BBK Worldwide Establishes Wholly-Owned Subsidiary in Japan

Newton, Mass., U.S. ⎯ BBK Worldwide, a global leader in patient recruitment for clinical trials, has announced the opening of BBK Worldwide – Osaka, G.K., in Osaka, Japan. The company will be committed to supporting Japanese pharmaceutical, biotechnology, and medical device companies, as well as CROs and SMOs, to help these groups more rapidly and effectively enroll and retain patients as participants in clinical research studies.

Throughout the world, the single most costly delay in bringing new treatments to market is the slow enrollment of clinical trials, with each day a trial doesn’t enroll potentially equivalent to millions of dollars in lost revenue due to treatment patent limitations. Moreover, it takes an average of 2.5 years longer for a drug to become available in Japan than in the U.S. or Europe, according to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Understanding the primary causes for this specific delay was the first step for BBK in exploring the Japanese marketplace, according to company co-founder and president Bonnie Brescia. “We conducted in-depth interviews with medical directors and leaders of clinical trial teams at many of the major Japanese pharmaceutical companies,” said Brescia, “And we found that four of the five top reasons for delay were issues that we have solved for our clients’ studies in more than 30 countries throughout the world. Inefficient patient accrual, contracting with sites, attitudes of patients or referring physicians, and insufficient or inaccurate enrollment feasibility planning-when we heard these concerns, we knew that we could offer real value to the Japanese marketplace.”

“While we believe we can offer expert consultation and services immediately for study sponsors with recruitment needs, we also recognize that, ultimately, to fully maximize our effectiveness – and our clients’ return on investment – we need to come at these patient recruitment issues with insight,” continued Brescia, “The kind of insight that only comes from understanding a country’s or region’s culture, traditions, and
attitudes about health and healthcare. It’s a process we found to be invaluable after opening our offices inLondon and in Prague.”

-moreBBKWorldwide – Osaka, G.K. / 2 /BBK Worldwide – Osaka, G.K., will be strategically placed in the city that is fast becoming the center of Japan’s biotechnology industry. In the fall of 2008, the local prefectural government launched an initiative to form a biomedicine joint research group, including firms and universities in the fields of biomedicine and pharmaceutical development. Several major global pharmaceutical companies are also based in the city, or have established operations there. “Osaka seemed the ideal place to establish the operational base for our building of bridges-between recruitment barriers and enrollment solutions, and between cultures and business practices,” said Jeremy Buchman, who will head up the Osaka office. “And, it is an optimal location from which to help operationalize our patient recruitment efforts on behalf of our clients throughout the Asia-Pacific region.”

This past fall, JETRO (Japan External Trade Organization), an official government organization, began consulting closely with BBK, helping the company with registration, visa preparations, and meeting arrangements with industry organizations in Osaka. “We are very excited about BBK establishing a presence in Japan. We’re certain that BBK’s knowledge and experience in patient recruitment will have a positive effect on the Japanese clinical trials marketplace.

We truly hope that BBK has continuous success,” said Taku Sato, Director of Business Development, JETRO New
York.

The opening of BBK Worldwide – Osaka, G.K., also synergizes with a five-year effort by the Japanese Government and the PMDA to improve clinical trials conduct, which went into effect in 2007. As part of this effort, in September 2007, the Ministry of Health, Labor, and Welfare (MHLW) published a report entitled “Basic Principles on Global Clinical Trials,” which detailed methods for harmonizing clinical study conduct between Japan and other countries.

“Here, BBK can also offer assistance,” commented Andrew Sacher, general counsel and key developer of the BBK Worldwide – Osaka, G.K., initiative. “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 enrollment initiatives.”

About BBK Worldwide
Founded in 1983 by Joan F. Bachenheimer and Bonnie A. Brescia, BBK Worldwide is a patient recruitment and ebusiness solution company for the clinical R&D and product marketing segments of the pharmaceutical, biotechnology, and medical device industries. BBK has helped to accelerate time-to-market for new medicines and treatments by successfully supporting hundreds of clinical studies in more than 60 countries, and in all major therapeutic areas. Staffed by some of the industry’s principal thought leaders, BBK continually contributes ideas that
advance the clinical development cycle. (bbkworldwide.com)