Career progression is rarely linear, and there is no single path to leadership. In our latest blog, Sinéad McKeon discusses what drove her move from the lab bench to project management. She reflects on the capabilities...
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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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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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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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Why assessing the pharmacokinetics of antibody-drug conjugates is so complex
In this article we look at some of the challenges of typical bioanalytical ADC assays and some recent developments in the area.
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Oligonucleotide progression into early phase studies
In this blog, we explore the importance of quality control testing for oligonucleotide formulations in early phase clinical trials. While not fully addressed by ICH Q3A/Q6A, these products must comply with parts of EU GMP Annex 1 and the draft EMA guideline to ensure regulatory readiness.
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CMC IMP considerations for oligonucleotides
There are numerous strategies being developed to enhance the delivery of oligonucleotides, potentially changing the formulation and mode of drug delivery. However for now, we have to manufacture a sterile injection formulation.
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Minimising impurity formation in oligonucleotide synthesis
In the first installment of our three-part series, we provide an introduction to oligonucleotide therapeutics and examine how API synthesis strategies impact impurity formation, highlighting best practices for risk mitigation.
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Investigating multi-indication drug targets
This blog will explore some of the multi-indication drug targets that have already been developed in multiple applications, as well as considerations for entering clinical trials, such as building evidence and trial design.
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Navigating early phase challenges for biotechs
To better understand the concerns of biotechs in early phases, ICON conducted a survey of 149 professionals representing small- and medium-sized biotech organisations from North America and Europe.
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Accelerating ATMP and CGT: The importance of regulatory CMC expertise in efficient biologics development
Discover how dedicated Regulatory CMC expertise benefits biologics development, ensuring compliance and efficiency, especially for innovative therapies like ATMPs and CGTs.
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Streamlining early phase clinical trial submissions under the EU CTR
The EU Clinical Trials Regulation (CTR) represented a significant shift in the regulatory landscape, aiming to create a more favourable environment for clinical research across Europe.
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Innovative approaches to ensuring participant safety in early phase clinical research
Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. With innovative tools and unique collaboration models, ICON is driving more proactive participant safety measures to effectively mitigate risks.
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Improving the experience of healthy volunteers during early phase clinical trials
How ICON’s application of a volunteer-centric approach is improving recruitment and retention rates of healthy participants in early phase studies.
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The importance of formulation studies in drug development
Formulation studies require time, money and expertise, and the race to clinic and beyond may tempt drug companies, especially smaller ones, to take shortcuts that end up costing more later.
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An introduction to applications of adaptive design
The adoption of an adaptive design strategy across the product development process brings a number of important benefits
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An Introduction to Applications of Adaptive Design
Learn how the adoption of an adaptive design strategy across the product development process brings a number of important benefits.
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Five key considerations for writing first-in-human protocols under EMA guidelines
As pharmaceuticals move from animal to first-in-human (FIH) clinical trials, establishing appropriate strategies to minimise risk in early phase clinical trials is necessary.
