Umang S. Shah

Dr. Shah joined Veloxis in November 2021 as Vice President of Regulatory Affairs. He has over 25 years’ experience in the pharmaceutical industry as a scientist, research fellow, and regulatory expert in small molecules, biologics (natural proteins, recombinant proteins and peptides, viral and nonviral gene therapy, blood and related products, vaccines) and devices.

Dr. Shah has provided regulatory expertise, insight, know-how, and leadership in the areas of current and developing regulatory policies, management of regulatory research functions (Division of Biological Standards and Quality Control), and establishment of research collaborations (Health and Human Services).

At Novartis Vaccines, Dr. Shah led the global registration and approval of the first cell-based influenza vaccine (Flucelvax). Subsequently at Merck he was responsible for leading the approvals of Zinplava (bezlotoxumab, monoclonal antibody for reducing recurrence of clostridium difficile infection) in several regions of the world, including the US and EU, and also led the approval of biosimilar Insulin Glargine (Pen Auto-Injector and vial) in the US and EU.

Most recently at Kedrion Biopharma, Inc., Dr. Shah led programs for orphan and rare disease indications, driving activities through TPPs, input into clinical development plans, protocol designs, and assessment of study results to meet regulatory and scientific objectives.

Dr. Shah earned his PhD at the University of Maryland, his MBA at the University of Michigan, and his MS from Johns Hopkins University. He has 4 patents, over 6 publications in peer-reviewed journals, several book chapters, and contributed as instructor in eLearning programs. He is also a registered pharmacist in New Jersey, North Carolina, and Georgia.