Policy & Regulation: Page 25

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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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    Trendline

    Rare diseases

    As drug developers find promise in the rare diseases, deals and treatments are on the rise

    By PharmaVoice staff
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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
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    PharmaCase

    Common to many nonprofits is the develop ment of national publiceducation initiatives or cam paigns to enhance awareness about particular health issues. Often,these campaigns are supported by educational grants from pharmaceutical compa nies. Partnerships with nonprofits are important to pharmace...

    By PharmaVoice Team • April 16, 2008
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    Opinions

    6 J un e 20 03 PharmaVOICE WHAT’S on your mind Breadth and depth I find that industry associations do an excellent job in providing networking, pro fessional continuing education, industry rela tions, and businessdevelopment resources. I can’t speak highly enough about the breadth and depth of op...

    By PharmaVoice Team • April 16, 2008
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    Drugs For Seniors Take Center Stage

    ever there was a political hot pota to, a Medicare drug benefit is it. For at least a dozen years now, there has been much debate — but little consensus — on how such a benefit for Medicare beneficiaries should be structured and financed. Senior cit izens, politicians, healthcare, and pharmaceu t...

    By Denise Myshko • April 16, 2008
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    25 Years of the Orphan Drug Act

    Synthetic drugs accounted for 62% of total orphan drug approvals, and synthetic polypep tides and hormones together accounted for 6%. Among biologics, growth hormones and growth factors together have the largest num ber of approvals at 8% of the total. Market approvals received for plasma product...

    By Cynthia Borda • March 27, 2008
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    Global Opportunities

    According to Ernst & Young, the sheer volume and growing economic muscle of consumers in emerging markets provide powerful investment incentives for multinational companies (MNCs). In particular, current and projected growth rates for pharmaceutical markets in the BRIC countries and Mexico ex...

    By Robin Robinson • March 2, 2008
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    User Fees: Devising a Shift in Policy

    BY DENISE MYSHKO New laws and regulations aimed at improving reviews of medical devices have been put in place. In September 2007, President George W. Bush signed a broadranging bill that expands the regulatory authority of the Food and Drug Administration. Combined with the legislation were seve...

    By Denise Myshko • March 2, 2008
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    Managing Investigator Initiated Trials

    Investigator initiated trials (IITs) can be a valuable part of a pharmaceutical or medical device manufacturer’s marketing claims arsenal, according to Rita Numerof, Ph.D., president, and Mark Morgan, M.S., senior business analyst, at Numerof & Associates Inc. The two contend that IITs are re...

    By PharmaVoice Team • Jan. 30, 2008
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    Gene Therapy Research Makes Progress

    With all the progress that has been made in genomics, targeting therapies to correct the defective genes responsible for disease seems quite realistic. But developing commercial gene therapies to treat diseases through modifying the expressions of an individual’s genes or correcting abnormal gene...

    By Denise Myshko • Jan. 29, 2008
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    UpFront

    THE PRICE IS RIGHT Drug Pricing Decisions More Critical Than Ever In aneraofmore competition from generics, expiring patent protection for many topselling drugs, and a slowdown in new drug discoveries, there is very little margin for error in drug pricing decisions. Kalorama Information’s recent ...

    By PharmaVoice Team • Jan. 29, 2008
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    Letter from the Editor

    Wh o w o u l d h a v e thought that in 10 short years, we would have gone from Dolly to Elsie? In February 1997, scientists in Scotland announced the birth of the world’s first successfully cloned mammal, Dolly the sheep. Dolly, which was created at the Roslin Institute in Edinburgh, was actually...

    By Taren Grom • Jan. 29, 2008
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    Talent Pool

    Executive Appointments and Promotions Pharma POOL Dr. Corey Goodman Dr. Martin Mackay Dr. Briggs Morrison Pfizer Announces Executive Changes Pfizer has launched an independent, stand-alone biotherapeutics and bioinnovation center under the direction of scientist and entrepreneur Corey Goodman, Ph...

    By PharmaVoice Team • Jan. 2, 2008
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    Last Word

    Internationally renowned vaccines, immunology, and virology expert Paul A. Offit, M.D., has dedicated his career to discovering vaccines to prevent infectious diseases, and is the co-inventor of the rotavirus vaccine, RotaTeq, developed by Merck. A pediatrician, author, and scientific researcher,...

    By PharmaVoice Team • Jan. 2, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies Thomson Scientific Offers Data Platform for Researchers Thomson Scientific has released BONDplus, an integrated, Web-based data platform designed to deliver real-time, comprehensive public and proprietary biological sequence, inte...

    By PharmaVoice Team • Jan. 2, 2008
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    What's New

    New Healthcare-related Products, Services, and Companies inVentiv Health Creates Patient Outcomes Segment New division combines capabilities that help patients achieve optimum health. inVentiv Health has launched inVentiv Patient Outcomes, a business segment focused on helping pharmaceutical comp...

    By PharmaVoice Team • Jan. 2, 2008
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    On the Calendar

    Industry Events January 2008 January 15-16 2nd Annual Medical Science Liaison Skill Set Training Doubletree Hotel Philadelphia, Philadelphia For more information, contact Andrea Chadis, Center for Business Intelligence, at 781-939-2428, e-mail [email protected], or visit cbinet.com. January 15-...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Pharmacists Could Impact $145 Billion in Drug Sales in Five Years One state, Florida, already allows pharmacists to independently prescribe prescription drugs, and new research suggests six other states may soon give pharmacists this pow...

    By PharmaVoice Team • Jan. 2, 2008
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    When the Stars Align

    By Robin Robinson The practice of using celebrities in marketing campaigns has not lost its luster, but the pharma industry is more selective in choosing icons who match brand images. As the industry approaches the 10th anniversary of the FDA’s ruling to allow DTC and subsequently the industry’s ...

    By Robin Robinson • Jan. 2, 2008
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    Human Resource Related Issues

    Otuska America Pharmaceutical’s Lorraine Daly, Leslie Eggleston, and Richard Obring discuss how HR issues, including compliance, compensation, and staffing can impact a pharmaceutical company’s culture. Otsuka’s Human Resources Department is responsible for more than 600 Otsuka employees in the U...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Contributed by Craig A. DeLarge Craig A. DeLarge discusses Web 2.0’s drawbacks and opportunities. January 2008 Web 2.0 — Opportunities and Drawbacks n the last month, I have been intensely researching the Web 2.0 phenomenon with respect to its healthcare manifestations. This research has involved...

    By Craig A. DeLarge • Jan. 2, 2008
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    Finding the Right Path -- Jane Hollingsworth

    NuPathe cofounder and CEO Jane Hollingsworth has a fearless attitude about the risks involved in starting and running a business — and defines what it means to be an entrepreneur. Competitive by nature and with a fearless attitude when it comes to the risks involved in starting and running a busi...

    By Kim Ribbink • Jan. 2, 2008
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    Letter from the Editor

    By Taren Grom, Editor I’m getting ready for Web. 2.0. Is your avatar up to date and ready to navigate the “new” World Wide Web? Web 2.0, social networking, or as the contributing author of this month’s Outlet refers to the recent phenomenon “the collective Web,” is seemingly on the tip of everyon...

    By Taren Grom • Jan. 2, 2008