In the preceding decades, profitability of pharmaceutical companies have been observing a downward trend in general. It is attributed to failed clinical trials and rising R&D costs. It is in this context; it is necessary to understand Pharma 4.0.
Pharma 4.0 is a structure that relies on the interconnectedness of systems. This interconnectedness means improved connectivity, compliance, and productivity. It gathers product information giving real-time solutions as product problems emerge. The basic premise behind its functioning is efficient sharing of information, continuous improvement of main and ancillary functions and ensure productivity and competitiveness in the end the profit margins.
What is Pharma 4.0?
Pharma 4.0, the term was conceived by the International Society for Pharmaceutical Engineers that envisions a pharmaceutical industry that is digitally mature. Founded in 1980, by a few visionaries, they are a not-for-profit association that leads technical, scientific, and regulatory advancements through the pharmaceutical product life cycle. They believe in the free exchange of ideas among their members leading to greater educational and technical efficiency. They are a solution provider to modern pharmaceutical challenges through innovation, workforce development, and compliance collaboration. They lead in facilitating industry knowledge to deliver manufacturing and supply chain innovations, operational excellence, and regulatory insights.
Digital maturity comprises several facets, it includes Resources, Information Systems, Organization and Processes, and finally culture. ISPE envisions a holistic plan which outlines priorities across business, IT, and manufacturing through the product lifecycle of a drug.
The conviction held by the advocates of Pharma 4.0 is that digitalization will facilitate quicker operations, reduced costs, and competitive markets.
Why Pharma 4.0?
The maturity model under Pharma 4.0, anticipates that primarily data silos would be eliminated across the product life cycle of a drug through better communication. Second, paper-based processes would be minimized. Third, transition to risk-based regulation. Fourth, improved data collection and data sharing facilitating touch relationship with regulatory bodies. Pharma 4.0 is not only a new technology it is an evolving manufacturing paradigm that allows for adaptive responses and iteration by manufacturers which would trickle down to improved patient outcome.
Five Stages of Pharma 4.0
The stages involved in Pharma 4.0 are as follows. First, computerization, this is the most rudimentary stage, and it automates simple manual processes by digitalization. It eliminates the monotony of repetitive and mundane tasks. Second, connectivity, in this stage IT, manufacturing, and business functions are integrated. Third, visibility, in this stage manufacturers yield the benefits of positive externalities from the connectivity stage, a digital profile is created for everybody that would result in real-time data-driven decisions. Fourth, transparency in this stage the mammoth volume of data results in new insights about complex systems. Fifth, predictability, manufacturers are able to correct their mistakes before it occurs.
Finally, adaptability, at this stage systems are self-learning and self-correcting.
Key Players in Pharma 4.0
There are several players in the Pharma 4.0, though the most promising ones are QbD vision, Electrosan technologies, GoSillico and Smart Factory. QbD vision is an American-based company that primarily focuses on providing cloud based software solutions for pharma companies to improve the drug development process. Electrosan technologies is an Indian based start-up that offers process and factory automation solutions for pharma industries. Smart Factory is an Italian based start-up that assures packaging of pharmaceutical products with minimal down time and maximum efficiency.
Challenges in Pharmaceutical 4.0
The major challenges facing Pharma 4.0 are identical to the challenges facing Industry 4.0, after all Pharma 4.0 is subsumed into Industry 4.0. First, was the coordination problem. The industry faces a problem in coordinating different stakeholders across the organization to come to an optimal solution. Second, is the lack of courage by the decisionmakers to enforce radical changes that Pharma 4.0 puts forward. Third, it is the lack of skilled labor like data scientists, experts in AI and the like. Finally, it is the inherent risks that data sharing poses to cyber security in an emerging domain like Pharmaceutical industry. Also, concerns regarding data ownership and uncertainty regarding insource and outsource knowledge providers have been raised at several instances.
Pharma 4.0 promises to usher in a new era, especially pertaining to bio-pharmaceutical industry. Though there are several constraints facing the industry like huge investment costs, it is expected to tide over these constraints in the next five years or so. The massive amount of data generated can be put to the benefit of humankind, Pharma 4.0 promises to provide meaningful insights through the mammoth scale of data generated.