November 17, 2020
Now is the time for proven technology that drives scale
A Vineti technology perspective from CEO and Co-founder Amy DuRoss
The underlying medical science behind cell and gene therapies continues to make remarkable progress, even amid clinical enrollment delays due to COVID-19. Scaling out the production and delivery of high-value, deeply personalized products, however, still requires significantly more simplification and standardization if we are to realize the promise of autologous cell therapies, allogeneic therapies, and personalized cancer vaccines for the benefit of many more patients.
Vineti’s Personalized Therapy Management (PTM) ® platform’s role in simplicity and standardization
Our team at Vineti is entirely focused on continuing to expand Vineti’s Personalized Therapy Management (PTM) ® platform, the leading digital solution for personalized medicine supply chains. We believe PTM will be crucial to help simplify and standardize how advanced therapies are delivered at scale.
Vineti’s PTM: an end-to-end digital solution, with three core components, for orchestrating advanced therapy 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. These complexities have “led to an extremely high cost of goods sold…, hesitation to utilize CAR T beyond end-of-line patients, and patient drop-offs along the treatment journey.”1 COVID-19 has exacerbated complexity, with one-third of cell therapy companies reporting manufacturing delays or a complete halt to operations in 2020 and 50 percent of CGT companies reporting a reduction in engagement with HCPs, clinical sites, and patients.2
PTM solves for inherent complexity by bringing the best principles and practices of enterprise software to advanced therapies. PTM is a true enterprise-grade solution—a common cloud-based digital platform with configurable workflows. Configuration tools in PTM offer our customers and partners the ability to build the unique facets of the support their workflows require in a consistent and singular platform, without creating new or customized codelines. Configurability means less effort and less long-term risk than custom code, and ensures that our clients are able to scale their workflows with the needs of an evolving and complex therapy. PTM is also purpose-built for our industry, and our team has always remained unilaterally focused on the unique challenges presented by personalized therapeutics. Standards and best practices are baked into PTM, as are the uniquely rigorous compliance and patient safety requirements of CGT. Configuration enables our biopharmaceutical partners to tailor the PTM platform to their brand, while our industry-leading security safeguards each partner’s IP and patient privacy. Integrations connect PTM to the rest of the CGT ecosystem—such as Lonza, Cardinal Health, Cryoport and more than a dozen other Vineti Alliance Network collaborators.
1. “Driving the next wave of innovation in CAR T-cell therapies,” McKinsey, 2019.
2 “COVID-19 and cell and gene therapy: How to keep innovation on track,” McKinsey, 2020.
PTM delivers a modern digital supply chain orchestration platform
Proven patient safety and compliance. Thousands of commercial cell therapy treatments have already been successfully managed via Vineti. CGT’s myriad regulations and compliance requirements, which can overwhelm bespoke or generic solutions, are already baked into PTM. State-of-the-art Chain of Identity (COI) and Chain of Custody (COC) tracking and traceability keep each patient journey moving safely and efficiently.
Simpler scale for multiple growth drivers, including regions, facilities, and drug products. The Vineti platform is already used in hundreds of leading clinical sites to manage advanced therapy patient processes in a safe, compliant, user-friendly manner. The PTM platform supports autologous and allogeneic products from early-phase clinical to commercial, as well as personalized cancer vaccines, in the U.S., E.U., and Asia-Pacific. The platform stays up to date as our still nascent industry grows and changes.
Reduced risk and guesswork with built-in standards. Insights from 70+ years of team CGT experience and a team of industry experts who’ve managed more than 125,000 doses of cell therapy are baked into PTM. Our team provides standards leadership for our industry. Want to see an example in action? Learn more about our recommendations for a new patient COI identifier for the personalized medicine era.
Security and speed via a proven, purpose-built solution. PTM’s enterprise-grade platform provides best-in-class security and peace of mind specific to advanced therapies. PTM’s purpose built foundation covers core CGT requirements right from the start. Because PTM lives in the cloud, updates are simple. And PTM delivers the data integrity and insights needed for both regulatory reviews and smarter commercial operations.
Simple for multiple, disparate stakeholders to use, with industry-leading user experience. Vineti’s platform has more than 1,000 users and growing, and their insights help keep us ahead of industry needs. Our leading user experience provides a platform that solves workflow complexity, so that CGT stakeholders can simply log into PTM and get to work on behalf of patients.
Advanced therapies need a true standardized platform, not patchwork customized solutions. PTM’s enterprise-based approach delivers simplicity and scale, so that cell and gene therapies can reach all patients in need.
For more information read our perspective from Vineti’s CCO Joe DePinto where he discusses how in traditional pharma, the supply chain is typically the purview of manufacturing — but in cell and gene therapies, the Commercial team is deeply involved. It is critical to have a good understanding of how your supply chain leverages value to the brand. That happens in two ways — when you can access data, and when you gain understanding along the product journey. Learn more now!
The proven digital solution for advanced therapy supply chains
See our PTM platform for yourself. Contact us to schedule a demo.
Amy DuRoss is CEO and Co-founder of Vineti. A long-time leader in biotechnology innovation, Amy began her leadership in regenerative medicine as the Co-founder and Executive Director of Proposition 71, California’s $3 billion stem cell research initiative passed in 2004. She has written and spoken widely on standards for advanced therapies, including this STAT News commentary on the industrialization of personalization.