Developability Assessment

Prior to advancing a new drug candidate from research to development it is standard pharmaceutical industry practice to perform an assessment of candidate’s developability to highlight known and anticipated issues that may affect product development. Typically, data and analyses from drug safety, MPK, chemical development, analytical, and pharmaceutical functions are compiled into a single assessment document. In theory, this assessment process is an early opportunity to highlight and intercept weak drug candidates that could eventually contribute to the high attrition rates observed commonly in pharmaceutical development pipelines and provide recommendations or solutions to overcome any issues. In practice however, these internal risk assessments can include substantial disabling biases due to internal company politics and policies at the Discovery-Development interface stage.

A successful assessment of pharmaceutical developability includes generating the necessary biopharmaceutical and physico-chemical data, but also requires unbiased scientists with cross-functional knowledge and an overall perspective of the development process to understand the impact of these data on the future development of the compound. By partnering with PDDC, clients can achieve this unbiased assessment of their drug candidate’s viability in development, but also receive concrete recommendations and solutions to identified development issues. In the case of small drug discovery organizations (i.e. academic, biotech, government), PDDC can assist clients in acquiring and assembling the critical data required to successfully progress new drug candidates through the out-licensing phase with external development partners.