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As oncology biologics face expiring patents, biosimilar developers need to prepare for a new era of opportunity and market growth. In this article, ICON’s Kim Salgado examines the opportunities and regulatory shifts th...

For AI biomarker discovery in oncology to move forward, developers must address several challenges. Find out what these are, and why AI is still positioned to transform the landscape of oncology therapeutics, in the arti...

AI can find patterns in large datasets and detect complex relationships in patient data — making it a key tool for finding relevant oncology biomarkers. Read the article to discover how AI is being used in oncology bio...

Automation offers new opportunities to increase efficiency and reduce costs associated with post-marketing pharmacovigilance. Yet with patient safety at stake, the adoption of new technologies requires careful assessment...

The FDA and other health authorities like the EMA require a well-defined and consistent drug development process and life cycle management plan. CMC is a critical and a ‘first step’ component in the creation of a develop...

Upstream and downstream process, structural characterisation, functional characterisation and processes are all major CMC related steps that need to be considered by emerging and biotech companies early in their developm...

Discover how GMP manufacturing can improve trial outcomes, reduce risk, and support regulatory success. During this webinar we will discuss the differences between GMP and USP compounding, and feature expert-led case stu...

Day One of #ESMO2025 is drawing to a close. Thank you to everyone who has visited the ICON booth (\#3034) on Level 2, Hall 3.2 today. Our team of experts is available throughout the congress to discuss innovative appro...

Impact assessments aren't just regulatory—they're strategic. In PharmaTimes, ICON’s Joanne Perry breaks down how sponsors and CROs can align on E6(R3) through cross-functional collaboration and dynamic planning. Read t...

Wondering how to prepare for ICH GCP E6(R3)? Start with an impact assessment—it’s more than a checklist. It’s your roadmap to strategic compliance. Check out our latest article in PharmaTimes to learn how sponsors and CR...

Only 16% of surveyed oncology researchers reported using AI in biomarker detection and assessment at the time of the survey, but nearly half (49%) identified it as the area where AI and ML could most accelerate oncology ...

Antibody-drug conjugates (ADCs) are transforming cancer treatment — but measuring free payload concentrations is critical to ensure their safety and efficacy. Even the smallest impurity can skew results. Discover how adv...