Target Safety Assessments: Strategies and Resources

Target Safety Assessment: Strategies and Resources, Chapter 12 of Drug Safety Evaluation Methods in Molecular Biology (vol 1641), was written by Dr Richard J Brennan, a Scientific Advisor at Sanofi in the United States.

The chapter presents a summary of the information types and sources that should be investigated, and approaches that can be taken to generate an early assessment of potential safety liabilities of proposed drug targets.  Target safety assessments, sometimes called target safety evaluations, reviews or reports are an invaluable resource throughout drug discovery and development.

In the summary the author commented:

“In our experience, the availability of a target safety assessment and a plan of action based on its findings has been successful in providing timely data for predicted liabilities that has had a direct impact on project progression decisions.”

 

Here at ApconiX, we have a team of experienced drug discovery toxicologists who conduct bespoke target safety assessments designed to meet your needs, with our strong focus on risk mitigation and actionable recommendations.

 

Abstract

An in-depth evaluation of target safety is an invaluable resource throughout drug discovery and development. The goal of a target safety evaluation is to identify potential unintended adverse consequences of target modulation, and to propose a risk evaluation and mitigation strategy to shepherd compounds through the discovery and development pipeline, to confirm and characterize unavoidable on-target toxicities in a timely manner to assist in early program advancement decisions, and to anticipate, monitor, and manage potential clinical adverse events. The role of an experienced discovery toxicologist in synthesizing the available information into an actionable set of recommendations for a safety evaluation strategy is critical to its successful application in early discovery programs. This chapter presents a summary of some of the information types and sources that should be investigated, and approaches that can be taken to generate an early assessment of potential safety liabilities.

Read more here: Brennan R.J. (2017) Target Safety Assessment: Strategies and Resources. In: Gautier JC. (eds) Drug Safety Evaluation. Methods in Molecular Biology, vol 1641. Humana Press, New York, NY

By |2018-12-07T09:58:25+00:00July 27th, 2017|TSA Page, Target Safety Assessments, Publications|Comments Off on Target Safety Assessments: Strategies and Resources

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.