LSL Web-Exclusive Content

  1. IPR For Biosimilars: Examining The Benefits And Drawbacks
    7/11/2019

    Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.

  2. The Debate On Standards In Biologics Development Heats Up
    7/11/2019

    Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

  3. Understanding The FDA’s Breakthrough Devices Program
    7/8/2019

    Well-prepared manufacturers can benefit from close collaboration with the FDA during the intensive approval process, propelling their products to market in a relatively short period of time.

  4. New FDA Guidance On Biosimilar Interchangeability
    7/3/2019

    A summary of the FDA’s recent guidance titled “Considerations in Demonstrating Interchangeability with a Reference Product” regarding biosimilars.

  5. Machine Learning In Clinical Trials: What Will The Future Hold (And What’s Holding Us Back)?
    7/2/2019

    While the industry is taking baby steps into using machine learning in clinical trials and for other data-generating objectives, the value of this data will depend on the transparency of algorithms, robustness of data sources, and extrapolation to real-world outcomes.

  6. Patient Voice: Determining Fair Market Value For Patient Insights Work
    6/25/2019

    Clinical research professionals often turn to healthcare professionals to critically assess the complex prioritization and planning of clinical research and to act as surrogates for the patient perspective.

  7. Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back
    6/20/2019

    Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.

  8. AI, Data Integrity, & The Pharma Industry: Let’s Not Wait Until Someone Dies
    6/18/2019

    Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.

  9. How To Ace Your Next CDMO Capabilities Audit
    6/18/2019

    A capabilities audit is an integral part of a sponsor's due diligence in vendor procurement. It is often the sponsor’s first exposure to a CDMO’s operations.

  10. Ranbaxy Revisited: Why We Need To Look Back
    6/14/2019

    The fraud, deception and damage Ranbaxy Laboratories Ltd. of India perpetrated around the world a decade ago in the form of shoddy and dangerous drug manufacturing practices, is legendary. It’s time to look back. Katherine Eban, author of “Bottle of Lies: The Inside Story of the Generics Drug Boom” has provided us the means.