In an effort to support development of today’s novel therapies and help clients get faster clinical trial results, we recently expanded the Asia-Pacific footprint by becoming the first major central laboratory in Japan to add anatomic pathology and histology (APH) services at its Kawagoe facility. Learn more about how this investment will help improve the drug development experience for sponsors in Japan.
The importance of flexible, fast solutions in drug development
“As the complexity of drug development grows, it’s imperative we invest in additional resources that will help advance science and meet patients’ needs,” said Vincent Drouillon, Vice President, Global Testing Services, Medical Affairs and Sciences, Drug Development.
“We know that physicians rely on our interpretation of biopsies to decide on patient inclusion in clinical trials, choose the right molecule, determine the appropriate dosage, and follow progression of a disease and efficacy of a treatment,” he added. “APH services are especially important to make significant progress in oncology and precision medicine.”
Central Labs Services supported by strong partnership
Following the Ministry of Health Labor and Wealth (MHLW) requirements, we partnered with a locally based company in 2010 to offer central laboratory services in Japan. The company chose to collaborate with BML, one of the largest and most trusted diagnostic labs in Japan. The successful partnership has even been dubbed “CB Lab”.
Just like other of our central laboratories at strategic global locations, the team in Kawagoe, Japan is aligned with the global standard operating procedures (SOPs) to ensure data combinability of resulting data. The lab has validated assays for HER2, as well as PDL1 IHC with other assays forthcoming. Highly skilled histotechnologists and pathologists in the dedicated space offer a number of services to clients, including:
- Tissue processing for wet biopsies
- Paraffin block embedding
- Block sectioning
- Hematoxylin and Eosin (H&E) staining
- Immunohistochemistry (IHC) services
The company’s in-country, “white glove” APH services in Japan are an important element in ensuring drug development sponsors’ success and ultimately bringing much needed treatments to the patients they serve. Over the next year, there are plans to build on this momentum by adding genomics services in Kawagoe. By offering an even wider range of solutions in Japan, we can ultimately help shorten turnaround times and increase the efficiency of today’s clinical trials.