Newsletter | May 1, 2025

Best of April: Top 5 Insights In Clinical Supply Chain & Logistics

Clinical Supply Leader

TOP 5 INSIGHTS IN CLINICAL SUPPLY CHAIN & LOGISTICS  

APRIL EDITION

#1 - Trends In FDA FY 2024 Inspection-Based Warning Letters

Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.

#2 - Five Key Trends In CMC

Explore how CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.

#3 - Counting The Steps To Decentralized Personalized Therapy Manufacturing

AltruBio's CEO Judy Chou 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.

#4 - Beyond Diversity: Cultural Competence And Humility In Clinical Trials

Explore how cultural competence and humility transform clinical trials beyond diverse recruitment and learn practical applications that create more inclusive, effective research worldwide.

#5 - 3 Strategies For mAb Manufacturing: How Do You Choose?

As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.