“Envigo’s new and developing De-Risking Program has been designed by our senior scientists to provide a focused and coordinated in vitro testing program that quickly assesses if a new drug has liability that can potentially threaten its approval by regulatory authorities,” Brian Burlinson Principal Scientist for Safety Assessment at Envigo told Outsourcing-Pharma.com.
The program is focused on three areas, including safety assessment, drug-drug interactions (DDI), and hepatotoxicity (drug-induced liver injury or DILI).
Burlinson explained, “The results of these specific in vitro tests are then reviewed by our program scientists and an executive summary and overall risk assessment is provided to the customer.”
“De-risking adds value to our customer’s product,” he added, as a compound that has a low drug-drug interaction profile, as an example, and low liver toxicity (DILI) potential, is considerably de-risked from non-approval and/or withdrawal post-market.
“Ultimately, De-Risking provides Envigo customers with additional confidence to invest in a new molecule early in the development process and aids licensing,” Burlinson said.
The technologies in Envigo’s new DILI assessment program consist of three tests: covalent binding, reactive metabolite formation, and time dependent inhibition (TDI) of cytochrome (CYP) enzymes.
“These are fast turnaround in vitro assays with low compound usage – requiring just milligrams of material, making them ideal for early discovery research, where typically only small amounts of compound are available,” explained Burlinson.
The DILI Assessment program can be run in full or using single assays as needed.