NORTH HOLLYWOOD, Calif.—Arnold A. Semler Inc., doingbusiness as Associated Industries, is a 65-year-old company best known as asupplier of ground tactical communications systems to the U.S. government,foreign governments and industry. As such, it might seem to be an unlikelycandidate to join five Asian contract research organizations (CROs) as afounding member of the Asia CRO Alliance (ACA).
According to the ACA website, it is the first and onlyalliance of niche, regional CROs in Asia who will be working together toenhance clinical research across the huge and varied continent.
Along with the Semler Research Center (SRC), headquarteredin Bangalore, India, and led by President and Executive Director Dr. KrathishBopanna, ACA members include Shanghai SLG in China, SRD International in Japan,LSK Global Pharma Services in Korea, Veras Research in Malaysia and StatPlus inTaiwan.
Most Asian regional and global clinical trials are eitherconducted by sponsors directly or by affiliates of multinational CROs withheadquarters in Western countries.
According to Dr. Young Jack Lee, presidentof LSK Global, who serves as chairman of ACA, most local Asian CROs—and ACAmembers in particular—are better prepared to work with sponsors than affiliatesof multinational CROs. ACA members have been participating in local, regionaland global studies, he says, while affiliates of multinationals tend to belimited to global studies. With diverse sponsor and study types, ACA's CROs aremore knowledgeable about local situations and more familiar with localidiosyncrasies than affiliates, states Lee, who adds that local CROs aremanaged by senior executives with authority and autonomy.
If a defense contractor doing business as AssociatedIndustries seems a bit ominous, Ravi Achar, managing director and chieffinancial officer of Semler Research, is quick and effective at dissipating anyhint of intrigue.
"I have been involved in several of the Semler ventures indefense electronics, broadband wireless, telecommunications, real estate familyentertainment, wine and now the Semler Research Center," he notes.
SRC's focus will be Phase II to Phase IV clinical trialswith "no limitations," he says, but the group will also handle regulatory,proof of concept, data management and pharmacology. SRC will also get involvedwith drug development on a shared-risk basis.
Achar notes that "it took a while" to merge the cultures andoperating styles of six companies which are, after all, based in countries asfar apart and distinctively different as South Korea, Japan, Taiwan, Malaysia,China and India. The individual CROs "know what they're doing," he states, andhave access to both patients and healthy volunteers.
According to Lee, all ACA members have worked with majorpharmaceutical companies and understand the importance of quality. The ACA hastaken measures for quality control and assurance by harmonizing SOPs andtraining programs. ACA members are all independent but work as a single entityfor regional studies. A crucial advantage of working with the ACA, he says, isprice. All ACA members are self-sustaining local CROs, and therefore it costsvery little to maintain the ACA. This saving in overhead is passed on tosponsors, Lee adds. At present, ACA covers 14 countries in Asia and expects tocover the entire Asia-Pacific region soon, offering the convenience of one-stopservice to sponsors.
Despite the merging of cultures and operating styles thatAchar refers to, it remains to be seen exactly how cooperation among the sixCROs will play out. For example, Lee states on the LSK website that "Korea isbecoming important in Asian clinical trials, particularly for trials in Chinaand Japan. China, Japan and Korea are very close in genetic polymorphism anddisease profiles. Recently, Japan has decided to accept clinical trial datafrom Korea, Taiwan and Singapore. This decision positions Korea as a veryimportant country for Japanese drug development, just as Canada is an importantclinical trial partner for the U.S."
According to LSK data, the number of trials in Korea hasgrown from 31 in 1999 to 156 just 10 years later. Also, Lee notes that Korea oftenplays the partner role for global clinical trials in China, because China oftendemands trials in other Asian countries. Korea will become the hub for clinicaltrials in Northeast Asia, Japan, China, East Russia and Korea, he states.
"The reason is very simple," Lee says. "The Koreanregulatory process is better streamlined than Japan and China. Korea has a veryadvanced medical infrastructure comparable to Western nations. Koreans arereceptive to clinical trials, too. It is generally accepted that recruitmenttends to be timely in Korea compared to Japan."
