COSTA MESA, Calif.,/PRWeb/–WCCT Global further expanding ability to conduct ethnobridging studies with the addition of Michell Ababa, MD to the WCCT Global Team. Ababa will serve primarily as principal investigator for many of the Ethnobridging studies already in the pipeline for 2013. Dr. Michelle Ababa has an extensive background working directly as the principal investigator in many ethnobridging studies including phase 1 Japanese bridging clinical trials and Chinese bridging clinical trials including first in human trials with both small molecules and biologics.
WCCT Global is excited to have someone with her expertise in asian bridging clinical research to help spearhead the company’s efforts towards expanding the amount of ethnobridging studies that the company takes on each year. Ethnobridging studies are an important aspect of clinical research in that studies of this nature can help to expedite the drug approval process on a global scale. Furthermore, Asian bridging studies such as the ones conducted by WCCT can contribute to finding important information about new chemical entities, in that the results can reveal how the drugs will affect people of different geographic regions and ethnic backgrounds.
With the pressures of making the drug development process more cost effective and time efficient, most multinational pharmaceutical sponsors are developing strategies to accelerate global development by planning to incorporate Asian data in their Phase I research programs program so that by the time a NCE reaches Phase III the program is being run globally and including Asian sites.
For sponsors who are interested in increasing the value of their NCE asset, WCCT can contract and draft a complete phase I program development that incorporates bridging into their program. In terms of innovative study design, it is not uncommon to add small cohorts of Korean or Chinese subjects in addition to Japanese subjects to ethnobridging studies depending on the company goals for the compound.