Guest Columns

  1. Why CMO/CDMOs Should Seek Opportunities To Collaborate
    7/30/2019

    When I look at the state of the contract manufacturing and development industry, I see an industry ripe for disruption. It isn’t inconceivable to envision an outsider coming in to shake things up.

  2. Developing Triple-Combination Immunotherapies: Lessons Learned From HIV
    7/30/2019

    Our body’s immune system appears to be the most effective therapy to fight cancer—more so than chemotherapy, radiotherapy, or any other anti-cancer therapy currently available. However, the immune system is only effective if it can detect cancer cells.

  3. How To Prepare For An FDA Inspection
    7/29/2019

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.

  4. IVDs And LDTs: Evolving Visions Of FDA Oversight Under The VALID Act
    7/29/2019

    The Verifying Accurate, Leading edge IVCT Development (VALID) Act represents the latest development in LDT regulation. This article examines how clinical tests have been regulated, as well as an overview of the proposed VALID Act, and where the potential legislation stands.

  5. Is Continuous Manufacturing A Good Fit For Generic Drug Products?
    7/25/2019

    Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.

  6. 3 Surefire Approaches To SOP Harmonization
    7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  7. How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy
    7/23/2019

    As follow-on biologics litigation expands, and the FDA provides additional information on the approval process for follow-on biologics, industry and observers are gaining clarity on how the Biologics Price Competition and Innovation Act (BPCIA) functions in practice. This article provides insight into two recent developments that will impact strategic and economic considerations for biologics developers.

  8. Will We Have Harmonized Standards By The MDR’s Date Of Application?
    7/22/2019

    The EU Commission has requested that EU Standardization Organizations draft revisions to their existing standards, adapt some international standards, and issue new standards in support of the MDR and IVDR before May 26, 2020. Which standards could meet the deadline, and where are there likely to be issues?  

  9. Next Steps For Serialization In The Pharma Supply Chain
    7/22/2019

    The industry has made unprecedented progress and addressed several challenges to ensure compliance with global pharmaceutical serialization and traceability requirements. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.

  10. 4 Trends In Recent FDA Warning Letters To OTC Drugmakers — And How To Avoid Them
    7/19/2019

    A recent flurry of warning letters issued to manufacturers of over-the-counter (OTC) drug and health products has revealed similar deficiencies related to current good manufacturing practice (GMP) and quality management expectations.