This isn’t about vague innovation buzzwords. This track highlights how biopharma professionals (e.g., end users, solution providers, and consultants) are actively redefining operations, analytics, quality control, and compliance with digital tools. With six data-driven, experience-rich sessions, attendees will gain practical insights they can apply right away.
Here’s a preview of the exciting content featured in this track.
From Manual to Machine: The Rise of Digital Process Analytics
Dhanuka Wasalathanthri, PhD, of Bristol Myers Squibb opens the track with a look into “Automation and Digital Transformation in Process Analytics.” As biologics grow more complex, the need to streamline in-process analytical testing becomes critical. Wasalathanthri presents a roadmap driven by clear key performance indicators (KPIs)—like speed and productivity—paired with three case studies that show how robotic process automation (RPA) and machine learning are reducing manual touchpoints and unlocking faster decision-making.
Takeaway: To successfully digitize analytics, organizations must build capabilities around plug-and-play automation, collaborative infrastructure, and strong performance metrics.
From Pilot to Production: Scaling AI That Works
Soumyopriyo Saha of TCG Digital shares one of the most compelling real-world digital wins in the session “Moving Beyond AI Pilots in Biopharma: Case Discussion.” He outlines how a plasma-derived product manufacturer used a unified data lake, predictive analytics, and generative AI to break through legacy systems—resulting in over US$1,000,000 in cost savings in year one and a market valuation jump from US$800,000,000 to US$4,300,000,000.
Lesson learned: The key isn’t just deploying AI; it’s scaling it with clear alignment, cross-functional collaboration, and a plan to turn pilots into enterprise-wide solutions.
Rethinking Data from the Ground Up
Chris Monchinski from InflexionPoint takes on one of the thorniest issues in biopharma digitization: data governance. His session, “Elevating Digital Data Governance in Biopharma,” argues for moving beyond siloed systems and toward data-centric architectures. He emphasizes ontologies (such as those from the Allotrope Foundation), ISA-95, and IEC 62264 as foundational tools to contextualize and standardize data from lab to production floor.
Real impact: Better governance isn’t just about compliance—it’s about enabling real-time insights and smoother integrations across the entire manufacturing chain.
Building Smarter Lifecycle Management Systems
From Takeda, Jennifer Tonning and Sarbajita Ray provide a comprehensive perspective on “Implementing Lifecycle Management Strategy” through digital tools. Their session covers how Takeda tackled the challenge of multiple siloed systems and tools being used, by mapping current-state processes, developing workstreams for specific focus areas, and benchmarking against industry standards to choose the right digital solutions.
Key insight: Lifecycle management isn’t just a regulatory necessity—it’s a strategic lever for speed, compliance, and product availability when paired with the right enterprise-wide systems.
Quality Control (QC) Labs Go Digital – and Lights Out
The vision of a fully automated “lights-out” lab might sound futuristic, but Clarence Friedman of Waters Corporation argues it’s already within reach. His talk, “Digital Transformation in QC Labs: Progress and Possibilities,” details how AI, cloud platforms, and integrated instruments are simplifying the analysis of complex biologics while boosting regulatory compliance.
Notable examples include cloud platforms enabling seamless collaboration with external labs, AI-driven tools that ease the burden of heterogeneous molecule analysis, and practical steps to transition from traditional labs to high-precision, automated environments.
Making Data Useful with a PI Historian
Jim Elliott and Mike LeBlanc walk through a grounded, relatable case study: “Capturing Benchtop Manufacturing Data with PI Historian.” Their presentation tackles a common problem (managing manual, paper-based data) and shows how connecting even small-scale lab equipment to centralized PI Historian systems can drastically improve traceability, compliance, and efficiency.
What’s different: This isn’t theory. It’s a step-by-step look at how to modernize data collection and unlock advanced analytics, even in legacy environments.
Why This Track Matters
What ties all these presentations together is simple: actionability. Each session offers a clear path from idea to implementation—whether it’s adopting AI, modernizing QC, digitizing lifecycle management, or building a digital data foundation.
In an industry where precision and compliance are non-negotiable, and speed determines how soon life-saving medicines can reach patients, digital transformation is more than a buzzword—it’s a competitive necessity. This track shows what it looks like when the biopharmaceutical industry embraces the transformation and reaps the benefits.
If you’re a biopharma professional looking to implement, improve, or accelerate your digital initiatives, this is the track you can’t afford to miss.
Register now for the 2025 ISPE Biotechnology Conference and secure a seat in the room where real digital transformation happens.
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