The Challenge:
TherapeutAix was approached by a small biotech company that operated in a fully virtual setting. To progress assets on a novel drug delivery platform technology, the biotech asked for help in defining the required steps to take the lead asset to IND-enabling studies and in the clinic.
The Action:
A thorough literature review was requested to support clinical positioning options, from which a preclinical program was to be derived. This program was to be put into perspective considering the status of the asset and the available data.
Based on the literature review and strategic considerations, we developed an indication shortlist and identified a core dataset that would be required to further narrow down the targeted indications. The TherapeutAix team reviewed the existing data and quickly identified gaps in the bioanalytical and DMPK package, which prevented a meaningful interpretation of the pharmacology data. We outlined new PK experiments as well as orienting and decision-making pharmacology data, including connecting to a high-quality provider to deliver these data.
The Result:
As a result of these activities, the program increased internal traction at the biotech who began hiring internal staff to which the project was transferred.