BIO From The Editor and Guest Columns

  1. Life Sciences Cybersecurity Incident Management: The End-to-End Approach 10/24/2024

    Life sciences companies are focusing on smart manufacturing, digital supply chain, and leveraging AI/ML. A good cybersecurity incident response plan can make the difference between a cybersecurity incident versus crisis.

  2. Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning 10/24/2024

    BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.

  3. Exploring Sanofi R&D's Batch Monitoring Initiative 10/23/2024

    The project established predictability during testing and release for the production of medicine to support clinical trials.

  4. What's Next After FDA's DSCSA Extension? 10/18/2024

    Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

  5. Data Quality Issues At The Heart Of FDA's DSCSA Troubles 10/18/2024

    Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

  6. A "Particular" Problem For Cell Therapy Products, Part 2: Cell Clumps And Other Inherent Particles 10/17/2024

    Cell clumps may be present prior to administration of your final drug product. In the absence of regulatory guidance, we recommend establishing a risk management strategy for control of particulates.

  7. CDER Wants Your Input On Improving Integrated Reviews 10/17/2024

    CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.

  8. Suppliers Pushing Novel Analytical Methods Testing Forward 10/17/2024

    The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?

  9. Tune Therapeutics On Clinical Readiness, Technology Adoption 10/16/2024

    Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.

  10. Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL? 10/16/2024

    When choosing your trading partner (CDMO or 3PL), an important element that can be overlooked is serialization and DSCSA compliance. Ensuring these partners can meet requirements is critical.