Russell Weiner
Executive Director and Global Head
Pharmaceuticals
Daiichi Sankyo
United States of America
Biography
Senior level biopharmaceutical professional with direct expertise in pharmaceutical and biologic drug discovery and development, clinical trial conduct and building regulated bioanalytical, molecular biomarker and companion diagnostic organizations. Over 22 years experience in regulated bioanalysis (GLP and clinical) of both pharmaceutical and immuno-modulatory/immuno-oncology (checkpoint blockers) biologic therapeutics. Directly involved in supporting the development and approval of Erbitux® (cetuximab, ant-EGFR), Orencia® (abatacept, CTLA4Ig), Nulojix® (belatacept, mutated CTLA4Ig), Yervoy® (ipilimumab, anti-CTLA4), Keytruda® (pembrolizumab, anti-PD-1) and its associated Dako PD-L1 IHC 22C3 pharmDx companion diagnostic assay. Extensive experience in project leadership, biologics/biomarker assay development, validation and global deployment (including India, China, Singapore and Japan). Led early clinical development teams responsible for transitioning five small molecule immunology/inflammation therapeutics from discovery through phase 2 proof-of-concept. Strategic thinker well versed in using biomarkers for early decision making. Recognized thought leader on regulated bioanalysis and biomarker assay development.
Research Interest
Biochemistry