How can Phase I data from Western medicine accelerate drug development in China and Japan? The Science and Practice of Ethnobridging

Collecting data on Japanese and Chinese populations early in development can help fast-track drug registration in these important markets and reach their patients sooner. With the right approach, learn how your trial can generate clinical data from ethnic populations living outside their native Asian countries to accelerate global product development.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/science-of-ethnobridging

Event Overview:

Ethnobridging studies collect data on Japanese and Chinese populations early in development to help fast-track drug registration in these two expanding and critical markets.

• Explore how integrating a cohort of Japanese or Chinese volunteers into SAD/MAD early phase trials can eliminate the need for a separate ethnobridging study
• Reach patients sooner in these countries with faster development
• Ensure better planning of Phase II and Phase III trials when more is known about the compound sooner
• Learn what is included within a successful and complete clinical data package to be acceptable to regulatory agencies in these countries

Key Learning Objectives:

• Recognize the value of a global, multi-ethnic approach to early-phase drug development
• Understand the intrinsic and extrinsic factors in drug response, with emphasis on ethnicity
• Review the current Chinese and Japanese regulatory requirements for data

Speakers:

Dr. Stanford Jhee
Corporate Vice President, Scientific Affairs
Parexel International

Stanford Jhee, PharmD is a clinical pharmacologist with over 30 years of pharmaceutical development experience specializing in early-phase development from first-in-human to proof-of-concept studies with an emphasis in the neuroscience therapeutic area. He pioneered the ethnobridging study concept providing ethnic sensitivity studies, allowing global development, especially in Asia, and has published over 90 manuscripts and 4 books on drug development topics.

Oliver Fuhrmann
Executive Vice President
Early Phase Development
Parexel Development

Oliver Fuhrmann holds a Ph.D. in molecular biology and has over 20 years of pharmaceutical development experience specializing in early-phase development. He has dedicated his career to strategic customer management and operational leadership roles and currently oversees Parexel's Early Phase business.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/science-of-ethnobridging