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This is Not Your Father’s “Supply Chain”

Rodney R. Neal
Oliver Stauffer
This is Not Your Father’s “Supply Chain” - ISPE Pharmaceutical Engineering

In 1988, the Oldsmobile automobile company attempted to rebrand themselves to appeal to a new generation of car buyers by introducing a marketing campaign that distanced itself from everything that it had stood for up to that point. The tagline line was “This is not your father’s Oldsmobile . . . This is the new generation of Olds.” The campaign became a Marketing 101 case study for how not to reinvent a brand and within 16 years the last Oldsmobile rolled off the assembly line and the 106-year-old brand lost to posterity. In hindsight this was not so much about a marketing failure as it was the underlying global shift in the auto industry.

The pressures and challenges of a modern pharmaceutical supply chain are not unlike those that faced the auto industry in the 1980s; e.g. shifting demand, aging work force, automation, globalization, technological innovation, etc. Pharmaceutical market dynamics include a desire to use low cost manufacturing clusters, logistics complexity, demand shift to emerging markets and remote collaboration by brand owners with CMOs and CDMO / CROs. These factors are causing the pharmaceutical industry to evaluate and implement new supply chain strategies, technologies, and practices. Programming of the 2019 ISPE Annual Meeting & Expo Supply Chain, Operations, and Packaging Track takes aim at these contemporary challenges.

Three sessions on Monday, 28 October will take a deep focus into empowering supply chain management through a common theme of leveraging big data through digitization.

  • Process management and container closure system performance can be driven by leveraging data gathered from supply chain information systems. Building an IT framework to gather the critical attributes of container performance and feeding performance data back into the manufacturing process in real time provides a high level of control to the pharmaceutical process. The track’s inclusion of container closure performance is a renewed view that the container is a cornerstone topic in a healthy supply chain.
  • End-to-end supply chain digitization provides competitive advantages via seamless integration of line operations, enterprise systems, quality, and regulatory compliance. A key value of the session is the identification of the impact of breakthrough technologies, including cloud, automation, big data, machine learning (ML), the Industrial Internet of Things (IIoT), and predictive analytics.
  • The novel therapies that have been delivered through the “CAR-T-cell” subsegment revolve around a unique supply chain. The focus will be on the interesting challenges presented by the CAR-T manufacturing process and how those are addressed during tech transfer, the C&Q phase, the Aseptic Process Simulation, methods validation, process validation and ongoing qualification. Real-world case studies from recent projects and will lead to a better understanding of the challenges.

Tuesday’s sessions in the Supply Chain, Operations, and Packaging Track address both traditional and non-traditional supply chain topics but support the premise that effective supply chains require a “holistic” business and regulatory view.

  • Supply chains start with intentional facility design. Traditional facility design activities informed by a process which focuses on improvement opportunities via integration of operational personnel results in a more effective supply chain. The session includes a live case analysis on efficient facility design, project management, all the way through to qualifying the facility for operation.
  • Container closure takes a front-row seat given a geographically diverse supply chain. A panel of specialists will discuss strategies for container closure integrity including a regulatory view. The session will draw on active experiences from regulatory compliance as well as the practical implementation of CCI test methodology. The session will offer the perspectives from industry experts related to technology, data integrity, validation strategies and global technology roll-out

The Supply Chain, Operations, and Packaging Track concludes on Wednesday with a session that examines the supply chain, design, and safety implications of single-use technology (SUT). Single-use technology supports the emerging trends of speed-to-market and Quality by Design (QbD). The session examines the nuances to single-use technology process design including sterility, cleaning validation and reduction in product changeover times. The session includes the interaction between container closure systems (CCS), manufacturing components, drug delivery devices, and final pharmaceutical product, all of which are increasingly under regulatory scrutiny in respect to new drug approval.

The Supply Chain, Operations, & Packaging track is designed to expose and equip a new generation of supply chain professionals with tools to effectively transform the industry to meet the challenges of today.


Get ready to Modernize. Globalize. Transform.

With 6 extensive education tracks, 85+ hours of targeted technical sessions, 24+ hours of networking opportunities, 200+ exhibitors, Discovery Stage in Expo Hall, 2 days of in-depth classroom training & more, the 2019 ISPE Annual Meeting & Expo is an event you don’t want to miss! Take advantage of the registration discount that is available through 17 September and register today.

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