With the recent news warning of a potential penicillin shortage in the midst of a recent outbreak of a form of Strep A in the UK, Rebekah Jordan sat with Kelly Doering, senior director, AspenTech, to learn more about how digitalisation in pharma manufacturing is key to overcoming drug shortages such as this one, and how the industry can build a more resilient and flexible supply chain.
Key insights:
- The digital transformation of pharma manufacturing supports the supply chain in growing more resilient and seamless, mitigating potential disruptions before they arise.
- People can rely on digital technology solutions, to proactively find optimal solutions with real time monitoring.
- Lessons learned from the Covid-19 pandemic have resulted in more pharma companies addressing the medicine access problem, and using digital tools to do so.
The symptoms of a supply shortage can be quite varied. Problems can stem from a raw material shortage, shipping issues or even accessibility. Disruptions can also be caused by batches that failed during the production process or quality assurance, therefore cannot be shipped as expected. As a result, pharmaceutical shortages can occur.
Flashback to the pandemic where there were difficulties distributing the Covid-19 vaccine, Doering points out that accessibility in some parts of the world is still an ongoing issue.
“If you think back to when the Covid-19 vaccine was manufactured, it required cold storage. Cold chain storage is difficult when you're trying to get it to remote parts of the world where there aren't the same resources to support that.
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“There may have been the possibility of shipping, but they wouldn't be able to ship it at appropriate temperatures and therefore, the vaccines wouldn't have remained safe and effective. Even if storage conditions were not an issue, another consideration would be how and where the vaccines would be administered. So there again, there are a lot of different factors that go into the global accessibility to all kinds of medicines.”
The digital transformation of pharma manufacturing supports the supply chain in growing more resilient and seamless, mitigating potential disruptions before they arise.
Doering said: “If there is a way to improve communication and to improve optimisation of how products are being brought to market, digital tools fit right in there because a lot of the hiccups are due to unanticipated disruptions. And so, someone who is doing the planning and scheduling, for instance, they need to be able to adjust on almost a minute-by-minute basis if any changes occur.
“Doing that manually is incredibly difficult. It's almost like you're playing a chess game of trying to move all of these pieces all at once, and no sooner do you get it right, you need to move them again.”
By using the so-called “digital ecosystem” of machine learning and artificial intelligence (AI), data can be seen and accessed in real time. Doering adds that disruptions can be navigated as you input data – “you can learn from it and build better outcomes as you move forward.” With this technology, people can rely on these programs to proactively find optimal solutions in light of any potential disruptions.
The AI technology can enter at any stage of the supply chain from drug development to production release, all the way down to the pharmacists who are moving stock around. The real-time communication, enabled by AI, allows pharmacists worldwide to communicate any issues down the line and allow time for preparation.
Hype or reality?
The problem is that people fear change. And pharma companies are no different. For a lot of organisations that have operated in a certain way for so long - especially those that are highly regulated – stand by the ‘we’ve always done it this way’ approach. Therefore, having to insert a whole new technology, learn new things and do things a different way can be a huge turn off.
“People have difficulty seeing the benefit versus the climb that is required.”
Doering pointed out that culture within organisations and this fear of change was reinforced in the audience feedback from the IPSE Pharma 4.0 conference, which is a conference showcasing the full potential of digitalisation and how it can be leveraged across the pharma product lifecycle.
On the other hand, lessons learned from the Covid-19 pandemic have resulted in more pharma companies stepping up to address the access to medicine problem, and using digital tools to do so.
Doering mentioned that the 2022 Access to Medicine Index (from the Access to Medicine Foundation) has seen “a real progression amongst the 20 companies that they're monitoring. So that's one indication that companies are taking it even more seriously.”
With an increasing demand for medicines across the globe, especially within low- and middle-income countries (LMICs), the increased visibility and optimisation that digitalisation provides can help strengthen pharma manufacturers’ role in wide-spreading the equitable access of medicines.
Out of the 20 pharma companies that the Index follows, this year has seen all 20 of them report an access-to-medicine strategy. Additionally, companies such as GSK and Pfizer are strengthening delivery in their pharmaceuticals in LMICs, with other companies engaging in voluntary licensing agreements.
Now although the commitments are set in stone, the pressure is now on the companies to follow through and take action. Doering concluded that there is still a long way to go, however there is “a real mobilisation that we've not seen previously.”