Issue link: https://www.e-digitaleditions.com/i/1411460
20 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m there will always be shortages when demand increases or a manufacturer stops producing for any reason. Therefore, we need a system that carries enough in- ventory to buffer a supply disruption. Where changes need to be made PharmTech: What part of the supply chain may need to make the biggest pivot to address drug shortages (if any)? VanTrieste (Civica RX): In the generic drug market, a race to the bottom in pricing leads to razor-thin mar- gins, especially for older products. Purchasing has become consolidated among a few very large players. The public benefits from the low prices, but not from the resulting instability of supply. And this price pres- sure has helped to drive the production of drugs out of the United States and other developed economies to countries such as India and China, which have lower labor and other costs but have also been responsible for well-documented quality problems. Right now, when a drug is FDA-approved, purchasers have no way to know where the drug ingredients are manu- factured or how reliable a company's quality systems are. To prevent drug shortages, the industry needs sustainable prices and stable purchase agreements. Purchasers should have the information they need to distinguish between manufacturers with good quality maturity and those with less commitment to quality. Patel (Clarkston Consulting): For many businesses, there will be a need to radically reconceptualize their entire supply planning model to be more resilient in the fu- ture. In the past, the focus of their supply chain opera- tions 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. Supply chain vulnerabilities PharmTech: In your opinion, what are the biggest supply chain vulnerabilities? What can be done to address these vulnerabilities? Patel (Clarkston Consulting): Operational challenges or mistakes, geopolitical instability, pandem- ics 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 busi- nesses 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 busi- nesses 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. McDonald (Proactive Worldwide): In my opinion, it [the biggest supply chain vulnerability] is redundancy of supply. We have seen issues in the past due to non- "As the world economies open back up, the shortages have improved but dependence on foreign country production of materials demonstrates the need for redundancy and local supply." - Paul McDonald, Proactive Worldwide Drug Safety