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

How Can Phase I Data from the West Accelerate Drug Development in China and Japan?
The Science and Practice of Ethnobridging

Wed, May 10, 2023 11:00 AM EDT

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

Featured 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.

Speaker’s Email: Stan.Jhee@parexel.com

Dr. Oliver Fuhrmann

Executive Vice President,

Early Phase Development Parexel International

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.

Speaker’s Email: Oliver.Fuhrmann@parexel.com

Who Should Attend:

Decision makers at Sponsor companies
Clinical Operations
Commercial
Diversity, Equity and Inclusion
Executive/C-level
Health Economic and Outcomes Research
Market Access
Medical Affairs
Patient Recruitment and Retention
Regulatory
Early Phase
Phase II-III

For any technical questions please contact Nicole Valle: nvalle@mjhevents.com

Complete this form to enter the webcast. (* indicates required field)

Complete this form to enter the webcast.
(* indicates required field)