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Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective 

Pharmaceutical Technology

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Tech innovations that curb complexity, setting clinical trials up for success

Pharmaceutical Technology

According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial. 1 Tufts Center for the Study of Drug Development (CSDD); Jan/Feb 2022 Impact Report.

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NUCLIDIUM and PharmaLogic partner to develop copper-based theranostics in US

Pharmaceutical Technology

NUCLIDIUM has signed a strategic collaboration deal with PharmaLogic for the manufacturing and clinical supply of copper-based theranostics ⁶¹Cu in the US. ⁶¹Cu The deal is set to speed up the development of NUCLIDIUM’s theranostic pipeline. The deal is set to speed up the development of NUCLIDIUM’s theranostic pipeline.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials.

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Why and How Will Ecommerce Transform the Interactive Response Technology (IRT) User Experience?

XTalks

Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial. IRT solutions help clinical trial sponsors meet the complexities of patient randomization and clinical supply management.

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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,