Newsletter | October 13, 2026

10.13.26 -- How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture

FEATURED EDITORIAL

Root Causes, Part 4: Why Clinical Supply Teams Are Always Firefighting

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

This fourth installment of our Root Causes video series examines why even the most well-planned clinical trials often push supply and operations into firefighting mode.

 

CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture

By Dora Wells

Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

 

What Your Tier 1 Supplier Map Might Be Missing

A conversation between David Fairnie, BSI Group, and Elizabeth Urbanek, Clinical Supply Leader

Your Tier 1 supplier map may not show the dependencies that can actually stop clinical supply. David Fairnie explains how to uncover hidden vulnerabilities.

 

INDUSTRY INSIGHTS

 

Comparator Selection And Supply: Best Practices For Clinical Success

Webinar | Catalent

Explore best practices for comparator selection and supply optimization in clinical trials, including sourcing strategies, risk mitigation, regulatory compliance, and real-world cost-saving case studies.

MORE GREAT EDITORIAL

How Clinical Supply Is Shaping The Next Generation Of Cell And Gene Therapies

By Rachel Grabenhofer, Chief Editor, Clinical Supply Leader

From CAR-T to gene editing, clinical supply realities are increasingly influencing therapeutic design, scalability, and patient access.

The $122 Billion Question: Can Clinical Trial Supply Systems Keep Pace With Cell Therapy Demand?

By Kien Tran

Cell therapy demand is outpacing manufacturing capacity, forcing clinical supply teams to rethink patient scheduling, production slots, and real-time coordination.

The NDC-12 Ripple Effect: Why Clinical Trial Supply Chains Must Act Seven Years Early

By Manish Kumar Garg, Hikma Pharmaceuticals

Clinical trial supply chains face a 2033 NDC-12 deadline; early action on product identity, labeling, and data governance can prevent costly disruptions and misalignment.