EP 8 — Takeda’s Michael Backhaus on As Local As Possible, As Global As Needed IT Architecture

Digital transformation in pharmaceutical manufacturing faces unique challenges that aren't present in other industrial sectors. In this episode of Industrial Visionaries, Michael Backhaus, Director of Digital Manufacturing at Takeda, provides an inside look at how one of the world's leading pharmaceutical companies balances innovation with stringent GxP compliance requirements. Michael walks ZJ through Takeda's strategic approach to empowering site-level innovation within a regulated framework, allowing their 25+ manufacturing sites to digitize at their own pace while maintaining regulatory compliance. 

From their successful paperless transformation initiative that's "exploding" with adoption across their network to their pragmatic data architecture philosophy of "as local as possible, as global as needed," Michael shares how Takeda is making progress toward their ultimate vision: fully autonomous manufacturing operations where algorithms and feedback loops maintain critical parameters with minimal human intervention.

Topics discussed:

• Regulated digitalization framework allowing individual manufacturing sites to implement solutions at their own pace within GxP compliance constraints, creating a balance between innovation and patient safety requirements.
• Network-wide demand capture methodology that identifies common pain points across multiple manufacturing sites before investing in solutions, ensuring digital initiatives address actual manufacturing challenges rather than implementing technology for its own sake.
• Paperless transformation initiative that empowers site-level engineers to create their own GxP-compliant digital forms and workflows, resulting in rapid adoption across the manufacturing network without central mandates.
• Takeda’s "as local as possible, as global as needed" IT architecture strategy that accommodates site-specific manufacturing processes while standardizing data structures for centralized analytics and cross-site reporting.
• Compliance-first ROI framework that prioritizes regulatory requirements over traditional return calculations for certain projects, while still maintaining value-based decisions for non-mandatory digital initiatives.
• Demand-driven adoption approach that eliminates resistance by focusing on solutions that directly address manufacturing pain points, creating pull rather than push for new technologies.
• Data harmonization strategy that transforms site-specific data formats before integration into central data lakes, enabling analytics while preserving site autonomy in data collection processes.
• Low-code enablement for engineers that allows manufacturing professionals to create their own dashboards and visualizations without deep programming knowledge, democratizing data access across the organization.
• Vision for autonomous manufacturing that leverages algorithmic feedback loops to maintain critical parameters in biological processes, potentially reducing human intervention while improving product consistency and quality.