Artificial intelligence is advancing quickly into laboratory operations, which is why thinking about the quality and integrity of the supporting data early on is important. In regulated environments, that means understanding where the data came from, how it changes, and how AI-generated insights or recommendations can be traced, reviewed, trusted, and ultimately defended.

In this GEN podcast, LabVantage’s Gary Stimson digs into what it takes to build a data foundation for trustworthy AI. The discussion covers concepts like data lineage, traceability, explainability and governance, and the importance of audit-ready laboratory operations. It also looks at the role of intended use, ongoing monitoring, and human review in deploying AI responsibly.

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Small molecules continue to play a major part in pharmaceutical development, but increasing molecular complexity, accelerated timelines, and evolving manufacturing and regulatory requirements are creating new challenges for the industry.

In this GEN Podcast – part 2 in a 3-part series -- a trio of experts from SK Pharmteco discuss how CDMOs are helping biopharma companies navigate critical areas including scale-up, technology transfer, advanced manufacturing, automation, sustainability, the emergence of AI, and supply chain reliability. The discussion explores practical strategies for improving development efficiency while supporting quality, scalability, and long-term commercial success.

Guest Speakers

Steve Barr, PhD -- Head of Small Molecule Business Unit and VP Global Alliances, SK Pharmteco.

Darryl Ratty -- Executive Director of Global ESG (Environmental, Social and Governance), SK Pharmteco.

Bill Dubay -- VP, Global Research and Development, SK Pharmteco.

Moderator:

Kevin Davies, PhD, Editorial Director, GEN

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This episode establishes the broader context for AI adoption. Rather than focusing on AI tools themselves, the discussion explores what laboratories must have in place before AI can be applied responsibly.

Key discussion areas include:

• Why fragmented workflows and disconnected systems limit AI effectiveness
• The importance of trusted, connected laboratory data
• Human-guided AI and human-in-the-loop governance
• Why compliance and auditability should be built into AI-enabled workflows from the outset

Relevant reference to LabVantage CORTEX:

LabVantage CORTEX embeds AI within laboratory execution workflows so that intelligence operates within existing scientific and compliance processes, rather than as an external layer.

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