality, precisely tailored medicines that give patients better lives.  

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