Discovery and Development is the initial stage of drug development, where researchers identify and investigate potential drug targets. This stage involves several steps, including:
Target Identification: Researchers identify a specific biological target or pathway that is involved in a disease. This can be done through various methods, such as studying the genetic mutations that cause a disease, analyzing proteins and enzymes involved in a disease, or identifying natural compounds that have therapeutic potential.
Lead Identification: Once a target is identified, scientists use various techniques such as high-throughput screening, computational modeling and genetic engineering to identify potential drug candidates. High-throughput screening, for example, is a process of rapidly testing thousands of compounds in order to identify those that interact with a specific target.
Lead Optimization: After identifying a promising lead compound, scientists work to optimize its properties, such as its potency, selectivity, and pharmacokinetics. This step involves a variety of techniques, such as chemical synthesis, structure-activity relationship analysis, and computer modeling.
Preclinical Development: After lead optimization, the drug candidate is tested in laboratory and animal studies to determine its safety and effectiveness. This includes in vitro (test tube) studies and in vivo (animal) studies to evaluate the drug’s pharmacology and toxicology.
Investigational New Drug (IND) Application: After preclinical studies are completed, the drug’s sponsor submits an Investigational New Drug (IND) application to the regulatory agencies such as the FDA in the US. The IND application provides information about the drug’s development, preclinical studies, and proposed clinical trial plans.
Clinical Development: After the IND application is accepted, the drug candidate enters into clinical development and begins the process of testing in human volunteers and patients.
It’s important to note that this process can be highly iterative and involve multiple rounds of testing and optimization. Not all drug candidates will make it through this process and become approved drugs. The discovery and development stage is a critical and expensive step in the drug development process and is often the determining factor for the success of the entire process.