This article, published in PMPS, written by Phorum Directors Robert Brooks, Nicola Coles, and Lesley Holt outlines some of the main challenges currently faced by the biopharmaceutical industry and how they can be overcome.
The COVID-19 pandemic had unforeseen repercussions on the biopharmaceutical industry. Companies, fearing shortages, stockpiled finished goods and raw materials during the pandemic causing a ripple effect throughout the supply chain. Global drug shortages persist prompting regulators to consider implementing minimal stock levels in countries. The economic uncertainty has made companies cautious leading to downscaling operations as they navigate pandemic-related delays in product development and clinical trials.
Existing patients relying on biotherapeutics faced challenges as resources were diverted to vaccine development leading to disruptions in clinical trials and unavailability of materials for ongoing treatments. The industry now grapples with staffing issues requiring a substantial lead time for recruitment and training. Technical challenges include an over-reliance on specific suppliers and insufficient capacity for sterilization alternatives.
To address these issues the industry advocates a holistic approach to the inbound supply chain emphasizing intelligence, safety, adaptability, digitization, transparency and sustainability. Collaboration between regulators and industry players is crucial to finding solutions that cater to the needs of patients globally. Improving demand signaling, enhancing data transparency, and extending visibility into wholesalers’ stock are identified as essential steps.
The article highlights significant global threats to raw materials such as per- and polyfluoroalkyl substances (PFAS) prompting the industry to seek derogation periods for transitioning to alternatives. The industry must also prepare for future pandemics by resolving foundational issues fostering sustainability and reducing emissions across the value chain. Considerations for sustainable transportation methods including order consolidation and modal shifts are emphasized.
Ultimately the industry acknowledges the need for a network approach with collaborations both internally and externally to address the challenges and implement lasting solutions. This comprehensive strategy involves multidisciplinary efforts to optimize packaging, digitize documents, increase recycled content, and develop reusable packaging ultimately working towards a more sustainable and resilient bio-pharma industry.