It’s no secret within the industry that running a clinical trial and getting a drug into the market is a costly endeavour. Therefore, it’s vitalsponsors strive to find ways to reinvent the wheel and make the drug development process more sustainable.
CTA spoke with Kyle Estes, Sr. Manager Global Clinical Supplies, Pfizer about supply chain processes, and why it’s important for companies to innovate to avoid stagnating.
Henry Kerali: Explain some of the challenges pharma companies face within the clinical supply chain
Kyle Estes: The biggest issue is building flexibility within the supply chain, and being able to move materials globally as fast as possible. Being able to react to the changing environment is critical so trial success. Anticipating what the lead times are to get materials into: the country, depots, sites and ultimately patient hands, and interpreting the various changing regulations to understand the effects on these actions.
Understanding those changes and incorporating them into their distribution plan, so to speak, is critical. Also adapting to changes associated with clinical protocols is important and if there is no flexibility in the supply chains these changes can have a huge disruption on the supply stream. Clinical teams are always making changes to study design such as, adding arms or patients. It’s so important to understand how that not only effects the distribution of the materials globally, but how that affects timelines, and all of the other downstream operations.
HK: Why should pharma companies innovate?
KE: It’s so important to innovate to stay ahead of the curve, otherwise you stagnate. Innovation helps to guard against losing that competitive advantage most companies work hard to establish. In today’s society, there’s so much technology available and we accrue so much data, how we use that data can be really impactful on today’s supply chain operations. We need to use that data to our advantage to understand ‘A’: what’s going on, ‘B’: what have we done, and ‘C’: how can we improve going forward based on the information we’re seeing. It’s incredibly important to able to understand what’s going on in terms of the trial atmosphere and provide those improvements, as they can lead to huge payoffs. Even if you can shave off just a few days from a trial, it gets the product to market that much faster and has the opportunity to generate huge amounts of revenue.
I think as pharmaceutical companies we do a good job of aggregating all this data, but we only focus specifically on the drug data (like ‘is the drug working, right?’). There are so many opportunities to look at other data that is being captured and stored and exploit it to create a more dynamic environment. An example of this is looking at all the data we generate on investigators. Most of it is captured in disparate systems and taking all that information, putting it all together and modelling or forecasting off of it can lead to a huge decrease in trial lead time. For example, you can create a pool of investigators that you know for vaccine studies are really efficient based off the modelling you have done previously; and if you have a study you need to get off the ground quickly, you now have a specific pool of a specific subset of investigatorsthat you want to use in your study to get that study moving as fast as possible.
HK: To follow on from that, how can companies change that their strategies?
KE: How? Well we need to get out of our own way first! We are so risk averse we need to start embracing the ideas generation and allow people to at least run with it, and I think that’s the most important thing at this point.
HK: So how can pharma companies rethink their supply chain processes?
KE: I feel rethinking the whole trial process in general is needed because we run clinical trials for the most part the same way; particularly, how we distribute drug products. Companies follow a very specific template, maybe some do things slightly differently, but for the most part we follow the same template. So rethinking the way we distribute products globally, as well as how we run our trials, is a big part of how we move forward as an industry. How technology plays a part is also important. Health care technology is playing such a large role in today’s industry and if we can start to leverage that we can start to build a more sustainable competitive advantage.
As companies also make a push passed emerging markets, passed BRICTM, moving further into even less developed regions it will be vital to rely on these technologies. A lot of these countries that don’t have the infrastructure so we tend to shy away from them, however by embracing tech solutions some pharma may be able to make a move into these markets beating their competition. Technology will allow them to develop a mobile site to allow them to randomise patients into a study and keep them going, this going to be important in finding that next unsaturated market.
HK: Explain the importance of pharma companies adapting and changing their processes
KE: It’s important from an evolutionary perspective. If you look at a company like DuPont that started off as one thing then morphed into something substantial different and then did it for a third time and now they’ve essentially changed what they do. They started out small and they’re still a major company player because they reinvented themselves.
I think pharma, while it’s existed for hundreds of years, at some point, if they don’t adapt and change the way they operate, their model will become extinct, and someone else will figure out a better model, whether that’s niche or not. But it’s also very cyclical – before everything was outsourced and now whereas before outsourced 60/70 percent if their trials, now it’s coming back down to 30/40 percent. With everything being so cyclical, being able to find a way of doing things and standing out from the crowd might give them a competitive edge.