ADCs have broad potential as targeted cancer therapies, but predicting which patients will benefit is a significant challenge. A single ADC combines three therapeutic components whose efficacy is then shaped by the tumor...
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How central laboratory strategies are transforming paediatric clinical trials
Paediatric trials require a different approach to laboratory planning. Discover how low-volume sampling, sample-sparing workflows and early laboratory involvement can help generate high-quality data while minimising blood collection and reducing burden on young participants.
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How is sustainability shifting from a reporting exercise to a design constraint in manufacturing and development?
How small-batch manufacturing and localised supply models can help reduce waste while maintaining flexibility, speed and quality required in early development.
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Refining biomarker-based patient selection for ADC trials
Explore how evolving biomarker strategies can help sponsors refine patient selection and navigate the growing complexity of ADC clinical.
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The adherence imperative: Clinical operations and patient centricity
ICON’s Brian Mallon examines how aligning study delivery with existing site workflows and technologies can reduce duplication, strengthen site engagement and enable more connected clinical trials.
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PM360 Think Tank – biosimilar rulings impact
Read ICON's Head of Centre for Biosimilar Drug Development lay out that as biosimilar pathways become faster and less costly, innovators need stronger differentiation, patient support and market access strategies.
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Managing post-marketing pharmacovigilance across global markets
In this article from The Pharma Letter, Dr. Quintin van Wyk explores the challenges of post-marketing pharmacovigilance across global markets, from patient safety oversight to evolving regulatory requirements.
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What’s holding back the gonorrhoea vaccine for women?
Despite decades of research, there is still no approved gonorrhoea vaccine. In this article, ICON experts explore the scientific, clinical and public health challenges that continue to shape vaccine development for women.
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Countdown to JCA: What APAC and US drug developers need to know and do today
Read our article to find out what North American and APAC sponsors need to know about EU Joint Clinical Assessment — and why EMA approval doesn't guarantee reimbursement.
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How risk-based monitoring redistributes and reshapes capacity planning
As clinical trials grow more complex, effective capacity planning is becoming a strategic differentiator. In BioPharm International, Helen Yeardley discusses how risk-based monitoring models are changing where monitoring effort is directed and what sponsors should consider as they evolve their oversight strategies.
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How evolving biosimilar guidance is reshaping bioanalytical strategy
This article discusses how regulatory change makes bioanalytical testing, such as CMC analysis, as well as PK/PD studies, more important for getting regulatory approval.
