Amit Gulwadi

Vice President- Head of Transformation, Alexion

Amit's Session

[September 9, 2022]
10:15 AM EST
Theme: Leveraging RBQM in Ways You Never Envisioned (Quality, Safety Review, etc.)

About Amit:


Amit is responsible for leading the transformation of Alexion’s clinical development operations and Quantitative sciences (DOQS) which involves use of several cutting edge technology, analytics,  partnership programs with a variety of partners and process redesign with a goal to accelerate the execution of the portfolio, drive patient centricity into clinical development, unlock value of data& strengthen risk posture. Post-acquisition of Alexion by Astra Zeneca (AZ), he leads the post-day 1 integration activities for Clinical Development to harmonize and secure access to advanced AZ capabilities across technology, analytics, geographic footprint expansion and frameworks. In addition, he is the Digital lead for rare disease, where he is responsible for the development and execution of innovative digital efforts for heterogenous use cases in the rare disease.

Prior to joining Alexion, Amit was the head of Clinical Innovation and Product Development for 2 years at Saama Technologies where he led the build of AI-enabled analytics platform for Risk Based Monitoring, Operational and clinical analytcs with unique innovations such a virtual assistant for exploratory analysis, smart data query etc. The platform is used by 40+ customers in the bio-pharmaceutical industry. For his leadership and innovations he was awarded the PM360 “Elite” Disruptor award for 2020.

Amit was the Executive Director for Global head of Clinical Operations , Analytics, Patient Engagement/Recruitment and Analytics at Celgene for 4 years responsible for operational execution of the development portfolio across all the Celgene franchises and leveraging analytics and cutting-edge patient engagement/recruitment strategies and tactics to support the Celgene portfolio.

Prior to joining Celgene, Amit worked for Bristol-Myers Squibb (BMS) for 16 years in different clinical operations roles and regions including Asia-pacific. He has lead large multi disciplinary teams for successful regulatory filings (NDA and BLA in US and EU) teams in immunology and virology. In his last role at BMS, he was the head of the North American regional operations group at BMS where he was instrumental in introducing use of analytics in driving data driven decision making to improve operational performance.

Amit holds a Masters Degree in Neuropharmacology from Massachusetts College of Pharmacy in Boston, Masters in Pharmacognosy from University of Mumbai (India) and Bachelors in Pharmacy from University of Pune (India).