At a time when global political shifts are impacting the pharmaceutical sector, it is vital that sponsors ensure collaboration between operations and supply happens at an early stage in clinical trials to improve efficiency.
Speaking during Arena International’s Outsourcing in Clinical Trials and Clinical Trial Supply Nordics in Copenhagen, Denmark, on 21 and 22 October, Sanofi’s head of clinical supply chain operations Arnaud Dourlens said that as the number of trials on a global scale has increased by 112% in the past ten years, ensuring collaboration between teams is even more important than ever to ensure success with a candidate.
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Dourlens explained: “The competition we see in clinical trials raises a lot of uncertainty. The capacity to quickly change and adapt our plans has never been so critical. This can only be done by close collaboration.”
Not only are shifts in competition impacting development to market, but in the US, President Donald Trump’s most favored nation (MFN) pricing and the TrumpRx platform, is set to impact R&D and could lead to some assets becoming less viable.
Dourlens added: “We are running more complex trials, more expensive trials with more competition and less potential commercial benefit. If you then add in a decrease in the potential profit gained from a US market that accounts for around 50% of the worldwide market, we start to be in a situation where the return on investment begin to be a challenge, even in a rich industry like pharma.
“If you consider a 20% price decrease in the US, it could disqualify a lot of assets. Efficiency is therefore even more critical, not only for the supplier, but in all functions to bring more sustainable drugs to patient.”
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By GlobalDataAs a result, teamwork will be vital in clinical trials to try and avoid wastage in supply which in turn will reduce R&D costs. Dourlens said that while sponsors will bring together clinical operations and clinical supply during the development period, he would like to see this happening earlier.
Dourlens anticipates that if these teams collaborate at protocol design, it can save sponsors between 15% and 25% in wastage during a trial, significantly reducing the cost of a study. At Sanofi, when Dourlens team started engaging with clinical operations at an earlier stage around five years ago, they were involved in approximately 15% of the sponsors’ trials. Now, the team is involved in the early stages of 90% of clinical trials, signifying how Sanofi is understanding the success of this model.
This early engagement also assists with milestone achievements. Having supply staff involved in the study can better manage the supply to sites dependent on recruitment, implementing the ability to upscale and downscale production for a particular site if it over or underperforms.
