Commercial drugs in clinical trials
Pharmaceutical companies spend a lot of their clinical trial budget each year to purchase commercial drug supply for their clinical research. We created a list of the most sold drugs for use in clinical trials. This list is based on our own research and activities within the market.
Some of the listed drugs are one of Merck’s top-selling drug Keytruda®, Roche’s Avastin® and the drug this article is about; Jonhson & Johnson’s best-selling drugs Stelara®. For companies conducting clinical trials, it is important to collaborate with a commercial drug supply company to offer them tailored solutions. This way pharmaceutical companies carrying out the clinical trials are able to focus more on research part and less on the sourcing.
The list is set in alphabetic order:
This article is a case about the number 9 of the list; Stelara®, with the focus on how we work with Johnson & Johnson’s immunosuppressant medicine used in clinical trials.
What was the objective?
BMclinical received a large-scale request for proposal (RFP) from a sponsor for Stelara® (ustekinumab) broken down into three purchases across 2021. Stelara® is an immunosuppressant prescription medicine used to treat plaque psoriasis and certain bowel conditions such as Crohn’s disease and ulcerative colitis.
The quantities requested by the sponsor were relatively large and therefore, BMclinical put together a plan based on two sourcing options; open market sourcing and direct sourcing from the manufacturer Janssen.
Based on the tight timelines due to FPFV (first patient, first visit) already being scheduled, BMclinical recommended that the initial purchase quantity across two batches from the open market. This would mean that the study would go ahead as planned without any delays.
Based on the demand of the biologic across Europe, we were initially quoted a lead time of five-six weeks. Lead time was very critical for the sponsor and needed the first quantities delivered as soon as possible.
BMclinical discussed the project internally and worked closely with the purchasing team to ensure that we could meet the customer’s timeline. Due to our extensive knowledge of the European market and movement of key biologics, we were able to find a solution where we could get the needed stock in the required two weeks lead time with Certificate of Analysis.
For the remaining supply needed later in the year, BMclinical recommended sourcing directly from
the manufacturer. Due to a lower price per unit and the large quantity require in single batch, this was the best solution for the clinical study.
What was the result?
The sponsor chose BMclinical due to the fast lead time and quality of service. We were able to secure the first packs in the same week that the sponsor placed the order. The first supply was delivered to them within 2 weeks.
We delivered the larger quantity via Janssen in accordance to the required timelines.
The great results achieved by BMclinical resulted in the sponsor company confirming that future supplies for the clinical study will be placed with BMclinical.
We at BMclinical are proud to contribute to this clinical trial, as it has the goal to make this world a healthier place for all people and their loved ones.
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