For small- and medium-sized pharmaceutical, biotech and medical device firms, the road to the Chinese market can easily hit a great wall.

Now, a new Philadelphia startup is offering those smaller players a roadmap through the business, cultural and regulatory challenges inherent in entering the fast-changing Chinese healthcare market, with the goal of leveraging the vast economic potential there.

"China is a highly dynamic environment," says Seth J. Goldenberg, president of Asia Pacific Bio-Intelligence (APBI).

China has set a goal of universal healthcare for its enormous population (currently at almost 1.4 billion) by 2020. Presently, most quality healthcare is available in and around the urban centers, with a population of 665.5 million; the Chinese government is spending vast sums to bring comparable care to its rural areas.

That push, coupled with a highly entrepreneurial government, a rapidly changing regulatory environment, an aging bureaucracy (and population) and an evolving approach to intellectual property, to say nothing of language and cultural differences, offers both opportunity and challenge for American firms.  

To help companies navigate all this in a cost-effective way, APBI has set up offices in Philadelphia and in Shanghai, China's hub for research and development. Leonard Pratt, a marketing expert with extensive China experience, heads the Shanghai office. Goldenberg, a Ph.D. pharmacologist who worked in biotech and in the Philadelphia office of the U.S. Food and Drug Administration, is based in Philly and makes quarterly trips to China.

APBI has established strategic partnerships in China with the Shanghai Medical Device Trade Association and in the U.S. with health care communications giant JMI. With those resources and its familiarity with both the FDA and its Chinese equivalent, APBI aims to encourage and foster the entry of best-in-class pharmaceuticals and medical device products into the Chinese market from initial planning through clinical trials and post-approval marketing.
   
APBI also hopes to facilitate the entry of Chinese companies into the American market. "They are spending lots of money and doing good R&D (in China)," says Goldenberg, "but cultural and linguistic differences mean that there are a lot of missed opportunities for collaboration in research and on the business side."

ELISE VIDER is a writer, editor, observer and advocate for economic development and design excellence in Philadelphia, her adopted hometown. Send feedback here.