Day 2 :
Sr. Director Quintiles IMS, Canada
Oxana Iliach is a PhD in Pharmaceutical Science from St. Petersburg Chemical and Pharmaceutical Academy, Russia and the Senior Director Global Regulatory Strategy and CMC at the Biosimilar Center of Excellence, QuintilesIMS, Canada. She has more than 15 years’ experience in healthcare industry, including the last 10 years in regulatory affairs. Her expertise lies in the development of global regulatory strategy for biosimilars with the focus on overall quality and CMC compliance. She has a particular focus and expertise in regulatory and CMC requirements for biosimilars and regularly presents and writes on the topic. Presently, she is a Professor at Seneca College of Applied Arts and Technology, Toronto, Canada and a Member of CAPRA (Canadian Association of Professionals in Regulatory Affairs) and RAPS.
Growing numbers of companies are pursuing a global development of biosimilars for multiple markets. This global approach presents multiple challenges from selecting a reference product for biosimilar development to designing and conducting a clinical trials including a marketing strategy development and pharmacovigilance program. How to ensure that the global development results in successful marketing authorization in each jurisdiction? How to incorporate specific country requirements for biosimilar development at the early stages of biosimilar program? The strategic approach to the alignment of product development, regulatory activities and clinical program provides an answer to these questions. This presentation will discuss strategy of the biosimilar product development through earlier development to regulatory approval and provide some practical examples.
Senior Medical Director Quintiles IMS, India
Charu Manaktala is an MD in Pediatric Medicine, the Senior Director, Strategic Drug Development (Asia) and Head of Asia Pacific Biosimilars Centre of Excellence at QuintilesIMS, Canada. She has over 20 years of work experience in the healthcare and pharmaceutical industry and has worked in all stages of clinical drug development from Phase-I through commercialization. Her experience spans a variety of disciplines including drug development, medical writing and pharmacovigilance. She has comprehensive experience in clinical development of pharmaceutical/biopharmaceutical products and advises biotechnology companies on region specific and/or global clinical strategies for the development of biopharmaceutical products with a special focus on biosimilars.
Clinical development of biosimilars is an expensive and time consuming undertaking. The biosimilars space continues to evolve rapidly and presents a number of unique challenges and fierce competition. There are as many as 20 biosimilars in development for some of the top-selling biologicals creating an intense race for the sponsors, especially those wishing to enter the western markets. To avoid any delays, biotech companies need solid clinical development plans built on the latest regulatory guidance with intimate knowledge of the clinical trial landscape. This presentation will discuss how companies could design their clinical development plans to meet the western regulators expectations. It will share insights on determining the extent of clinical data requirements, design of clinical studies, considerations on the study population/indication, endpoints, evaluation of risk of immunogenicity and designing global development programs. Further, the presentation will share insights on efficient operational delivery of the safety and efficacy studies and outline best practices for accessing and retaining patients in biosimilars clinical studies.