Dubbed PATHWAY, the solution integrates safety assessment study types and bioanalytical support and can manage the complexity of the entire safety assessment process on behalf of Envigo’s pharmaceutical and biotechnology customers.
Envigo developed the PATHWAY solution to help its customers navigate the increased scientific and regulatory complexity facing advanced therapies going through safety evaluation.
The solution has been designed to leverage Envigo’s capacity, capabilities and experience in the field and deliver translational biology insights to prepare customers for first-in-human clinical trials.
Envigo chief scientific officer Lee Coney said: “Our deep expertise in the complex fields of biologics and advanced therapies adds particular value to our customers with drug development programmes in these growing categories.
“On our customers’ behalf, we frequently work with regulators to determine the most appropriate interpretation of regulatory guidance as it applies to a specific therapeutic.
“PATHWAY makes full use of our beginning-to-end understanding of the safety assessment process, and optimises the journey to first-in-human studies.”
Coney further added that the company designs and conducts studies in various therapeutic modalities.
Envigo works with regulatory agencies across the globe and can anticipate the requirements of a programme at the design stage. Accordingly, it plans studies and manages an optimal timeline of study execution.
The company has harmonised facilities with AAALAC accreditation in Europe and North America and further seeks to optimise safety assessment programmes by ensuring studies are carried out at centres of excellence.