Samir Shah

Dr. Shah guides teams on regulatory strategies to achieve worldwide approval of drug/device combination products, including novel products containing software and electronics, across all therapeutic areas. His approvals include the first three integrated smart/digital inhalers, the DIGIHALERS. He currently works at AstraZeneca and previously worked at Teva Pharmaceuticals. Prior to joining regulatory, he was a formulation scientist at Merck / Schering-Plough for respiratory and nasal products. Dr. Shah earned his B.S. from Case Western Reserve University in Polymer Science Engineering and a PhD in Biomedical Engineering from Wake Forest University School of Medicine/Virginia Tech. He also enjoys sharing tips on using technology to learn faster, improve productivity, and visualize complex ideas, all crucial to obtaining regulatory success with novel delivery platforms.