The Clinical Supply Chain Situation
In the world of bringing a pharmaceutical product to market, supply chains play a vital and multifaceted role, ensuring the seamless flow of materials, timely delivery of products, and adherence to regulatory requirements across complex global networks. A McKinsey study states, “…On-time delivery generally is not a problem. On-time, in-full (OTIF) fulfillment levels are 97 percent. Clinical drug supply professionals corroborated these findings, as they focus primarily on not missing doses…On the other hand, waste levels for investigational medicinal product (IMP) kits reached a concerning 50 percent, driven primarily by poor forecasting and planning—highlighting a significant opportunity to capture value.” (mckinsey.com).
Just like a Commercial Supply Chain, a Clinical Supply Chain has multiple interconnected nodes and inherent complexity at a global level from the moment the first patient is enrolled. Naturally, the volume of product requirements is relatively low, so the Supply Chain is not yet experiencing high-volume operational constraints and intensive resource requirements. Nevertheless, a continuum of capability building should be present. The reason is simple: there are already escalating costs and potential risks that must be proactively anticipated and mitigated.
Figure 1 below illustrates the relationship between complexity and time for two variables: The technical readiness of the product itself, as well as its manufacturing, and Supply Chain Maturity. It highlights the interplay between product development and supply chain scalability, emphasizing the challenges and transitions leading to commercial readiness.
Figure 1. Clinical Supply Chain Complexity vs. Technical and Clinical Uncertainty
The point of the illustration in this figure is to simply acknowledge an evolving landscape across the domains of technical development, clinical uncertainty, and the supply chain’s increasing complexity over time. In many respects, technical and clinical complexity are also increasing, so this is not to suggest otherwise. However, for clinical supply chain purposes, over time, more unknowns are becoming at least directionally better understood and more easily shared by the clinical and technical development groups. For the supply chain, this makes the biggest difference as they are now receiving more robust input to make decisions and establish operational capabilities.
Let’s decompose the Clinical Supply Chain into its parts, see Figure 2 below.
Figure 2. Primary nodes in the End-to-End Clinical Supply Chain
While the 4th segment of the Supply Chain in Figure 2 above is the most visible and widely appreciated outside of the CMC function, a great deal of the supply chain risk lies in nodes 1-3. Commonly, there is a management separation from a Supply Chain point of view at node 3. In other words, nodes 1-3 are managed under one Supply Chain governance, while node 4 is managed under another.
This division makes sense from a workload perspective, but it does create two domains of competency that are not always fully in sync. Let’s discuss improved alignment across these segments.
Achieving Better Clinical & Operations Alignment
An often overlooked, but impactful governance mechanism that can be used to maintain alignment across these functions is a Clinical & Operations Planning (C&OP) process. Typically used for Clinical and CMC alignment, this process actually supports alignment within CMC and outside of it. The key is that cross-functional participation and learning about each function’s key drivers enables streamlined integration of the ever-evolving plans.
The reality is that Clinical Supply Chain sits in-between to highly variable environments; i.e. CMC development and its inherent variability and clinical operations and its equally variable nature. The position and effective role of the Clinical Supply Chain is illustrated in Figure 3 below.
Figure 3. Clinical Supply Chain as the link between two evolving functions in the development and clinical trial phases
The role of the Clinical Supply Chain is, therefore, to smooth both sides, de-risk critical connection points, and sustain a stable supply to Clinical Operations. These particular processes closely mirror those linking complex Commercial Supply Chains, offering an opportunity to build capabilities by leveraging ‘light’ Commercial Supply Chain tools and methodologies. These may include Supply Chain Management dashboards, forecast accuracy measurement, performance-to-plan tracking, and others. All of these being core elements of a well functioning C&OP process.
Following this ‘light’ tools approach can significantly enhance a teams’ readiness to support growth, establish risk management processes, and develop future capabilities.
A great example of establishing and operating on-going alignment through C&OP is the Clinical Supply Chain function clearly articulating its information and timing requirements on a recurring basis and through the formal forum of C&OP. A simple diagram of these parts coming together is illustrated in figure 4 below.
Figure 4. The simple elements that are core to a successful C&OP
The formal forum is needed because the clinical supply chain function has to do this in both the CMC and Clin Ops directions since the information needs are to align both.
The processes are ongoing, but there are critical information elements that have critical timing implications. Many of these information elements seem simple to the originator of the information (CMC or Clinical Ops) but they are critical to the clinical supply chain. Things like expected yield, timing of output, and target quantity. From Clin Ops, these may include expected first patient in, dose, and number of patients.
There is always hesitation to provide some of this information given the uncertainty in the processes, and again, this is the case with both CMC and Clinical Ops. This is understandable, but a good rule of thumb is that it may take 12 months for a supply chain to produce and make a product available. While this number can vary, it is helpful to think in this order of magnitude since it is indeed a long time to get a product from beginning to end.
In the world of the Clinical Supply Chain and given these long timeframes, an uncertain number is better than a more accurate one too late in the process. For examples like this, C&OP as a consolidated forum is indeed the best practice as a formal governance process to enable optimized alignment across clinical and supply chain operations.
Wish to discuss more about this subject and how ScaleUp Inc can help you with Clinical & Operations Planning (C&OP) in Clinical Supply Chains? Schedule a quick connect with Marcos Buelvas here.
Author – Marcos Buelvas, Managing Director, ScaleUp Inc
