Raymond Huml
Vice Precident, Quintiles IMS, USA
Title: Biosimilars: Accelerating early clinical development
Biography
Biography: Raymond Huml
Abstract
This presentation will discuss how early clinical development with biosimilars is paramount to later development and registration success. It will provide an overview of ECD services successfully used for implementing Phase-I biosimilar trials in Asia Pacific as well as the West (e.g., US and EU) for global registrations. It will present an overview of site selection and feasibility data using a Next Generation approach driven by IMS legacy data to aid recruitment especially in tough areas to recruit patients for biosimilar trials such as the US and Europe. Finally, a model to accelerated biosimilar development will be presented that has been successfully used by one of the world’s largest providers of pharmaceutical services.