Employer Roundtable Highlights Biosimilar Knowledge Gap
Employer Roundtable Highlights Biosimilar Knowledge Gap

Though this event encompassed a small cross-section of employers, the discussions and questions asked about biosimilars revealed the topics that need to be considered, reiterated, and regularly reinforced.

  • 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.

  • The Progress And Pitfalls Of Global Biosimilar Development
    The Progress And Pitfalls Of Global Biosimilar Development

    While we’ve certainly seen progress on the march towards true global development, there’s still a way to go. There were several points I learned recently that stood out about which regulatory inconsistencies still exist between developed nations, as well as how certain aspects of regulatory science can be improved upon in the future.

  • How Can Biosimilars Make Headway In The U.S. Market?
    How Can Biosimilars Make Headway In The U.S. Market?

    ISPOR, the professional society for health economics and outcomes research (HEOR), recently held its annual conference, which brought together nearly 4,000 researchers, regulators, payers, drug developers, providers, and other stakeholders from across the healthcare continuum. During one panel session, experts in biosimilar regulatory, legal, and reimbursement discussed the crucial elements needed to foster a robust and sustainable U.S. biosimilars marketplace over the long term.

  • Maintenance 4.0: The Next Revolution In Bio/Pharma Manufacturing
    Maintenance 4.0: The Next Revolution In Bio/Pharma Manufacturing

    The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.

  • USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    USP Highlights Biosimilar Analytical Development Challenges, Possibilities

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.  

  • Off-Site Modular Fabrication Of Biopharma Facilities — What You Need To Know
    Off-Site Modular Fabrication Of Biopharma Facilities — What You Need To Know

    Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.

  • Are Biopharma's Strong Pipeline Innovations Reaching Patients?
    Are Biopharma's Strong Pipeline Innovations Reaching Patients?

    The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?

  • FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?
    FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?

    In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

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