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...
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Managing risk for medical devices
In this series, we review ISO 14971 (Application of risk management to medical devices)—its history, the principles embedded within it and how it relates to other standards and regulation.
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Mitigating data disruptions in open claims datasets
Healthcare data now makes up 30% of global data and is growing rapidly. While this offers life sciences firms more insights, it also brings disruptions—from new data sources to cyberattacks—that can either enhance or hinder analytics.
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Driving biosimilar adoption in APAC
To succeed in APAC, biosimilar sponsors must build patient and provider trust. This blog explores adoption barriers and strategies for outreach and education to boost biosimilar uptake.
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CMC in Drug Development and Life Cycle Management
This blog provides emerging and biotech companies with a significant overview of the considerations for CMC. There are a multitude of complexities and points to consider when creating an asset and product development is at the centre
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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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Measuring the impact of ICH E9(R1) on UK research protocols
The ICH E9(R1) Addendum, adopted in November 2019, aims to clarify treatment effects in clinical trials. Tim Clark, ICON’s VP of Clinical Sciences, co-authored a study reviewing how UK research protocols apply estimands and how usage has evolved since the addendum’s adoption.
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Modern tools for cardiovascular studies
Cardiovascular disease is the leading global cause of death, driving urgent research efforts. CV studies are key to evaluating heart-related treatments and impacts. Digital health technologies (DHTs) now play a growing role, improving data capture and patient-centricity in CV research.
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Reimagining clinical programming: The strategic role of R in modern trials
This blog explores how adopting R is transforming clinical programming by meeting growing complexity, tighter timelines, and the need for transparency, positioning it as a catalyst for innovation across pharma and biotech.
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Getting the values right: Which QT correction formula is most accurate in healthy volunteers?
ICON assessed ECGs from 22,063 medically healthy individuals participating in phase 1 trials between 1997-2023. Learn which QTc formula performed best in age, sex, BMI and heart rate subgroups.
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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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Beyond tradition: An analysis of modern vaccine technologies
This blog explores some of the most promising non-viral vaccine development platforms, highlighting their mechanisms, advantages, and limitations.
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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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The importance of stability programs in early clinical drug product development
Stability studies assess how a drug’s quality changes over time under environmental stress like heat, humidity, and light. They ensure safety and efficacy throughout the product’s lifecycle, supporting reliable clinical data and regulatory approval.
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To avoid HTAR bottlenecks NICE and MHRA offer a strategic alternative
This blog explores how drug and medical device developers can engage with the MHRA and NICE as a strategic alternative when access to Joint Scientific Consultations (JSCs) is limited.
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How GCP updates make way for an RBQM revolution
Explore how the new ICH GCP E6(R3) empowers sponsors and CROs to strategically innovate and optimise trials by embedding RBQM at the core of quality management.
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Designing Delphi panels: A useful, non-standardised tool for patient-centric research
ICON’s PCO experts outline how to successfully design different types of Delphi panels for expert consensus, patient-centric COA and ClinRO development.
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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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Why long-term follow-up should start early in vaccine trials
Learn more about why demonstrating long-term safety should start early in vaccine trials. With early planning, vaccine developers can gather real-world data and evidence needed to help individuals make informed decisions about vaccination.
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The revision of ISO 10993-1 – what does it mean for medical devices?
Biological evaluation is a toxicological risk management process. The revised standard, expected by year-end, places it in proper context, emphasizing Clause 4's unchanged principles. The update aligns evaluation with ISO 14971 and accepted toxicological risk assessment practices.
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The real weight of real-world data: Key factors for successful real-world data RFP/RFI
Learn key factors for making the right RWD supplier selection and the hidden complications in seemingly straightforward numbers.
