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Digital Transformation Strategies that are Making Pharma 4.0 a Reality for Innovative Pharmaceutical Commercial Operations

By Kimberly Gregorio | January 13, 2021

As pharmaceutical executives continue to grapple with COVID-19 related obstacles and an ever-increasing array of complexities, costs and regulations associated with operations, a greater number of them are turning to Pharma 4.0 manufacturing as a possible solution to help enhance the bottom line. Yet, despite its emergence as a concept, confusion remains regarding the best strategies for achieving Pharma 4.0. The following highlights three strategies that every executive should consider when embarking on the road to Pharma 4.0.  


What is Pharma 4.0?    

Before diving into the Pharma 4.0 strategies every executive needs to know, we will first explain what Pharma 4.0 is in the first place. Simply put, Pharma 4.0 is a framework for adapting digital transformation strategies within the context of pharmaceutical manufacturing. In other words, it means more connectivity, more productivity, simplified compliance, and the ability to identify and respond to problems as they emerge – in real-time. 


Years in the making, there are four evolutionary stages of manufacturing that have brought us to Pharma 4.0. The first stage emerged with the invention of steam power, which helped mechanize key aspects of the manufacturing process. The second stage involved mass production and the introduction of the assembly line, which was powered by electricity. The third stage began with computers and automation, the evolution of which created the fourth stage – Pharma 4.0.


Pharma 4.0 is currently evolving before our eyes, and is being powered by technologies like Artificial Intelligence (AI), the Internet of Things (IoT) and robotics, which are enabling fully digitized pharmaceutical manufacturing. These technologies work in tandem to create human-to-digitalnetworks that combine human and machine inputs to create more efficient, error free operations within the factory. In simpler terms, these systems help support manufacturing by automating processes across both digital and physical domains.


Digital Transformation is the Key to Pharma 4.0

While new technologies have enhanced opportunities for process improvements, the unique environment in which Pharma operates has slowed adoption relative to other industries. Requirements for documentation, data integrity, and process validation all create an environment where compliance outweighs continuous innovation. However, despite this, manufacturers that charge ahead thoughtfully and strategically can benefit. There are more tools for improving quality and efficiency than ever before, and digitization can even make compliance an automatic, seamless part of the manufacturing process.


Digitalization is an extremely important component of Pharma 4.0 and will connect everything, creating new levels of transparency and reliability for a smarter manufacturing operation. This will enable faster decision-making, and provide real-time control over business, operations, and quality. Manufacturing operations that make digital transformation a part of their strategy will benefit from fewer errors, lower operating costs and better compliance.

In order to take advantage of this emerging digital revolution, here are three strategies that every executive should know. 


AI is a Must Have

Smart autonomous factories managed with data and powered by AI will lower pharmaceutical manufacturing costs, improve quality and reduce capacity constraints. It’s a big leap, because until recently most companies have been slow to adopt digital manufacturing tools such as AI, worrying that their systems, data and people weren’t ready. But many have decided further delay isn’t an option and have started to deploy these solutions on a massive scale.


According to Bain & Company1, Pharma executives expect smart, AI-driven factories to produce total savings of 20% or more, while improving quality and making deliveries more reliable. Specifically, they forecast a 17% reduction of costs related to poor quality, a 15% decline in the cost of converting raw materials into drugs and a 14% increase in delivery reliability.


Even if products are within given specifications, being close to the borderline of acceptable tolerances can prompt quality issues. Recognizing patterns linked to quality problems in production, packaging and logistics can help companies react faster and avoid defects. AI’s ability to search for patterns in a sea of seemingly unrelated data is what enables Pharma manufacturers to deploy predictive quality management that is unrivaled by other technologies


In addition, on the supply side, more and more pharmaceutical manufacturers are using AI to gain insights from historical data to improve demand management, reduce inventory stockpiling and streamline production plans and schedules. AI helps production managers determine the right resources, inventory and sequence of production orders for optimal results. This level of analysis not only streamline operations significantly, it also helps improve the bottom line.


In addition to quality control and production management, AI also plays a role in determining future needs. When connected to a data hub like Data360, tools like the BirdzAI Sales Enablement platform help pharmaceutical commercial organizations better understand product churn and future inventory needs based on precise sales forecasts. This direct data pipeline from commercial operations through to manufacturing, when powered by AI, enables efficiencies well beyond what traditional methods are capable of.           


Autonomous, Automated Machines are the Future


While AI and IoT are quickly becoming staples within manufacturing operations, there is one emerging innovation that is certain to take Pharma 4.0 to new heights; autonomous robots. Automated production methods powered by autonomous robots is a seminal example of where the future of manufacturing is headed. By connecting robots to a central database and AI, the actions of robots can be coordinated and automated to a greater extent than ever before. They can complete tasks intelligently, in an orchestrated manner with minimal human input. 


A small example of the work autonomous robots can do is transporting materials across the facility, avoiding obstacles, coordinating with other machines, and identifying where pickups and drop-offs are needed in real-time. However, because they’re connected digitally, and can work in tandem with AI and IoT enabled smart devices, the sky’s the limit for these machines.


The Time to Plan is Now

The promise of Pharma 4.0 lies in its ability to unlock new potential for productivity and quality while making the rigors of compliance a seamless part of the manufacturing process. Executives who take the necessary steps to embrace a digital future stand to benefit from its capabilities. By adopting a Pharma 4.0 strategy that includes the strategies outlined above, manufacturers can make great strides in future-proofing their operations.


About P360

P360 is a leading developer of technology for the life sciences industry. Product offerings include the BirdzAI sales enablement platform, BirdzAI ZING Communication Module for compliant SMS text messaging, Data360 data management suite, Trials360 clinical trial management system, Swittons IoT-enabled smart devices, and the PatientJourney360 patient lifecycle management solution.

References

1: https://www.bain.com/insights/digital-manufacturing-is-finally-coming-to-pharma/