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On The Cover Flying high on a vision Even as pharmaceutical companies merge to form giant conglomerates, business leaders are choosing to step out on their own and are taking some calculated risks. They embrace the challenges that come with being an entrepreneur and strive to make a difference in the life-sciences industry. FEATURES Behind the closed door The physician exam room is an ideal frontier for pharmaceutical marketing messages. Companies that develop desk-top anatomic models, charts and graphs, and even exam-table paper are gaining access to an area that was once considered off-limits. The goal is to trigger conversations between patients and physicians in this intimate setting. A more efficient FDA for the device world In the device industry, user fees provide a valuable resource to regulators as manufacturers submit applications for products that employ advances in genomics, proteomics, and nanotechnology. Assessing and predicting patient behavior for effective DTC DTC advertising has been demonstrated to be effective in bringing diagnosed patients into doctors’ offices but less so in driving undiagnosed patients to see their physicians. Suzanne Ramspacher and Alan Steinberg of Market Measures/Cozint discuss why pharma marketers need to better understand consumer behavior. Diana Anderson — Recruiting an authority Bringing together her knowledge in rheumatology and her expertise in patient recruitment, Diana L. Anderson has helped turn RRI into a leader in rheumatology services and is positioning its sister company as a leader in patient recruitment. in every issue Letter from the Editor Opinions PharmaCounsel Rachel Abramovitz talks about how to apply HIPAA in clinical research. For Art’s Sake A creative review by the experts PharmaOutlet Lynn Meyer and Sandra Young discuss HIPAA’s impact on informed consent. PharmaTrax Sales, marketing, and R&D trends from industry analysts On The Calendar Industry events What’s New New healthcare-related products, services, and companies E-Media New electronic and Web-based applications, sites, and technologies Talent Pool Executive appointments and promotions Scott Freedman and Dr. Rod Saponjic say leadership is about harnessing the power of individual employees to achieve the objectives of an organization. Ed March says the FDA is trying to put more effort into presubmission meetings to provide guidance before the review process begins. Overcoming the huge obstacle of patient recruitment in clinical trials is one of Diana Anderson‘s goals as she positions her franchise of companies. October 2003 Contents