Manish S. Yadav
Head, Clinical Research and Bioanalysis
Alkem Labs Ltd, India
Having more than 15 years of Bioanalytical and Clinical research experience, Manish is considered authority in bioanalytical science from APAC region. Currently, he is heading CRO, Alkem Labs Ltd, Mumbai, and contributing to 3 harmonization teams-A1, A6 & A9 of GBC, BSAT-APA, CVG-Canada, CPhI Conferences, Omics group and various international organizations as speaker and/or organizing committee. He has delivered >50 invited talks in national and international conferences. Moreover, Manish is actively involved in research and published >35 original research articles, He is serving as reviewer to JPBA, JCS and JBB, and reviewed >50 manuscripts as on today. Manish has handled >375 molecules and 850 BA/BE studies, 20 Clinical Trials and a few Phase I studies. He was the key player in setting up and run Bioanalytical Labs of Aurobindo, GVKBIO and Veeda CR, Cadila & Alkem; and CROs like GVK-BIO and Veeda CR, and also executed Aurobindo, GVK and Veeda CR’s first HPLC-MS/MS experiment.
Regulatory and Discovery Bioanalysis using LC-MS/MS
Bio-assay Reproducibility in long run (Bio-transformations, ISR, ISS, Investigations, CAPA)
Endogenous and Exogenous Biological components associated Matrix effects
Role of Bioanalytical science to its allied sciences like Formulation Development and Drug Development