Whitepapers and in-depth articles from Vineti
The year 2020 has been noteworthy for cell and gene therapies (CGTs), which conservatively account for 12% of the pharmaceutical industry’s clinical pipeline and 16% of its preclinical pipeline. Although COVID-19 has slowed some clinical studies and key research and development activities, investments and financing in the regenerative therapy market have remained robust – and more than 1,000 therapeutic developers remain active in the space worldwide.
Today’s advanced therapies are novel and hold great promise, but pose new challenges that sponsors and stakeholders are rallying to solve. One such challenge is in-process and final product labeling. The requirement for appropriate and approved labeling is not new in biotech and pharma – it is foundational to every drug product. Advanced therapies, however, introduce patient or donor cellular raw material into the supply chain, resulting in a much more complex process and treatment journey to produce these therapies. This white paper demonstrates that certain practices lead to successful labeling and support the ability to deliver safe treatments to patients.
Amid COVID-19, Quality Management matters more than ever for cell and gene therapy. Use this white paper to build on essential Quality and risk-management principles, including important information on critical risks, vendor management, and Quality metrics specific to advanced therapies.
Supply Chain strategies matter more than ever for cell and gene therapy. Use this white paper to build on essential Supply Chain management strategies and principles, helping to move your advanced therapies out of the lab and into human trials.
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.