From MS to NMOSD to early Alzheimer's disease, neurologic mAbs are delivering proven clinical benefit. But as efficacy becomes less of a differentiator, what determines whether these therapies reach patients? In this art...
ICON experts frequently author or contribute to industry trade press.
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Viral Safety 2.0: Plant-Ready Actions for ICH Q5A(R2) Compliance
This article explores practical actions for manufacturing and chemistry, manufacturing, and controls (CMC) teams to align with Q5A(R2)’s updated guidance and stay ahead of the rapidly changing viral safety environment. Implemented well, these actions can shorten testing timelines and strengthen assurance of participant safety.
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Overcoming Formulation Challenges for Biosimilars
Media article discussing how high-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.
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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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The Bayesian challenge: complexity that pays off
ICON's Andrew Garrett and Tim Clark discuss the recent FDA draft guidance on how sponsors can use Bayesian models for clinical trials.
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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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How digital health technologies are reshaping clinical development
Digital health technologies are rapidly becoming essential to clinical trial strategies as regulators and sponsors embrace them to streamline operations, reduce patient burden, and generate higher‑quality real‑world data.
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Submitting clinical data to the FDA and PDMA: An efficient and compliant approach
In this article, our data standards experts explain how sponsors can efficiently prepare clinical data submissions that meet both FDA and PMDA requirements by leveraging the substantial alignment between the two agencies’ standards.
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Pharma communications resilience: Navigating regulatory policy shifts with strategic precision
Regulatory change often brings unexpected challenges to an already complex environment. Product labelling is no exception. Yet, with the right foundation, organisations can transform uncertainty into opportunity. A well-balanced mix of skilled personnel, timely intelligence and agile processes equips organisations to stay ahead of regulatory shifts.
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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.
