Europe is emerging as an attractive route to global market access for Chinese sponsors. Early consideration of EMA requirements can help avoid costly delays and improve approval success. Read the article: https://ow.ly...
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Establishing ctDNA as a validated primary surrogate endpoint
Unlocking faster paths to precision oncology. This article examines the promise of ctDNA as a validated surrogate endpoint and what it could mean for accelerating drug development and expanding patient access to innovative cancer therapies.
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Liquid biopsy and the future of tumour-agnostic treatments
Explore how liquid biopsy is reshaping oncology and paving the way for truly tumour‑agnostic therapies. Read the latest insights on what this shift could mean for drug development and patient care.
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Mission (im)possible? Efficient Global Antibody Drug Conjugate Product Approvals
Antibody-drug conjugates (ADCs) continue to reshape global oncology, yet navigating the evolving regulatory landscape remains a significant challenge. In this latest ICON Regulatory Affairs article we outline the strategic considerations essential for efficient global development. See page 42.
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More than a statistic: What EU Joint Clinical Assessment changes for oncology patients
This article by Dr. Liz O’Brien of ICON, outlines how the EU Joint Clinical Assessment is reshaping global oncology drug development by driving earlier evidence generation, strengthening patient‑centered trial design and enabling more equitable access to innovative treatments across Europe. It underscores the growing emphasis on patient insights, PROs and cross‑functional evidence planning one year after JCA implementation.
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Next-generation modalities, precision trials, and AI-driven breakthroughs in oncology
The panelists discussed promising scientific and strategic pathways in oncology, including next-generation therapeutic modalities, precision trial strategies, AI applications with demonstrated and measurable impact, regulatory and market readiness, and collaborative models for accelerating early-phase oncology programs.
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Precision medicine meets machine learning: AI and oncology biomarkers
AI is redefining oncology biomarker discovery, unlocking new precision in patient selection and trial design. Explore how this evolving technology is shaping the future of cancer drug development.
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Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
In a recent interview with Citeline, the head of ICON's Centre for Biosimilar Drug Development discussed the upcoming patent expirations in oncology biologics, the opportunities, regulatory pathways and challenges this presents for developers and greater treatment access for patients.
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What sets oncology biosimilars apart: Anticipating key challenges in the development landscape
Advancements in biologic therapies have greatly improved our ability to treat cancer over the last few decades — but are typically very costly. With patent expirations encompassing numerous notable oncology biologics, opportunities for oncology biosimilar development are abundant.
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Marking the Path Ahead: Integrating Oncology Biomarkers Into Clinical Development
In this article, ICON experts discuss strategies to implement biomarkers in clinical development, saving sponsors time and money while positioning therapies for success.
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Combination therapies may be the future of oncology – How can we navigate development challenges today?
In this article, ICON experts discuss common ways oncology therapies are combined to achieve synergistic effects, and considerations oncology developers should employ to de-risk combination therapy development.
