Developability assessment in pharmaceutical industry: An integrated group approach for selecting developable candidates

This article describes the role and responsibilities of the Developability Assessment Group (DAG), a pharmaceutical Research and Development (R&D) subgroup, which supports drug discovery and development scientists with screening, developability assessment, and selection of new molecular entities (NMEs) for clinical studies. A strong collaboration between discovery group and DAG is essential for selecting the right NMEs for late-stage development, and consequently decreasing the NME attrition rate in late-stage development as well as in bringing down the associated cost and timelines. The investigations performed by DAG for evaluating research leads as well as the significance of these investigations in the developability assessment, the value of cutting edge tools and technologies, and the usefulness of the data in the decision making process are discussed in this review. Developability assessment of NMEs often includes physicochemical and biopharmaceutical characterization, development of suitable formulations for pharmacokinetic (PK), efficacy, and toxicity studies, selection of suitable physical form (salt, polymorph, etc.), and formulation development for phase I clinical studies. Overall DAG activities not only contribute to streamlining efficacy–toxicology evaluation, but also in building developability screens, which allow pharmacologically effective, minimally toxic, and developable candidates to reach the clinic and eventually to the market. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1962–1979, 2009 This article describes the role and responsibilities of the Developability Assessment Group (DAG), a pharmaceutical Research and Development (R&D) subgroup, which supports drug discovery and development scientists with screening, developability assessment, and selection of new molecular entities (NMEs) for clinical studies. A strong collaboration between discovery group and DAG is essential for selecting the right NMEs for late-stage development, and consequently decreasing the NME attrition rate in late-stage development as well as in bringing down the associated cost and timelines. The investigations performed by DAG for evaluating research leads as well as the significance of these investigations in the developability assessment, the value of cutting edge tools and technologies, and the usefulness of the data in the decision making process are discussed in this review. Developability assessment of NMEs often includes physicochemical and biopharmaceutical characterization, development of suitable formulations for pharmacokinetic (PK), efficacy, and toxicity studies, selection of suitable physical form (salt, polymorph, etc.), and formulation development for phase I clinical studies. Overall DAG activities not only contribute to streamlining efficacy–toxicology evaluation, but also in building developability screens, which allow pharmacologically effective, minimally toxic, and developable candidates to reach the clinic and eventually to the market. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1962–1979, 2009