Industry Insights

11. From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

    Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

12. Facility Design & Construction Tips For Up-Start Biotech Companies 1/4/2021

    Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.

13. Turning Point In U.S. History: Our Chance To Do Better With Clinical Trials 2/16/2021

    We are at the beginning of important conversations. Conversations that need to happen so we can definitively address the health disparities that continue to impact outcomes among ethnic and racial groups in the United States. 

14. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

15. What Are The 5 Key Differences Between A Good CDMO And A Great One? 7/19/2022

    Market dynamics will continue to favor engaging with CDMO partners who have the capabilities and experience to manage short-term needs while anticipating and planning for long-term requirements.

16. Navigating Expanded Access For Experimental Cell & Gene Therapies 8/9/2023

    With the hype of cell and gene therapies' potential, more and more patients have become interested in non-trial access to experimental therapies that haven't yet been approved. One mechanism is the FDA’s expanded access pathway. This article shares the International Society for Cell & Gene Therapy's three areas of concern and recommendations for developers.

17. New DSCSA Guidance Details Layers Of Verification System Requirements 2/15/2024

    A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.

18. A Look Ahead: US FDA And Medical Device Regulations In 2021 3/10/2021

    Now that we are in 2021, what big developments can we expect from FDA in general and with regard to medical devices in particular? This article explores some of the FDA initiatives and activities worth following this year. 

19. Recommendations For Managing Complexity In Biopharma Operations 1/21/2020

    There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.

20. Applying The Four Dimensions Of Sustainability To Create Capacity That Delivers Results Faster

    There are no shortcuts to growing capacity that delivers results faster and maintaining it is difficult. The key ingredient in growing enterprise value is sustainability. Learn how by applying the principle of sustainability using its four dimensions, finite resources are more wisely used with extraordinary results, lead time from concept to commercialization is greatly improved, and patients receive better medications faster.