Dubbed Pathway, the solution is designed to manage the entire safety assessment process, integrating safety assessment study types and bioanalytical support with scientific and regulatory consulting, program design and project management.
“Our deep expertise in the complex fields of biologics and advanced therapies adds particular value to our customers with drug development programs 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,” Lee Coney, Envigo’s chief scientific officer, said in a press release.
Coney said Pathway leverages the company’s “beginning-to-end” understanding of the safety assessment process, and “optimizes the journey to first-in-human studies.”
“Experience of designing and conducting studies in a wide range of therapeutic modalities, and in working with regulatory agencies around the world, means we are able to anticipate the needs of a program at design stage, plan studies accordingly, and manage an optimal timeline of study execution,” he added in the release.