How Are New Drugs Developed? Discovery to Approval
How new drugs are developed: target discovery, preclinical testing, clinical trials, regulatory review by FDA and EMA, manufacturing, and post-approval monitoring.
Drug discovery is the search for a molecule worth developing: identifying a biological target implicated in disease, screening for compounds that act on it, and refining an initial hit into a candidate with acceptable potency, selectivity and drug-like behaviour. For biological products the equivalent work is design and engineering rather than chemistry.
We follow discovery because it sets the terms for everything downstream, and because it is the stage where announcements are most frequent and least conclusive. A validated target is a beginning, not a treatment.
How new drugs are developed: target discovery, preclinical testing, clinical trials, regulatory review by FDA and EMA, manufacturing, and post-approval monitoring.
The drug development process from laboratory research to patients: translational research, decision gates, who does what, and how a medicine reaches clinical use.
How biotechnology companies develop new treatments: biologics, monoclonal antibodies, mRNA, cell and gene therapy, manufacturing, funding, and regulation.