Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges

Publication date: Available online 17 July 2018Source: Regulatory Toxicology and PharmacologyAuthor(s): Frank R. Brennan, Laura Andrews, Antonio R. Arulanandam, Jorg Blumel, Jim Fikes, Christine Grimaldi, Janice Lansita, Lise I. Loberg, Tim MacLachlan, Mark Milton, Suezanne Parker, Jay Tibbitts, Jayanthi Wolf, Krishna P. AllamneniAbstractNonclinical safety testing of biopharmaceuticals can present significant challenges to human risk assessment with these innovative and often complex drugs. Emerging topics in this field were discussed recently at the 2016 Annual US BioSafe General Membership meeting. The presentations and subsequent discussions from the main sessions are summarized. The topics covered included: (i) specialty biologics (oncolytic virus, gene therapy, and gene editing-based technologies), (ii) the value of non-human primates (NHPs) for safety assessment, (iii) challenges in the safety assessment of immuno-oncology drugs (T cell-dependent bispecifics, checkpoint inhibitors, and costimulatory agonists), (iv) emerging therapeutic approaches and modalities focused on microbiome, oligonucleotide, messenger ribonucleic acid (mRNA) therapeutics, (v) first in human (FIH) dose selection and the minimum anticipated biological effect level (MABEL), (vi) an update on current regulatory guidelines, International Conference on Harmonization (ICH) S1, S3a, S5, S9 and S11and (vii) breakout sessions that focused on bioanalytical and PK/PD challenges with bispecific antibodies, ...
Source: Regulatory Toxicology and Pharmacology - Category: Toxicology Source Type: research