Policy & Regulation: Page 21

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The GLOBAL Regulatory Environment

By Denise Myshko The concerns of regulators around the globe lean toward the safety and the cost-effectiveness of prescription drugs. Cost-containment has and will continue to be the buzzword as governments around the world struggle with slowing economies and rising healthcare costs. In fact, som...
By Denise Myshko • Feb. 27, 2009
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Technology Key for GLOBAL Development

BY DENISE MYSHKO Experts say technology has the potential to help pharmaceutical sponsors address communication challenges, manage data effectively across geographic regions, and ultimately speed processes. “Communications technology is core to global development," says Brad Thompson, Ph.D., chai...
By Denise Myshko • Feb. 27, 2009
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Trendline

Commercialization, marketing and social media

As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical.
By PharmaVoice staff
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Last Word

Ms. Stokes says companies need a safety plan, one that includes efficacy and safety data as well as risk-benefit information, before a drug reaches the market. Drug Safety Alliance’s Cathy Stokes defines safety expectations As CEO and President of Drug Safety Alliance Inc., Cathy Stokes is focusi...
By PharmaVoice Team • Feb. 26, 2009
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Upfront

Milestones kinetix turns 10 Kinetix, a specialized healthcare consulting firm that uses exclusive, proprietary communication channels to build and implement live and online marketing programs, is celebrating its 10th anniversary. Over the last 10 years, Kinetix has developed strategies to communi...
By PharmaVoice Team • Feb. 26, 2009
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Talent Pool

TALENT POOL EXECUTIVE APPOINTMENTS AND PROMOTIONS IN THE HEALTHCARE INDUSTRY Pharma POOL Lamberto ANDREOTTI Dr. Andrew G. BODNAR Donald J. HAYDEN Dr. James B. D. PALMER Thomas J. PICKARD David L. ZABOR Bristol-Myers Squibb Announces New Senior Leadership Team — Appoints Former GlaxoSmithKline V...
By PharmaVoice Team • Feb. 23, 2009
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What's on your mind: Opinions

OPINIONS Information standards In the November/December issue of PharmaVOICE, we asked if the Food and Drug Administration should consider relaxing its standards for press releases about drug approvals, which currently are almost always considered a promotion. The regulatory agency issued a call ...
By PharmaVoice Team • Feb. 22, 2009
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Medical Privacy: At What Cost

By Denise Myshko WHILE QUESTIONS REMAIN ABOUT WHAT THIS ULTIMATELY WILL MEAN FOR CLINICAL RESEARCH AND THE INDUSTRY’S ACCESS TO DATA,ONE THING IS CERTAIN: AN EXTRA LAYER OF ADMINISTRATION HAS BEEN ADDED FOR EVERYONE. Privacy has become a political hot potato in the healthcare industry as advances...
By Denise Myshko • Feb. 17, 2009
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Carl Feldbaum: Beyond Imagination

CARL FELDBAUM BIOTECHNOLOGY INDUSTRY ORGANIZATION BIO HELP WANTED: President of a new biotech industry association, no industry experience necessary. Position has enormous promise for personal and professional growth. “In 1992, I didn’t know a single person in the industry,” Carl Feldbaum says. “...
By PharmaVoice Team • Feb. 16, 2009
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Independent Agencies

To paraphrase Mark Twain, reports of their death have been greatly exaggerated. Independent agencies are a viable strategic and creative option for many healthcare clients. True, the number of independent agencies has dwindled over the past few years; many making the strategic decision to join a ...
By PharmaVoice Team • Feb. 16, 2009
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Global Harmony Comes to Drug Development

That document — called the common technical document or CTD — is now being accepted by regulatory agencies in the United States, Europe, and Japan as part of a transition phase. Consensus was reached by the international pharmaceutical community in May of this year. This document will eventually ...
By Denise Myshko • Feb. 16, 2009
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E-Media

NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES RapidTrials.com, launched by PCRS Inc., is the first Webbased platform to provide realtime bench mark metrics on trial progress for research centers. The pro gram helps drive revenue, study programs, and marketing research projects...
By PharmaVoice Team • Feb. 12, 2009
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Table of Contents

We invite you to explore the digital edition of PharmaVOICE magazine. The interactive format allows you to easily read, share with friends, and click on podcasts, videos, webinars, whitepapers, and Website links to access additional resources. Getting started with your digital edition is this eas...
By PharmaVoice Team • Jan. 28, 2009
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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
PharmaVoice Team/PharmaVoice

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
PharmaVoice Team/PharmaVoice

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
PharmaVoice Team/PharmaVoice

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
PharmaVoice Team/PharmaVoice

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
PharmaVoice Team/PharmaVoice

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
PharmaVoice Team/PharmaVoice

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