Gen AI in Pharma: Simulation, AI Agents, and Empowering Operators
Zydus CTO Prashant Sharma and Leucine co-founder discuss how generative AI will reshape formulation simulation, deviation investigations, and operator empowerment on the shop floor.
Vivek Gera Host
Co-founder · Leucine
Prashant Sharma
CTO · Zydus
About this episode
In this episode, Vivek Gera (Leucine) sits down with Prashant Sharma, CTO at Zydus, to explore what generative AI actually means for the shop floor. The conversation covers AI-powered formulation simulation that could replace physical PPQ batches, the rise of AI investigator agents trained on organisational historical data, and the nuanced risks of over-reliance on AI-generated outputs. Prashant Sharma draws a striking analogy between pilots and pharmaceutical operators — both have lives in their hands, yet only one receives rigorous, continuous training. The episode closes with a sharp take on audit readiness: it is a culture question, not a compliance exercise, and companies doing it for the regulator are already getting it wrong.
Topics
Key takeaways
- The operator is the most critical person on the shop floor — AI's highest-ROI application is empowering them with predictive, contextual data before a problem escalates, not just reporting after the fact
- AI simulation of formulation behaviour — predicting CPPs, CMAs, and batch performance digitally before the first physical batch — could eliminate the need for multiple PPQ batches
- AI investigator agents work like experienced hires: pre-trained on scientific literature, then fine-tuned on an organisation's historical deviation data from day zero
- The biggest risk of AI-generated reports is not accuracy — it is people signing off without applying their minds, treating AI output as a rubber stamp
- Data abundance without interpretation capability is itself a risk; training people to reason with data matters as much as collecting it from machines
- All-time audit readiness is a culture question, not a compliance exercise — if you are preparing for the regulator rather than for the patient, you are already getting it wrong
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