Clinical supplies & logistics
Russia’s invasion of Ukraine resulted in the early closure of 132 active clinical trials across the country.
Local intelligence With all these pressures in mind, one might expect the industry to be deeply conscious of any potential disruption. Yet both Jacobs and Cotter describe a sector cut in two. On the one hand, commercial manufacturers, especially major industry players like Pfizer or Novartis, boast what Cotter calls “emergency operations centres”, which receive and disseminate relevant geopolitical intelligence at all hours of the day.
“Those of us who actually see the world in trends and patterns were like: ‘Hey, is anybody getting ready to do something with Ukraine? Because it sure looks like Russia’s amassing on the border.’ And the answer was: ‘No! Why?’”
Steve Jacobs 90%
The percentage of pharmacies in Tanzania that reported shortages of essential products due to the pandemic.
Journal of Pharmaceutical Policy and Practice
30
That’s echoed by foreign expertise; with operations in 103 countries, why wouldn’t a firm like J&J rely on local staff to keep them abreast of diseases or coups? Naturally, not every upheaval can be predicted: the panic precipitated by the pandemic proves that. All the same, it seems reasonable to agree with Jacobs when he says that commercial manufacturers are “oriented” towards thinking about risk in a holistic way. Sadly, clinical players don’t have it so easy. Apart from challenges around the scale and speed of trials, probably the easiest way of understanding these difficulties is philosophical. “In essence,” says Jacobs of trial conveners, “they’re very data- oriented. And they make decisions based on logic and rationale. They are not futurists: they are present folks that love metrics.” But if this approach works well when things are running smoothly – understanding how much a trial costs is clearly important, as is appreciating how many doses each patient needs – the slightest mishap can
quickly spark chaos. A case in point, Jacobs says, was the war in Ukraine. “What was interesting was that those of us who actually see the world in trends and patterns were like: ‘Hey, is anybody getting ready to do something with Ukraine? Because it sure looks like Russia’s amassing on the border.’ And the answer was: ‘No! Why?’” This nonchalance would soon cause issues, with 132 active clinical trials across Ukraine ultimately wound up early. Happily, Jacobs is optimistic that attitudes are shifting, explaining that especially young clinical trial conveners are reflecting more seriously on planning and forecasting. As so often, technology can help too. If, for example, insiders can use digital trackers to understand exactly how many doses remain unused at a trial site threatened by war or unrest, they can more plausibly ship them off elsewhere before things get too dicey. And if all else fails, Cotter stresses the value of relationships with the state. In his native US, only the federal government had the cash and authority to build manufacturing facilities for Covid-19 vaccines, or indeed forgo some of the usual conventions around trial timings and length. As he puts it: “There were a lot of public-private partnerships that worked really well – essentially government throwing money at the industry to absorb the risk.”
Are you shore?
This focus on state support hints at another option: onshoring. Increasingly popular on both sides of the Atlantic, President Biden has already committed $2bn to rejuvenate his country’s pharmaceutical manufacturing base. And, in theory, at least, this approach makes sense. Rather than worrying about the bewildering state of global politics, or else the next wet market fiasco in provincial China, the industry could instead rely on domestic supply chains for both trial and production capacity. Unfortunately, and as our United Nations of suppliers vividly implies, the interconnectedness of the global supply chain precludes such isolation in practice. It’s really difficult, Cotter says, to incentivise the US or other Western nations to build manufacturing spaces domestically – simply because they’ll inevitably be forced to compete with China, India and other developing economies, all of which can pump out drugs much more cheaply. The same naturally applies to clinical trials too, particularly at a time when conveners are hunting about for fresh patients. Nor are the underlying problems brought out by Covid or Russia disappearing anytime soon. As Winters says, the latest Israel-Hamas conflict “never telegraphed itself” to anyone – warning enough that other shocks, in various guises, are surely bound to follow. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Kutsenko Volodymyr/
Shutterstock.com
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