For clinical supply managers, overseeing the supply chain throughout the course of a study could be considered an unenviable task. There are numerous players involved, including the sponsor, CROs, CMOs, investigators, site staff, and of course patients themselves.
Maintaining control of all moving parts is critical to ensuring supplies reach sites in a timely manner, patients receive their medication on time, and the trial runs as smoothly as possible.
But for smaller sized companies, operating on limited budgets and few resources, what are some of the key considerations supply chain managers should take on board when involved in a trial?
In the latest Industry Viewpoints, Clinical Trials Arena sits down with Pedro Pala who’s the Clinical Trial Supply Manager at Bial.
Pala is responsible for the production of drugs and acts as the bridge between the company, the CROs (contract research organizations) and the CMOs (contract manufacturing organizations).
In this interview, Pala speaks to CTA editor, Henry Kerali, about some of the challenges he faces working within the clinical supply chain on limited resources.
Clinical Trials Arena: What are the most important aspects of a robust supply chain?
Pedro Pala: In my mind, it’s important to have dedicated partners as you rely a lot on their expertise. This is true not only for CROs but CMOs as they are the experts when it comes to clinical supply management. While CMOs are responsible for the distribution, the CROs manage enrolment, which is the last stage of the clinical supply chain. If you’re unable to enrol patients, then simply put you can’t test your medication. Without patients, you don’t get the feedback and without the feedback you’re unable to launch your product commercially, so a robust supply chain is needed to ensure success.
CTA: In your experience, what are some of the logistical challenges you face as a small company shipping supplies from A to B?
PP: One of the biggest problems we have is the constant changes in regulations. If you take, for instance, Argentina, the regulations are regularly changing, which makes it difficult for us. We subcontract CMOs to import our products, and if they are unable to get into the country due to a change in regulations that costs us money. The impact can be damaging because we are not only losing the validity of our medication, we are also losing the patients who might not be able to receive the medication on time, potentially jeopardising the study.
CTA: How do you go about mitigating the problems that these amendments create? Is it a case of keeping track of the latest regulations from country to country?
PP: For me, there are two ways of overcoming these challenges: firstly, you need to invest a lot of money and produce more medication than you require. Secondly, ship enough medication to the sites to cover them for a year. When it gets to six months, start applying for an import license, so that you have a window to prepare should there be any changes in regulations.
CTA: How crucial is it to build relationships with CROs and CMOs to ensure trial success?
PP: It’s vitally important. When a lot of companies start out, they might meet vendors through networking, word of mouth and so forth. Once the sponsor and the vendor have established a strong working relationship, they partner up with one another time and again just by virtue of familiarity; the sponsor knows what they’re getting from their partner and vice versa.We tend to go for small CMOs because they can easily adapt to our way of working. What’s more, they’re flexible and they can accommodate your needs more effectively.
CTA: Do you find that’s probably one of the drawbacks of working with a large CRO/CMO because you’re not their only partner, and therefore you’re not as big a priority?
PP: Yes, because you’re a small company and you’re likely competing with far bigger pharmaceutical companies (more resources andmore funds). That said, we’ve worked with bigger CROs and CMOs before and in the past we’ve been happy with them, but we don’t see the same level of flexibility as the smaller ones.
CTA: What are some of the best practices you’ve developed over time as a supply chain manager that you feel would benefit sponsor companies of all sizes?
PP: Essentially, I think you need an accurate forecasting system. Ensure you’re up to date with protocol development. If you are in constant contact with your clinical operations team then you will know when the protocol is approved, when they start enrolling as well as when the clinical trial approval is available. Based on the forecast, you can administer the medication, reduce the amount of waste and the amount of money you lose.
From my point of view, trials are becoming more complex and I think it’s important for sponsor companies to invest in themselves. By getting to the stage where you have everything in-house, you can have more control over processes meaning you rely less on other parties.