Title : How to chose right Clinical Research Organization (CRO) partner when developing new cancer drug while meeting challenges of current critical trends in oncology drug development?

During the last decade there have been major breakthroughs in cancer treatment options driven by immunotherapy and most recently cell and gene products. With increased number of new cancer drug candidates entering clinical development there is elevated need for identification of best suitable clinical research organization (CRO) partner by Biopharma community. 

Presentation will cover: What defines expertise of CRO to conduct oncology clinical trials and how to evaluate depending on future product development stage to meet regulatory expectations?

How to evaluate CRO proposals for strategic execution-feasibility, risk assessment, project management and quality.

Critical elements for new drug assets developed outside of US aimed at entering US landscape.

Most optimal time during development to establish need for CRO partner and criteria for selection.

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.