Pharma 4.0 projects may have gotten off to a slow start, but they have ramped up recently.

Big Pharma has led the charge in deploying Pharma 4.0 projects, which involve the use of digital technology to draw operational efficiency.

“It makes sense because a lot of these digital technologies have a big dollar sign with them and Big Pharma tends to have the funds for that,” said Yvonne Duckworth, senior automation engineer at CRB and co-author of CRB’s 2021 Life Sciences Horizons report.

As adoption matures, more startups will likely embrace Pharma 4.0 technologies, Duckworth said. Even cash-strapped startups building new facilities could lay the groundwork for smart factory upgrades in the future. “It’s about being forward-thinking in designing new facilities,” Duckworth said.

[Related: Pharma 4.0: Industry 4.0 Applied to Pharmaceutical Manufacturing]

That said, navigating the waters of Pharma 4.0 can be challenging, given the industry’s historical reticence in embracing emerging technologies. While the pandemic has ramped up the adoption of technologies such as AI and digital twins, most pharma companies remain at an early stage of their digital journey.

To shed light on best practices related to Pharma 4.0 deployments, we interviewed three experts at CRB who have firsthand experience helping pharma companies with digital transformation initiatives.

The term ‘digital twin’ can sometimes be ambiguous

NASA likely used digital twin technology — before the term ‘digital twin’ existed — decades ago when working on Apollo 13. While the concept may not be new, the digital twin sometimes remains elusive. “When we say ‘digital twin,’ that could mean a lot of different things,” Duckworth said.

A digital twin might include dynamic models of instrumentation or equipment. Digital twins could also inform programming process control systems. “Having a duplicate of what you have live would enable a company to test changes before rolling them out on the production floor,” Duckworth said.

“From a design standpoint, the digital twin is the 3D model or the building information modeling (BIM) model,” said Matt Edwards, director of digital delivery at CRB. Having a digital copy of a physical facility has significant potential from an operational\facilities maintenance standpoint as well as a design and construction standpoint.

The notion of sophisticated plant-wide digital twins is “still a bit of a pie in the sky vision,” said Niranjan Kulkarni, senior director, consulting services at CRB. “There are pockets where you will see digital twins adoption in automation, for instance, but I have yet to see a truly integrated, autonomous self-learning facility in pharma.”

An ROI for Pharma 4.0 technologies isn’t all about money

While Pharma 4.0 technologies promise to yield efficiency gains that can lead to cost savings, determining the return on investment (ROI) for such investments can be hard to quantify. From an ROI perspective, life science companies deploying smart factory technology also prioritize regulatory benefits. “Compliance and regulatory affairs are a bigger priority than a [purely financial] ROI,” Kulkarni said.

Organizations looking to determine the ROI should remember to thoroughly consider the installed cost as well as recurring costs associated with the deployment of technology.

Other aspects of an ROI include quality improvements, potential risks associated with the technology, safety considerations and the potential for reducing headcount. Robotics and automated storage and retrieval systems, for instance, have the potential to minimize workforce needs.

“A key component that needs to be evaluated when considering adoption of these technologies is the impact on your workforce,” Duckworth said.

Smart factories need smart workers

When deploying smart factory technology, some of the most important considerations relate to talent and culture. “If you are looking at a truly automated system, maybe you don’t need as many operator-level people, but you need a data scientist,” Kulkarni said.

Companies with Pharma 4.0 initiatives may find themselves swimming in data and may need new employees to help manage and sift through the data exhaust. “There’s nothing worse than having data and not doing anything with it,” Duckworth said.

That said, pharma companies may find it hard to woo data scientists away from well-paid jobs at tech and finance companies. But universities are getting better at training workers in areas such as data analytics and robotics, which is creating a larger talent pool. “While a gap still exists within the manufacturing, I think we’ll see that gap reducing,” Kulkarni said.

At the same time, the rapid embrace of AI and data science in other industries allows pharma companies to survey emerging best practices from other industries and potentially hire workers who may lack a formal pharma background but have skills related to data analytics. “Pharma is generally very reserved in adopting technology, but I think those doors have opened,” Duckworth said.

Leverage the construction industry’s recent embrace of digital technology

The construction industry is also being forced to become more tech-savvy and open in its hiring practices, said Matt Edwards, director of digital delivery at CRB, where there is a need to focus on developing a data-driven mindset and hire new workers. A recent study by the Associated Builders and Contractors (ABC) concluded that the construction industry would need to hire almost 650,000 more workers in 2022 over its normal hiring rate. “In construction, we need to retrain and recruit outside of our industry,” Edwards said.

As more pharmaceutical companies build smart factories from scratch, they can benefit from construction companies’ investment in technologies such as asset tracking and data analytics.

“Asset tracking is a low bar as far as using platforms like the construction cloud, where you can do QR tracking and tie in checklists,” Edwards said.

Construction companies are also investing in digital twin platforms, virtual tour software, 3D modeling and facility management software. “Younger companies — even more mature pharmaceutical companies — getting into the digital space can get their feet wet with technologies like these,” Edwards said.

Look outside for digital inspiration

As tech companies push the envelope of digital technologies, pharmaceutical companies can find inspiration for smart factory projects in various contexts. “Some of our clients have looked at Formula One racing,” Kulkarni said. The F1 industry uses that data to make real-time decisions — to decide when to pull the car off the track and when and how to do maintenance and change over quickly.”

Pharma companies can also consider Amazon’s supply chain innovation and see if they can implement similar technologies.

“There is a lot of opportunity for cross-pollination to benefit life sciences,” Kulkarni said.

Build in cybersecurity protections as early as possible

The shadow side of Pharma 4.0 technologies is a potentially larger attack surface for cybercriminals. “We want everything connected. We want data from all these different pieces of equipment and skids all brought back to a central location,” Duckworth said.

Cybersecurity is a vital consideration when designing network infrastructure or deploying new systems on top of existing infrastructure. “You want to ensure that things are segregated properly,” Duckworth said. Pharma companies without significant in-house talent should tap experts to ensure that appropriate security measures are in place.

Pharmaceutical companies also should ensure that data meant to flow in a single direction doesn’t flow bidirectionally and that firewalls are correctly configured. “From an automation perspective, make sure that everything is FDA 21 CFR Part 11 compliant,” Duckworth added, referring to the FDA’s electronic records and signatures guidance.