Digital Manufacturing Networks in the Real World: Practical Steps for CDMO-Sponsor Integration

At CDMO Live 2025, a panel of digital manufacturing experts explored how pharma companies are transforming external manufacturing operations through digital integration. Sponsored by Aizon.

The Digital Divide: Big Pharma vs Mid-Size Players

The panellists painted a stark contrast in digital maturity across the pharmaceutical manufacturing landscape. Dave O’Gara, pharmaceutical business consultant at Aizon with over 30 years experience at Novartis, outlined the current state of play.

“When you move into pharma and segregate into big pharma, they have digital strategies… When you move into the mid-range CDMOs and smaller CMOs, it’s not so active,” O’Gara explained, highlighting what he termed a “massive opportunity” for mid-size players.

Franziskus Kath, founder of Kath-Consulting and former VP of Emerging Technology for QA at Johnson & Johnson, confirmed this assessment: “The larger the companies, the more digital is already there… Most of them have been for the past eight to 10 years really tackling the topic.”

From the CDMO perspective, Vishnu Dwadasi, Director of Life Sciences at West Monroe, described significant implementation challenges: “A lot of these companies are still very manual, so they have to move from paper to digital and then digital to eventually leveraging analytics and AI.”

Quick Wins vs Grand Strategies

Perhaps the most practical insight came from the tension between comprehensive digital transformation and targeted quick wins. While Johnson & Johnson invested millions in their digital strategy, the panellists emphasised that smaller players needn’t follow the same path.

“You don’t want to go on a digital journey and not see the return on that investment in a reasonable time frame,” O’Gara stressed. He cited a compelling example: “An API that they’ve been producing for many years, a project on yield optimisation where they extracted an additional 1.5% of yield… The ROI on that was multiple, multiple quantities.”

Stephen Sheehan, Director of External Development and Manufacturing at Alkermes, shared a more modest approach that delivered significant benefits: “We created an external SharePoint site… Everything is hyperlinked so when we run into issues, the data is at your fingertips.”

The Power of Digital Twins and Real-Time Visibility

Kath provided insight into more advanced implementations at J&J, where digital twins have created substantial value. “There is visibility to real-time production data… The experts then can see, hey, your pH is shifting away, so you’re going to go and feed your cells a little bit more, and that can save you weeks of manufacturing capacity,” he explained, noting that “the payback definitely was” worth the investment.

Integration Challenges and Opportunities

The panellists identified significant obstacles in CDMO-sponsor integration. Dwadasi pointed out a fundamental issue: “The data is in paper, might be in system X, might be in your ERP, might be in your LIMS, might be in your QMS… By that time that data is sent to you, it’s probably outdated.”

However, the benefits of integration were clear. “When you are integrated, you all look at the same set of data, and there’s total clarity,” Kath explained. “You really can go into the content.”

Business Strategy, Not Digital Strategy

A crucial distinction emerged around how companies should approach digitalisation. Sheehan emphasised: “Every company has a business strategy, and I think it’s important that digitalisation is incorporated into the business strategy. Whereas if people start talking about a digital strategy, to me, it seems like it’s a little bit siloed.”

Kath took this further: “The business needs to own that. It’s a business strategy, and digital helps you to enable the business strategy.”

Key Takeaways

• Dave O’Gara: “Go back and look at your most important product and evaluate. Could we implement a digital solution on this product?”
• Stephen Sheehan: “Look at your three biggest issues and your three most important CDMOs, try and see what is the solution to that, and if digital is a part of that, implement it first.”
• Franziskus Kath: “Do we speak the same language? Do we have the same priorities? If it’s about digital, then you can go there and select jointly what is the right target.”
• Vishnu Dwadasi: “As you’re moving into more of a digital organisation, change management and adoption is going to be critical… Make sure that the entire organisation is part of this journey.”

The overriding message was clear: digital transformation in pharmaceutical manufacturing doesn’t require a complete overhaul.

As O’Gara put it, “You can eat the elephant one piece at a time, and that piece that you eat first, if you can create real value out of it and show it in your organisation that you’ve created value, you’ll get adoption.”