BBK Worldwide, a US-based company that provides patient recruitment and e-business solutions to the clinical R&D and marketing segments of the pharmaceutical, biotechnology and medical device industries, is tackling Japan’s notorious drug lag by setting up a wholly owned subsidiary in Osaka.

The new subsidiary, BBK Worldwide – Osaka, GK, will help Japanese companies in these sectors – including contract research organisations (CROs) and site management organisations (SMOs) – get their products to market quicker through more rapid and effective patient enrolment and retention for clinical trials.

According to Japan’s Pharmaceuticals and Medical Devices Agency, it takes on average 2.5 years longer for a drug to become available in Japan than in the US and Europe.

BBK’s interviews with medical directors and leaders of clinical trial teams at a number of the major Japanese pharmaceutical companies revealed that four of the top five reasons for delays were inefficient patient accrual; contracting with sites; attitudes of patients or referring physicians; and insufficient or inaccurate feasibility planning for enrolment.

“When we heard these concerns, we knew that we could offer real value to the Japanese marketplace,” commented the company’s co-founder and president, Bonnie Brescia. "While we believe we can offer expert consultation and services immediately for study sponsors with recruitment needs, we also recognise that, ultimately, to fully maximise our effectiveness … we need to come at these patient recruitment issues with insight,” she added.

That calls for an understanding of local culture, traditions, and attitudes about health and healthcare. “It’s a process we found to be invaluable after opening our offices in London and in Prague,” Brescia pointed out.

BBK Worldwide – Osaka will be strategically located in a city that is “fast becoming the centre of Japan’s biotechnology industry”, the company noted. In the autumn of 2008, the local prefectural government launched an initiative to form a biomedicine joint research group, including companies and universities in the fields of biomedicine and pharmaceutical development. Several major global pharmaceutical companies are also based in Osaka or have established operations there.

The new subsidiary also chimes with a five-year effort to regenerate the environment for clinical trials in Japan, including subsidies for medical institutions, resourcing initiatives, standardisation, a review of guidelines on ethics approvals, the development of centres for regenerative medicine and the promotion of trial site networks.

As part of this initiative, announced by the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) in March 2007, the MHLW in September 2007 published a report entitled Basic Principles on Global Clinical Trials, which detailed methods for harmonising clinical study conduct between Japan and other countries, BBK observed.

“Here, BBK can also offer assistance,” commented Andrew Sacher, general counsel and the prime mover behind BBK Worldwide – Osaka. “With its extensive range of recruitment tools and international experience – previously unavailable from a company operating in East Asia – BBK has the potential to be a catalyst for even greater industry growth, and to foster novel ideas for clinical trial enrolment initiatives.”