Central laboratories are under more pressure than ever. Increasingly complex protocols, frequent amendments, and growing data demands require speed, agility, and uncompromising scientific integrity. At ICON Laboratories,...
In the News
ICON experts frequently author or contribute to industry trade press.
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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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What’s evaluated in a stability study?
This article discusses the importance of stability programs in early clinical drug product development.
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Navigating protocol development in early phase trials
In an ICON survey of 149 biotech professionals, 45% of survey respondents identified protocol design as one the most significant challenges faced when transitioning from preclinical to clinical testing. Here, we discuss considerations for several key elements of protocol development in early phase trials, including selection of healthy volunteers (HVs) or patients, trial design and endpoint selection.
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The rising impact of biomarkers in early clinical development
Dr. Cyril Clarke at ICON Biotech reveals how biomarkers are transforming early-phase clinical trials by offering valuable insights into the safety and efficacy of novel therapies.
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Partnering for success in early phase clinical development
Early-phase clinical trials serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market. However, these early stages present significant challenges—nearly half of all drugs entering clinical trials do not make it past phase 1. With the average phase 1 trial costing millions of dollars and consuming valuable time, biotechs have little room for error. This article discusses how partnering with a CRO can benefit a small biotech - helping to fill the gaps in knowledge, resources infrastructure.
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Exploring the advantages of innovative early phase trial design
For sponsors considering how to most efficiently and effectively allocate resources, innovative trial designs offer advantages. In early phase trials—specifically, phase I and II trials involving safety, dosing, and proof of concept—innovative designs offer potential for improvements in efficiency and decision-making, as well as lowering costs. Innovative trial designs, such as adaptive trials, Bayesian methodologies and master protocols, can be utilised to add value when used in early phases.
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Clinical development strategy in oncology
In Dr Tanja Obradovic's article in The Cancer Letter, she discusses how to navigate early clinical development and support robust registrational strategy and late-stage development in oncology.
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Moving closer to dynamic drug development
Dr Ute Berger, President of Development and Commercialisation Solutions and Ted Broering, President of Early Clinical and Bioanalytical Solutions contribute to this feature in BioPharm International, which looks at how novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore.
Murphy, J.Moving Closer to Dynamic Drug Development. BioPharm International 36 (6) 2023.
