PAREXEL completes 100th Asian ethnobridging study

PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, announced today that it has achieved a significant milestone by completing its 100th Asian ethnobridging study, which is designed to help biopharmaceutical companies accelerate development for the Asia/Pacific market.  PAREXEL is the innovator of the ethnobridging study—an approach to determine safety and tolerability, as well as possible pharmacokinetic and pharmacodynamic differences, in target ethnic populations. The goal of these studies is to assist PAREXEL clients in saving time and development costs in their global early phase programs.

"PAREXEL created the ethnobridging study concept, which was built on decades of experience in the science and practice of ethnically-sensitive clinical programs," said Sy Pretorius, M.D., M.S., M.B.A., Corporate Vice President and Worldwide Head of Early Phase.  "Our pioneering ethnobridging approach assists clients in expediting early phase approval of compounds in certain international markets."

According to Dr. Pretorius, "The inclusion of Asian countries in global drug development strategies and registration of drugs in the Asia Pacific region have become increasingly important in recent years. To help our clients to fast-track development in Asian countries, PAREXEL applies leading-edge expertise through Asian ethnobridging studies to collect Chinese, Japanese and Korean data in the U.S. and UK for registration regionally in Asia. Achieving the milestone of our 100th Asian ethnobridging study reinforces our commitment to help biopharmaceutical companies prepare and execute global development plans for emerging regions, and bring new treatments to patients in Asia."

PAREXEL has enrolled over 3,500 subjects in Asian ethnobridging studies.  Early phase experts at PAREXEL conduct Asian ethnobridging studies at its accredited sites in the U.S. and UK.  These sites have access to an Asian population of over 1.2 million people, which allows PAREXEL to perform studies that conform to the regulatory requirements of China, Japan and Korea. PAREXEL experts have worked closely with Asian regulators to design studies, conducted outside of Asia for acceptance by the Asian regulators, that adhere to the International Conference on Harmonization (ICH) E5 guideline.  PAREXEL provides consultation on regulatory issues, protocol designs and analysis of data with relation to ethnobridging studies. The Company has a proprietary database and a dedicated enrollment team with experience in various specialized recruitment methods and access to some of the largest populations of first-generation Asians outside of Asia.