Guest Columns

  1. Champions Against Nonsense: A Better Way To Talk (And Think) About Quality
    1/30/2019

    This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.

  2. How Healthy Is The Biopharma Pipeline Heading Into 2019?
    1/28/2019

    This article analyzes key indicators of pipeline strength over the past three years, including R&D spend, new chemical entity approvals, and Phase 2 and Phase 3 development. 

  3. Understanding The Inspector General’s Critique Of The FDA Over Cybersecurity — And What It Means For Manufacturers
    1/28/2019

    This article examines a report issued by the Office of the Inspector General of the Department of Health and Human Services, resultant of an audit of the FDA’s internal processes to ensure cybersecurity in the postmarket phase of medical devices – as well as the FDA’s disagreements with the findings and what this means for manufacturers going forward.

  4. How Would Proposed Congressional Price Control Policies Impact Biosimilars?
    1/24/2019

     

    Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.

  5. CAR T-Cell Therapies In The EU5: What Can We Expect From Payers?
    1/24/2019

    The difficulty of balancing paying for innovation with budgets has plagued Europe for years, and the emergence of cell and gene therapies has only exacerbated that conundrum. 

  6. CDMO Facility Design: What Biopharma Companies Should Be Looking For
    1/24/2019

    This series of articles address manufacturing facility and laboratory design elements that enhance the sponsor’s experience, protect its product against cross contamination, and meet regulatory requirements.

  7. Reimagining Aseptic Processing: What Must Change?
    1/21/2019

    This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations. 

  8. Liquid Biopsy: Market Drivers And Obstacles
    1/21/2019

    This article examines present and near-term opportunities for liquid biopsy, as well as what’s needed to elevate this innovative diagnostic tool to a standard of care.

  9. Cleaning Process Development: Cleanability Testing And “Hardest-To-Clean” Pharmaceutical Products
    1/18/2019

    Cleanability is clearly an important parameter for determining the hardest-to-clean product for use in cleaning validation studies, and reliable methods for this determination are needed. For any analysis, quantitative methods should be preferred over qualitative methods as they are scientific, not subjective, and allow the easy application of statistical evaluation.

  10. ICH Q12: Bringing Regulatory Flexibility To Post-Approval Changes
    1/16/2019

    The convergence of regulatory agencies and acceptance of ICH Q12 across multiple agencies opens up opportunities for changes with minimal supply chain disruptions.