By Martha Lee, Rory Popert and Mayko Musiol
The same can be said of the speed at which regulatory approvals have now been achieved. In the face of a global pandemic, the usual ways of working were found wanting, and had to be transformed at pace. It has taken careful consideration and immense effort to bring the vaccines to market and provide much needed hope to the global population and economies.
The logistics networks required to distribute some of these complex new products have also been established at record speed. The uniqueness of both the products and the global circumstances make this a much more significant endeavour than a mere scaling up of existing infrastructure. Below we explore some key considerations for bringing these products to market, how some of the challenges may have been addressed, how to improve these further, and what the legacy of this effort might be...
As we’ve seen in the headlines, each government has been negotiating contracts for millions of doses of vaccines from the different manufacturers. The PharmaCo order management processes therefore have to be amended to balance these with incoming sales orders and actual production each week. Checks need to be conducted to ensure that the orders don’t exceed the contracted amount or the logistics and storage capacities of the network. The complexity of this balancing act, and the technology and communications required to enact it, involves new team structures, system updates, careful mapping and clear guidance.
Most of the vaccines on offer for COVID-19 require two doses before they are effective, and the window for administering the second dose is both variable, depending on the vaccine, and short. This means that while two doses are identical in content, the second is more critical to deliver in time. Setting up processes to prioritise the second dose in clinics, thereby maximising coverage and minimising waste, has been an important problem to solve. Keeping customers up to date with supply issues will also be essential. Careful patient communications will help ensure that patients attend the centres for treatment.
Many of the new vaccines require storage at a much lower temperature than standard logistics networks are equipped to provide. This is due to their use of groundbreaking new mRNA transfection technology. It requires investment in ultra-low freezers, temperature-controlled boxes that use dry ice, and active temperature trackers. These all have interesting implications:
One benefit of investing in this infrastructure is that, while these are the first of these advanced, modern therapies to be provided on this scale, they will not be the last. This is an opportunity to set up an ultra-low cold chain for high volume, high demand products so that when the lower volume advanced therapeutics, such as gene therapies, of the future come to market less upfront capital will be required.
Considering the complexity of bringing these new innovative products to market, how can PharmaCos ensure markets and customers are ready to receive and administer the vaccines?
A baseline go-to-market model can be designed as a starting point, which can be adapted to address any market-specific nuances. These specific requirements can be identified by conducting a market readiness assessment, looking for capability gaps. Tailoring to markets helps reduce risk and can manage the demands of ultra-low cold chain transportation, distribution and storage. For example, a direct to point of care model may be preferred by a PharmaCo for quality and security assurance, but this model may not work in some markets.
Adding third parties into the supply chain introduces control and oversight risks, especially if they are introduced into the ‘last mile’, i.e. the final stretch of the product’s journey to the end user. Close and transparent ways of working need to be introduced with these third parties to maintain a comfortable level of control at regional and global levels.
Once the go-to-market model is defined, in-market teams and customers need clear guidance and communications on the required market operations and processes. Done properly, this helps ensure market readiness while reducing the workload of regional and global teams, who can dedicate their time to supply and demand across the network.
When a market goes live, effective, constant operational support is required to help in-market teams swiftly address customer issues and queries, as well as robust data collection tools to gather patient feedback and outcome data. This is necessary not only from a pharmacovigilance perspective, but will also provide valuable insight into the longer term immunisation capability of the vaccines.
As well as the global benefits that these vaccines will provide, the unprecedented speed of development and delivery seen in the Pharma industry for these products will have lasting impact, with many lessons learnt. It will be interesting to observe over the coming months and years what the legacy of the COVID-19 pandemic will be on Pharma R&D, regulators, go-to-market planning and logistics. Harnessing the value from these lessons and really moving the needle on future BioPharma supply champion performance will be a critical ‘win’ across the industry for future generations.
The authors would like to thank Scott Lawson and Thalita Marinho for their contribution.