Root Causes, Part 4: Why Clinical Supply Teams Are Always Firefighting

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

How Upstream Decisions Shape Clinical Supply Outcomes: A Five-Part Video Series

In the fourth installment of our Root Causes series, Elena (Ella) Sinclair and Tatyana Matveeva, Ph.D., examine why even the most well-planned studies can become reactive shortly after execution begins. Drawing from both operational and manufacturing perspectives, they discuss what happens when plans built on a snapshot of reality encounter the constantly changing conditions of clinical trial execution.

(Revisit part 1, part 2, and part 3 here)

Main Highlights

• Why planning assumptions begin to break down once trials move into execution
• The difference between static plans and dynamic operating environments
• How site capabilities and operational realities can diverge from expectations
• Why supply plans become reactive when operational assumptions collide with real-world conditions
• What "perfect plan meets reality" looks like in practice
• How manufacturing teams balance highly controlled environments with unpredictable external conditions
• Why timelines, forecasts, and operational strategies require ongoing reassessment
• Why some degree of firefighting is inevitable in clinical trial execution

Watch now:

About the Experts

Elena (Ella) Sinclair is a principal consultant at FlexPoint Bio, focused on operational strategy and logistics, clinical vendor outsourcing, and clinical quality assurance. She’s held various leadership roles, including as CEO and co-founder of the Life Science & Tech Consultants Association, and as both Seattle Chapter Chair of the membership committee and board member for the Women in Bio organization. She also served in clinical trial and operations management and director roles for five years at Sangamo Therapeutics – after 17+ years in clinical research at UT Southwestern Medical Center.

Tatyana Matveeva, Ph.D., is a neuroscientist with a background in systems and molecular neuroscience. She is now director of cGMP operations for cell therapy and regenerative medicine at a major university and connected hospital. There, she helped build a GMP cell therapy facility from the ground up — creating the full GMP infrastructure, programs, documentation, and training required to support early phase clinical trials.

What’s Next – Root Causes, Part 5: The Structural Changes Clinical Supply Needs

If today's challenges are largely the result of how clinical trials are designed, governed, and executed, what would need to change? In the final installment, Sinclair and Matveeva discuss the structural, organizational, and cultural shifts required to improve clinical trial execution.

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