May 19, 2022

How simpler implementations enable complex cell and gene therapies

After spending 12 years working in the biopharmaceutical industry – three of those here at Vineti – I’ve learned first-hand that cell and gene therapies (CGTs) present a unique environment for software implementation.

The CGT supply chain straddles a number of different institutions that each come with their own distinct roles and users, including clinical sites, cryopreservation labs, manufacturing facilities, and in some cases, distribution depots. At these institutions, there are dozens of involved user roles driving functional requirements. All of those users and their organizations have to be onboarded, and each has its own security and IT requirements. On top of that,  CGT is a heavily regulated environment – implementation needs to take requirements such as Good Manufacturing Practice into account. 

These unique aspects of CGT require a new approach to the implementation of supporting software systems. To enable these complex therapies, implementation needs to be simple.

Here at Vineti, we’ve been turning our expert team’s hundreds of hours of first-hand CGT experience into a new approach to implementation that is resulting in faster, high-quality supply chain software delivery. Here’s how we’re helping our biopharmaceutical clients reach more patients with cell and gene therapies, more quickly and simply.

We have created repeatable processes designed to work in CGT, with clearly defined roles and hand-offs, and drafted various templates to aid our process. Time to value, quality (get it right the first time),  and alignment with our customers are the pillars of Vineti’s implementation approach. None of the three pillars is possible without the other two. 

To secure those implementation pillars, we focus on three key tactics:

1. Templated solutions for common industry problems. While CGT is still a relatively new field of biopharma, enough therapies have been deployed in the clinic to provide repeatable, reliable best practices. A templated approach does not mean that the unique features of each therapy are ignored or removed – the flexibility inherent in Vineti’s PTM^® platform ensures that unique requirements are covered. But where workflows can be standardized, a template-based approach provides a faster, proven approach.
2. A strong emphasis on automation from the start. Vineti’s implementations follow a repeatable, standardized process. We have developed industry-specific standards and automations, especially where critical hand-offs between teams occur. Running implementation in the cloud allows us to quickly and inexpensively spin up environments for testing, validation, training and production without the need for the customer to procure any hardware or run large IT teams to manage environments and install software. Moreover, we are able to deploy to the various environments in an automated fashion, with less effort and more frequency, significantly speeding up the feedback cycle with the customer, leading to faster delivery times and higher quality. 
3. Single source of truth. We work from a mutually agreed-upon design spec, developed together with each customer. As part of ensuring that we create single sources of truth for agreements with and reporting to our customers, we encourage customers to engage in a Vineti sandbox from the very beginning of the engagement. We’ve also honed a ticketing system that is set up to capture all the needed information on feedback and requests in one place for triage, discussion, action, and reporting. 

The end result – faster implementations with high quality and strong working relationships with our customers. To enable the project team to focus on finding the best solution, we’ve been working to create automation and simple, unambiguous communication interfaces so that routine tasks and communications can be executed in a repeatable manner, with minimum disruption.

More than 5,000 patient-specific cell and gene therapy products have been managed via Vineti’s technology to date. With our proven implementation approach, developed through years of direct CGT experience, my team and I look forward to providing solutions that will support even more patients in need of these transformative new treatments.

Stefan Koch is Vice President of Professional Services at Vineti. If you’d like to learn more about our PTM® platform for cell and gene therapy supply chain orchestration, please contact us.