Guest Columns

  1. FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    9/4/2019

    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. Does Gender Disparity In Biotech Really Matter?
    9/3/2019

    Why it does, and how one startup is winning the biotech talent wars with a diversity-centric strategy.

  3. Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?
    9/3/2019

    Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?

  4. Project Execution Models For Biopharmaceutical Facilities
    8/29/2019

    Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.

  5. Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs
    8/29/2019

    Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.

  6. What’s A Cure Worth? ICER Publishes Value Assessment Framework For Curative Therapies
    8/27/2019

    The Institute for Clinical and Economic Review (ICER) recently conducted a study of value assessment methods considered for “cures” or “potential cures” and solicited input from international HTA bodies. The research will form the basis of a value framework that will be applied in the assessment of potential cures and other treatments that qualify as what ICER refers to as “single or short-term transformative therapies.”

  7. Is Your Personnel Hygiene Plan Up To Date?
    8/27/2019

    Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

  8. How To Conduct Better GCP Audits (Even When You Feel Like An Impostor)
    8/22/2019

    How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

  9. 2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars
    8/20/2019

    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.

  10. Negotiating Quality Technical Agreements: Strategies for Non-Quality Professionals
    8/20/2019

    Of the four critical documents that must be negotiated and executed by both sponsor and CDMO (NDA, quotation, MSA/SA, and QTA), the QTA is often the least-prioritized by the procurement team. Yet, in practice, the QTA will be the most useful for development- and clinical-stage companies, because it provides a framework for operations and a road map for building quality systems.