A coordinated supply chain management plan is crucial when developing advanced therapies.
Conducting the advanced therapy supply chain orchestra is more than waving a stick at people – it is an “end to end”, complicated, inter-related system that requires controlled, consistent management (1). For the purpose of this blog, advanced therapies are seen as cell and gene based therapies. These therapies are showing fantastic clinical results and are now on the brink of becoming a commercial reality. Initially, advanced therapies are likely to be for small, orphan indications, but over the coming years I expect them to expand to address larger health challenges, such as stroke or diabetes. The value of advanced therapies is that they can potentially offer long-term solutions, and even cures, to unmet medical needs.
There are many challenges involved in developing an advanced therapy product – and rightly so R&D is the main focus for any company in the field. While focusing on building a strong melody, however, it’s important not to overlook how it will be delivered to the audience. Otherwise you may find that your delivery is closer to a garage band than a full Philharmonic. In other words, it is important to consider a coordinated supply chain management plan. In my view, this should be done as early as possible within the therapies development.
Unlike more traditional biologics, a cell or gene therapy supply chain often has multiple time critical components, needs to be shipped under controlled, often to cryogenic, temperatures and can be directly linked to the patient. During clinical trials this is manageable as the scale of operation is limited; however, as we move into global commercialization, the complexity will increase. Much like moving from a musician’s demo tape into a fully produced Top-40 single.
It is surprising just how many companies fall into the trap of thinking that advanced therapy supply chain management is “easy” and something that can simply be grabbed off the shelf as required. The danger is that this viewpoint can lead to disjointed, ad-hoc supply chains that end up requiring extraordinary levels of manual intervention. To develop the capability to provide a harmonious supply chain management system, you need to think about:
Choosing the right musicians
When I use the word “supply chain” I am talking about an entire supply chain, rather than just logistics. The supply chain involves the management of processes, whilst logistics is the flow between points (2). The local “busker”, no matter how talented, may be able to help with a small-scale Phase I project, but is unlikely to be able to offer what is necessary to commercialize a therapy on a global scale.
Work together – or it’s just noise
Much like an orchestra, the advanced therapy supply chain comprises a mix of different people, skills and positions. This inter-relationship is what allows the music to flow. It is the same for the supply chain where challenges such as moving therapies between countries, or even provinces, can easily stop the music mid-verse and leave a therapy drifting out of temperature.
The art of a conductor is that he/she makes the job look easy. The “stick waving” at the front is all that is visible, but the conductor has had to recruit the musicians and validate their capability; organize them so that one group does not over-power the other; build a system that allows all the instruments to work together; manage the cultural differences between the diverse groups of individuals; use their expertise to control the flow of the concert from one piece of music to another – or from one part of the supply chain to another.
Meeting the audience needs
For advanced therapies the audiences are clinicians and patients. These are the people who get the value from what you are producing. While there is no point playing jazz in a heavy metal venue, from a supply chain point of view, this critical component is often under-managed.
Advanced therapies are often transported cryogenically. This means that they arrive at the clinical site in large containers that need specialist training to control. Additionally the therapy within them, much like a famous soloist, needs to be managed very carefully. For example, until recently the therapies were thawed in a water bath. This can lead to variation in the thawing cycle, which could impact the therapies efficacy, and therefore the value to the patient.
Cryo shipping is the key to controlling cost in the supply chain but you also need to think about how the clinician wants to receive the therapy. Do they have to monitor water baths or can you provide digital thawers that control the cycle for them? Essentially, do they want to see the concert live or listen online? In a supply chain, you need to consider what will add value to your end consumer.
These are really exciting times for the advanced therapy industry. Some life-changing therapies are already on the market, but more will follow – many large investments are being made in the industry after promising clinical results. When thinking about manufacturing, don’t forget about your supply chain. Considering a supply chain early on will give your company a competitive advantage (3). If you don’t have a plan then you risk sitting down to listen to your favorite tune and finding that the loudspeakers are missing.
Do you have an advanced therapy in development? If so, there are several variables that must be addressed to ensure you don't inadvertently limit your product's scalability and commercial viability, incur uneccesary costs and complications downstream, or fail to meet FDA criteria for documentation of cold chain requirements. Download our eBook Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield to learn more about how to mitigate these challenges.
- Storey et al., “Research Opportunities in supply chain management,” Journal of the Academy of Marketing Science (2006).
- Lummus et al., “The relationship of logistics to supply chain management: developing a common industry definition,” Industrial Management and Data Systems, 101, 426-32 (2001).
- Li et al., “The impact of supply chain management practices on competitive advantage and organisational performance,” Omega, 34, 107 (2006).