Clinical Trial Supply Europe 2020 is only a few days away, promising a great opportunity to rub shoulders with more than 85 exhibitors and over 500 attendees. William Hayes, Sales and Operations Leader at CSI, sat down with Vanessa Dekou, Managing Director, to ask her about her upcoming presentation at the event.
You’re scheduled to be speaking on ‘Safeguarding the progress of medicine through optimal comparator sourcing’. For many clinical trial sponsors, the financial cost will most likely be the main factor they consider. Is it as straightforward as that when it comes to comparator sourcing?
It can be tempting to think primarily in terms of upfront financial cost, but that is often a false metric. If you were to source a large quantity of Avastin® for a clinical trial, it would be tempting to look at the cost per unit from various sourcing partners and simply go with the cheapest. The reality, however, is that the surface level cost is often a false representation of value. Other factors, such as continuity of supply, batch numbers, documentation and acceptable expiry dates, are essential to consider. Insufficient preparation can lead to the sponsor’s staff wasting precious time on administration, and a lack of understanding of regulatory adherence and licensing may lead to import and export complications, creating costly delays and even compromising the clinical trials.
People often mention relationships with manufacturers. How critical are they to successful comparator sourcing?
Comparator sourcing is a complex process where extensive scientific knowledge and strong relationships make a big difference. For example, I can recall one specific case where we needed to send 1,500 units of Abraxane® – a pancreatic cancer drug – to China. The active pharmaceutical ingredient (API) used to be made from Pacific yew trees, which are now endangered, so we had to get confirmation from two suppliers in Asia that their API was made using a semi-synthetic process. While this sounds straightforward, it’s not so simple to persuade manufacturers to disclose information about their APIs.
Sure. I guess it’s normally best kept a secret!
Understandably, manufacturers are wary of supplying their products for biosimilar development. After all, it’s rather like asking a Michelin star chef to provide you with their best dish over and over again so you can make yours tastier. However, clinical trials are vital to safeguarding medical progress and continued development, and so building long-lasting relationships with manufacturers is an essential part of comparator sourcing. Relational intelligence is needed just as much as scientific knowledge, and a partner with a strong network is far more likely to be able to source the necessary drugs in sufficient quantities for clinical trials than a less knowledgeable alternative supplier.
What other key elements, in your opinion, are necessary to optimise comparator sourcing?
I think the actual people in an organisation play a huge role. Going into comparator sourcing, as with any industry, can simply be part and parcel of someone’s career progression, so it’s important for a sponsor to ask: Are the team members experienced? Will they be able to support us with protocol analysis if needed? Are they likely to go the extra mile to understand the medical device or comparator they are sourcing to better understand regulatory requirements? It’s hard to over-emphasise the importance of the people you’re working with in what can often be mistaken for simply a logistical problem.
You’re obviously proud of CSI’s work and the growing team you’ve assembled. What, in your opinion, has enabled CSI to establish itself as a partner of choice for leading pharmaceutical companies?
There are many comparator sourcing solutions out there, some of which represent one of multiple income streams for a multinational company. Diversification may be a benefit for some, but we’ve discovered that being scientists and specialised enables us to ensure that every client receives an excellent, responsive service and we’re able to hire staff for whom comparator sourcing becomes their niche expertise. At CSI, comparator sourcing is not one service among many that we provide, it’s the service we provide, and I think that makes all the difference to the service we offer.
Vanessa will be speaking on ‘Safeguarding the progress of medicine through optimal comparator sourcing’ at 9:30 am on Thursday the 12th of March, followed by an expert panel discussion at 3:30 pm on ‘Exploring various comparator sourcing models to establish which is most cost effective and ensures the least disruption to your supply chain’. Please feel free to get in touch in advance or visit us at Stand #42 if you have any questions about comparator sourcing and how we can make your clinical trial a success. We look forward to meeting you there.