A true platform is the engine for advanced therapies
by Phil Calvin | November 30, 2020
A Vineti technology perspective from Chief Technology Officer Phil Calvin
Phil Calvin, Vineti’s Chief Technology Officer, is a long-time leader in enterprise software, with more than 25 years of entrepreneurial and executive experience, including nearly a decade at Salesforce.
Q. From a technology perspective, what’s unique about cell and gene therapy (CGT) and why is an enterprise platform necessary?
Phil Calvin: I think there are a few contributing factors to the uniqueness of CGT that reinforce the need for an enterprise platform approach. First, the complexity of the multi-directional nature of the supply chain, intermixed with a necessity for a broad spectrum of integration requirements, makes it incredibly difficult to build bespoke solutions for a particular use case. A foundational platform approach providing targeted services gives us a baseline to deliver for our customers. Layered upon that foundation is the necessity and complexity of jurisdictional-specific compliance requirements. These, combined with common platform features, such as authentication, roles-based access, and administrative configuration all built upon a foundation of quality, reliability and security make Vineti’s PTM the right solution for CGT.
Q. What big technology lesson is the advanced therapy sector learning right now?
Phil Calvin: Our industry is going through this journey of learning what a true platform is. In the past, many systems in pharma were custom-built, and organizations still think in terms of custom build -- “Here's my spec, go build it.”
Vineti’s PTM is different. PTM is an aPaaS (Application Platform as a Service). It’s a purpose-built enterprise service providing a common technological foundation that meets individual customer needs through configuration, not by creating stand-alone custom builds. We’re always increasing the value of our aPaaS for our clients, both through adding more features and continuously gaining knowledge as a platform. PTM just continues to grow.
The most fundamental reason why you do a platform versus a custom build is that this is a new industry, and our customers are figuring out their processes themselves in real time. The only way you're going to be able to adapt to an evolving industry is through a platform. So if you're a Director of Supply Chain, and your workflow has seven steps, instead of three, or if it goes from seven steps to six steps over time, we can adapt to that. We provide an “opinionated” but flexible platform that guides how to orchestrate an advanced therapy supply chain structurally, but not specifically.
Q. Can’t a bespoke system also be updated over time?
Phil Calvin: When you're building a bespoke application, you go off and have someone build your application. And then you move on to the next one, which may be completely different. You're not really gaining collective knowledge, and you're left with a bunch of different things to manage and update and maintain.
What happens to a custom build after a first go-live? The team moves on. And that knowledge is gone. And so whenever you have to make any changes to that build, you have to ask, “What do we do exactly?” It's a whole big effort. The big problem is not “Version 1.” It's what happens after “Version 1.”
That's exactly the problem we're trying to avoid with PTM. Everybody is on the same platform foundation, benefitting from the fact that it always gets better. We always have the ability to improve PTM, learning from the best practices in the industry, for the benefit of every client.
Q: What’s a specific challenge that you’re excited about solving through PTM?
Phil Calvin: One of the really interesting things for me as far as a technological product and platform strategy is building validation into our entire sequence from end to end.
There are two parts to this challenge -- there is the platform, and the customer configuration on the platform. The game-changing value for our customers is in automating their testing of the configured software. Because with so many clients, that's their biggest headache.
The platform will always be validated, and our Engineering team works hand-in-glove with the Vineti validation team to ensure this as part of our software development lifecycle (SDLC). We've structured our validation program and releases to make sure our release cycles are predictable and manageable for customers.
Automating validation of the customer configuration and their scripts is the interesting -- and challenging -- part. We do our testing, and they also do their testing. When we automate that part of the process for customers, we are solving one of their major problems.
Q: If you could describe three to five years out, what does the ideal technology solution for a personalized medicine ecosystem look like?
Phil Calvin: Our ultimate goal is that our technology helps more and more patients. The system is trusted by patients and users -- and supports the industry’s growth as the engine running in the background. We want to get to the point where the platform is the foundation on which advanced therapy supply chains operate, and where PTM is the standard for how CGTs are delivered to patients.
PTM ® Platform Modules
Order Available to Promise - Manage scheduling in real time for time-critical patient procedures based on resource availability
Logistics - Automated complex courier/3PL logistics for custom business processes
Labeling - Print on demand to any printer, or print-and-ship
Tracking and Analytics - Real-time order status tracking and aggregate self-service supply chain analytics
Ordering and Patient Management - Order commercial and clinical therapies inside the clinic on a branded experience
Collection and Infusion - Paperless cell collection & final product processing at clinical sites supporting GMP and clinical phase SOPs
Manufacturing - Traceability and control of product within manufacturing
Quality Assurance - Permanent and transparent association of a therapy to the complete record of all activities involved from end to end
Data and Auditing - Ad hoc out-of-the-box and custom reporting on complete historical audit trail
Admin and Configuration - Setup, manage, and control access to the Vineti system
Integration - Robust and flexible integration platform for use with systems throughout the healthcare ecosystem
Application Engine - Shared platform functionality that powers and scales all application experiences
For more information read our perspective from Vineti's CEO Amy DuRoss where she discusses how our team is entirely focused on continuing to expand Vineti’s Personalized Therapy Management (PTM) ® platform, the leading digital solution for personalized medicine supply chains. As industry analysts have widely noted, complexity is a critical limiting factor for advanced therapies, especially in the areas of manufacturing and supply chain. We believe PTM will be crucial to help simplify and standardize how advanced therapies are delivered at scale. Learn more now!
The proven digital solution for advanced therapy supply chains
See our PTM platform for yourself. Contact us to schedule a demo.
Phil's areas of expertise include technical strategy, cloud architecture, and engineering executive management. Prior to Vineti, Phil spent nearly a decade at Salesforce in a variety of architectural and engineering leadership roles, most recently leading the Platform Engineering organization. Phil joined Salesforce in 2010, after the acquisition of his company Sitemasher. His earlier career includes several startups and engineering roles, including serving as Principal Architect at Citrix.