The Discovery Phase begins when a disease or condition has an unmet need. It includes several steps, such as identifying which compound or therapy has the greatest chance of success, assessing its safety, and building a solid scientific foundation for its development.
The completion of these steps leads to target identification—a broad term that applies to a range of biological entities and their efficacy, safety, clinical and commercial viability.
Once identified, the target needs to be fully validated using in-vitro and in-vivo testing techniques. The results of these tests determine the best candidate for further evaluation.
Before pre-clinical safety testing can begin, a regulatory and development strategy is defined by key product goals such as net value estimation and market access.
Notoriously complex and regulatory-driven the Discovery to Pre-Clinical Phase often seems overwhelming. And while regulatory approval is critical to getting a drug to market, it does not guarantee market access.
Other non-medical tasks such as defining intellectual property rights and generating enough medicinal product for clinical trials must also be dealt with.