Jeff Alberts
Advisor Scientist-ADME, Eli Lilly and Company
The Journey of Bioanalytical Support for Peptides from Target of Interest to Post Market
Abstract
This presentation will share a case study that highlights a bioanalytical strategy to transition peptide biotherapeutics from early discovery through commercial launch. Support for critical in vitro and in vivo ADME and non-GLP toxicology studies will be highlighted along with their associated LC/MS methodologies. For discovery stages, the presentation emphasizes the importance of optimizing instrument cycle time to enhance capacity and reduce data turnaround times. Additionally, the validation of clinical methods to support development-stage studies internationally, including in the US and China, will also be discussed. At the end of the presentation, a summary of pre-clinical and clinical study statistics associated with an NDA submission will be shared.
Bio
Jeff graduated from Michigan State University in 1992, worked as a protein chemist at MSU, and then held various roles at Waters Corporation and Bristol Myer-Squib. He joined Lilly in 2003 as a Biotransformation Structure ID Chemist, later becoming the small molecule bioanalytical lead in 2017, and recently transitioned to leading ADC/AOC bioanalysis.