Target Safety Reports: What’s in a Name?

Irrespective of what we call them, target safety reports form a key part of risk assessment and risk mitigation plans in drug discovery and development.

Why is that?  Well, target-related toxicity accounts for >50% of all drug project failures (Cook et al., 2014) so it’s vital to understand the potential unintended consequences of target modulation.  Despite the many different names they are given such as target safety reports, target safety reviews, target assessment report or just target reviews, they all have two key elements.

Firstly, there should be a comprehensive review of the role of the target in normal physiology focusing primarily on expression, species differences and consequences of activation/inhibition.  This is relatively easy to obtain via online searching of published literature and databases either manually or using ever more sophisticated search tools.

This assembly of key information forms the basis for the second part and the main focus of the target safety assessment:  an expert interpretation and evaluation of the potential toxicity of inhibitors or activators of the target coupled with a rational, pragmatic and staged risk assessment and risk mitigation plan.

Considering the relatively low cost of target safety assessments (TSAs) compared with the costs of a drug discovery programme overall, surely it makes sense to do this for all projects.

As we said in our previous publication, there’s no such thing as bad news in early drug projects!

By |2018-10-12T14:15:50+00:00October 12th, 2018|Target Safety Assessments|Comments Off on Target Safety Reports: What’s in a Name?

About the Author:

Professor Ruth A Roberts, PhD, ATS, FBTS, ERT, FRSB, FRCPath Director and Cofounder, ApconiX, UK and Chair and Director of Drug Discovery, University of Birmingham, UK Ruth is chair of drug discovery at Birmingham University, UK and Cofounder of ApconiX, an integrated toxicology and ion channel company that brings together a team of world-renowned nonclinical safety experts with over 400 years of drug discovery and development experience. Previously, Ruth was Global Head of Regulatory Safety at AstraZeneca and Director of Toxicology for Aventis. Ruth is an established science professional bringing rigorous expert thinking to toxicology, drug discovery and drug development. With >140 publications in peer reviewed journals, she is focused on reducing attrition attributable to safety and toxicity. A former president of the British Toxicology Society, former president of EUROTOX, former secretary to SOT and president elect of the Academy of Toxicological Sciences, Ruth was the recipient of the SOT Achievement award in 2002, the EUROTOX Bo Holmstedt Award in 2009 and the SOT Founders award in 2018 for outstanding leadership in toxicology.