Where is that?
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Osaka
is located at the mouth of the Yodo River on Osaka Bay, in the Kansai region of the main island of Honsh, Japan. Japan's
pharmaceutical hometown, Osaka is the second largest city in Japan, after Tokyo, and the world's ninth largest metropolitan
area. Pharmaceutical company Tanabe Seiyaku (now merged with Mitsubishi Pharma) was founded in the city more than 300 years
ago.
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Martinsried –Planegg
is a suburb of Munich in the Bayern region of Germany. It is known as the "center of the biotech cluster" with some 100 biotech
companies, and in near distance to Ludwig-Maximilian University, Munich Technical University, and the Max Planck Institutes
for Biochemistry.
More Funds Needed Abroad
by Angie Drakulich
Total FDA Foreign Drug Inspections, FY 2007: 494 Source: FDA, December 2007.
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The US Food and Drug Administration's 2008 President's budget requests approximately $16 million* out of an overall drug inspection
budget of nearly $56 million** for inspections conducted by the Office of Regulatory Affairs (ORA) of overseas drug facilities
and related import activities. Despite the need for increased inspections abroad, the budget is actually $700,000 less than
what the agency spent on foreign drug inspections and import activities six years ago, in 2002. According to the Government
Accountability Office, 3,000 companies are registered to import drugs into the United States. But FDA was only able to conduct
310 preapproval or good manufacturing practice (GMP) inspections at these sites in FY2007. The remainder of the 494 inspections
conducted abroad was primarily for bioresearch monitoring purposes (e.g., clinical investigators). The above pie chart shows
where those inspections where conducted.
*Foreign inspection budget includes laboratory analyses of imported drug products, import activities at the border, and foreign
inspections. **Overall budget adds domestic inspections to the foreign inspection budget request. Neither budget figure includes
funds expended by FDA's Center for Drug Evaluation and Research (CDER) in support of inspections conducted by ORA.
COMING DOWN THE PIKE...
by Michelle Hoffman
Facility Roundup
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The most significant early-stage discovery to hit the journals in late 2007 (or at least the most highly publicized) were
the dual announcements from two independent research groups that they had managed to turn adult human skin cells into cells
with properties that are seemingly identical with human embryonic stem (hES) cells. The teams each inserted four genes (only
two of which overlap) into the adult cells to make them revert to the embryonic-like state. Among other things, the achievement
may allow US scientists to explore the properties of hES cells—and their potential uses in regenerative medicine—while circumventing
the debate on the morality of destroying human embryos to get the cells. Of course, both teams and scientific commentators
stress that it will take a while to determine how similar the so-called induced pluripotent cells are to true hES cells.
For now, however, it may allow US scientists to catch up to foreign counterparts studying hES cells.
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