Anne Keane
About Anne Keane
Anne Keane serves as the Senior Vice President of Regulatory and Quality at Amunix Pharmaceuticals, bringing extensive experience in regulatory affairs across various therapeutic areas. Her career includes leadership roles at several pharmaceutical companies and a strong academic background in law and biology.
Current Role at Amunix Pharmaceuticals
Anne Keane serves as the Senior Vice President of Regulatory and Quality at Amunix Pharmaceuticals. She has held this position since 2020, contributing to the company's regulatory strategies and quality assurance processes. Her role involves overseeing regulatory compliance and ensuring that the company's products meet the necessary standards for approval in various markets.
Previous Experience in Regulatory Affairs
Prior to her current role, Anne Keane held several significant positions in regulatory affairs. She worked at Lyell Immunopharma as Vice President of Regulatory Affairs from 2018 to 2020. Before that, she was Vice President of Regulatory and Clinical Quality Assurance at Achaogen from 2014 to 2018. Her earlier experience includes roles at Genentech Roche and Jazz Pharmaceuticals, where she managed regulatory affairs in oncology and neurology, respectively.
Educational Background
Anne Keane earned a Bachelor’s degree in Chinese and East Asian Studies from the University at Albany, SUNY, graduating Summa Cum Laude. She furthered her education at the University of Washington School of Law, where she obtained a Doctor of Law (JD) with a focus on Asian and Comparative Law. Additionally, she studied Molecular Biology, Cancer Biology, and FDA Law at Harvard Extension School, achieving multiple doctorates.
Expertise in Regulatory Interactions
Anne Keane has extensive experience in leading regulatory interactions and drug approvals in the US and EU. She has successfully managed New Drug Applications (NDAs), supplemental Biologics License Applications (sBLAs), and Investigational New Drug (IND) submissions across various therapeutic areas, including oncology, infectious diseases, and cardiology. Her expertise includes harmonizing orphan applications for specific populations.
Professional Development and Certifications
In addition to her formal education, Anne Keane completed the Physician Assistant Program at Albany Medical College, achieving certification. Her career has been marked by a commitment to professional development, particularly in areas related to regulatory affairs and quality assurance in the pharmaceutical industry.