The thought for the day, as Lou Pillai started his discussion of how Pfizer is dealing with PAT and the FDA's new focus on continuing process improvement, is "Be the change you want to see in the world." Gandhi's phrase sums up Pfizer's change management around GMP for the 21st century. The top issues facing the pharmaceutical industry are: --Patent expiration (14 major drugs will expire next year) --Pressure to reduce drug costs. (The US spends over 10% of its GDP on health care, and the fastest growing component is drugs) --Challenges to Intellectual Property-- It costs an average of $800 million to bring a drug to market, and legislatures are considering reducing patent protection. --Counterfeiting and Piracy are rampant throughout global supply chains and it is very hard to "track back" and find out where they came from, or who made them.