Erica Kratz, PhD, is a regulatory affairs and quality executive with more than 20 years of experience leading global regulatory strategy and development quality across the biotechnology industry. Most recently, she served as Senior Vice President, Regulatory Affairs and Head of Development Quality Assurance at Denali Therapeutics, where she built and led the team from the company’s first clinical trial through the advancement of multiple programs into the clinic, including the BLA submission and FDA approval of Avlayah® in Hunter Syndrome. Prior to Denali, Erica spent a decade at Genentech, where she led global regulatory strategy for multiple oncology programs spanning early development through commercialization, including U.S. and Canadian marketing applications for Herceptin® in gastric cancer. She holds a PhD in Molecular and Cell Biology from the University of California, Berkeley and a BS in Cell and Molecular Biology from the University of Arizona.
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