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FDA

#107: FDA's Real-Time Clinical Trial Revolution: A Wake-Up Call for the Life Sciences Industry

The shift is seismic, within a year, a regulatory body moved from 1% to 80% AI adoption, unified 40 systems, launched real-time trials signaling pharma must modernize rapidly or risk falling behind.

Nagesh Nama, +1

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May 6, 2026

FDA Special Programs

#0106: From Vision to Reality: AI, Compliance, and the Reinvention of Pharma Manufacturing

xLM’s LinkedIn Live highlighted how pharma is evolving toward real-time compliance, data-driven operations, and regulatory collaboration, enabling practical, human-centered innovation that balances speed, quality, and compliance in modern manufacturing.

Nagesh Nama, +1

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Apr 29, 2026

#0105: Engineering Trust: Making AI Credible, Compliant, and Scalable (Part 4)

Now, with the latest draft guidance from the U.S. FDA, the conversation has matured. The introduction of a structured credibility assessment framework signals a decisive shift: AI is no longer evaluated by capability alone. It must be validated, traceable, and defensible within a clearly defined Context of Use (COU).

Nagesh Nama, +1

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Apr 22, 2026

LinkedIn Live

#104: Designing the Future of API Manufacturing: Insights from PRG’s Digital Factory Vision

Adopting AI in pharmaceutical R&D poses a unique challenge. Unlike many industries, pharmaceutical innovation operates in highly regulated environments where compliance, data integrity, and patient safety are non-negotiable.

Nagesh Nama, +1

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Apr 15, 2026