It's no secret the drug development process is laden with obstacles requiring a variety of experts on hand to deal with the challenges that come their way. When it comes to the clinical supply chain, however, some experts argue there's a dearth of supply chain managers with the right competencies to carry out the role effectively. So what can be done to address this widening problem? CTA spoke with an industry expert - who spoke on condition of anonymity - to discuss the pressing need for more supply chain management professionals.
Clinical Trials Arena: What are some of the biggest challenges facing the clinical supply chain at the moment?
Industry Expert: For me, when you think about clinical supply, there are two words: 'clinical', which implies the medical side of things and 'supply', which refers to supply chain management. The problem, I find, is that supply chain management is its own professional field. I think in clinical trial supply, we're still in a time where the supply component has a professional competency that is somewhat lacking. When you think about other industries, like consumer product goods, you see people in those fields in the supply chain space who are supply chain management professionals in their own right.
My opinion is that pharma as a whole is still behind other industries (i.e. consumer product goods). We're on a journey where there's still a question mark in terms of the capability of the talent we have in this space. I feel as though we leave a lot of money on the table. We don't always seem to have the right individuals with the specific competencies.
CTA: Can you provide an example?
IE: Many times you will get a "specialist", a person who might not have any "supply chain" business acumen, per se. They've spent most of their careers in a non-business related function at which point they decided to do something new, so the company places them into a supply chain role. And that's the crux of the problem. The supply chain function is a clearly defined role where there's a very straight road that may contrast widely from non-business related / "specialist" role.
Nevertheless, I think we're in a period of transition where the industry is moving forward to where it should be where it has the right people in the right roles; people who are specialised in supply chain management.
CTA: Is it fair to say there's a skills gap within the clinical supply chain where there aren't enough people who skilled in this area?
IE: Yes, I agree. There's a disconnect between the reality of the constraint imposed upon us by the real world.
CTA: What do you mean by that?
IE: If you're working in the clinical supply chain, there are real world constraints. Say for example, you want to get your product into the Ukraine, country where you can encounter regulatory barriers, as well as political issues. But supply chain professionals understand there are lead times that cannot be circumvented and there are techniques that can be employed to mitigate this. For example, we can be managing a forecast within the country with the appropriate safety stock to ensure we are able to better manage the volatility within that country. If you get someone from a non-business related function, they may not be aware of those techniques that can be used to help mitigate the risk of getting drugs into countries like the Ukraine.
So what typically happens is we may end up stocking out on clinical supplies. At that point, we're forced to expedite work through our packaging centres, and our logistics suppliers need to get rushed, which means you now have to pay more to rush products into the market. Whereas if you had a proper supply chain management professional helping to understand the demand aspect of the country, making sure you had the correct channels in place, that might not have occurred.
CTA: So how do you see things moving forward in clinical trial supply?
IE: It's an evolution. We are not unique; if you go back 10-15 years, you would see the same exact paradigm occurring then in big pharma as a whole where you didn't have supply chain management professionals in the field, whereas today you do. So I think that's where we are today in the clinical trial space.