The End of the Supply Chain Is the Patient: Shortages, Governance, and Risk with Dr. Angeliki Kotsianti

What happens when a biopharma supply chain breaks upstream from the clinic? It doesn't just delay manufacturing, it forces doctors at the bedside to choose which patients receive curative therapy and which ones have to wait.

In this episode of Out of the Lab, host Nicholas Crudele sits down with Dr. Angeliki Kotsianti, founder and scientific advisor of Oncolyze and former Senior Global Medical Benefit Risk Lead at Pfizer. Drawing on her unique perspective as both a treating physician and a senior biopharma executive, Angeliki breaks down why drug shortages must be re-framed as clinical events, how evolving regulatory guidance (like Computer Software Assurance) demands human medical judgment, and why operational governance must be engineered into drug development from day one.

Key Takeaways:

• The Bedside Realities of Shortages: Lessons from the 2009 oncology supply chain crisis and why single-source dependencies leave zero buffer for clinical delivery.

• Shortage as a Clinical Event: How manufacturing line downtime, API consolidation, and quality deviations directly impact medical choices and patient survival.

• Human Accountability vs. Automation: Why software tools cannot take management decisions or replace clinical judgment when evaluating patient exposure.

• Designing the Line from the Outset: Why operationalizing advanced therapies requires one owner across the entire pathway from bench to patient.