Franklin Vairinhos

Franklin was born and raised in Australia, receiving his Ph.D. in Biochemistry from the University of Adelaide, South Australia. After completing postdoctoral work in Montreal, Canada he started his career in Regulatory Affairs at the Canadian affiliate of Hoechst-Roussel Inc. He has worked for over 30 years in pharma/biotech, with increasing responsibilities in Regulatory Affairs, mainly in oncology drug development after moving to the US (Sanofi, Array Pharma), more recently as Head of Regulatory Affairs at Axcella Health Inc, working on liver diseases and Long COVID.

He is well versed in US, Canada, EU and UK Regulatory requirements having submitted numerous INDs/CTAs and NDAs/MAAs, which in some cases were based on precedent setting strategies. He has also had some experience in clinical development and drug approval in Japan. He is highly motivated to develop novel strategies to expedite drug approvals for unmet needs and brings a wealth of experience working globally with drug development partners.

He enjoys mentoring and motivating regulatory affairs individuals to build and implement effective strategies for drug development and approval.

He enjoys traveling and gardening and lives in Watertown, MA with his husband and aussiedoodle.