Dr. Tanja Obradovic

VP, Oncology Medical Strategy ICON, USA.

Abstract Title: How to foster next wave of innovation in oncology clinical development and medical affairs strategy

Biography:

Dr. Obradovic has over 25 years of experience in oncology drug development. Her leadership in clinical development, medical affairs strategy and research collaborations was gained from contributions to development of major immunooncology assets such as Keytruda and numerous other products by large, mid-size and biotech companies. She has been part of successful early-to-late development, regulatory approvals and launches of antibodies, small molecules and cell therapy in more than 20 solid and heme malignancies and lines of therapy in over 40 countries including US, EU and Asia. She is currently VP Oncology Scientific Affairs within Medical Strategy at ICON.

Research Interest:

During the last decade there have been major breakthroughs in cancer treatment options driven by immunotherapy and most recently cell and gene products. Despite fast pace of innovation, success rates across oncology development phases 1 to 3, and from phase 3 to NDA/BLA, submission are still below 50%, with transition from phase 2 to 3 especially low at 25%. This session will focus on discussing most promising venues for development, including novel therapies, combinations, as well as critical aspects of decision making and product characteristics across phases of development and onset of medical affairs strategy planning and seamless accelerated label expansion while drive successful regulatory and practice incorporation decisions. Presentation will cover: • What defines future value of the product (with special attention to novel agents, novel combinations, and tumor indications with large unmet need) and how to evaluate across development stages to meet global expectations? • Need to establish safety and efficacy of multiple doses during early development in order to comply with FDA Project Optimus expectations and how to execute in accelerated manner.  • Most optimal time during development to establish biomarker-selected population with implications on time-to market, label extension studies and impact of policy in the US and ex US.