Life Science Leader Magazine Supplements

CMO 2015

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Page 22 of 83

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 23 time-to-time). But it's that important. India is an undeniable powerhouse in the biopharma outsourcing industry and an accelerating drug home-market. Yes, there was too much negative news out of India in 2014, and serious challenges remain, from compliance to final quality to IP. Nonetheless, facts are facts: Over 500 Indian facilities are registered with FDA, the highest number for any country out- side the U.S. Indian companies account- ed for 39 percent of all abbreviated new drug application (ANDA) approvals in 2013 and accounted for 40 percent by vol- ume of U.S. generic drug imports in 2013. Plugging into India could prove valuable. So there are options for Western researchers and companies in APAC. To be fair, our session at OPW touched on some of these countries and topics, par- ticularly Japan; to have covered them all would have taken a full day. (Hey, that's an idea.) CHINA, CHINA, CHINA However, for the most part, our OPW session was focused on China. And, of course, that mirrors what we experience everywhere nowadays. Perhaps due largely to a growing famil- iarity with the subject, we often talk about China as a typical capitalist country with an emerging (and potentially huge) healthcare consumer population, open to the global pharma industry and home to competitive biopharma service providers. Opportunities seem limitless. But there's a need to add levity, some would say reality, as a few attendees actually did at the conference. As I recently wrote in an article for Outsourced Pharma , we're reminded of "the lucrative — some say anticompeti- tive, anticapitalist, and unfair — benefits handed down from Chinese government at various levels, including subsidizing facilities and tax breaks." Strategies at all Western companies, vis-à-vis China, must take into consideration the current government mandate that new drugs for the Chinese market be manufactured domestically. And while some of the best outsourcing service providers on the globe are Chinese, we still recall news stories surrounding some suppliers, with one of the worst historic examples — the heparin contamination tragedy that led to patient deaths globally. Intellectual property issues can't be swept under a rug like so many CD-ROMs crushed under bulldozers to demonstrate new attitudes. And while China is now one of the world's largest stock markets, it's "largely closed to foreign investors," according to The Wall Street Journal . None of this implies the China jugger- naut in the biopharma industry is slow- ing down precipitously. Hopefully, there Manufacture with an award winning expert Our cutting edge expertise has now been recognised with two prestigious industry awards - the 2014 CMO Leadership Award for Innovation and the 2014 CMO Leadership Award for Reliability. Innovation is at the heart of our organization. Developed by our expert scientists, our renowned pAVEway™ microbial and Apollo™ mammalian expression systems are demonstrating industry-leading titers in the development of biopharmaceuticals.

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