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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Logistics by design: a framework for advanced therapy developers to create optimal Logistics Platforms

EXPERT INSIGHT


Simon Ellison*, Ryan McCoy*, Marc Bell, Kelly Frend & Stephen Ward


Advanced therapeutic medicinal products (ATMPs) are delivering a new wave of treatment options for unmet healthcare needs. Their impact however, will be severely truncated if supply chain infrastructure is unable to robustly and cost-effectively connect patient to product. Guaranteeing logistical success is becoming an ever-increasing focal point as the field rapidly delivers. Establishing a seamless development approach, including logistics, will be critical in delivering a successful commercial logistics strategy. Paramount to facilitating ATMP commercial realisation is a support structure for logistics planning. In this article we present ‘Logistics by Design’ (LbD) – a framework for logistics-based decision making, based in-part, on Quality by Design principles. This is accompanied by case studies that illustrate the value in applying LbD principles early in the development lifecycle, thereby de-risking the probability of logistics strategy failure.
* Joint First Authors

DOI: 10.18609/cgti.2018.102
Submitted for review: October 8, 2018
Citation: Cell Gene Therapy Insights 2018; 4(10), 1019-1040.
Open access
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