Clinical Supply Planning Articles

1. 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.

2. Supplying Complex, Controversial, And Intercontinental Clinical Trials 3/13/2024

   Planning a clinical supply strategy for a complicated substance, psilocybin, is tricky. It's even more tricky doing it from the other side of the planet. Here's one company's approach.

3. 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. 

4. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

   Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

5. Clinical Trial Supply Market Outlook, Developments, & Technology Trends 12/26/2023

   The clinical trial supplies market is estimated at $3.9 billion in 2023 and is projected to reach $6.3 billion by 2028. Explore more insights from Markets and Markets.

6. Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply 11/30/2023

   While it is challenging to make precise predictions for clinical trial supplies, applying Bayesian statistics will help. This article shares steps to plan your Bayesian approach and how it helps to reduce waste and prevent shortages.

7. 7 Improvements in Clinical Supply Chain Management Your CFO Will Love 10/2/2023

   There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.

8. Vendor/Supplier Management To Maintain A Drug’s Safety Profile In End-To-End Supply Chain Planning 8/17/2023

   FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.

9. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

   In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

10. Beware The Manufacturing Bottleneck: Lessons From Inside 6/6/2022

    Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.”