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Future-proofing drug development with GenAI

Drug Target Review

Given macro healthcare influences (eg, economic uncertainty, environmental changes) and the numerous available treatments for major diseases, drug developers may need to reassess their therapeutic strategies. This has led drug developers to unintentionally limit their potential within chosen therapeutic spaces.

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FDA Eliminates Animal Testing: Impact on Biotechs

The Premier Consulting Blog

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. 7] This was a landmark change in philosophy.

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Time for change: non-human primates in drug research

Drug Target Review

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). Trends in Non-Human Primate Use for Research and Testing.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application. The draft guidance also describes pre-BLA meeting considerations, noting that FDA strongly recommends scheduling one.

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Streamlining the path from lab to market with 3D bioprinting

Drug Target Review

How do recent advancements in bioprinting technology promise to revolutionise the traditional drug development process, in terms of cost and timeline? By enabling a more direct assessment of drug interactions with human tissue, bioprinting can streamline the path from lab to market.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. over this period.

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

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