Clinical trials are often discussed in terms of scientific breakthroughs, patient recruitment, and regulatory approvals.

Yet, behind every successful trial is a less visible but equally critical function: the pharmaceutical supply chain.

From toxicology studies to late-stage oncology trials, the integrity of medicines, how they are planned, produced, labeled, stored, and delivered, can determine whether a trial succeeds, fails, or puts patients at risk. This reality is especially important as more global trials expand into emerging markets, including Africa.

Between 2019 and 2022, I worked as a Global Supply Planner at Amgen Inc., one of the world’s leading biotechnology companies. My role sat at the intersection of science, regulation, and operations, translating highly technical clinical study requirements into real-world, compliant supply plans that protected patients and preserved data integrity.

Turning Science Into Safe Supply

Clinical trials begin long before a patient receives a dose. Early-stage data from toxicology, pharmacokinetics, and drug metabolism (PKDM) studies must be interpreted and transformed into actionable supply strategies. This translation is not trivial.

Each decision, how much material to produce, how it is packaged, how it is labeled, and where it is shipped, must comply with strict global regulatory standards. Errors at this stage can lead to trial delays, regulatory findings, or worse, patient harm.

In my role, I ensured that clinical supplies were accurately labeled, packaged, and shipped using SAP systems to maintain full traceability and compliance. These controls are essential not only for regulatory approval but also for preventing counterfeit or diverted medicines from entering the supply chain, a growing global risk.

Planning Against Shortages and Counterfeiting Risks

One of the most underestimated threats in clinical research is supply disruption. Shortages of raw materials or finished drug products do not just slow trials; they can create conditions where counterfeiting and informal sourcing emerge.

To mitigate this risk, I used Anaplan forecasting software to build multiple planning scenarios, stress-testing supply plans against potential shortages or demand volatility. Rather than relying on a single forecast, scenario planning allows teams to anticipate disruptions and respond proactively.

By coordinating regular forecasting and alignment meetings with clinical study teams, I helped resolve conflicts between clinical demand and supply constraints early, before they escalated into compliance or patient safety issues.

Precision at Scale

During my tenure, I managed 10 materials across more than 20 oncology and hematology clinical studies for Amgen and NASCR. These were not routine products. Oncology trials require extreme precision, tight controls, and rapid issue escalation when deviations occur.

Every shipment, reconciliation, and adjustment had to align with Good Clinical Practice (GCP) and validated SAP processes. I also led material reconciliation activities at third-party depots, ensuring that inventory records matched physical stock and that all discrepancies were investigated and resolved according to regulatory standards.

This level of discipline is what ensures adverse drug effects can be properly monitored, traced, and reported, an essential pillar of patient protection.

Supporting a Breakthrough Cancer Therapy

One of the most significant responsibilities I held was serving as the lead supply planner for sotorasib (LUMAKRAS), a groundbreaking cancer therapy targeting the KRAS, a cancer target long considered “undruggable”. This medicine received accelerated approval and was designated as a breakthrough therapy from the Food and Drugs Authority, USA

For such a high-profile and innovative therapy, compliance was non-negotiable at every step: raw material sourcing, production planning, packaging, labeling, and delivery. Any weakness in the supply chain could have delayed patient access to a life-changing treatment or compromised regulatory confidence.

Why This Matters for Emerging Markets

As clinical trials increasingly expand into emerging markets, supply chain capability will determine whether these regions are treated as equal research partners or operational afterthoughts.

Strong supply planning protects patients, builds regulatory trust, and strengthens local research ecosystems. Weak planning does the opposite.

Africa has the talent, the patient populations, and the clinical expertise to play a larger role in global research. What is needed is sustained investment in supply chain systems, skills, and governance.

Conclusion

Clinical trials do not succeed on science alone. They succeed when science is supported by disciplined, compliant, and resilient supply chains.

By bringing supply planning, forecasting, and lifecycle management into the center of clinical research conversations, we can improve patient safety, protect data integrity, and ensure that innovation reaches those who need it most, everywhere

By: Jonathan Baan Naab

Global Partnership Supply Manager at Amgen with a Master’s degree in Biotechnology from Keck Graduate Institute