Artificial intelligence is transforming how life sciences teams plan, execute, and scale commercial strategy—but the true differentiator isn’t the algorithm. It’s the data foundation behind it. In our latest blog, we ex...
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Challenges of free payload concentration analysis in ADC studies
Analysing free payload concentration vital to assess the efficacy, toxicity and safety of ADC therapies but doing so requires sophisticated methods.
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Rising to the challenge with innovative therapies
Global regulators are streamlining access to innovative therapies—but navigating these pathways takes strategy. From FDA’s Breakthrough to EMA’s PRIME, early planning and expert partnerships make the difference.
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How Project Optimus has impacted oncology-focussed biotech companies
By focussing on dose-optimisation the FDA’s Project Optimus is changing how oncology-focussed biotechs develop their treatments.
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Oncology biosimilars on the rise: Key clinical development insights
As cancer treatment advances, biosimilars are becoming key players in oncology. While biologics have improved outcomes, their high costs remain a barrier. Biosimilars offer a more affordable alternative, closely replicating biologics whose patents have expired.
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Solving common challenges to develop oncology combination therapies
ICON surveyed oncology developers in North America and Europe to explore challenges in therapeutic development. This article highlights key findings and offers strategies to de-risk combination therapy trials—explored further in our whitepaper.
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Submission strategies for combined studies in the EU
In this article we look at how an oncology study sponsor managed their submission process which spanned more than 30 countries, many in the EU.
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Transforming CML patient monitoring with ICON’s innovative RNA-based NGS assay
ICON's new RNA-based NGS assay improves CML monitoring, offering higher sensitivity and specificity, including for the identification of typical and atypical BCR::ABL1 transcript types and the detection of TKI resistant mutation.
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Navigating shifting paradigms in dose optimisation and dose selection for oncology therapeutics
The maximum tolerable dose (MTD) is increasingly seen as suboptimal for emerging oncology therapies, which lack chemotherapy’s generalised cytotoxic effects. More contemporary dose-selection designs can now identify the lowest dose of an oncology therapy with the highest rate of efficacy that is tolerable for patients. Learn more.
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Innovations contributing to the reemergence of antibody drug conjugates
ADC candidates that address the limitations of their first-generation predecessors are receiving approvals, and a new wave of ADCs are in clinical development. Read the blog to explore the innovations contributing to the re-emergence of ADCs.
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Navigating oncology development decisions for long-term success
Read the blog to learn how to navigate key challenges in oncology and the important decision points including early clinical development, robust registrational strategy and late-stage development.
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Leveraging healthcare intelligence to increase diversity of oncology clinical trials
New regulatory requirements for diversity require sponsors to submit a diversity action plan alongside key trial documents to the FDA. Read the blog to learn how healthcare intelligence can be leveraged to increase diversity in oncology clinical trials.
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Expanding CAR T-cell Therapy into solid tumours
In this blog, learn more about a range of approaches that researchers are taking to improve the efficacy and safety of CAR T-cell therapies in solid tumours.
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My patient story - Claudia Egremont-Lee
ICON's Claudia Egremont-Lee shares her personal experience with breast cancer.
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My patient story - Margaritte De Falco
ICON's Margaritte De Falco shares her personal experience with ovarian cancer.
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Using Bayesian-based, model-assisted designs to improve dose selection in early phase oncology trials
As oncology therapeutics and early phase design models evolve, sponsors will benefit from working with a partner experienced in innovative adaptive designs for phase 1 and 2 oncology trials.
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Navigating complexity in oncology cell and gene therapy clinical trials
As more knowledge is revealed about the genetic underpinnings of cancers, cell and gene therapies (CGT) are playing an increasingly important role in treating oncology patients
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Innovation in oncology drug development: A focus on patient benefits
Improved diagnostic technologies, prevention methods and the advent of targeted therapeutic approaches have together contributed to lowering the mortality rate for the 10 most prevalent cancers
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Multidiagnostic approaches for patient selection biomarkers in immuno-oncology
Advances in our understanding of cancer biology and the tumour microenvironment (TME), have led to the development of personalised drug and therapy designs to better prevent disease progression and relapse.
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Cancer research post-COVID-19
The COVID-19 pandemic has been a catalyst for change in cancer research, forcing a shift towards remote monitoring, virtual arms and other uses of digital tools as global lockdowns reduce the ability of patients to go to clinics.
