November 17, 2020
A modern patient ID for personalized medicine
Patient-specific therapeutics must be delivered to the patient they are intended to treat. That concept is easy to say — and not always easy to do.
An entire ecosystem of workflows, drug product processes, and supply chain steps must be orchestrated flawlessly to make sure that a personalized drug product, such as a CAR-T cell therapy, reaches the correct patient. This safety-preserving synchronicity is achieved, in part, by making sure it’s clear that a patient and product are always matched, using a patient ID that works for personalized medicine.
Unfortunately, approaches to these patient ID’s are often outdated. It’s time for a patient ID that is as advanced as the therapies themselves, so that personalized medicine has a safer, scalable, and more transparent future.
Vineti is now joining industry standards efforts to develop a modern patient ID for personalized therapeutics. To further standard-setting discussions, we also want to share our recommended approach publicly, to further encourage dialogue on this critical topic for cell and gene therapies (CGTs). (You’ll find a presentation with our recommendations a little further down in this post.)
First, here’s a little more background on patient IDs in personalized medicine.
The process of tracking and matching a personalized therapeutic to a patient is driven by a core concept known as Chain of Identity (COI), or the permanent, transparent association of a patient and/or donor’s unique identifiers to their tissue and/or cells from order through collection, manufacturing, administration, and post-treatment monitoring. Pairing COI with Chain of Custody (COC) — or the permanent data capture of tracking and handling information for a therapy at every step — provides a truly traceable, trustworthy process.
At the most basic level, Chain of Identity is enabled by a COI Identifier (COI ID), a set of numbers and/or characters that is the overarching “ID badge” for each patient. The COI ID must link a therapy to the intended patient and protect patient privacy. The COI ID is used in multiple places on the patient journey,
from medical records to in-process drug labels.
The current approach to the structure and format for COI IDs is based on existing patient-specific, donation-based processes, such as bone marrow collection.
While these prior approaches to COI ID are well-known, they are not sufficient for CGTs. CGTs are often more complex than other donation-based treatments. Some treatments may be patient-based, some may be donor-based, and some may be based on a mix of source materials. Some may be single-dose products, while others may be multi-dose products.
Based on extensive experience, Vineti believes that the advanced therapies industry needs an updated standard for COI ID.
The Standards Coordinating Body for Regenerative Medicine, an independent non-profit organization working to drive industry standards, has a current workstream that is working to update cell therapy labeling standards. Vineti presented this vision for COI ID to the SCB working group as part of an ongoing standards discussion in October 2020.
In sharing our vision for a new COI ID publicly, we’re hoping to engage our industry in dialogue and debate as we all work together on this new industry standard. Please send us your feedback, and thank you in advance for your input!
Louise Pacini is the Chief Strategy Officer of Vineti. Amy Fonte is a Product Manager at Vineti. You can learn more about Vineti and how our digital solution supports advanced therapy supply chains here. If you have feedback on our COI ID proposal, please contact us.