As Arena International’s Clinical Trial Supply Nordics conference gets underway this week in Copenhagen, Denmark, Clinical Trials Arena will spotlight issues surrounding the supply chain. Only months after our last focus on clinical trial supply, due to popular demand, CTA will once more draw attention to most pressing concerns facing supply professionals.
Be sure to visit CTA tomorrow when Cristina Chang of OBI Pharma explores how the right comparator sourcing strategy can effectively mitigate a trial sponsor’s risk. On Wednesday, CTA Editor Henry Kerali speaks to Henk Dieteren from Grünenthal about the keys to monitoring temperature-sensitive shipments.
Later in the week, Tim Holmes of Biogen stresses the need for greater levels of communication among stakeholders. There’s also a feature from Bayer AG’s Kathrin Machens who outlines key drivers for improvement and innovation in the clinical supply chain. So as ever, a wide range of issues will be given the spotlight this week on CTA, so don’t miss out!
But first, catch up on some of the most recent stories that you might have missed… (click on the headline to finish reading).
The rapid technological advancements in the clinical supply chain today are undeniably solving complex logistical problems, while inadvertently creating new ones. This leads to the increasing need for regulations to address how to properly implement new technologies. There are multiple challenges, such as inventory and warehouse management, that need to be addressed in order to avoid the worst outcomes. That can include shortage, expiration, product loss, and temperature deviations in the final delivery.
When biopharmaceutical companies plan clinical trials, they often underestimate the challenges of securing adequate supplies of the product being tested. While clinical research professionals put much thought into protocol design, site selection and patient recruitment, the development, manufacture and supply of the physical product itself is typically the responsibility of a CMC (Chemistry, Manufacturing and Control) development team that works in parallel to the clinical team under a totally different regulatory regime (GMP vs GCP). Because clinical professionals (and investors) don’t have a full appreciation of the requirements of GMP, trial start dates and milestones are often missed because availability of the drug candidate has not been fully considered.
Biopharmaceutical start-up companies are challenged with raising capital and time to build their own manufacturing supply chain facilities to launch their products. There is a lot of time and expense required to recruit resources in quality control (QC), process development, manufacturing (MFG), supply chain, maintenance, engineering, and general support staff.
The MFG supply chain workstreams required can be overwhelming, so there is a tendency to move toward contract MFG organization (CMO), contract research organization (CRO), and contract testing laboratory (CTL) models.