Faced with changing one's mind, or proving that there is no need to do so, most people get busy on the proof. -John Kenneth Galbraith

This issue focuses on challenges — some new, some old and/or perennial — all of which require knowledge to find or move toward a solution as well as the desire to set something in place to build upon for the future.

In the “new challenges” category, we address nanotech design and outsourcing to China.

In his article, “Nanotechnology Research Requires a Different Breed of Laboratories and Cleanrooms,” Ahmad Soueid gives real-world examples of the challenges raised in the design of nanotech facilities. Though guidelines are being developed (and the first set is scheduled to be published in 2010), facilities are being built now. While merely saying, “It’s not your grandfather’s cleanroom” is an understatement, navigating through the similarities typical to all controlled environments and the differences posed by nanotech is a process fraught with potentially expensive pitfalls. The challenge here is to move forward wisely without being so cautious as to hinder the technology.

Bikash Chatterjee recently spoke at a conference in Shanghai on regulatory guidelines issued by China’s State Food and Drug Administration (SFDA). The goal was to address the “critical role quality plays in the regulated life sciences.” His Regulatory Forum column, “The China Quality Challenge,” posits that parity with westernized companies is possible with investment by first, understating the role of quality and second, moving towards operational excellence.