In the latest edition of Industry Viewpoints, Clinical Trials Arena sat down with Godson Lomax who’s a senior manager of clinical trial management at a mid-sized pharma company.
Lomax oversees a team that has oversight on manufacturing, packaging, and distributional logistics. In his role, Lomax and his team liaise with clinical operations groups and end design during the execution of clinical trials. It’s a multifunctional group that includes regulatory affairs, clinical trial managers, safety and quality assurance. His role primarily focuses on the management of investigational products.
In this compelling interview, Lomax describes some of the obstacles he faces in what is a wide-ranging role.
Clinical Trials Arena: What is the most challenging aspect when you’re managing differing aspects of the clinical trial process, from a supply chain point of view?
Godson Lomax: Unlike many other companies that have separate departments for different functions (i.e. forecasting, vendor recruitment, etc.), I work with a team that’s primarily responsible for all of it. To that extent, there are a variety of challenges that are all-encompassing. From the onset, we need to have robust enrolment data in order to accurately forecast what the demand is going to be. We need to gather as much information so prospective vendors can bid on a project before we choose the right partner.
It all starts from the forecasting point and there’s always a timeline – the study can’t begin unless the IP is ready and available. The initial pressure is always on us to provide a reasonable idea of what the timeline is going to be for having a product manufactured, packaged and available. So the plans that are made upfront are dependent on when we have a viable protocol, and that includes good enrolment data we can use.
CTA: Explain some of the difficulties you face working within the clinical supply chain?
GL: Well another aspect of project management, as I alluded to previously, is selecting the right vendors. Many vendors have varying strengths and weaknesses so it’s important to ensure they are extremely qualified. Additionally, you have IRT (Interactive Response Technology), which also plays a crucial role in choosing the right partner. It enables you to gather the requirements for the protocol, validate it, launch it, and then monitor the system throughout the lifecycle of the study. So it’s not just the recruitment of the vendors and developing a robust system, you also need to have the experience to program your re-supply algorithms, while ensuring you’re not over exhausting your supplies or shorting out. Imagine if you built the system wrong and you were randomizing your subjects incorrectly – that could have a major impact on your study.
CTA: What challenges do you face when shipping trial materials?
GL: While shifting products from Point A to Point B in a regional study is much simpler, moving a shipment globally is where things get more complicated. In international shipments, you have think about import/export requirements, the rules and regulations for each country, and timelines. Furthermore, you have to gauge what your buffer levels will be from your depot to the site. This is all the while ensuring your supply chain is uninterrupted, unadulterated, and on time in order for subjects to be dosed.
CTA: When a trial is underway, how do you deal with and manage unforeseen events, such as protocol amendments?
GL: You have to be prepared for changes; nothing is ever static. When it comes to protocol amendments, depending on the magnitude of the change, it may impact your IRT system or even your packaging. In these instances, you always have to change your control process. When there’s a protocol amendment, we create certain systems and processes that give us more leeway to address these changes. For instance, we can have a simple request form that contains key enrolment details. When changes are made in enrolment, they’re noted in that document, and from that point we have to determine what impact that will have on the study, our IRT systems as well as our timelines. So there needs to be a constant flow of information and communication between all parties involved.
CTA: What advice would you give to fellow professionals working in a similar environment?
GL: As what we do is so specialised, there really isn’t a set curriculum you can defer to that will prepare you for this. In many companies, there are certain functions that are separated, for instance, you may have a team that’s solely responsible for IRT systems, or forecasting, and so forth. In our organization it’s different as you have to be well versed in all areas. When managing all aspects of the clinical supply chain, I would say a lot depends on experience, but in a role such as this, you need to have a project management skill set.