Taren Grom, Editor
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As the summer comes to an end and the hint of fall enters the air, this September issue brings you articles as fresh as a fine Macoun — or Red Delicious, if you prefer. Hard to believe, but yes 2008 is rapidly coming to a close. We thought it was an appropriate time to take inventory of several trends developing in the industry. This month’s Forum features a full complement of pharmaceutical leaders who deliberate the risks, challenges, and benefits of marketing targeted products to smaller physician and patient audiences. In their discussions with Robin Robinson, they also out line and identify the methods the industry is employing to do more with less, only better. Online tactics appear to be one of the avenues that is generating a great deal of interest and that has the potential for the greatest ROI. These techniques will become even more important, if as predicted the blockbuster era does fade out and is replaced by a more patient centric model of drug development. These are important trends and ones that we will explore in more depth in coming months. Please turn to page 8 to read more about what’s hot in the specialty marketplace. We may be heading into fall, but we are still talking about green — green chemistry that is. Denise Myshko follows up on last October’s article — Going Green — as she investigates the industry’s efforts to minimize its environmental footprint. She was encouraged to find that in the last few years, several large pharmaceutical companies have made significant strides in the area of green chemistry, also known as sustainable chemistry, especially with regard to minimizing the waste created by current manufacturing processes and modifying processes to use less raw material. Companies are also working to reduce and even eliminate the use of solvents and reagents, another positive for the environment. For a list of the 12 principles of green chemistry, please turn to page 32. Having identified safety as a major theme at the recent 44th DIA Annual Meeting, Ms. Myshko explores the merging of regulations and technology. In an enlightening article, industry experts discuss how pharma companies are beginning to use advanced pharmacovigilance technologies to develop new processes for the analysis of adverse events in the post marketing environment and during development. Pharmacovigilance efforts continue to grow in importance, in part because the FDA has added more teeth to its RiskMAPs policy; it now requires some Higher risk drugs to submit a Risk Evaluation and Mitigation Strategy. And in Europe, new legislation requires companies to collect, collate, and evaluate information about suspected adverse reactions. A host of industry experts discuss why these new regulations will require new technological tools in the article that begins on page 22. While at the DIA conference in Boston, PharmaVOICE took the opportunity to reach out to more than three dozen thought leaders. In short videos, these experts share their insights on what they believe are the biggest challenges in the industry and their sectors, as well their thoughts on the meeting. For a line up of these “industry stars,” please turn to page 56. To view our Editor’s Take videos, please log onto www.pharmavoice.com/editorstake. For this issue, I had the great pleasure to interview one of the industry’s most visible and active advocates, Michael Pucci. As VP, external advocacy at GlaxoSmithKline, Mr. Pucci is fighting the good fight and is on a mission to change the perception of the industry. His message is centered on the value that medicines bring to the healthcare continuum. His tireless efforts to improve the industry’s reputation over the past five years are paying off. Mr. Pucci has been kind enough to provide us with several data rich whitepapers that are definitely worth checking out. To download these free supporting documents, go to pharmavoice.com/whitepapers. We hope you take a moment to enjoy this issue and remember an apple a day might just keep the doctor away. Taren Grom Editor Pharmaceutical business models, green chemistry, safety and pharmacovigilance, and the industry’s reputation are just a few of the trends we are following in this issue. Taren Grom Trends to watch PUBLISHER Lisa Banket EDITOR Taren Grom CREATIVE DIRECTOR Marah Walsh MANAGING EDITOR Denise Myshko SENIOR EDITOR Robin Robinson FEATURES EDITOR Kim Ribbink CONTRIBUTING EDITORS Cynthia Borda Carolyn Gretton DESIGN ASSOCIATE Cathy Liszewski NATIONAL ACCOUNT MANAGER Cathy Tracy CIRCULATION ASSISTANT Kathy DeIuliis Copyright 2008 by PharmaLinx LLC, Titusville, NJ Printed in the U.S.A. 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