Session – Preparation and Process Validation Practices for Drug Product Development & Manufacturing and Concerns Surrounding Outsourcing Partners Praveen Prasanna is currently Senior Director and Head of Biologics Development and Manufacturing at AVEO Oncology. He is responsible for the development of AVEO’s biologics pipeline including Ficlatuzumab and AV-380. Praveen previously worked at ImmunoGen as Director, External Manufacturing and Supply Chain and Shire as Associate Director and Principal Engineer. Praveen facilitated the process transfer, validation, routine manufacturing initiation for four commercial products including liquid vials, lyophilized vials, and pre-filled syringes. Praveen is active in the Parenteral Drug Association and was a co-author of Technical Report 60. His interests are phase appropriate QbD implementation and external manufacturing best practices. Praveen Prasanna received his Bachelors and Masters of Engineering from McGill University and his PhD in Chemical Engineering from Tufts University.