Digitising the clinical supply chain
08 August 2019
Over the last few decades, clinical trials have become exponentially more complex. This complexity has created a plethora of challenges in managing the clinical supply chains of large trials. While new technology has been slowly adopted to increase efficiency, there is still a significant opportunity to further optimise supply and logistics during clinical development.
Late stage clinical trials are being run at an increasingly global scale, with various interdependent processes and stakeholders. Pharmaceutical companies and contract research organisations (CROs) are struggling to increase efficiency and effectiveness within the clinical supply chain while maintaining compliance. The market for clinical trial supply and logistics is forecasted to grow annually at 7% in the coming years.
Below are some key trends that have amplified the challenges within clinical supply chains:
1) Complex trial design: Most large pharmaceutical companies now routinely sponsor operationally complex trials with hundreds of sites across multiple continents. This has been driven by numerous factors including the cost differential between geographies, a demand from regulators for local trial data, and a shift towards niche therapeutic areas with scarce patient populations. Furthermore, the emergence of adaptive clinical trials further means that trial processes have to be flexible to change even after the trial has begun.
2) Complex products: There is currently a shift away from simple small molecule products towards biologics and complex active ingredients that require very specific manufacturing, distribution and storage conditions. Before these can be shipped however, they must also be accurately labelled with the language translations based on their intended destination. This complexity is magnified by adding in placebos and comparator drugs. Failing to get sufficient product to the right place at the right time can mean patients must be turned away at the site, while the converse can lead to inflated storage costs and waste.
3) Increased outsourcing: The past couple of decades have seen large CROs become a fundamental piece of the clinical development puzzle. But outsourcing has not ended there. Pharmaceutical companies are increasingly turning to contract manufacturing (CMO) and packaging organisations (CPOs), as well as boutique CROs and courier/logistics companies. These independently operating services must be holistically sourced and managed strategically. There is an opportunity in most organisations to break down silos, thereby reducing delays, inefficiencies and in extreme cases, regulatory breaches.
4) Regulatory and tax landscape: Pharmaceutical companies and CROs running trials must ensure compliance with a range of constantly changing regulatory obligations including good practice (GxP) requirements, import/export regulations and tax/customs laws. Trial design as well as the supply chain should be proactively optimised to reduce tax liabilities, as well as costs of regulatory non-compliance, since unforeseen issues can easily burn through a trial’s budget. For example a top-10 global pharma company was hit with a multi-million dollar tax bill in China where authorities claimed the value of imported investigational medicinal product (IMP) was many fold higher, pointing to the price it was being sold at in the USA.
Pharmaceutical companies that successfully overcome these challenges will see significant returns and strategic competitive advantages in the form of decreased costs, quicker time to market and increased compliance. However, the journey to implementing a next generation supply chain capable of rivalling those in more advanced industries such as in fast moving consumer goods businesses will be neither easy nor painless.
Companies seeking to revolutionise their clinical supply chains will need to drive forward a culture of strategic planning, collaboration and technological enablement. The move towards a fully digitised, integrated supply chain is necessary for companies aiming to succeed at efficient clinical development.
Some key steps that organisations should take to exploit this opportunity are:
Companies aiming to stay ahead of the curve must fully digitise their clinical supply chain to increase robustness and enable complete visibility and traceability of products. Manufacturers should leverage existing technologies, such as those used to implement serialisation and the EU Falsified Medicines Directive (FMD), to minimise disruption and costs. Digitisation of the supply chain would also increase accountability, thereby reducing the burden of site monitoring. Finally, this digitisation would also enable the collection of high-quality data which can yield further benefits.
Access to detailed, real-time track and trace data will give companies a strategic advantage, enabling the rapid identification of issues, mitigation of delays and optimisation of processes. Once this is in place, companies should seek to learn from other more advanced industries, and adopt strategies such as just-in-time supply to reduce costs. A secondary benefit of having good data is that this can be used to monitor and encourage patient adherence, leading to better quality clinical data.
2) Artificial Intelligence (AI) and analytics: A key part of building a next generation clinical supply chain is to not only collect an abundance of relevant data, but to apply this data to drive business decisions. The use of AI and advanced analytics can highlight previously overlooked insights, generate predictive forecasting and enable the mitigation of risks before they materialise. The vast amounts of data already gathered by companies today is a massive untapped asset, and implementing the right tools and technologies to generate value from this resource will pay huge dividends.
3) Integrated platform: Visibility is a crucial ingredient for success, particularly in the world of clinical supply. Organisations should implement an innovative trial management platform that integrates supply chain data with project management capabilities and trial information from Interactive Web Response (IWRS) and Electronic Data Capture (EDC) systems, to foster data-driven decision making. This platform must also enable effective collaboration with external partners along the supply chain and build in supply and demand tracking. The ability to access this information and have oversight of a trial remotely can further help reduce costs, particularly in large, multi-country trials.
4) Continuous manufacturing: While pharmaceutical companies are increasingly recognising the proven advantages of continuous manufacturing, in practice the use of this technology remains limited, and usually adopted only in late-stage development or post-commercialisation. Implementing continuous manufacturing from the very start of development could reap benefits including reduced distribution costs through the use of decentralised micro-factories, reduced storage and waste through on-demand production and quicker time to market due to the modular, scalable nature of the manufacturing technology.
5) Future-proofing: The challenge of managing a clinical supply chain is ever-increasing and companies that wish to stay ahead of the curve will need to embed a continuous improvement mindset. One way to achieve this is to establish an internal Centre of Excellence that works across functions and collaborates effectively with external third parties to drive culture change, innovation and act as a source of local intelligence. Since scalability is a huge challenge in clinical supply, another option is to partner across the industry to take advantage of economies of scale. Only with a set of resources dedicated to achieving clinical supply excellence can companies expect to fully and sustainably realise the value hidden within their clinical supply chains.
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