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File 1 from BIO `06: It takes all the running you can do just to remain in the same place”
April 9, 2006, Chicago
BIO 2006 opened to sunny, warmer weather and a conspicuous absence of animal rights, "Frankenfood," and anti-globalization protestors---I know they're here [here's what one group was up to] and some speakers have alluded to protestors outside their hotels, but they aren't demonstrating in front of the McCormick Center---at least not yet.
Of course, they may be waiting until tomorrow, when former president Bill Clinton gives his plenary address (and offers them a much riper photo opp).
Chicago's taxi drivers are clearly loving BIO, and the 18,000 visitors it has brought to the city. The choice of venue this year ("Hog Butcher to the World," as Carl Sandburg once called it, an epithet that Chicago's been distancing itself from ever since) underscores the growing importance of food and agricultural bio, which is often lost in the hoopla about new biotherapies.
EMEA and EC Initiatives
One of the best quotes of the day came from Georgette Lalis of the EC, Director of the Directorate for Consumer Goods, who summarized regulatory developments in Europe. In describing the state of the global biotech industry, she quoted the Red Queen from Lewis Carroll's "Alice in Wonderland": "It takes all the running you can do just to remain in the same place."
She could easily have been talking about this conference as well, since many compelling presentations were scheduled at the same time. Ms. Lalis' talk focused on how the EC is working with EMEA, and summarized EMEA's plans for biosimilars and orphan drug regulations.
John Purves, head of EMEA's Biologicals and Biotech sector, followed with an overview of EMEA, how it works, and what its priorities are. One interesting point from Purves' discussion: EMEA formally includes a presubmission stage designed for "front end communication" a designated period where companies ask for advice on quality, safety and efficiency.
Approval times average 210 days, he said. On Wednesday, EMEA and FDA will give a side-by-side overview of "Critical Path" and EMEA's counterpart, which promises to be interesting.
Stephane Hogan of the EC's Unit for Biotech and Applied Genomics, described the research projects underway as part of the "Framework" program, including in vitro tests that will reduce the need for animal testing, and generate results that are more specific to humans.
Representatives from Japan discussed that nation's biotech sector, the factors influencing its growth, and some critical focal points. Over the last six years, Japan's government has allocated $220 billion to R&D for biotech, and the country now has 464 biotech companies, and 55 startup companies in various biotech clusters throughout the country; its bio industry is roughly the size of Canada's.
Tsunehiko Yanagihara, VP of Mitsubishi's Life Sciences business, discussed the overall context. The nation spends $263 billion per year on medical costs, with cancer the number one cause of death.
Its pharma and biopharma industry is the world's second largest based on revenues ($50 billion in 2004). Its biotech industry is the world's fifth largest by revenue, and fourth largest based on market cap, with $0.8 billion, following Australia.
Laura Francis, CFO of Promega Corp., a Madiscon, Wisconsin based company, discussed her company's efforts in Japan---Promega now has Tokyo and Osaka offices with 35 employees and 10% of its sales come from Japan. Their collaboration began in 1990 after a trade mission.
She had some good advice for U.S. companies:
- Forget about your standard business model. Go there first and establish a relationship before investing. Don't go "direct" but develop and leverage a broad network of dealers and distributors, and work with organizations with which you can expect to have a long relationship.
- Remember the importance of the journey and not just the results (a focus for most U.S. companies). Remember the importance of ceremony
- And a few basics: domestic and international airports are at a great distance from each other; the Japanese drive on the left side, and don't be surprised by a 100,000-Yen dinner tab for any dinners that include Kobe beef.
Proposal would double Japan's biotech R&D budget
Michio Oishi, director of the Kazusa DNA Research Institute, then outlined the nation's biotech program and major focuses of today's research. Where Japan's government had been quick to recognize the importance of electronics and optics research, it took a bit longer for officials to recognize the importance of biotech.
The first national strategy was launched in 2002, and Prime Minister Koizumi, with seven ministers and 12 industry, academic and other expert devised the strategies as well as 200 action plans formulating targets timing and ministries. A current proposal would double the nation's budget for bioscience and biotech in five years.