By Carla Reed, president, New Creed LLC
5 Proven Steps To Successfully Select & Onboard Outsourced Logistics Partners
In preceding articles in this series, we reviewed some of the challenges and remediation approaches for the storage and distribution of life science products, highlighting some of the specific risks related to storage, transportation, and material control across an extended chain of custody. This brings us to the final article, in which we will discuss best practices for selecting the partners that will be an extension of your staff for monitoring and control across an ever-changing global landscape.
From R&D To Commercial Product — Transitioning Your Supply Chain
Life science R&D is a complex and arduous process, spanning many years from the identification of a promising molecule to the completion of clinical trials to the nirvana of commercialization. During the course of this process, there are often many players involved, each of whom may have their own preferred network of supply chain partners.
Once commercialization has been achieved, however, it is up to the marketing authorization holder to review the requirements for the storage and distribution of inbound materials into manufacturing operations — as well as the storage and distribution of the finished product to patients — no matter how convoluted the drug’s supply chain has become.
The supply chain for a commercial product will often be very different than it was during R&D, with specific locations for manufacturing, packaging, and distribution. In most cases, regional distribution centers are needed to meet the needs of specific markets, as are capabilities to distribute product across international geographic boundaries. Each distribution model will have different levels of complexity, with related rules and regulations, beyond the basic requirements of good distribution practices (GDPs).
Frequently, the level of expertise within the marketing authorization holder’s ecosystem will be inadequate for this degree of complexity, and it will be necessary to engage the services of subject matter experts in the areas of global trade compliance. Supply chain planning should ideally take place concurrent with preparations for ramp-up to commercialization.