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Custom Medicine for the MassesInvestor expectations, fueled by promises of genetic breakthroughs, are at an all-time high. Markets segmented by genetics-based diagnoses and rising demand for individualized care will soon make their mark on the industry's dominant blockbuster strategy. Rather than losing sleep over that, pharmaceutical executives can secure competitive advantage by capitalizing on the combination of consumers' rising power, increased access to information, and rejection of one-size-fits-all treatment regimens.
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The New Era of Risk ManagementFDA has issued the industry a new charge-pay closer attention to risk management. Now that prescription drug user fees have helped the agency approve candidates more rapidly, FDA has returned to its basic mandate: assuring that marketed pharmaceuticals are safe. In the past, that meant clear labeling with adequate directions and warnings based on clinical trials. The agency now believes that product safety extends beyond warning labels and wants to ensure that prescriptions are used safely as well. As a result, it is asking the pharma industry to demonstrate products' safety before approval and to further control their use after
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The power of enthusiasmNo one wants to hang around people who are sad all the time, or who have a chip on their shoulder.
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Toward the See-Through CorporationConsumer outrage at daily reports of new financial scandals creates a dangerous environment for corporate reputations, but pharma companies can turn the public's low opinion-and questions about rising drug prices-to their advantage if they work systematically to build long-term trust.
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Also Known As...The Value of Generic NamesIn the world of pharmaceutical names, the trademark has always been the star, and every other word has played a supporting role. But recent developments at FDA-and the industry's response to those developments-have set the stage for a new approach to nomenclature.
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How to make a powerful impact in two minutes or lessSee how you can incorporate these five B's in some of your two-minute-or-less encounters with physicians.
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Chaotic Content: Streamlined Solutionst's 4 pm on Friday. The board of directors has just made an important decision and wants to announce it over the weekend. The challenge? Publish an English-language version on the company's global Web portals immediately. The problem? It's the weekend and offices around the world are about to close. In the past, that meant hunkering down for a weekend of e-mails to coordinate the effort, but now there is a better solution. After writing the document in Microsoft Word, the sender simply clicks on a special menu item, "Publish to Portals," and off it goes. Confirming dialogue boxes allow
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The Challenge of Prescription Drug PricingIndustry Must Set Product Prices That Ensure Reasonable Profit - and Minimize Political Fallout
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How to Make Rx-Dx Alliances WorkPartnerships between pharmaceutical (Rx) and diagnostic (Dx) companies are difficult to achieve because most managers don't understand what it takes to make them work.
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Competing European Bids to Fund New AntibioticsUncertainty swirls on just how effective policy competition between the EU and UK on these much-needed products will be.
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The Blank PageNo greater challenge faces any writer than the empty page. To sully that beautiful white space with mere words can seem so arrogant, so pretentious, that one's urge is to leave it alone, in perfect blankness. To paraphrase an old writer's adage, just to begin may require lowering your standards-an act salvaged later only by careful editing.
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New Gains for PainThe global pain market will reach nearly $29.8 billion in 2008, of which $21.8 billion will come from the United States.
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Customer access: Can we ever have dialogue?Physicians say they are now much more likely to limit their time and dialogue with sales representatives … except for a few individuals who take a different approach.
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War Games: Win Your Brand with ActionStan Bernard outlines the seven ways for pharmas to ensure successful execution of action steps following brand ‘war games’.
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Path of Uncertainty: Pharm Exec’s 2017 Industry ForecastThe populist-driven shifts trumpeted from the US to the EU leaves plenty of question marks when trying to size up the trajectory of the global pharma industry. One certainty, however, will be change.
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Compliance and Reporting The Case for a Single SystemPharmaceutical companies are awash in a sea of compliance regulations that affect their business operations both inside and outside the US.
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Pharm Exec's 2018 Pipeline ReportAnalysis shows that persistence is paying off for drug developers, driven by the rise of CAR-T and other gene therapy, newly discovered cancer targets, better patient identification methods-and the realization that failures have their place in shaping the pipeline of tomorrow.
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New Patent-Defense Path for PharmaInter Partes Review can potentially offer a more economical and streamlined litigation strategy for pharma and biotech players, writes David Dalke.
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Planning for the Future of SerializationCompliance with the new traceability requirements necessitates an understanding of how and when to begin implementing changes in an ever-evolving industry.
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Crowdfunding: The Open-Source Option Against Capital CrunchIs crowdfunding an attractive alternative to finance pharma and biotech start-ups? Seth R. Ogden and M. Andrew Holtman report.
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Crowdfunding: The Open-Source Option Against Capital CrunchIs crowdfunding an attractive alternative to finance pharma and biotech start-ups? Seth R. Ogden and M. Andrew Holtman report.
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Executive Coaching: Transforming Big Pharma from WithinDefining the critical coaching steps necessary for top managers to realize their potential in an industry undergoing significant restructuring of human and financial capital.
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Brexit Report: What's Next for the Industry?As the UK exits the European Union, the pharmaceutical and life sciences industries should prepare for changes by identifying key business issues, mitigating risks and creating plans for multiple scenarios.
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The Human Microbiome—Our Body's Secret WeaponNew research on the role of microbes in fighting disease is transforming the way medicine views bacteria, writes Lee Jones.
