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Agency Best Practice in Regulatory ComplianceNO ONE REALLY KNOWS WHAT A DOCTOR IS thinking most of the time, and those of us who are patients can be happy about that. We are comforted when physicians keep their counsel until they complete an examination.
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Sampling: Crimes in the ClosetThe pharmaceutical industry devotes more of its promotional budget to samples than anything else, unless you count the army of sales representatives that delivers them. This year, the average wholesale price of samples passed out to doctors will approach $15 billion-roughly twice the value of samples five years ago. And although few in the industry have come to grips with it, the federal regulations governing this enormous investment have undergone drastic changes.
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Key Opinion Leaders Interactions with PharmaData suggest that pharma companies engage the same key opinion leaders on assignments in three to seven departments or product groups at once.
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Meeting Unmet Medical Needs: The Disparity DilemmaThe US drug regulatory system fails to address the country’s most urgent medical needs with the resources appropriate for the task. But change is possible, say Christopher-Paul Milne and Kenneth I. Kaitin.
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Vaccines: Market on the ReboundMergers have cut the field of companies with real marketing and manufacturing muscle from 25 to five. The 2004 vaccine market will double by 2009.
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Why It’s Time to Get Smarter about Content Management and Document ProductionStructured authoring is an approach that has eluded life sciences, limiting firms’ ability to transform routine regulatory processes. But this could all change, writes Romuald Braun.
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Knowledge-Based Outsourcing: Driving Deeper InsightsTracking, monitoring, and trend evaluation is not enough. Companies must now do more than assess what happened and why.
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Protecting IP Throughout the Product LifecycleNow that patents on several blockbuster drugs have expired, the industry-feeling the pinch-has focused its attention on intellectual property. Because every additional month of market exclusivity can mean an extra $50 million or more in revenue, pharma companies have gone to great lengths to block the entry of generic competition.
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Goodbye, Willy LomanThe days of pharma sales reps going office-to-office with samples and brochures are done. These days, they need to turn their attention to payers, pharmacists, and consumers
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Everything I need to know about pharma sales I learned in kindergartenI have been in pharmaceutical sales for less than a year, and the following are the things that I've learned.
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Legal: Jumping the PondClass actions threaten industries that deal with the public. If European lawmakers remove the restriction on class-action suits, consumers will be free to file cases. Pharma companies should take heed.
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Marketing to Professionals: DetailingWhile the typical brand invests more than $100 million in annual sales force support, it spends on average less than $2 million to determine whether the detail piece is driving prescriptions.
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Formulary Additions: The Big PictureTo get along with the CFO, drug companies need to express more data in units that a health plan can integrate into its own internal actuarial analysis. The financial decision makers at a health plan want to know how a new drug affects the value of expected claims on the whole.
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Orchestrating ComplianceProduct managers would be less disrupted if compliance activities at pharma companies were more anticipatory than reactionary.
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Dear eDiaryElectronic patient-reported outcomes tools let trial sponsors enforce recording deadlines and compliance. They help keep subjects honest.
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Legal: Foreign PolicyCompliance requires overcoming cultural barriers. To start with, in some countries the taboo against bribery is not as strong as it is here.
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Track and TraceThe issue of pedigree requirements is emerging at the state level-and figuring out to what extent that will push back to the manufacturers.
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Pressed Into Action: Measuring Pharma’s Reputation ReversalStudy analyzes mainstream media coverage of the industry before and after the COVID-19 lockdown.
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Vaccines: Market on the ReboundMergers have cut the field of companies with real marketing and manufacturing muscle from 25 to five. The 2004 vaccine market will double by 2009.
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Agency Best Practice in Regulatory ComplianceNO ONE REALLY KNOWS WHAT A DOCTOR IS thinking most of the time, and those of us who are patients can be happy about that. We are comforted when physicians keep their counsel until they complete an examination.
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Pfizer on the Line for Warner-Lambert's Past ProblemsA former Warner-Lambert employee has blown the whistle on the company's "shadowing program," alleging that some physicians accepted money in exchange for allowing pharma sales representatives to meet with patients, review charts, and recommend prescriptions. According to the lawsuit, Warner-Lambert-since acquired by Pfizer-tried to boost sales of its epilepsy drug Neurontin (gabapentin) by tracking prescriptions and rewarding high-prescribing physicians with gifts such as cash, trips to resorts, and lucrative speaking and consulting jobs-as well as paying them to enter patients in clinical trials. The program allegedly paid 75-100 US doctors at least $350 per day to let sales reps watch
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Sewing Up New SalesMore than high-call frequency will be necessary to succeed in an increasingly competitive sales environment.
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Who Pays for Specialty Medicines?Providers and patients fish for that delicate balance between access and abandonment.
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The Ins and Outs of EAPsFor a patient who is running out of hope, waiting for a drug to be approved can be interminable. Even on the fast track, a review can take six months or longer. Some patients with life-threatening diseases cannot afford to wait. In response, many countries have developed expanded access programs (EAPs) that give patients with no other viable alternative access to medically important drugs before they are commercialized.
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Physician FrustrationAs the industry thinks about new sales force models, it should look beyond ROI numbers, toward a new paradigm that not only works for pharma, but also for its customers.
