Best of August 2025: Top 5 Insights In Clinical Supply Chain & Logistics

#1 - 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies

The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

#2 - Five Ways To Get Ready For IRT Regulatory Inspections

Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

#3 - Inside Arbor Biotech's In Vivo Gene Therapy Approach

To talk about the specific challenges in producing an in vivo gene therapy, we asked Chief Executive Officer Devyn Smith and Chief Operating Officer Pam Stetkiewicz about their approach, particularly now as they take ABO-101 into the clinic for the first time.

#4 - How To Build Effective Clinical Trial Oversight And Leadership

In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

#5 - Clinical Trial QA Strategies In Low- And Middle-Income Countries

The author shares key learnings and insights around quality assurance coming out of Gates MRI's vaccine clinical trials in low- and middle-income countries.