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A commercial biopharmaceutical company was preparing for their second product launch and looking to prioritize the supply chain and manufacturing mandates and provisions of the CARES Act. Supply chain leadership saw the new risk management requirements as an opportunity to improve their capabilities and build the required supplier redundancy plans. At that time, the company did not have an official clinical or commercial supply chain and manufacturing risk mitigation strategy aligned to their diverse set of global suppliers of raw materials, drug substance, drug product, and packaging and labeling. The Head of Supply Chain called for conducting a formal risk assessment for their clinical supply chain, commercial supply chain, and manufacturing suppliers, as well as creating a mitigation plan. This would ensure that the company could respond quickly if a future shortage impacted their supply chain, while also complying with the CARES Act requirements.
Today, our client has a comprehensive plan that identifies and evaluates supply risks for each supplier’s location. It also includes options for mitigating a potential shortage or other interruption, as well as an individual redundancy plan for each supplier.
They also have both a process and methodology for conducting future risk assessments, along with a robust risk management plan for their entire supply network. They meet the CARES Act requirements and should pass a supply chain risk audit easily, if required.
This effort also helped the client’s Supply Chain team determine how to manage their supply risks on a day-to-day basis. They are now considering the development of a full Supplier Relationship Management process that includes incorporating and documenting governance for the entire plan.
All internal employees were focused on upcoming launch efforts, so the company engaged an external partner. This also ensured objective evaluation of cGMP clinical and commercial supplier risk because the partner would not have a prior working relationship with each supplier.
Converge Consulting was working with this client already on a variety of critical supply chain initiatives (sales & operations planning, long range manufacturing & capacity planning), so we were familiar with their manufacturing supply lines and suppliers in general. This allowed for speedy and smooth project onboarding and ramp up.
We conducted a formal Clinical and Commercial Manufacturing Supplier Risk Assessment, evaluating each supplier using a methodology based on weighted scoring dimensions within defined supplier and quality risk categories.
Then, a Clinical and Commercial Manufacturing Supplier Risk Management Plan was developed that included a phased approach to mitigating each supplier’s identified risk. The plan aligned with both the company’s Quality Risk Management Policy and CARES Act Sec. 3112: Additional manufacturer reporting requirements in response to drug shortages.
