HomeCase StudiesGlobal Comparator Equivalency for Phase 3 Study

Global Comparator Equivalency for Phase 3 Study.

  • Published 14/07/2022
  • Author Bionical Emas
  • Division Clinical Trial Supply (CTS)

Market Insight.

Year on year oncology clinical trials are becoming more costly and complex to run, with one of the largest proportions of the clinical supplies budget now being taken up by the sourcing and supply of comparator products. The increase in comparator cost can be correlated with the uptake of new complex biologics and immunotherapies which are now the gold standard for oncology treatments. Most products launched between 2009 and 2014 cost more than $100,000 USD per patient per year (1), encouraging sponsors to find new solutions to manage costs at a time when budgets are increasingly under pressure.

Client Challenge.

A global pharma company running a phase 3 head-to-head study reached out to Bionical Emas requesting assistance with their sourcing strategy of a high-value oncology comparator product. Their current regional sourcing approach was proving both costly due to higher priced comparator product in some regions, and inflexible due to the high variability in patient enrolment across different study countries.

Bionical Emas Solution.

Bionical Emas reviewed the sourcing approach, and by utilizing their network of global manufacturer affiliates, were able to identify a single source of product from a sustainable, more cost-effective, and Mutual Recognition Agreement (MRA) country.

In addition to support the use of the product in their study, Bionical Emas were able to obtain an equivalency statement to confirm that the product was manufactured and released to the same standards, globally.

Through this approach, Bionical Emas were able to simplify the comparator sourcing process by identifying a single source, allowing for streamlined management of supply forecasting to keep up with patient enrolment and save > $2,000,000 million on comparator costs.

References.

  1. Barbara K. Rimer, D. (2018, March 15th).
    The Imperative of Addressing Cancer Drug Costs and Value. Retrieved from National Cancer Institue: https://www.cancer.gov/news-events/cancer-currents-blog/2018/presidents-cancer-panel-drug-prices

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