Strategic development of novel cancer immunotherapies – medical strategy toward regulatory success

Over the past decade checkpoint inhibitors directed against the programmed death ligand 1 (PD-L1) emerged as major therapeutic advance across numerous tumor indications. While immunotherapy with PD-L1 inhibitors achieved durable responses and long-term survival in many patients still substantial patient populations respond poorly or develop resistance thus triggering efforts to identify novel immunotherapies such as bi-specific antibodies, antibody drug conjugates and cell therapy as well as novel targeted therapies. To meet this medical need numerous monotherapies as well as combinations with PDL1 inhibitors are ongoing lending urgency to apply critical strategic approaches during clinical development. Presentation will focus on optimization aspects of: A) dosing schedule, B) minimization of safety risks and C) innovative end points to assure patient centric approach and drive regulatory success.

Dr. Tanja Obradovic has over 20 years of experience in Oncology pharmaceutical development. Her work encompasses all stages of clinical development and medical affairs gained from holding senior positions at Merck where she significantly contributed to Keytruda development, regulatory approvals and life cycle management across tumor types including melanoma, lung, women’s cancers and many other indications for over 10 years. Most recently she was leading development of drug and cell therapies at Takeda followed by leadership in oncology strategic drug development as VP of Drug Development Services, Scientific Affairs within Medical Strategy at ICON. She is currently on Advisory Boards for several Biotech companies and Consultant at Arc Nouvel Clinical Development LLC.