This symposium will address the paradigm shifts now occurring with the partnering and outsourcing models in India as a result of the evolution of global and local regulatory, scientific and business needs related to the clinical development of drugs and biosimilars. We will discuss case studies and lessons learned from conducting trials in India with a focus on biosimilars, as well as address the realities of the shifting center of the pharmaceutical world and the implications for implementing various strategies both in outsourcing as well as in-licensing and other partnering models.