Clinical Research and Drug Development Process


Starting from patient demand, new drug R&D needs to go through molecular discovery, preclinical research, IND application, clinical research, NDA application, and post-marketing research, which not only takes a lot of time but also requires strong financial and technical support. Finding ways to improve the success rate and efficiency of clinical research and development and shorten the clinical development cycle is imperative for getting a new drug to market.

By reviewing and analyzing the entire drug research and development process, this module helps decision-makers to enhance their global awareness of clinical research and development. Furthermore, the module discusses how to properly formulate the target product profile (TPP) from the perspective of development management so as to provide effective guidance for pharmaceutical companies in planning clinical development strategies in specific therapeutic areas (such as oncology and ophthalmology).

The instructor will introduce classic cases during the workshop to help the participants fully understand the practical applications.

ワークショップ Objective

  • Master the entire process of new drug research and development as well as the stage-specific focal points and their impact
  • Establish the “begin-with-the-end-in-mind” concept, and learn how to utilize TPP in formulating the clinical development plan

Workshop Outline

  • Full picture of new drug research and development
    • Establish a full view and study the entire life cycle of new drug research and development
    • Clarify the important considerations and requirements
    • Explain the key results in each clinical research phase and their impact on the research process (molecular discovery to preclinical research, IND application, clinical research, NDA application, and post-marketing research)
  • Target product profile (TPP)
    • Understand the purposes, importance, structure, and content of TPP
    • Master the skills of developing TPP and learn how to use TPP to fulfill effective planning and decision-making in clinical research and development
    • Build a more flexible and progressive clinical development plan
プログラム| Global Clinical Development Strategy Workshop Series