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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). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

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Altasciences Completes Expansion of New State-Of-The-Art Laboratory in Columbia, Missouri

Alta Sciences

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies , including formulation, manufacturing, and analytical services.

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. FDORA § 3209(a)(2).

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Assays for the Future of Drug Discovery

PerkinElmer

Successful researchers and companies master and use different technologies, making sure the interpretation of data does not suffer experimental or analytical bias and leads to better success rates and higher profitability for drug developers. By assessing residence time, failure further down the drug discovery workflow can be avoided.

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Accelerating Drug Discovery Through Repurposing

DrugBank

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. Key techniques include high-throughput screening (HTS), cell-based assays, and animal models.

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AI At The Frontier: Empowering Early Career Professionals In Drug Discovery

Elrig

Co-Chair: Millie Fox Co-Chair: Millie Fox Senior Drug Discovery Scientist, AstraZeneca Millie graduated from the University of Sussex with a Biochemistry degree in 2016, which included an industrial placement year at GSK, Stevenage.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”