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Short & Long-term Challenges for Pharma Supply Chain

Oliver Stauffer
Aaron Weinstein
Short & Long-term Challenges for Pharma Supply Chain

What are the Short & Long-term Challenges that Pharma Supply Chain, Operations, and Packaging Need to Address?

In a year where speed has become a critical component of the pharmaceutical industry’s mission, the SCOPE track at the 2020 ISPE Annual Meeting & Expo, 2 – 6 November, aims to deliver in-depth discussions on meeting patient needs. SCOPE stands for Supply Chain, Operations and Packaging Excellence. Never have the topics related to SCOPE become so relevant and urgent as today. Every aspect of the pharmaceutical supply chain is driving towards developing and delivering the most effective vaccine against COVID-19, while also continuing to support all other patient needs.

The challenges are numerous. Pharmaceutical ingredients are sourced from a global network that has been challenged by lockdowns. Clinical trials have been stalled due to patient access. Standard activities need to continue amidst shifting resources. Personnel have had to react to the demands of on-site / offsite work during a pandemic. Vaccine development is targeting the fastest development cycle ever known with safety and performance of the vaccine in the global spotlight. This is the industry’s opportunity to establish itself as the cornerstone to a vibrant global community. Many aspects of these challenges fall within the SCOPE discussion.

This year’s SCOPE track has a strong focus further improving the industry’s ability to develop, scale-up and distribute critical medicines. It is difficult to address SCOPE without thoroughly understanding how the pandemic has reshaped the industry in just a few months and increased the criticality of supply chains. The SCOPE track will highlight some important topics such as cell and gene therapy, rapid site development and vaccine distribution.

Packaging topics will cover container performance and alternative delivery solutions. Container performance for cell and gene therapy has unique requirements. The requirements of small batch cell and gene therapy needs an alternative look at assuring container closure integrity for patients receiving critical parenteral treatments. Two presentations will cover blow-fill-seal (BFS) container formats as a solution for rapid and effective deployment of vaccines on the global scale. There is currently no supply chain limitation of BFS materials as the global volume of injections is in a rapid upswing and availability of borosilicate glass is a potential limiting factor. BFS formats are considered one of the most cost-effective solutions to administer vaccines.

Drug shortages will come into the spotlight with support of ISPE’s drug shortages team and the FDA. The session will take an in-depth discussion on how manufacturers and health authorities can better partner in identifying critical drug shortages well in advance. The pandemic has created an immediate shift in the industry, while the historically common drug shortages continue to present challenges for the healthcare industry. A virtual roundtable discussion with the FDA and industry leaders will evaluate valuable changes aimed at improving this long-standing issue during a critical time.

In this race to heal an ailing society, supply chains are becoming more creative and dynamic to deliver possible solutions. Manufacturing space is being snapped up and built-out for what may be yet to come. Manufacturers are contracting out their own production capacity for more needed treatments. The defense Production Act has been invoked to compel supply chains to align critical resources towards a unified mission. In these unprecedented times the industry has never been held to such a high call to action.

Facilities and labs are vital in the success of expanding drug delivery to the market. A presentation on rapid facility design will reveal opportunities for rapid expansion. In the immediate search for a cure, lab space and development resources are at a premium. Rapidly responding to the need for more laboratory resources will allow the current trajectory of pharmaceutical research to continue while a surge of energy is poured into pandemic related work. A discussion around outsourcing pharmaceuticals will weigh the costs and benefits of using third-party manufacturers to achieve short-term growth. Manufacturers that are vying for production capacity and laboratory space will be presented with a variety of strategies and concepts to support their efforts.

Cell and gene therapies are a rapidly growing section of the industry that are also evolving with the technology used to coordinate, manufacture and distribute these medicines. With CAR-T (Chimeric Antigen Receptor, T-Cell) therapies, the supply chain is not only critical, but circular. The very same cells isolated from a single patient must be used as the therapy for that same patient. The importance of Cell and Gene therapy brings a host of unique supply chain requirements and deep discussions that will build on in the collaborative sessions.

It is difficult to address SCOPE without thoroughly understanding how the pandemic has reshaped the industry and the criticality of supply chains. The pharmaceutical industry is involved in a high stakes challenge in which effectively navigating the current environment and properly deploying resources can have a drastic impact on society. Please join our strong lineup of industry experts for presentations and, more importantly, discussions on how we might address the near-term and long-term needs to strive for a healthy global community at the 2020 ISPE Annual Meeting & Expo on 2 – 6 November.

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