Industry Insights

  1. Taking Serialization to the Next Step

    Keeping up with regulatory requirements has kept the pharmaceutical industry at the forefront of track-and-trace technologies for years. Now, those regulations are set to get even more stringent on a global scale. With some key deadlines on the horizon, pharmaceutical manufacturers and their OEM suppliers are stepping up their serialization strategies.

  2. Supply Agreements — Removing The Stress From 'Failure To Supply' Negotiations

    The failure to supply (FtS) provision in a drug product or drug substance supply agreement can be the most hard fought over “what if” in the agreement and, after price and volume, the section of an agreement with a high potential to fracture a customer-supplier relationship.

  3. Preliminary Hazard Analysis Can Determine Equipment And Instrument Requalification Frequency

    Using a risk management tool such as preliminary hazard analysis, a periodic review frequency can be identified and applied to qualified equipment. This will enable a timely review of the equipment by means of pertinent data such as manufacturing performance trend data, change history, and/or deviation history.

  4. Blockchain’s Evolving Role In The Life Sciences Supply Chain

    The primary business case for blockchain in the pharmaceutical industry is its ability to serve as a “ledger of truth” when complex information needs to be shared with business partners across the supply chain, including those unique to life sciences, such as regulators, pharmacy benefit managers, and contract manufacturers.

  5. The Biosimilar Patent Dance: What Can We Learn From BPCIA Litigation?

    Of the 17 biosimilar products litigated under BPCIA to date, in most cases (about 70 percent), the applicants engaged in and completed the patent dance before the lawsuits (setting aside allegations of noncompliance with the disclosure requirements).  So far, in three instances, the biosimilar applicants have declined to dance outright.

  6. CAPA Effectiveness Checks 101: How To Verify That Your Actions Plans Are Successful

    Verifying the effectiveness of a CAPA closes the loop between identifying a problem and completing the actions to solve a problem. This article explains how to choose an appropriate measurement for CAPA effectiveness checks, what methods to use, and when to perform them.

  7. Translating Biopharma Knowledge To Cell And Gene Therapies

    Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

  8. Inside FDA's Proposed Program To Establish Voluntary Quality Standards

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.

  9. A Simplified, Five-Step Approach To Applying FDA’s Human Factors Guidance

    FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices. 

  10. 4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development

    It will be increasingly important for biopharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets.