April 7, 2022
Cell and gene therapies: the necessity of a purpose-built platform
Cell and gene therapies rely on the most complex production and delivery workflows in the history of medicine – complexity too sophisticated for generic technology.
Given the wide array of CRMs and other digital systems already serving healthcare and biopharma, that reality might sound like overkill. But after more than five years of creating supply chain management solutions to serve the needs of advanced therapies at all phases of development, I’m convinced of its certainty. Cell and gene therapies (CGTs) represent a new paradigm at every level of the patient and product journey, and as such, require purpose-built technology to manage workflows and produce patient-specific therapeutics.
The shortfall in generic enterprise solutions such as CRMs lies in their foundational models. Standard digital solutions considered for the management of CGT patients and drug products are built on a database-centric approach. But in the patient-centric paradigm of CGT, where living cells are often a raw material for a therapy, the pharmaceutical supply chain is flipped on its head – requiring a solution centered around workflows, not databases.
CGT manufacturers are figuring out how to scale out (not up) with “raw material providers” – clinicians and patients who are new to biopharmaceutical manufacturing. Now, as a part of the supply chain, these groups are an extension of the manufacturing process because they serve as inputs to it. The procedures that they are responsible for must be completed consistently and with high quality every time. This is less of a data management/database challenge, and more a complex, widely distributed set of procedures that must be facilitated through a set of controlled workflows.
As such, the non-purpose built database-centric approach leaves systems such as CRMs with some significant shortfalls in CGT:
- Such systems are often not ready to meet the complex, unique web of regulations and requirements found in CGT — regulations that go beyond the already-stringent requirements of standard healthcare (GMP, 21 CFR Part 11, Annex 11, and more).
- Core patient/product challenges in CGT, such as Chain of Identity (COI) and Chain Custody (COC), are ancillary to generic systems and often require clunky workarounds.
Caption: Chain of Identity and Chain of Custody definitions
- Many generic systems are not yet proven as a platform of record for regulatory filings.
- Many such systems lack key platform controls, such as versioned configuration. This gap puts mission-critical traceability and COI/COC at risk when processes change.
- Generic systems may be subject to data-throughput limits that can cause interruptions and cost spikes.
In contrast, Vineti’s Personalized Therapy Management® (PTM) platform is a workflow-centric solution that has been purpose-built to address the challenges within the CGT industry. Our solution leverages a state-of-the-art workflow engine to provide configurable solutions that address the most complex supply chain challenges in healthcare.
Our approach, from the beginning, has been focused on leveraging user-centered design and deep domain expertise to develop a solution that can manage tremendous complexity. Vineti started with deeply understanding CGT problems and developed a platform solution for those problems, rather than searching for a problem with a solution. The sophistication of our workflow-centric approach has ultimately led to the delivery of solutions that scale with our customers and that can orchestrate a cell therapy process from start to finish – meeting our end users where they are and ensuring patient safety.
The end result is PTM® – a purpose built platform for CGT, rather than a more generic tool that has been customized to try to manage unprecedented complexity. This means that solutions on PTM® enable long term scale out and maintainability for manufacturers. CGT has introduced the most complex biological workflows that healthcare has ever seen. These business challenges require an equally sophisticated and proven workflow centric solution to serve patients at scale.
Stuart Altman, Chief Product Officer at Vineti, has been solving mission-critical problems in CGT for more than five years. If you’d like to learn more about our PTM® platform for cell and gene therapy supply chain orchestration, please contact us.