Weaving the digital thread for life sciences

For several years, the life sciences industry has been experiencing and continues to experience massive disruption and increased pressure. The disruption started before the pandemic began, but was amplified at the onset of COVID-19, which uncovered core challenges and put a spotlight on the need for more virtual and digital solutions to support the entire ecosystem.

Today, there is increased pressure on life sciences companies to improve processes—especially end-to-end through the value chain, from R&D to manufacturing to supply chain. The ratio of R&D spend per each new treatment approved has increased at 5% per new molecule and 7% per approval annually over the last ten years. At the same time, products are becoming increasingly complex—for example, biologics versus ADCs versus cell and gene therapy (CGT)—while the main goal of getting products to patients faster and safer, in more personalized ways, with a high standard of patient experience, remains. All of this has created tremendous challenges for life sciences companies that require complex digital solutions.

Our work has shown that the best way to tackle the multiple and ongoing challenges within life sciences is through greater connectivity and increased data visibility across the ecosystem, which we call the “digital thread.” The digital thread delivers quick access to broader sets of data with better tools for discovery and application of research, supply chain modelling and a host of other complex challenges throughout the value chain.

A digital thread for life sciences

Outside of life sciences, in our daily lives, we interact with digital tools and processes constantly, almost without noticing or thinking about it. As we do this more and more, we’ve come to expect the same experiences in all aspects of our lives, yet life sciences has been slow to adopt and deeply integrate digital functions across the ecosystem. This is in part due to several old, misinformed orthodoxies that have remained in LS, such as the idea that we can’t change the way we discover medicine or deviate from in-person clinical trials.

• Orthodoxy 1
  We can’t change the way we discover medicine.
• Orthodoxy 2
  We can’t deviate from in-person clinical trials, at premier sites.
• Orthodoxy 3
  We can’t rapidly scale manufacturing for new modalities.

The Digital Thread for Life Sciences (DTLS) helps flips some of the old orthodoxy thinking on its head. It accelerates the scale up of complex treatments from clinical trials through commercial launch and production, using SAP as its core platform. The potential for it to drive innovation and improve patient outcomes is immense, as it enables companies to better understand product efficacy and quality. As well, looking beyond traditional boundary data provides a key convergence point for the entire healthcare ecosystem—and in doing so, enables both the life sciences and healthcare industries to tackle broader socio-economic challenges such as health equity.

Unlocking the value of a digital thread

Our work has shown that the best starting point for the digital thread is technology transfer, which is a crucial part of the product journey. As a product transitions from R&D to manufacturing, the digital thread helps improve the process through knowledge management and meaningful access to data, allowing for key insights to be put into action. DTLS has the potential to transform the industry by managing the associated data sets in a holistic and digital context, from early process development to accelerated filing and approval of the CMC dossier, to optimization of the manufacturing process and seamless tech transfer of manufacturing process between teams.

By building upon established tools, the digital thread can create better collaboration for faster decision-making and lower risk of non-compliance or under-performance in supply. Additionally, it has the potential to:

1. Free-up resources
2. Rapidly scale manufacturing to support new clinical and commercial launches
3. Create end-to-end visibility by integrating operational manufacturing information from disparate systems
4. Gain faster, deeper insights through analytics
5. Ensure security, compliance and resiliency
6. Help organize for speed and agility
7. Bridge skills and experience gaps
8. Seamlessly bring data together across data lakes and source systems to enable additional processing or transfer of information

As health and life sciences industries continue to experience pressure, both from within the business and from external forces, companies are seeking solutions that will not only deliver improved patient outcomes, but also help alleviate some of the resource compression that is affecting the ecosystem. By taking meaningful steps toward building a digital thread, companies can better manage disruption and accelerate processes throughout the value chain to deliver on the promise of digital, driving innovation and creating the highest standard of patient care possible.