Advanced Therapy Medicinal Products (ATMPs) covers a rapidly growing area of research, development and manufacturing. ATMPs include cell therapy, gene therapy and tissue engineering. The supply chains for these therapies can be intricate and specifically challenging. At the conference, the Supply Chain Optimization sessions will include presentations and discussions on ATMP supply chain challenges. There will be case studies and best practice discussions around clinical activities versus GMP activities, chain of identity versus lot genealogy and how to ensure that theses therapies are supplied to the patients that urgently need them.
Blockchain is the use of individual, encrypted “blocks” of information to create a secure system of digitally identifying and tracking information. In this way, records can be widely transmitted, but not destroyed. Blockchain was first introduced as a concept in 1991, but was not used routinely for transactions (in this case cryptocurrency) until 2009. Since then, industries, including biopharmaceuticals, have been working to implement blockchain as a way of tracking drug substance, excipients, critical materials and drug product. In the Supply Chain Optimization sessions, we will hear some experiences and identify trends of using blockchain within the pharmaceutical supply chain. There will be an update on the evolution of PharmaLedger, a discussion about relying on blockchain technology within a GxP environment, and some lessons learned from blockchain initiatives. Staying within distributed ledger technology, another session will present and discuss the application of blockchain to ATMPs. One of the important questions to be tackled by this session is how to use this flexible technology within a highly regulated environment.
One of the most topical sessions in our Supply Chain Optimization will be Drug Shortages: Progress in a Challenging Year. This year, drugs and the materials needed to make them, have been in short supply. With manufacturers being given long wait times for items such as single-use materials and even valves, keeping the supply of medicines flowing has rarely been more challenging. The ISPE Drug Shortages Initiative was established with the goal of helping to navigate these issues and they have modernized their drug shortages prevention plan while providing more detail on using risk management to increase drug availability. Members of ISPE Drug Shortages Initiative team will present on how the plan was updated to address some of the recent challenges while providing guidance on risk management for this complex subject.
As part of the new effort to enhance the biopharmaceuticals supply chain and increase speed to market, the US government challenged vaccine manufacturers to work smarter in all aspects of development and manufacturing. The Good Practice Guide: Good Engineering Practice 2nd Edition was released in October 2021 with the intent of aligning the guide with the 2nd Edition of the ISPE Baseline® Guide: Commissioning and Qualification. The hope of this alignment is that projects can be implemented faster and keep pace with the requirement that industry and the government work smarter to bring medicines to market. The session GPG Good Engineering Practices at Operation Warp Speed, will provide background on this update while presenting the case study of a BARDA funded Operation Warp Speed BSL-2 Aseptic / Isolated Formulation and Filling Facility that had a project duration of 11 months from concept to aseptic process simulation readiness.
In our second year back live (and in Orlando!), I look forward to hosting the Supply Chain Optimization session at ISPE Annual Meeting & Expo. I hope you can travel to sunny Florida and participate in our sessions to learn more about the supply chain challenges related to ATMPs and drug shortages, how the industry is utilizing blockchain to better understand and perhaps address these challenges and how ISPE members are using their knowledge and ISPE guidance to help plan and implement innovative initiatives and approaches to projects. With these educational sessions, perhaps you will be inspired to tackle one or more of your supply chain issues and streamline the effort to quickly get your important and life-changing therapies to the patients that need them.
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