Envigo paves new first-in-human trial solution

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Ipopba)
(Image: Getty/Ipopba)
The non-clinical contract research services and research model provider Envigo launches a new solution it says optimizes non-clinical safety assessment programs to enable first-in-human clinical trials.

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. 

Related news

Show more

Related products

show more

Ultra Low Temperature Packaging solutions

Ultra Low Temperature Packaging solutions

Content provided by Almac Group | 12-Feb-2024 | Case Study

Advanced Therapy Medicinal Products (ATMPs) offer ground-breaking opportunities for treating injuries and disease, in particular for cases of severe, untreatable...

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Related suppliers

Follow us

Products

View more

Webinars