Process Control and Japan to be the focus of June’s issue of Pharmaceutical Manufacturing

How are drug companies using PAT and advanced process control?  What do they think about continuous processing? In June's issue, we'll interpret results of our first process control survey.  We'll also take a look at what's happening in Japan's pharmaceutical manufacturing sector, and regulatory agencies. Japan is, or will be, a key market for more drug manufacturers and contract manufacturers (now that Japanese companies can outsource manufacturing). But one of the biggest issues so far has centered around ICH E-5 and the acceptance of non-Japanese clinical trial data: Japan is a key member of ICH, and sanctioned the concept of coordinated "global review" with FDA and EMEA, as well as "bridging data" for clinical trials, yet some U.S. companies claim that this acceptance is theoretical at best.  June's issue will feature an interview with Osamu Doi, one of the founders of ICH, as well as U.S.-based experts; it will also include best practices and case histories, including a profile of a company that is developing "personalized" therapies for cancer. -AMS