Ajaz and Me

paparazziMany within the industry are more than curious about Michael Moore's new film, Sicko, which is expected to premiere in Cannes this summer.  Do any of you remember Mr. Moore's debut feature, Roger and Me, which immortalized his fruitless quest to interview Roger Smith, then president of GM, to discuss plant closings and their economic impact on Moore's home town.  (Since then, we've learned that Moore did interview Smith.) For the record, even we tried to contact Moore, hoping that his allegiance to manufacturing might work to our benefit. Big surprise: It didn't.  (For more on this, read "The Scruffy Guy Cometh," which a former colleague wrote way back when Moore sightings at pharma plants were the news of the day. ) But I have been on a similar quest of my own for the past year and a half:  to secure an interview with Ajaz Hussain, now the head of drug development for Sandoz, the former deputy director of CDER's Office of Pharmaceutical Sciences, and considered by many to be the father of Process Analytical Technologies (PAT) in pharma, one of the first to advocate the drug industry's use of the tools and techniques that would test drug quality during, rather than after, manufacturing. Our readers are all admirers of Dr. Hussain.  In fact, they appear to hang on his every word. And many are curious as to how the transition between FDA and industry, between concept and practical application, has been going. Requests for op eds on dissolution science and biosimilars were politely declined. ("This subject has already been addressed by peer-reviewed journals") And the quest for a personal interview, which began at IFPAC 2006, and which has been promised to our readers, twice so far, continues.  Dr. Hussain is now a key figure in the hugely complex and controversial area of biosimilars, and has testified before the Senate and just made a presentation at a panel discussion on this subject at BIO. But he also seems to be a very interesting human being, who is now living and working on two continents, a pattern that is becoming the rule for more people in this global industry. After a  larger-than-life presence at FDA, Dr. Hussain appears to be avoiding publicity.  This is absolutely his right, and condoned by an industry that doesn't encourage people to speak to media of any kind. It would be impossible to accommodate requests for interviews or articles from every little trade magazine that's out there covering this space, especially with a grueling travel schedule, but it can be done. The problem is that silence and the flat, safe and scripted Q&A's that have appeared in other trade magazines, fine publications that they are, may send the unintentional message, that it's much harder to put PAT into practice than it was to theorize about it. We are not National Inquirer papparazzi or "60 Minutes,"Ajaz, but a little publication devoted to the message of modernizing drug manufacturing.  And you needn't even deal with "the press", but with one of your fellow PAT experts who has contacted you.   Please do not worry. We won't harrass you further, but we haven't given up hope that you'll pick up the phone and make the connection when you can.