Clinical Supply Planning Articles

1. Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting 4/16/2025

   Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.

2. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

   AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

3. Is The BIOSECURE Act The First Real Step Toward Reshoring? 11/22/2024

   The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

4. 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.

5. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

   Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

6. When Should You Select Your Supply Partner? 9/19/2024

   In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.

7. If The CDMO Shoe Fits, Wear It Now 9/16/2024

   Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

8. 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.

9. The Small Biotech's Checklist For FIH Trials 8/27/2024

   Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

10. 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.