How To Streamline The Development Of Your Molecule From Candidate Selection To First-In-Human Clinical Testing

By Stephen Byard, Principal Research Fellow, Science & Technology, Candidate Development, Quotient Sciences

Small molecules (organic molecules with molecular weights of typically less than 900 Da) continue to dominate over biologics in new pharmaceutical product launches, comprising 33 of the 50 approvals by the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) in 2021. The continued high level of interest in small molecules presents multiple opportunities to select a candidate that is ‘developable’, with subsequent rapid progression toward first-in-human (FIH) clinical testing. However, there is a high level of attrition during the pharmaceutical research and development process, which is an indicator of the vast number of potential drug substances considered for progression. Therefore, it is vital to choose molecules for pharmaceutical development very carefully.

Given the plethora of new chemical entity (NCE) candidates, pharmaceutical research groups frequently face challenges when selecting the most promising candidate for development purposes. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?