Case Study – Supplying Specific Tested Batches of Oncology Product from the Market
Client approached us with a very specific request to test samples of an expensive oncology product and then purchase the same batches that had passed the testing stage. This was a challenging request as it required visibility of batches currently on the market before purchasing. This is only possible in certain markets where product availability is moderate. Due to the nature of the trial the client was not willing to disclose trial details and required documentation (Certificate of analysis and pedigree).
Without the possibility of disclosure, we had to source from the open market. This was challenging because we had to fulfill four requirements:
The most effective solution was to work with our audited suppliers with a ‘hit list’ of batches that had a positive result from
testing. This relied on working closely with suppliers in markets where batch visibility and documentation is possible, to keep an up to date list of what batches are on the market at a given time, and if they have had a positive or negative test.
Challenges and Results
A sourcing strategy such as this is dependent on very close communication between client, CSI, and suppliers. As the suitable markets usually have limited availability, product had to be collected over a period of time before being delivered to the client. At all times the most important thing was to guarantee a stable supply chain to the client and ultimately the patient. CSI leveraged all good relationships with suppliers to keep stock on hold with the promise to purchase if the batch testing was successful. Such undertaking is only possible when there is mutual trust, understanding of the specific requirements and a united team with the grit and perseverance to deliver for the benefit of the patient.
The advantages of biosimilars vs branded products in clinical trials
The growth in the biosimilar market since 2006 has been significant.