Challenge:

A biotech developing a novel drug for NASH asked Alacrita to create a project plan outlining costs and timelines for preclinical IND-enabling studies.

Solution:

We recommended the best animal models, such as DIAMOND and STAM, of NASH for evaluating the activity of the novel drug. We also identified the most suitable IND-enabling studies for this indication, specifically focusing on preclinical studies in module 2 of the IND which includes pharmacology (in vitro and in vivo pharmacodynamic test), ADME, toxicology, and pharmacokinetics. We also estimated the time and the cost for these preclinical studies.