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Developability assessment in pharmaceutical industry: An integrated group approach for selecting developable
Vishal Saxena1, Riccardo Panicucci, Yatindra Joshi
1Technical Research and Development, Novartis Institutes for Biomedical Research, Inc., 250 Massachusetts Avenue, Cambridge, Massachusetts 02139, USA.
Journal of Pharmaceutical Sciences
|October 16, 2008
Summary
The Developability Assessment Group (DAG) aids pharmaceutical R&D by screening and assessing new molecular entities (NMEs). Early collaboration with DAG reduces late-stage attrition, costs, and timelines for drug candidates.
Area of Science:
- Pharmaceutical Research and Development
- Drug Discovery and Development
- Medicinal Chemistry
Background:
- The Developability Assessment Group (DAG) is a critical subgroup in pharmaceutical Research and Development (R&D).
- DAG supports scientists in screening, assessing, and selecting New Molecular Entities (NMEs) for clinical studies.
- Effective collaboration between discovery teams and DAG is vital for successful drug development.
Purpose of the Study:
- To describe the role and responsibilities of the DAG in pharmaceutical R&D.
- To highlight the importance of DAG's investigations in NME selection and developability assessment.
- To discuss the impact of advanced tools, technologies, and data utilization in the decision-making process.
Main Methods:
- Physicochemical and biopharmaceutical characterization of NMEs.
- Development of formulations for pharmacokinetic, efficacy, and toxicity studies.
- Selection of optimal physical forms (salts, polymorphs) and formulation development for early clinical phases.
Main Results:
- DAG activities streamline efficacy-toxicology evaluations.
- Developability screens are established to identify promising drug candidates.
- Reduced NME attrition rates in late-stage development are achieved through DAG's support.
Conclusions:
- Strong collaboration between discovery and DAG is essential for selecting viable NMEs.
- DAG's comprehensive assessments decrease drug development costs and timelines.
- DAG's work ensures that pharmacologically effective, safe, and developable candidates progress to market.
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