Amit Gulwadi

Bio:

Amit Gulwadi is a biopharmaceutical R&D leader focused on using data science, digital innovation, and transformation to modernize development, regulatory, and safety organizations. At Alexion, he has led initiatives spanning advanced analytics, technology enablement, process redesign, and integration efforts that help accelerate portfolio execution, strengthen risk management, and support more patient-centric clinical development in rare disease. He also serves as digital lead for rare disease, advancing innovative solutions across a range of high-value use cases. Amit is responsible for leading Data Science, Digital and Transformation of Alexion�s Development, Regulatory and Safety (DRS) functions 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, regulatory and safety operations to unlock value of data & strengthen risk posture. Post-acquisition of Alexion by Astra Zeneca (AZ), he led a very large and complex integration program to harmonize and secure access to advanced AZ capabilities across technology, analytics, geographic footprint expansion and frameworks such as RBQM to accelerate Alexion�s clinical development pipeline. Amit continues to lead numerous technology and other transformation programs across Alexion and AZ. 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. Before joining Alexion, Amit held leadership roles at Saama, Celgene, and Bristol-Myers Squibb, where he helped advance clinical innovation, analytics, patient engagement, global clinical operations and operational excellence across global development organizations. His work has included building AI-enabled analytics capabilities for clinical trials, leading large cross-functional teams, and driving data-informed decision-making across the pharmaceutical value chain. Amit brings a practical perspective on how innovation can translate into measurable impact for patients, teams, and clinical programs.