Root Causes, Part 1: When Trial Design Locks In Supply Risk
By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader
How Upstream Decisions Shape Clinical Supply Outcomes – A Five-Part Video Series
Clinical supply industry conversations inspired this five-part video series. Engagement around our recent “What Clinical Wishes Supply Did Better …” series with clinical operations leader Elena (Ella) Sinclair made one thing clear: to better understand clinical supply challenges, we need to look further upstream to the decisions, assumptions, and tradeoffs that are made before clinical supply even enters the room.
To explore those upstream influences, Clinical Supply Leader brought Sinclair back, along with GMP operations and manufacturing expert Tatyana Matveeva, Ph.D. Drawing on perspectives from clinical operations, manufacturing, and operational readiness, they examine the root causes behind many of the issues that ultimately surface in clinical supply.
Part 1: When Trial Design Locks In Supply Risk
By the time supply and operations join a clinical trial, many of the decisions that shape execution have already been made. In this first installment of Root Causes, Sinclair and Matveeva examine how those early trial design choices create downstream operational and supply consequences.
Main Highlights
- Why clinical supply is often brought into planning after critical decisions have already been made
- How protocol design choices create downstream manufacturing and supply challenges
- The impact of eligibility criteria, biomarkers, comparators, and study geography on trial execution
- Why manufacturing and operations inherit risks they did not help create
- How delays, rework, and operational complexity emerge when supply considerations are introduced too late
- What experienced operations and manufacturing teams look for when evaluating protocol feasibility before execution begins
- Why early protocol decisions directly influence drug availability, waste, and operational feasibility
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 2: The Translation Problem Behind Clinical Trial Execution
If early decisions create downstream consequences, how do those consequences emerge during execution? The next discussion explores the gap between protocol intent and operational reality.
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