Members

Dr. Shah’s CMC organization includes the development of both small molecules and biologics molecules to move them from discovery stage through pre-clinical, IND filing, Phase 1 first in human studies and towards NDA/BLA. His pharmaceutical operations organization includes both clinical and commercial Drug substance and Drug product manufacturing, packaging and labelling to support Exelixis clinical stage and marketed products. His teams have successfully taken products through the development cycle, process optimization, process validation and subsequent product launches.

Previously, Dr. Shah managed and oversaw development, optimization, validation, and launch of COMETRIQ® (cabozantinib capsules) which was approved by the FDA in 2012 and in the EU following approval by the European Commission in 2014. Subsequent to that, his teams successfully developed and launched CABOMETYX® in the US and EU 2016, where in the US, commercial product was made available to patients within 36 hours of FDA approval. Dr Shah’s clinical supplies organization supports packaging, labeling and distribution of all Exelixis ongoing and partnered clinical trials across the multiple oncology clinical study portfolio. His team has successfully provided investigational products to more than 20000 patients over the last several years. Dr. Shah’s commercial supply chain team consists of logistics, global distribution, demand and supply management. In 2016, his team was oversaw CABOMETYX launch with supplies at the distribution depot within 48 hours. Dr. Shah has previously worked at Abbott Labs where he was successfully involved with Niaspan and Simcor product launch and NDA filings. He has a Pharmacy degree from the UK and a Ph.D. in Pharmaceutics.