- An overview of biological products and how they differ from small molecule drugs. - Identify potential complexities & strategies in designing a Biosimilar Development Program - Examine the regulatory framework for approving biosimilar products - Review the FDA Regulatory pathway for Biosimilars: Case Study
Dr. Paula O’Connor Paula O’Connor, MD, is a hematologist oncologist with significant clinical expertise in Oncology drug development. She has exceptional leadership skills and a strong record of accomplishment, delivering results in over 15 years working in the biotechnology field. Most recently, Paula has served as the Executive Vice President of Clinical Development at Coherus Biosciences, a company dedicated to developing biosimilars in Oncology and Immunology. Prior to joining Coherus, Paula held positions of increasing responsibility within Clinical Development and Medical Affairs at several biotechnology companies focused on Oncology, including Medivation, Genentech, Onyx Pharmaceuticals and Clovis Oncology.
She served as the Global Development Leader, responsible for the clinical development strategy and implementation of several high profile assets, including Rituxan and Tarceva, and for the investigational agents, Talazoparib and Oprozimib. In addition to leading clinical development programs, Paula has spearheaded numerous post-marketing initiatives including disease and treatment registries, expanded access and Investigator Initiated Trials programs; all aimed at addressing critical clinical data gaps to enhance commercialization.