5th mRNA Process Development & CMC Summit

After receiving his Ph.D. in Chemistry from the University of Virginia, USA, Gautam held academic faculty positions at the University of Florida, Mayo Clinic and Hamilton College before moving to pharmaceutical industry. During the 27 years that Gautam spent in pharmaceutical industry, he headed R&D departments and groups at Merck, AstraZeneca and MedImmune (AstraZeneca Biopharmaceuticals). For the past several years, Gautam has focused his efforts on global health initiatives. He is a CMC Subject Matter Expert with the Gates Foundation and has been associated with other global health organizations such as CEPI, PATH and the International Vaccine Institute. Gautam is a scientific expert in development of analytical and biophysical methods that are essential to batch release and characterization of vaccines and biopharmaceuticals. His expertise extends to rational formulation design, as demonstrated by delivery of several safe and effective formulations to clinical trials for recombinant protein based VLPs and attenuated viral vaccines as well as therapeutic proteins and oncolytic viruses. More recently, Gautam has been involved in advisory roles on projects emerging from the newer vaccine technologies, with a focus on analytical characterization and assays for mRNA vaccines. Apart from his extensive work on vaccines and biologics, Gautam led biochemistry, biophysics and protein science teams in target-based discovery of antibacterial therapeutics. He has an extensive record of highly cited publications including original research papers, review articles and book chapters.