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

Vishal Saxena1, Riccardo Panicucci, Yatindra Joshi

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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.

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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.