Leachable risk management continues to be of regulatory interest. However, we continue to rely on experimental extractable studies as predictors of leachable risk. These are complex to design and implement and do not always offer the answer to what is the leachable risk for a drug product or medical device.
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ICON
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disorder affecting some 40,000 individuals in Europe at any time, causing 10,000 deaths each year. As with other age-related neurodegenerative diseases, the drug development field is littered with inconclusive or negative trials. Modifying Immune Response and Outcomes in ALS (MIROCALS) is an international European Union H2020-funded trial of low-dose interleukin-2 in motor neuron disease (MND)/ALS. It aims to break this impasse in the development of disease-modifying agents through novel trial design, incident (early post-diagnosis) recruitment, integration of biomarkers/transcriptomics and cohort stratification. Join this webinar to hear about an overview of the study in addition to a discussion of the challenges both anticipated and unanticipated in recruiting participants recently diagnosed with a rare, rapidly disabling and ultimately life-limiting condition.
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In the realm of DNA sequencing, technology developers contribute to advancement in important ways, by building increasingly fast-moving tools that untangle the intricacies of the human genome, and by constructing analytics platforms to wade through the resulting mountains of genetic data.
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Discovering new “drug-like” and synthetically viable compounds via artificial intelligence (AI) is of great interest to medicinal chemists.
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