Dinesh de Alwis

SVP, Head of Clinical Drug Development | Generate Biomedicines

Dinesh de Alwis has over 25 years of global experience in the pharmaceutical industry, working with large and small molecules from discovery to regulatory filing and post marketing. He is currently SVP, Head of Clinical Drug Development at Generate Biomedicines and has responsibility for all aspects of clinical development and IND submissions, across immunology and oncology therapeutic areas. He has been involved in building the clinical development group from scratch and bringing forward four monoclonal antibodies into the clinic (healthy volunteers and patients). Dr de Alwis was previously an Associate Vice President in Quantitative Pharmacology within Oncology Early Development at Merck. During the 10 years at Merck, Dinesh played a significant part in the early oncology dose finding and registration of Keytruda for Melanoma, NSCLC and multiple other cancer indications including the first tumor agnostic biomarker (e.g MSI-hi) approval for cancer using a basket trial design. Dinesh is considered a global expert in his field and has extensive drug development and regulatory experience with multiple modalities such as mAB’s, Antibody drug conjugates, oncolytic viruses, bi-specifics and cancer vaccines and has played a significant part in multiple oncology programs in early and late development. He has also been an opinion leader in the field of oncology dose finding and model informed drug development and presented at multiple FDA-AACR workshops and an invited speaker at the Oncology Office of Center of Excellence FDA. Before Merck, Dinesh held several leadership and scientific roles at Eli Lilly and Company for 15 years and led the PK/PD Group in the UK from preclinical to late development across several therapeutic areas. Dr de Alwis has published over 50 peer reviewed papers and received his PhD from the University of Manchester, UK in the field of Population PK/PD