Drug Reviewers Back in Japan with New FDA Outlook

Researchers and officials from Japan visited the School of Pharmacy in May for its third training course for Japanese scientists on American drug development and regulatory processes.

By Steve Berberich
June 24, 2008

Researchers and officials from Japan visited the University of Maryland School of Pharmacy in May for its third training course for Japanese scientists on American drug development and regulatory processes. The five day program was developed and led by faculty from the School’s Departments of Pharmaceutical Sciences and Pharmaceutical Health Services Research and its Center on Drugs and Public Policy, with presentations from representatives with the university’s School of Medicine.

Clinical researcher Satoshi Uno of Translational Research, Ltd. said he was very fortunate to attend the course. His company is a member of the Shin Nippon Biomedical Laboratories Group which also runs the 96-bed SNBL Clinical Pharmacology Center at the University of Maryland BioPark. And SNBL president, Ryoichi Nagata, has collaborated for many years with University of Maryland, Baltimore President David J. Ramsay, DM, DPhil.

SNBL sent people to a similar course for Japanese scientists at the School of Pharmacy in 2006. Once back in Japan, those scientists gave the course such high marks that Uno got a chance to participate in the 2008 five-day training course with seven other Japanese scientists.

The training course this year provided the visitors with an up-to-date overview of the drug development process in the United States, largely as a University of Maryland, Baltimore effort to promote business relationships. Also, the course helped leaders in Japanese pharmaceutical research and industry better prepare to conduct clinical trials and other drug-development-related research in this country.

Japanese drug makers recently have expanded their interests in this country either by setting up divisions here or in mergers and acquisitions. Their interest is partly driven by a global trend in big pharma of diminishing product lines, and partly by the large U.S. market. For example, giant drug company Takeda Pharmaceutical Co. Ltd. recently announced purchasing Millennium Pharmaceuticals and Alnylam Pharmaceuticals in Cambridge, Mass. In Maryland, Sucampo Pharmaceuticals Inc., a Bethesda biopharma that collaborates with Takeda Pharmaceutical Co. Ltd., went public late last year.

Also attending the School of Pharmacy course was Micheko Iwamoto MD of the Pharmaceuticals and Medical Devices in Tokyo (Japan’s food and drug regulatory agency), who was eager to pass her new knowledge to companies back home.
Iwamoto, a gastro internist who joined the PMD agency last year, said there may be more companies in Japan than in the United States whose drug development specialists are unfamiliar with the “slowness” of a government approval process.

“I will report these processes to them in detail and maybe next year they will be better.” She worked in the United States from 1998 to 2002 at the National Institutes of Health with a major interest in colonoscopy and endoscopy and research on gastric cancer and colon cancer. In her current job, she reviews new drugs and medical devices. “I came here to learn the system of the FDA,” she said, and plans to relate to “the authorities” in Japan that many more companies should attend conferences like those offered at UMB.

During a lecture in the course by nurse Kathleen Palmer of the University of Maryland School of Medicine, two other PMD scientists in the course, Chieko Ishiguro and Seiko Masuda, took a keen interest in how researchers handle things that go wrong, so-called “adverse events” during clinical trials. Palmer explained that in trials of cancer drugs or vaccines, it is difficult to tell if the event, such as an unexpected reaction by patients, is due to the drug or the cancer. Ishiguro said she appreciated Palmer’s deliberate explanation of such details because it is very difficult to get a vaccine approved in Japan, yet in the U.S., the approval structure for an investigational new drug application is “more high level,” she said. In Japan, Ishiguro analyzes such adverse events using an extensive PMD database of past trials and notifies the testing company of the event and her analysis.

Andrew Coop PhD, professor and chair of the School of Pharmacy’s Department of Pharmaceutical Sciences, said that throughout the week long course, faculty members and visiting officials from the U.S. Food and Drug Administration reviewed pertinent FDA guidelines that are critical to the drug design and approval processes. They used “real world” examples throughout the week from an industrial and regulatory perspective that focus on Phase I-III protocol development and study implementation.

School of Pharmacy faculty who participated in the course are: Ken Bauer, PharmD, PhD, associate professor of pharmacy practice and science; Tom Dowling, PharmD, PhD, associate professor of pharmacy practice and science; C. Daniel Mullins, professor and chair of pharmaceutical health services research; Frank Palumbo, PhD, JD, professor of pharmaceutical health services research and executive director of School’s Center on Drugs and Public Policy; Jim Polli, PhD, professor of pharmaceutical sciences and Peter Swaan, PhD, professor of pharmaceutical sciences and director of the Center for Nanomedicine and Cellular Delivery.