In my experience, sponsors should begin evaluating their commercial supply chain strategy once a programme demonstrates a credible path towards commercialisation, which for many products occurs during Phase II development. At that point, key decisions regarding manufacturing strategy, packaging configuration, analytical support, and regulatory requirements begin to take shape and can significantly influence future scalability.
The most successful transitions are those where companies look beyond the next clinical milestone and start aligning development and commercial objectives early. However, early planning alone is not enough. A structured transition process, supported by cross-functional collaboration and early risk assessments, is equally important. This helps anticipate scale-up challenges, reduce complexity, and create a smoother path to commercial manufacturing and market supply.
What is the most frequent point of failure when scaling a drug supply chain from Phase III to full market launch?
One of the most common challenges is treating commercialisation as a simple scale-up exercise. A clinical supply chain can accommodate a certain degree of flexibility, whereas commercial supply requires much greater planning discipline, forecasting accuracy, and supply reliability.
What I often see is that companies focus heavily on manufacturing capacity while underestimating other critical factors, such as material availability, logistics, long-term supply planning and regulatory requirements. As products move towards launch, these elements become increasingly important. Successful commercialisation requires not only sufficient capacity, but also the ability to reliably supply patients and markets at a global scale.
How are you leveraging real-time data or digital tools to improve end-to-end supply chain visibility?
Supply chain visibility has become increasingly important as products, distribution networks, and regulatory requirements continue to grow in complexity. At Vetter, we leverage digital tools and real-time data, and where appropriate, data sharing with customers to create greater transparency across material availability, production planning, logistics activities, and delivery timelines.
For me, the real value lies in turning data into actionable insights. Early visibility of potential risks allows teams to evaluate alternatives, respond proactively, and make better decisions before disruptions affect supply. Ultimately, better visibility supports more reliable planning and greater supply continuity for patients and markets.
Given recent global disruptions, what strategies have proven most effective for building supply chain resilience?
Over the past few years, the industry has learned that supply chain resilience cannot be achieved through a single measure. At Vetter, we rely on a combination of strong supplier partnerships, structured risk management and business continuity planning. We also place great importance on maintaining appropriate stock levels of materials to help mitigate potential supply disruptions.
Equally important is end-to-end visibility across the supply chain. The better organisations understand their supply chain and its critical dependencies, the better positioned they are to anticipate challenges and maintain reliable supply even in an increasingly uncertain environment.
How do you optimise cold-chain delivery for tight project timelines without inflating costs?
Although many people associate cold-chain management primarily with logistics, I see it first and foremost as a planning challenge. The earlier storage conditions, transportation requirements, packaging configurations, and distribution strategies are defined, the greater the opportunity to build efficient solutions and avoid unnecessary complexity, expedited shipments and other avoidable cost drivers later in the process.
At the same time, the growth of biologics and other temperature-sensitive therapies is increasing the demands on global supply chains. This makes robust cold-chain infrastructure, real-time shipment monitoring, and experienced logistics networks more important than ever. The objective is not simply to move products faster, but to maintain product integrity while balancing efficiency, risk, and cost throughout the global supply chain.
What is the key to maintaining seamless communication between clinical development teams and commercial suppliers?
The key is establishing alignment well before commercial manufacturing begins. Development and commercial teams may share the same objective, but their priorities naturally evolve as a product progresses through its lifecycle.
As an experienced CDMO, we have established a transfer process that supports the transition from clinical development to commercial manufacturing. A critical part of this process is the continuous exchange between our clinical and commercial teams, allowing knowledge, experience, and expectations to be shared throughout development, scale-up, and commercialisation. This creates transparency, helps identify potential gaps early, and supports a smooth transition from clinical development to commercial manufacturing.
