Walles, Markus and Hainzl, Dominik (2019) New guidelines for the pharmacokinetic and Drug drug interaction assessments of ADCS-input to templates for IQ consortium. the excel template swill be shared at IQ consortium (TC) , na (na). na. ISSN na

Abstract

Novartis is member of IQ consortium on ADCs. Dominic Hainzl and myself represnet Novartis at Consortium to define new guidelines for Pharmacokinetic monitoring and DDI assessment of ADCs.
The final goal of consortium is to draft a white paper with cross comany recommendation. To accomplish this goal we need to populate the templates with preclinical and clinal information of ADcs. Although we have currently only 1 ADC program in clinical deveopment (PCA062) , we have not mentioned the Novartis code, nor the target. However, preclinical information about the payload (DM1) was shared at this information is already available. For other information provided information in these templates we have referred to public available information (journal articles) as listed below. We seek your approval to submit the prefilled templates to the IQ consortium.

papers from which we extracted information:

New Insights in Tissue Distribution, Metabolism, and Excretion of [3H]-Labeled Antibody Maytansinoid Conjugates in Female Tumor-Bearing Nude Rats. Walles M, Rudolph B, Wolf T, Bourgailh J, Suetterlin M, Moenius T, Peraus G, Heudi O, Elbast W, Lanshoeft C, Bilic S. Drug Metab Dispos. 2016 Jul;44(7):897-910. doi: 10.1124/dmd.115.069021. Epub 2016 Apr 27.

ADME and Safety Aspects of Non-cleavable Linkers in Drug Discovery and Development.
Walles M, Connor A, Hainzl D. Curr Top Med Chem. 2017;17(32):3463-3475. doi: 10.2174/1568026618666180118153502. Review.

Item Type:	Article
Date Deposited:	18 Jun 2019 00:45
Last Modified:	18 Jun 2019 00:45
URI:	https://oak.novartis.com/id/eprint/37791