Expert Statement: Michelangelo Canzoneri, Merck

The Transition to Digitalization in the Pharmaceutical Industry

06.09.2021 - ISPE and its members are developing the roadmap to introduce Industry 4.0, also called the Smart Factory, at the pharmaceutical industry as Pharma 4.0 – an operating model that is interconnected, meaning that the digital tools allow for a fully connected network to enable direct communication between all levels in an organization.

Despite the transformational potential of digitalization, the pharma industry has historically been slower than other sectors in adopting digital tools, such as cloud storage, artificial intelligence (AI), machine learning (ML), blockchain, and remote communication technologies, and in ­mak­ing associated changes in workplace culture and strategic priorities. Now, however, the Covid-19 pandemic may be accel­erating the pace of change.
What are the digitalization trends in the industry? What is the business case to develop and implement digital tools and digitalization strategies? And how can organizations introduce and use them?

CHEManager asked executives and industry experts to share their views on digitalization trends in the pharmaceutical industry and challenges on the way to realize the sector’s digital transformation. We proposed to discuss the following aspects:

  • What do you think are the key digitalization trends in the pharmaceutical industry?
  • What do you consider to be the most important benefits of digitalization in the pharmaceutical industry?
  • Is your company involved in system­atic, ongoing action to digitalize operations?
  • At present, digitalization in the pharmaceutical industry is immature. In your view, what are the biggest obstacles that need to be overcome in the digitalization of the sector?
  • How would you rate the digital maturity level of your company?


“Digitalization will enable our industry
to streamline its processes, increase speed to market,
identify opportunities to reduce costs,
and elevate performance.”


Michelangelo Canzoneri: We have unprecedented amounts of data at our fingertips, yet we’re only scratching the surface of its value. To build industry-wide capabilities for deriving genuine and actionable insights from manufacturing data analysis for example is becoming increasingly success-critical in the industry. Some big questions here are ‘How is my batch doing?’ and ‘Has this deviation affected product quality?’ In the labs and manufacturing facilities of the future everything will be fully connected, with automated processes and data driven foresights too. Managing knowledge is where digital and data can elevate the connection between R&D and operations. It is not just about accessing and compiling the data. Everyone involved will require access to high qualitative information (reintegration of learnings from all batches) to build process and business excellence.

Secondly, the drive towards more resilient manufacturing. According to an Accenture report, two out of five cyberattacks are now indirect causing the industry tens of billions of US-dollars due to IP theft yearly. Companies in the pharma sector need to look beyond their own four walls to their broader ecosystems. Investing in robust cyber resilience, while bridging the gap between information and operational technology, will be key to prevent, manage, monitor, analyze and predict risks for attacks and intrusions and important to conduct counteractive protocols and report incidents, along with examining and evaluating security strategies and defense.

Digitalization will enable our industry to streamline its processes, increase speed to market, identify opportunities to reduce costs, and elevate performance. And if we continue to evolve and put the patient at the center of everything we do, then we will unlock treasures for unmet medical needs across the digital continuum. This will create opportunities for precision, personalized, and preventative medicine, and deliver tangible benefits to patients faster. Digital is not an end state – it’s a journey.