Panel: The Future of Managing Cold Chain Supply in Clinical Trials

With COVID-19 continuing to impact trials, a shift in temperature management processes is accelerating.

Sponsors are fostering new approaches that significantly benefit patient safety, audit readiness, and reduce drug wastage. For some, decreasing manual paper processes at sites and going digital has resulted in quicker process times. Other supply teams are easing into temperature management automation in shipments with the help of digital loggers.

The continuing decentralization of trials also has sponsors looking to integrate temperature management into direct to patient shipments. Drug supply managers who are early adopters in temperature management are learning better organize clinical studies around an increasingly digital cold chain.

In this panel discussion, you’ll learn about:

• How study teams have incorporated temperature management functionalities into their workflow
• How sponsors can plan for future trials to integrate meaningful automated and digital solutions
• Challenges and opportunities with temperature excursion management and direct-to-patient studies

Speakers

Henk Dieteren, Clinical Supply Chain Solutions Consultant, Suvoda

As Clinical Supply Chain Solutions Consultant, Henk currently assists Suvoda with his deep knowledge in various areas of clinical trial supply management. Prior to Suvoda, he co-founded the clinical trial supplies department at Grünenthal GmbH and served as its Associate Director for 10 years. While at Grünenthal, he developed operational processes and championed risk management procedures to establish the company as a clear market leader in the area of clinical supply chain. More recently, Henk served as Senior Investigational Medicinal Product Manager at BioNTech SE, where he streamlined data processing operations in the clinical supply chain for personalized oncology therapies. Henk is well-regarded in the field for his expertise in IRT, temperature excursion management, and direct-to-patient logistics. In addition, he is very experienced in conducting supplier audits, having participated in more than 30 audit visits as a technical expert. He holds a Bachelor of Science degree from Zuyd University of Applied Sciences in Physiotherapy.

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Mary Pat Walsh, Associate Director, Clinical Supplies, Endo Pharmaceuticals

As Associate Director of Clinical Supplies at Endo Pharmaceuticals, Inc., Mary Pat is responsible for all aspects of clinical supplies from planning through return reconciliation/accountability for all clinical studies requiring study drug. She is also responsible for the development and implementation of the IRT systems for these studies.

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Ayelet Weissbach, Clinical Supply Chain Manager, NeuroDerm

As Clinical Supply Chain Manager at Neuroderm, Ayelet is responsible for setting up the infrastructure for clinical trial supply chain (Phase 1, 2, and 3, blinded and unblinded), including IRT, Packaging & Labeling, and distribution. Ayelet is experienced in implementing innovative solutions that manage temperature sensitive drug at depots and sites. Prior to her role at Neuroderm, she acted as a Clinical Logistics Leader for OPKO Biologics.

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Harald van Weeren, Segment Manager Clinical Trials, Berlinger & Co. AG

Harald van Weeren is Segment Manager Clinical Trials at Berlinger & Co. AG, a leading supplier of integrated soft- and hardware temperature monitoring solutions for pharma and med-tech industries. He has over ten years of experience in Product Management and Market Segment Management, bringing value to customers with high-tech innovative solutions. van Weeren has a PhD in physics from the University of Twente, Netherlands.

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