Q&A With Hui Cai on Biotech in the Asia Pacific Region: Sharing Risks and Building Sustainable Businesses

Xconomy San Diego — 

As cross-pacific partnerships multiply among life science companies in California and Asia, San Diego biotech companies are increasingly interested in learning how to do business in China, India, and other countries. At least 250 representatives of the international life science community are expected to gather for CalAsia, a two-day conference that begins today at the downtown San Diego Marriott Hotel & Marina.

This is the first year the event has been hosted by Biocom, San Diego’s life sciences industry association. Those attending include established pharmaceutical companies, startups, investors, and researchers, as well as individuals and delegations from China, Singapore, Korea, Australia, India, and other countries in the Asian Pacific region. Workshops and plenary sessions include an overview of opportunities and challenges for the biopharmaceutical industry in key markets, licensing deals with Asian partners, raising money in Asia, and evolving intellectual property rights in China and India,

In a preview of the event, I asked Dr. Hui Cai to answer some questions about doing business in Asia. She is president and CEO of Inflexion BioPartners, which provides international management and consulting services in the life sciences, and she has been involved in international sourcing of drug candidates, cross-Pacific operations, strategic planning, and strategic partnerships. She also serves as chairwoman of the board at the Sino-American Biomedical and Pharmaceutical Professionals Association, although she notes these are her personal comments.

Xconomy: What does it mean that the FDA has opened an office in China?

Hui Cai: Setting offices in China reflects the shift in the FDA’s prevention-focused approach to ensure quality at the point of manufacture and that U.S.-bound goods are safe before they are exported. It also plays a positive role in facilitating better communications, and in sharing information and best practices with Chinese regulatory authorities and manufacturers. In reality, good cooperation is key to maintaining a mutually beneficial practice, and it’s important to ensure intentions remain true to sharing best practices, rather than imposing standards unilaterally.

X: What are the chief concerns today for U.S. biotechs that want to form partnerships in Asia, and especially China?

HC: Many U.S. biotechs are reaping … Next Page »

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