Drug Development Support

  • Translation of discovery to proof of concept and first in man study
    • Prioritization and indication assessment for Phase II studies
  • Development strategy/conceptualization, hypothesis, milestones definition and evaluation, feasibility studies
  • Protocol development and adjustment:
    • Proposal of study population sample size, sample size optimization & variability estimations
  • Development strategy and support
    • Treatment difference estimation using in vitro data, in vivo correlation
    • Inhalation drug product developmen
    • Generic drug product development
  • Pharmacokinetic expertise and statistics, data mining, root cause analysis of unsuccessful developments
  • Cost effective solutions and risk analysi
    • CRO tendering and risk analysis
    • Evaluation of the development projects for investor in and out licensing including audits of the dossier