Articles in this Issue

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  In-Flight Data Control: Key to Efficient Life Sciences Business Processes

  As pharma companies work on creating a continuous, reliable, harmonized data flow across their operations, the focus is turning to ‘in flight’ data control. This is about ensuring that information captured and used in one part of ... read more
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  Visualizing for the Future – Prioritizing Data and Increasing Expertise for Enhanced Data...

  Data science is the current buzzword in the pharmaceutical industry. It offers solutions to the challenges of increasing clinical data sources in a multi-provider, decentralized, digitally-enabled environment. But to make sure it ... read more
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  Most Significant Risk Factors for Emerging and Mid-Market Biopharma Companies - Costly Clinical...

  In 1820, a group of physicians, driven by concerns regarding the quality and reliability of medicines, set up and released the first United States Pharmacopeia (USP). This pioneering publication included formulas for preparing 217... read more
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  The Role and Challenges of Plasma Protein Binding in Oligonucleotide Drug Development

  Plasma protein binding refers to the degree drugs bind to proteins within the blood or plasma. In pharmacology, drugs exist in two forms: unbound, or "free," and the bound form. Unbound drug molecules are pharmacologically active,... read more
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  Four Questions to Determine the Health of Your Company’s QMS

  According to the American Society for Quality, a quality management system (QMS) is a “formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.” For companies in ... read more
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  Transitioning to Precision Medicine

  While pharma has produced some incredible blockbusters, it has largely remained unremarkable at the individual patient level, with only an estimated 30% to 50% of patients fully responding to many leading conventional drugs. One ... read more
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  The Power of Solubilization – How CDMOs Help Low Solubility Drug Candidates Reach Their Full...

  Water solubility is a key factor in determining the extent of a drug molecule’s therapeutic effect. There is a clear relationship between poor water solubility and bioavailability, as drug uptake may be variable and insufficient ... read more
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  A Quarterly Review of New Drug Applications – April-June, 2023

  This quarterly review on New Drug Applications contains data for applications approved during the second quarter of 2023, which includes New Molecular Entities (NMEs) and new biologics. A total of 39 applications were approved by ... read more
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  A Review of How Real-World Evidence Enhances Regulatory Submissions

  The importance of using real-world evidence (RWE) for efficacy has gained significant momentum over the past few years as regulators are increasingly calling for the use of real-world data (RWD) and RWE. Regulatory bodies across ... read more