Clinical Supply Management Articles

  1. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

    How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

  2. A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries 8/30/2024

    To find suppliers and partners for our clinical trial programs, we need to go beyond just selecting the best offer and then managing them. For virtual organizations in particular, we must strive to be the partner of choice. 

  3. A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services 8/15/2024

    These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

  4. Clinical Trial QA Strategies In Low- And Middle-Income Countries 8/9/2024

    This author shares key learnings and insights around quality assurance coming out of Gates MRI's vaccine clinical trials in low- and middle-income countries.

  5. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

  6. Digitalized Drug Forecasting Minimizes Waste In Clinical Trial Supply Chain 6/5/2024

    Why should pharma companies strive for more sustainable clinical trials? And how can digitalizing drug forecasting reduce waste in the supply chain? J&J Innovative Medicine's Kristel Rens explains.

  7. Adapting Clinical Supply Strategies Through The Phases 5/17/2024

    Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.

  8. What Really Happens When A Cell Therapy Supply Chain Fails? 4/5/2024

    A freezer left unpowered can have devastating effects on delicate supply chains. These true stories led to tough lessons for biotech companies producing personalized medicine.

  9. The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials 3/6/2024

    Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.

  10. The Impact Of Protocol Design On An IRT System 1/31/2024

    DTP and home treatment studies can get expensive — and be a hassle to patients — if the IRT element isn’t well planned for during trial design. In their SCOPE Summit presentation, Irina Grishina and Kelsey Kern of CSL Behring plan to share their personal anecdotes and lessons learned from both types of trials as they pertain to IRT.