Antibody-drug conjugates (ADCs) continue to reshape global oncology, yet navigating the evolving regulatory landscape remains a significant challenge. In this new BioSpectrum Asia feature, ICON’s regulatory expert, Eili...
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Accelerating timelines and reducing cost in early clinical drug development
Innovation is accelerating progress in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions bring together advanced formulation design, real-time dose flexibility, and world-class CMC expertise to simplify complexity and speed timelines. This article discusses how the integration of science, technology and strategic insight can transform challenges into opportunities for breakthrough success.
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Bold moves
CRAs are at the centre of clinical trial evolution. Risk-based monitoring, intelligent oversight tools and AI are changing how trials are managed. ICON explores what this means for the future in Pharma Times.
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Transforming central labs with automation and AI: setting new standards for modern trials
Demands on central laboratories are consistently increasing, heightening the challenge to deliver operational excellence and the highest standard of scientific integrity with both speed and agility. ICON Laboratories is transforming the way we leverage data and intelligent operational models to meet evolving trial needs.
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Investing in anti-HIV: How anti-HIV therapeutic developers can reshape the future of HIV control
Despite decades of progress transforming HIV from a fatal diagnosis into a manageable chronic condition, today’s antiretroviral therapies still face a stubborn barrier: They work brilliantly in theory but fall short when access, adherence, and real-world challenges get in the way.
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Formulation Strategies, Tech Advances, Challenges and Considerations in Novel Drug Delivery
The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.
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Regulatory strategy reimagined: Three trends accelerating drug development
The regulatory landscape is being rewritten. The future belongs to those who anticipate, adapt and act with purpose. In this article we look at 3 macro trends that are redefining regulatory strategy.
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Harmonising global approaches to transformative theranostics
This article explores the landscape, regulatory considerations, infrastructural and operational requirements along with future directions for expanding Radiopharmaceuticals and Theranostics therapies into clinical settings.
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Multidrug-resistant infections necessitate bacteriophage treatment: Can we get there in time?
As antibiotic resistance surges globally, bacteriophage therapy is emerging as a promising alternative for treating multidrug-resistant infections. To scale this life-saving approach, investment in phage development, clinical trials, and diagnostic infrastructure is urgently needed.
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CRO reforms: Tilting scale towards accelerated growth and transparency
The article, featuring commentary from Nagalakshmi Shetty, highlights how India's clinical research sector is rapidly expanding. Regulatory reforms like the Central Drugs Standard Control Organisation's NDCR (Amendment) Rules 2024, mandatory CRO registration and digitised portals are boosting transparency, shortening approval timelines and positioning India as a global hub for clinical trials.
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Keeping it real
In this PharmaTimes article, Nagalakshmi Shetty explores how clinical data science is evolving from traditional management toward intelligent, risk-based, patient-centric research frameworks.
