Linlin Luo

Background

About Linlin Luo

Scientific supervisor and manager responsibility in contributing to multiple successful IND and BLA submissions, including preparing bioanalytical sections (e.g, eCTD 2.7.4, 5.3.1.4 and 5.3.5) for regulatory submissions and interacting with regulatory agencies; providing scientific strategy and responses to health authority questions, assay and clinical protocol guidance; hiring, training, managing and developing direct reports and matrix reports. • Preclinical and clinical bioanalytical sciences professional with 15 years of pharmaceutical industry experience. Extensive experience in pharmacokinetic (PK), immunogenicity (IMG or ADA), and neutralizing antibody (NAb) assay development and validation (e.g, measurement of drug, ligand, anti-drug antibody and neutralizing antibody), in support of preclinical and clinical studies of bio therapeutic development using multiple platforms (e.g, MSD, ELISA, Gyros, Alphalisa, hybrid LC-MS). • Hands-on experience in immunoassay design and development; implementation and result analysis of immunohistochemical assays; biochemical and cellular biological techniques such as ELISA, MSD, ForteBio, Gyros, flow cytometry, protein purification and characterization, SDS- PAGE, Western blot, cell culture, PCR, DNA and RNA purification, and in vivo mouse tumor models. • Strong written and verbal communication skills demonstrated by manuscripts in peer-reviewed journals and presentations (oral and poster) at scientific meetings and progress reports at internal meetings. Authoring responsibilities also include response letters to regulatory authorities, BLA and IND sections, bioanalytical and clinical study reports, method validation plans and reports, and SOPs.