Bin Chen
Clinical Sciences Bayer, China
Title: Demystifying opportunities and conquering challenges in the development of innovative biologics in China
Biography
Biography: Bin Chen
Abstract
Therapeutic biologics hold significant promise to achieve breakthrough innovation and to address largely unmet medical needs in many disease areas. To ensure a successful IND application and eventually get the novel biologics to the patients faster, it becomes more and more critical to streamline the transition from biologics discovery to preclinical development and then to a Fist-in-Human (FIH) study. This presentation will share with the audience Janssen’s experience in implementing key strategies and critical development activities during this stage of drug development. Firstly, a brief introduction will be given to biologic discovery process from target identification, to lead generation and optimization, to preclinical enabling, and to clinical candidate selection. Secondly, special considerations in a biologic toxicology package will be presented due to the unique characteristics of biologics related to their pharmacologic activity, structure, and production. Lastly, general considerations of biologic FIH study design and dose selection will be discussed with case studies in which PK/PD modeling approach is utilized. In summary, seamless integration of biologic discovery, toxicology and clinical pharmacology is the key to drive a successful IND application of novel biologics.