Featured Editorial
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Donating Surplus Clinical Trial Supplies Drives Pharma Sustainability Success
2/7/2023
Corporate sustainability efforts have been the hot topic since this decade began. However, some clinical operational professionals think that there's no place for sustainability in their role of conducting clinical trials. However, there is one simple way to implement a sustainability initiative within your organization's clinical trial conduct.
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Multiplying Forces Of Clinical Supply Outsourcing
1/30/2023
There are a number of varying and converging forces baring down on sponsors looking for CROs/CDMOs who can provide a full slate of services around their clinical-trial material. Both CDMOs and sponsors need to add or subtract from their strategies to adjust.
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The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
1/19/2023
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
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EU Reg. 536/2014’s Expiry Label Requirement Forces Us Backward, Not Forward
9/14/2022
In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.
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The Process Map To Ensure Biopharma Raw Materials Supply
8/16/2022
In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
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Beware The Manufacturing Bottleneck: Lessons From Inside
6/6/2022
Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.”
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How To Create An Effective Clinical Supply Visual Dashboard
4/5/2022
It is challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Randomization and trial supply management (RTSM) systems do not encapsulate all the necessary data. It is vital to have an internal central inventory system that maintains oversight of the IP inventory from start to finish and to manage resupplies.
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Boosting Pipeline Acceleration With A Strategic Pharma/CDMO Relationship
3/25/2022
Pharma portfolio managers and CDMOs should seek more strategic modes of working together. By coordinating with each other to change all your development and capacity "red lights" to green, and balancing operational efficiency and flexibility, you can accelerate your pipeline. Here's how.
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How To Turn Your Clinical Supply Chain Pandemic Learnings Into New Best Practices
3/10/2022
Pivoting, navigating, and problem solving in real time during the pandemic has led to many real-time lessons that have evolved into adapted best practices in the global clinical supply space. This article discusses the new demand curve, packaging operations, IRT considerations, and more.
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What’s A “Hybrid Externalized” Manufacturing Model?
3/10/2022
Anthos Therapeutics’ phase 2 antibody candidate abelacimab could dramatically improve the way clinicians treat very common, high-risk arterial and venous thromboembolic events. The company is exercising manufacturing creativity to maintain clinical supply. Anthos CEO John Glasspool shares on the Anthos approach to outsourcing.