In the latest episode of the Augmented Ops podcast, host Natan Linder sat down with Jim Fox, Senior Vice President of America’s Supply Chain Operations at AstraZeneca, to discuss the evolution of digital transformation in the complex world of biopharmaceutical manufacturing.
Fox, a veteran of the pharma industry, shared his journey from working on life-changing drugs like HIV treatments to joining AstraZeneca, attracted by the company’s ambition and pace. He noted that the industry’s approach to digital transformation has shifted significantly over the years, from a focus on automation and data collection to a more sophisticated use of data for visualization, trend analysis, and decision-making.
A key milestone in AstraZeneca’s digital transformation journey was its Sweden site winning the Global Lighthouse Network Award, recognizing its use of process twins and mathematical models to predict performance attributes from the physical properties of drug substances. Fox emphasized the importance of building trust in these technologies through close collaboration with the development organization.
“A lot of what we put forward was around making sense of data, looking at trends, making data available to all sorts of people in the organization,” Fox explained. “But year on year, the bar from the Worldwide Economic Forum was getting harder and harder to join that, that club, if you like.”
One of the guiding principles in AstraZeneca’s approach to digital transformation is the integration of lean principles. Fox stressed the importance of following a “simplify, standardize, then automate/digitize” framework to avoid digitizing bad processes or waste. By leveraging a lean mindset, organizations can improve processes before embarking on digitization initiatives.
The conversation also touched on the challenges of managing the complexity of Standard Operating Procedures (SOPs) in a highly regulated industry like pharma. Fox shared AstraZeneca’s approach of consolidating SOPs into a single global repository, rationalizing and simplifying them, and disseminating work instructions in an agile manner, close to the operators on the shop floor.
When it comes to the debate between automated and autonomous manufacturing, Fox expressed a preference for the term “automated,” emphasizing the importance of the human touch, a concept known as Jidoka in lean manufacturing. While some pharma operations may lend themselves to a “lights out” approach, drug product facilities still require human intervention, he argued.
Personally, I think in pharma, certain operations lend themselves potentially to lights out, but in the main, when we look at drug product facilities, that is not the way to go. I still think you need some human intervention as you start turning powders into product or liquids into final product.
Looking ahead, Fox discussed the impact of biologics on pharmaceutical operations, noting the different production environments and cycle times for large molecule drugs compared to small molecule counterparts. As the industry shifts towards niche products and smaller-scale manufacturing for rare diseases, agility and flexibility in manufacturing systems will be critical to accommodating varying scales.
Throughout the conversation, Fox underscored the importance of data utilization, lean principles, and the ability to adapt to changing manufacturing needs as key drivers of successful digital transformation in the biopharma industry.
To hear more insights from Jim Fox and other industry leaders, tune in to the Augmented Ops podcast, available on LinkedIn, YouTube, and wherever you get your podcasts. And for more on the latest trends and best practices in pharmaceutical manufacturing, be sure to subscribe to the Tulip Interfaces blog.
