GUEST COLUMNISTS

  • Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
    Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”

    With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.

  • FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018

    In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

  • 2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars
    2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars

    Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.

  • 4 (More) Critical Considerations For Drug Delivery Device Development
    4 (More) Critical Considerations For Drug Delivery Device Development

    The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

  • Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  • 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. In this installment, we will look at the areas of primary container, device development, device selection, and design control.

  • 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.

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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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LIFE SCIENCE EVENTS

Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Smarter Development Of Chromatography Processes September 24, 2019
Time: 11:00 AM Eastern Daylight Time. Duration: 1 hour
SMi’s 10th Annual Biosimilars Conference September 25 - 26, 2019
London
Stability Programs – Key Factors in Meeting FDA/ICH Expectations September 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success September 30 - 30, 2019
1pm-2:30pm EDT, Online Training
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