Clinigen Clinical Supplies Management
Customised Clinical Supply and Biological Sample Services
Shell Lee and Xiaomin Chen provide the quintessential guide to clinical supply logistics
lo·gis·tics
/l?’jistiks/
“the detailed coordination of a complex operation involving many people, facilities, [and/]or supplies.” (1)
It is important to understand the word's language(s) of origin, which could help us better understand the art of what we do. According to Merriam-Webster, “[b]oth logic and logistics ultimately derive from the Greek logos, meaning ‘reason’." But while logic derives directly from Greek, logistics took a longer route, first passing into French as ‘logistique,’ meaning ‘art of calculating,’ and then into English from there. Its first known use is believed to have been circa 1861 (2).
In our experience, three criteria, at a minimum, need to be met to achieve best practice in clinical supply logistics:
Naturally, there is no one size fits all formula/playbook, but the core guiding principles are the same. What follows in this article is a lessons learned account drawing on our personal experience working in the biotech/pharma industries for 10-plus companies.
Technically, there are three types of shipment categories: bulk, site and patient (direct-to-patient), and returns. Each type of shipment is a critical piece in a successful clinical trial, and each pose its own challenges, from the risks incurred in handling multimillion-dollar shipments, to frequent time-sensitive shipments.
Each challenge will be systematically broken down using the five Ws and H approach, listing critical criteria to consider, while providing actionable information for readers to achieve flawless execution. Additionally, we will also provide advice for readers on how to foolproof their logistics. What’s key to ensure is having the discipline to follow through on each step of the way, after all, your supply chain is only as strong as its weakest link. One wrong move can cause disruption, and you would be accountable for any delays. Therefore, don't let anything happen by chance.
First, it’s critical to know what you are shipping for regulatory, compliance, and safety-handling purposes:
Next, it’s critical to know the shipping and storage conditions of your material, as well as the acceptable temperature excursion parameters. Be sure your chemistry, manufacturing and controls (CMC) department has conducted a freeze-thaw study.
TIPS: For a temperature controlled shipments, it is critical to verify the exact temperature control settings prior to your shipment to pre-empt a Murphy’s Law scenario.
Following is a list of documents for bulk, site/patient, and return shipments. For each shipment, ensure the import/export requirements are met:
Always determine what your shipping strategy is. Much depends greatly on the study design, packaging and labeling configurations, and the availability of supply. Make a note of the following factors for consideration:
TIPS: Label a small quantity of your IMP for your first three approved countries, thereby minimizing any impact on your FPI date, R&D milestone, and company goal
It’s important to build reliable systems, while understanding your system’s limitation and timing. If you decide to use an interactive response technology (IRT) system, consider the following factors:
TIPS: Implement self-adjustable features during the design phase, so you won’t need to submit a Data Change Form to your IRT vendor in the event site demands change. Furthermore, map out your system’s timing between input and output. This will allow you to align your request submission time with your distributor shipping schedule.
Additionally, align your IRT automatic system shipment requests while conducting a holistic end-to-end User Acceptance Test (UAT). All systems should be fully-tested from IRT to distributor prior to your first site initiation visit (SIV), as you don’t want to impact your R&D milestone.
In addition to the standard operations, ensure all shipment documents are accurate and reviewed by all stakeholders. Here are three considerations that will help to combat any risks:
Knowing what you know is only a piece of a puzzle. While it’s good to be assured in the knowledge that you possess, have an open mind and learn what you don’t know. Have the discipline to follow through on each step of the process.
Shell Lee has diverse experience across all phases of development, commercial and CMO. He has worked for multiple biotech/pharma companies, managing clinical supply in therapeutic areas, such as ADHD, Cardiovascular, Oncology, and HIV/AIDS. Shell holds two bachelor’s degrees in Packaging Engineering, and Ceramic Engineering from Rutgers University. He also has an MBA from the University of San Francisco's Executive MBA program, and is Lean Six Sigma certified from the Rutgers School of Business.
Xiaomin Chen is an MBA candidate in New York University, Stern School of Business. She previously completed a Master’s degree in Pharmaceutical Sciences from the State University of New York, University at Buffalo. She has since advanced professionally in a number of global pharmaceutical/biotech companies in clinical development. Previously, she led 50 cross-functional team members in over 14 countries for a complex Phase III clinical trial.
References:
1) https://www.google.com/?gws_rd=ssl&safe=active&ssui=on#safe=active&q=logistics+definition
2) https://www.merriam-webster.com/dictionary/logistics
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