Contributing Editors

  1. Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data
    9/18/2019

    This article is the first in a series of articles that will explore some of the typical issues that may be encountered during recovery studies and show how the use of statistical tools for assessing the recovery data can provide greater insight into the results and enable data-driven decisions concerning recovery studies. In this installment, we will look at three case studies.

  2. FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    9/16/2019

    In Part 1 of 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 presented #10 through #6 of the top drug GMP inspection citations for FY2018 and provide insight into the observations. This part counts down citations #5 through #1.

  3. Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again
    9/12/2019

    Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

  4. 5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them
    9/11/2019

    Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.

  5. 7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing
    9/11/2019

    Any company with successful Phase 1 study data must ensure sufficient and consistent supply of drug product for possible Phase 2 and Phase 3 trials. For this reason, Phase 1 companies planning to outsource manufacturing of their clinical supply should take some essential steps early in the clinical manufacturing campaign to assure a timely and reliable supply of material throughout their clinical trials.

  6. Examining FDA’s New Patient Labeling Draft Guidance
    9/9/2019

    In accordance with the increasing emphasis on human factors as it applies to medical products and their associated written materials, the FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

  7. Pharmaceutical Transport Validation — Where To Begin?
    9/6/2019

    This article provides a road map for transport validation, which is used to qualify packaging for the entire product supply chain. When transport validation is done incompletely, poorly, or not at all, it can result in off-label drugs that are potentially harmful to patients.

  8. 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.

  9. 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?

  10. 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.