GUEST COLUMNISTS

  • 4 Important Things To Consider Before Developing A Drug Delivery Device
    4 Important Things To Consider Before Developing A Drug Delivery Device

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.

  • 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    2019 U.S. State Policy Trends Impacting Pharma Manufacturers

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

  • How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy
    How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy

    As follow-on biologics litigation expands, and the FDA provides additional information on the approval process for follow-on biologics, industry and observers are gaining clarity on how the Biologics Price Competition and Innovation Act (BPCIA) functions in practice. This article provides insight into two recent developments that will impact strategic and economic considerations for biologics developers.

  • Applications For Single-Use Systems In Biosimilar Development
    Applications For Single-Use Systems In Biosimilar Development

    Exploring the benefits, challenges, and future of disposable systems in biosimilar manufacturing.

  • IPR For Biosimilars: Examining The Benefits And Drawbacks
    IPR For Biosimilars: Examining The Benefits And Drawbacks

    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.

  • 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design
    4 Key Usability Considerations For Biopharmaceutical Delivery Device Design

    Often, the last thing on the minds of drug development teams working is the human factors engineering (HFE) performance of the drug delivery devices that will ultimately deliver their innovative medications to patients. Yet, such an oversight can cause major delays in delivering these new medications to market. 

  • Bio/Pharma Maintenance 4.0: How To Get Started
    Bio/Pharma Maintenance 4.0: How To Get Started

    Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, we will discuss how to get started with Maintenance 4.0, along with how to develop benchmark metrics that allow assessment of the gap between the current and desired states.

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BIOSIMILAR WHITE PAPERS

More Biosimilar White Papers
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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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Free collection of articles highlighting some of the dynamics playing out in the hospital setting for biosimilars, as well as how physicians and drugmakers can foster a greater understanding of biosimilar medicines.

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Lyophilization - An Introduction to the Scientific Principles August 27 - 27, 2019
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The Top Method Validation Mistakes – And How to Avoid Them September 9 - 9, 2019
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Pediatric Clinical Trials: Special Considerations and Requirements September 13 - 13, 2019
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