Internal Medicine & Immunology
Reducing uncertainty in early-intervention development for chronic disease
Explore ICON's framework for biomarker-based trial design and the key development decisions that can help sponsors reduce uncertainty in early-stage chronic disease development, from patient selection and trial design to regulatory strategy.
Immunotherapy beyond cancer
Expanding immunotherapies beyond oncology requires a different development playbook. Discover practical strategies to mitigate risk, improve patient retention, and accelerate clinical development in chronic disease populations.
Global regulatory strategies for immunology
Innovation in immunology is reshaping how therapies are developed and approved worldwide. This whitepaper provides practical insight into how regulatory frameworks are evolving across key regions and how development programs can be structured to support long term success.
Biomarkers and Precision Medicine media & blog contributions
Advances in risk assessment shift the calculus of early intervention trials for MASLD
Discover how evolving risk assessment strategies are helping sponsors optimise early intervention trials in MASLD. Read the full article.
Navigating the adoption of biomarker-informed trial enrollment beyond oncology
Learn how biomarker-informed enrollment strategies can help sponsors improve trial efficiency, identify likely responders and accelerate development beyond oncology, while avoiding common pitfalls that can impact approval and access.
Navigating the risks and rewards of biomarker-based surrogates and accelerated approval
Examine how accelerated approvals can unlock earlier market access and why weak biomarker foundations, self-competitive confirmatory trials and payer misalignment remain critical risks.
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.
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.
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.
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.
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.
Comment: Realising the full potential of biomarker-informed clinical trials for neurodegenerative disorders
This article by Peter Schueler is based on the recent whitepaper, “Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D”. It explores how the recent approval of amyloid-targeting monoclonal antibodies for Alzheimer’s, following decades of failed trials, can be partially attributed to the development of improved biomarkers for patient screening and outcomes assessment.
Internal Medicine & Immunology blogs and media contributions
The new era of COPD drug development: How precision medicine is reshaping clinical strategy
COPD drug development is entering a new era, with biologics and biomarker-driven approaches transforming patient identification, evidence generation, and asset differentiation in an increasingly competitive market.
Aging with HIV: What the next major challenge is for drug development
As people with HIV live longer due to ART, new challenges are emerging. Aging with HIV is linked to higher risks of comorbidities, chronic inflammation, and drug interactions, while gaps in clinical trial inclusion and care models highlight the need for more integrated, patient-centered treatment strategies.
Pushing boundaries in idiopathic pulmonary fibrosis clinical research
The landscape of IPF research is evolving and early-stage biopharmaceutical teams need a new roadmap to success. We offer strategies to meet the challenges to develop new treatments.
Complexities of running clinical trials in retinal disorders and ways to overcome them
In this blog, we will explore the complexities of running clinical trials in retinal disorders and discuss ways to overcome these challenges.
Telemedicine is yet to overcome diversity challenges in dermatology clinical trials
This article explores the benefits and challenges of telemedicine in dermatology clinical trials.
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