Franklin Vairinhos

Head of Global Regulatory Affairs
Franklin Vairinhos

Franklin leads the Regulatory Affairs efforts at Dewpoint Therapeutics, across all sites and brings over 30 years of experience in advancing drugs from bench to bedside in pharma and biotech.

Franklin started his career in Regulatory Affairs at the Canadian affiliate of Hoechst-Roussel Inc. Throughout his career, Franklin held roles of increasing responsibilities in Regulatory Affairs at Sanofi and Array Pharma in the US, mainly in oncology drug development. Most recently, Franklin served as the 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 over 25 INDs/CTAs and NDAs/MAAs, which in some cases were based on precedent setting strategies. He also has 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.

Franklin was born and raised in Australia, received his Ph.D. in Biochemistry from the University of Adelaide, South Australia and completed his postdoctoral work in Montreal, Canada. 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.

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