Patient centricity is the focus and a key metric in measuring the overall success of a study so when planning supply, reviewing the intended patient population is a great place to start.

By looking at who will make up the participant group and what countries will be involved, sponsors will gain insight into particular sensitivities that need to be considered. This will influence the development of ‘made to measure’ operations that assure supply to patients, while controlling costs. For instance, if a sponsor seeks to engage patients in a remote area, study design, logistics and supply strategies will need to be built around this patient-specific sensitivity. By exploring potential roadblocks early, biotechs can develop pro-active mitigations, such as – in this scenario – opting for a bespoke direct to patient distribution strategy that maintains access for patients who would otherwise struggle to enroll/participate.

International trade is another aspect that should be top of the agenda. Thorough understanding of regulatory frameworks and import/export requirements for participating countries, in addition to commercial drug procurement options, will shape realistic timelines, help sponsors identify potential challenges and develop solutions to assure timely, cost-conscious supply.

Time and again the biggest pitfalls relate to leaving the planning too late and failing to consider the supply chain function with the rest of the study planning process. They’re common mistakes and ones that lead to a game of catch up where critical activities like drug manufacture, procurement and IRT set-up must be retro-fitted to align with the broader supply strategy.

To avoid this fate, supply chain teams should be engaged at least 6 months before the first in-patient date. This may seem premature but will allow for the generation and implementation of a proactive clinical supply chain. Secondly, the critical link between patient recruitment forecasts developed by clinical teams and drug forecasts developed by supply managers necessitates teamwork. It’s vital all stakeholders pull together in the same direction, share perspectives, and understand their role in striking the right balance and establishing an effective supply chain. The importance of communication and collaboration cannot be underestimated.

Additionally, the need for the continual oversight of the clinical supply plan once the study starts has often been a process that is overlooked. The clinical supply forecast is only as good as the data flow utilized to produce it. As a study is ongoing, the need to realign the clinical supply forecast to meet the demand of the actual patients enrolled in the study becomes a critical step to ensure an efficient and successful clinical supply plan.

Diversifying manufacturing and procurement activities across multiple sites and suppliers should be a top priority to promote business continuity. During the early days of the pandemic, countless sponsors learned this lesson the hard way through an existing dependency on running manufacturing operations exclusively in China.

Of course, there are many other ways to manage supply-based risk. For biotechs in particular, running smaller, more frequent or demand-led batches will help preserve high value product and limit the financial impact of batch failure. Equally, planning early will give sponsors the foresight needed to make informed decisions and reduce the risk, cost and delay associated with retrospectively adjusting supply chains to meet requirements that become apparent once programs are up and running.

Technology has and continues to transform almost all aspects of life, right? Clinical supply is no different. We have IRT systems to improve the way we manage enrollmenT, randomization, inventory management and drug assignment, which delivers huge value for multiple trial stakeholders by automating processes associated with managing patient interactions and ordering/shipping supplies. Material resource planning technology has also transformed the way sponsors approach forecasting demand – helping to optimize production and distribution strategies by facilitating smart decision making. And when it comes to temperature surveillance for low stability biologics, where would we be without technology like phase change shippers, USB monitoring devices and temperature management systems that provide cold chain visibility and uphold compliance during each leg of a drug’s journey?

Yet, while technology can be a huge force for good, it also can bring to light some challenges if not approached correctly. If it isn’t integrated – if digital systems are not aligned with physical supply chain functions – it is impossible for sponsors to obtain the visibility needed to effectively control supply and deliver optimized, efficient and patient-focused operations. To keep timelines on track, patients dosed and costs under control, aligning the digital and physical supply chains is mission critical.