Innovative Approaches to Supply Chain Quality

On February 23, 2017, I attended a Supply Chain event at the North Carolina Biotechnology Center. The speakers at the event focused on new approaches and advances to supply chains in the biotechnology sector. It was a very good learning experience for myself and the others who attended to conferen

The first speaker of the day was Mark Paxton, CEO of Rx360. Rx360 is a nonprofit industry consortium which was founded in 2009. The company supports large and small pharmaceutical and biotech companies. The goal is to spread best practices of the regulated supply chains these companies have to operate in. Patient safety is the ultimate goal and what they must commit to throughout their whole supply chains including their suppliers. Counterfeit products are a major issue for the biotech and pharma industry. The companies have a responsibility to provide their patients with safe and effective products. A good regulatory authority is necessary in this industry and the companies must follow and adapt better practices. The supplier approval process can become burdensome with the high number of audits and visits before gaining approval. Rx360 helps the suppliers and the biotech companies that will use the same suppliers by standardizing the process of supplier approval. Improving the supply chains in a safe manner is the way Rx360 runs its business.

The next speaker was Dave Lescinski who is the Vice President of Avantor Life Sciences. He has worked in the industry for over 30 years and in his current role he oversees a contract manufacturing organization or CMO. CMOs have grown over the last 10-15 years as big pharma and biotech companies look to outsource some of their manufacturing. He touched on the importance of the suppliers and all that go into producing a biotech product. Even simple inputs need to be tested and made sure they are quality. The quality standards must be met to show the companies they are keeping the standards of the drug production for later use.

Another speaker was Charlotte Hicks who is the founder of Supply Chain Risk Mitigation. She walked us through how to create and monitor a “Zero Budget Supply Chain Map.” Without buying any subscriptions or using any money we learned how to manage our supply chain and risk mitigation strategies. The first tip was mapping your current suppliers through google maps. This way you can get a visual of all your suppliers and where they are located. Then if a natural disaster occurs in the area of your supplier you can be ready to react. The main benefits to monitor your supply chain risks is to reduce costs or lower costs of any potential disruptions upstream or downstream in your supply chain.

The final speaker was Augustine Ullmann, Territory Director from PharmocoAAPER. His work is in relation to upcoming USP mandates to Active Pharmaceutical Ingredients (API) for biotech and pharma manufacturing. These mandates are already in place for the European Medicines Agency and will be coming to the U.S. Food and Drug Administration in 2018. It will require manufacturers to test for a greater range of heavy metals in API. These mandates are coming and pharmaceutical and biotechnology companies need to be prepared and begin implementing new process to ensure their products meet the mandated standards of heavy metals limitations.