Expert Statement: Teresa Minero, LifeBee

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?


“Digital transformation is too often perceived
to be only about technology. It is not.
It is about people and information.


Teresa Minero: Pharma 4.0 embodies the same characteristics of Industry 4.0, but there is an extra dimension in its complexity: compliance with regulations for patients benefit. The Patients are waiting at the end of our supply chain for a medicine that must be more and more effective, safe, promptly available at sustainable costs. We must assure this with Pharma 4.0.

From what we find in ISPE, and also in my company LifeBee, we must underline that digital transformation is too often perceived to be only about technology. It is not. It is about people and information. The main benefit is to empower human beings with the right information at the right time, in order to act and make the best decisions, at every level in the organization, from the line operator to the lab analyst, to the supervisor, to the QA, to the CEO, up to the regulators. In pharma there is also an additional complexity: information needs to be managed in full “data integrity”.

Regarding challenges specific to Pharma 4.0, they were deeply analyzed in a workshop in 2020, held at the ISPE European Pharma 4.0 conference. Results were clustered in six key topics as follows: 1. Compliance: the need to assure the company of the alignment between 4.0 and regulatory guidance; 2. Economics: costs of a 4.0 program versus the tangible value; 3. Knowledge: a wide spectrum of information on the 4.0 initiative must be shared with management and personnel from the outset; 4. Organization: the company organization will need to change – cut the silos – to benefit from and manage the 4.0 perspective; 5. Competencies: questions from management about workforce 4.0 features and workers’ potential resistance to change; 6. Strategy: many companies have developed 4.0 pilots and projects, but there is a lack of a mid to long term strategy, with a definition of business targets and a sound road map.

The benefits are undoubtedly far more important for our patients compared to the complexity of challenges. Let’s start the Pharma 4.0 journey!