Policy & Regulation: Page 20


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    Push for Transparency Creates New Environment for KOLs

    Proposed legislation, a new policy announcement by Pfizer, and criticism of reports published in medical journals fed the frenzy of media coverage surrounding key opinion leaders during the summer of 2008. While the debate on the ethics and value of key opinion leaders (KOLs) rages on inside and ...

    By PharmaVoice Team • Jan. 28, 2009
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    UpFront

    UpFront Milestones Almac turns 20 Dr. Robert Dunlop, president and managing director of Almac Clinical Services (left), and Sir Allen McClay, chairman of Almac Group, celebrate the division’s 20th anniversary. Almac Clinical Services, one of the key divisions at Almac Group, has grown to become t...

    By PharmaVoice Team • Jan. 27, 2009
  • biotech market Explore the Trendline
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    Trendline

    Emerging biotech

    After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

    By PharmaVoice staff
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    Letter from the Editor

    Amazing stories of personal commitment! All too often we hear what’s wrong with our industry — drug prices are too high, companies aren’t transparent enough, the FDA’s review of drug safety data is subpar, and so on. Rarely publicized are the good works that companies, no less members of the heal...

    By Taren Grom • Jan. 27, 2009
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    Table of Contents

    ON THE COVER Partnering for Success In these times of adversity, strategic alliances become even more crucial than ever for survival. FEATURES No Pens or Mugs? No Problem. The industry is discovering it won’t lose the ability to message effectively under the new PhRMA code. The Green o...

    By PharmaVoice Team • Dec. 22, 2008
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    IRBs: Training for Patient Protection

    IRB’s Training for Subject Protection In the absence of a regulation requiring training and education for those involved with clinical study subjects, many IRBs and investigator sites are voluntarily putting their staffs through the paces to ensure patients are protected. BY DENISE MYSHKO Protect...

    By Denise Myshko • Dec. 22, 2008
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    Salesforces

    SALES & Marketing Salesforces The Salesforce of the Future: MORE SERVICE, LESS SELL As companies — Sanofi-Aventis, Merck, Wyeth, Schering-Plough, Novartis — continue to make headlines for collectively laying off thousands of sales representatives, the industry looks for innovative ways to do ...

    By PharmaVoice Team • Nov. 22, 2008
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    Development

    development RESEARCH & Development BY DENISE MYSHKO Models of CHANGE In the future, successful biopharmaceutical companies will be those that have reviewed R&D business models and implemented updated strategies for improving the development of new products. The pharmaceutical industry is ...

    By PharmaVoice Team • Nov. 22, 2008
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    Counterfeit Drugs

    Corporate Strategy Counterfeit Drugs Fighting an uphill battle BY DENISE MYSHKO The counterfeit medicines market is a real, clear, and present danger to public health. And while there have been efforts to minimize the threat of counterfeit and substandard medicines, there is a need to coordinate ...

    By Denise Myshko • Nov. 22, 2008
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    Talent Pool

    Pharma POOL Dr. Barry Goldstein Merck Appoints Head of Diabetes, Obesity Development Global pharmaceutical company Merck, Whitehouse Station, N.J., has named Barry Goldstein, M.D., Ph.D., FACP, FACE, VP of diabetes and obesity clinical development. In addition to leading overall development of co...

    By PharmaVoice Team • Nov. 22, 2008
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    Letter from the Editor

    Pharmaceutical companies as well as their partners are feeling the heat. They are facing unprecedented challenges on a global scale. More so than ever, their business strategies are being put to the test. How well they do will depend on the resilience of their operations and the vision of their l...

    By Taren Grom • Nov. 22, 2008
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    Medicare Incentives Push E-Prescribing to Top of Mind

    2008 VIEW on ESolutions EPRESCRIBING It’s no secret that thousands of private practice physicians throughout the country face a financial crunch. Declining reimbursement rates have produced a profoundly negative impact in several areas of healthcare — particularly in oncology, nephrology and othe...

    By PharmaVoice Team • Oct. 24, 2008
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    New Requirements for Advisory Meetings Provide New Opportunities

    This past decade has brought increased focus and attention to pharmaceutical company interactions with healthcare providers regarding marketed products. Further to the 1992 AMA Guidelines on Gifts to Physicians from Industry, pharma marketers must now take into consideration the PhRMA Code on Int...

    By Joan Bradley • Sept. 30, 2008
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    PharmaTrax

    Cubist Pharmaceuticals’ Cubicin (daptomycin), the first of the cyclic lipopeptides to gain U.S.market approval, is currently the fastest growing product in the antibiotic class, with 2007 sales surging 53% to $290.4 million. The first oxazolidinone to win U.S.Food and Drug Administration approval...

    By PharmaVoice Team • Sept. 30, 2008
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    Compliance Wrap Up

    Compliance Forum The pharmaceutical industry continues to face major obstacles in attaining patient persistency and compliance. During CBI’s two day conference, thought leaders addressed the topic of patient compliance from many different avenues and provided their insights on ways that key stake...

    By PharmaVoice Team • May 28, 2008
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    On the Calendar

    February 10,2003,Park Hyatt San Francisco — San Francisco European Regulatory Affairs: An InDepth Review of Registration Procedures in the European Union This Drug Information Association training course will cover the evolu tion of the registration systems available for approval of products sinc...

    By PharmaVoice Team • April 24, 2008
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    PharmaTrax

    Survey Shows One Third of Americans USE ANTIBIOTICS INAPPROPRIATELY A survey conducted by Harris Interactive has revealed that one out of three Americans mistakenly believes antibiotics are effective in treating viruses such as cold and flu and takes these drugs to fight these viruses. The survey...

    By PharmaVoice Team • April 24, 2008
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    Talent Pool

    EXECUTIVE APPOINTMENTS AND PROMOTIONS IN THE HEALTHCARE INDUSTRY Pharma POOL John I. COOPER Former GlaxoSmithKline VP Brings Global Manufacturing and Operational Management Expertise to ICN ICN Pharmaceuticals Inc. has appointed John I. Cooper as executive VP of global manufacturing and supply. I...

    By PharmaVoice Team • April 22, 2008
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    PharmaCase

    What Pharma can Learn from Insurance e-Business SELLING HEALTHCARE INSURANCE ONLINE IS ONE OF THE MORE COMPLEX E-COMMERCE APPLICATIONS.HOW ONE INSURER, BLUE CROSS BLUE SHIELD OF FLORIDA, OVERCAME THE TECHNICAL AND CUSTOMER RELATIONSHIP CHALLENGES TO CREATE A PROFITABLE ONLINE SALES CHANNEL CAN S...

    By PharmaVoice Team • April 22, 2008
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    Opinions

    WHAT’S on your mind Is mentoring a lost art? For the past two years, January has been designated as National Mentoring Month (NMM). Led by the Harvard Mentoring Project and MENTOR/National Mentoring Partnership, NMM also was supported by President George W. Bush, the U.S. Congress, state governor...

    By PharmaVoice Team • April 22, 2008
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    Letter from the Editor

    THE FORUM FOR THE INDUSTRY EXECUTIVE Volume 3 . Number 4 PUBLISHER Lisa Banket EDITOR Taren Grom CREATIVE DIRECTOR Marah Walsh DIRECTOR OF SALES Darlene Kwiatkowski MANAGING EDITOR Denise Myshko CONTRIBUTING EDITORS Elisabeth Pena Kim Ribbink Alex Robinson Lynda Sears Copyright 2003 by PharmaLinx...

    By Taren Grom • April 22, 2008
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    The Shifting Relationship Between Pharmaceutical Companies and Suppliers

    The shifting relationship between pharmaceutical company and supplier: Are partnerships in peril? Fundamental aspects of the supplier/client relationship are changing. At the extreme these changes could threaten the very relationship; at the minimum these changes will require a modification in th...

    By PharmaVoice Team • April 21, 2008
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    PharmaCounsel

    Legal Counsel: COMPLYING WITH PDMA Avoiding FDA Fire Sample Accountability: Employing Compliance Measures COMPLIANCE WITH THE PRESCRIPTION DRUG MARKETING ACT (PDMA) HAS BECOME AN INCREASINGLY URGENT ISSUE FOR PHARMACEUTICAL SALESFORCES AND THEIR REPS. AS GOVERNMENTAND INDUSTRY MOVE TO HEIGHTEN E...

    By PharmaVoice Team • April 21, 2008
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    Letter from the Editor

    PharmaVOICE THE FORUM FOR THE INDUSTRY EXECUTIVE Volume 3 . Number 5 PUBLISHER Lisa Banket EDITOR Taren Grom CREATIVE DIRECTOR Marah Walsh DIRECTOR OF SALES Darlene Kwiatkowski MANAGING EDITOR Denise Myshko CONTRIBUTING EDITORS Elisabeth Pena Kim Ribbink Lynda Sears Copyright 2003 by PharmaLinx L...

    By Taren Grom • April 21, 2008
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    Overcoming Diversity Obstacles: A Clinical Imperative

    22 Aug u s t 20 03 PharmaVOICE HE HUMAN GENOME PROJECT, research into responses to medicine, even the results of several clinical trials indicate that race and ethnicity do have bearing on the safety and efficacy of pharmaceuti cals. Consequently, it is critical that pharmaceutical companies, CRO...

    By PharmaVoice Team • April 17, 2008
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    E-Media

    76 J u n e 20 03 PharmaVOICE EMEDIA NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES Choice Media has expanded its health newscov erage through an agreement with Ivanhoe Broad cast News, a newsgathering organization covering medical information for television stations. The rela t...

    By PharmaVoice Team • April 16, 2008