DECEMBER 2023LIFE SCIENCES REVIEW8In My OPINIONMMAKING THE COMPLEX LOOK SIMPLEBy Tony Street, Vice President, Clinical Trial Supplies, Orifarmore than ever, significant macro-economic and geopolitical challenges push the clinical development industry to deliver more with less.Following two years of COVID-19 studies having priority status with competent authorities, sponsor companies, and service providers, coupled with conflict in Ukraine and Russia, two countries that provide a large patient population for clinical trials, we are now seeing healthcare systems and the clinical trials industry playing "catch up" in an increasingly competitive landscape. Trial sponsor companies determinedly compete for patients, vendor resources, and commercial pharmaceutical products to be used as comparators and co-medications in clinical trials.As a clinical trial sponsor, ensuring your study is attractive to patients and study sites is essential for achieving recruitment goals.For the clinical supplies industry, this requires us to provide a reliable, high-quality supply chain, minimizing the hassle factor for study sites and patients, while at the same time achieving the optimal balance between a lean and waste-free supply chain, supply continuity, and costs of distribution.Tackling the Challenging Clinical Trial Supply ForecastsForecasting clinical trial supply is notoriously challenging. Despite the multitude of forecasting and simulation tools now available on the market, a lack of robust input data often results in forecasts that are unreliable. To counter the fluctuating levels of demand and ensure all patients receive the right product at the right time, the pharma and biopharma industries have traditionally been ready to sacrifice a lean supply chain, with some sponsors reporting that up to 65­80 percent of products manufactured or procured for clinical trials are never administered to patients.Sourcing of commercial products for use as comparators and co-medication will ordinarily be undertaken via either a "direct to manufacturer" approach or by sourcing stock "out of market" via wholesalers. Products sourced directly from a manufacturer can provide batch size guarantees and paperwork such as Certificates of Analysis, but they are frequently priced at a premium -- up to 80 percent more expensive than out-of-market supplies -- and have long lead times. Sourcing these same products off the market can significantly reduce product acquisition lead times, but batch sizes may vary and, in some cases, the provision of a certificate of analysis may be difficult but not impossible. A hybrid approach of direct from the manufacturer and out-of-market supply may be a practical solution for supply assurance and cost effectiveness.The sourcing of comparator products is often transactional by nature; specialist providers work with study sponsors to source the products required for a specific clinical trial at a defined time point. This transactional approach can provide real challenges for out-of-market Tony Street
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