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June 18, 2018updated 13 Jul 2022 9:14am

Announcing The Return of ‘Supply Chain Week’ on Clinical Trials Arena

Throughout this week, CTA will draw attention to the latest innovations taking shape within clinical trial supply

By Staff Writer

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.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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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 Clinical Supply Chain: Putting in Place a Cornerstone Strategy

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.

CDMOs Responding to Pipeline Complexity

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 Manufacturing Success Strategies with Contract Manufacturing Organizations

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.

Related Companies

Free Case Study
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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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