Innovative drugs' R&D and industrialization

Cource number: 84020022

Cource Description: This course will explain in detail the whole process of innovative drugs’ R&D and industrialization. Including how to start a new drug discovery project from the beginning to completing the lead optimization and selecting the clinical candidate; and then doing the formal preclinical studies systematically, including CMC, preclinical DMPK, GLP tox, MOA and efficacy, clinical trial plan, and further filing FDA and CFDA’s IND. After obtaining the IND approval, how to carry out first in human safety and clinical POC trials. When the drug discovery program is matured in certain degree, how to move it into industrialization is the key, including the startup of the company, fund raising, IP transfer, legal and business strategy, and future co-development with the multinational pharmaceutical companies. This course focuses on the development of small molecule innovative drugs, emphasizing the drug development purpose to solve the unmet medical needs. The course only involves some of the biologics drug development. We have invited 14 hardcore drug discovery and development experts, entrepreneurs, lawyers and VC fund partners to deliver 18 lessons. They will share a wealth of examples and lessons learned, and clearly describe the key technical details and decision-making process in the whole R&D process. So that the audiences can get an overview of innovative drug research and development and learn some of the key points.