From The Editor | October 6, 2026

Root Causes, Part 5: The Structural Changes Clinical Supply Needs

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By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

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The system isn't broken. It's producing the outcomes it was designed to produce. The question is whether it's designed for the outcomes we want.

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

In the final installment of Root Causes, Elena (Ella) Sinclair and Tatyana Matveeva, Ph.D., turn from diagnosis to solutions. Building on the challenges discussed throughout the series, they examine what would need to change structurally, not just behaviorally, to improve clinical trial execution and clinical supply outcomes.

(Revisit part 1, part 2, part 3, and part 4 here)

Main Highlights

  • Why today's clinical trial and supply systems often produce the outcomes they were designed to produce
  • The limitations of supply networks originally built for more predictable therapies
  • How advanced and personalized therapies are exposing gaps in traditional supply models
  • Why supply, manufacturing, and operational expertise should be incorporated earlier in study planning
  • The importance of changing habits, assumptions, and planning processes, not just technologies
  • How KPI misalignment can drive unintended behaviors across functions
  • Why organizations often celebrate milestones more than successful execution
  • The case for giving execution teams greater influence during protocol and study design
  • Why sites and other downstream stakeholders should have a stronger voice in planning decisions
  • What it would take to build more adaptable and resilient clinical trial systems
  • Why clinical supply expertise should influence trial design rather than merely support it

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.

Explore the Complete Root Causes Series