What is Bio/pharmaceutical R&D?

Bio/pharmaceutical R&D is the scientific exploration of disease mechanisms progressing to the discovery and development of agents which impact specific disease mechanisms and provide therapeutic benefit.  There is so much Research in Development, we tend to discuss R&D in terms of Discovery and Development, D&D. 1

Drug Discovery encompasses all scientific exploration leading up to the discovery of a clinical candidate.  The clinical candidate is a chemical or biopharmaceutical substance which can be produced in large quantity and has been shown to impact a specific disease mechanism in cellular and animal disease models, suggesting therapeutic benefit to patients.  More recently some companies have elected to consider Discovery as running up to Proof of Concept, e.g. the GSK Centers for Excellence in Drug Discovery which manage the pipeline from Lead Optimization to POC.  Here Development will begin with Preclinical Evaluation.

Drug Development encompasses all scientific exploration of a clinical candidate to prove its safety and efficacy in humans and its therapeutic benefit to patients.  Drug Discovery is considered to be less routine than Drug Development (but is it?)

  1. See “Drugs, from Discovery to Approval”, Rick Ng, Wiley-Blackwell, 2009.

     

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