Developability Assessment and Drug Development Philosophy

Successful drug discovery and development programs critically evaluate discovery leads to ensure they are developable (have the desired attributes without major demerits) and then design and conduct nonclinical and clinical development studies to more fully characterize a selected drug candidate.  These efforts determine early whether or not a drug candidate has the potential of becoming a therapeutic agent, thus allowing companies to devote their resources on compounds or compound classes most likely to be winners.

A successful developability assessment (or logically defined discovery lead optimization) program critically evaluates discovery leads to ensure they have the necessary attributes, without substantial or major demerits, to become drug candidates.  Depending on the disease indication and other parameters, attributes (in addition to pharmacological activity) may include acceptable drug delivery and bioavailability, limited metabolism to non-active metabolites, sufficient solubility and stability for administration, a pharmacokinetic profile that allows a pharmacologically active compound to reach the site of action, and toxic effects only at doses substantially above those required for pharmacological activity.

Drug development studies are designed to more fully characterize the biological activity, toxicology and safety, and metabolism and disposition profiles of drug candidates.  These studies are conducted in compliance with GLP Regulations and ICH guidelines.  When appropriately designed and conducted, these preclinical research studies determine if a drug candidate has the potential to become a successful clinical candidate and then a therapeutic product, thus allowing companies to devote precious and limited clinical research resources on those drug candidates most likely to be winners.