LSL Web-Exclusive Content

  1. Biosimilars: An Evolving Commercial Model

    In this series of articles, the biosimilar market has been carefully examined to help identify the ways in which it is on the brink of considerable and rapid change.

  2. Impact Of International Trade Regulations

    The significant number of national and international trade regulations are challenging for the development of logistics strategies for global clinical research. Identifying the similarities, differences and obstacles pharmaceutical companies face while importing and exporting medicinal products for clinical trials creates an opportunity to streamline the process, remove barriers, and improve efficiency.

  3. Biosimilars: Differentiating And Surviving The Cost Of Entry

    This is the third article in a series on biosimilars. The first two pieces layout the background of the biosimilar market to date and the challenges shaping the market. This article sets out to explain how biosimilar companies are achieving differentiation and what it will take to establish market share.

  4. China’s Healthcare Reforms: Double-Edged Sword For The Pharmaceutical Industry

    Without change, China’s current healthcare system will become unaffordable. The latest round of reforms are aimed at ensuring sustainability by reducing costs. The reforms, if implemented effectively, will have a significant impact on companies operating in the sub-sectors of medical devices, pharmaceuticals, and healthcare services.

  5. The Players In The Biosimilar Market

    This article provides details of the different players that exist in the complex biosimilar market, all of which have different characteristics, histories, reasons for entry, internal capabilities and resources available to support their programs.

  6. Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies

    President Trump promised to take action to streamline the federal government. Within just a few days of taking office, he launched his deregulatory agenda, and he has now issued several executive orders that build on each other. How the concept will be implemented and by whom will continue to evolve with the addition of key staff.

  7. An FDA Perspective On Patient Diversity In Clinical Trials

    Since the late nineteenth century, it has been well-known that individuals can vary widely in their responses to the same medication. Yet, accurately predicting and addressing the effects of that variability during drug development has continued to bedevil researchers, drug sponsors, and regulators.

  8. USP Keeps Pharmaceutical Quality In Focus

    Fueled by its nearly 200-year history, the USP is taking a new look at the value and execution of pharmaceutical quality

  9. Biosimilars: What’s Happened So Far?

    Based on a detailed review of the biosimilar market, it is clear that  this market is highly dynamic. While the biosimilar market has not yet fully lived up to the initial expectations, it may be on the brink of considerable and rapid change.

  10. FDA's Quality Metrics Guidance: Reading Between The Lines

    A previous article covered several key things the FDA's Revised Quality Metrics Guidance document did communicate to industry, Lou Angelucci, currently a project management consultant to Johnson & Johnson, focuses more on what the guidance document failed to say and do … and the implications of those omissions.