Three success factors to accelerate your program to clinical trial

Drug development can be expensive and risky. Less than one-tenth of candidates that leave discovery reach commercialization, and the cost of development to market may reach billions of dollars. At the same time, candidate molecules are extremely complex, the need for product differentiation is greater than ever, and developers more frequently have ambitions to take their program further along the path to market so that they can realize greater value when it is sold or licensed.

For these reasons, gaining a solid understanding of a molecule’s characteristics is vital to a program starting well.

Ask the right questions from the beginning

At the beginning of a program, when money and materials are often in short supply, it pays to collaborate with a partner whose team has deep experience in early phases of development. This experience ensures the right questions are being asked and answered from the start. Asking the right questions will help guide customers to early milestones, ensuring informed decisions can be made with minimal investment.

For example, despite the advent of in silico techniques and the now ubiquitous AI, a program that screens and selects the most promising preclinical candidates needs to be formulated in a way that is both practical and iterative. More small molecules exhibit sub-optimal physicochemical characteristics, and it should be considered early on how ongoing development will address issues such as poor solubility and bioavailability.

Attention to chemistry, manufacturing and controls (CMC) is also important at this stage. CMC activities include the establishment of manufacturing processes along with defining product testing methods to ensure that the product is safe, effective, and consistent.