Antibodies

Biography

Hazel Gorham, PhD, Director, Biosimilars Development, Scientific Affairs, has 26 years of experience in both academic and pharmaceutical research/industry across a wide range of roles including developing Clinical Development Plans for biosimilars. Dr. Gorham has experience in all aspects of biosimilar development including study design and regulatory agency discussions. She has experience in all aspects of clinical trial project management and has managed the conduct of multiple Phase I through IV clinical trials and post-marketing studies across geographical regions and differing therapeutic areas. Dr Gorham completed her post-doctoral graduate studies in microbiology at the University of Warwick, UK.

Abstract

Abstract : Challenges in demonstrating biosimilarity and interchangeability of biosimilar products