Orifarm

Tony Street

More 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 Forecasts

Forecasting 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 65–80 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[1]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[1]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[1]of-market sourcing, where wholesalers need to balance the needs of their local markets with the peaks and troughs of irregular requests for products needed for clinical trials.

Applying a Data and Market Intelligence Driven Supply Chain

As one of Europe’s largest traders in pharmaceutical products, Orifarm CTS is able to shift the procurement dynamic from the standard transactional approach to a data- and market-intelligence-driven supply chain.

Each month, Orifarm acquires in excess of 4,000 line items off the market from >250 approved suppliers and holds stock worth in excess of 200 million euros in its own warehouses. This regular cadence of purchase and scale of spend allows us to gather data on pricing, availability, batch rotation, and potential shortages at a level that is unthinkable to those sourcing in the more standard transactional model.

" In addition to the data-driven and scale of procurement, our ‘multimarket sales model’ also allows us to collaborate with study sponsors to develop strategies that allow for later decision-making regarding order size and timelines "

In addition to the data-driven nature and scale of procurement, our “multimarket sales model” also allows us to work in partnership with study sponsors to develop strategies that allow for later decision-making regarding order size and timelines. Shifting decision-making closer to the patient treatment timeline enables greater flexibility to respond to shifts in patient recruitment rates and the geographic spread of patients.

Utilizing Existing Retail and Pharmacy Networks – a Game Changer for Risk, Expiry, and Waste

For the ultimate lean supply chain in North America, Orifarm CTS is also able to utilize the retail and specialty pharmacy networks in the US and Canada to provide prescription-based, on-demand supply. This is achieved by tapping into the established US and Canadian healthcare systems, where prescriptions are fulfilled at specialty and retail pharmacies and payment for the products supplied is managed through healthcare insurance. In place of the usual healthcare insurance process, Orifarm CTS can provide technology that replaces the insurance requirement with a payment process customized to a sponsor’s clinical trial needs, giving access to a network of over 68,000 retail and specialty pharmacies.

In this model, a formulary of products that are required for the clinical trial is agreed upon and defined in the supply platform. As patients are enrolled, they are dynamically allocated a virtual pharmacy card, which can be sent directly to the patient’s mobile phone. When the investigating physician provides a prescription for a product on the approved formulary, the patient can collect the prescribed products at a retail pharmacy of their choice or can even have the product delivered directly to their home. Products from specialty pharmacies are delivered to the specified hospital site. This model is a game changer for the supply chain, removing all inventory risk, expiry date, and forecasting challenges for the trial sponsor in a zero-waste supply chain. Ultimately, the sponsor only pays for products that are dispensed to a patient in their clinical study.

In summary, by leveraging procurement scale and data-driven market insights, Orifarm CTS is in a unique position to provide best-in-class access to European commercial products with reduced inventory risk, late[1]stage decision making, and the ultimate zero-waste prescription-based supply for the North American market. By reducing costs and ensuring supply chain continuity and product integrity, this transformational approach to the clinical supply chain benefits patients, study sites, and study sponsors, all while making the complex look simple.