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Enabling faster clinical trial timelines through an optimal supply chain


Amaury Jeandrain, N-SIDE head of business development engineering, explores the ambitions of biopharmaceutical companies to accelerate clinical trial timelines and discusses how optimisation enables it by removing bottlenecks from the supply chain.


T The rise of accelerated trial timelines


he year 2020 was a challenging one for the clinical trial industry: COVID-19 expanded throughout the world. While


pharmaceutical companies were struggling to keep trials running despite supply chain challenges and delayed patient recruitment, 2020 was definitely a year that will ultimately redefine the industry. Indeed, a pandemic is a time when the companies that can do something about it have to shine, and quickly. Vaccine developments were conducted in parallel to treatments that would alleviate the symptoms or cure the disease. A positive shift, achieved by a huge effort, has taken place in the industry. All stakeholders, internal or external, were collaborating to make one single objective feasible: get the treatment to the patient as fast as possible. And we are talking about a highly regulated industry, where drug development timelines are often longer than 10 years.


Project Lightspeed1,2 , aptly named by Pfizer


and BioNTech, was one of the pillar programmes to achieve this. From the launch of the Ph1-2 trial in April 2020 and the first approval by the Food and Drug Administration (FDA), less than eight months passed. Of course, exceptions were allowed due to the health emergency, but pharmaceutical companies are seeing these successes as proof that faster timelines are feasible. Most of the top pharmaceutical companies are now in the process of experimenting with accelerated programmes – more trials, on more indications, faster. However, for accelerated timelines to be feasible, a


lot of puzzle pieces must fit together perfectly. And a significant piece is the supply chain.


Clinical supply chain challenges in a fast-moving environment


Clinical supply chain is a very critical element in clinical trials, as anything other than lean puts a strong pressure on the company’s financials and might put the recruitment timelines and patient’s treatment continuity at risk. This pressure is set to grow with the ambition the industry has to accelerate the time from protocol to first patient, recruitment and the initiation of late-phase trials. This translates into less time to plan, producing drugs without knowing which dose will be efficient, without knowing if the previous phase will have positive results, all while supplying a larger number of countries and sites. This can set the supply chain up for increased waste, which, in turn, often ends up being a cause for slower clinical trial timelines. Waste reduction has been an important focus in the past decades. But, today, the focus of waste avoidance is no longer on reducing costs – wasted drugs, if efficiently allocated, could have been an enabler of faster timelines.


For a more efficient supply chain, look beyond planning In order to solve this complex puzzle, companies often turn to solutions that automate supply chain decisions, standardise methodology, or regulate the amount of waste per trial. In N-SIDE’s experience, this can provide a false impression of efficiency and security.


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