Authors
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Closing the Loop: Manufacturing & Regulatory Functions as Data CollaboratorsInformation gaps between manufacturing and regulatory, between ERP and RIM systems, are preventing all the practical and strategic benefits of data-based collaboration, writes Catherine Gambert.
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What the Purdue Pharma Case Teaches Us About Reputational TornadoesPurdue Pharma and its corporate leadership featured prominently in the media recently as litigation mounts over their sales and marketing of Oxycontin. Nir Kossovsky offers some observations about the lessons this situation provides for all corporate leaders responsible for their companies’ reputations.
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The Implications of Connected Medical Devices & Digital HealthcareLoetitia Jabri considers the broader implications as healthcare providers embraces new digital connectivity options as part of the Medicine 2.0 era.
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The Patient Comes First with Outcomes-Based ContractingThe benefits and challenges of outcomes-based contracting.
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What Does the ‘Third Age’ Look Like for BioPharma Employees as They Plan for Longer Life Spans?A Q&A with Dr. Ken Dychtwald, Recipient of the McKinsey Award for his Harvard Business Review article, “It’s Time to Retire Retirement.”
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Are Pharma Marketers Fighting the Last War?Despite being the fastest growing influencers in healthcare, ad campaigns targeted at payers are often an afterthought.
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Cystic Fibrosis: The Importance of Patient AdvocacyThe importance of patient advocacy in boosting research for cystic fibrosis.
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Three Tips to Managing Multiple Agency PartnersOutlining three practices that are key to navigating today’s multiplayer agency landscape - and getting more value from each external vendor.
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The Path to Patient-Focused AccountabilityBenchmark survey assesses the industry’s progress so far in moving from words to action in its approach to patient centricity.
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Patient Support Programs: Cost, Benefit, and ResourcingWorking group explores the challenges of patient support programs (PSPs) and market research programs (MRPs) for pharmacovigilance (PV) professionals-and solutions currently being put into practice.
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Patient Support Programs: Cost, Benefit, and ResourcingWorking group explores the challenges of patient support programs (PSPs) and market research programs (MRPs) for pharmacovigilance (PV) professionals-and solutions currently being put into practice.
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Patient Support Programs: Cost, Benefit, and ResourcingWorking group explores the challenges of patient support programs (PSPs) and market research programs (MRPs) for pharmacovigilance (PV) professionals-and solutions currently being put into practice.
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FDA Modernizes Controlled Correspondence Interactions with Pharma IndustryAs part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
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FDA Modernizes Controlled Correspondence Interactions with Pharma IndustryAs part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
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How Blockchain Can Support FDA’s AgendaThe digitization of healthcare is paving the way to accelerate drug development in the industry, and the FDA is doing its best to support industry.
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Pharma's Incentive Compensation Plan LandscapeAs pharmaceutical companies become increasingly focused on retaining key sales people, they continually consider ways to leverage variable compensation as a strategic tool for maximizing the return on their investment in top talent.
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“Drug Transparency”: Each Bill Needs Careful EvaluationCould the new Vermont Drug Transparency law “lead the US Pharmaceutical industry to an awful end”? Tom Norton reports.
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M&A: Range of Fundamental Factors Will Drive Strong Deal FlowThe outlook for pharma M&A continues to be strong, writes Michael Jewell.
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RAPS Statement - BREXIT delayRegulatory Affairs Professionals Society's Executive Director, Paul Brooks, discusses the looming uncertainty about what will happen after the UK leaves the European Union as many important details remain unclear.
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Measuring Product-Market-FitJean-Francois Denault outlines a systemic approach to evaluating the commercial viability of a product.
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Work Planning and Approaches to Overcome Bottlenecks – an analytical department in drug developmentCommon strategies to overcome bottlenecks and how fast they might lead to results are discussed.
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Primed for Progress: FDA’s Pre-Cert Program for Digital Health DevicesExecutives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.
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Primed for Progress: FDA’s Pre-Cert Program for Digital Health DevicesExecutives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.
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Gene Therapy: Managing the Clinical Trial MinefieldsAdvice for developers in steering gene therapies from concept to trials to hopeful approval in what is an uniquely complex path.
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Operations: Gateway to Success in Cell and Gene TherapiesLife sciences therapies are moving away from a one-size-fits-all approach to a targeted approach using a patient's own genetic information and immune system to treat previously incurable diseases.
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Operations: Gateway to Success in Cell and Gene TherapiesLife sciences therapies are moving away from a one-size-fits-all approach to a targeted approach using a patient's own genetic information and immune system to treat previously incurable diseases.
Latest:
Operations: Gateway to Success in Cell and Gene TherapiesLife sciences therapies are moving away from a one-size-fits-all approach to a targeted approach using a patient's own genetic information and immune system to treat previously incurable diseases.
