We currently experience change driven by the disruptions brought forth by the pandemic and advancements in drug innovation. These disruptions tend to manifest in waves1 in the pharmaceutical industry, prompting a significant technological shift towards more resilient and digitized supply chains. Consequently, there is a continuous process of reimagining supply chains, anchored in proactive measures and informed by valuable insights.
What is triggering pharma supply chains to be reimagined?
On the one hand, another wave of drug innovation with the rise of personalized medicine, CGT, advanced targeted drugs, overall therapies based on biologics is changing the requirements, stakeholders, and collaboration in building pharma supply chains and manufacturing. As of March 2024, the FDA approved 36 Cell and Gene Therapies with many more coming this year.2 More than 1.200 experimental cell and gene candidates are in the pipeline*. Safeguarding those API, IMPs, and drugs with lower stability requires dedicated cold chain (i.e. frozen, cryogenic packaging and monitoring) and storage capabilities as well as tailored SOPs. Excursion prevention is key. Visibility, speed, and intervention are critical to optimizing clinical and commercial supply chains for those products. This can be achieved by reimagining the way supply chains are built, which also includes technology for greater visibility, such as real-time condition monitoring.
Other key drivers are compliance, cost-effectiveness, and sustainability. Creating resilient supply chains that adhere to the utmost requirements of this triangle are an industry’s daily challenge. Initiatives such as validating alternative modes of transportation and closing the visibility gap with end-to-end monitoring rely on sound data aggregation and intervention. Again, it is important to reimagine the way stakeholders collaborate and respond to disruptions in a more digitized environment.
Whether we are talking about supply chain disruptions or drug innovation, more sophisticated requirements to pharma supply chains rely on more sophisticated condition monitoring of supply chains and drugs in real-time. This influences the way we reimagine monitoring data to use it to re-shape supply chains.
Don’t miss Berlinger’s masterclass on How full condition monitoring is revolutionizing the safeguarding of advanced targeted drugsat LogiPharma 2024 on Tuesday, April 16, 2024.
Get first-hand insights from Linda Schwär and Ana-Zeralda Canals Hamann, Associate Director, Clinical Trials Supply, at Debiopharm, who provide first-hand insights into a pilot case that Berlinger was involved recently in, helping to safeguard Debiopharm’s valuable IMPs/Drugs Debio 0228/0328 on temperature monitoring and beyond. During the presentation, they will elaborate on excursion prevention, management, and analysis.
Get more information on Berlinger at LogiPharma 2024: Pharma Supply Chains Reimagined
Sources:
1 www.pharmavoice.com/trendline/cell-gene-therapies/329/?utm_source=BioPharma&utm_medium=LI0408&utm_campaign=QuestDiagnostics
2 www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products