Issue link: https://www.e-digitaleditions.com/i/1411460
Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 19 well through Emergency Use Authorization to help seed these vaccines to conditional approval. It typi- cally takes three to four years (or more) to go through enough clinical trials with a sufficient number of pa- tients to get a vaccine approved. Changes to the supply chain PharmTech: What have been some of the biggest changes to the supply chain from the COVID-19 pandemic? Patel (Clarkston Consulting): With COVID-19 impact- ing both supply and demand, drug supply was hit from both ends of the spectrum. With labor shortages and disruption in the supply chain to fearful consum- ers stocking up on medications and other products, the industry was faced with a tough situation. The biggest change, however, is that companies are now faced with increasing pressure to domesticate produc- tion, eliminate risks, and minimize reliance on foreign manufacturers. Areas of improvement PharmTech: In what ways can the industry still improve to address drug shortages? Patel (Clarkston Consulting): The industry needs to focus on collaboration, communication, and digiti- zation to address drug shortages. Manufacturers must closely monitor potential disruptions in the supply chain and proactively communicate when short- ages might occur. Companies need to invest in new manufacturing models to support new drugs being developed, such as mRNA. By continuing to invest in this area, companies can address drug quality and potential shortages in the supply chain and manufac- turing early on. Other necessary routes that compa- nies should take include shifting drug production to areas of minimal disruption, having alternate sources of suppliers, improving data sharing, and lengthening expiration dates, where applicable. VanTrieste (Civica RX): We need to think in terms of a resilient 'peacetime' supply chain that does not fail us under ordinary circumstances. (We do not have that now.) We also need a supply chain that is resilient in the face of a shock, such as a surge in de- mand due to a global public health emergency, like a pandemic, or other potential disruptions, including natural disasters and trade disputes. In either case, we must have inventory management practices that provide a buffer when demand exceeds supply. We also need to address drug quality so that supply in- terruptions become less likely. Preparing for an increase in demand PharmTech: In what ways can bio/pharmaceutical com- panies anticipate or prepare for increases in demand for medications? Patel (Clarkston Consulting): Pharma/biotech compa- nies need to invest in digital and analytical capabilities to improve decision making and enhance predictive capabilities. Having access to more meaningful data can help anticipate potential shortages and allow com- panies to proactively address it to minimize or avoid any shortages. VanTrieste (Civica RX): Even under the best of circum- stances, it takes time for a facility to ramp up produc- tion. If the system operates on just-in-time inventory, "It is important to emphasize that drug shortages have been a chronic problem for more than a decade." —Martin VanTrieste, Civica RX