Curriculum Vitae
Full Name Hayley Lewis
Position / Job Title Senior Vice President, Operations
Affiliation Zosano Pharma
Email hlewis@zosanopharma.com
Website www.zosanopharma.com
Hayley Lewis is the Senior Vice President of Operations at Zosano Pharma, where she oversees the functional areas pertaining to CMC development and Regulatory Affairs. Zosano Pharma, located in the Silicon Valley, in California, is the first pharmaceutical company to have submitted a New Drug Application in the US, for microneedles. The NDA was submitted in December 0f 2019, and if approved, will be first and only microneedle product on the market for pharmaceutical use. Hayley has over 25 years of multinational pharmaceutical combination device/drug development and regulatory compliance experience in small and large Pharma companies, and her pharmaceutical development experience covers solid oral dosage forms, and combination products such as systemic and local inhalation products, a single entity combination injectable, and transdermal systems. Prior to joining Zosano, Hayley spent over 11 years in Regulatory Affairs at a specialty pharmaceutical company, where she was involved in the development, and eventual approval of 3 novel products. Over the course of her career, she has enabled 8 investigational products to be studied in humans, 5 of which have advanced to completion of Phase 3 trials. Hayley received a B.S. in Pharmaceutical Sciences from the University of Greenwich in England, and has attained several management diplomas from Kellogg School of Management, as well as Stanford’s Graduate School of Business.