The idea of what “Industry 4.0” is in pharma has been widely debated and heavily associated with the digital disruption shaping healthcare. At its core, the concept points to the adoption of technologies and processes to benefit pharma’s workflow.
Elements such as cloud computing, data analysis, and AI tools come into play here. But what defines the concept of “Industry 4.0” in pharma these days? Let’s dig deeper into the concept.
Industry 3.0 VS Industry 4.0
To many, Industry 3.0 is the stage in which many pharmaceutical companies stand right now. Before we dive deeper into this concept, let’s look at the previous “revolutions” in the pharmaceutical industry.
- Industry 1.0:
This concept came to be at the starting point of modern pharma. It began back in the 19th century with the rise of large-scale drug production through non-electrical power-driven machinery. It was possible due to two main sectors: individual pharmacies and the chemical industry. The wholesale production of drugs was the first step that shaped pharma as we know it today.
- Industry 2.0:
In the second revolution, electricity played a determining role. These new electric machines gave rise to an even better production process for drugs. Some advantages included better monitoring of process performance, not to mention the use of passive control strategies. Some argue that the pharma manufacturing industry still operates within this panorama.
- Industry 3.0:
Here we’ve reached the third industrial revolution, in which computers and communications technologies have entered the picture. The common usage of the internet enabled a higher list of automation processes and equipment. Human-computer interfaces also improved control strategies, as well as the quality of processes. In some panoramas, computers took over or helped human control here.
Why is there an ongoing debate regarding companies still being in Industry 3.0? Because many pharmaceutical companies are only now exploring new possibilities provided to them by rising technology. Despite this, Industry 3.0 has improved our understanding of how to capture, analyze, and protect the vast amounts of data generated by pharmaceutical manufacturers.
Industry 4.0 is the moment that brings together manufacturing technologies to allow new manufacturing systems to operate without the requirement of a human hand. However, for this to be successful, pharma companies must take their experience from Industry 3.0 into account.
Industry 4.0: The next step
The truth is that Industry 3.0 saw relevant advances regarding individual operations and tools. The next phase, promised by Industry 4.0, brings a huge advance for manufacturing systems and infrastructures.
Here, digital disruption comes into play. It represents a new journey from data collection to an advanced maturity that opens new possibilities. In this context, you can turn performance data into a game-changer that you can use in operational decisions and new processes.
What’s the main difference between Industry 3.0 and Industry 4.0? The latter uses data to enable real-time monitoring, predictions, responses, and control processes within the value chain.
Digitalization, automation, and real-time data integration are changing operating paradigms in pharmaceutical manufacturing, resulting in better quality than six sigma. Yet, production isn’t the only field to be affected by this disruption. Here, partnerships between IT and pharma will play a huge role in the development of this stage.
IT meets Pharma: What are the possibilities?
The partnership between pharma and IT is more evident by the day. The growing trend of digital health is a clear sign of the eventual mutation between the two sectors.
More than one aspect of technology is shown to have positive effects on healthcare. AI companies and big pharma have teamed up to produce results in more than one way. Not only in the automation of processes but also in drug discovery.
Another area in which pharma is set is the implementation of CTMS (clinical trial management systems). Through these solutions, it will be possible to make these processes more flexible. Some solutions for these include:
- Developing remote enrollment capabilities;
- Managing their data;
- Streamlining data transfer;
- Work on achieving greater transparency regarding the trial conduction;
- Improving research documentation;
- Making trial audits clearer.
Continuing with the subject of clinical trials, a process that is becoming more prevalent is decentralized clinical trials (DCTs). With the help of remote patient monitoring (RPM) and telehealth, many processes are being optimized. Stages such as patient registration, clinical data collection, and patient monitoring in real-world settings are being carried out without the required presence of participants in the whole process.
Automation processes will play a big role in the success of this transition from Industry 3.0 to 4.0. A process that can facilitate the data exchange between an electronic health record (EHR) and electronic data capture (EDC) is currently being studied in this regard.
What about the challenges to this process?
One of the first main challenges to this transformation is the absence of regulations to assign critical decisions to equipment rather than to people. This matter can result in the retainment of conventional processes, even if it’s proven that the machine can increase product quality.
The good news is that the US FDA has been moving toward performance-based regulation for more than a decade. Their regulation will be based on measuring outcomes instead of focusing on prescriptive procedures.
Other matters such as technical limitations will also have to be addressed. Some process parameters are inflexible by the use of automated processes. The matter of offline testing and the need for human involvement in manufacturing options, for now, will also condition some future procedures.
Some cultural changes are also at hand on the path to fully adopting Industry 4.0. Pharma companies must tackle knowledge and training apps for the adoption of a new paradigm. These will require new skills to integrate AI into pharma. This will have a significant impact on the healthcare workforce.
The present era provides a wide range of opportunities for IT solutions to shine. The growing partnership between these two sectors is contributing significantly to an effective reorganization of processes regarding drug discovery and more.
Integration of AI, blockchain tools, cloud tech, and software solutions, in pre-existing procedures will have lasting benefits. That way possibilities that will optimize a variety of processes will become a reality as we walk into a more automated era for pharma.
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