Oncology
Insights on the major trends in oncology including the development of targeted therapies in clinical trial designs and patient care.
De-risking clinical development of precision medicines in oncology
This whitepaper reviews the most pressing challenges and opportunities facing the oncology therapeutic landscape in the emerging era of precision medicine, and reports on how those opportunities and challenges vary by organisational size and region.
ICON survey report: Innovation in oncology - Accelerating R&D in an evolving landscape
In Spring of 2024, ICON conducted a survey of 104 professionals engaged in oncology drug development in North America and Europe, representing organisations ranging from small to large biotech and pharmaceutical companies.
Advances in imaging biomarkers: Estimating drug efficacy with tumour growth rate modelling
This whitepaper compares the use of imaging biomarker methodologies such as RECIST 1.1 with novel tumour growth rate (TGR) modelling. Using this methodology eliminates the need for a comparable control arm which can reduce research costs. TGR modelling also more efficiently captures heterogeneous tumour measurements and whole-body tumour burden.
Strategies for commercialising oncology treatments for young adults
In this whitepaper we delve into the dynamic landscape of oncology treatments tailored specifically for young adults. As cancer incidence among young individuals surges globally, it's imperative to explore innovative strategies that address their unique needs and challenges.
Approaching the CAR T-cell therapy horizon
Approved CAR T-cell therapies have shown remarkable results in patients with certain types of blood cancers, but further innovations are needed before the technology can reach its full potential. In this whitepaper, we explore the most exciting clinical developments in CAR T-cell therapy, and relate them to limitations of approved therapies.
Research strategies to support the acceleration of oncology antibody drugs to market
This presentation will address important issues in antibody drug development, including choosing the right biomarker, drug formulation and manufacturing. It will also discuss critical aspects of clinical trial design and leveraging regulatory pathways, in addition to outlining the differences between fast track, break through therapy, priority review regulatory designations and accelerated approval pathways.
From genomics to the coming of age glycomics
Discover how glycan biomarkers are quickly becoming key elements of cancer, cardiovascular, and gastrointestinal research, setting the stage for a new golden age of epigenetic research and personalised therapeutics.
Multi-diagnostic approaches for patient selection biomarkers in immuno-oncology
The development of diagnostic tests which can predict patient response to these therapies are crucial to the clinical success of an immunotherapy candidate. This webinar recording helps to:
- Define the different classes of immunotherapy being developed for cancer treatment
- Identify the utility and limitations of current biomarkers for the selection of patients for checkpoint inhibitor therapy
- Compare/contrast methods and assays being used for biomarker analysis
Evolving oncologic development in the decades ahead
Successive revolutions of prevention strategies and precision medicine in the past two decades have contributed to lowering the mortality rate for the ten most prevalent cancers by more than 10% across most of Europe, Asia, and North America. In the coming years, emergent therapeutic strategies, including immuno-oncologics and liquid biopsy-based companion diagnostics, may yield some of the most transformative clinical benefits to date. Yet, oncology pipelines remain rife with challenges. This whitepaper provides specific ideas and innovative approaches that make a real difference to the successful conduct of industry-sponsored clinical trials.
Optimising oncology clinical research through site partnership and investigator support
The goal of oncology drug development is to bring effective treatments and improved individual care to patients suffering from cancer. The process to get a new therapy approved by the FDA may take 10–15 years and requires the timely completion of numerous clinical trials. The success of the process rests on finding and supporting the investigators and site staff that ultimately recruit the patients for the studies. CROs can reduce barriers to clinical research participation for sites, by finding ways to create administrative efficiencies, keep investigators engaged throughout the process,
Immuno-oncology setting the scene
Immuno-oncology (I-O) plays an increasingly important part in cancer treatment, utilising the body’s own immune system to fight the disease. Although not a new concept, I-O has progressed considerably in the last 10-15 years with approvals for numerous I-O therapies including vaccines, cytokines, tumour-directed monoclonal antibodies, and immune checkpoint inhibitors.
Oncology clinical development media contributions
Survey shows varied views on impact of new cancer drugs
This article published in The Pharma Letter highlights findings from an ICON survey has found that despite the increasing investment in emerging oncology-related therapeutics, developers have varied views on the impact of new cancer drugs for patients.
Biomarker Identification a Challenge and Opportunity in Cancer Drug Development, Survey Finds
This news piece from Precision Medicine Online provides an overview of the findings from ICON’s recent survey of professionals engaged in oncology-related clinical research.. It shares respondents' insights on how precision medicine approaches are changing development strategies and the to the extent these therapeutic advances will benefit patients in the future.
Overcoming Challenges in the Development of Antibody Drug Conjugates
In this article, ICON’s Andreas Dreps reviews the innovations that have helped ADCs overcome clinical development challenges.
Engineering CAR T-cell sharpshooters
In this article, ICON's Brian Huber explains why and discusses the prospects for the next-generation of CAR T-cell therapies engineered to be more adaptable, precise and controlled.
Lifecycle management for CGTs: Solving operational challenges in an expanding market'
The development of cell and gene therapies (CGTs), such as CAR T-cells and autologous and allogeneic therapies, is gaining momentum. To deliver these cures to patients with unmet needs, life sciences companies must navigate clinical trials—a process that is more complex for CGTs than for small molecules.
From Vaccines to Oncology and Beyond: Tracking mRNA’s Progress
In this article, ICON’s Andreas Dreps and Martin Lachs discuss how the success of mRNA-based vaccines paves the way for mRNA in oncology and beyond.
Logistical considerations in mRNA vaccine development
In this article, ICON’s Andreas Dreps and Martin Lachs discuss the logistical considerations in mRNA vaccine development.
Challenges of expanding CAR-T Cell Therapy into solid tumors
Learn more about the challenges associated with developing CAR-T therapies for solid tumors in this article.
Improving early phase oncology clinical trial design: A case study
Tim Clark and Alan Phillips present a case study on the first in human Bayesian Optimal Interval design.
Improving early phase oncology clinical trial design using Bayesian-based BOIN and BOP2 designs
ICON experts offer insights on selecting and implementing the appropriate model-based or model-assisted design for early phase oncology trials.
The personalised medicine paradigm
Cindy Spittle shares insights on the growth of molecular diagnostic testing in clinical trials.
Glycomics applications reinforce precision medicine
Nicole A. Cowan explores how glycomics is joining genomics and proteomics in the study of disease mechanisms and the development of novel therapeutics.
Panel discussion: setting the roadmap for optimising cancer clinical trials
In this podcast, Martin Lachs discusses how clinical trials have been the backbone of cancer research.
Recent advances and future challenges using biomarkers in oncology precision medicine
Dr. Brian Huber outlines the role biomarkers play in guiding therapeutic strategies.
Innovation in oncology clinical trials
Dr. Brian Huber discusses the shift from histology-based to lesion-based trial design in precision medicine (page 54-57).
The new cancer treatment frontier: Why clinical trials need to keep pace with innovations in cancer research
An overview of the current treatment landscape, including cell and gene therapies, of and challenges that cancer research faces.
Ask the experts: advancing real-world data in the precision medicine era
Evolvement of RWD collection in oncology in the coming years.
Adapting for the future of oncology
External pressures and rapid scientific advancements are changing oncology, and innovative trials are needed to keep pace.
Innovation in oncology drug development: A focus on patient benefits
Innovation in oncology drug development is driving more efficient and effective development of new cancer treatments.
Access and reimbursement for adoptive T-Cell transfer drugs
Groundbreaking treatments involving adoptive cell transfer, such as CAR -T drugs, call for innovative commercialisation strategies.
The burden of choice
ICON Oncology’s opinion of how we can reach for the stars with a moonshot. (PDF)
Countermeasures to oncology trial failure
Five smarter approaches to trial design and analysis.
Innovation in oncology drug development
Recent innovation in clinical drug development and approval for oncology drugs.
The rapid evolution of immunotherapy combination trials
Why transforming immuno-oncology trial design is a competitive necessity. (PDF)
Oncology blogs
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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.
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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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Using Bayesian-based, model-assisted designs to improve dose selection in early phase oncology trials
Learn how ICON successfully identified, modified and implemented two Bayesian model-assisted designs in a two-part, first-in-human trial in our blog.
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Navigating complexity in oncology cell and gene therapy clinical trials
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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CAR-T therapies
Scaling Up CAR-T Therapies Requires Overcoming Manufacturing, Regulatory and Distribution Challenges.
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Patient centricity in oncology trials
Patient centric strategies to focus more on patient needs and increase efficiencies.
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Restricted Mean Survival Time (RMST) in oncology trials
Biostatistics: Using Restricted Mean Survival Time (RMST) in Oncology Trials to Improve Outcomes.
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Smart bioanalytical strategies in Immuno-Oncology trials
Biomarker-based methods and how they can be leveraged to add value to oncology trials.
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Immuno-oncology: Am I choosing the right biomarker?
ICON has been immersed in the development of both passive and active immunotherapy approaches, allowing sponsors to overcome challenges in Immuno-Oncology.
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Overcoming limitations in Multiple Myeloma trial designs
The discovery of novel biomarkers has made MMMultiple Myeloma diagnosis and monitoring much easier and more efficient.
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Novel cancer trials demand that participating sites act differently
The evolution of adoptive cellular transfer (ACT) for the treatment of lymphoma, leukaemia and myeloma patients has grown exponentially.
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Oncology clinical trials in Asia Pacific
Although Asia Pacific (APAC) is sometimes referred to as a homogenous unit, it is a heterogeneous region, with divergent countries, languages, populations and cultures.
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Innovation in oncology drug development
Significant progress has been made in our understanding of the molecular lesions responsible for tumor cells.
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Immunotherapy in cancer treatment
Immunotherapy has been the focus of medical research for many years, and scientists continue to experiment with and learn about this form of therapy in cancer treatment.
Receive more insights on oncology from ICON
Please visit ICON's Preference Centre and select 'oncology' under 'Therapeutic Areas of Interest' to receive new insights on oncology.
ICON's Oncology capabilities
Oncology services
ICON’s Oncology Solution expedites every aspect of a cancer drug trial. It combines global experience in all Phases of oncology drug development (including early phase, immuno-oncology and cell and gene therapies) with expertise in tumor imaging, laboratory (including PK/PD and Biomarkers) IVRS, central data management, electronic data capture and regulatory oncology issues.