When a drug is “alive,” and a person’s living cells are the foundational ingredient in a therapeutic product, medicine’s supply chain will never look the same. This fact means that enabling technologies don’t look the same either.
We are at the beginning of the cell therapy revolution. Cell therapies, such as Gilead’s Yescarta and Novartis’ Kymriah, are incredibly powerful and personalized to match each patient. According to the FDA, “By 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year.”
The FDA’s Drug Supply Chain Security Act (DSCSA) is limited to prescription drugs only and does not cover any blood or blood components. Therefore, established solutions for DSCSA such as the one from TraceLink work well for the traditional drug supply chain where the product is manufactured in bulk but not so well for the personalized medicine.
With cells coming from a patient, getting re-engineered into a therapy and going back to that patient, the supply chain is always multidimensional:
• The process revolves around the patient constantly.
• Speed is essential, as are transparency and safety. The success of many advanced therapies depends greatly on the ability to transport living material (starting materials and final drug product) in a controlled, traceable state through coordination of a range of disparate ecosystem partners.
These tasks and processes cannot be done for more than a handful of patients without a rigorous, regulated, repeatable, reliable digital tracking system. There are a handful of software providers in this space, including Vineti (the company I work for), TrakCel and Be The Match, while companies such as SAP are also beginning to develop solutions in this space.
For those in the healthcare space who are looking to take part in the cell therapy revolution, it’s important to have the right tools in place. So here are seven factors to consider when researching an orchestration platform for personalized medicine.
1. Offers quick implementation
There could be hundreds of cell or other human “raw material” collection sites for a single personalized therapy, all of which have their own internal systems, processes and regulatory requirements. Additionally, many manufacturers are operating worldwide, with geographically distributed facilities, in an effort to more efficiently serve different regions and reach all patient populations. So it’s important to look for a digital platform that can be quickly configured to meet the specific needs of each therapy and region.
2. Intuitive and ‘always on’ for HCPs
Simplicity is key so that healthcare providers (HCPs)s can perform cell therapy operations in a safe, compliant manner. However, the variable nature of personalized medicine means that not all HCPs use the collection system regularly, and they may forget their training.
An intuitive and familiar user interface available online, across multiple browsers and devices, creates a user-friendly environment for HCPs, so you want to research a system that uses a common framework and familiar, intuitive UI to streamline the collection process, keep HCPs up to date and ensure patient safety.
3. Flexible for an evolving therapy landscape
In advanced therapies, our scientific innovation has often outpaced legacy supporting technologies. Flexibility and scalability is imperative.
Right now, best practices and industry standards are still being developed, and manufacturing processes are continually being optimized. Software should adapt to evolving processes and expanding geographic footprints, so it’s key to seek out a system built with user-friendly configurability that can keep pace with industry changes.
4. Configurable and cloud-based
As witnessed across other industries, companies once chose to deploy customized ERP platforms and ended up spending an exorbitant amount of money for on-site management and upgrades and yet getting slow innovation.
Make sure your orchestration platform makes it easy for all users to onboard and use the system and that it enables regular, automated updates, which can be based on usage and feedback.
5. Able to track the three ‘chains’
There are three chains (chain of custody, chain of identity and chain of condition) that are the foundation of a personalized supply chain orchestration platform. The creation of a single dose could include dozens of widely different stakeholders, points of contact and geographies.
Any delays, scheduling errors, or mishandling of a dose could throw off the manufacturing process or make the therapy detrimental to the patient’s health. It’s critical to look for a system built specifically for advanced therapies, with a foundation of built-for-purpose audibility and traceability features.
6. Integrates with external systems
Partners across the advanced therapy ecosystem/supply chain have diverse technology systems and processes required for each patient-centric product batch. Therefore, an orchestration platform should include an integration framework that can map to various API protocols and formats. This is even more imperative for advanced therapies, where the majority of calls to outside systems take place over a network of disparate systems (e.g., CTMS, MES, Couriers, ERP, EHR, etc.).
7. Adaptable to regulatory compliance
In the U.S., software platforms for advanced therapies must be GAMP– and HIPAA-compliant. Therapeutics that are launched globally are subject to further regional and local standards, such as GDPR and/or country-specific requirements.
To ensure compliance, make sure next-gen privacy and security come standard with the software you are researching for your cell therapy projects. Make sure data for each therapy manufacturer can be encrypted and protected by key management.
Technology providers are rising to this challenge. However, this is new territory. Patients and healthcare providers should demand advanced software systems—they are what’s required to make advanced therapies possible for all.
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