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FDA's $100 Million RWE Project: Making It All It Can BeFDA's proposal to build a modern system to gather real-world evidence (RWE) from about 10 million individuals could have profound implications, but it will realize its potential only if FDA takes a more expansive view of what RWE can be, writes Paul Glimcher.
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RMAT Designations: Lessons Learned on the “Clinical Evidence” RequirementThe Regenerative Medicine Advanced Therapies (RMAT) designation was introduced by the 21st Century Cures Act as a pathway to accelerate FDA approval and market entry of regenerative medical therapies. Two years on, William Rose and Suchira Ghosh identify the trends in how FDA assesses the clinical evidence supporting successful RMAT candidates.
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Pharmacovigilance Software's “Salesforce” MomentAlthough it is unlikely that mock demonstrators will be seen at any drug information or regulatory conferences, pharmacovigilance software is indeed having its “Salesforce” moment.
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Pipeline Drill-Down: Expert Perspectives on Alzheimer's, Opioids, and CannabisAnalysts from Informa Intelligence take a deeper dive into these three pivotal areas of R&D today-the crisis points and progress.
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Pipeline Drill-Down: Expert Perspectives on Alzheimer's, Opioids, and CannabisAnalysts from Informa Intelligence take a deeper dive into these three pivotal areas of R&D today-the crisis points and progress.
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Pipeline Drill-Down: Expert Perspectives on Alzheimer's, Opioids, and CannabisAnalysts from Informa Intelligence take a deeper dive into these three pivotal areas of R&D today-the crisis points and progress.
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Trust—Biotech’s Hidden AdvantageHow companies can trust now to cultivate corporate reputations that build business.
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Developing Mindful Pharma LeadersMindfulness is a key factor in enhancing productivity and success in clinical development leaders and the entire pharmaceutical industry.
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Developing Mindful Pharma LeadersMindfulness is a key factor in enhancing productivity and success in clinical development leaders and the entire pharmaceutical industry.
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Developing Mindful Pharma LeadersMindfulness is a key factor in enhancing productivity and success in clinical development leaders and the entire pharmaceutical industry.
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Machine Learning: The Next Frontier in Commercial PlanningKeshia Vaughn looks at how machine learning can transform commercial planning and outlines what teams will need to deploy it effectively.
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Ascending the Uncanny Valley in HealthcareBeing more human in brand engagement doesn’t mean being less transparent
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Securing Medical Devices Means Securing NetworksOrganizations should focus just as much of their attention on securing the actual medical devices they produce as the network they depend on, writes Chris Souza.
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Reacting to Reference PricingThe industry should take a twin-track approach to the potential threat of the Trump administration's proposed move to reference pricing, writes Todd Edgar.
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A Match Made in ClinicHow artificial intelligence, wearable devices, and translational informatics are changing healthcare.
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A Match Made in ClinicHow artificial intelligence, wearable devices, and translational informatics are changing healthcare.
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5 Ways to Shape a Regulatory Affairs Workforce for the FuturePharmaceutical regulatory divisions should use the same discipline, rigor and focus on the talent pipeline as they do the product pipeline, writes Karin Van Baelen.
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Measuring the Probability of Pricing and Access SuccessThere is still no structured method of assessing pricing and access risk for drug manufacturers. Presented here is a straightforward measure for integrating pricing and access risk into portfolio planning and decision-making.
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Commercial Sustainability of Pharmaceutical Innovations for PandemicsAssessing the landscape of the pharma industry’s readiness for future pandemics by looking at past pandemics, funding and revenue, and sustainability.
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Measuring the Probability of Pricing and Access SuccessThere is still no structured method of assessing pricing and access risk for drug manufacturers. Presented here is a straightforward measure for integrating pricing and access risk into portfolio planning and decision-making.
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Measuring the Probability of Pricing and Access SuccessThere is still no structured method of assessing pricing and access risk for drug manufacturers. Presented here is a straightforward measure for integrating pricing and access risk into portfolio planning and decision-making.
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Is Patient Engagement Brexit-Ready?Whatever the final outcome of Brexit, investing in supporting advocacy communities will be an important element of maintaining trusted relationships with patient groups and stakeholders in the UK and the EU, write Nick Hicks and Tamsin Rose.
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Three Key Dynamics to Understand for Canadian Market AccessThis article discusses three key considerations a manufacturer should either understand or seek a consulting partner to guide them through a commercialization plan.
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The Biopharma-Led Platform Business Model in HealthcareWhat we can learn from an early leader?
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Why Pharma Should Pay Attention to Copay Accumulator ProgramsAn understanding of copay accumulator and maximizer benefit design programs.
