Chiltern has acquired Japanese CRO Integrated Development Associates (IDA), strengthening its presence in Asia.
Founded in 2004, IDA provides drug development and commercialization consultancy for projects that include Japan filings in the process.
“The acquisition of IDA is driven by our commitment to establish a substantial presence in all major global markets and support our clients with clinical development capabilities worldwide,” said Chiltern CEO Jim Esinhart, Ph.D., in a statement. “IDA will enable us to grow in the APAC region through well-established relationships and local expertise and knowledge.”
The company offers a comprehensive package of services mainly based in Japan. It develops market strategies with IT-driven capabilities, evaluating drug market positioning. It can identify and recruit patients, select trial sites and manage clinical trials using electronic methods. The company can help with regulatory preparations and such interactions with authorities, and after that, commercial launch planning, as well as supporting post-marketing trials.
In 2015, Japan's Ministry of Health, Labor and Welfare rolled out an accelerated regulatory approval pathway called “Sakigake” (or the “Forerunner Initiative”), aiming at speeding up approvals for drugs that address high, unmet medical needs. IDA says it became one of only five companies to have obtained that designation and is still the first and only CRO to maintain it for a client abroad.
With professional support from a local CRO, Chiltern could be better positioned to integrate Asia, especially Japan, into global drug development. The company has been active in 47 countries, Japan included. The tie-up, financial details not disclosed, could in return open opportunities for Japanese pharma companies to enter a wider market with Chiltern’s global reach.
Besides Japan, IDA also has staff based in South Korea and an office in Manila, the Philippines. It will operate as a wholly owned subsidiary of Chiltern and be renamed as “IDA, a Chiltern Company.” Its founder and CEO, John Winebarger, who has more than 30 years of experience working in Japan, will continue to lead the team there.