COSTA MESA, Calif., Dec. 19, 2012 /PRWeb/ — WCCT Global, LLC, a contract research organization (CRO) supporting Phase I – IV biopharmaceutical and device development, today welcomes Michelle Ababa, MD back to the medical team after four years. Ababa will serve primarily as principal investigator for many of the Asian Bridging trials already in the pipeline for 2013. Dr. Michelle Ababa has an extensive background working directly as the principal investigator in many ethnobridging research studies including phase 1 Japanese ethnobridging clinical trials and Chinese ethnobridging clinical trials including first in human trials with both small molecules and biologics. Her experience in pediatrics, asthma and HCV early development trials also fits well with the WCCT Global research experience portfolio. She has a strong background in family medicine and is board certified which has led her to work with well-known organizations. Her expertise in early phase ethnobridging clinical trials is a key asset to the team. Kenneth Kim, MD, WCCT Global CEO said, “I am pleased to have Dr. Ababa re-join our team to further expand our early clinical development capabilities here at WCCT Global”
WCCT Global’s Past Ethnobridging Clinical Trials Experience:
In one of the largest Ethnobridging Clinical Trials ever, WCCT, as a single site, recruited 26 Japanese, 26 Caucasian, 26 Asian Indian, 26 Korean, 26 Chinese, 26 Filipino, and 26 Vietnamese volunteers for a rosuvastatin study. This study, along with other data generated, resulted in a label change for rosuvastatin stating that Asians, but not Asian Indians, needed to be given half the dose as compared to Caucasians.
For sponsors who are interested in increasing the value of their New Chemical Entity asset, WCCT Global can contract and draft a complete phase I program development that incorporates Asian 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 an ethnobridging trial depending on the company goals for the compound.