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A Perspective on "Expanded Access" to Experimental (Cell) Therapies

“Expanded Access,” is a regulatory pathway for physicians to gain access to experimental therapies for patients who usually do not qualify for the clinical trial. This pathway often represents one final chance against a condition that is severely debilitating and/or fatal. Often called “Compassionate Use,” the number of patients and physicians requesting access to experimental therapies has been growing steadily over the past three decades.

Topic: Cold-Chain Logistics, Topic: Cell Therapy S..........

An Alternative Model for Clinical Trial Product Management: Exploring Distribution and Dispensing

Managing limited supplies of an investigational agent in a clinical trial can present challenges. The typical practice is to ship inventory to the research pharmacy or the principal investigator’s office at clinical a site in anticipation of enrollment. One challenge is that the amount needed at study sites can only be estimated, and inadequate inventory may delay the study while providing extra is expensive and wasteful. In the meantime, the agent(s) and clinical supplies sit in storage until enrollment proceeds and dispensing begins. This ties up inventory and can create additional challenges with expiration dates. However, there is an alternative model of clinical trial support for consideration.

Topic: Clinical Trial Sample Management, Content: ..........

Expansion Cohort Clinical Trials and Your Cryogenic Supply Chain

One advantage to the traditional phase 1, 2, and 3 format of clinical trials is that it allows reasonable forecasting with regard to the clinical supply chain. This phase 1-2-3 format is rapidly changing, however, especially with regard to biological therapies, as more and more clinical trials include expansion cohorts. If you are planning clinical trials for a cell-based therapy that must be maintained in liquid nitrogen, and may potentially take the expansion cohort route, you should consider the impact on your distribution capabilities as soon as possible.

Topic: Cold-Chain Logistics, Topic: Cell Therapy S..........