Manufacturing & Supply Chain

By Barry Heavey, Life Sciences practice lead, Accenture in Ireland

I recently had the pleasure to meet Emily Whitehead, the first CAR T cell therapy patient who has now been declared cured of cancer.  It is ten years since her parents were told that her cancer was incurable and they enrolled her in an experimental trial for this new treatment.  Her treatment involved transporting her immune cells (T cells) between her hospital bed and a specialised lab, under strict temperature control, to keep the cells alive.  We spoke about the importance of cold chain capabilities as this and other complex biological treatments like biologic drugs and mRNA continue to show enormous promise in treating and preventing disease. By 2024, therapies reliant on cold chain capabilities are expected to grow 48% globally, outpacing growth for noncold chain therapies by 21 percentage points. This means cold chain capabilities need to grow in parallel with therapeutic innovations to satisfy patient demand.

The cold chain infrastructure landscape, however, is in flux and demand is increasing. Since Emily’s T cells were processed 10 years ago, over 15,000 cancer patients have had their T cells processed in a similar way in labs around the world. In recent years, the focus on speed to market of complex disease fighting therapies that are dependent on cold chains has reshaped the expectations of healthcare supply chains, globally. In Ireland, manufacturing firms are running out of cold-storage facilities to store completed products such as vaccines and other products that require specialist transport conditions. Building more cold-storage facilities would help to future-proof the sector in Ireland against further issues of this type.

Although cold chain logistics in the pharmaceutical industry aren’t a new development, the growing complexity and demand are. As a result, life sciences companies, distributors, and carriers—cold chain participants—are under pressure to scale delivery and storage capabilities, support and monitor variable temperature ranges in real time, and offer services like predictive and dynamic estimated time of arrival tracking. Indeed, UPS Healthcare recently announced plans to open a high-end global healthcare facility in Dublin which will offer specialised cold storage and packaging and connect Ireland’s growing pharma and medical technology industries to a logistics network that services customers globally.

To understand the key challenges life sciences professionals experience in building and managing a cold chain in this new landscape, Accenture recently conducted a survey of 200 industry executives from Europe and North America. These insights shed light on how life sciences companies can work with partners to incorporate a patient-centric cold chain into their overarching supply chain operating model. 

Fragmented infrastructure networks and evolving requirements

While cold chain products are growing steadily, current capabilities and operational insights are insufficient to meet future needs—and patient demands—for consistent visibility, quality assurance, flexibility, and agile execution. Life sciences companies, however, cannot just lift and shift old ways of operating to serve new needs.

Cold chain infrastructure involves physical and logistics capabilities, such as automated, high-density storage warehouses and thermal shippers for ultra-low and cryogenic temperatures to no more than 2-8˚C. The infrastructure is supported by Internet of Things solutions that collect and transmit environmental monitoring data in real time. However, many life sciences companies find such complex demands difficult to navigate. Our research shows that 31% are looking for better equipped internal/external logistics networks, particularly those investing in automation and multi-chamber storage/transportation for different temperature requirements. Quality management, tracking capabilities, and eco-friendly options are also highly sought after.

Elsewhere, approximately 90% of our research respondents say their companies are using multiple disconnected solutions to collect data across the cold chain. As a result, the lack of coherent real -time environmental monitoring makes it difficult to gain visibility into the product while in transit, risking ETA management, security and document compliance, and continuous temperature monitoring across multiple logistics legs. The lack of insight exacerbates functional organisational siloes.

Meanwhile, about 56% of survey respondents are using visibility tools in the cold chain but find them unsatisfactory. There’s little automation, and some still use manual processes to identify actionable business insights from data. This suggests that many respondents had little understanding of their future cold chain requirements when initially building capabilities.

Creating an intelligent patient-centric cold chain

Patients and customers increasingly demand an Amazon-like fulfilment model. To comply, the cold chain infrastructure and delivery network will need to be constructed around the patient experience. Creating a patient-centric operating model doesn’t mean participants will necessarily need to revamp their entire supply chain. Establishing a strategy and roadmap, however, are critical first steps to successfully scale at speed while avoiding ill-considered investments.

Meanwhile, real-time technology promises to make cold chain safer and reduce waste, as well as provide new ways to manage the business. But much of the enabling cold chain technology hasn’t existed until recently and, like infrastructure, is still maturing. How can cold chain participants use digital technologies and the Internet of Things to support enhanced data requirements? Participants can re-define their end-to-end operating model by leveraging more artificial intelligence, machine learning, automation, and virtual reality based digital capabilities such as data insights, predictive alerts, and digital twins.

Lastly, industry changes demand new talent and skills, which form the lifeblood of any organisation. Life sciences companies will need to reconsider how they design their organisations and talent strategies. Achieving “operational readiness” within the cold chain requires new ways of working—not business as usual. To understand recent trends in New Science and manage cold chain implications, life sciences companies need to recruit and train high performing individuals who can think strategically, lead global projects, and develop new talent.

A critical link in the supply chain

As life sciences companies and their partners plan for their future success, an intelligent, patient-centric cold chain will be an essential component to deliver the personalised experiences patient’s desire. It’s as central as innovating new therapies because what good will innovative treatments be if they can’t reach a broad base of patients or are rendered ineffective in their delivery?

Cold chain participants need to be ready to act, whatever their role is in the ecosystem, and they will need to think through the broad implications for their needs now and in the future. Making the system technologically agnostic and flexible enough to accommodate what lies ahead will be a payoff in and of itself. The escalation of pharma cold chains can positively impact millions of patients, their families, and communities. This will not only improve survival rates and quality of life, but also launch a new era of revenue and possibility for the intelligent pharmaceutical industry.