Introduction

Bridging Studies

Phase I studies involving both Japanese and White volunteers are a key element for a rapid global drug development strategy. Collecting "bridging data" in the early stages of global clinical development with studies in Japanese volunteers conducted outside Japan can serve two purposes:

• Provide bridging data from West to East or vice-versa
  i.e. pharmacokinetic comparison
• Contribute to clinical studies for Japanese registration package
  i.e. first-into-man, high dose safety studies, interaction studies, bioequivalence with marketed formulation

FOCUS can provide pharmaceutical and biotech companies a more efficient way to conduct ICH-E5 compliant bridging studies outside Japan. This approach will allow our clients to make informed decisions sooner on the global potential of new drugs, which is critical to enhancing product pipeline value.

The FOCUS experience shows that Phase I bridging studies

• can be successfully done outside Japan
• are acceptable to the Japanese authorities
• are cost-competitive to the development in Japan

 Relevant links

ICH Guideline E5: Ethnic Factors in the Acceptability of Foreign Clinical Data
MHLW: Japanese Ministry of Health, Labour & Welfare
Questions & Answers on ICH-E5 by MHLW

Please contact claudia.tamura@focus-cdd.de (Japanese speaking):
Direct: +49 (0)2131-155-301
Fax: +49 (0)2131-155-394

Who is FOCUS?

FOCUS Clinical Drug Development, split in 1992 from SmithKline Beecham, is a privately owned Contract Research Organisation (CRO) with a successful track record in the reliable performance of most complicated and creative early drug development.

FOCUS offers the service of 120 employees located in Neuss/ Düsseldorf, Germany (Headquarters, Phase I-II Clinical Pharmacology Unit), Heidelberg, Germany (Immunology Lab), Moscow, Russia (Phase I-III Clinical Research Unit) and Tokyo, Japan (Representative Office).

Our scientific expert team provides customised fast-track creative solutions from first-into-man to Proof of Concept, accessing special patient populations of any indication and disease stage.