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

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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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According to a report by  Fortune Business Insights, the global pharmaceuticals market was valued at USD 1,500 billion in 2021 and is projected to grow to USD 2,400 billion by 2029, exhibiting a CAGR of 6.1% during the period.

The expected business opportunity provoked a surge in R&D spend and expansion of manufacturing capabilities. While the big pharma giants focused on finding solutions to the core diseases, the small and medium enterprises targeted small but niche opportunities to gain momentum.

The Risk

While it’s very easy to consider the pharma sector ‘lucky,’ we can’t forget that such a global crisis disrupt entire business models and their value chains. For example, who would imagine that manufacturing lines would come to a standstill due to non-availability of manpower; who could believe that batch after batch of GMP production would have to be quarantined due to risk of exposure to virus infected employees; or, getting a flight booking for material transfer would feel like scrambling for a ticket to Mars; not to forget the 10 to 15 days quarantine period to clear cold chain shipments from airports. How about the risk of derailing clinical trials for not being able to reach patients and delivering the repeat doses on-time.

In an era when just-in-time is the guiding spirit, supply chain teams had to explore every possible opportunity to sneak additional batches in manufacturing plans to build months-on-hand inventory. To aggravate the situation further, an average lead time for completing one pharma manufacturing cycle from raw material production to finished goods inventory (RM > API > DP > FG) can easily be over 12 months. Despite having no visibility on sales projection, the management had to approve steep increase in manufacturing budgets even at a risk of having to dispose entire production lots if not used within the approved  stability period at a later stage.

The increased inventory forecast surged demand for cold storage warehouses across the globe. The sector which is predominantly buyer driven saw companies running from pillar to post to contract for whatever additional GDP space available and at any premium demanded by service providers.

Most importantly, on one hand, supply chain executives were firefighting immediate concerns to keep businesses afloat and, on the other hand, they worked aggressively to assess expected changes in geopolitical situations which could collapse entire supply chain operations. There was a strategic rush to find ways of mitigating risk by expanding manufacturing, storage and distribution networks to safe geopolitical zones for maintaining business continuity under any circumstances.

The Mitigation Plan

Following are some of the ways in which successful pharma companies mitigated supply chain risk transforming global crisis into a business opportunity:

• Supply chain teams prioritized network optimization over landed cost reduction to ensure a continuous and uninterrupted product supply across the value chain.
• Leaders gave high preference to continuous risk assessment. The executives led crisis response teams whose sole task was to review the supply chain risks and derive mitigation plans for immediate resolution.
• A detailed supplier risk assessment was conducted for tier 1 and tier 2 suppliers with some organizations extending to tier 3 suppliers. The teams built the trust of contract manufacturing organizations (CMO’s) by providing longer-term forecasts and signing master service agreements with volume commitments. This helped CMO’s have business visibility who in-turn could provide volume commitments to tier 3 and 4 raw material and component suppliers.
• Supply chain teams built excess capacity by targeting dual sourcing, and geographic diversification. They added additional supply chain nodes to get production closer to end markets or in lower-risk countries that are less subject to disruption.
• Organizations enhanced workforce agility by allowing employees to work remotely wherever feasible. The industry was quick to accommodate web based collaborative platforms and signing tools like Sharepoint, Google Drive, DocuSign etc to maintain documentation accuracy and traceability with strict compliance to GMP standards.
• The logistics challenges were overcome by prioritizing speed and security over cost. There was high emphasis on documentation accuracy to avoid customs and FDA holds which ensured timely shipment delivery and helped meet planned production schedules.
• Quality assessment processes for site validations, batch approvals and vendor qualifications were simplified by allowing remote monitoring and quality audits along with faster adoption of electronic batch records.

The Resilient Future

While the results of the above initiatives have been positive for the industry, there is still a vast scope for improvement in operational efficiency. Historically, the pharmaceutical industry has been slow to accommodate new technologies to respond to changing times. The right balance of new technology implementation with old compliance parameters holds great promise for the operational future of the industry. A few initiatives to consider could include:

• Automation: Currently, the production of starting raw materials and active pharma ingredients requires a lot of manual intervention to comply with GMP norms. This became a big bottleneck during the pandemic when employees had to undergo frequent tests before entering the GMP production area. Despite testing, there were instances when employees developed symptoms later which resulted in temporary hold in production lines to verify potential risk to the entire batch. This delayed the manufacturing steps and impacted upcoming production schedule.  The future should bring a lot of in-process checks and analytical samplings that could be done by using mobile robots. Aerial drones and cameras could also be used to oversee the manufacturing progress without entering the quarantine area
• Blockchain: Traditional supply chains often involve multiple intermediaries, manual record-keeping, and time-consuming reconciliations. With blockchain, companies could document production updates to a single shared ledger, which provides complete data visibility and a single source of truth. This would reduce time required to verify the analytical batch records and also expedite the quality review and batch approval process.  Blockchain can also be used to compile data on shipping movements, determine faster shipping routes and produce contracts that are transparent and hold all parties accountable. While implementation of blockchain technology in pharma manufacturing requires careful consideration of various factors such as regulatory compliance, data privacy, and security, the future should bring a lot of transparency and efficiency if we succeed.
• Standardization: Cold chain packaging is a fast-growing niche segment and a crucial part of pharma logistics operations. With air-freight being the predominant mode for transporting life-saving pharmaceuticals (over 75% pharma cargo moves by air), the demand for active and passive shippers is increasing exponentially year-after-year.  Unlike Sea-freight where the cargo movement is standardized in 20’/ 40’ containers, there is no uniformity in cold chain box sizes. Every manufacturer tries to develop their own unique selling proposition by trying to promote a specialized unit. Unfortunately, this creates confusion in trade on most efficient unit size for the movement.  The future should unite cold shipper packaging industry to finalize standard dimensions of manufacturing active and passive shipping boxes. While we would still need multiple shipper variants considering varied size of pharma shipments, the standardization of box sizes would increase awareness on the type of box appropriate for shipments and, also reduce unnecessary waste in pharma movements. Further, as temperature monitoring is a mandatory requirement for pharma shipments, the cold boxes could come with inbuilt monitoring and tracking solutions.
• Internet of Things (IoT): IoT can be used to connect entire manufacturing and distribution networks to exchange real time data to improve supply chain visibility and enhance operational effectiveness. It can be used to supervise different unit operations, track material in transit or identify risk during clinical trials. In future, the use of IoT can assist in better inventory controls and reduced costs.
• Artificial Intelligence (AI): The biggest challenge for Pharma industry is data integration as we still work in silos with minimal information sharing within the value chain. If only we can change this and promote data-centric approach allowing required information to be accessed across all channels, the AI tools can come to play and in future be useful to collate enormous data to help in forecasting demand, optimizing production, process automation, increasing shipments visibility and, reducing costly expedites thereby improving overall supply chain efficiency.

Conclusion

Pharmaceutical industry has shown great resilience to overcome major crisis with robust and quantitative analysis of the situation and prioritization of risk-response based on criticality. The strict regulatory guidelines also ensured quality, consistency, and safety in development, manufacturing, and distribution of medicines.

The companies embracing digital transformation and supply chain innovation will be better equipped to navigate business challenges faster. By leveraging advanced technologies, collaborating across the enterprise, and focusing on longer-term outcomes, the industry can drive growth, increase efficiency, and improve resiliency.

As the pharma industry continues to evolve, it’s essential for supply chain leaders to stay ahead of the curve and remain agile in the face of change.

About ScaleUp Inc

ScaleUp Inc is a boutique management consulting firm with global operations spread across US, Canada, EU, and India. We have a history of solving global business problems and delivering great results for Fortune 500 and leading companies across a broad range of industries. Know more about us here.

About Amar Shelar

Amar is a Senior Consultant at ScaleUp Inc and has more than 24 years’ experience in Global Logistics & Supply Chain Management. He had managed end to end supply chain in diverse industries like Pharmaceuticals, Energy, Infrastructure & Telecom. He has also worked extensively in Shipping & 3PL industry which gives a complete overview of worldwide logistics operations. Amar helps in designing effective logistics solutions by considering the specific complexities and unique supply chain requirements of the client and its industry. ​

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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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