PHARMA 4.0: Race to digitalization

THE CHALLENGE OF PHARMA 4.0

In recent years, digital transformation has affected all sectors, allowing them to improve the quality of products and services, operational efficiency, and the acquisition of new value through new technologies.

Even the pharmaceutical area, despite the high level of regulation it is subject to, has undergone digital transformation processes that have influenced not only the manufacturing process, but also quality control and the integrity of scientific data.

This technological evolution is moving the sector towards what has been defined as Pharma 4.0, a new

organizational and productive idea that embraces all stakeholder in the pharmaceutical companies, from R&D up to the distribution system.

Overall, digitalization has the potential to revolutionize the pharma industry, helping to improve drug development, patient outcomes, and overall efficiency, but this is happening not without concerns.

Certainly, there are many advantages of Digitalization in Pharma companies, some examples of the key benefits are:

• Improved efficiency and productivity: Digital solutions can streamline many processes within a pharma company and this can help to reduce costs and improve productivity
• Better compliance with regulations: Digital solutions can help pharma companies to comply with regulations more easily and efficiently
• Enhanced data analysis and insights: Digital technologies can help to collect and analyze vast amounts of data, enabling pharma companies to gain insights into drug efficacy, safety, and other important metrics
• Improved supply chain management: Digital solutions can help to optimize the supply chain, reducing waste and improving the availability of drugs and other medical products
• Personalization of care and Improved patient engagement: Digital solutions can enable pharma

companies to provide more personalized care and help to improve patient engagement by providing patients with access to information and resources they need to manage their health

• Advanced analytics and predictive modeling: Digital solutions can enable advanced analytics and predictive modeling, helping pharma companies to identify new opportunities for drug development and to better predict drug efficacy and safety in addition to having a faster time-to-market On the other hand, since Digitization is a technological and cultural revolution, it certainly brings some obstacles in its implementation.

Some concerns to overcome in pharmaceutical companies are and will be:

• Regulatory barriers: The pharmaceutical industry is heavily regulated, and complying with regulations can be a challenge when implementing digital solutions
• High implementation costs: Implementing digital technologies can be expensive
• Legacy IT systems: presence of outdated IT systems which are difficult to integrate with newer technologies
• Lack of digital skills: Implementing digital solutions requires a workforce with the necessary digital skills and expertise
• Lack of standardization: The pharma industry is complex and diverse, with many different stakeholders and processes. This lack of standardization can make it difficult to implement digital solutions that work across the entire industry.
• Resistance to change: Employees may be resistant to adopting new digital technologies

DIGITALIZATION STATUS IN ANGELINI PHARMA

In Angelini Fine Chemicals Business Unit the digitalization process started some years ago and, it moves ahead according to a continuous improvement system.

To date, the majority of the steps of supply chain are connected to digital systems, such us ERP, LIMS, CDS, eQMS, MES and RIMS which cover the entire life cycle of the product, from procurement, management of material, planning, manufacturing up to analysis, release, quality topics and, finally, also for regulatory requirements.

The digital implementations inside the Angelini Fine Chemicals Business Unit are just a part of a bigger digital innovation project put in place by our parent company “Angelini Pharma”, in fact Angelini Pharma triumphed at “The About Pharma Digital Awards 2024”, winning the title of Best Digital Company for the second consecutive year. “The About Pharma Digital Awards 2024” represents the most prestigious Italian recognition for projects that promote digital implementation in the healthcare sector, supporting citizens, pharmacists, doctors, patients, and healthcare institutions. These awards testify to Angelini Pharma’s ongoing commitment to digital innovation in the pharmaceutical sector, aiming for a more technological, innovative, and sustainable healthcare system.

CONCLUSION

The race to digitalization has already started and will always go ahead, but it presents some challenges which must be addressed, especially for smaller companies, such as technological changes, regulatory compliance, high costs of implementation and technical Skills.

The increase in incentives could make these implementations affordable to everyone, in order to properly achieve the biggest challenge of digitalization that is to speed up and optimize the entire supply chain, from manufacturing to distribution of drugs and thus improve people’s health and quality of life.

ANNA ROSARIA NOCERINO

Sales & Custom Synthesis BD Manager

Angelini Pharma | Fine Chemicals Business Unit