Risk and Business Continuity Management
Development of a standardized/harmonized approach to risk and business continuity management between biomanufacturers and suppliers so they can develop and apply best practices to make the supply chain more robust and resilient and increase the surety of supply for all raw materials – underpinning manufacturing performance and availability of biotherapeutics for patients.
Lack of consistent approach and transparency between end users and suppliers
The BioPharma Industry needs to demonstrate that it is always able, to manage risks and sustain business continuity in the threat of risks being realized. There is currently a lack of consistency (harmonization) in the approach and expectation of requirements between End Users and Suppliers and a lack of comprehensive understanding of risk throughout the supply chain. The Industry currently prioritizes risk to reaction to disruptive events rather than a more proactive approach and implementation of effective business continuity management is not consistent in the industry. Not being able to manage risks and sustain business continuity can result in disruption in the manufacturing and supply of vaccines and biotherapeutics and pose a serious threat to patient well-being/lives. Additionally, the misalignment of economic and geopolitical factors are driving supply chain decisions that can increase risk. Current approaches can lead to a false sense of security.
Surety of supply
The goal of the Workstream is better transparency and communication between all tiers within the industry – biomanufacturers, suppliers, CMOs, etc resulting in improved surety of supply for customers, suppliers and ultimately, the patient. Streamlined approach between end user and supplier “freeing up” resources, resulting in less time managing customized requests improving efficiency and an increased awareness of the importance of BCM as a critical business function.
Risk and Business Continuity Management deliverables
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