Reports

Whitepapers and in-depth articles from Vineti

This whitepaper, co-authored by Vineti leaders Heidi Hagen and Subbu Viswanathan, provides a guide to Quality Management Systems (QMS) and Quality Risk Management (QRM) which will lay the foundation teams need to understand how to utilize proven QMS principles to de-risk this complex supply chain. Starting with a review of QMS essentials then diving into the six areas that benefit most from special attention in advanced therapies.  The focus then shifts to establishing an understanding of a risk-based approach and then providing practical tips to achieve Quality success for the advanced therapy supply chain. Working collaboratively with ecosystem partners, including Vineti, to establish and utilize QMS principles early will pay off as therapy development progresses and scales.

This whitepaper, co-authored by Vineti leaders Heidi Hagen and Marc Puich, provides a four-step guide to supply chain management readiness and is designed to help lead your team through this complex planning and implementation process. This Guide outlines the questions and considerations your team should address at each stage, and provides useful references and checklists to help make sure that nothing gets overlooked.

This whitepaper, co-authored by industry veterans and Vineti leaders Heidi Hagen and Christophe Suchet, outlines the unique data management needs and challenges in advanced therapies and offers six proven strategies for success.

This article, co-authored by Simon Ellison of World Courier and Heidi Hagen and Christophe Suchet of Vineti, looks at proven lessons from commercial cell therapies and discusses how these insights can benefit clinical-phase development, including a look at the unique R&D phases commonly seen in cell and gene therapy. Additionally, sharing best practices that help with progress in each phase.