March / April 2021

Emerging Leaders Editorial: Pharma 4.0™ - The Pillars for Success

John Clarke
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Understanding and utilization of Pharma 4.0™ technologies will be critical for students and Emerging Leaders (ELs) as they develop in their careers in the pharmaceutical and life sciences industries. To learn more, I spoke with Edoardo Schiraldi, an Emerging Leader based in Florence, Italy, who works as a Corporate R&D Business Solutions Specialist with Menarini Group, about the “pillars” of Pharma 4.0™ that Emerging Leaders and others need for success with this important initiative.

Edoardo Schiraldi
Corporate Program Manager

Tell me about your role and how it relates to Pharma 4.0™.

I coordinate the resources working on R&D IT implementation projects, providing coaching and supervision and serving as a contact for key business stakeholders. I also manage a R&D corporate project portfolio collecting business needs and supporting the corporate directors in defining and updating the five-year plan for R&D functions. My role requires me to stay at the forefront of emerging Pharma 4.0™ technologies to incorporate and utilize them to their full potential. I also work to define the strategy of Menarini Group robotic process automation and coordinate RPA process discovery activities and project implementation.

What is your involvement with the ISPE Pharma 4.0™ Special Interest Group?

I’ve been involved with the special interest group for the past two years, participating in monthly meetings to define the Pharma 4.0™ communications strategy for upper management. This includes the Pharma 4.0™ LinkedIn group and publishing articles in Pharmaceutical Engineering®. I have met many industry experts in this field and now have a network of people to reach out to for information or advice on technical challenges I encounter in my work.

What challenges do you see for companies with implementing Pharma 4.0™?

Attention and interest in the Industry 4.0 concept have greatly increased in the last decade, but there is still not enough awareness about it. Many companies in different industries have started 4.0 pilots and project implementation, but few have defined a clear long-term 4.0 strategy due to the huge initial investment required. In the pharmaceutical industry, specifics such as GxP regulations, validation processes, and patient safety have played a role in delaying exploring and implementing Pharma 4.0™ initiatives.

How can the industry overcome these challenges?

A common mistake is to consider a Pharma 4.0™ project just “IT oriented.” While the IT/operational technology (OT) enabling technologies should be considered, other fundamental pillars of Pharma 4.0™ include processes, resources, organization, culture, and change management.

Investing in the right technologies requires a preliminary digital maturity assessment. Considering the T/operational technology enabling technologies in relation to the current digital maturity level of the company ensures time and money will be invested in the right implementation projects. Wrong choices can waste resources and have a negative impact on the “4.0 confidence” needed to define a long-term strategy.

Understanding the main features of Pharma 4.0™ and how it can be applied to the pharmaceutical industry is essential. Then processes need to be considered and thoroughly analyzed so they can be reshaped to prepare the general framework for Pharma 4.0™ adoption. These areas are key: intro-duce workforce cross training and qualification in 4.0 technologies; address culture issues; adopt data integrity by design; and share information about Pharma 4.0™ and its achievements.

Many thanks to Edoardo for sharing his experience and insight into Pharma 4.0.

Learn More About Pharma 4.0™ 

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If you are looking to get involved with your local ISPE Emerging Leaders Chapter or Affiliate, or want to start one, contact John Clarke.