Newsletter | August 7, 2025

08.07.25 -- Best Practices For CROs In 2025

In-Vivo CAR Therapies — Global Research And Development Landscape

Delve into the evolving in-vivo CAR therapy landscape, examining key technological innovations, major industry players, recent clinical progress, and regulatory developments.

 

Accelerating Trial Start-Up: CRO Best Practices For 2025

In 2025, accelerating clinical trial start-up is critical for sponsors seeking faster market entry, and Clinical Research Organizations (CROs) are applying innovative approaches to drive efficiency in site activation, enrollment, and regulatory approvals.

 

Mitigating Risk With Ex-U.S. Clinical Trials

This webinar explores how ex-U.S. clinical trials can help biotech and mid-size pharma companies accelerate timelines, reduce risk, and build investor confidence. Gain insight into the strategic advantages offered by certain regions and how to effectively integrate them into your development strategy.

 

SOLUTIONS

Trusted Partner For Clinical And Regulatory Success

Novotech’s Regulatory Affairs team offers customized, end-to-end clinical and regulatory solutions, guiding biotechnology, pharmaceutical, and medical device companies through the entire product lifecycle.

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Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry

Live Biotherapeutics (LBPs) are no longer just a scientific curiosity; they are becoming one of the most promising frontiers in modern medicine.

 

By harnessing live microorganisms to restore or modulate human health, LBPs are opening new pathways for treating chronic and complex diseases with precision and minimal toxicity. From gastrointestinal and metabolic disorders to neurodegeneration and oncology, LBPs have the potential to fundamentally reshape how we approach drug development.

 

As interest in LBPs accelerates, Novotech’s recent white paper outlines the opportunities and early-stage challenges shaping this rapidly advancing therapeutic class.  

 

Download the white paper.