The four phases in the drug development pathway are:
- Early discovery and development
- Clinical testing and trials
- FDA review
- Post-market research & monitoring
The development process of a new medicine across all therapeutic areas can take anywhere between ~12-15 years. The complexity of drug development has increased in the past few decades, requiring a phase of preclinical development, investigational new drug (IND) application, and complete clinical testing before submission for marketing approval from major regulatory agencies (ie. FDA, EMEA).
In addition to the lengthy process, pharmaceutical companies face challenges in profitability and growth as the number of truly innovative new medicines that are approved by regulatory agencies continues to decrease. The average cost for these companies to bring a new medicine to market is estimated to be ~$1.8 billion, and is rising rapidly. With these exorbitant costs and fewer new medicines reaching the market, the impact on the health and well-being of millions of patients could ultimately be devastating as incidences of diseases continue to rise.
Improving the research and development (R&D) productivity of these drug discovery pipelines often requires streamlining the early discovery and development phase to result in fewer attrition rates of candidates that enter the phase of clinical testing and trials. Below, we dive into the early discovery and development phase and provide a list of our resources available that are associated with each stage involved in discovering therapeutic antibodies (Figure 1).