Mike Eby

WORK HISTORY

EDUCATION

SKILLS

ABOUT MIKE EBY

Bioassay expert with several GxP bioassays on control systems (see Poster and Patent sections for my Genentech work). For 23andMe, I was working on target selection and validation of immune-related genes from 23andMe\'s GWAS/PheWAS data for early-stage drug development with an emphasis on making QC-ready bioassays and supporting orthogonal primary bioassays for drug candidate selection.I most enjoy cell line engineering to generate QC-ready bioassays as early as possible not only to make better drugs for patients, but also to save time and money in development. Using crenezumab as an example of why earlier is better, I had been tasked with generating the regulatory-required bioassay for crenezumab while in Ph3 (see Patent section). With my assay, we discovered issues with new higher-yield lots of the late-stage drug that were NOT seen in the characterized/validated binding assays used through Ph2 - Delaying generating the characterized/valdiated bioassay until Ph3 proved to be expensive and a waste of resources. ELISA assays are generally faster to validate, but they cannot address important relevant functional information (e.g. interaction w/ the plasma membrane, co-receptor interaction(s), hyperpotency of HMWS/LMWS impurities in DS/DP, etc). Had we had the assay in place in Ph1/2, we could have made a proper higher-yield biosimilar of our own drug.A well-made QC-ready reporter cell line is easy to use, captures a major mechanism of action and, ideally, should be well characterized in early stage research to enable consistency through commercialization. If possible, a well-characterized orthogonal primary cell-based assay should also be in place before Ph1. This is what I do for my metabolism and immunology projects at TCG Labs Soleil.