LSL Web-Exclusive Content

  1. Assessing The Impact Of Civica Rx Business Model For Pharma Manufacturers

    While the full impact of the Civica Rx approach remains to be seen, it will depend largely upon which drugs the company decides to produce.

  2. Real World Evidence And The Collision Between Pharma R&D And Healthcare

    The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?

  3. How Will New Trade Agreements Impact The Pharma Industry … And Patient Access To Medicines?

    The new trade regime unleashed by President Trump has not only heightened trade tensions, it has the potential to affect patient access to affordable medicines. His administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.

  4. Designing Clinical Trials With The Payer In Mind

    Imagine your company just received FDA approval of a new pharmaceutical, the result of years of clinical research and difficult regulatory scrutiny. The product is being manufactured and is shipping to distributors and wholesalers. Providers and patient advocacy groups seem excited for the launch, and sales goals are considered aggressive. However, one key variable remains: coverage.

  5. If Four-Letter Suffixes Aren’t Used In Biosimilar Tracking, What Use Are They?

    The implementation of the Biologics Price Competition and Innovation Act1 (BPCIA) raised a number of critical issues for manufacturers, payers, and prescribers. These include the big-picture questions of extrapolation of indications, interchangeability, and a radical new approach to evaluating the comparability of these drugs to their reference biologics, as well as approving them.

  6. 4 Emerging Commercialization Strategies For Gene And Cell Therapies

    Progress in development of gene and cell therapies around the world has potential to transform standards of care for a range of diseases and address significant areas of unmet need in healthcare over the coming years. In the U.S. alone, almost 20 gene and cell therapy products have been approved thus far,1 with many other development programs reaching later clinical stages. The technology platforms of many of these drugs also offer the potential for curative efficacy and expansion for use in multiple indications.

  7. How Amgen Uses AI Tools To Improve Manufacturing Deviation Investigations

    Amgen is piloting a process using artificial intelligence (AI) that has the potential to greatly enhance its ability to trend and find patterns in manufacturing deviations and to prevent their recurrence. The AI tool will look across large data sets and find correlations between obscure signals and events which the previous system could have missed.

  8. Be Brave, Be Curious, Be Determined.

    Some leadership steps to take when you want to engage employees, colleagues, partners and customers to join you in your quest for knowledge to find cures to today’s most pressing business challenges.

  9. The Top 5 Trends To Watch In Bioprocessing

    Biopharmaceutical processes — and the technologies that enable them — have experienced remarkable progress in the past 30 years, since the first biopharmaceuticals were approved for human use. This article will highlight some of today’s top trends in bioprocessing, as this exciting field continues to flourish.

  10. 7 Reasons There Was Never Going To Be A Bioprocessing Capacity Crunch

    “Basically, industry perceives, reports, and expects no major capacity crunches” related to global bioprocessing needs. So concludes an editor of BioPlan Associates, Inc.’s Fifteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (April 2018), in a response to my recent editorial saying as much. Now we have the data to back the assertions up.