All Legal & Compliance articles – Page 2
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ArticleOvercoming barriers to oncology combination therapies in the UK and EU
Colleagues at IQVIA discuss ways to expedite positive HTA outcomes for innovative combination therapies, alleviating the bottlenecks inherent in the current system.
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NewsRare disease drugs get boost from new NICE guidelines
NICE has raised the cost-effectiveness thresholds for ultra-rare disease drugs under its Highly Specialised Technology programme – a move welcomed by patient advocates and biotech leaders.
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ArticleBetter assays: the key step in moving drugs from lab to clinic
From gene therapy to Long Covid, better assays are helping researchers move promising drug candidates from early studies into clinical trials. Dr Alexandre Lucas explains the technologies, challenges and innovations driving this progress.
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NewsEurofins Assurance gains ISO/IEC 17065:2012 GMP accreditation
The Eurofins Assurance network has secured ISO/IEC 17065:2012 accreditation from ANAB for its Good Manufacturing Practices (GMP) certification programme.
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ArticleMaking sense of AI: bias, trust and transparency in pharma R&D
AI is increasingly used in drug discovery, but hidden bias and ‘black box’ models threaten trust and transparency. This article explores how explainable AI can turn opaque predictions into clear, accountable insights.
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ArticleLab of the future: four technologies to watch
From precision proteomics to AI-powered immune profiling, next-generation laboratory technologies are changing how new therapies are discovered and developed. Here are four innovations set to shape the lab of the future - and the future of drug discovery.
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ArticleAnimal-free drug discovery is closer with QSP
Quantitative Systems Pharmacology (QSP) is fast becoming a standard tool in drug development, offering a human-relevant way to predict drug effects before the clinic. Dr Josh Apgar of Certara explains how it is helping to cut reliance on animal testing and speed discovery.
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ArticleBeyond the hype: a veteran’s honest assessment of AI in drug discovery – Part 3
AI is starting to transform drug discovery, but progress is still slow and big challenges remain. Thibault Géoui explores the gaps, hurdles and breakthroughs needed before it can truly change pharma R&D.
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NewsChikungunya’s 2025 surge sparks urgent research response
The 2025 chikungunya outbreak has surged from the Indian Ocean to Europe, prompting an urgent global research response. With no antivirals and limited vaccine access, laboratories and biotech firms are under pressure to deliver solutions fast.
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ArticleWhat if drug discovery took months, not decades?
Drug discovery is slow, costly and often unsuccessful. DTR hears how GATC Health is applying AI and multiomics to make the process faster, more precise and less reliant on trial and error.
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ArticleChallenges in developing robust potency assays for ADCs
Developing robust potency assays for Antibody-Drug Conjugates (ADCs) is crucial for ensuring their clinical success, but designing assays that meet both technical and regulatory standards is challenging. Here, Abzena’s CSO Campbell Bunce explores the complexities of assay development and the importance of ensuring accuracy, consistency and regulatory alignment for ADCs ...
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NewsAI-driven Alzheimer’s therapies show promise in early studies
Porosome Therapeutics has announced new advancements in Alzheimer’s treatment – presenting therapies that restore neuronal function, reduce Tau protein levels and reverse disease pathology in human brain organoids.
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ArticleManaging CGT trials: the role of IRT from discovery to clinical development
Discover how interactive response technology (IRT) is revolutionising the management of cell and gene therapy (CGT) trials by streamlining complex workflows, ensuring regulatory compliance and enhancing patient outcomes.
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ArticleWhy smarter financial planning could be key to clinical trial success
Effective financial management is vital for clinical trial success, yet many preclinical and clinical companies face inefficiencies due to outdated systems. Jennifer Kyle, CEO of Condor Software, explains how advanced financial platforms can streamline processes, improve forecasting and ensure better resource allocation throughout drug development.
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ArticlePlasmids: Tackling Supply Chain and Manufacturing Challenges
Gene therapy’s progress depends on reliable supply chains and efficient manufacturing. In this episode, we explore the challenges and strategies involved in plasmid production - an essential component in advancing life-changing therapies.
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NewsNew weekly injection could transform Parkinson’s disease treatment
A new weekly injection developed by University of South Australia scientists could change Parkinson’s treatment by replacing the need for multiple daily pills – potentially helping millions of patients worldwide.
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ArticleThe future of CNS drug development: signs of real progress
New therapeutic approaches are emerging for CNS disorders – but can they overcome the toughest barriers in drug development? Find out what is driving progress and what still stands in the way.
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ArticleTime for change: non-human primates in drug research
As ethical pressures and new regulations shake up preclinical research, the industry faces a turning point: can we finally move beyond non-human primates? Dr Mariana Argenziano, Associate Director Manufacturing Technologies at Ncardia, discusses the innovations reshaping drug development and what’s coming next.
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ArticleFuture-proofing drug development with GenAI
Using GenAI and expert reasoning, drug developers can now explore an asset’s long-term potential as early as the preclinical stage. This shift is helping to reshape pipeline planning and refine therapeutic strategy.
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ArticleThe AI model that is changing clinical trial design
AI is changing how clinical trials are run - quietly but significantly. Find out how digital twins are helping sponsors reduce control arms and accelerate development without changing trial endpoints.
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