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. It was previously a part of the M3 group since March 2015.
“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, including using its network of healthcare professionals to evaluate drug market potential and positioning. It can identify and recruit patients, select trial sites and manage clinical trials using electronic methods. After that, the company can help with commercial launch preparation and product communications with physicians to ensure accurate understanding of product, 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.
By Angus Liu
Source: Fierce Biotech
A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness. Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday.
Moderna’s recent chief financial officer debacle—in which Jorge Gomez departed on his second day on the job—raised questions about the company’s hiring process given its rush to global biopharma prominence. The most obvious one: How was it possible for Gomez to be hired when he was under investigation by his previous employer, Dentsply Sirona of Charlotte, N.C.
Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by. The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.”