Achieving digital maturity has revolutionized businesses, helping make them more efficient, profitable and resilient. However, the life sciences industry continues to lag behind, failing to realize the available benefits and limiting their potential.
Like other industries, those organizations that fail to innovate through better use of data will fall behind their competitors. Given the current global financial situation, that may mean complete failure.
So, what are the challenges preventing life sciences companies from achieving digital maturity?
1. Outdated supply chain and manufacturing
Despite investing millions each year on discovering and selling new medicines, spend on manufacturing and distribution operations is far more modest. And this could be a mistake. Investment in updating manufacturing and distribution operations often pales compared to the millions invested in research and development. This can lead to costly production glitches and other supply chain challenges.
In the COVID-19 reality, production glitches are more relevant than ever before. We are all affected by the speed of vaccine production and companies such as Pfizer and Moderna are under immense pressure to scale up production quickly; Pfizer is aiming to cut the vaccine production time by 50% in the near future.
As the industry moves towards the use of more outsourced manufacturing, the supply chain becomes ever more important – and complicated. Existing supply chains tend to be under-utilized and inefficient, making them incompatible or ill-equipped for the next generation of treatments and products.
At the same time, flexible production requirements and the uptake of continuous processing and automation will herald major changes in operations. But there is a risk that without digitalization, systems, processes and supply chain will limit potential advances.
2. Government policy, regulation and mandates
Regulations governing the life sciences continue to change and develop as regulatory bodies strengthen protections for citizens. To stay compliant, businesses will need to adopt a proactive approach to monitoring, tracking and applying changes. This will allow them to implement refinements quickly to avoid periods of non-compliance and to better control costs.
Firms will also need to share information and enhancements with their supply chain partners. This will help to ensure compliance across the entire production lifecycle, including those aspects for which the business is not directly responsible.
3. Achieving a golden batch
The “Golden Batch” remains the ultimate goal for research and development in the pharma industry. Improved access to data can help to shorten the regular trial-and-error development phase by automatically identifying “trajectories” that are likely to yield a “Golden Batch”.
Digitally mature businesses are able to reduce the need for human intervention and operator workload to improve yield. Operators are also able to formalize controls to ensure that every future production run remains within the Proven Acceptable Range (PAR), delivering a superior product every time. At the same time, data collection routines ensure that metrics are captured from every point of the process to inform and optimize future production runs as part of a continuous program of improvement.
4. COVID-19 disruption
2020 saw a massive diversion of funding towards developing vaccines and treatments for the COVID-19 virus. At the same time, consumer demand for over-the-counter medications has surged as people build their own stockpiles in case of further lockdowns or shortages.
National responses to the pandemic have varied, creating numerous issues for cross-border production and trade. This is adding to supply chain uncertainty, further complicating operations for the life sciences industry.
Another key topic that the pandemic has brought up is cybersecurity – in July last year, cybersecurity agencies and authorities in Canada and the UK announced a joint warning of attacks targeting COVID-19 research and vaccine development facilities. These attacks can cause further delays in delivering vaccines, in addition to the threat of stolen intellectual property, downtime, and possible need to repeat already completed trials.
How to solve these challenges
Preparing for digital maturity involves much more than simply deploying new technology. Your organization will need to undertake a comprehensive review of operations to identify where processes can be enhanced and streamlined using data.
To learn more about these four challenges and how to solve them, download our latest eBook Digitalization and Digital Transformation in Life Sciences.
Amr is the business development director for Hexagon PPM’s digital transformation, commissioning, and plant turnaround efforts for Europe, the Middle East, India and Africa region. Find him on LinkedIn.