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

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

Pages: Page 1, Page 2

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.