The drug development process, from drug discovery to the clinical proof of concept (PoC) is costly and high-risk. The high rewards of a successful development, both ethical and commercial, excites scientists, researchers, and investors . Starting from scientific endeavors, drug discovery is mainly driven by the pre-clinical pharmacology and toxicity as well as the fast entry into the clinical phase to establish the clinical PoC.
Once a pharmacological target is identified and lead chemical compounds emerge from the drug screening process, many activities around drug development take place in parallel, while at the same time depending on each other. Drug development is a multidisciplinary process by which data are generated in various scientific fields: the chemical synthesis of the drug candidate, its characterization, purity, stability, formulation into a finished drug product, the drug product performance, and biopharmaceutics in animal models. These data represent the critical learning curve for a drug and are essential for entry into clinical trials, risk mitigation, and ultimately, development into a marketable product. The systematic processing and documentation of these Chemistry Manufacturing and Control (CMC) data pose a major challenge, especially in expedited drug development and approval procedures, and for smaller companies.
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