Clinical Supply Logistic Articles

1. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

   The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

2. Peeling Back The Layers Of Radiolabeled Peptide Production 6/12/2025

   From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

3. Multispecific Trial Supply Stability Hinges On CDMO Agility 6/10/2025

   Naya's CEO describes the dynamics of producing a complex therapeutic for clinical trials on another continent, and how choice of CDMO plays heavily into that strategy.

4. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

   As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

5. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

   The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

6. Good Distribution Practice Is Evolving — Here's How 5/15/2025

   Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

7. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

8. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

   The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

9. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

10. 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.