Regulatory overhaul, international trade tariffs, and the burgeoning disruption imposed by artificial intelligence (AI) are moving the clinical trials industry to place greater focus on managing risk in pharmaceutical supply chains.
Risk management dominated the conversation among panellists at the opening session of the 2025 Clinical Trial Supply West Coast 2025 (CTSWC25) conference on 9 September in Burlingame, California. The panel discussed the challenges and solutions offered by shifting geopolitical and technological trends to clinical trial supply, moderated by Paul Hingst, supply chain consultant at Crinetics Pharmaceuticals.
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“It seems that the unforeseen circumstances are getting bigger and more frequent: pandemic, some geopolitical instability, natural disaster, regulatory shifts”, Hingst stated. The Covid-19 pandemic saw an influx of funding for the clinical sector, but a subsequent dip means developers must demonstrate not only their drugs’ efficacy, but also post-marketing potential, as investors become increasingly risk-averse, according to Dr Prasun Mishra, founding director of Agility Pharmaceuticals.
Drug developers must maintain backup plans, with dual sourcing of critical materials and close coordination on drug transport, to mitigate risk-riddled global transport routes, said Naymisha Patel, senior vice president at Tenaya Therapeutics. She stated investors now seek greater insight into factors like regulatory compliance and quality assurance to better secure returns.
Among the leading drivers of uncertainty are rising tariffs on pharmaceutical imports. New trade regulations are fuelling the growth of manufacturing hubs in the US, said Mishra, yet regions like China and India retain an edge with robust infrastructure, low costs, and speed of manufacturing. According to Patel, developers can best navigate tariffs by stockpiling critical materials while considering alternative therapies if supply is threatened.
Panellists also recognised the impact of AI, the cost-saving fruits of which are beginning to be made apparent, according to Hingst. This innovation is accelerating the move from site-centric to patient-centric clinical trials, stated Mishra. However, Patel highlighted AI’s limitations in interventional trials where data are often scarce and fragmented, an area where she said human input remains essential.
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By GlobalDataSeveral regulatory changes are poised to impact the sector, according to Patel. She pointed to guidance from the US Food and Drug Administration (FDA) on decentralised trials finalised in September 2024, fostering the shift to patient centricity alluded to by Mishra.
The FDA previously drafted a Diversity Action Plan, requiring sponsors strategies for enrolling underrepresented groups. This was to be finalised by June 2025, however Patel noted these materials were removed from FDA’s website in early 2025. Robert F. Kennedy Jr., upon his nomination to secretary of health and human services, committed to finalising the diversity guidance, but no firm timeline has emerged.
