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January 24, 2014
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
Last issue, I promised a new design for the magazine, and I delivered! (Courtesy of the expert work of our art department, especially Mike Del Purgatorio and Jessica Carlin!) Our readers and advertisers are concerned about deliverables of much higher value than this, so I won’t do too much crowing about hitting this one target. I will note that we do a finer job keeping our system in order and delivering on time than some companies I could mention. . . For example, in this space back in January/February 2011 (bit.ly/1eDTd4m), I railed about Continental Airlines’ pre-merger cost-cutting, which led to an utter meltdown when a Christmas blizzard hit the northeast U.S. I figured the newly combined United would smooth out the bumps over time. As it turns out, not so much. Three years into the merger, United is still having trouble integrating its computer systems. According to Bloomberg (bloom.bg/1aQ4s7g), United “lost track of hundreds of pilots around the world” and canceled 8,700 flights between Jan. 1 and 8 of this year, due to bitter cold temperatures, new FAA regulations on rest time, and . . . missing pilots. United moved all of its pilots’ tracking and assignments onto a computer system that was previously only handling Continental’s pilots. Apparently, it doesn’t scale up well and has a propensity to, um, crash, which is never a good word to use in the airline industry. Oh, and according to Bloomberg reporter Julie Johnsson, the computer system “even assigned [flights] to pilots who are retired or deceased.” Stories like this get me thinking about the issue of Supply Chain control. The pharma industry is concerned with it from both directions, of course: where are the ingredients coming from, and how can the end-user trust that a therapy is legit and not counterfeited? This issue has several pieces on the shortcomings of the Drug Quality and Safety Act (DQSA), which was passed into law last November. DQSA offers up the framework for a national track-and-trace system for pharmaceuticals (the latter part of the Supply Chain equation), but it doesn’t provide guidance for what happens when things melt down into chaos. All I know is, I racked up around 40,000 miles last year on United, but from now on, I’m definitely going to look in the cockpit when I board. Gil Roth, Editor [email protected] twitter.com/contractpharma P.S.: In last Jan/Feb’s Pharma Resolutions (bit.ly/1dTXY8k) I wrote, “Don’t be blindsided by some significant M&A activity in the CMC services sector.” However, I did get blindsided by the news of the Patheon/DSM merger. To make up for it, we have a great Newsmakers Q&A with Patheon (and NewCo) CEO Jim Mullen! What I’m Reading Pharma The Big Sleep Ian Parker, The New Yorker • nyr.kr/1ahxGzl Comment: A long (10,000 words) piece on Merck’s development of insomnia treatment suvorexant. It’s a pretty impressive article, framed around an FDA advisory committee meeting in May 2013, and covering the history of sleep drugs, the new science that went into suvorexant, what it’s like to breed narcoleptic dogs, and the futilities and frustrations of drug development. It also might be the first mainstream article I’ve ever read that has a segment on stability testing. Non-Pharma Strange Relation: A Memoir of Marriage, Dementia and Poetry Rachel Hadas • amzn.to/1ceDFkY Comment: George Edwards, a composer and professor of music, was diagnosed with early-onset dementia when he was 61. This book by his wife, the poet, translator and professor Rachel Hadas, is a heartbreaking memoir about his decline and her attempts at coping with the slow-motion disappearance of the man she married. It balances the poetic and the practical; she writes wonderfully about both her loss and the poems that gave her solace through this nightmare. Why don’t you tell us what you’re reading? You can write us in lots of ways — [email protected] • goodreads.com/groth • linkedin.com/groups?gid=1775433 • facebook.com/contractpharma. The first respondent each issue wins a prize! (It’s a book.)
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