2023-06-15

There is a clear hype around the new technologies to develop a Pharma 4.0 landscape in the life sciences industry. This makes its implementation a real challenge. To reduce stress when selecting these technologies and being realistic with the status-quo of each site, building a pragmatic digital transformation roadmap is key.

As all the complex challenges, it should have a very simple solution. It starts with a three-step approach:

• Step 1: Perform an audit to know the status of the site in terms of digital transformation capabilities – people, technologies, and processes.
• Step 2: Agree on a roadmap involving all the key stakeholders across the organization (vertical and horizontal) to define the desired status of the site in the short and mid-term.
• Step 3: Execute the agreed roadmap efficiently, being cost-effective with business cases supporting initiatives, timely and with proven track technologies and suppliers.

There are many different digital maturity models to define the status of a site and give an overview of the requirements needed to move further across the next levels and become a truly digital site.

One of the most pragmatic and realistic to implement is the Digital Plant Maturity Model developed by Biophorum. Since its creation in 2004, BioPhorum has become an open and trusted environment where senior leaders of the biopharmaceutical industry openly share and discuss the emerging trends and challenges they are facing.

Currently, BioPhorum comprises over 135 manufacturers and suppliers deploying their top 6000 leaders and subject matter experts to work in nine focused phorums. Articulating the industry’s technology roadmap, defining the supply partner practices of the future, and developing and adopting best practices in drug substance, fill&finish, process development and manufacturing IT.

BioPhorum has developed a ‘Digital Plant Maturity Model’ to address all the above with a very pragmatic approach. They have defined technological and business requirements needed to move further across the different digital maturity levels independently of the current digital level of the site.

The 5 levels of digital maturity defined by BioPhorum are well described in their ‘Digital Plant Maturity Model – DPMM’ white paper. In summary:

• Level 1 (Pre-Digital Plant)
• Level 2 (Digital Silos)
• Level 3 (Connected Plant)
• Level 4 (Predictive Plant)
• Level 5 (Self-driven Plant)

To assess a plant’s maturity level, two categories of dimensions have been established:

• Business capability dimensions: This category includes the primary business capabilities required to design, build, operate and maintain the digital plant and its role in the end-to-end enterprise value chain.
• Enabling capability dimensions: This includes the people, processes, technology and information capabilities required to enable the above business capabilities.

In particular, when approaching ‘Level 4: Predictive Plant’ or even before, an AI implementation roadmap should be defined. In that regard ‘Xavier University’ has established its own methodology based on the working groups that includes professionals from FDA, academia and biopharmaceutical companies.

The ‘AI Maturity Model’ poster provide a good summary how to assess an audit and develop a roadmap in regards of AI:

In conclusion:

1. Performing a digital maturity level audit is a must to start your digital transformation journey. There are several options out there. Let’s start with an easy and pragmatic one as the ‘Digital Plant Maturity Model’ defined by BioPhorum.
2. To develop and execute a digital transformation roadmap you must be realistic with your internal capabilities (people) and budget constrictions. A good approach would be: start with small pieces of the overall roadmap supported with business cases, then the scale-up factor will justify the rest of the roll out.
3. Choosing the right partner to perform the audit and help you on the roadmap definition and execution, is key. Furthermore, as much vendor agnostic much better to really execute your roadmap without hide interests to deploy certain software packages.