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Lifecycle: End GameVery few drugs live forever. Barring remarkable scientific advances and radical market dynamics, most drugs hit old age-and sharply declining sales-several years before their patent expires. But some drugs go out with a bang, not a whimper.
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The Intelligence DiariesBusiness intelligence in a time of greater transparency is a whole new ball game. To play it well, be sure to look for surprising insights, expand your list of competitors of interest, and don't let Google be your only guide.
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The Lesser of Two EvilsIs the American Medical Association's (AMA) Prescribing Data Restriction Program (PDRP) the answer to physicians' privacy concerns, or will it just hamper the relationship between rep and doc? Observant LLC recently gauged reactions to the PDRP and doctors' expectancies of how this initiative affects physicians' practices and their relationships with pharmaceutical representatives. The findings suggest that the initiative may have paradoxical negative implications for physicians.
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Bottom Line BoosterGiven the colossal revenue generated by just one blockbuster drug, it's no surprise that R&D always finds its way to the top of management's agenda. But now more than ever, pharmaceutical companies can't thrive on discovery alone. Price pressure from the public and private sectors drives companies to create savings through operational efficiencies. One of the biggest areas for financial gain"better management of capital assets"is often overlooked.
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Salesforce Survey 2008Welcome to the new employer's market for reps. The Hay Group's annual survey reports how, as the primary sales force contracts, so too does its pay.
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FDA vs. the IndividualWho should make decisions about drug safety-FDA or patients and doctors? In this excerpt from his important new book Overdose, the renowned (and ever controversial) legal scholar Richard A. Epstein argues that the current system overvalues risk, ignores individual differences, and needlessly deprives patients of valuable treatments.
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Legal: E-headacheDocuments from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.
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Drug Safety: Failure to CommunicateMany see Vioxx and Avandia as clear signs that the drug safety system has failed. As soon as reports of these drugs' adverse events began to flood the media, consumers-and Congress-demanded to know: "Why didn't we know sooner?"
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Vouchers: More Data, Fewer DollarsSampling is a sales rep's foot in the door to doctors' offices and the quickest way to get products into consumers' hands. That's why reps handed out $5 billion worth of the freebies last year, spending 30 percent of companies' promotional budgets in the process. Despite that huge investment, few product managers can assess its impact on product inventory, consumer demand, prescription rates, or market share. But sampling's greatest failure is its inability to provide the healthcare industry with product-use or patient data.
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Sharing IP, Sharing RiskThanks to growth in international trade, rapid technological innovation, and a willingness to share intellectual property (IP), the number of corporate cross border alliances has grown steadily.
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Hits Like a BRICThe first wealth is health, wrote American thinker Ralph Waldo Emerson. Indeed, history has taught us (even before Emerson) that health and wealth are inextricably linked-the more money one has, the healthier one is likely to be.
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Glaxo Vies for a Second Act in HIVA novel joint venture between Glaxo and Pfizer is big on promise. But the combined portfolio and pipeline of HIV drugs? Not so much.
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The Lesser of Two EvilsIs the American Medical Association's (AMA) Prescribing Data Restriction Program (PDRP) the answer to physicians' privacy concerns, or will it just hamper the relationship between rep and doc? Observant LLC recently gauged reactions to the PDRP and doctors' expectancies of how this initiative affects physicians' practices and their relationships with pharmaceutical representatives. The findings suggest that the initiative may have paradoxical negative implications for physicians.
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Extension of Medicare is the Affordable Solution to Current Healthcare ProblemsCOVID-19 has only magnified well known flaws of our healthcare system. An extension of Medicare is the affordable solution, writes Bruno Delagneau, and pharma needs to start planning for this to minimize its impact on US revenues.
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Lifecycle: End GameVery few drugs live forever. Barring remarkable scientific advances and radical market dynamics, most drugs hit old age-and sharply declining sales-several years before their patent expires. But some drugs go out with a bang, not a whimper.
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Manufacturing’s True North: The Quality CompassThe need for biopharma executives to combine a "culture of quality" with value-added processes and improvements in the area drug manufacturing is critical. Here are steps and strategies than can help.
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Back Page: Let's Get GutsyWe all know that pharma is facing hard times: cut-throat competition, regulatory constraints, patent expirations, rusty pipelines, rising generics, falling revenues-and, perhaps most important, a firestorm of consumer anger over drug prices and safety now being restoked by the new Democratic Congress. Nevertheless, industry persists in "staying the course"-sound familiar?-rather than charting a bold new strategy. Its two top priorities remain opposing government price controls and thwarting patent laws favorable to generics. These defensive tactics are hardly the hallmark of leadership.
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Test and Learn: Making Confident Decisions on the Commercial SideCompanies that adopt this new methodology will have a longstanding competitive advantage over those companies conducting business as usual.
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Keep Your Pinstripes VerticalThe federal government's enforcement juggernaut rolls on-and the pharmaceutical industry is squarely within its sights. In recent years, the industry has paid close to a billion dollars in fines, civil settlements, and penalties.
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Retooling the Pharma Marketing ModelIt's time for pharma market research to advance science-based decisions and foster judgement calls
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Salesforce Survey 2008Welcome to the new employer's market for reps. The Hay Group's annual survey reports how, as the primary sales force contracts, so too does its pay.
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Good Recruitment Practice = Patient PullPatient recruitment for clinical trials is one of the most significant bottlenecks in drug development. As a result, several organizations have called for the establishment of recruitment best practices, beginning in 2000 with the Office of the Inspector General's (OIG) report on recruiting human subjects and most recently in a Clinical Research Roundtable report published in the March 12, 2003 issue of the Journal of the American Medical Association (JAMA).
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Lifecycle: End GameVery few drugs live forever. Barring remarkable scientific advances and radical market dynamics, most drugs hit old age-and sharply declining sales-several years before their patent expires. But some drugs go out with a bang, not a whimper.
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Back Page: The Post-Trust WorldPeople are up to a thousand times more worried about involuntary risks (living by a cell phone tower) than they are about voluntary ones (using a cell phone). And they see pharma products as involuntary risks.
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The Complete Pharm Exec Guide to PDUFAThe history of prescription drug laws is a complex mix of evolution and politics-in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills-the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)-would both continue existing programs and create new regulatory burdens.
