Mridula is a Global Program lead of Regulatory Affairs at Adverum Biotechnologies. As a lead and point-of-contact for Regulatory Affairs she ensures effective execution of regulatory projects, strategy, and interactions with FDA and global health authorities for global submissions (IND, CTA, BLA, MAA). Prior to joining Adverum, she has worked with companies such as Regeneron, ThermoFisher and SillaJen etc. Mridula has extensive experience in several therapeutic areas including Gene Therapy, Oncology and Immunology. She has more than 12 years of experience in regulatory affairs, product development and research. The focus of her career has been designing and deploying complex, multiple-market global regulatory strategies for innovative drugs products to enable business growth. Mridula has studied business program from Stanford – Graduate School of Business, Masters in Biotechnology from Georgetown University and has a certificate in Regulatory Affairs from RAPS. Mridula has authored various publications, including the Orphan Drug chapter for RAPS Fundamental of International Regulatory Affairs (4th Edition for RAC) and holds a patent on HPV cancer device (U.S. Application No.: 13/015,915; Publication number: US9689047 B2).
Conference Keynote Speaker