Speakers

Andy Aguanno is Associate Director, Product Lifecycle Management (PLCM) Biosimilars and Liquid Products at Apotex, where he leads a regulatory affairs team responsible for the lifecycle management of biosimilars, combination device products, and liquid dosage forms. With nearly 30 years of pharmaceutical industry experience, Andy has held roles spanning Quality Control, Research & Development, and Regulatory Affairs. He has extensive expertise in global regulatory strategy and submissions, having supported product approvals across North America, Europe, Australia, and ASEAN markets. His experience includes biosimilars, sterile injectables, oral solids, topical products, ophthalmics, oral suspensions, and nasal sprays, with a strong focus on ensuring regulatory compliance and product lifecycle excellence.