In a world where R&D discovery is moving at light speed, why are quality systems still tethered to paper? Join host Becky Stewart and AI leader Patrick Callahan as they dive into the critical intersection of technology and life sciences. This episode breaks down the hurdles to regulatory acceptance of synthetic data and the rise of "agentic AI"—systems that don't just assist humans but proactively manage lab workflows.

Discover how Delaware’s innovative AI sandbox is allowing companies to "fail fast" safely to accelerate biopharmaceutical manufacturing. If you’re struggling to navigate the transition to autonomous labs, this episode provides the expert insight needed to ensure your data traceability and regulatory frameworks keep pace with innovation.

Resources:

➥ Harmonizing Progress: Bridging BioPharma, Technology, Academia, and Healthcare for Advanced Drug Manufacturing: https://pmc.ncbi.nlm.nih.gov/articles/PMC10759976/

➥ The National Institute for Innovation in Manufacturing Biopharmaceuticals: https://www.niimbl.org/

➥ Delaware’s AI Sandbox: https://news.delaware.gov/2025/07/23/delaware-launches-bold-ai-sandbox-initiative-cementing-its-role-as-a-national-leader-in-responsible-tech-innovation/

➥ Subscribe to Informatics Insider Newsletter: https://info.csolsinc.com/subscribe-to-newsletter

Chapters:

00:00 Introduction to AI in Life Sciences

02:07 Bridging the Gap: AI in Biopharmaceutical Manufacturing

05:27 Synthetic Control Arms: Revolutionizing Drug Trials

09:06 Personalized Medicine: The Batch of One

10:14 Trusting AI: The Threshold for Autonomous Experiments

12:53 Delaware's AI Sandbox: Innovation in High-Stakes Environments

15:44 Practical Tips for Implementing AI in Labs