Dakshina Reddy

As Head of Global Regulatory Strategy and Operations at the Bill & Melinda Gates Medical Research Institute, Dakshina Reddy, MSc, and his team develops and implements innovative global regulatory strategies that support accelerated product development, playing a critical role in helping to advance drug and vaccine candidates toward licensure globally.

Dakshina is a regulatory professional with over 25 years’ experience in drug regulatory affairs and clinical research. He has expertise in global drug regulatory strategy, drug development and regulatory life-cycle management. He is experienced in working with leading Regulatory Authorities including US FDA, EMA, PMDA, Health Canada, as well as emerging regulatory bodies in developing markets.

Prior to joining Gates MRI, Dakshina held various positions of increasing responsibility, where he contributed towards growing and developing regulatory strategy and establishing teams, leading regulatory programs for expedited review and market approval as well as shaping regulatory markets that enabled increased access. He led and achieved multiple approvals in the US, EU, Japan, Canada, Brazil, and Mexico. In his career he worked across a wide range of regulatory therapeutic fields that included Cardiovascular, Metabolism, Respiratory, Neuroscience, Oncology, Immunology and HIV.

Daksina previously held positions at Altimmune Inc., Galectin Therapeutics, Novartis Corporation, Amgen, AstraZeneca, and Merck KGaA. He holds a degree in Pharmacy from Rhodes University, South Africa and a Master of Science degree in Medicine from the University of the Witwatersrand, South Africa and continues to be a member of several professional regulatory organizations.