Industry Insights

  1. Design Thinking: A Shared Methodology Between Sponsor And CMO To Benefit Patients 9/15/2020

    Collaborative efforts made by the sponsor and the CMO, coupled with a well-defined process grounded in design thinking, can lead to improved patient compliance.

  2. How Amgen Is Taking An Adaptive Approach To Clinical Trials 6/11/2019

    Clinical research is sometimes viewed as a box-checking exercise, where we run fairly cut-and-dried randomized, placebo-controlled studies based on long-established protocols. But things are actually changing very rapidly in the world of clinical development, which is by far the largest part of pharma R&D spending. We are on the threshold of a transformation that will allow us to dramatically accelerate the acquisition of useful knowledge, get new medicines to patients sooner, and expand their usage to new indications more quickly.

  3. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

  4. Using Carbon Nanotubes To Pinpoint Optimal Harvest Time in Bioprocessing 2/18/2026

    Cell-free expression systems confound the moment of peak expression. These nanosensors signal through crude lysate for process optimization and endpoint monitoring.

  5. Future Delivery Models For ATMPs: Practical Considerations 2/17/2021

    With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.

  6. Top 6 Questions To Ask When Evaluating A Biologics CDMO 12/15/2023

    Learn how a CDMO with a commitment to quality and decades of industry experience can help overcome development hurdles and bring your treatment to patients in need.

  7. If Sustainability Is A Priority, Why Is Progress So Slow? 2/10/2026

    Sustainability is now central to biopharma strategy. New data reveals why commitments aren’t translating into action, and the roadblocks leaders must address to turn environmental ambition into change.

  8. A Mouse (Trap) For Disease 2/4/2014

    About a quarter century ago, a trio of scientists developed a game-changing technology that enabled researchers to genetically engineer mouse strains with a particular gene missing. Finally, researchers had a tool to observe—in a backhanded way—how mice behaved when a critical piece of their DNA was missing. By Rosalba Sacca, Ph.D. and Regina McEnery

  9. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

  10. Part Three: Rapid LVV Titering Determination 6/6/2025

    Explore how a platform compares data to traditional qPCR, p24 ELISA, and TU assays in measuring both physical and functional titers.