I am a pharmacist by training from Mumbai University and have a Masters in Regulatory Affairs from Northeastern University, Boston. My Regulatory experience includes working in this field for 11 years starting with being a Regulatory liaison with FDA for Sun Pharmaceuticals for their generic portfolio. I moved on from the generic side to the innovator side as part of GlaxoSmithKline’s US Regulatory lead for their Respiratory and Gastrointestinal pipeline. I was always passionate about working in the oncology space which led to my roles as US and Global Regulatory leads for Boehringer Ingelheim and AstraZeneca most recently where I am the Regulatory Affairs Director for their Phase 3 assets. My hobbies include traveling and painting!
Conditional oncology drug approvals: A sponsor’s perspective on the evolving landscape of FDA accelerated approvals
The FDA’s accelerated approval (AA) pathway is an important regulatory mechanism that allows patients with serious or life-threatening conditions, potentially earlier access to treatments than under a standard, regular approval development pathway...