The risks within the pharmaceutical supply chain are many and varied. However, the risk level of a given supply chain can be assessed, and risk reduction and strategic readiness plans can be created. While it is impossible to mention all the possible supply chain risks within one article, the following two scenarios are very common.
A small pharmaceutical company in the middle of late-stage clinical trials ran into a huge problem when it was uncertain whether or not their contract development and manufacturing organization (CDMO) could meet their resupply timelines due to capacity restrictions. The substantial market approval delay, which could result from a clinical trial delay, would threaten their funding and jeopardize patient access to this new medication.
A mid-sized pharmaceutical company decided to source their Active Pharmaceutical Ingredients (API) from a promising, but reasonably untested, supplier. Both the sourcing within an under-regulated market and the newness of the relationship posed substantial risk.
Both of these scenarios represent substantial risk but the risk can be mitigated utilizing Alcami’s new Protect Your Brand™ service. How does Protect Your Brand work?
Assessing Supply Chain Risk and Readiness
First, we use our proprietary State of Alcami Readiness™ scoring system to assess and assign a risk level to the supply chain in question. When implementing the scoring system, we review utilized test methods, product specifications, process, facility fit, batch readiness, regulatory approaches, raw materials supply, and stability data. Taking all of these factors into account, we provide a baseline and then project, based on all of these factors, how quickly Alcami can be ready without doing anything. In short, how long would it take us to be ready to reproduce any given part of the client’s supply chain? We then weigh risk factors which relate to the client’s organization, the product’s stage within its lifecycle, and anticipated product need.
A level (Level 1, 2, 3 or 4) based on the Alcami Readiness score is assigned reflecting both the risks associated with the product and the readiness desired. For instance, a Level 4 product is one with a low readiness demand – a product that we can allow 12 months to be production ready. On the other hand, a Level 1 product is one that must be production ready within three months. It is easy to see how a Level 4 product would require minimal investment to assure readiness given the 12-month window of time. For example, we complete the tech transfer and process validation, so that Alcami is a readily available source if the need arises. On the other hand, a Level 1 product might require production and storage of material and other measures that would facilitate rapid production mobility.
Thorough Assessments Facilitate Strategic Decisions
With this thorough assessment and the options before them, the client is now well positioned to make an informed and strategic decision based on the unique characteristics of their product, business needs, and product lifecycle stage.
Circling back to the scenarios presented at the beginning of this post, the client needs that were outlined in Scenario #1 resulted in a Level 1 Alcami Readiness score. This finished drug was a complex product and any meaningful disruption in supply could have resulted in delayed market approval and potential jeopardy of the company’s venture capital funding. On the other hand, although the company described in Scenario #2 definitely needed a backup plan, we collaboratively settled on a Level 3 Alcami Readiness score as the Alcami team was comfortable that we could be manufacturing this API within nine months if needed.
Protect Your Brand service which does exactly that, all the while our clients do not pay for unneeded services or pay for services before the services are needed.
Learn more by reading about Identifying and Reducing Risks within the Pharmaceutical Supply Chain and downloading our on-demand webinar: The Future State of Supply Chain Solutions.