In supply chain planning, for example, imagine a critical milestone scheduled for June. Typically, teams backtrack from that date to identify key information inputs and decisions needed as early as January or March.

While project management tools provide scheduling functions based on specific dates, the reality is: if these date-based schedules do not evolve into sustained operating frameworks, they are often forgotten and inconsistently reapplied across projects. For instance, a November product launch may backtrack key readiness activities to June, yet without a framework, cross-functional groups may still trigger work too late, risking the milestone. Although organizations conceptually understand time, dates, and durations, we consistently observe a low appreciation of lead times across corporate functions.

The practical evidence is unfortunately clear: teams frequently encounter tight, stressful timelines because the triggers to initiate work were delayed, not because the execution was poor, but because the framework for timely activation was missing.

This lead us to a critical insight: tight timelines often stem from the absence of a standardized timeline framework with predictable, cross-functionally understood triggers as shown in Figure 1 below.

Figure 1: a “T minus” framework mapped to Day 0 (go-live) and aligned with Project Specific Dates. 

Triggers for starting critical activities depend heavily on information availability. However, it is not merely whether information is available — it is whether the certainty of that information is sufficient at the right time. 

Figure 2 illustrates that if a team needs two months to react effectively (Point A), then if information is available only two weeks (Point B) before the milestone, it is inadequate regardless of its accuracy. Thus, the issue is not perfection of information, but sufficiency of reaction time. Information must be shared early enough to allow for necessary actions, even if that information is imperfect. While the tension between accuracy and timing is an age-old challenge without a definitive solution, organizations can significantly mitigate risks by raising awareness and intentionally designing standard frameworks around timing needs. 

To build organizational resilience and predictability, companies must establish timeline guidelines, particularly for high-impact projects like product launches and regulatory filings. These guidelines form the operational backbone for timely execution across functions. One proven structure is the “T minus” framework. In this model, Day 0 represents the go-live date. Activities are scheduled against relative time markers: for instance, T-30 (30 days before), T-60 (60 days before), and so on. This framework detaches planning from calendar-specific dates and shifts the focus to lead times and necessary durations, creating organizational consistency. Refer to Figure 1 again to visualize the “T-minus” mapping.

Instead of saying “Have marketing materials ready by September 15,” the framework would state, “Marketing materials must be ready by T-30,” whatever the launch date is. This reduces confusion across projects and builds repeatable execution muscle. Of course, you will need the September date for project specific alignment, but organizational understanding of the activity as a T-30 day activity enables repeatability and consistency of understanding across projects.

In other words, The T-minus framework does not eliminate the need for project-specific scheduling tools, but it provides a reusable reference architecture that dramatically improves timing predictability. A simple timeline table or Gantt chart structured around T-minus milestones can further clarify deliverable expectations.

Establishing a T-minus timeline framework and embedding it within functional playbooks ensures that the understanding of lead times and critical triggers becomes part of the organization’s operating system, not dependent on individual memory or ad hoc planning. Functional Playbooks should map activities to lead time structures: what must happen at T-120, T-90, T-60, T-30, etc. This approach creates clarity and accountability. Cross-functional launch teams using such Standards and Playbooks at major pharma companies have achieved significant acceleration and/or stayed on timeline despite risks and set backs.

By building these frameworks and playbooks into standard operating practice, organizations can move from reactive firefighting to proactive, scalable execution, while driving better outcomes across product development, supply chain, and regulatory functions. Just like in many other environments, Standards need to be established for the timing and accuracy (or lack thereof) in information sharing. A cross-functional understanding of these standards (i.e. expectations) enables on-time delivery of projects and can even accelerate results.

Wish to discuss more about Advanced Project Management Practices and Playbooks? Schedule a quick connect with Marcos Buelvas here.

Author – Marcos Buelvas, Managing Director, ScaleUp Inc

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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

The post Making the Case for Clinical & Operations Planning (C&OP) in Clinical Supply Chains appeared first on ScaleUp Consulting..

Does your DTC strategy align with the times? What if you could cut supply chain costs and future-proof your supply chain design through hypothetical scenarios to tell you exactly where to source, manufacture and stock new SKUs? With ever increasing last mile costs, changing customer expectations around delivery times, rise of regional parcel providers and shared fulfilment models, it is imperative to continuously design your networks to improve supply chain efficiency.

Join Scaleup Inc. and Lambda Supply Chain Solution along with E-commerce expert Andre Pharad as they highlight the benefits of adopting a continuous network design mindset to boost supply chain efficiency.

ScaleUp Inc – https://scaleupinc.com/

For any inquiries, please email at info@scaleupinc.com

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Context

• The company specializing in seasonal vaccine production, poised to become a life-saving entity globally
• The emergence of COVID heightened the importance of seasonal vaccine manufacturing, making it a critical component against the pandemic
• With the seasonal nature of respiratory viruses, adapting the product annually became imperative. Operating across 40 countries, the company faced the challenge of tailoring product presentations to suit diverse markets, distribution channels, and financial capacities
• This endeavor demanded close collaboration among regulation, quality, supply chain, operations, marketing, and R&D teams, forming cross-functional units to address the massive geographic scope and fast-paced requirements

Approach:

• The company initiated a launch leadership team with necessary capabilities, governance structures, and reporting tools to manage global scaling complexities
• This included rapid prototyping, clear communication channels, and tools like Smartsheets and governance dashboards to ensure a single source of truth and facilitate quick decision-making from leadership to the shop floor
• Urgency and mission were emphasized, and close collaboration among regulatory, commercial, marketing, and sales teams was prioritized to address unique market needs and challenges

Results:

• The diligent implementation of the approach yielded significant results. The company successfully launched its products in key markets worldwide, including the US, Europe, Japan, and emerging markets, within 24 hours of regulatory approval
• These launches enabled the organization to reach millions of people across diverse geographies and economic conditions, bolstering its position as a critical player in the market
• The company achieved remarkable business objectives, including sales exceeding $1 billion from vaccine revenue, significant reductions in operating costs, and improved inventory turns and volumes
• By entering and performing in a competitive industry environment, demonstrating its capacity for agile and effective global scaling to urgent public health needs

If you have any questions or feedback regarding the case study, feel free to send an email to info@scaleupinc.com. If you wish to know more about ScaleUp and our offerings, please get in touch. You can send an email at mbuelvas@scaleupinc.com

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Despite the criticality of the answer to these questions, that information is not at the fingertips of executives, leaders and personnel. Needless to say, this should not be the case.

The problem is not exclusive to large pharmaceutical companies with multiple business units and thousands of SKUs; it also shows up in clinical-stage, pre-commercial companies, and companies about to launch products. The challenge manifests very differently of course, if we are talking about a large company vs. a small one, and everything in-between. The drivers differ, and so does the decision-making process. 

However, there is hope. This is not a complicated process, but it does require some doggedness and attention. This is best described with an example, so let us look at small biotechs. These teams are mostly under-resourced and uber-busy fighting fires. What falls to the wayside is time to think through where and how to start attacking the problem of building capability, process and tools that are cost-effective, easy to use, and implement. They often give up before simple barriers simply because they don’t have someone to turn-to (e.g., an excel formula, a template for suppliers, emails and quick working sessions to round people up).

4 easy steps to address the problem

Let’s start by breaking down the process:

1. Obtain inventory status from each supply chain node at the end of the month
2. Aggregate key inventory data elements into a data repository
3. Link data repository with a reporting engine (e.g. PowerBI, Tableau, Excel)
4. Establish a recurring review and inventory adjustment process

Believe it or not, what will determine the success of this process is step 4, and by the way, that step can be as short as 30 min/month once you get it IN CONTROL. This is absolutely critical because the superb principle at work here is the one popularized by Lean-Six-Sigma about shining a light on something. You shine a light on this, and it will run. The prior 3 steps are also quite easy to run once implemented.

For Step3, the reporting/analytical engine provides robust insights using tactical visualizations and using the right reports makes a world of difference in how pain points are identified and how teams drive decision making.

Here is an example of a simple visualization technique that can substantially impact operational teams and execution.

The above chart, while simple, is a horizon view of expiry across a product portfolio and supply chain nodes. This will enable your personnel enough time to react Vs the alternative of learning expiries within 1-2 months of when it happens. Even small companies can manage and produce this type of insight very easily with expert support. It makes a huge difference to visualize expiries across the horizon Vs present it on a simple list. 

What if the inventory review process is not followed?

This process is not running consistently in a large percentage of companies. Given the simplicity of this, why is it not running everywhere?  As I said earlier, it is not running consistently because of simple things that teams just can’t get passed. I apologize for repeating myself here, but it can be an excel formula, a template for suppliers, the emails and quick working sessions to round people up.

Another powerful angle to doing something in this area is the support you will get from your Finance department. In my opinion, they should be the first to get in your corner. They will definitely support what you may need to get this process up and running. Their lives will be that much easier and the confidence in where the business stands in this critical dimension will substantially improve.

There are some infamous examples of the staggering cost of failure in this department, and I am sure some of these will resonate, but I can only highlight a few because there are too many scenarios to cover.

• Near-term product expiry at clinics leaving no time to react (e.g., next month)
• Short supply of bulk material to run the next batch and development requirements
• Not enough inventory reserved for a specific batch for a particular study
• Not enough components (e.g., vials, syringes) to perform the last step of the process

The implication of any of these scenarios can derail a program, a launch or commercial operations and ultimately impact patients. The fix is simple and may only require a little nudging from a concerned executive or leader. Get ahead of this one; inventory is like cash…you really don’t want to run out of it.

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Let’s take a look.

How China monopolized supply chains?

Until the pandemic raided us, the world overlooked the dangers of putting everything in the Chinese basket. As multinational companies remained obsessed with keeping the cost of production low, the western governments allowed colossal outsourcing of industrial and manufacturing capabilities in return for financial gains. China leveraged this opportunity and monopolized the global supply chains. 

China soon became the “world’s factory” and simultaneously developed a complex network of internal supply chains and interoperability. This made relocation more difficult, and as a result, the world became even more reliant on China.

China’s role as a dominant supplier of components and goods across nearly all industrial sectors- automotive, pharmaceuticals, technology, consumer goods, and equipment made it impossible to reroute the global supply chains. However, now with the disruption caused due to the coronavirus outbreak, the possibility of removing China’s dominance in global supply chains is being discussed.

How is the US pushing to remove the global supply chain from China?

According to a Reuter’s report, to remove global supply chains from China, the Trump administration is weighing the new tariffs to punish Beijing for its handling of the COVID-19 pandemic. The undersecretary for Economic Growth, Energy, and the Environment at the State Department, Keith Krach told Reuters that they have been working over the last few years to reduce their reliance on supply chains in China, but now they are “turbo-charging” that initiative. 

Ahead of the US presidential elections, President Donald Trump has stepped up recent attacks on China and has long pledged to bring manufacturing back home. In May 2020, the President even said that if US cuts-off ties from China, it would “save $500 billion”. The US government is working with countries such as India, Australia, New Zealand, Japan, Vietnam, and South Korea to take the global economy forward. According to Mike Pompeo, secretary of State, the discussions include- how to restructure the supply chains to prevent something like this happening again.

However, many analysts and government officials in the Asia-Pacific region in their interviews, which are in the public domain, have said that any big effort to restructure the global supply chains is still wishful thinking. It would not be easy to dismantle a rooted system when most of the companies are struggling to survive.

COVID-19 And Decoupling

Most likely, the COVID-19 outbreak will accelerate the change that was already driven by market forces as rising cost and wages in China in the last decade have led to an exodus of lower-value manufacturing, most of it to South-East Asia. This is despite the desire from a few in the Trump administration to begin decoupling the two biggest economies of the world as the US and China continue to spar over everything from pandemic to Hong Kong to 5G network.

Most importantly, many advantages of China being the global supplier cannot be easily replicated by many countries and regions. The US-China trade war has increased uncertainty and costs for the global supply chain, which has prompted a few businesses to move out of China or adopt a ‘China plus one policy’. However, what remains in China is production that has somewhat limited room to change significantly. Moreover, it’s a hard sell for companies. Many companies in the US have invested heavily in Chinese manufacturing and are largely dependent on China’s population for a big chunk of their sales.

Even if the US government uses executive orders to force US businesses to move out of China or impose exorbitant tariffs, it will be highly undesirable. For example, production may move somewhere else rather than return to the US due to years of stagnation in the production sector and structural change of the country into a service-based economy.

The slow-paced relocation of Apple’s production out of China and the Tesla opening factory near Shanghai are both testaments that China is a critical part of the global supply chain. Decoupling the two largest economies would not be an easy process.

Our View

As of now, the idea of ending China’s monopoly on the global supply chain lacks firm footing. The US State Department does not have jurisdiction over trade, and many Asian countries officials have said that there have been no formal talks. Diluting China’s role in the global supply chain will be a slow evolution as China holds the major manufacturing output, which is so huge that even a group of companies would struggle to do just a fraction of it.

It’s not easy to wave a magic wand and say “make it so”. So who would control the global supply chain in the post-pandemic-world – we will have to wait and see.

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The general geopolitical trend towards nationalization, Brexit, the US-China trade war, and lately, the pandemic have changed the priorities of many supply chain frontrunners. They have to now balance operational efficiency and cost with more resilience.

Building a resilient supply chain

There is no hundred percent certain way to overcome the threats to supply chains like natural disasters, accidents, and international disruptions. The situation becomes even more complicated in case of a global pandemic or a terrorist attack. This is because the historical data does not include the use of predictive statistical tools to ensure that risks like these can be contained.

However, some organizations cope much better than others with both manifestation and prospect of indefinable risk. These organizations don’t have a common secret formula or even many of the same processes to deal with such situations, but they share an essential trait – resilience.

The concept of resilience is not new. The ability of an organization to successfully face the unforeseen has always been the essential element of success.

Achieving resilience

Supply chain resilience no longer means merely the ability to manage risks. In fact, the ability to manage risks means being better placed than the competitors to deal with it and even gain advantage from such disruptions.

Here are the three most important strategies to adopt to build resilience in your supply chain.

Diversify resources

Despite being the foremost step in alleviating risk, many organizations carry vital parts of their supply portfolios with one point of failure. Businesses need to reduce their dependence on sourcing from a single region, supplier, or country. During the Tsunami and Tohoku earthquake in 2011, the global automotive industry was crippled as the large concentration for automotive parts and accessories was manufactured in Japan. Even in the present situation, when the coronavirus first appeared in China and the ‘world’s factory’ went under lockdown, many industries and economies suffered. 

There has to be a simple yet effective strategy, which should be a combination of offshore and near-shore suppliers for every component. Broadly speaking, there is a need to develop a strategy where the regional supply chains are developed that can source and distribute products within a region. Besides that, the focus should also be on building redundancy so that if one region is disrupted, other region’s suppliers can step up.

Impact is broad, getting diversified can reduce risk because if you have a concentration of suppliers at high risk of financial default, then it is sensible to qualify alternative sources with a better financial footing.

Build reserves

The typical safety-stock calculations and inventory-optimization can disregard the element of fundamental risk. With the concept of eliminating single points of failure, it is crucial to carry exigency safety-stocks, especially for low-volume parts that might impact the availability of high-value features. Broadly speaking, a business needs to develop inventory plans to ensure supplies over a long projection by taking into account possible shortages during a disruption.

During the ongoing pandemic, approximately 5 million masks and 2000 respirators were released by the US Department of Defense from its stock reserves to help fight the crisis. Most of the time, these strategic reserves go unnoticed unless there is a crisis like this. The value of building strategic reserves has become increasingly clear over the last few years. These reserves can safeguard against the ‘black swan’ events that are rare but can cause a pragmatic threat to businesses.

Besides strategic reserves, there is also a need to build strategic relationships that can make a difference in the long run. The foundation of all businesses is built on relationships with your business partners, customers, and suppliers.

Sense, foresee and respond with agility

The best supply chain teams stay ahead in the market trends for their products, customers, the latest design practices, suppliers, and emerging technology trends. They utilize the content services that help them consolidate such sources of insight to forestall risks and opportunities and promptly take proactive actions even before their competitors. For instance, monitoring leading indicators of a supplier’s financial status to anticipate the risk of default.

Furthermore, businesses need to be mindful of single sources that could be formed from the ripple effect of other risks. For instance, obsolescence or default of one source within a two-fold-sourced component will create a single-source situation that will be high-risk.

To help organizations recognize market shifts early, and take pre-emptive actions, the sourcing platforms need to track inflection points in demand, trends, cost, lead time, the financial health of the supplier, and consolidation of suppliers across various commodities. 

To conclude, there will always be events that cannot be anticipated beforehand. However, the best performers build processes with upright learning cycles. The rewards for building a resilient supply chain are significant – the business will not only be able to withstand all kinds of disruptions but also increase its competitiveness.

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