Case Studies

Candidate Nomination Case Studies

Oncology Program I

Efficacy ROA : I/P in mice

Administered drug I/P in 4 rats for preliminary tox, all rats died within 1 hour

THE NO QUESTION, YES ANSWER SUGGESTION – Tease out toxicitiy by formulation v/s API

Over next 3 months –

  • Team identified API is not toxic IP or IV in rats
  • Isolated a component of the formulation that was toxic
  • Identified another formulation iv, then changed it to po with 70% absorption
  • Compound entered Phase I (Canada) in fall 2014 as oral drug

Metabolic disorders program I

Potential best in class compound. Client shared mechanism of action of the drug

THE NO QUESTION, YES ANSWER SUGGESTION (based on competition analysis)

Front running compound has identified liver tox in Phase IIa

  • Team suggested conducting preliminary mass balance in screening mode
  • Identified one of the compounds that was excreted via kidney and liver (dividing the load)
  • Compound is in Phase II with no reported tox in animals or humans