Unpredictability is now the only certainty. Clinical trials are being disrupted by everything from pandemics to geopolitical shifts, forcing the pharma industry to look critically at supply chains and to adapt quickly to change. The rapidly evolving environment has exposed the limitations of processes designed for clinical trials of the past, and the supply chain challenges are particularly acute for developers of cell and gene therapies. Faced with the unpredictability, forward-thinking sponsors are developing more agile and resilient supply chains.
The COVID-19 pandemic is the dominant moment in a series of unforeseeable events that have exposed the fragility of supply chains and clinical trials designed for a more stable time. As the spread of the virus shut down economies around the world in April 2020, the number of new patients entering study sites fell 59%.1
Sponsors pivoted quickly to decentralized and hybrid clinical trials to enable patients to keep receiving their medicine and studies to continue generating data, but still faced supply chain issues, particularly for complex therapeutics such as cell therapies. Because of COVID-19, one-third of cell therapy companies reported production delays or halts.2 One-fifth of companies reported disruptions in the procurement of supplies.
Companies continue to feel the after effects of the initial disruption brought by COVID-19, with supplies of certain materials remaining constrained and periodic lockdowns in parts of the world still disrupting the manufacture and shipping of some products.3 Developers of cell and gene therapies need to assume more disruption and unforeseen events are coming and adapt their supply chains accordingly.
“Uncertainty is the new normal. How do you work, and how do you succeed in this environment, where uncertainty is predictable? It is going to happen. We know this is not going to be smooth sailing. How do you build the network, clinical to commercial storage and distribution strategy, with that level of unpredictability in mind? It is essential to create processes and networks that are flexible and agile,” Julia Tarasenko, SVP, Global Commercial Operations & Sales and Pricing at Marken, said.