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Analysis of Risk-Based Quality Management Approach - White PaperThis white paper investigates best practices and tangible benefits associated with a risk-based quality management (RBQM) approach to clinical trial management.
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Halting the HypeUnfortunately, companies sometimes violate the public trust by issuing false or misleading statements about FDA-related issues, such as the progress of FDA's pre-market review. When we identify suspected misstatements, we have a new process to bring them to the attention of the SEC staff as quickly and efficiently as possible." Then FDA Commissioner Mark McClellan issued that statement in a February press release.
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Case Study: Science-Based SellingThe relaunch team focused on clinical differentiation to drive business with science.
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Effectiveness Not Volume: Q&A with Pooja LalAI is transforming content reviews to focus on relevant use, not just generation.
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Inside DDMAC: A Conversation with Thomas AbramsDespite heightened scrutiny from industry advocates and the beginnings of self-imposed regulation, pharma companies' violations of DTC regulations have been getting worse, says Tom Abrams, director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). Abrams has been on all sides of drug marketing, from receiving promotions as a pharmacist to creating promotions as a member of industry to regulating promotions as the head of DDMAC. As such, he's in good position to see the big picture.
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Optimal Pricing StrategiesPricing has never been more of a key issue for the industry than it is right now. Yet, even with the increased importance of pricing strategies, a lack of focus on critical market factors leads many manufacturers to forego profits or increase their vulnerability to aggressive payers. Aligning pricing and contracting can achieve a sustainable competitive advantage-if product managers objectively assess a product's clinical benefits and address two key questions:
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Data Unleashed: Cooperation Among CompetitorsCharting two years of collaborative progress in clinical trial data sharing.
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Paying for the Future of MedicineThe three leading justifications for sticker-shocking drug prices in the US.
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A New Game Plan for Pharma HRNew dynamics are forcing the industry's human resource departments to rethink their operational game plans. The drivers-consolidation, globalization, scientific advances, public policy, and competition-have pushed HR leaders into new territory to address business needs.
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Dangerous Liaisons: Terrorism and PharmaHow vulnerable is Big Pharma to the predations of organized terrorist groups or that rogue malcontent with an agenda to wreak havoc on society?
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Specialty Service Programs: Gearing up for Next Generation TechnologiesInnovation in hub program design for patient scrip data and clinical support services can lead to increased market share in the hotly contested specialty medicine space.
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Innovation Calls Across the C-suite: Lessons From Wall StreetThe lifeblood of the life sciences industry is continuous innovation-it is not a business that can survive by standing still.
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The JOBS Act: A Boost for Biopharma?Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart.
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Managed Markets: Positioning Your Product For Success with Pull Through StrategiesA patient-centric approach to drug development delivers the benefits that actually create value.
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Rare Disease Week: Progress, But Still Very Few TreatmentsSteve Smith provides an advocates account of last month's Rare Disease Week on Capitol Hill.
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Dangerous Liaisons: Terrorism and PharmaHow vulnerable is Big Pharma to the predations of organized terrorist groups or that rogue malcontent with an agenda to wreak havoc on society?
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Early Engagement with Medical LaboratoriesTimely engagement is the key to expanding the use of companion diagnostics.
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Marriages Made in Heaven?In recent years, some of the industry's largest companies have said "I do" at the merger altar. Midsized pharma, small biotech, and genomics companies have also joined the mating frenzy. The mixed results of those unions have left shareholders, customers, and employees wondering-are such marriages made in heaven or in hell?
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The keys to territory & time managementGood territory and time management is the foundation of all successful selling, and successful territory and time management involves thorough knowledge of your territory.
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Recognize Reward Retain: The Three Rs of Performance ManagementEmployees are most attracted to products they might feel guilty about buying for themselves, but when they have points to redeem, they feel fine about splurging.
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The Best Price for the Most RevenueA global life-cycle management strategy should be baked into a drug's initial price at launch, write Alice Swearingen and Patrick Homer.
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Policing CRM SamplingParma sales reps have long been using customer relationship management (CRM) systems to detail doctors and provide them with samples. But it was not until late 2000, when FDA initiated the final rule of 21 CFR Part 203 and 205, enforcing the Prescription Drug Marketing Act (PDMA) of 1987, that the industry grew attentive to the regulations governing CRM systems, also known as sales force automation (SFA) or sales force effectiveness (SFE) systems.
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Running a Tight ShipIn a tight market, pharma companies are asking themselves: "How can we get more from scarce resources?" As a result, R&D and sales/marketing expenditures are under increased scrutiny-and they should be. Both areas consume significant resources (about 25 percent of revenues combined) have experienced rapid growth, and their results have been difficult to quantify. But to make the most of both human and non-human assets, management must first understand how those assets are currently allocated, how to make them more productive, and if there are better ways to deploy them. That substantial task will be further exacerbated as the industry
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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.
