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Clarkston Featured in Pharmaceutical Technology’s September Regulatory Sourcebook

Clarkston Consulting was recently featured in the Pharmaceutical Technology’s Regulatory Sourcebook issue for September 2021, which is an eBook series by Swati Patel, director of Clarkston Consulting shared perspectives on supply chain disruptions, predictions for drug shortages, and suggested actions to alleviate threats to the drug supply. To read the expert opinions from Patel, read the excerpts of quotes below, or view the full ebook here.

September 30, 2021 | Durham, NC

Pharmaceutical Technology & Drug Safety: Changing the Course of Drug Shortages

“COVID-19 has caused drug shortages in all areas within the supply chain. The rush to develop and manufacture vaccines has resulted in major raw material shortages in the industry for other drugs. Drug manufacturers are struggling to keep production running, while suppliers are maxed and unable to keep up with demand. This has occurred because vaccine manufacturers were prioritized to receive any materials needed to manufacture doses. As a result, other drug manufacturers either didn’t receive what they ordered on time, or no supply was available when they did place an order. In addition, consumers are stocking up on supply [the finished drug product], further depleting supplies [both the finished drug product and the raw materials used to make them].”

“With COVID-19 impacting 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 consumers 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 production, eliminate risks, and minimize reliance on foreign manufacturers.”

Read the Full Pharmaceutical Technology eBook Here

“The industry needs to focus on collaboration, communication, and digitization to address drug shortages. Manufacturers must closely monitor potential disruptions in the supply chain and proactively communicate when shortages 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 manufacturing early on. Other necessary routes that companies 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.”

“Pharma/biotech companies 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 companies to proactively address it to minimize or avoid any shortages.”

“For many businesses, there will be a need to radically reconceptualize their entire supply planning model to be more resilient in the future. In the past, the focus of their supply chain operations has been agility and flexibility. But what we’re seeing now is a pivot to focus on resiliency in the face of global disruption. By diversifying manufacturing operations and embracing technological innovations, companies in the industry will be better suited to handle drug shortages in the future.”

Read the Full Pharmaceutical Technology eBook Here

“Operational challenges or mistakes, geopolitical instability, pandemics and epidemics, natural disasters and climate change, cybersecurity breaches, and dependency on a globalized and distributed supply model are some of the biggest supply chain vulnerabilities facing the life sciences industry today. Many businesses are investing in digital supply chains as a means for modeling supply operations in the face of adverse events. Coupled with analytics-backed decision-making, digital supply chains allow businesses to plan accordingly in order to improve resiliency and quickly adjust in the face of these vulnerabilities. A strong supply network is critical for the industry.”

“In general, the industry will rely on FDA more heavily to open up channels for collaboration and communication both between the regulatory authorities and manufacturers and also amongst manufacturers together. With increased focus from stakeholders in the value chain, including patients and consumers, we will likely see sustainability rising as a focus for supply chains moving forward. Also, as the past 18 months have shown, more and more businesses will begin to focus on digitalization through data analytics, advanced technological manufacturing, etc.”

“The rush to develop and manufacture vaccines has resulted in major raw material shortages in the industry for other drugs.”

Read the Full Pharmaceutical Technology eBook Here