07.11.25 -- What Global Survey Says About Scant Patient Access To CAR-T Therapy

How can biopharma reduce its environmental footprint? Discover a refurbishment model that transforms single-use components into a multi-use system, significantly cutting down on disposable plastic waste.

Explore the critical aspects of GMP-grade raw materials in cell and gene therapy manufacturing, including contamination control, aseptic strategies, quality systems, and regulatory compliance.

Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.

Effectively commercializing cell and gene therapies requires a strong market access strategy. Learn key steps for ensuring your therapy reaches patients at the right time and place.

While clinical trial planning often emphasizes rapid enrollment, sustained patient retention is equally vital to success.

To address limitations of traditional dose-escalation, FDA’s Project Optimus promotes finding optimal biological doses instead of relying only on maximum tolerated doses (MTD).

While both trial auditing and trial monitoring have the same goal of protecting participant safety and rights, they are two separate yet important pieces of the clinical trial process.

Real-world data (RWD) is transforming Colorectal cancer (CRC) research by complementing traditional clinical trials, accelerating drug development, and improving patient outcomes.

Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.

While compassionate use and expanded access programs provide lifesaving treatments outside clinical trials, the lack of structured protocols can lead to inconsistent data, compromising crucial evaluations.

Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

Prioritize data management that adheres to FAIR principles — findable, accessible, interoperable, and reusable — to gain operational insights that enable quick decisions and ensure participant well-being.