Aptuit | IND Enbling | Late Lead Optimization

Late Lead Optimisation and Attrition Derisking

Integrated assessment of overall attrition risk

Aptuit proposes a tailored approach to reduce the risk of attrition through an integrated Drug Discovery and Development paradigm at the Late Lead Optimization stage.

Aptuit | Late Lead Optimisation and de-risking

Our expertise in several disciplines encompassing the entire flow of drug discovery and development has permitted us to build a flexible Late Lead Optimization program to reduce the risk of failure of your drug candidate at later stages during the regulatory development or to resolve key caveats during the developability stage. Our LLO program combines chemistry, pre-formulation, early and/or predictive tox, including translational approaches (biomarkers, efficacy models, allometric evaluations) to optimise the drug candidate selection based on the desired target product profile. Our unique expertise allows us to design a streamlined and successful Regulatory Development plan to bring candidate drugs rapidly and successfully to CTA/IND submission.

Aptuit’s offering is based on a team of highly skilled discovery scientists (medicinal chemistry, discovery pharmacology, discovery DMPK and analytical chemistry) and complemented by drug development experts in pharmaceutical development and safety assessment.

We design fast turn-around packages of studies and investigations tailored to the Target Product Profile of the drug candidates to assess their developability, combining, but not limited to,:
  • In vitro and in vivo ADME characterisation
  • In vitro and in vivo toxicity
  • Efficacy studies
  • Chemical synthesis (Drug Substance)
  • Early or pre-formulation